Evidence Report/Technology Assessment 

Number 135 

Management of Eating Disorders 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-02-0016 

Prepared by: 

RTI-UNC Evidence-Based Practice Center, Research Triangle Park, NC 

Investigators 

Nancy D. Berkman, Ph.D. 

Cynthia M. Bulik, Ph.D. 

Kimberly A. Brownley, Ph.D. 

Kathleen N. Lohr, Ph.D. 

Jan A. Sedway, Ph.D. 

Adrienne Rooks, B.A. 

Gerald Gartlehner, M.D. 

AHRQ Publication No. 06-E010 

April 2006
This report is based on research conducted by the RTI International–University of North Carolina 

at Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPC) under contract to the Agency for 

Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0016). The 

findings and conclusions in this document are those of the author(s), who are responsible for its 

content, and do not necessarily represent the views of AHRQ. No statement in this report should 

be construed as an official position of AHRQ or of the U.S. Department of Health and Human 

Services. 

The information in this report is intended to help clinicians, employers, policymakers, and others 

make informed decisions about the provision of health care services. This report is intended as a 

reference and not as a substitute for clinical judgment. 

This report may be used, in whole or in part, as the basis for the development of clinical practice 

guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 
ii

This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Berkman ND, Bulik CM, Brownley KA, Lohr KN, Sedway JA, Rooks A, Gartlehner G. 

Management of Eating Disorders. Evidence Report/Technology Assessment No. 135. (Prepared 

by the RTI International-University of North Carolina Evidence-Based Practice Center under 

Contract No. 290-02-0016.) AHRQ Publication No. 06-E010. Rockville, MD: Agency for 

Healthcare Research and Quality. April 2006. 
iii

Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The report topic was nominated by the American 

Psychiatric Association (APA) and the Laureate Psychiatric Clinic and Hospital. Funding for this 

report was provided by the Office of Research on Women’s Health at the National Institutes of 

Health (NIH) and the Health Resources and Services Administration. The reports and 

assessments provide organizations with comprehensive, science-based information on common, 

costly medical conditions and new health care technologies. The EPCs systematically review the 

relevant scientific literature on topics assigned to them by AHRQ and conduct additional 

analyses when appropriate prior to developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by e-mail to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. 

Director 

Agency for Healthcare Research and Quality 

Vivian W. Pinn, M.D. 

Director 

Office of Research on Women’s Health 

National Institutes of Health 

Sabrina A. Matoff-Stepp, M.A. 

Director 

Office of Women’s Health 

Health Resources and Services Administration 

Jean Slutsky, P.A., M.S.P.H. 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Beth A. Collins Sharp, R.N., Ph.D. 

Acting Director, EPC Program 

Agency for Healthcare Research and Quality 

Marian James, Ph.D. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality
v

Structured Abstract 

Objectives. The RTI International—University of North Carolina at Chapel Hill Evidence-based 

Practice Center (RTI-UNC EPC) systematically reviewed evidence on efficacy of treatment for 

anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED), harms 

associated with treatments, factors associated with the treatment efficacy and with outcomes of 

these conditions, and whether treatment and outcomes for these conditions differ by 

sociodemographic characteristics. 

Data Sources. We searched MEDLINE®, the Cumulative Index to Nursing and Applied Health 

(CINAHL), PSYCHINFO, the Educational Resources Information Center (ERIC), the National 

Agricultural Library (AGRICOLA), and Cochrane Collaboration libraries. 

Review Methods. We reviewed each study against a priori inclusion/exclusion criteria. For 

included articles, a primary reviewer abstracted data directly into evidence tables; a second 

senior reviewer confirmed accuracy. We included studies published from 1980 to September, 

2005, in all languages. Studies had to involve populations diagnosed primarily with AN, BN, or 

BED and report on eating, psychiatric or psychological, or biomarker outcomes. 

Results. We report on 30 treatment studies for AN, 47 for BN, 25 for BED, and 34 outcome 

studies for AN, 13 for BN, 7 addressing both AN and BN, and 3 for BED. 

The AN literature on medications was sparse and inconclusive. Some forms of family 

therapy are efficacious in treating adolescents. Cognitive behavioral therapy (CBT) may reduce 

relapse risk for adults after weight restoration. 

For BN, fluoxetine (60 mg/day) reduces core bulimic symptoms (binge eating and purging) 

and associated psychological features in the short term. Individual or group CBT decreases core 

behavioral symptoms and psychological features in both the short and long term. How best to 

treat individuals who do not respond to CBT or fluoxetine remains unknown. 

In BED, individual or group CBT reduces binge eating and improves abstinence rates for up 

to 4 months after treatment; however, CBT is not associated with weight loss. Medications may 

play a role in treating BED patients. Further research addressing how best to achieve both 

abstinence from binge eating and weight loss in overweight patients is needed. 

Higher levels of depression and compulsivity were associated with poorer outcomes in AN; 

higher mortality was associated with concurrent alcohol and substance use disorders. Only 

depression was consistently associated with poorer outcomes in BN; BN was not associated with 

an increased risk of death. Because of sparse data, we could reach no conclusions concerning 

BED outcomes. 

No or only weak evidence addresses treatment or outcomes difference for these disorders. 

Conclusions. The literature regarding treatment efficacy and outcomes for AN, BN, and BED is 

of highly variable quality. In future studies, researchers must attend to issues of statistical power, 

research design, standardized outcome measures, and sophistication and appropriateness of 

statistical methodology. 
vii

Contents

Executive Summary...........................................................................................................................1 

Evidence Report...............................................................................................................................9

Chapter 1. Introduction .....................................................................................................................9 

 Scope of the Problem...................................................................................................................9 

 Anorexia Nervosa ........................................................................................................................9 

 Clinical Characteristics ..........................................................................................................9 

 Diagnostic Criteria.................................................................................................................9 

 Epidemiology.........................................................................................................................9 

 Etiology..................................................................................................................................11 

 Course of Illness ....................................................................................................................12 

 Treatment ...............................................................................................................................12 

 Bulimia Nervosa ..........................................................................................................................13 

 Clinical Characteristics ..........................................................................................................13 

 Diagnostic Criteria.................................................................................................................13 

 Epidemiology.........................................................................................................................15 

 Etiology..................................................................................................................................15 

 Course of Illness ....................................................................................................................16 

 Treatment ...............................................................................................................................16 

 Eating Disorders Not Otherwise Specified (Binge Eating Disorder) .........................................16 

 Clinical Characteristics ..........................................................................................................16 

 Diagnostic Criteria.................................................................................................................17 

 Epidemiology.........................................................................................................................18 

 Etiology..................................................................................................................................18 

 Course of Illness ....................................................................................................................18 

 Treatment ...............................................................................................................................18 

 Production of This Evidence Report............................................................................................18 

 Organization...........................................................................................................................18 

 Technical Expert Panel ..........................................................................................................19 

 Uses of This Report ...............................................................................................................19 

Chapter 2. Methods...........................................................................................................................21 

 Key Questions and Analytic Framework.....................................................................................21 

 Key Questions........................................................................................................................21 

 Literature Review Methods..........................................................................................................22 

 Inclusion and Exclusion Criteria............................................................................................22 

 Literature Search and Retrieval Process ................................................................................24 

 Literature Synthesis .....................................................................................................................26 

 Development of Evidence Tables and Data Abstraction Process..........................................26 

 Quality and Strength of Evidence Evaluation........................................................................27 

 Peer Review Process....................................................................................................................29 
viii

Chapter 3. Results: Anorexia Nervosa..............................................................................................37 

 Overview of Included Studies......................................................................................................37 

 Participants.............................................................................................................................40 

Key Question 1: Treatment Efficacy .................................................................................................42 

 Medication Trials...................................................................................................................46 

 Behavioral Intervention Trials (for Anorexia Nervosa).........................................................46 

 Key Question 2: Harms of Treatments for Anorexia Nervosa ....................................................52 

 Key Question 3: Factors Associated With Treatment Efficacy...................................................53 

 Key Question 4: Treatment Efficacy by Subgroups ....................................................................54 

Chapter 4. Results: Bulimia Nervosa................................................................................................57 

 Overview of Included Studies......................................................................................................57 

 Participants.............................................................................................................................59 

 Key Question 1: Treatment Efficacy ...........................................................................................60 

 Medication-only trials............................................................................................................60 

 Medication Plus Behavioral Intervention Trials....................................................................70 

 Behavioral Intervention Trials (for Bulimia Nervosa)...........................................................74 

 Key Question 2: Harms of Treatment for Bulimia Nervosa........................................................84 

 Key Question 3: Factors Associated With Treatment Efficacy...................................................84 

 Medication Trials...................................................................................................................84 

 Behavioral Intervention Trials ...............................................................................................87 

 Self-help Trials.......................................................................................................................87 

 Other Interventions ................................................................................................................87 

 Key Question 4: Treatment Efficacy by Subgroups ....................................................................87 

Chapter 5. Results: Binge Eating Disorder.......................................................................................89 

 Overview of Included Studies......................................................................................................89 

 Participants.............................................................................................................................91 

 Key Question 1: Treatment Efficacy ...........................................................................................92 

 Medication-only trials............................................................................................................92 

 Medication Plus Behavioral Intervention Trials....................................................................98 

 Behavioral Interventions Trials..............................................................................................100 

 Key Question 2: Harms of Treatment for Binge Eating Disorder ...............................................106 

 Key Question 3: Factors Associated With Treatment Efficacy...................................................106 

 Key Question 4: Treatment Efficacy Subgroups .........................................................................106 

Chapter 6. Outcomes of Eating Disorders ........................................................................................109 

 Anorexia Nervosa ........................................................................................................................112 

 Key Question 5: Factors associated with outcomes...............................................................112 

 Key Question 6: Outcome Difference by Sex, Gender, Age, Race, Ethnicity, or 

 Cultural Group .................................................................................................................125 

 Bulimia Nervosa ..........................................................................................................................126 

 Key Question 5: Factors Asociated with Outcomes ....................................................................126 

 Key Question 6: Outcome Difference by Sex, Gender, Age, Race, Ethnicity or 

 Cultural Group .................................................................................................................132 

 
ix

 Binge Eating Disorder..................................................................................................................133 

 Key Question 5: Factors Associated with Outcomes.............................................................133 

 Key Question 6: Outcome Difference by Sex, Gender, Age, Race, Ethnicity or 

 Cultural Group .................................................................................................................134 

Chapter 7. Discussion .......................................................................................................................135 

 Critical Findings and Implications for Treatment of Eating Disorders ......................................135 

 Quality of Literature and Strength of Evidence.....................................................................135 

 Managing Patients with Medication Alone............................................................................138 

 Managing Patients with Behavioral Interventions Alone ......................................................138 

 Managing Patients with Combination Interventions..............................................................139 

 Managing Patients with Novel Interventions.........................................................................139 

 Reducing Mortality ................................................................................................................139 

 Methods and Other Deficiencies in Reviewed Studies and Recommendations to Overcome 

 Them ......................................................................................................................................139 

 Sample Sizes, Attrition, and Statistical Power.......................................................................139 

 Study Design and Statistical Analysis Issues.........................................................................140 

 Reporting Issues.....................................................................................................................141 

 Future Research Needs ................................................................................................................142 

 Gaps in the Literature for Interventions.................................................................................142 

 Gaps in the Literature for Certain Types of Patients .............................................................144 

 Gaps in the Overall Evidence Base........................................................................................146 

 Issues in Outcomes Research.................................................................................................147 

 Conclusions..................................................................................................................................149 

References and Included Studies .......................................................................................................151 

Figures 

Figure 1. Analytic framework............................................................................................................ 22 

Figure 2. Eating disorders article disposition .................................................................................... 25 

Tables 

Table 1. Diagnostic criteria: anorexia nervosa .................................................................................. 10 

Table 2. Diagnostic criteria: bulimia nervosa.................................................................................... 14 

Table 3. Diagnostic criteria: binge eating disorders .......................................................................... 17 

Table 4. Eating disorders literature searches: inclusion and exclusion criteria .................................23 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and 

 outcome studies............................................................................................................................. 30 

Table 6. Reasons for poor quality ratings and number of trials with poor ratings: anorexia 

 nervosa .......................................................................................................................................... 38 

Table 7. Dropout rates for randomized controlled trials: anorexia nervosa ......................................41 

Table 8. Results from medication trials: anorexia nervosa................................................................43 

Table 9. Results from behavioral intervention trials in adults: anorexia nervosa.............................. 47 
x

Table 10. Results from behavioral intervention trials in adolescents only and adolescents 

 and adults combined: anorexia nervosa ........................................................................................ 49 

Table 11. Adverse events reported: anorexia nervosa ....................................................................... 53 

Table 12. Reasons for poor quality ratings and number of trials with poor ratings: bulimia 

 nervosa trials ................................................................................................................................. 58 

Table 13. Dropout rates for randomized controlled trials: bulimia nervosa...................................... 60 

Table 14. Results from medication trials: bulimia nervosa ............................................................... 64 

Table 15. Results from medication plus behavioral intervention trials: bulimia nervosa ................. 71 

Table 16. Result from behavioral intervention trials: bulimia nervosa ............................................. 75 

Table 17. Results of self-help trials, no medication: bulimia nervosa............................................... 81 

Table 18. Results of other trials: bulimia nervosa ............................................................................. 83 

Table 19. Adverse events reported: bulimia nervosa trials................................................................ 85 

Table 20. Reasons for poor quality ratings and number of trials with poor ratings 

 binge eating disorder .................................................................................................................... 90 

Table 21. Dropout rates for randomized controlled trials: binge eating disorder..............................93 

Table 22. Results from medication trials: binge eating disorder ....................................................... 95 

Table 23. Results from medication plus behavioral intervention trials: binge eating disorder ......... 99 

Table 24. Results from behavioral intervention trials, no medication: binge eating disorder........... 101 

Table 25. Results from self-help trials, no medication: binge eating disorder .................................. 103 

Table 26. Results from other trials: binge eating disorder................................................................. 104

Table 27. Adverse events reported: binge eating disorder................................................................. 107 

Table 28. Outcome studies: reasons for poor quality ratings and number of poor ratings 

 by disease type .............................................................................................................................. 110 

Table 29. Eating-related outcomes: anorexia nervosa ....................................................................... 113 

Table 30. Psychological outcomes: anorexia nervosa ...................................................................... 119 

Table 31. Biomarker outcomes: anorexia nervosa ............................................................................ 121

Table 32. Mortality outcomes: anorexia nervosa ..............................................................................122 

Table 33. Eating-related outcomes: bulimia nervosa......................................................................... 127

Table 34. Psychological outcomes: bulimia nervosa ........................................................................ 130 

Table 35. Biomarker outcomes: bulimia nervosa ............................................................................. 131

Table 36. Mortality outcomes: bulimia nervosa ............................................................................... 132 

Table 37. Strength of evidence concerning four treatment key questions......................................... 136 

Table 38. Strength of evidence concerning two outcomes key questions ......................................... 137 

Appendixes 

Appendix A: Exact Search Strings 

Appendix B: Sample Data Collection Forms 

Appendix C: Evidence Tables 

Appendix D: List of Excluded Articles 

Appendix E: Acknowledgments 

Appendixes and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
xi
1 

Executive Summary 

Introduction 

The RTI International–University of North Carolina at Chapel Hill Evidence-based Practice 

Center (RTI-UNC EPC) conducted a systematic review of the literature on key questions 

concerning anorexia nervosa (AN), bulimia nervosa (BN), and eating disorders not otherwise 

specified (EDNOS) (focusing on binge eating disorder [BED]) to address questions posed by the 

American Psychiatric Association and Laureate Psychiatric Hospital through the Agency for 

Healthcare Research and Quality (AHRQ). Funding was provided by AHRQ, the Office of 

Research on Women’s Health at the National Institutes of Health, and the Health Resources and 

Services Administration. We received guidance and input from a Technical Expert Panel (TEP). 

We systematically reviewed the evidence on two categories of issues—treatment and 

outcomes for AN, BN, and BED—in six key questions (KQs): (1) efficacy of treatment, (2) 

harms associated with treatment, (3) factors associated with the efficacy of treatment, (4) 

whether efficacy of treatment differs by sex, gender, age, race, ethnicity, or cultural group, (5) 

factors associated with outcomes, and (6) whether outcomes differ by sex, gender, age, race, 

ethnicity, or cultural group. 

AN is marked by low body weight, fear of weight gain, disturbance in the way in which 

one’s body size is perceived, denial of illness, or undue influence of weight on self-evaluation. 

Although amenorrhea is a diagnostic criterion, it is of questionable relevance. 

BN is characterized by recurrent episodes of binge eating in combination with some form of 

compensatory behavior. Binge eating is the consumption of an uncharacteristically large amount 

of food by social comparison coupled with a feeling of being out of control. Compensatory 

behaviors include self-induced vomiting; misuse of laxatives, diuretics, or other agents; fasting; 

and excessive exercise. 

BED is marked by binge eating in the absence of compensatory behaviors, a series of 

associated features of binge eating, and marked distress regarding binge eating. Overweight and 

obesity are commonly seen in individuals with BED. 

Although rigorous epidemiologic data are lacking in the United States, the mean prevalence 

of AN is 0.3 percent, of subthreshold AN 0.37 percent to 1.3 percent, of BN 1.0 percent, and of 

BED 0.7 percent to 3.0 percent. Mortality from AN is about 5 percent per decade of followup. 

Treatment for severe AN can involve inpatient or partial hospitalization in costly specialized 

settings. Inadequate insurance coverage often truncates the recommended duration of treatment. 

Treatment costs for AN are higher than those for obsessive-compulsive disorder and comparable 

to those for schizophrenia. In contrast, treatment for BN in the United States is typically on an 

outpatient basis. 

Methods 

We searched MEDLINE®, the Cumulative Index to Nursing and Applied Health (CINAHL), 

PSYCHINFO, the Educational Resources Information Center (ERIC), the National Agricultural 

Library (AGRICOLA), and Cochrane Collaboration libraries. Based on key questions and 

discussion with our TEP, we generated a list of article inclusion and exclusion criteria. We 

reviewed studies of humans, ages 10 years and older, of both sexes, published in all languages 

and from all nations, from 1980 to September 2005. Studies had to include populations 

diagnosed primarily with AN, BN, or BED and to report on at least one of our outcomes 
2 

categories of interest: eating-related behaviors, psychiatric and psychological outcomes, and 

biomarker measures. We reviewed each abstract and article systematically against a priori 

criteria to determine whether to include it in the review. One reviewer initially evaluated 

abstracts for inclusion or exclusion. If that reviewer concluded that the article should be included 

in the review, it was retained. Articles that the reviewer determined did not meet our criteria 

were re-reviewed by a senior reviewer who could include the article if she disagreed with the 

initial determination. We assigned each excluded article a reason for exclusion. 

The RTI-UNC EPC team abstracted data from included articles directly into evidence tables. 

For both the treatment and the outcomes literatures, a primary reviewer abstracted data directly 

into evidence tables; a second (senior) reviewer confirmed accuracy, completeness, and 

consistency. The two staff reconciled all disagreements about information in evidence tables. 

Each abstractor independently evaluated study quality. Because of differences in the 

treatment and outcomes literature, we evaluated the two bodies of literature using separate 

criteria. For the treatment literature, our evaluation used 25 items in 11 categories: (1) research 

aim/study question, (2) study population, (3) randomization, (4) blinding, (5) interventions, (6) 

outcomes, (7) statistical analysis, (8) results, (9) discussion, (10) external validity, and (11) 

funding/sponsorship. For the outcomes literature, we evaluated the evidence against 17 items in 

8 categories: (1) research aim/study question, (2) study population, (3) eating disorder diagnosis 

method, (4) study design, (5) statistical analysis, (6) results/outcome measurement, (7) external 

validity, and (8) discussion. 

We focused our analysis on studies that received fair or good quality ratings. This included 

19 studies discussed in 22 articles concerning treatment for AN: 38 studies discussed in 48 

articles concerning treatment for BN: 20 studies discussed in 21 articles concerning treatment for 

BED: 26 studies discussed in 32 articles concerning outcomes for AN: 9 studies discussed in 13 

articles concerning outcomes for BN: 7 studies discussed in 7 articles concerning outcomes for 

both AN and BN: and 3 studies discussed in 3 articles concerning outcomes for BED. 

Results 

Treatment Studies 

Anorexia Nervosa. We divided the treatment literature into medication-only (generally in 

the context of clinical management or hospitalization), medication plus behavioral intervention, 

and behavioral intervention only for either adults or adolescents. The literature regarding 

medication treatments for AN is sparse and inconclusive. The vast majority of studies had small 

sample sizes and rarely had adequate statistical power to allow for definitive conclusions. 

Although studies did include medication administered during or after inpatient intervention, no 

AN studies that systematically combined medication with behavioral interventions met our 

inclusion criteria, revealing a substantial gap in the literature. 

In the behavioral intervention literature, preliminary evidence suggests that cognitive 

behavioral therapy (CBT) may reduce relapse risk for adults with AN after weight restoration. 

Sufficient evidence does not exist to determine whether CBT has any effect during the acute 

phase of the illness, and one study, also requiring replication, showed that a manual-based 

treatment combining elements of sound clinical management and supportive psychotherapy by a 

specialist was more effective than CBT during the acute phase. Family therapy as currently 

conceptualized does not appear to be effective with adults with AN with longer duration of 

illness. Specific forms of family therapy initially focusing on parental control of renutrition is 
3 

efficacious in treating AN in adolescents and leads to clinically meaningful weight gain and 

psychological change. The lack of follow-up data compromises our ability to determine the 

extent to which treatment gains are maintained. 

Bulimia Nervosa. In medication trials, fluoxetine (60 mg/day) administered for 6 weeks to 

18 weeks reduced the core bulimia symptoms of binge eating and purging and associated 

psychological features in the short term. The 60 mg dose performs better than lower doses and is 

associated with prevention of relapse at 1 year. Evidence for the long-term effectiveness of 

relatively brief medication treatment does not exist. The optimal duration of treatment and the 

optimal strategy for maintenance of treatment gains are unknown. 

Studies that combine drugs and behavioral interventions provide only preliminary evidence 

regarding the optimal combination of medication and psychotherapy or self-help. How best to 

treat individuals who do not respond to CBT or fluoxetine remains a major shortcoming of the 

literature. For behavioral interventions for BN, CBT administered individually or in group 

format is effective in reducing the core behavioral symptoms of binge eating and purging and 

psychological features in both the short and long term. Further evidence is required to establish 

the role for self-help in reducing bulimic behaviors. 

Binge Eating Disorder. For BED, we addressed two critical outcomes—decrease in binge 

eating and decrease in weight in overweight individuals. Various medications were studied, 

including selective serotonin reuptake inhibitors (SSRIs); a combined serotonin, dopamine, and 

norepinephrine uptake inhibitor; tricyclic antidepressants; an anticonvulsant; and one appetite 

suppressant. In short-term trials, SSRIs led to greater rates of reduction in target eating, 

psychiatric and weight symptoms, and severity of illness than placebo controls. However, in the 

absence of clear endpoint data, and in the absence of data regarding abstinence from binge 

eating, we cannot judge the magnitude of the clinical impact of these interventions. Moreover, in 

the absence of follow-up data after drug discontinuation, we do not know whether observed 

changes in binge eating, depression, and weight persist. 

The combination of CBT plus medication may improve both binge eating and weight loss, 

although sufficient trials have not been done to determine definitively which medications are 

best at producing and maintaining weight loss. Moreover, the optimal duration of medication 

treatment for sustained weight loss has not yet been addressed empirically. 

Collectively, clinical trials incorporating CBT for BED indicated that CBT decreases either 

the number of binge days or the actual number of reported binge episodes. CBT leads to greater 

rates of abstinence than does a waiting list control approach when administered either 

individually or in group format, and this abstinence persists for up to 4 months posttreatment. 

CBT also improves the psychological aspects of BED, such as ratings of restraint, hunger, and 

disinhibition. Results are mixed as to whether CBT improves self-rated depression in this 

population. Finally, CBT does not appear to produce decreases in weight. 

Various forms of self-help were efficacious in decreasing binge days, binge eating episodes, 

and psychological features associated with BED. Self-help also led to greater abstinence from 

binge eating than waiting list; short-term abstinence rates approximate those seen in face-to-face 

psychotherapy trials. 

Strength of Evidence in Treatment Literature. We graded the strength of the body of 

evidence for each question separately. For efficacy of treatment (KQ 1), we graded evidence for 

AN treatment as weak, that for BN medication and behavioral interventions as strong, and that 

for BED therapies as moderate. For harms associated with treatment (KQ 2), we graded 

medication interventions for BN and BED as consistently strong; the literatures for all AN 
4 

interventions and all other BN and BED interventions were graded as weak to nonexistent 

because many studies failed to address harms associated with treatment. For factors associated 

with efficacy of treatment (KQ 3), with the exception of behavioral interventions for BN, which 

we graded as moderate, we graded the literature uniformly as weak. No published literature 

provided evidence on whether the efficacy of treatment for these conditions differs by 

sociodemographic factors (KQ 4). Overall, the literature on the treatment of AN in particular was 

deficient. 

Outcomes Literature 

Outcomes of Eating Disorders. One prospective cohort study, conducted in Sweden, 

followed individuals with AN in the community. Over a 10-year period, approximately half of 

the group had fully recovered; a small percentage continued to suffer from AN, and the 

remainder still had other eating disorders. Members of the AN group no longer differed from 

those in the comparison group in terms of weight, but they continued to be more depressed and 

to suffer from a variety of personality disorders, obsessive-compulsive disorder, Asperger 

syndrome, and autism spectrum disorders. 

The remaining AN studies followed patient populations. Typically, at least one-half of the 

patients no longer suffered from AN at followup. However, many continued to have other eating 

disorders such as BN or EDNOS, and mortality was significantly higher than would be expected 

in the population matched by sex and age. Factors associated with recovery or good outcomes 

included lower levels of depression and compulsivity. Factors associated with increased 

mortality included concurrent alcohol and substance use disorders. 

All of the BN outcomes studies followed patient populations. This literature emphasizes 

comparisons of various definitions of disease outcomes and diagnostic subtypes. Generally, more 

than one-half of the patients followed no longer had a BN diagnosis at the end of the study. A 

substantial percentage continued to suffer from other eating disorders, but BN was not associated 

with an increased mortality risk. A limited number of analyses uncovered factors significantly 

associated with outcomes of this disease, but only depression was consistently associated with 

worse outcomes. 

Only sparse evidence addresses factors associated with BED outcomes. The three included 

studies have vastly different designs and research questions; more importantly, they do not 

converge on any systematic findings. Recalling that no studies of EDNOS outcomes exist, we 

conclude that the literature regarding outcomes of both EDNOS in general and BED in particular 

is seriously lacking; we believe that no conclusions can be drawn about factors influencing 

outcomes of these disorders. 

Age of AN disease onset was examined in several AN outcomes studies. However, the 

relation between this variable and outcomes was mixed. No additional differences by participant 

sex, gender, age, race, ethnicity, or cultural group emerged from the AN, BN, or BED outcomes 

literature. 

Strength of Evidence in Outcomes Literature. The strength of the evidence addressing 

factors associated with outcomes among individuals with AN and BN is moderate. In contrast, 

given the limited information about factors related to outcomes among individuals with BED 

(KQ 5), we rated BED evidence as weak. We used the body of literature concerning KQ 5 to 

examine differences in outcomes by sociodemographic factors (KQ 6). We graded the AN 

literature as weak and the BN and BED literature as nonexistent. 
5 

Discussion 

In conclusion, the literature regarding treatment efficacy and outcome for AN, BN, and BED 

is of highly variable quality. In the treatment literature, the largest deficiency rests with treatment 

efficacy for AN where the literature was weakest. Future studies require large numbers of 

participants, multiple sites, appropriate biomarker outcomes, and clear delineation of the age of 

participants. For BN, future studies should address novel treatments for the disorder, optimal 

duration of intervention, and optimal approaches for those who do not respond to medication or 

CBT. For BED, future studies should identify interventions that are effective for both elimination 

of binge eating and reduction of weight (in overweight individuals), optimal duration of 

intervention, and effective strategies for prevention of relapse. For all three disorders, 

exploration of additional treatment approaches is warranted. In addition, for all three disorders, 

greater attention must be paid to factors influencing outcomes, harms associated with treatment, 

and differential efficacy by sex, gender, age, race, ethnicity, or cultural group. 

For all three disorders, consensus definitions of remission, recovery, and relapse are 

essential. Greater attention to disease presentations currently grouped under the heading of 

EDNOS is required for both treatment and outcome literature. For outcome studies, especially 

for BN and BED, population-based cohort studies with comparison groups and adequate 

durations of followup are required. For both future treatment and outcome studies, researchers 

must carefully attend to issues of statistical power, research design including the use of similar 

outcome measures across studies, and sophistication and appropriateness of statistical analyses. 
Evidence Report 
9 

Chapter 1. Introduction

Scope of the Problem 

The eating disorders discussed in this report include anorexia nervosa (AN), bulimia nervosa 

(BN), and eating disorders not otherwise specified (EDNOS). Although rigorous epidemiologic 

data specific only to the United States are lacking, the mean prevalence of AN in young females 

in Western Europe and the United States is 0.3 percent and the mean prevalence of BN is 1.0 

percent. Clinically concerning subthreshold conditions are more prevalent.1 These eating 

disorders are associated with substantial morbidity and mortality.2,3 The financial and social 

impact of these potentially fatal disorders on disability, productivity, and quality of life remains 

unknown. 

Anorexia Nervosa 

Clinical Characteristics 

AN is a serious psychiatric illness marked by an inability to maintain a normal healthy body 

weight, often dropping well below 85 percent of ideal body weight. Patients who are still 

growing fail to make expected increases in weight (and often height) and bone density. Despite 

increasing weight loss, individuals with AN continue to obsess about weight, remain dissatisfied 

with the perceived size of their bodies, and engage in an array of unhealthy behaviors to 

perpetuate weight loss (e.g., purging, dieting, excessive exercise, fasting). Individuals with AN 

place central importance on their shape and weight as a marker of self-worth and self-esteem. 

Although amenorrhea is a diagnostic criterion, it is of questionable relevance. There do not 

appear to be meaningful differences between individuals with AN who do and do not 

menstruate.4,5 Typical personality features of individuals with AN include perfectionism, 

obsessionality, anxiety, harm avoidance, and low self-esteem.6 

The most common comorbid psychiatric conditions include major depression7,8 and anxiety 

disorders.9,10 Anxiety disorders often predate the onset of the eating disorder,9,10 and depression 

often persists post-recovery.11 

Diagnostic Criteria 

Table 1 presents the diagnostic criteria that authors of articles reviewed in this report use. 

They include Russell criteria,12 Feighner criteria,13 Diagnostic and Statistical Manual for Mental 

Disorders III, III-R and IV (DSM III, III-R, and IV),14-16 and the International Classification of 

Diseases-Versions 9 and 10 (ICD-9 and ICD-10).17 

Epidemiology 

The mean prevalence of AN in young females in Western Europe and the United States is 0.3 

percent.1 The prevalence of subthreshold AN, defined as one criterion short of threshold, is 

greater—ranging from 0.37 percent to 1.3 percent.18,19 

Although awareness of the disorder has increased, the data on changing incidence are 

conflicting. Some studies suggest that the incidence is increasing,20-26 and others report stable 
10 

Table 1. Diagnostic criteria: anorexia nervosa 

Diagnostic Criteria 

Russell’s Criteria for 

Anorexia Nervosa 

1. Patient resorts to a variety of devices aimed at achieving weight loss (starvation, vomiting, 

laxatives, etc.) 

2. Evidence of an endocrine disorder, amenorrhea in the female, and loss of sexual potency and 

interest in the male 

3. Patient manifests the characteristic psychopathology of a morbid fear of becoming fat. This is 

accompanied by a distorted judgment by the patient of her body size 

Feighner’s Criteria for 

Anorexia Nervosa 

1. Onset prior to age 25 

2. Anorexia with accompanying weight loss of at least 25 percent of original body weight 

3. A distorted implacable attitude toward eating food or weight that overrides hunger, admonitions, 

reassurances, and threats 

4. No known medical illness accounts for the anorexia [nervosa] and weight loss 

5. No other known psychiatric disorder, with particular reference to primary affective disorders, 

schizophrenia, obsessive, and compulsive and phobic neurosis 

6. At least two of the following manifestations: amenorrhea, lanugo, bradycardia, periods of 

overactivity, episodes of bulimia, vomiting 

DSM III Criteria for 

Anorexia Nervosa 

(307.10) 

A. Intense fear of becoming obese, which does not diminish as weight loss progresses 

B. Disturbance of body image (e.g., claiming to "feel fat" even when emaciated) 

C. Weight loss of at least 25% of original body weight or, if under 18 years of age, weight loss 

from original body weight plus projected weight gain expected from growth charts may be 

combined to make the 25% 

D. Refusal to maintain body weight over a minimal normal weight for age and height 

E. No known physical illness that would account for the weight loss 

DSM III-R Criteria for 

Anorexia Nervosa 

(307.10) 

A. Refusal to maintain body weight over a minimal normal weight for age and height (e.g., weight 

loss leading to maintenance of body weight 15% below that expected or failure to make 

expected weight gain during period of growth, leading to body weight 15% below that expected)

B. Intense fear of gaining weight or becoming fat, even though underweight 

C. Disturbance in the way in which one’s body weight, size, or shape is experienced (e.g., the 

person claims to "feel fat" even when emaciated, believes that one area of the body is "too fat" 

even when obviously underweight) 

D. In females, absence of at least three consecutive menstrual cycles when otherwise expected to 

occur (primary and secondary amenorrhea). (A woman is considered to have amenorrhea if her 

periods occur only following hormone, e.g., estrogen, administration.) 

DSM IV Criteria for 

Anorexia Nervosa 

(307.10) 

A. Refusal to maintain body weight at or above a minimally normal weight for age and height (e.g., 

weight loss leading to maintenance of body weight less than 85% of that expected or failure to 

make expected weight gain during period of growth, leading to body weight less than 85% of 

that expected). 

B. Intense fear of gaining weight or becoming fat, even though underweight. 

C. Disturbance in the way in which one's body weight or shape is experienced, undue influence of 

body weight or shape on self-evaluation, or denial of the seriousness of the current low body 

weight. 

D. In postmenarchal females, amenorrhea i.e., the absence of at least three consecutive cycles. 

(A woman is considered to have amenorrhea if her periods occur only following hormone, e.g., 

estrogen administration.) 

Specify type: 

• Restricting Type: During the current episode of anorexia nervosa, the person has not regularly 

engaged in binge-eating or purging behavior (i.e., self-induced vomiting or the misuse of 

laxatives, diuretics, or enemas). 

• Binge-Eating/Purging Type: During the current episode of anorexia nervosa, the person has 

regularly engaged in binge-eating or purging behavior (i.e., self-induced vomiting or the misuse 

of laxatives, diuretics, or enemas). 

DSM, Diagnostic and Statistical Manual; ICD, International Classification of Diseases. 

For citations, see text. 
11 

Table 1. Diagnostic criteria: anorexia nervosa (continued) 

Diagnostic Criteria 

ICD-9 Criteria for 

Anorexia Nervosa 

(307.1) 

A disorder in which the main features are persistent active refusal to eat and marked loss of 

weight 

The level of activity and alertness is characteristically high in relation to the degree of 

emaciation 

Typically the disorder begins in teenage girls but it may sometimes begin before puberty and 

rarely occurs in males 

Amenorrhoea is usual and there may be a variety of other changes including slow pulse and 

respiration and low body temperature and dependent oedema 

Unusual eating habits and attitudes toward food are typical and sometimes starvation follows or 

alternates with periods of overeating 

The accompanying psychiatric symptoms are diverse 

ICD-10 Criteria for 

Anorexia Nervosa 

(F50.0) 

A. There is weight loss or, in children, a lack of weight gain, leading to a body weight at least 

15% below the normal or expected weight for age and height 

B. The weight loss is self-induced by avoidance of “fattening foods” 

C. There is self-perception of being too fat, with an intrusive dread of fatness, which leads to a 

self-imposed low weight threshold 

D. A widespread endocrine disorder involving the hypothalamic-pituitary-gonadal axis is 

manifested in women as amenorrhoea and in men as a loss of sexual interest and potency. 

(An apparent exception is the persistence of vaginal bleeds in anorexic women who are on 

replacement hormonal therapy, most commonly taken as a contraceptive pill) 

E. The disorder does not meet criteria A or B for bulimia nervosa 

ICD-10 Criteria for 

Atypical Anorexia 

Nervosa (F50.1) 

Disorder that fulfills some of the features of anorexia nervosa but in which the overall clinical 

picture does not justify that diagnosis. For instance, one of the key symptoms, such as 

amenorrhoea or marked dread of being fat, may be absent in the presence of marked weight 

loss or weight-reducing behavior. This diagnosis should not be made in the presence of known 

physical disorders associated with weight loss 

rates.27-31 Epidemiological studies indicate that the peak age of onset is between 15 and 19 

years.32 Anecdotal reports suggest increasing presentations in prepubertal children33 and new 

onset cases in mid- and late-life.34,35 The gender ratio for AN is approximately 9:1, women to 

men.16

Etiology 

The etiology of AN remains incompletely understood. Although numerous psychological, 

social, and biological factors have been implicated as potentially causal, few specific risk factors 

have been consistently replicated in studies of the etiology of the disorder.36,37 Although not 

disorder-specific, common risk factors across eating disorders include sex, race or ethnicity, 

childhood eating and gastrointestinal problems, elevated shape and weight concerns, negative 

self-evaluation, sexual abuse and other adverse events, and general psychiatric comorbidity.36 In 

addition, prematurity, smallness for gestational age, and cephalohematoma have been identified 

as risk factors for AN.38 

The preponderance of reports from western cultures fueled early conceptualizations of AN as 

a culturally determined disorder, but the past decade of biological and genetic research has 

revealed that AN is familial39 and that the observed familial aggregation is attributable primarily 

to genetic factors.40-42 Moreover, molecular genetic studies have identified areas of the human 
12 

genome that may harbor susceptibility loci for AN43,44 and specific genes that may influence 

risk.45,46 

In addition, an array of pharmacologic, genetic, and neuroimaging studies have identified 

fundamental disturbances in serotonergic function in individuals with AN even after recovery.47

Although serotonin has received considerable research attention, given the interrelatedness of 

neurotransmitter function, other neurotransmitter systems, most notably dopamine, are also 

implicated in these disorders.48 The ultimate understanding of AN etiology will likely include 

main effects of both biological and environmental factors as well as their interactions and 

correlations. 

Course of Illness 

AN has serious medical and psychological consequences that can persist even after recovery. 

Features associated with the eating disorder including depression, anxiety, social withdrawal, 

heightened self-consciousness, fatigue, and multiple medical complications.7,49-51 The social toll 

of AN interferes with normal adolescent development.52 Across psychiatric disorders, the highest 

risks of premature death, from both natural and unnatural causes, are from substance abuse and 

eating disorders.53 

A history of AN is associated with greater problems with reproduction,54 osteoporosis,55-57

continued low body mass index (BMI, a commonly used measure of normal weight, overweight, 

or obesity calculated as weight in kilograms divided by height in meters squared [kg/m2

]), and 

major depression.11 Chapter 6 reviews eating-related, psychological, and biomarker-measured 

outcomes of AN in detail. 

Treatment 

Given the high morbidity and mortality associated with AN, developing effective treatments 

for AN is critical. Because of the frequent medical complications and nutritional compromise, 

clinical practice typically includes a comprehensive medical evaluation and nutritional 

counseling. Typically, less medically compromised cases of AN are treated on an outpatient 

basis by psychiatrists, psychologists, and other therapists with primary care providers managing 

medical care. Professional organizations have developed several English-language treatment 

guidelines or position papers for the treatment of AN; these include the American Psychiatric 

Association,58 the National Institute for Clinical Excellence,59 the Society for Adolescent 

Medicine,60 the American Academy of Pediatrics,61 and the Royal Australian and New Zealand 

College of Psychiatrists.62

Psychotherapeutic approaches include individual psychotherapy (cognitive-behavioral, 

interpersonal, behavioral, and psychodynamic), family therapy (especially for younger patients), 

and group therapy. The American Psychiatric Association Working Group on Eating Disorders 

concluded that hospitalization is appropriate for individuals below 75 percent of ideal body 

weight.58 Weight is not the only parameter to be considered in level of care decisions. Other 

considerations include medical complications, suicide attempt or plan, failure of outpatient or 

partial hospitalization treatment, psychiatric comorbidity, role impairment, poor psychosocial 

support, compromised pregnancy, and lack of availability of less intensive treatment options.58

Such treatment commonly involves highly specialized multidisciplinary teams including 

psychologists, psychiatrists, internists or pediatricians, nutritionists, social workers, and nurse 

specialists. 
13 

Striegel-Moore et al. reported the average length of stay to be 26 days using an insurance 

database of approximately 4 million individuals in the United States;63 this is substantially 

shorter than the lengths of stay in other countries, including New Zealand (72 days)64 and 

Europe, which ranges from 40.6 days (Finland) to 135.8 days (Switzerland).65 They found that, 

per patient, AN treatment costs in the United States were higher than those for obsessivecompulsive disorder and comparable to those for schizophrenia, both of which have prevalences 

similar to those of AN.63 

A workshop sponsored by the National Institute of Mental Health (NIMH) examined 

problems in conducting research on AN treatment.66 It highlighted obstacles such as relatively 

low incidence and prevalence, lack of consensus on best treatments, variable presentation within 

the patient population based on age and illness factors, high costs of providing treatment, and the 

complex interaction of medical and psychiatric problems associated with the illness. This report 

also highlighted the importance of improving and expanding the workforce in the eating 

disorders research field. 

Bulimia Nervosa 

Clinical Characteristics 

BN is characterized by recurrent episodes of binge eating in combination with some form of 

inappropriate compensatory behavior. Binge eating is the consumption of an abnormally large 

amount of food coupled with a feeling of being out of control. Compensatory behaviors (aimed 

at preventing weight gain) include self-induced vomiting; the misuse of laxatives, diuretics, or 

other agents; fasting; and excessive exercise. 

The onset of BN usually occurs in adolescence or early adulthood and is most frequently 

seen in women who are of normal body weight.16 Although the gender ratio is approximately 

9:1, women to men, the diagnostic criteria themselves are gender-biased. In contrast to women, 

men tend to present with a greater reliance on nonpurging forms of compensatory behavior such 

as excessive exercise.67,68 Considerations of differences in the clinical presentation of BN in 

men may lead to revised estimates.67,69 

Approximately 80 percent of patients with BN are diagnosed with another psychiatric 

disorder at some time in their life.70 Commonly comorbid psychiatric conditions include anxiety 

disorders, major depression, dysthymia, substance use, and personality disorders.9,71-77

Personality features of individuals with BN include some features shared with AN such as high 

harm avoidance, perfectionism, and low self-esteem. Features more specific to BN include 

higher novelty seeking, higher impulsivity, lower self-directedness, and lower 

cooperativeness.78-80

Diagnostic Criteria

Table 2 presents DSM III, III-R, and IV and ICD-10 diagnostic criteria for BN. According to 

DSM IV criteria, a diagnosis of BN requires a minimum of 3 months of binge eating and 

compensatory behavior occurring twice a week or more. Similar to AN, individuals have to 

report the undue influence of weight and shape on their self-esteem. In addition, BN is diagnosed 
14 

Table 2. Diagnostic criteria: bulimia nervosa 

Diagnostic 

Criteria 

DSM III Criteria 

for Bulimia 

Nervosa (307.51) 

A. Recurrent episodes of binge eating (rapid consumption of a large amount of food in a 

discrete period of time, usually less than two hours) 

B. At least three of the following: 

(1) consumption of high-caloric, easily ingested food during a binge 

(2) inconspicuous eating during a binge 

(3) termination of such eating episodes by abdominal pain, sleep, social interruption, or 

self-induced vomiting 

(4) repeated attempts to lose weight by severely restrictive diets, self-induced vomiting, 

or use of cathartics or diuretics 

(5) frequent weight fluctuations greater than 10 pounds due to alternating binges and 

fasts 

C. Awareness that the eating pattern is abnormal and fear of not being able to stop eating 

voluntarily 

D. Depressed mood and self-deprecating thoughts following eating binges 

E. The bulimic episodes are not due to anorexia nervosa or any known physical disorder 

DSM III-R Criteria 

for Bulimia 

Nervosa (307.51) 

A. Recurrent episodes of binge eating (rapid consumption of a large amount of food in a 

discrete period of time) 

B. A feeling of lack of control over eating behavior during the eating binges 

C. The person regularly engages in either self-induced vomiting, use of laxatives or 

diuretics, strict dieting or fasting, or vigorous exercise in order to prevent weight gain 

D. A minimum average of two binge eating episodes a week for at least 3 months 

E. Persistent overconcern with body shape and weight 

DSM IV Criteria 

for Bulimia 

Nervosa (307.51) 

A. Recurrent episodes of binge eating. An episode of binge eating is characterized by both 

of the following: 

(1) Eating, in a discrete period of time (e.g., within any 2-hour period), an amount of food 

that is definitely larger than most people would eat during a similar period of time and 

under similar circumstances 

(2) A sense of lack of control over eating during the episode (e.g., a feeling that one 

cannot stop eating or control what or how much one is eating) 

B. Recurrent inappropriate compensatory behavior in order to prevent weight gain, such 

as self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications; 

fasting or excessive exercise 

C. The binge eating and inappropriate compensatory behaviors both occur, on average, at 

least twice a week for 3 months 

D. Self-evaluation is unduly influenced by body shape and weight 

E. The disturbance does not occur exclusively during episodes of anorexia nervosa 

Specify type: 

Purging type: During the current episode of bulimia nervosa, the person has regularly 

engaged in self-induced vomiting or the misuse of laxatives, diuretics, or enemas 

Nonpurging type: During the current episode of bulimia nervosa, the person has used 

inappropriate compensatory behaviors, such as fasting or excessive exercise, but has 

not regularly engaged in self-induced vomiting or the misuse of laxatives, diuretics, or 

enemas 

DSM, Diagnostic and Statistical Manual; ICD, International Classification of Diseases. 

For citations, see text. 
15 

Table 2. Diagnostic criteria: bulimia nervosa (continued) 

Diagnostic 

Criteria 

ICD-10 Criteria for 

Bulimia Nervosa 

(F50.2) 

A. There are recurrent episodes of overeating (at least twice a week over a period of 3 

months) in which large amounts of food are consumed in short periods of time 

B. There is persistent preoccupation with eating, and a strong desire or sense of 

compulsion to eat (craving) 

C. The patient attempts to counteract the “fattening” effects of food by one or more of the 

following: 

(1) self-induced vomiting 

(2) self-induced purging 

(3) alternating periods of starvation 

(4) use of drugs such as appetite suppressants, thyroid preparations, or diuretics; when 

bulimia occurs in diabetic patients they may choose to neglect their insulin treatment 

D. There is self-perception of being too fat, with an intrusive dread of fatness (usually 

leading to underweight) 

ICD-10 Criteria for 

Atypical Bulimia 

Nervosa (F50.3) 

Disorder that fulfills some of the features of bulimia nervosa, but in which the overall 

clinical picture does not justify that diagnosis. For instance, there may be recurrent bouts 

of overeating or overuse of purgatives without significant weight change, or the typical 

overconcern about body shape and weight may be absent 

secondary to AN (i.e., the illness is diagnosed as BN only if the criteria for AN are not met). 

Thus, to be diagnosed with BN, individuals should have a BMI greater than 17.5 or the 

equivalent in children and adolescents. The DSM distinguishes two subtypes of BN based on the 

individual’s compensatory behavior: purging (including vomiting and misuse of laxatives, 

diuretics, or enemas) and nonpurging (restricted eating and exercise). The ICD-1017describes 

only the compensatory mechanisms of vomiting and use of purgatives for BN, because of 

societal pathologizing of vomiting and laxative misuse when compared with exercise or 

restrictive eating. ICD-10 does acknowledge alternate periods of starvation in BN. 

Epidemiology 

A recent review estimated the prevalence of BN to be 1 percent for women and 0.1 percent 

for men across Western Europe and the United States.1 The prevalence of subthreshold BN was 

considerably higher: 1.5 percent for full syndrome and 5.4 percent for partial syndrome. Because 

of the late introduction of BN into psychiatric nomenclature, few studies have explored temporal 

changes in the incidence of the disorder. Moreover, few studies have estimated the prevalence of 

BN among children and adolescents. 

Etiology 

Historically, like AN, BN has been conceptualized as having sociocultural origins. 

Substantial familial aggregation of BN has been reported.39 Twin studies reveal a moderate to 

substantial contribution of additive genetic factors (between 54 percent and 83 percent) and 

unique environmental factors to BN.81,82 Linkage analyses have identified areas on chromosome 

10p that may be implicated in BN.83 Numerous candidate genes have been studied for their role 

in risk for the disorder.46

Ongoing biological studies suggest fundamental disturbances in serotonergic function in 

individuals with BN.80,84 The ultimate understanding of the etiology of BN and of other 

disturbances that contribute to the development of inappropriate responses to satiety clues85 will 
16 

most likely include main effects of both biological and environmental factors as well as their 

interactions and correlations. 

Course of Illness 

Although BN is not typically associated with the serious physical complications normally 

associated with AN, patients commonly report physical symptoms such as fatigue, lethargy, 

bloating, and gastrointestinal problems. Individuals with BN who engage in frequent vomiting 

may experience electrolyte abnormalities, metabolic alkalosis, erosion of dental enamel, swelling 

of the parotid glands, and scars and calluses on the backs of their hands.86 Those who frequently 

misuse laxatives can have edema, fluid loss and subsequent dehydration, electrolyte 

abnormalities, metabolic acidosis, and potentially permanent loss of normal bowel function.86

Chapter 6 reviews eating-related, psychological, and biomarker-measured outcomes of BN in 

detail. 

Treatment 

In the United States, most treatment for BN is conducted on an outpatient basis. Given the 

frequency of medical87 and nutritional complications, a comprehensive medical evaluation is the 

typical first step in treatment. Thereafter, psychotherapy, delivered either individually or in 

group format, is usually the cornerstone of BN interventions. Common approaches include 

cognitive-behavioral therapy and interpersonal psychotherapy. In cases in which the individual is 

experiencing medical complications of BN, is pregnant, or is unable to bring an entrenched 

binge-purge cycle under control on an outpatient basis, partial hospitalization or inpatient 

treatment is often warranted. 

In 1996, the Food and Drug Administration (FDA) approved fluoxetine for the treatment of 

BN. Currently, this is the only FDA-approved medication for the treatment of any eating 

disorder. 

Eating Disorders Not Otherwise Specified 

(Binge Eating Disorder) 

Clinical Characteristics 

Eating disorders not otherwise specified (EDNOS) is a diagnostic category that captures 

those individuals with eating disorders who do not meet criteria for AN or BN. The DSM IV lists 

six different examples of presentations of EDNOS: 

1. all features of AN except amenorrhea; 

2. all features of AN except remaining in a normal weight range; 

3. all criteria for BN except frequency of binge eating or purging or duration of 3 

months; 

4. regular inappropriate compensatory behavior after eating small amounts of food; 

5. chewing and spitting out food; and 

6. binge eating disorder (BED). 
17 

Clinical reports suggest that individuals with EDNOS constitute the majority of individuals 

seeking professional help for an eating disorder.88,89 This suggests that the nomenclature for 

eating disorders is imperfect. Moreover, our attempts to address the key questions of this 

evidence report for the global category of EDNOS indicated a paucity of investigations on the 

nature of the highly heterogeneous category of EDNOS and on the treatment and outcome of 

specific presentations of EDNOS. We redirected the task to focus on BED, the one category of 

EDNOS that has a corpus of research. 

Diagnostic Criteria

The symptom of binge eating was first recognized in a subset of obese individuals by 

Stunkard in 1959.90 BED has had a slow and controversial evolution in the psychiatric nosology 

for eating disorders.91-94 DSM IV currently includes BED as a disorder requiring further study. 

The DSM IV criteria appear in Table 3. Individuals with BED engage in regular binge eating 

behavior. A binge eating episode is determined in the same manner as in BN; it requires 

consumption of an unusually large amount of food and a sense of being out of control. The 

frequency criterion of twice per week is the same as in BN, although this criterion is not well 

supported by the literature.95,96 Unlike BN, individuals with BED do not regularly engage in 

compensatory behaviors. Several other criteria in the provisional BED diagnosis require further 

empirical support. 

Table 3. Diagnostic criteria: binge eating disorder 

Diagnostic Criteria 

DSM IV Criteria for 

Binge Eating 

Disorder (307.50) 

A. Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the 

following: 

(1) Eating, in a discrete period of time (e.g., within any 2-hour period), an amount of food that 

is definitely larger than most people would eat in a similar period of time under similar 

circumstances 

(2) The sense of lack of control over eating during the episode (e.g., a feeling that one cannot 

stop eating or control what or how much one is eating) 

B. Binge-eating episodes are associated with three (or more) of the following: 

(1) eating much more rapidly than normal 

(2) eating until feeling uncomfortably full 

(3) eating large amounts of food when not feeling physically hungry 

(4) eating along because of being embarrassed by how much one is eating 

(5) feeling disgusted with oneself, depressed, or very guilty after overeating 

C. Marked distress regarding binge eating is present 

D. The binge eating occurs, on average, at least 2 days a week for 6 months 

Note: The method of determining frequency differs from that used for bulimia nervosa; future 

research should address whether the preferred method of setting a frequency threshold is 

counting the number of days on which binges occur or counting the number of episodes of 

binge eating 

E. The binge eating is not associated with the regular use of inappropriate compensatory 

behavior (e.g., purging, fasting, excessive exercise, etc.) and does not occur exclusively 

during the course of anorexia nervosa or bulimia nervosa 

DSM, Diagnostic and Statistical Manual. 

Epidemiology 

Population-based studies suggest that between 0.7 percent and 3 percent of individuals in 

community samples meet criteria for BED.92,97-99 Community studies of obese individuals have 

found a prevalence of BED between 5 percent and 8 percent.100,101 Population-based studies of 
18 

BED and the component behavior of binge eating report a relatively equal gender 

distribution,92,99 few differences in prevalence across races or ethnic groups,102 and possibly 

increased risk associated with lower socioeconomic status.103,104 In a population-based study of 

female twins, 37 percent of obese women (BMI ≥ 30) endorsed the symptom of binge eating,105

representing 2.7 percent of the female population studied. 

Etiology 

In a community-based case-control study, Fairburn et al.106 found significant differences in 

exposure to risk factors between women with BED and healthy controls, but surprisingly few 

differences between women with BED and BN. In comparison to healthy controls, women with 

BED reported greater adverse childhood experiences, parental depression, personal vulnerability 

to depression, and exposure to negative comments about weight, shape, and eating. 

BED has been shown to aggregate in families.107 Although heritability estimates for frank 

BED are not yet available, the heritability of binge eating in the absence of compensatory 

behaviors has been estimated to be 41 percent.108 In addition, binge eating has been explored as a 

potential intermediate behavioral phenotype in understanding the genetics of obesity. It has also 

been preliminarily identified in some studies as an important phenotypic characteristic of 

individuals with a mutation in the melanocortin 4 receptor (MC4R), a candidate gene that 

influences eating behavior,109 although this finding has not been replicated.110

Course of Illness 

Given that BED has only recently entered the psychiatric nomenclature, we have minimal 

population-based data on morbidity and mortality. The presence of binge eating or BED in obese 

individuals carries substantial risk. Obese individuals with binge eating or BED in clinical and 

community studies report earlier onsets of obesity and dieting,92,111,112 greater weight 

fluctuations,112 more cognitive features of disordered eating,113 lower self-esteem and selfefficacy,114 and higher scores on depression indices.114-117 Chapter 6 reviews eating-related, 

psychological, and biomarker-measured outcomes of BED in detail. 

Treatment 

In the United States, treatment for BED is typically conducted on an outpatient basis. 

Psychological and dietary interventions aim to reduce binge eating and control weight.118

Common psychotherapeutic approaches include cognitive-behavioral and interpersonal 

psychotherapy; nutritional approaches include very low calorie diets and behavioral selfmanagement strategies.118 Pharmacotherapy targeting both the core symptoms of binge eating 

and weight loss are also available as off-label interventions.119 

Production of This Evidence Report 

Organization 

Given that eating disorders are an important public health problem, the Agency for 

Healthcare Research and Quality (AHRQ), the National Institutes of Health’s Office of Research 

on Women’s Health, together with the Health Resources and Services Administration (HRSA), 

and in consultation with National Institute of Mental Health (NIMH), commissioned an evidence 
19 

report through its Evidence Based Practice Program and assigned it to the RTI InternationalUniversity of North Carolina Evidence-Based Practice Center (RTI-UNC EPC). The issue is also 

of particular concern to the American Psychiatric Association and the Laureate Psychiatric Clinic 

and Hospital, which nominated the topic. 

Chapter 2 describes our methodological approach, including the development of key 

questions and their analytic framework, our search strategies, and inclusion/exclusion criteria. In 

Chapters 3 through 5, we separately present the results of our literature search and synthesis on 

the treatment of each disease (respectively, AN, BN, and BED). Chapter 6 documents our 

findings about outcomes associated with each disease. Chapter 7 further discusses our findings, 

grades the strength of the bodies of literature, highlights methodological shortcomings of the 

extant research, and offers recommendations for future research. Appendixes (available 

electronically at http://www.ahrq.gov) provide a detailed description of our search strings 

(Appendix A*

), our quality rating forms (Appendix B), detailed evidence tables (Appendix C), 

list of excluded studies (Appendix D), and acknowledgments including our Technical Expert 

Panel and peer reviewers (Appendix E). 

Technical Expert Panel 

We identified experts in the field of eating disorders to provide assistance throughout the 

project. The Technical Expert Panel (TEP) (see Appendix E) contributes to AHRQ’s broader 

goals of (1) creating and maintaining science partnerships as well as public-private partnerships 

and (2) meeting the needs of an array of potential customers and users of this product. The TEP 

served as both a resource and sounding board during the project. Our TEP comprised 10 

individuals: three psychiatrists and two psychologists with eating disorder expertise; two nurses; 

one pediatric/adolescent medicine physician; one nutritionist; and one patient advocate. 

To ensure accountability and scientifically relevant work, the TEP was called upon to 

provide guidance at all stages of the project. TEP members participated in conference calls and 

e-mail exchanges to 

• refine the analytic framework and key questions at the beginning of the project; 

• refine the scope of the project; and 

• discuss inclusion and exclusion criteria. 

Because of their extensive knowledge of the literature on eating disorders, including 

numerous articles authored by TEP members, and their active involvement in professional 

organizations and as practitioners in the field, we also asked TEP members to participate in 

external peer review of the draft report. 

Uses of This Report 

We anticipate this report will be of value to members of the various professional 

organizations who treat eating disorders. These include the Academy for Eating Disorders, 

American Academy of Pediatrics, American Academy of Family Practice, American College of 

Obstetricians and Gynecologists, American Dietetics Association, American Psychiatric 

Association, American Psychological Association, International Association of Eating Disorders 

Professionals, National Association of Social Workers, and Society for Adolescent Medicine. 

 

*

 Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
20 

More generally, the report will assist these organizations in their mission to inform and 

educate practitioners. From this review, the National Institutes of Health can identify serious 

gaps in the research on eating disorders to guide funding policy. It can inform practitioners on 

the current evidence about outcomes associated with having these eating disorders and treating 

patients with them. Researchers will benefit from the concise analysis of the current status of the 

field, which will enable them to design future studies to address deficiencies in the field. Health 

educators can use this report to improve health communication. Finally, policymakers can use 

this report to allocate resources toward future research and initiatives that are likely to be 

successful. 

21 

Chapter 2. Methods 

In this chapter, we document the procedures that the RTI International – University of North 

Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) used to develop this 

comprehensive evidence report on the management and outcomes related to eating disorders. To 

provide a framework for the review, we first present the key questions and their underlying 

analytic framework. We then describe our strategy for identifying articles relevant to our key 

questions, our inclusion/exclusion criteria, and the process we used to abstract relevant 

information from eligible articles and generate our evidence tables. We also discuss our criteria 

for grading the quality of individual articles and the strength of the evidence as a whole. Last, we 

explain the peer review process. 

Key Questions and Analytic Framework 

This report spans key questions (KQs) regarding both treatment and outcomes of three 

eating disorders: anorexia nervosa (AN), bulimia nervosa (BN), and eating disorders not 

otherwise specified (EDNOS), which we refined to focus exclusively on binge eating disorder 

(BED) because of the lack of availability of data on other EDNOS conditions. We examine 

issues concerning treatment efficacy and disease outcomes separately for each disorder. The 

American Psychiatric Association and Laureate Psychiatric Clinic and Hospital initially offered 

these questions, and we put them into final form with input from our Technical Expert Panel 

(TEP).

Key Questions 

• 1. What is the evidence for the efficacy of treatments or combination of treatments 

for each of the following eating disorders: AN, BN, and BED? 

• 2. What is the evidence of harms associated with the treatment or combination of 

treatments for each of the following eating disorders: AN, BN, and BED? 

• 3. What factors are associated with the efficacy of treatment among patients with the 

following eating disorders: AN, BN, and BED? 

• 4. Does the efficacy of treatment for AN, BN, and BED differ by sex, gender, age, 

race, ethnicity, or cultural group? 

• 5. What factors are associated with outcomes among individuals with the following 

eating disorders: AN, BN, and BED? 

• 6. Do outcomes for AN, BN, and BED differ by sex, gender, age, race, ethnicity, or 

cultural group? 

In the analytic framework for these questions (Figure 1), we depict the partially overlapping 

syndromes of AN, BN and BED, the two types of studies included in this review (treatment and 

outcome analyses), and factors that influence both treatment response and disorder outcome. We 

do not include in our figure influencing factors, such as physical and sexual abuse, that are not 

discussed in the literature meeting our inclusion criteria. 

Also depicted on the framework are the six KQs discussed in this report. KQ 1 addresses the 

efficacy of available treatments for the three disorders; we categorize outcomes as eating-related 
22 

Figure 1. Analytic framework 

outcomes that deal with the core behavioral and psychological pathology of the disorders, 

psychiatric or psychological outcomes that focus on the presence of comorbid depression and 

anxiety, and biomarker outcomes that reflect weight, body mass index (BMI), and other 

biological indices of the disorders. Treatment may include relapse, diagnostic crossover, and 

symptomatic change. KQ 2 explores the harms associated with both medication and 

psychological treatments for these disorders. KQs 3 and 4 highlight the roles of illness-related 

factors (e.g., comorbid depression, subtype of the eating disorders, early onset of illness) and 

illness-independent factors (e.g., sex, gender, race or ethnicity, age) in influencing the outcomes 

of treating these conditions. 

KQ 5 addresses short- and long-term outcomes of the disorders. We apply information from 

observational, cohort, and case series investigations and focus on eating-related, psychiatric or 

psychological, and biological indices. Finally, KQ 6 highlights whether these outcomes differ by 

sex, gender, age, race or ethnicity, or cultural groups. 

Literature Review Methods 

Inclusion and Exclusion Criteria 

After discussions with our TEP, we generated a list of article inclusion and exclusion criteria 

(Table 4) for these KQs. We limited our review to human studies, including participants ages 10 

years and older. Although interest is growing in developing appropriate nomenclature and 

interventions for young children with eating disorders,120 we judged this literature to be beyond 

the scope of this review. We considered studies published in all languages from 1980 to 

September 2005. We included studies conducted with participants of both sexes, in all nations. 

The study population must be primarily diagnosed with AN, BN or BED. 
23 

Table 4. Eating disorders literature searches: inclusion and exclusion criteria 

Category Criteria 

Study population Humans 

All races, ethnicities, and cultural groups 

10 years of age or older. 

Study settings and geography All nations 

Time period Published from 1980 to the present 

Publication criteria All languages 

Articles in print 

Articles in the “gray literature,” published in nonpeer-reviewed journals, or 

unobtainable during the review period were excluded. 

Admissible evidence (study design and 

other criteria) 

Original research studies that provide sufficient detail regarding methods 

and results to enable use and adjustment of the data and results. 

Anorexia nervosa must be diagnosed according to DSM III, DSM III-R, 

DSM IV, ICD-10, Feighner, or Russell criteria. 

Bulimia nervosa must be diagnosed according to DSM III-R, DSM IV, or 

ICD-10 criteria. 

Eating disorders not otherwise specified (binge eating disorder) must be 

diagnosed according to DSM IV criteria. 

Relevant outcomes: eating related, psychiatric or psychological, and 

biomarker measures; must be able to be abstracted from data presented 

in the papers. 

Eligible study designs include: 

Randomized controlled trials (RCTs): 

Double-blinded, single-blinded, and cross-over designs (data from prior 

to the first cross-over). 

Anorexia nervosa studies: initiated with 10 or more participants and 

followed for any length of time. 

Eating disorders not otherwise specified (binge eating disorder) studies: 

initiated with 10 or more participants and followed for any length of time. 

Bulimia nervosa studies: initiated with 30 or more patients and followed 

for a minimum of 3 months. 

Outcomes studies: 

Observational studies including prospective and retrospective cohort 

studies and case series studies, with and without comparison 

populations. 

Disease population must be followed for a minimum of 1 year. Disease 

population must include 50 or more participants at the time of the 

analysis. 

We excluded data that combined diseases because such mixed information would preclude us 

from separately examining evidence on any one of the three conditions. We also excluded 

editorials, letters, and commentaries; articles that did not report outcomes related to our key 

questions; and studies that did not provide sufficient information to be abstracted. Studies were 

required to report on at least one of our outcomes categories of interest: eating, psychiatric and 

psychological, or biomarker measures. 
24 

We defined individuals as having one of the three disorders of interest according to specific 

diagnostic criteria. We examined the impact of treatment through a review of the RCT efficacy 

of treatment literature. 

To address a TEP concern that the size of the available AN and BED literature was too 

limited to permit us to constrain this review based on sample size or followup duration, we 

included very small AN and BED RCT treatment studies in our review (10 or more participants) 

and did not require specified followup durations for a study to be included. The BN literature, 

however, is much more voluminous, which allowed us to limit the treatment studies to larger 

ones (i.e., those with 30 or more participants). 

To help ensure that we were not measuring short-term fluctuations in disease symptoms, we 

required BN efficacy of treatment studies to follow patients for a minimum of 3 months. The 

decision to place more stringent requirements on the BN literature was made in consultation with 

our TEP. Because of financial and time considerations, we used a recently completed EPC report 

entitled Drug Class Review on Second Generation Antidepressants121 as a starting point for our 

discussion of harms or side effects related to receiving treatment for AN, BN, and BED; we then 

supplemented this information with harms reported in the RCT studies meeting our inclusion 

criteria. 

We examined outcomes related to having one of the three eating disorders through a review 

of observational studies; outcomes included eating, psychiatric or psychological, and biomarker 

variables and death. Although many participants followed in these studies have received 

treatment, the outcomes of interest relate not to efficacy of treatments but rather to disease levels 

and other problems that persist over time. To avoid reporting short-term fluctuations among the 

disease populations and to have sufficient sample sizes to observe changes over time, we limited 

our review to studies of 50 or more individuals, followed for a minimum of 1year, with or 

without comparison groups. Our TEP concurred with this plan. 

For both the RCT and outcome literatures, we were unable to perform pooled meta-analyses. 

Given the absence of consensus definitions of remission, recovery, and relapse for eating 

disorders, as well as the overabundance of outcome measures, we judged meta-analysis to be 

both inadvisable and infeasible. 

Literature Search and Retrieval Process 

Databases and search terms. To identify the relevant literature for our review, we 

conducted systematic searches based on search terms, reviewed included studies by our TEP, and 

hand searched reference lists. We searched standard electronic databases such as MEDLINE®, 

the Cumulative Index to Nursing and Applied Health (CINAHL), PsycINFO, the Educational 

Resources Information Center (ERIC), the National AGRICultural OnLine Access 

(AGRICOLA), and Cochrane Collaboration libraries. 

Based on inclusion/exclusion criteria specified above, we generated a list of Medical Subject 

Heading (MeSH) search terms, supplemented by key word searches of MEDLINE®. 

Comparable terms were used to search other databases. MeSH terms included anorexia, anorexia 

nervosa, and bulimia. Text terms included binge eating disorder. We limited our searches by type 

of study, including RCT, single-blind method, double-blind method, random allocation, 

longitudinal studies, and observational studies. For interventions, we used therapeutics or 

cognitive therapy or family therapy or drug therapy or therapy, computer-assisted. For outcomes 

of disease, we used outcome assessment (health care), treatment outcome, outcome and process 

assessment (health care), and recurrence. Finally, we asked our external peer reviewers for titles 

of articles that we may have missed. 
25 

Figure 2 presents the yield and results from our searches. We conducted our initial search in 

late 2004 and updated it in August 2005 (treatment studies) and September 2005 (outcome 

studies). Beginning with a yield of 2,188 titles and abstracts, we reviewed and further narrowed 

this pool to 478 articles. 

Figure 2. Eating disorders article disposition 

Non-duplicate articles identified in searches

N = 2,188

Citations excluded

N = 1,701

Included but full text unavailable

N = 3

Published in abstract form only

N = 6

Full text articles excluded:

N = 245

79 Sample size too small

10 No control or comparison group

9 No original data (e.g., letters, editorials, reviews)

21 Does not focus on subjects with primary problem of AN, BN, BED

52 Wrong study design (e.g., case series only)

22 Wrong outcome (or no outcome)

12 Insufficient statistical analysis to make comparisons

3 Wrong year (i.e., outside of our inclusion period of 1980 – 2005)

1 Drug no longer on the market

20 Uses DSM-III definition for BN

12 Does not follow individuals for at least 1 year

3 RCT that does not follow BN individuals for 3 months

1 Not published in a peer-reviewed journal

Full text articles reviewed

N = 478

Full text articles included in review

N = 181

RCT

N = 119

Observational

N = 62

35 AN

58 BN

26 BED

38 AN

14 BN

7 AN and BN

3 BED

Marked as background

N = 52

We retained the following for our review to answer KQs about treatment efficacy: 35 articles 

on AN, 58 articles on BN, and 26 articles on BED. To answer KQs about disease outcomes, we 

retained 38 articles on AN, 14 articles on BN, 7 articles on both AN and BN, and 3 articles on 

BED. 
26 

Article selection process. Once we had identified articles through the electronic database 

search, review articles, and bibliographies, we examined titles and abstracts to determine 

whether the studies met our inclusion criteria. One reviewer initially evaluated abstracts for 

inclusion or exclusion. If one reviewer concluded that the article should be included, it was 

retained. Abstracts initially excluded from the study by one reviewer received a second review 

by senior project staff—Nancy Berkman, PhD, MLIR (Project Director), Cynthia Bulik, PhD 

(Scientific Director), or Gerald Gartlehner, MD, MPH (UNC Project Manager). 

In all, 478 articles appeared to meet our inclusion criteria through abstract review, so we 

obtained the full articles. For the full article review, one senior reviewer read each article and 

determined if it met our eligibility criteria. Those articles that the reviewer determined did not 

meet our criteria were re-reviewed by a second senior reviewer to ensure agreement that the 

article should be excluded. We assigned each of these articles one or more reasons for exclusion. 

Literature Synthesis 

Development of Evidence Tables and Data Abstraction Process 

The senior staff members for this systematic review jointly developed the evidence tables. 

We created two designs for the evidence tables, one for KQs 1 to 4 (treatment studies) and one 

for KQs 5 and 6 (outcome studies). They are intended to provide sufficient information for 

readers to understand the study and determine its quality; we emphasized presenting information 

essential to answering the main questions. The formats of the two sets of evidence tables were 

based on successful designs used for prior systematic reviews. 

Columns in the evidence tables for treatment studies report baseline and outcome measures 

for eating-related, psychological or psychiatric, and biomarker variables. For each outcome 

measured, the tables present data in a consistent format. Given the large number of outcomes that 

these studies typically report, our evidence table entries are relatively long. In contrast, the 

outcome studies evidence tables are shorter. However, because of the appreciable variety of 

study approaches and outcomes reported in this literature the presentation of outcome data is, by 

necessity, less consistent than that for the treatment studies. 

For this work, the RTI-UNC EPC team decided to abstract data from included articles 

directly into evidence tables; this system has worked effectively in many of our past reviews. 

Because we bypassed the use of data abstraction forms, we had significant efficiencies in 

production. 

We trained data abstractors intensively, thoroughly familiarizing them with table designs, 

required information and formats, and examples of abstracted articles. As the work progressed, 

we shared various reporting requirements with abstractors to ensure that information appeared in 

a consistent and easily understandable manner. 

For both the treatment and the outcomes literatures, the first reviewer (UNC faculty, 

postdoctoral psychology fellow, or psychology graduate student) initially entered data from the 

article into the evidence table. The second reviewer (Drs. Berkman, Bulik, Brownley, Carey, or 

Gartlehner) read the article and edited the initial table entry for accuracy, completeness, and 

consistency. All disagreements concerning the information reported in the evidence tables were 

reconciled by the two abstractors. 
27 

The final evidence tables are presented in their entirety in Appendix C.*

 Separate tables are 

included for treatment studies by disease and type of treatment intervention: 

• AN: Evidence Table 1, medication trials; Evidence Table 2, medication plus behavioral 

intervention trials; Evidence Table 3, behavioral intervention trials (adults); and Evidence 

Table 4, behavioral intervention trials (adolescents ages 10 and older); 

• BN: Evidence Table 5, medication trials; Evidence Table 6, medication plus behavioral 

intervention trials; Evidence Table 7, behavior intervention with no medications trials; 

Evidence Table 8, self-help interventions trials; and Evidence Table 9, other interventions 

trials; 

• BED: Evidence Table 10, medication trials; Evidence Table 11, medication plus 

behavioral interventions trials; Evidence Table 12, behavioral intervention with no 

medications trials; Evidence Table 13, self-help intervention trials; and Evidence Table 

14, other interventions trials. 

Appendix C also presents three evidence tables for outcome studies organized only by 

disease: 

• AN outcome studies, Evidence Table 15; 

• BN outcome studies, Evidence Table 16; and 

• BED outcome studies, Evidence Table 17. 

Within each evidence table, entries are listed alphabetically by the last name of the first 

author. Abbreviations and acronyms used in the tables appear in a glossary at the beginning of 

the appendix. 

Finally, as noted earlier, the number of assessment instruments that investigators used for 

both diagnosis and outcome measurement in the studies reviewed here was extremely large. To 

help readers identify these, we created Table 5 (found at the end of this chapter) to briefly 

identify all measures, their acronyms or abbreviations, and their subscales, with a citation to a 

definitive source for the instrument. 

Quality and Strength of Evidence Evaluation 

Rating the quality of individual articles. For this systematic review, we developed our 

approach to assessing the quality of individual articles using domains and elements 

recommended in the evidence report by West and colleagues, Systems to Rate the Strength of 

Scientific Evidence.

122 We developed two quality-rating forms, one for the treatment literature 

and the other for the outcomes literature. Quality rating forms did not differ by disease. We 

tested several drafts of these forms, revising them as needed to ensure that they efficiently 

captured the desired information. The final grading forms can be found in Appendix B. 

We assessed the treatment literature through 25 items in 11 categories: (1) research aim/study 

question, (2) study population, (3) randomization, (4) blinding, (5) interventions, (6) outcomes, 

(7) statistical analysis, (8) results, (9) discussion, (10) external validity, and (11) 

funding/sponsorship. We did not exclude any studies with so-called fatal flaws, such as the 

approach to randomization. Rather, we reduced the study’s overall score if a category was flawed 

 

*

 Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
28 

or inadequate. Because patients and those administering interventions in the psychological 

treatment studies could not be blinded, we did not evaluate these items when studies included 

these interventions. However, we always evaluated whether the outcome assessor was blinded. 

Studies that were reported in more than one article were given the same quality grade. 

We weighted each item equally and calculated a score out of 100 percent. We then collapsed 

those scores into three categories: poor, 0 percent to 59 percent; fair, 60 percent to 74 percent; 

and good, 75 percent or better. 

For the outcomes literature, we used 17 items in 8 categories: (1) research aim/study 

question, (2) study population, (3) eating disorder diagnosis method, (4) study design, (5) 

statistical analysis, (6) results/outcome measurement, (7) external validity, and (8) discussion. As 

with the RCTs, we weighted each item equally. Rather than calculating a score out of 100 

percent, however, we converted ratings for each item into numeric values of 0, 1, or 2, in which 

0 = poor, 1 = fair, and 2 = good. Studies without comparison groups were not evaluated by items 

addressing this aspect of design. However, studies that included comparison groups were scored 

as “good” on one item, whereas those without were scored as “poor” on that item. We calculated 

the mean score for all graded items and we concluded that, overall, an article should be graded as 

poor with a rating < 1, fair with a rating ≥ 1 and < 1.5, and good with a rating of ≥ 1.5. 

Each quality grade was the composite (averaged) rating of two independent evaluators. The 

only items reconciled between the evaluators were those in which one rater provided a score for 

the item and the other said the item was not applicable. In assessing quality of the treatment 

studies, we asked the two evaluators to discuss their results if the difference in their total scores 

was 20 points or greater, but we did not require them to come to agreement. 

Rating the strength of the available evidence. We rated the strength of the evidence base 

for both interventions and disease outcomes separately for the three diseases, using a single 

scheme for all bodies of evidence. Starting with the West et al. report that compared various 

schemes for grading bodies of evidence,122 we based our evaluation on criteria developed by 

Greer et al.,123 which we deemed most applicable to the study designs in this review. It includes 

three domains: quality of the research, quantity of studies (including number of studies and 

adequacy of the sample size), and consistency of findings. 

We graded the body of literature applicable to each of the six KQs separately. For the 

treatment literature, we further divided studies by whether the intervention was pharmaceutical, 

behavioral, or a combination. Three senior staff defined by consensus four strength-of-evidence 

categories, as follows: 

• I. Strong evidence base. The evidence is from studies of strong design; results are 

both clinically important and consistent with minor exceptions at most; results are 

free from serious doubts about generalizability, bias, or flaws in research design. 

Studies with negative results have sufficiently large samples to have adequate 

statistical power. 

• II. Moderate evidence base. The evidence is from studies of strong design, but some 

uncertainty remains because of inconsistencies or concern about generalizability, 

bias, research design flaws, or adequate sample size. Alternatively, the evidence is 

consistent but derives from studies of weaker design. 

• III. Weak evidence base. The evidence is from a limited number of studies of weaker 

design. Studies with strong design either have not been done or are inconclusive. 

• IV. No evidence base. No published literature. 
29 

Peer Review Process 

Among the more important activities involved in producing a credible evidence report is 

conducting an unbiased and broadly based review of the draft report. External reviewers for this 

report included clinicians, representatives of professional societies and advocacy groups, and 

potential users of the report, including TEP members (see Appendix D†). We charged peer 

reviewers with commenting on the content, structure, and format of the evidence report and 

asked them to complete a peer review checklist. We revised the report, as appropriate, based on 

their comments. 

 

†

 Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
30 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

Acronym and Full Name 

of Test Description of Test and Subscales 

ABOS: Anorectic Behaviour 

Scale for Inpatient 

Observation124

Proxy-report (relatives) questionnaire to obtain information about patient’s behaviors 

and attitudes; 3 factors: eating behaviors, concerns with weight and food, denial of 

proteins; bulimic-like behaviors; hyperactivity. 

ABS: Anorectic Behavior 

Scale125 Administrator-completed questionnaire about patient’s behavior while in hospital; 8 

items on resistance to eating, 8 items on methods of disposing of food, 6 items on 

overactivity. 

ANSS: Anorexia Nervosa 

Symptom Score126 Clinical rating scale with psychological, social, and physical severity scores and 

subscales. 

BAT: Body Attitudes 

Test127,128 Self-report questionnaire to measure subjective body experience and attitude towards 

one’s body; 3 factors: negative attitudes about body size, lack of familiarity with one’s 

own body, body dissatisfaction. 

BDI: Beck Depression 

Inventory129 One of the most widely used self-report measures for depression. It is a 21-item test 

presented in multiple choice format that measures the presence and degree of 

depression in adolescents and adults. 

BEDCI: Binge Eating 

Disorder Clinical 

Interview130

Structured clinical interview to establish the diagnosis of BED and both purging and 

nonpurging types of BN. 

BES: Binge Eating Scale131 Self-report measure of binge eating severity as measured by loss of control over eating 

behavior; 8 items on behavioral manifestations, 8 items on feelings and cognitions. 

BIAQ: Body Image 

Avoidance Questionnaire132 Self-report measure to assess avoidance of situations that provoke concern about 

physical appearance (including wearing tight fitting clothing, social outings, physical 

intimacy); 4 subscales: Eating Restraint, Clothing, Grooming/Weighing, Social Activities

BITE: Bulimic Investigation 

Test Edinburgh133 Brief self-report questionnaire with 2 subscales designed to assess the symptoms and 

severity of binge eating episodes. 

BSI: Brief Symptom 

Inventory134 Brief self-report instrument to assess patients at intake for psychiatric problems; 9 

Primary Symptom Dimensions: Somatization, Obsessive-Compulsive, Interpersonal 

Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, 

Psychoticism; 3 Global Indices: Global Severity Index, Positive Symptom Distress 

Index, Positive Symptom Total. 

BSQ: Body Shape 

Questionnaire135 

Self-report inventory to measure worries about weight and body shape. 

BSQ-short version: Body 

Shape Questionnaire – 

Short Version136

Self-report inventory to measure worries about weight and body shape. 

BSS: Body Satisfaction 

Scale137 Self-report instrument to assess body image satisfaction; 3 subscales: general, body, 

head. 

Bulimic Thoughts 

Questionnaire138 Self-report instrument of cognitive patterns and distortions associated with bulimic 

behavior. 

CBCL: Child Behavior 

Checklist139 Parent-report standardized assessment of behavioral problems and social 

competencies of children ages 4 to 18; 3 scores: total, internalizing behaviors (fearful, 

shy, anxious, inhibited), externalizing behaviors (aggressive, antisocial, under 

controlled). 

CCEI: Crown-Crisp 

Experimental Index140 Scale to measure neurotic symptomatology; 6 subscales: free-floating anxiety, phobic 

anxiety, obsessionality, somatic concomitants of anxiety, depression, hysterical 

personality. 

CDI: Children’s Depression 

Inventory141 Brief self-report test to measure cognitive, affective, and behavioral signs of depression 

in persons 6 to 17 years of age; 5 factors: negative mood, interpersonal problems, 

ineffectiveness, anhedonia, negative self-esteem. 
31 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

(continued) 

Acronym and Full Name 

of Test Description of Test and Subscales 

CDRS: Contour Drawing 

Rating Scale142 Instrument to assess body size perception and dissatisfaction; 9 male and 9 female 

contour drawings shown to subjects who are asked to indicate which most closely 

resembles their current size and their ideal figure; the discrepancy is a measure of 

body dissatisfaction in 3 scores: real body, ideal body, body satisfaction index. 

CGI or GIS: Clinical Global 

Impression143 Clinician-rated scale to assess treatment response in psychiatric patients; 3 subscales: 

severity of illness (CGI-S), global improvement (CSI-G), efficacy index (CGI-EI). 

DICA-R: Diagnostic 

Interview for Children and 

Adolescents – Revised144

Semistructured clinical interview to determine Axis I psychiatric diagnoses in children 

and adolescents. 

DIET: Dieter’s Inventory of 

Eating Temptations145 Self-report inventory to assess behavioral competence in 6 weight control situations: 

overeating, negative emotions, exercise, resisting temptation, positive social, food 

choice. 

DSED: Diagnostic Survey 

for Eating Disorders146 Self-report questionnaire to quantify frequency of disturbed behavior. 

EAT: Eating Attitudes 

Test147 Standardized self-report measure of symptoms and concern characteristics of eating 

disorders; 2 versions: EAT-26, EAT-40. 

EDE: Eating Disorder 

Examination148 Semistructured interview to measure specific psychopathology of anorexia nervosa and 

bulimia nervosa; 4 subscales: dietary restraint, eating concern, weight concern, shape 

concern. 

EDE-Q4: Eating Disorders 

Evaluation Questionnaire – 

Version 4149

Self-report assessment of thoughts and behaviors commonly found in eating disorders; 

4 subscales: dietary restraint, eating concern, weight concern, shape concern. 

EDI-1: Eating Disorder 

Inventory-1149 Self-report questionnaire to measure psychiatric and behavioral traits commonly 

associated with eating disorders; 8 scales: drive for thinness, bulimia, body 

dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive 

awareness, maturity fears. 

EDI-2: Eating Disorder 

Inventory- 2150 

Standardized self-report measure of psychiatric symptoms commonly associated with 

anorexia nervosa, bulimia nervosa, or other eating disorders; 8 subscales as for 

EDI-1, plus asceticism, impulse regulation, and social insecurity. 

FACES III: Family 

Adaptability and Cohesion 

Evaluation Scales151 

Instrument to assess family adaptation and cohesion. Family cohesion assesses 

degree of separation or connection of family members to the family; 4 levels of family 

cohesion range from extreme low cohesion to extreme high cohesion: disengaged, 

separated, connected, enmeshed; 4 levels of adaptability: rigid, structured, flexible, 

chaotic. 

FAM III: Family 

Assessment Measure152 

Self-report measure that assesses the strengths and weaknesses of functioning within 

a family; can be completed by pre-adolescents, adolescents, and adult family members 

(ages 10 years to adult); contains 7 subscales: Task Accomplishment, Role 

Performance, Communication, Affective Expression, Involvement, Control, Values and 

Norms. 

FES: Family Environment 

Scale153 Instrument to assess actual, preferred, and expected social environment of all types of 

families; 10 subscales: cohesion, expressiveness, conflict, independence, 

achievement, intellectual-cultural, active-recreation, moral-religious, organization, 

control. 

FMPS: Frost 

Multidimensional 

Perfectionism Scale154

Self-report measure of perfectionism; original measure had 6 subscales (Concern Over 

Mistakes, Personal Standards, Parental Expectations, Parental Criticism, Doubts About 

Actions, Organization). 

FNE: Fear of Negative 

Evaluation155,156 Scale to measure social anxiety about receiving negative evaluations from others; 2 

subscales: Negative Expectations, Negative Public Evaluation. 

Brief-FNE: Brief Fear of 

Negative Evaluation157 Brief version of the original FNE. 
32 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

(continued) 

Acronym and Full Name 

of Test Description of Test and Subscales 

FRS: Figure Rating 

Scale158 Silhouette drawings of male and female adult body figures ranging from very thin to 

very large used as measure of personal body perception; 3 subscales: Real Body, Ideal 

Body, Body Satisfaction Index. 

GAAS: Goldberg Anorectic 

Attitude Scale159 

Scale to measure short-term changes in anorectic cognitions across treatment 

including measures of hyperactivity, access, self-care, selective appetite, and denial of 

illness. 

GAF: Global Assessment of 

Functioning16 Clinician-derived instrument to measure the highest level of social and occupational 

functioning in the previous week and year; sometimes broken down into the GAF-F 

function score (not including symptoms) and the GAF-S symptom score (not including 

function). 

GIS: Global Improvement 

Scale143 See CGI (Clinical Global Improvement Scale). 

HAM-A: Hamilton Anxiety 

Rating Scale160 Semistructured interview to assess severity of anxiety symptomatology. 

HAM-D or HDRS: Hamilton 

Depression Rating Scale161 Semistructured interview to assess an array of behavioral, affective, and vegetative 

symptoms of depression. 

HGSHS: Harvard Group 

Scale of Hypnotic 

Susceptibility, Form A162

Measure of susceptibility to a wide range of hypnotic experiences, designed for 

assessing groups of subjects. 

HRQ: Helping Relationship 

Questionnaire163 Patient-rated instrument to measure therapeutic alliance. 

HSCL: Hopkins Symptom 

Checklist134 Self-report screening instrument to identify common psychiatric symptoms; 9 

subscales: somatization, obsessive–compulsive symptoms, interpersonal sensitivity, 

depression, anxiety, anger or hostility, phobic anxiety, paranoid ideation, psychotic 

symptoms. 

IBC: Interactive Behavior 

Code164 A global interferential measure of communication, problem solving, and conflict, with 22 

coded items rated by independent observers; summary scores are computed for 

negative and positive communication. 

IIP: Inventory of 

Interpersonal Problems165 Instrument to measure interpersonal problems and level of distress arising from 

interpersonal sources. 

LCB: Locus of Control of 

Behavior166 Instrument to measure the extent to which individuals believe they are responsible for 

personal problem behavior. 

LIFE: Longitudinal Interval 

Continuation Evaluation167 Semistructured interview and rating system to assess longitudinal course of psychiatric 

disorders in several areas: psychopathology, nonpsychiatric mental illness, treatment, 

psychosocial functioning, overall severity, narrative account. 

MCMI: Millon Clinical 

Multiaxial Inventory168 Lengthy test to diagnose 14 personality disorders and 10 clinical syndromes; scales: 14 

Personality Pattern Scales, 10 Clinical Syndrome Scales, 3 Modifying Indices, 1 

Validity Index. 

MMPI: Minnesota 

Multiphasic Personality 

Inventory169

Test of adult psychopathology; 8 Validity Scales, 5 Superlative Self-Presentation 

Subscales, 10 Clinical Scales, 9 Restructured Clinical (RC) Scales, 15 Content Scales, 

27 Content Component Scales, 20 Supplementary Scales, 31 Clinical Subscales 

(Harris-Lingoes and Social Introversion Subscales), and various special or settingspecific indices. 

MOCI: Maudsley 

Obsessive Compulsive 

Index170

Self-report questionnaire to measure the presence of obsessional-compulsive 

behaviors; scores: total obsessional symptoms; checking; washing; 

doubting/conscientious; slowness/repetition. 

MPS: Multidimensional 

Perfectionism Scale154 Self-report instrument to assess perfectionism; 6 subscales: concern over mistakes, 

personal standards, parental expectations, parental criticism, doubts about action, 

organization. 
33 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

(continued) 

Acronym and Full Name 

of Test Description of Test and Subscales 

M-R Scales: Morgan and 

Russell Scales171 Structured interview to give a brief but thorough assessment of the central clinical 

features of anorexia nervosa; 5 subscales: eating behavior, menstrual state, mental 

state, relevant attitudes, socioeconomic state; sixth scale allows a self-progress rating. 

M-R-H Scale; MorganRussell-Hayward Scale172 Guided interview concerned with clinical features of anorexia nervosa to evaluate 

eating behavior, body weight, mental state, and other attitudes relevant to anorexia 

nervosa; 5 scales: nutrition, menses, mental state, psycho-sexual state, socioeconomic 

state; additional subscales include: food intake, concern at body image, body weight, 

menstrual pattern, disturbance of mental state, attitudes toward sexual matters, overt 

sexual behavior, attitude to menstruation, relationship with family, emancipation from 

family, personal contacts, social activities, employment record. 

MRT: Vandenberg and 

Kuse’s Adaptation of 

Shepard and Metzler’s 

Three-dimensional Mental 

Rotations Test173

Self-report test of visuospatial ability in which participants view a depiction of a 3-

dimensional target figure and 4 test figures and determine which of the test figures are 

rotated versions of the target figure. 

PARQ: Parent Adolescent 

Relationship 

Questionnaire174

Instrument completed by parents and adolescents 10 through 19 years of age to 

measure relationship between parents and adolescents; 3 scales: Overt Conflict/Skill 

Deficits, Extreme Beliefs, Family Structure. 

PGWB: Dupuy’s 

Psychological General 

Well-being Index175

Self-report inventory to measure self-representations of intrapersonal affective or 

emotional states reflecting a sense of subjective well-being or distress; 6 intrapersonal 

subscales: anxiety, depressed mood, positive well-being, self-control, general health, 

vitality. 

PSE: Present State 

Examination176 

Global index of mental state disturbance. 

PSR: Psychiatric Status 

Rating177 

Clinician-administered instrument to determine the severity of a range of psychiatric 

disorders that has been used to determine eating disorder outcomes. 

QEWP-R: Questionnaire of 

Eating and Weight Patterns 

– Revised178 

Self-report questionnaire to assess a range of features and problems associated with 

obesity and eating disorders. 

RAS: Rathus Assertiveness 

Schedule179 Self-report instrument to measure assertiveness. 

RSE: Rosenberg SelfEsteem Scale180 Self-report instrument to measure overall self-esteem. 

SADS-C: Schedule for 

Affective Disorders and 

Schizophrenia-Change 

Version181

Structured interview to differentiate schizophrenia from mood disorders; 2 subscales: 

depression, mania. 

SAMS (Situational Appetite 

Measures) Urge and SAMS 

Efficacy182 

Complementary scales to measure the strength of the urge to binge in 40 different 

situations and the degree of confidence in one’s ability to resist a binge in those same 

40 situations. 

SAS: Social Adjustment 

Scale183 Self-report questionnaire to assess social and work-related functions; 6 subscales: 

work, social and leisure, extended family, marital, prenatal, family unit. 

SCFI: Standardized Clinical 

Family Interview184 Standardized clinical interview used with families in which the interviewer tries to get 

responses from all family members and adopts a neutral style. Questions concern 

numerous areas of family life, mainly what sort of family it is, who does what, who is 

like whom, life cycle, roles and responsibilities, conflicts, decisions, discipline, relation 

to the environment. 

SCI: Shapiro Control 

Inventory185 

Self-report measure of the psychological construct of control (comparable to Locus of 

Control scales) with 9 subscales. 
34 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

(continued) 

Acronym and Full Name 

of Test Description of Test and Subscales 

SCID-I: Structured Clinical 

Interview I for the DSM 

IV186

Structured diagnostic interview to assess presence of current or past DSM IV Axis I 

major psychiatric disorders. 

SCL-90 R Symptom 

Checklist 90-Revised134 General measure of psychopathology, including various forms of anxiety, depression, 

paranoia, psychotic features. Subscales: Global Severity Index (GSI) to measure 

overall psychological distress; Positive Symptom Distress Index to measure the 

intensity of symptoms; Positive Symptom Total of number of self-reported symptoms 

(Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Hostility, 

Phobic Anxiety, Paranoid Ideation, Psychoticism). 

SDS: Zung Self-rating 

Depression Scale187 Self-report assessment to quantify depression, using criteria of pervasive depressed 

affect and its physiological and psychological concomitants. 

SF-36: Medical Outcomes 

Study Short Form Health 

Survey188

Self-report questionnaire to assess health-related quality of life; 8 subscales: physical 

function, role physical, bodily pain, general health, mental health, role emotional, social 

function, vitality, 2 composite scores: physical health; mental health. 

SIAB-P: Structured 

Interview for Anorexia and 

Bulimia Nervosa189 

Interview to assess severity of current eating disorder symptoms; 6 subscales: body 

image and ideal of slimness, social integration and sexuality, depression, obsessive 

compulsive syndromes and anxiety, bulimic symptoms, laxative abuse. 

SMFQ: Short Mood and 

Feeling Questionnaire190 Self-report measure of childhood and adolescent depression for children 8 to 16 years 

of age. 

SOC: Stages of Change 

Scale191 

Self-report inventory to describe how respondents feel as they initiate counseling; 4 

subscales: Precontemplation, Contemplation, Action, Maintenance. 

SPAQ: Seasonal Patterns 

Assessment 

Questionnaire192

Self-report instrument to rate the presence and severity of seasonal variation in mood, 

sleep, and eating-related variables; 2 added items monitor seasonal bingeing and 

purging patterns. 

STAI: State Trait Anxiety 

Inventory193 

Standardized self-report assessment of both state and trait anxiety (2 subscales). 

STAXI: State Trait Anger 

Expression Inventory194 Self-report inventory to assess components of anger and anger expression of normal 

and abnormal personality. 

STPI: State Trait 

Personality Inventory193 

Self-report personality inventory. 

SUDS: Subjective Units of 

Distress195 Self-report measure of intensity of subjective distress in response to a particular 

stimulus. 

TAS-20: Toronto 

Alexithymia Scale196 Self-report inventory to assess the alexithymia construct (difficulty recognizing, 

identifying, and communicating emotions; reduced fantasy capacity; and an externally 

oriented cognitive style); 2 dimensions: identifying feelings (DIF), describing feelings 

(DDF). 

TCI: Temperament and 

Character Inventory197 

Self-report measure of temperament and character; 7 subscales: Novelty Seeking, 

Harm Avoidance, Reward Dependence, Persistence, Self-Directedness, 

Cooperativeness, Self-Transcendence. 

TFEQ: Three-Factor Eating 

Questionnaire198 Self-report inventory; 3 subscales: Cognitive-Restraint, Hunger, Disinhibition. Also 

known as the Eating Inventory. 

WAIS: Wechsler Adult 

Intelligence Scale199 Structured, clinician-administered general test of intelligence for persons 16 years of 

age and older; 6 Verbal tests: Information, Comprehension, Arithmetic, Digit Span, 

Similarities, Vocabulary; 5 Performance subtests: Picture Arrangement, Picture 

Completion, Block Design, Object Assembly, Digit Symbol. 

WELSQ: Weight Efficacy 

Life Style Questionnaire200 Self-report measure of confidence about successfully resisting the desire to eat; 5 

situational subscales: Negative Emotions, Availability, Social Pressure, Physical 

Discomfort, Positive Activities. 
35 

Table 5. Diagnostic and outcome measures used in randomized controlled trials and outcome studies 

(continued) 

Acronym and Full Name 

of Test Description of Test and Subscales 

WLFL: Work, Leisure and 

Family Life 

Questionnaire201 

Self-report instrument to measure social adjustment and functioning; 8 scales: work 

outside the home, housework, social and leisure activities, extended family, marital, 

parental-older children, parental-baby, family unit. 

YBC-EDS and YBOCS-ED: 

Yale-Brown-Cornell Eating 

Disorder Scale202

Interview to assess preoccupations and rituals associated with eating disorders: 

symptom checklist produces 3 dimensions of preoccupations and rituals (severity, 

motivation, ego syntonicity) and covers 18 general categories of rituals and 

preoccupations. 

Y-BOCS- BE: Yale-Brown 

Obsessive Compulsive 

Scale Modified for Binge 

Eating203

Clinician-rated inventory of obsessive-compulsive problems adapted for use with bingeeating disorder. 

Y-BOCS Score: YaleBrown Obsessive 

Compulsive Scale204

Clinician-rated scale with separate subtotals for severity of obsessions and 

compulsions; 2 subscales: obsessions, compulsions. 

Youth Self-Report139,205 Self-report inventory on various behavior problems. 
37 

Chapter 3. Results: Anorexia Nervosa 

This chapter presents results of our literature search and our findings for the key questions 

(KQs) regarding treatment for anorexia nervosa (AN). We examine evidence for the efficacy of 

various treatments or combinations of treatments for AN (KQ 1), harms associated with the 

treatment or combination of treatments for AN (KQ 2), factors associated with the efficacy of 

treatment for AN (KQ 3), and whether the efficacy of treatment for AN differs by sex, gender, 

age, race, ethnicity, or cultural groups (KQ 4). 

We report first on specific details about the yields of the literature searches and 

characteristics of the studies, then on literature pertaining to treatment (KQs 1 to 4). For each 

included study, detailed evidence tables appear in Appendix C.* We report first on medication 

trials (Evidence Table 1), then combined medication and behavioral interventions (Evidence 

Table 2), then behavioral interventions separately for adults (Evidence Table 3), and adolescents 

(Evidence Table 4). We distinguish between behavioral interventions for adolescents and adults 

in order to address age differences (KQ 4) as clearly as possible, given the current state of the 

literature. Within each evidence table, studies are listed alphabetically by author. 

Overview of Included Studies 

We identified 32 studies published in 35 articles addressing treatment efficacy for AN; of 

these 15 were medication trials. We were unable to categorize medication studies into adolescent 

and adult trials given the paucity of medication trials focusing on adolescents. 

We rated two medication trials as good,206 six as fair,207-213 and seven as poor (not discussed 

further).124,214-219 Of the studies judged fair or good, the medications studied included secondgeneration antidepressants,206,207 tricyclic antidepressants,208,209 nutritional supplements,213 and 

hormones.210-212 Study designs included medication versus placebo (six trials), medication A 

versus medication B versus placebo (one), and medication versus waiting list or nonmedication 

control (one). 

Eighteen of the 32 studies were behavioral intervention trials. In this report behavioral 

interventions refer to all forms of psychotherapy including cognitive, supportive, dynamic, 

family, individual, and group. One trial was of therapeutic warming.220 We rated two of these 

trials as good,221,222 nine as fair,223-231 and six as poor (not discussed further).220,232-236 Of the 11 

trials reviewed here, six were conducted among adults and five among adolescents. Behavioral 

interventions studied include cognitive behavioral therapy (CBT),223-225 cognitive analytic 

therapy (CAT),226 focal psychoanalytic therapy,228 and various forms of family 

therapy.221,222,229-231,237 The behavioral intervention trials used two designs: psychotherapy A 

versus psychotherapy B, and psychotherapy A versus psychotherapy B versus control. 

We do not discuss studies with a quality rating of “poor” further; reasons these studies 

received this rating are presented in Table 6. While studies were not lacking in all areas, the most 

frequent deficiencies across studies contributing to a poor rating include the following: a fatal 

flaw in the approach to randomization or the approach not being described; investigators and 

outcome assessors not being blinded to study arm or their blinding status not being 

described; adverse events not being reported; the statistical analysis not including or not 

reporting whether a power analysis was conducted; a lack of necessary controls for confounding 

 

*

 Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
38 

Table 6. Reasons for poor quality ratings and number of trials with poor ratings: anorexia nervosa 

Reasons Contributing to 

Poor Ratings Types of Intervention, Number of Times Flaw Was Detected, and Citations 

Research Aim 

Hypothesis not clearly 

described 

Medication-only trials: 0 

Behavioral intervention trials (adults): 0 

Behavioral intervention trials (adolescents): 0 

Study Population

Characteristics not clearly 

described 

Medication-only trials: 0 

Behavioral intervention trials (adults): 0 

Behavioral intervention trials (adolescents): 0 

No specific inclusion or 

exclusion criteria 

Medication-only trials: 1214

Behavioral intervention trials (adults): 1233

Behavioral intervention trials (adolescents): 0 

Randomization

Protections against 

influence not in place 

Medication-only trials: 6124,214-216,218,219

Behavioral intervention trials (adults): 1233

Behavioral intervention trials (adolescents): 0 

Approach not described Medication-only trial: 6124,214-216,218,219

Behavioral intervention trials (adults): 1233

Behavioral intervention trials (adolescents): 1236

Whether randomization 

had a fatal flaw not known 

Medication-only trials: 6124,214-216,218,219

Behavioral intervention trials (adults): 1233

Behavioral intervention trials (adolescents): 2235,236

Comparison group(s) not 

similar at baseline 

Medication-only trials: 3214,215,219

Behavioral intervention trials (adults): 0 

Behavioral intervention trials (adolescents): 1236

Blinding

Study subjects Medication-only trials: 4215-217,219

Behavioral intervention trials (adults): N/A 

Behavioral intervention trials (adolescents): N/A 

Investigators Medication-only trials: 6124,215-219

Behavioral intervention trials (adults): 1220

Behavioral intervention trials (adolescents): 0 

N/A, not applicable. 
39 

Table 6. Reasons for poor quality ratings and number of trials with poor ratings: anorexia nervosa 

(continued) 

Reasons Contributing to 

Poor Ratings Types of Intervention, Number of Times Flaw Was Detected, and Citations 

Outcomes assessors Medication-only trials: 6124,215-219

Behavioral intervention trials (adults): 3220,233,234

Behavioral intervention trials (adolescents): 2235,236

Interventions

Interventions not clearly 

described 

Medication-only trials: 0 

Behavioral intervention trials (adults): 0 

Behavioral intervention trials (adolescents): 0 

No reliable measurement 

of patient compliance 

Medication-only trials: 5214-217,219

Behavioral intervention trials (adults): 1220

Behavioral intervention trials (adolescents): 1235

Outcomes

Results not clearly 

described 

Medication-only trials: 0 

Behavioral intervention trials (adults): 2220,233

Behavioral intervention trials (adolescents): 0 

Adverse events not 

reported 

Medication-only trials: 3214,215,217

Behavioral intervention trials (adults): 2233,234

Behavioral intervention trials (adolescents): 1235 

Statistical Analysis

Statistics inappropriate Medication-only trials: 0 

Behavioral intervention trials (adults): 3220,232,233

Behavioral intervention trials (adolescents): 0 

No controls for 

confounding (if needed) 

Medication-only trials: 3214,218,219

Behavioral intervention trials (adults): 2232,233

Behavioral intervention trials (adolescents): 2235,236

Intention-to-treat analysis 

not used 

Medication-only trials: 5214,215,217-219

Behavioral intervention trials (adults): 2220,233

Behavioral intervention trials (adolescents): 2235,236

Power analysis not done or 

not reported 

Medication-only trials: 7124,214-219

Behavioral intervention trials (adults): 4220,232-234

Behavioral intervention trials (adolescents): 1235 
40 

Table 6. Reasons for poor quality ratings and number of trials with poor ratings: anorexia nervosa 

(continued) 

Reasons Contributing to 

Poor Ratings Types of Intervention, Number of Times Flaw Was Detected, and Citations 

Results

Loss to followup 26% or 

higher or not reported 

Medication-only trials: 2214,215

Behavioral intervention trials (adults): 1233

Behavioral intervention trials (adolescents): 0 

Differential loss to followup 

15% or higher or not 

reported 

Medication-only trials: 1214,215 

Behavioral intervention trials (adults): 3220,233,234

Behavioral intervention trials (adolescents): 1236

Outcome measures not 

standard, reliable, or valid 

in all groups 

Medication-only trials: 0 

Behavioral intervention trials (adults): 1220

Behavioral intervention trials (adolescents): 0 

Discussion

Results do not support 

conclusions, taking 

possible biases and 

limitations into account 

Medication-only trials: 0 

Behavioral intervention trials (adults): 0 

Behavioral intervention trials (adolescents): 0 

Results not discussed 

within context of prior 

research 

Medication-only trials: 0 

Behavioral intervention trials (adults): 0 

External validity: 

population not 

representative of US 

population relevant to 

these treatments 

Medication-only trials: 3215,217,218

Behavioral intervention trials (adults): 1220

Behavioral intervention trials (adolescents): 0 

Funding/sponsorship not 

reported 

Medication-only trials: 6214-219

Behavioral intervention trials (adults): 3220,232,234

Behavioral intervention trials (adolescents): 1235

or results not presented using an intention-to-treat approach; and sources of funding not being 

stated. 

Dropouts are a significant element in the quality of all these trials. Table 7 documents the 

total sample size and attrition rates in the trials reviewed in this chapter. 

Participants 

Of the 19 studies rated fair or good, 10 were conducted in the United States, six in the United 

Kingdom, two in Canada, and one in New Zealand. A total of 891 individuals participated in fair 

or good clinical trials for AN. One study failed to report sex. From those studies that reported 

sex, 861 women and 23 men participated. Seventeen studies failed to report ethnicity for 

participants. Of those that did, 123 participants were identified as white, eight as Asian and three 

as other ethnicity. 
41 

Table 7. Dropout rates for randomized controlled trials: anorexia nervosa 

Author 

Total 

Enrollment 

Total 

Dropouts 

Group 1 

Treatment 

(% dropout) 

G2 

Treatment 

(% dropout) 

G3 

Treatment 

(% dropout) 

G4 

Treatment 

(% dropout) 

Medication Trials 

Attia et al., 

1998206 33 1 (+1 

unreliable 

self-reporter) 

(3%) 

Fluoxetine 

(NR) 

Placebo (NR) 

Kaye et al., 

2001207 39 26 (66%) Fluoxetine 

(16% at 30 

days, 47% at 

1 year) 

Placebo (5% at 

30 days, 85% at 

1 year) 

 

Biederman et 

al.,1985209 25 0 (0%) Amitriptyline 

(0%) 

Placebo (0%) 

Halmi et 

al.,1986208 72 18 (25%) Amitriptyline 

(30%) 

Cyproheptadine 

(25%) 

Placebo 

(20%) 

Hill, et al., 

2000212 15 0 (0%) Recombinant 

human growth 

hormone (0%) 

Placebo (0%) 

Klibanski et al., 

1995210 48 4 (8%) Estrogen/ 

progestin 

(14%) 

Control (4%) 

Miller, Grieco, 

and Klibanski 

2005211

38 5 (13%) Testosterone 

(NR) 

Placebo (NR) 

Birmingham, 

Goldner, and 

Bakan1994213

54 19 (35%) Zinc (39%) Placebo (32%) 

Behavioral Intervention Trials (Adult)

Channon et al., 

1989225 24 3 (13%) CBT (0%) Behavioral 

treatment (13%) 

Control (25%) 

McIntosh et al., 

2005224 56 21 (38%) CBT (37%) Interpersonal 

psychotherapy 

(43%) 

Nonspecific 

supportive 

clinical 

management 

(31%) 

Pike et al., 

2003223 33 3 (9%) CBT (0%) Nutritional 

counseling 

(20%) 

 

Dare et al., 

2001228 84 30 (36%) Focal 

psychotherapy 

(43%) 

Family therapy 

(27%) 

Cognitive 

analytic 

therapy (41%) 

Routine 

(32%) 

Treasure et al., 

1995226 30 10 (33%) Educational 

behavioral 

therapy (38%) 

Cognitive 

analytic therapy 

(29%) 

 

Crisp et al., 

1991227 and 

Gowers et 

al.,1994238

90 17 (19%) Inpatient 

(40%) 

Outpatient 

psychotherapy/ 

family therapy/ 

dietary 

counseling 

(10%) 

Group therapy 

(15%) 

No further 

treatment 

(0%) 

CBT, cognitive behavioral therapy; NR, not reported. 
42 

Table 7. Dropout rates for randomized controlled trials: anorexia nervosa (continued) 

Author 

Total 

Enrollment 

Total 

Dropouts 

Group 1 

Treatment 

(% dropout) 

G2 

Treatment 

(% dropout) 

G3 

Treatment 

(% dropout) 

G4 

Treatment 

(% dropout) 

Behavioral Intervention Trials (Adolescent)

Eisler et al., 

2000221 40 4 (10%) Conjoint 

family therapy 

(11%) 

Separated family 

therapy (10%) 

 

Geist et al., 

2000229 25 0 (0%) Family 

therapy (0%) 

Family group 

psychoeducation 

(0%) 

 

Russell et al., 

1987231 and 

Eisler et al., 

1997239

80 28 (35%) Family 

therapy (37%) 

Individual 

therapy (33%) 

 

Robin et al., 

1994230 and 

Robin, Siegel, 

and Moye 

1995237

24 2 (8%) Behavioral 

family 

systems 

therapy (8%) 

Ego-oriented 

individual 

therapy (8%) 

 

Lock et al., 

2005222 86 17 (20%) Long-term 

treatment 

(24%) 

Short-term 

treatment (16%) 

 

Key Question 1: Treatment Efficacy 

Medication Trials 

Table 8 presents results from medication treatment trials for AN, including treatment aims, 

setting (inpatient or outpatient), and a summary of outcomes. Similar to text, it is organized by 

medication class. Of the identified AN trials, eight were randomized controlled double-blind 

medication trials. Medication trials for AN were most commonly conducted in the context of 

clinical management or during or following inpatient refeeding. Of these, none reported race or 

ethnicity of participants, while all but one reported sex of participants; six were conducted in the 

United States. One study explicitly reported intention-to-treat analyses.212 The number of 

participants in the medication trials ranged from 15 to 72, with the total enrollment for all 

medication trials being 345. Thus, the average number of patients per study was 23. Based on 

those studies that reported sex, this includes 319 women and 1 man. 

Weight gain is the primary outcome variable in the treatment of AN. Secondary outcomes in 

this population include reduction of the psychological features of AN (e.g., body dissatisfaction 

and drive for thinness), reduction of associated behaviors such as overexercising, resumption of 

menses, and, in the bingeing and purging subtype, decreased binge eating and purging behaviors. 

Additional psychiatric outcomes include reduction in depression and anxiety. 

Second-generation antidepressants. The term “second-generation antidepressants” is 

commonly used in the psychiatric and pharmacological literature to distinguish newer 

antidepressants such as selective norepinephrine reuptake inhibitors (SNRIs), selective serotonin 

reuptake inhibitors (SSRIs), bupropion, nefazodone, and trazodone from traditional or firstgeneration antidepressants such as tricyclic antidepressants and monoamine oxidase inhibitors. 

We adopted this term to be consistent in terminology with other research conducted in the area of 

psychopharmacology. 
43 

Table 8. Results from medication trials: anorexia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Attia et al., 

1998206

Fluoxetine vs. 

placebo 

Inpatient 

Good 

Eating: 

AN behavior 

BSQ 

CGI 

EAT 

YBC-EDS 

Biomarker: 

IBW 

Psych: 

BDI 

CGI 

SCL-90 

Both groups 

experienced decreased 

clinician-rated ED 

symptoms and illness 

severity, ED concerns, 

depressed mood, 

obsessive-compulsive 

symptoms, and food 

preoccupation and 

rituals. Both groups 

increased percent IBW.

No statistics reported. No differences on any 

measures. 

Kaye et al., 

2001207

Fluoxetine vs. 

placebo 

Inpatient and 

outpatient 

Fair 

Eating: 

YBC-EDS 

Biomarker: 

ABW 

Psych: 

HAM-A 

HDRS 

YBOCS 

Fluoxetine completers 

experienced decreased 

anxious and depressed 

mood and increased 

percent ABW 

No differences on any 

measures. 

No differences on any 

measures. 

Biederman et al., 

1985209

Amitriptyline vs. 

placebo 

Inpatient and 

outpatient 

Fair 

Eating: 

EAT 

Biomarker: 

Weight 

Psych: 

Global severity 

HSCL 

SADS-C 

No statistics reported. No differences on any 

measures. 

No statistics reported. 

ABW, average body weight; AN, anorexia nervosa; BDI, Beck Depression Inventory; BMI, body mass index; BN, bulimia 

nervosa; BSQ, Body Shape Questionnaire; CGI, Clinical Global Impressions; EAT, Eating Attitudes Test; ED, eating disorders; 

HAM-A, Hamilton Anxiety Inventory; HAM-D, Hamilton Depression Inventory; HDRS, Hamilton Depression Rating Scale; 

HSCL, Hopkins Symptom Checklist; IBW, ideal body weight; Psych, psychiatric and psychological; rhGH, recombinant human 

grown hormone; SADS-C, Schedule for Affective Disorders and Schizophrenia-Change Version; SCL-90, (Hopkins) Symptom 

Checklist; tx, treatment; vs., versus; YBC-EDS, Yale-Brown-Cornell Eating Disorders Scale; YBOCS, Yale-Brown ObsessiveCompulsive scale. 
44 

Table 8. Results from medication trials: anorexia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Halmi et al., 

1986208

Amitriptyline vs. 

cyproheptadine 

vs. placebo 

Inpatient 

Fair 

Eating: 

Caloric intake 

Biomarker: 

Weight 

Psych: 

HAM-D 

BDI 

SCL-90 

No statistics reported. Cyproheptadine 

associated with fewer 

days to target weight, 

higher caloric intake, and 

less depressed mood 

compared to placebo. 

BN subgroup: 

amitriptyline associated 

with improved tx efficacy 

compared to 

cyproheptadine; neither 

drug differed from 

placebo. 

For non-BN subgroup: 

cyproheptadine 

associated with improved 

tx efficacy compared to 

placebo. No other 

subgroup comparisons 

were significant. 

No statistics reported. 

Hill et al., 

2000212

rhGH vs. 

placebo 

Inpatient 

Good 

Biomarker: 

Orthostasis 

Weight 

No statistics reported. rhGH associated with 

fewer days to restoration 

of normal orthostatic 

response compared to 

placebo. 

No statistics reported. 

Klibanski et al., 

1995210

Estrogen/ 

progestin vs. 

nonmedication 

control 

Outpatient 

Fair 

Eating: 

Recovery 

Remission 

Biomarker: 

Bone density 

Percent Body fat 

Percent IBW 

Weight 

No statistics reported. No differences on any 

measures. 

No differences on any 

measures. 

Miller et al., 

2005211

Testosterone vs. 

placebo 

Setting unknown 

Fair 

Biomarker: 

BMI 

IBW 

Psych: 

BDI 

No statistics reported. Testosterone associated 

with less depressed 

mood compared to 

placebo. 

Depressed mood 

increased less in 

testosterone-treated 

group. 

Birmingham et 

al., 1994213

Zinc vs. placebo 

Inpatient 

Fair 

Biomarker: 

BMI 

Percent body fat 

Weight 

No statistics reported. No differences on any 

measures. 

Zinc superior to placebo in 

rate of BMI increase. 
45 

Fluoxetine. Two trials used fluoxetine at different stages of refeeding in AN patients. In an 

inpatient study, Attia et al.206 randomized 31 females between 16 and 45 years who had achieved 

weight restoration of at least 65 percent of ideal body weight (IBW) to fluoxetine (60 mg/day) or 

placebo. The mean BMI at randomization was 15 kg/m2

. Patients continued to receive 

psychotherapy. No significant differences emerged between fluoxetine and placebo on weight 

gain (16 versus 13 pounds), psychological features of eating disorders, or depression or anxiety 

measures. Three percent of participants dropped out of fluoxetine treatment. 

In the second study, patients were randomly assigned to either initiation on fluoxetine or 

placebo before inpatient discharge with a beginning dosage of 20 mg/day adjusted over 52 weeks 

to a maximum of 60 mg/day.207 The range of weight for all participants at randomization was 76 

percent to 100 percent average body weight (ABW) with the majority above 90 percent. 

Outpatient psychotherapy was permitted. Dropout was considerable. Of 39 individuals 

randomized, only 13 remained at the 52-week endpoint (47 percent of fluoxetine and 85 percent 

of placebo). In this small group of completers, fluoxetine was associated with significantly 

greater weight gain, reduced anxiety, depression, obsessive-compulsive features, and eatingdisorder-related symptoms.

Tricyclic antidepressants. Two trials of fair or good quality investigated tricyclic 

antidepressant medication use. Neither provided strong data supporting the use of these 

medications in treating AN patients. 

Amitriptyline in doses up to 175 mg/day in 25 youth ages 11 to 17 years led to no significant 

differences in eating, mood, or weight outcomes in comparison to placebo.209 No patients 

dropped out in this trial. Halmi et al. compared amitriptyline (160 mg/day) versus 

cyproheptadine (32 mg/day) versus placebo in 72 females 13 to 36 years, determined to have AN 

according to the Diagnostic and Statistical Manual, third edition (DSM III).208 Daily caloric 

intake was significantly higher in cyproheptadine than placebo and significantly fewer days were 

needed to achieve target weight (in those who did) in both the amitriptyline and cyproheptadine 

groups, compared with placebo. Drop out was thirty percent in the amitriptyline group, 25 

percent in the cyproheptadine group, and 20 percent in the placebo group. 

Hormones. Investigators have studied three hormones in the treatment of AN: growth 

hormone (rGH), testosterone, and estrogen. Three weeks of transdermal testosterone (150 mg or 

330 mg) administered to 38 patients with AN ages 18 to 50 led to greater decreases in depression 

in patients who were depressed at baseline, but differences in weight were not interpretable.211

Dropout was 13 percent overall. 

Growth hormone (15 mg/kg/day) administered to 14 female and 1 male patient receiving 

inpatient care for AN led to fewer days to display normal orthostatic heart rate response to a 

standing challenge among the treatment group than among placebo group.212 No patient dropped 

out of this study. 

Klibanski et al. compared estrogen/progesterone (0.625 mg Premarin® or 5 mg Provera® per 

day) versus nonmedication control in 48 females 16 to 43 years and found no differences 

between groups on bone density at 6 months.210 Dropout was 14 percent in hormone group and 4 

percent in the nonmedication group. 

Hormone treatment during the acute phase of AN illness does not appear to improve bone 

density.210 Scant, preliminary evidence suggests that rGH leads to faster normalization of 

orthostatic changes seen in AN212and that testosterone improves depression in individuals with 

AN and depressed mood.211 
46 

Nutritional supplements. The one study of nutritional supplements was performed in 54 

female inpatients older than 15 years with 14 mg/day zinc. It provides preliminary evidence that 

zinc may increase the rate of increase in BMI.213 Dropout was 39 percent in zinc and 32 percent 

in placebo, suggesting that conclusions from this study must be viewed with great caution. 

Summary of drug trials. All eight studies assessing the efficacy of medication interventions 

on AN examined weight gain; most reported on eating outcomes and some reported on additional 

symptom change. 

Overall, none of the pharmacological interventions for AN had a significant impact on 

weight gain. Although tricyclic antidepressants may be associated with greater improvement in 

secondary mood outcomes, this outcome does not appear to be associated with improved weight 

gain. No trial has been adequately replicated. 

Dropout rates for medication studies for AN are substantial, especially in outpatient trials. 

Conclusions drawn from studies with such high attrition must be reviewed with extreme caution. 

Taken together, the literature regarding medication treatments for AN is sparse and 

inconclusive. The vast majority of studies had small sample sizes and rarely had adequate 

statistical power to allow for definitive conclusions. Many studies examined patients who were 

receiving additional treatments in conjunction with the study medication, including 

psychological interventions and concurrent pharmacological treatments. Some of these studies 

examined patients who were in inpatient settings, thus limiting generalizability to outpatient 

treatment. Only one conducted intention-to-treat analyses; the remaining studies reported 

completer analyses only. With one exception,209 no medication trials have focused on adolescent 

patients. Because followup was limited, assessing longer-term impact of interventions on such 

outcomes as bone density was impossible. Finally, only one male participated in any of these 

studies, thereby making it impossible to draw any conclusions about the pharmacological 

treatment of AN in boys and men. 

Behavioral Intervention Trials 

Of the 11 behavior trials rated good or fair (Tables 9 and 10), four focused solely on 

adolescents (mean ages 14 to 15), six focused solely on adults (approximately 18 years and 

older), and one combined adolescent and adult patients. Of the 11 trials, four were conducted in 

the United States. We present behavioral interventions for adults with AN in Table 9. 

Behavioral interventions for adults with anorexia nervosa. In the psychotherapy trials for 

adults only and the combined adult and adolescent trials, investigators tested CBT (three trials), 

various types of nonspecific therapy (three), family therapies (two), CAT (two), dietary 

counseling (one), interpersonal psychotherapy (IPT) (one), behavioral therapy (BT) (one), and 

focal analytic therapy (one). 

Cognitive behavioral therapy. CBT studies generally used a form of therapy tailored to AN 

that focused on cognitive and behavioral features associated with the maintenance of eating 

pathology. Of the three CBT studies, one followed inpatient weight restoration223 and two were 

done in the underweight state.224,225 CBT significantly reduced relapse risk and increased the 

likelihood of good outcome compared to nutritional counseling based on nutritional education 

and food exchanges after inpatient weight restoration.223 Of those receiving CBT, a greater 

number of individuals with good outcomes were also receiving antidepressant medication. 

One study of underweight AN outpatients compared CBT with IPT and nonspecific 

supportive clinical management (NSCM).224 IPT in the treatment of AN is based on IPT used for 

the treatment of depression240 and BN;241 it focuses on one of four interpersonal problem areas: 
47 

Table 9. Results from behavioral intervention trials in adults: anorexia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Channon et al., 

1989225

CBT vs. BT vs. 

‘Usual care’ 

control 

Outpatient 

Fair 

Eating: 

EDI 

M-R scale 

Biomarker: 

BMI 

M-R scale 

Psych: 

BDI 

MOCI 

M-R scale 

No statistics reported. At 6-month FU, CBT 

associated with better 

psychosexual functioning than 

BT and BT was associated 

with greater improvement in 

menstrual functioning than 

CBT. 

At 1-year FU, the BT group 

scored better than the CBT 

group on preferred weight. 

CBT and BT combined were 

associated with greater 

improvements on nutritional 

functioning than the control 

group. The control group 

showed greater improvements 

on drive for thinness than the 

combined CBT and BT 

groups. 

No statistics reported. 

McIntosh et al., 

2005224

CBT vs. IPT vs. 

NSCM 

Outpatient 

Fair 

Eating: 

EDE 

EDI 

Biomarker: 

BMI 

Percent body fat 

Weight 

Psych: 

GAF 

HDRS 

 Compared to IPT, NSCM 

associated with higher 

likelihood of ‘good’ global 

outcome. 

NSCM superior to IPT in 

improving global 

functioning and eating 

restraint over 20 weeks. 

NSCM superior to CBT 

in improving global 

functioning over 20 

weeks. 

CBT superior to IPT in 

improving eating 

restraint over 20 weeks. 

Pike et al., 

2003223

CBT vs. 

nutritional 

counseling 

Outpatient 

Fair 

Eating: 

Recovery 

Relapse 

Tx failure 

M-R scale 

No statistics reported. Compared to nutrition 

counseling, CBT associated 

with lower percentage tx 

failures, higher percentage 

‘good’ outcome, and longer 

time (weeks) to relapse. 

No statistics reported. 

ABW, average body weight; BDI, Beck Depression Inventory; BMI, body mass index; BT, behavioral therapy; CAT, cognitiveanalytic therapy; CBT, cognitive behavioral therapy; EBT, educational behavioral therapy; EDE, Eating Disorders Examination; 

EDI, Eating Disorders Inventory (EDI-2, Garner, 1991); FU, follow-up; GAF, Global Assessment of Functioning [DSM-IV]; 

HDRS, Hamilton Depression Rating Scale; IBW, ideal body weight; IPT, interpersonal therapy; MOCI, Maudsley Obsessional 

Compulsive Index; M-R, Morgan and Russell; NSCM, nonspecific supported clinical management, Psych, psychiatric and 

psychological; pt, patients; Tx, treatment, vs., versus. 
48 

Table 9. Results from behavioral intervention trials in adults: anorexia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Dare et al., 

2001228

CAT vs. focal vs. 

family vs. 

‘routine’ therapy 

Outpatient 

Fair 

Eating: 

M-R scale 

Recovery 

Biomarker: 

BMI 

Percent ABW 

M-R scale 

Psych: 

M-R scale 

No statistics reported. At 1-year FU, compared to 

routine tx, focal and family tx 

associated with higher weight; 

also, higher percentage of 

patients in focal and family tx 

were recovered or significantly 

improved (i.e., > 85% IBW, 

no/few menstrual or BN 

symptoms). 

No statistics reported. 

Treasure et al., 

1995226

CAT vs. EBT 

Outpatient 

Fair 

Eating: 

M-R scales 

Biomarker: 

BMI 

Weight 

Psych: 

M-R scales 

Self progress 

scale 

No statistics reported. Compared to EBT, CAT 

associated with higher selfrating of improvement. 

No statistics reported. 

Crisp et al., 

1991227 and 

Gowers et al., 

1994238

Inpatient tx vs. 

outpatient 

individual and 

family therapy 

and dietary 

counseling vs. 

group therapy 

vs. no formal tx 

Inpatient and 

outpatient 

Fair 

Eating: 

M-R scale 

Remission 

Biomarker: 

BMI 

M-R scale 

Weight 

Psych: 

M-R scale 

At 1-year FU, global 

score and menstruation 

improved in all 4 

groups, nutrition score 

improved in 3 active tx 

groups, and mental 

state improved in 

outpatient family/diet 

counseling group. 

At 2-year FU, mental 

state improved in 

outpatient family/diet 

counseling; global 

score, menstruation, 

and nutrition improved 

in groups that received 

outpatient family/diet 

counseling and no 

formal tx. 

Compared to ‘no formal tx’, 

outpatient family/diet 

counseling associated with 

higher weight and BMI at 1- 

and 2-year FU. 

Compared to ‘no formal 

tx,’ weight increased 

more at 1-year FU in all 

3 active groups. 

Weight increased more 

at 2-year FU in 

outpatient family/diet 

counseling compared to 

‘no formal tx’ group. 
49 

Table 10. Results from behavioral intervention trials in adolescents only and adolescents and adults 

combined: anorexia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Eisler et al., 

2000221

CFT vs. SFT 

Outpatient 

Good 

Eating: 

Bulimic symptoms 

EAT 

EDI 

Biomarker: 

Percent ABW 

BMI 

Weight 

Psych: 

MOCI 

SMFQ 

Depression 

Obsessionality 

No statistics reported. No statistics reported. CFT superior to SFT in 

reducing ED-related 

traits, depression, and 

obsessionality. 

Geist et al., 

2000229

Family therapy 

vs. family group 

psychoeducation 

Inpatient 

Fair 

Eating: 

EDI 

Biomarker: 

Percent IBW 

Psych: 

BSI 

CDI 

FAM III 

No statistics reported. No differences on any 

measures. 

No differences on any 

measures. 

Russell et al., 

1987231 and 

Eisler et al., 

1997239

Family therapy 

vs. individual 

therapy 

Outpatient 

Fair 

Eating: 

M-R scales 

Readmit rate 

Biomarker: 

Percent ABW 

M-R scales 

Weight 

Psych: 

M-R scales 

No statistics reported. No statistics reported. Among early onset, less 

chronic AN patients, 

family therapy superior to 

individual therapy in 

improving nutritional 

status, menstrual and 

psychosexual function, 

and weight over 1 year tx; 

family therapy also more 

likely associated with a 

‘good’ outcome over 1-

year tx and 5-year FU. 

ABW, average body weight; AN, anorexia nervosa; BDI, Beck Depression Inventory; BFST, behavioral family systems therapy; 

BMI, body mass index; BSI, Brief Symptom Inventory; BSQ, Body Shape Questionnaire; CDI, Children’s Depression Inventory; 

CFT, conjoint family therapy; EAT, Eating Attitudes Test; ED, eating disorders; EDE, Eating Disorders Examination; EDI, 

Eating Disorders Inventory; EOIT, ego-oriented individual therapy; FAM-III, Family Assessment Measure; FU, follow-up; IBC, 

Interaction Behavior Code; IBW, ideal body weight; MOCI, Maudsley Obsessional Compulsive Index; M-R, Morgan and 

Russell; PARQ, Parent Adolescent Relationship Questionnaire; Psych, psychiatric and psychological; SFT, separated family 

therapy; SMFQ, Short Mood and Feeling Questionnaire; tx, treatment; vs., versus; YBC-EDS, Yale-Brown-Cornell Eating 

Disorders Scale. 
50 

Table 10. Results from behavioral intervention trials in adolescents only and adolescents and adults 

combined: anorexia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Robin et al., 

1994230 and 

Robin et al., 

1995237

BFST vs. EOIT 

Outpatient and 

inpatient 

Fair 

Eating: 

EAT 

EDI 

Eating conflict 

Biomarker: 

BMI 

Weight 

Menstruation 

Psych: 

BDI 

BSQ 

PARQ 

IBC 

No statistics reported. No differences on any 

measures. 

BFST superior to EOIT in 

increasing BMI to post-tx 

and 1-year FU, and in 

improving mother’s 

positive communication at 

FU. 

Lock et al., 

2005222

Long-term vs. 

short-term family 

therapy 

Outpatient 

Good 

Eating: 

EDE 

YBC-EDS 

Biomarker: 

BMI 

Weight 

No differences on any 

measures. 

No differences on any 

measures. 

No differences on any 

measures among those 

with most severe YBCEDS symptoms. 

Longer-term tx 

associated with better 

BMI outcome in those 

with most severe ED 

symptoms, and with 

better EDE global 

outcome in those with 

non-intact families. 

interpersonal disputes, role transitions, grief, or interpersonal deficits. NSCM was designed for 

this study to mimic the type of treatment an individual could receive in the community from a 

provider familiar with the treatment of ED and incorporates elements of sound clinical 

management and supportive psychotherapy. In an intention-to-treat analysis, NSCM performed 

significantly better than IPT in producing global good outcome ratings; CBT outcomes fell in 

between and were not significantly different from the other two outcomes.224 The second study 

compared CBT with BT and a control group for 6 months.225 At 12-month followup, CBT 

showed no advantage over BT or control in eating, mood, or weight outcomes. 

On the basis of one trial, preliminary evidence suggests that CBT delivered after weight 

restoration may help to decrease relapse. In contrast, when delivered during the acute phase of 

the illness, CBT does not appear to offer significant advantage over NSCM, which did offer 

advantage over IPT. No evidence suggests that nutritional counseling alone is efficacious in the 

treatment of AN. 

Cognitive analytic therapy (CAT). The two studies that utilized CAT, a treatment which 

integrates psychodynamic with behavioral factors and focuses on interpersonal and transference 

issues, failed to find any advantage of CAT over educational behavioral therapy or focal family 

therapy in eating, mood, or weight outcomes.226,228 Focal family therapy focused on eliminating 
51 

the eating disorder from its controlling role in determining the relationship between the patient 

and other family members.

Family therapy. Of the three studies in this category, Dare et al. found family therapy to be 

superior to routine treatment but equivalent to a focal time-limited psychodynamic 

psychotherapy in increasing percentage of adult body weight, restoring menstruation, and 

decreasing bulimic symptoms; overall clinical improvement was modest, however.228 

Crisp et al.227 found outpatient individual and family therapy with variable numbers of 

sessions to be superior to referral to a family physician for increased weight at 1- and 2-year 

followup. 

The efficacy of family therapy in treating adults with AN has not yet been completely 

addressed. It may be more effective than medical management by a family physician and routine 

treatment; family therapy (including the family of origin) may be more effective in younger 

patients with shorter duration of illness. No studies have explored family therapy for adult 

patients that included the family of insertion (spouse and offspring of the patient) rather than the 

family of origin.

Behavioral interventions for adolescents with anorexia nervosa. We present behavioral 

interventions for adolescents with AN in Table 10. 

Family therapy. Four family therapy studies focused exclusively on adolescents and one 

combined adolescent and adult patients.231 Family therapy was more effective for younger 

patients with earlier onset than for older patients with a more chronic course in the United 

Kingdom trial performed by Russell et al.231 and the followup by Eisler et al.239 These studies did 

not yield evidence that the specific type of family therapy administered was helpful for the older 

more chronic group.228,231 A form of family therapy focusing initially on parental control of renutrition delivered in two different manners revealed a significant advantage of conjoint therapy 

(family treated as a unit) over separated family therapy (parents and patient seen separately) on 

eating and mood outcomes but not on weight outcomes.221 

In a second study, no differences emerged between family therapy and family 

psychoeducation on any outcomes at 16 weeks.229 For a specific form of family therapy, when 

delivered in conjunction with a common medical and dietary regimen, behavioral family systems 

therapy (BFST), also characterized initially by parents taking control of renutrition, Robin et al. 

found BFST to be superior to ego-oriented individual therapy in increasing BMI and restoring 

menstruation, although neither therapy was superior on eating or mood outcomes.230,237

Addressing the issue of optimal duration of family therapy, Lock et al. randomized adolescents 

to either short (10 sessions over 6 months) or long (20 sessions over 12 months) manualized 

family therapy based on the initial parental control of refeeding model242 and found no 

differences on eating, psychiatric, or biomarker outcomes.222 Longer-term family therapy 

suggested that those with more severe eating-related obsessions and nonintact families did better 

with longer treatment. Finally, in the one study that included both adolescents and adults, family 

therapy was superior to individual therapy for adolescent patients with shorter duration of illness. 

This difference did not emerge for adult patients with longer duration of illness.231 Although few 

differences were observed across interventions, specific forms of family interventions did 

consistently show improvement over time with adolescent patients. 

Summary of behavioral interventions for adults and adolescents with anorexia nervosa.

Overall, one study of adults provides tentative evidence that CBT may reduce relapse risk for 

adults with AN after weight restoration has been accomplished.223 Sufficient evidence does not 

exist to determine whether CBT is effective during the acute phase of the illness (i.e., in the 
52 

underweight state before weight restoration); one study found that a manualized nonspecific 

supportive treatment (NCSM) was more effective than CBT or IPT in terms of global outcome 

during the acute phase.224 The three family therapy studies provide no support for the efficacy of 

the type of family therapy delivered in adults with AN with longer duration of illness; the 

superiority of this approach for younger patients with a shorter illness course is based on one 

study.231 Two studies failed to find any benefit of CAT for eating, mood, or weight outcomes 

when compared to other treatments for this population.226,228 No methodologically sound studies 

that systematically tested combinations of medication and psychotherapy were identified. 

Serious methodological concerns arose with some of these trials. Two were very small (8 to 

12 participants per group),225,230 which does not provide adequate statistical power for the 

comparative analyses conducted. In addition, both had marked pretreatment differences between 

groups. Failure to control for contact time with a clinician while comparing multiple treatments, 

with some groups getting up to 80 percent more time in treatment than others, was another 

problem.228 In addition, only one group of researchers conducted a follow-up study to determine 

the long-term impact of their interventions.239 

Five studies evaluated family therapy in adolescents with AN. Overall, family therapy based 

on principles of parental control of initial refeeding leads to clinically meaningful weight gain 

and psychological change. However, the majority of family therapy studies compares one form 

of family therapy to another form and were underpowered to detect significant differences 

between active similar treatments. One study suggested that family therapy was superior to a 

non-family therapy comparison intervention for adolescent patients with relatively short duration 

of illness.231 One additional study reported significantly greater weight gain at the end of 

treatment in family therapy than in ego-oriented individual therapy for adolescent AN patients.230

The other three studies all involved some sort of family treatment – either comparing conjoint to 

separated family therapy or comparing family therapy to family psychoeducation.221,229 Conjoint 

therapy was superior to separated family therapy for improving eating and mood but not weight 

outcomes.221 Similarly, one study examining family therapy versus family psychoeducation 

found no differences between groups.229 

Inadequate statistical power was a common problem among the behavioral interventions in 

AN, and power calculations were rarely reported. No studies had a pure no-treatment condition, 

which is appropriate given the gravity of the illness, although “usual” treatment took various 

forms. Many of these studies had adequate power to detect pre-post within-group differences or 

differences between no treatment and an active treatment, but few were adequately powered to 

detect differences across two or more treatment groups. 

Key Question 2: Harms of Treatment for Anorexia Nervosa 

Table 11 presents adverse events associated with treatments for AN reported in each of the 

32 studies reviewed. Assuming that all relevant adverse events were reported, the most common 

was the need for inpatient treatment among participants in an outpatient trial. Eight studies 

reported that one or more participants dropped out because of the need for inpatient treatment. In 

one study, a participant died before commencing the intervention. In these cases, the events 

observed may be more ongoing features of the course of illness than an adverse event caused by 

the intervention per se. In behavioral interventions, physical and psychological harms of 

interventions are rarely reported. 

For the trials using second-generation antidepressants, we refer to recent publications on the 

comparative effectiveness and tolerability of second-generation antidepressants.243 Common side 
53 

Table 11. Adverse events reported: anorexia nervosa 

Intervention Adverse Events Reported* 

Medication Trials 

Fluoxetine vs. placebo206 Fluoxetine group: insomnia and agitation; blurred vision 

Fluoxetine vs. placebo207 No adverse events observed 

Amitriptyline vs. cyproheptadine vs. placebo208 Amitriptyline: drowsiness, excitement, confusion, 

increased motor activity, tachycardia, dry mouth, 

constipation. 

Cyproheptadine: no consistent pattern observed 

Placebo: drowsiness, excitement, increased motor 

activity. 

Amitriptyline vs. placebo209 Amitriptyline group: diaphoresis (2), drowsiness (6), dry 

mouth (4), blurred vision (1), urinary retention (1), 

hypotension (2), leucopenia (1) 

Placebo: dry mouth (2), palpitations (1), dizziness (2) 

Estrogen vs. nonmedication control210 Estrogen group: depression (1), hyperlipidemia (1) 

Growth hormone vs. placebo212 No adverse events observed 

Testosterone vs. placebo211 Testosterone group: Mild skin irritation at patch site (3), 

increased depression (1), increased fatigue and vertigo 

(1), nausea (1) 

Placebo: Mild skin irritation at patch site (1) 

Zinc vs. placebo213 NR 

Behavioral Interventions Trials 

Behavioral family systems vs. ego-oriented 

individual230,237

NR 

CBT vs. behavioral therapy vs. control225 NR 

CBT vs. interpersonal psychotherapy vs. 

nonspecific supportive clinical management224 No adverse events observed 

CBT vs. nutritional counseling223 CBT: Depression and suicidal ideation (1) 

Nutritional: Depression and suicidal ideation (3) 

Cognitive analytical vs. educational behavioral226 NR 

Conjoint family vs. separated family221 NR 

Family therapy vs. family group psychoeducation229 NR 

Family therapy vs. nonspecific individual231,239 NR 

Focal psychotherapy vs. family therapy vs. 

cognitive analytical vs. routine treatment228 NR 

Inpatient + 12 individual/family vs. outpatient 

individual/family variable vs. 10 outpatient group vs. 

family physician vs. dietary counseling227,238

NR 

Short- vs. long-term family therapy222 NR: Dropout attributed to other psychological problems 

CBT, cognitive behavioral therapy; NR, not reported; vs., versus. 

* If no numbers appear in parentheses, authors had only listed adverse events but not reported the number of cases. 

effects associated with the use of second-generation antidepressants in major depressive disorder 

are nausea, headache, diarrhea, constipation, dizziness, fatigue, sweating, and sexual side effects. 

Rare but severe adverse events include hyponatremia, suicidality, and seizures. Up to 90 percent 

of patients experienced at least one adverse event during treatment. Overall, discontinuation rates 

attributed to adverse events did not differ significantly among individual drugs and ranged from 

6 percent to 14 percent. The authors report no substantial differences in adverse events with 
54 

respect to drugs that were also used in eating disorders trials (i.e., citalopram, fluoxetine, 

fluvoxamine, and sertraline). 

Given the small sample sizes and completion rates of the two fluoxetine trials, we cannot 

draw definitive conclusions regarding whether harms associated with fluoxetine treatment in the 

underweight state differ in any way from treatment of normal-weight individuals with other 

psychiatric diagnoses. In these studies, Kaye et al. failed to report adverse events;207 Attia et al. 

reported one case of insomnia and agitation and one case of blurred vision.206 

For tricyclic antidepressants, Halmi et al. reported sporadic cases of drowsiness, excitement, 

confusion, increased motor activity, tachycardia, dry mouth, and constipation associated with 

amitriptyline;208 however, the rate of adverse events did not differ from placebo. 

The only specific adverse event associated with testosterone administration was skin 

irritation at the patch site. Estrogen administration yielded one case of depression and one of 

hyperlipidemia. No adverse effects were reported with either growth hormone or zinc 

administration. 

Key Question 3: Factors Associated With Treatment Efficacy 

We found no consistent factors associated with better or poorer treatment outcome across 

studies. In medication studies, individuals with the nonbulimic subtype of AN had better 

therapeutic outcomes on cyprohoptadine than amitriptyline and placebo.208 Bone density 

increased more in women with AN who were less than 70 percent of ideal body weight on 

estrogen replacement therapy.210 These subgroup analyses had very small samples, and 

conclusions should be regarded as tentative. 

One observation that was an artifact of experimental design,223 post-weight restoration trial 

of CBT and nutritional counseling is related to patients being permitted to be on antidepressant 

medication. In one trial, a significantly higher percentage of CBT successes occurred among 

patients on medication. Miller et al.211 reported that 3 weeks of transdermal testosterone was 

superior in decreasing depression in individuals who were depressed at baseline. 

In terms of family therapy, Lock et al. found that adolescents with severe eating-related 

obsessive-compulsive-related thinking and those who come from nonintact families benefitted 

from longer-term rather than shorter-term manual-based family therapy treatment.222 Eisler et al. 

found that families that scored higher on maternal criticism did better in separated rather than 

conjoint family therapy.221

Finally, with reference to weight gain, family therapy was more effective for AN patients 

whose illness began at an early age and had not become chronic.231,239

Key Question 4: Treatment Efficacy by Subgroups 

The total number of individuals enrolled in the eight medication trials that reported the sex of 

the participants was 320. Of those, one was male. No medication studies reported differential 

outcome by age. With the exception of the one rGH trial212 and one amitriptyline trial,209 no 

medication studies have explicitly focused on the treatment of adolescent AN. Not a single 

medication study reported race or ethnicity of participants. Of the eight trials, seven were 

conducted in the United States and one in Canada. Based on these results, we conclude that no 

information exists regarding differential efficacy of pharmacotherapy interventions for AN by 

sex, gender, age, race, ethnicity, or cultural group. 
55 

The total number of individuals enrolled in the 11 psychotherapy trials was 572; of these, 22 

were men or boys. Only two trials reported race or ethnicity of participants; they included eight 

Asian Americans, 10 Hispanic Americans, no African Americans, and three individuals of 

“other” race or ethnicity. In no instance were results analyzed specifically by race or ethnic 

group. No data exist regarding differential efficacy of psychotherapeutic treatment for AN by 

sex, gender, race, ethnicity, or cultural group. 

In terms of age, scant evidence shows that interventions involving the family have greater 

efficacy for individuals below the age of 15 than for patients above that age. This information is 

based solely on studies by just one team of investigators who found family therapy to be more 

effective for adolescent AN patients with a shorter duration of illness than for adults with a more 

chronic course.231,239 However, no definitive replications have been done. Moreover, no studies 

have explored the role of family therapy in adults focusing on the family of insertion rather than 

family of origin, which may be the relevant comparison, or other adaptation of family therapy for 

adults or adolescents. 

57 

Chapter 4. Results: Bulimia Nervosa

This chapter presents results of our literature search and our findings for the four key 

questions (KQs) that pertain to bulimia nervosa (BN), including the efficacy of various 

treatments or combinations of treatments (KQ 1), harms associated with the treatment or 

combination of treatments (KQ 2), factors associated with the efficacy of treatment (KQ 3), and 

whether the efficacy of treatment differs by sex, gender, age, race, ethnicity, or cultural groups 

(KQ 4). 

We report specific details about the yields of the literature searches and characteristics of the 

studies. For each included study, detailed evidence tables appear in Appendix C.** We report 

first on medication trials (Evidence Table 5), then combined medication and behavioral 

interventions (Evidence Table 6), behavioral interventions (Evidence Table 7), self-help 

interventions (Evidence Table 8), and other interventions (Evidence Table 9). Within each 

evidence table, studies are listed alphabetically by author. Summary tables in this chapter present 

selected outcomes by type of intervention. 

Overview of Included Studies 

We identified 47 studies reported in 58 publications addressing treatment efficacy for BN. Of 

these, 14 were medication-only trials.244-257 We rated two of these trials as good,246,248 9 as 

fair,244,247,249-255,257 and three as poor.245,256,258 The drugs studied included second-generation 

antidepressants,244,247-250,252,254,255 tricyclic antidepressants,257 an anticonvulsant,251,259

monoamine-oxidase inhibitors (MAOIs),253 and a 5HT3 antagonist.246 

Six trials combined medication with behavioral interventions.260-265 Three used secondgeneration antidepressants,261,262,265 one used a tricyclic antidepressant,260 and two used both a 

second-generation antidepressant and a tricyclic antidepressant sequentially.263,264 Of these, we 

rated two as good264,265 and four as fair.260-263 

We identified 19 behavioral intervention psychotherapy studies published in 24 articles.266-289

We rated three psychotherapy intervention trials as good,269,270,282 10 as 

fair,266,273,274,276,278,280,281,283,287,288 and six as poor.275,279,284-286,289 Of the 13 fair- and good-rated 

studies, 11 used some form of cognitive-behavioral therapy (CBT) in comparison to other 

interventions,266,269,270,273,274,276,278,280,283,287,288 one used dialectical behavior therapy (DBT),282

and one used nutritional management and stress management.281

We also identified five trials of various self-help methods.290-294 We rated four as fair290-293

and one as poor.294

Finally, we identified three studies of “other” interventions including active light,295 guided 

imagery,296 and crisis prevention.297 We rated all three studies as fair. 

Of the 47 studies addressing treatment efficacy for BN, we rated 10 as poor. Studies with a 

quality rating of “poor” are not discussed below. Reasons that these studies received this rating 

are presented in Table 12. Although each study was not lacking in all areas, the most common 

concerns contributing to the low rating included a fatal flaw in the approach to randomization or 

the approach not being described, assessors not being blinded or their blinding status not being 

described, adverse events not being reported, outcomes not being reported using an intention-to-

 

** Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
58 

Table 12. Reasons for poor quality ratings and number of trials with poor ratings: bulimia 

nervosa 

Reasons Contributing to 

Poor Ratings Types of Intervention, Number of Times Flaw Was Detected, and Citations 

Research Aims 

Hypothesis not clearly 

described 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

Study Population 

Characteristics not clearly 

described 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 1289

No specific inclusion or 

exclusion criteria 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

Randomization 

Protections against 

influence not in place 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 1284

Approach not described Medication-only trials: 1245

Behavioral intervention and self-help trials: 4275,279,284,294,298

Whether randomization 

had a fatal flaw not known 

Medication-only trials: 2245,256

Behavioral intervention and self-help trials: 6275,279,284,286,289,294,298

Comparison group(s) not 

similar at baseline 

Medication-only trials: 2245,256

Behavioral intervention and self-help trials: 1289

Blinding 

Study subjects Medication-only trials: 0 

Behavioral intervention and self-help trials: 1289

Investigators Medication-only trials: 0 

Behavioral intervention and self-help trials: 1289

Outcomes assessors Medication-only trials: 2245,256

Behavioral intervention and self-help trials: 7275,279,284-286,289,294,298

Interventions 

Interventions not clearly 

described 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

No reliable measurement 

of patient compliance 

Medication-only trials: 1256

Behavioral intervention and self-help trials: 3279,285,289

Outcomes 

Results not clearly 

described 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

Adverse events not 

reported 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 6275,279,284-286,289
59 

Table 12. Reasons for poor quality ratings and number of trials with poor ratings: bulimia nervosa 

(continued) 

Reasons Contributing to 

Poor Ratings Types of Intervention, Number of Times Flaw Was Detected, and Citations 

Statistical Analysis 

Statistics inappropriate Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

No controls for 

confounding (if needed) 

Medication-only trials: 1245

Behavioral intervention and self-help trials: 1289

Intention-to-treat analysis 

not used 

Medication-only trials: 1256

Behavioral intervention and self-help trials: 5275,284-286,289

Power analysis not done or 

not reported 

Medication-only trials: 1245

Behavioral intervention and self-help trials: 7275,279,284-286,289,294,298

Results 

Loss to followup 26% or 

higher or not reported 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 2289,294,298

Differential loss to followup 

15% or higher or not 

reported 

Medication-only trials: 1245

Behavioral intervention and self-help trials: 3275,286,289

Outcome measures not 

standard, reliable, or valid 

in all groups 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

Discussion 

Results do not support 

conclusions, taking 

possible biases and 

limitations into account 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 0 

Results not discussed 

within context of prior 

research 

Medication-only trials: 1256

Behavioral intervention and self-help trials: 0 

External validity: 

population not 

representative of US 

population relevant to 

these treatments 

Medication-only trials: 1256

Behavioral intervention and self-help trials: 6279,284-286,289,294,298

Funding/sponsorship not 

reported 

Medication-only trials: 0 

Behavioral intervention and self-help trials: 4279,285,286,289

treat approach, the statistical analysis not including a power analysis or not stating whether one 

was conducted, and concerns in relation to the external validity of the findings (the study 

population was not representative of the US population or the information of provided was 

insufficient to determine representativeness). 

Participants 

Of the 38 studies rated fair or good, 19 were conducted in the United States, five in Canada, 

four in Germany, three in the United Kingdom, two in Australia, and one each in Austria, 
60 

Finland, New Zealand, and Norway. In addition, one multinational trial had US and Canadian 

sites; another had German and Australian sites. 

Of the fair and good studies, three failed to report the age of participants; of the remainder, 

the age range of participants was 16 to 61 years with the majority of participants being adults. A 

total of 3,403 individuals participated in fair or good clinical trials for BN. From those that 

reported sex, 2,985 women and 23 men participated. 

Thirty-one studies failed to report the race or ethnicity of participants. Of those that did, 

1,203 participants were identified as white, 79 as nonwhite, 27 as African American, 40 as 

Hispanic American, 30 as Asian or Pacific Islander, and one as Native American. 

Similar to the AN studies, some BN trials also had high attrition. Table 13 documents the 

percentages of dropouts in total and in each arm of the study. Three studies had five study 

groups; those are combined with information relating to the fourth treatment group. 

Key Question 1: Treatment Efficacy 

Medication-only Trials 

We report on 12 randomized controlled double-blind medication-only trials (Table 14). The 

total number of individuals enrolled was 1,430. Based on studies that reported sex, 1,364 women 

and 21 men participated in medication-only trials. The number of participants ranged from 26 to 

398. The age of participants ranged from 16 to 55. Two trials reported the race of participants; in 

these, 521 individuals were reported as white and 27 as nonwhite. Seven trials were conducted in 

the United States, two in Canada, and one each in Australia, Germany, and Finland. 

The medication-only trials used the following two designs: medication versus placebo (10) 

and medication (dose a) versus medication (dose b) versus placebo (1). The results of these 

studies are presented below by drug class. 

Second-generation antidepressants. Fluoxetine. Six trials compared fluoxetine to placebo 

in outpatient and inpatient settings. The mean age of participants was mid-twenties; no studies of 

fluoxetine focused exclusively on adolescents. 

Overall, fluoxetine (60 mg/day) administered for between 8 weeks and 16 weeks led to 

significant reductions in binge eating in most244,249,250,254 but not all studies.248,252 Fluoxetine (60 

mg/day) also performed significantly better than fluoxetine (20 mg/day) in decreasing binge 

eating.249 No effect of fluoxetine (60 mg/day) compared with placebo was observed in the one 

study in which patients were already receiving intensive inpatient psychotherapy.248

Fluoxetine (60 mg/day) was superior to placebo in decreasing purging behavior,244,249,250,254

although not in the inpatient setting.248

All six fluoxetine trials either failed to report abstinence rates (absence of binge eating and 

purging behaviors) or did not report whether abstinence rates differed significantly between drug 

and placebo groups. 

With reference to eating-related attitudes, fluoxetine (60 mg/day) was associated with 

significant improvements in measures of restraint, weight concern, and food preoccupation and 

with Eating Disorders Inventory (EDI) subscale scores of bulimia, drive for thinness, and body 

dissatisfaction.244,249,250,254 Again, the exception was the inpatient study.248

Fluoxetine had mixed results on depression and anxiety scores. Some studies showed greater 

efficacy than placebo in decreasing depression scores,249,252 but others showed no advantage of 

fluoxetine.244,248,250,254
61 

Table 13. Dropout rates for randomized controlled trials: bulimia nervosa 

Author 

Total 

Enrollment, 

N 

Total Dropouts 

N (% dropout) 

G1 Treatment 

(% Dropout) 

G2 Treatment 

(% Dropout) 

G3 Treatment 

(% Dropout) 

G4 Treatment 

(% Dropout) 

G5 Treatment 

(% Dropout) 

Medication Trial 

Beumont et al., 

1997244 67 27 (40%) Fluoxetine 

(50%) 

Placebo 

(30%) 

Fichter et al., 

1991248 39 0 (0%) Fluoxetine 

(0%) 

Placebo 

(0%) 

 

Fluoxetine BN 

Collaborative 

Study Group, 

1992249

387 117 (30%) Placebo 

(37%) 

Fluoxetine, 

20 mg (23%) 

Fluoxetine, 

60 mg (30%) 

Goldstein et 

al.,1995250 398 173 (43%) Fluoxetine 

(40%) 

Placebo 

(52%) 

 

Kanerva et al., 

1995252 50 4 (8%) Fluoxetine 

(8%) 

Placebo 

(8%) 

 

Romano et al., 

2002254 150 131 (87%) Fluoxetine 

(83%) 

Placebo 

(92%) 

 

Fichter et al., 

1996247 and 

Fichter et al., 

1997299

72 24 (33%) Fluvoxamine 

(51%) 

Placebo 

(14%) 

 

Pope et al., 

1989255 46 4 (9%) Trazodone 

(13%) 

Placebo (4%) 

Hoopes et al., 

2003251 and 

Hedges et al., 

2003259

68 28 (41%) Topiramate 

(34%) 

Placebo 

(47%) 

 

Kennedy et al., 

1993253 36 8 (21%) Brofaromine 

(21%) 

Placebo 

(24%) 

 

Faris et al., 

2000246 26 1 (4%) Ondansetron 

(7%) 

Placebo 

(0%) 

 

Walsh et al., 

1991257 78 15 (19%) Placebo 

(16%) 

Desipramine 

(23%) 

 

Medication Plus Behavior Intervention Trials 

Goldbloom et 

al.,1997261 76 33 (43%) Fluoxetine 

(39%) 

CBT 

(35%) 

Fluoxetine + 

CBT 

(55%) 

Mitchell et al., 

2001262 91 2 (2%) Placebo 

(5%) 

Fluoxetine 

(0%) 

Placebo + 

self-help 

manual 

(0%) 

Fluoxetine + selfhelp manual 

(5%) 

Walsh et al., 

2004265 91 63 (69%) Fluoxetine + 

guided self 

help 

(54%) 

Placebo + 

guided self 

help 

(88%) 

Fluoxetine 

(70%) 

Placebo 

(64%) 

B-ERP, exposure therapy with response prevention for bingeing; CBT, cognitive behavioral therapy; GP, general practitioner; 

IPT, interpersonal psychotherapy; N, number; NR, not reported; P-ERP, exposure therapy with response prevention for purging. 
62 

Table 13. Dropout rates for randomized controlled trials: bulimia nervosa (continued) 

Author 

Total 

Enrollment, 

N 

Total Dropouts 

N (% dropout) 

G1 Treatment 

(% Dropout) 

G2 Treatment 

(% Dropout) 

G3 Treatment 

(% Dropout) 

G4 Treatment 

(% Dropout) 

G5 Treatment 

(% Dropout) 

Agras et al., 

1992260 and 

Agras et al., 

1994300

71 18 (25%) Desipramine 

16 weeks 

(NR) 

Desipramine 

24 weeks (NR) 

Desipramine 

16 weeks + 

CBT (NR) 

Desipramine 24 

weeks + CBT 

(NR) 

CBT (NR) 

Mitchell et al., 

2002263 62 25 (40%) IPT 

(32%) 

Antidepressant 

medication 

(48%) 

 

Walsh et al., 

1997264 and 

Wilson et al., 

1999301

120 41 (34%) CBT + 

medication 

(NR) 

CBT + Placebo 

(NR) 

Supportive 

therapy + 

medication 

(NR) 

Supportive therapy 

+ placebo 

(NR) 

Medication only 

(43%) 

Behavioral Intervention Trials 

Agras et al., 

2000269 220 57 (26%) CBT 

(28%) 

IPT 

(24%) 

 

Wolk and 

Devlin, 2001268 110 44 (40%) CBT 

(NR) 

IPT 

(NR) 

 

Cooper and 

Steere, 1995274 31 4 (13%) CBT 

(13%) 

Behavioral 

therapy 

(13%) 

 

Fairburn et al., 

1991276 and 

Fairburn et al., 

1993267

75 15 (20%) CBT 

(16%) 

Behavioral 

therapy 

(24%) 

IPT 

(12%) 

Wilfley et al., 

1993287 56 8 (14%) CBT 

(33%) 

IPT 

(11%) 

Waiting list 

(0%) 

Wilson et al., 

2002288 220 Post 

treatment: 

66 (30%), 

Follow up: 91 

(41%) 

CBT 

(NR) 

IPT 

(NR) 

 

Garner et al., 

1993278 60 10 (17%) CBT 

(17%) 

Supportive 

expressive 

(17%) 

 

Hsu et al., 

2001280 100 27 (27%) Nutritional 

therapy 

(39%) 

Cognitive 

therapy (15%) 

Cognitive and 

nutritional 

therapy 

(11%) 

Sequential group 

(46%) 

SundgotBorgen et al., 

2002283

64 6 (9%) Exercise 

(20%) 

CBT 

(13%) 

Nutrition 

(0%) 

Waiting list 

(6%) 

Healthy control 

(0%) 

Chen et al., 

2003273 60 16 (27%) Individual 

CBT (27%) 

Group CBT 

(27%) 

 

Agras et al., 

1989266 77 67 (13%) Waiting list 

(5%) 

Self monitoring 

(16%) 

CBT 

(23%) 

CBT + response 

prevention 

(6%) 
63 

Table 13. Dropout rates for randomized controlled trials: bulimia nervosa (continued) 

Author 

Total 

Enrollment 

Total 

Dropouts 

N (% 

dropout) 

G1 Treatment 

(% Dropout) 

G2 Treatment 

(% Dropout) 

G3 treatment 

(% Dropout) 

G4 Treatment (% 

Dropout) 

G5 Treatment 

(% Dropout) 

Bulik et al., 

1998270 and 

Bulik et 

al.,1998271

111 5 (5%) Exposure to 

B-ERP 

(5%) 

Exposure to 

P-ERP 

(6%) 

Relaxation 

training 

(3%) 

Laessle et al., 

1991281 55 7 (13%) Nutritional 

management 

(19%) 

Stress 

management 

(7%) 

 

Safer, Telch, 

and Agras, 

2001282

31 2 (6%) Dialectical 

behavior 

therapy 

(13%) 

Waiting list 

(7%) 

 

Self-help Trials

Bailer et al., 

2004290 81 25 (31%) Self help 

(25%) 

CBT 

(37%) 

 

Carter et al., 

2003291 85 20 (24%) CBT 

(18%) 

Nonspecific 

(25%) 

Waiting list 

(28%) 

Durand and 

King, 2003292 68 14 (21%) GP self-help 

(24%) 

Specialist 

treatment 

(18%) 

 

Thiels et al., 

1998293 62 13 (21%) CBT 

(13%) 

Guided self 

change 

(29%) 

 

Other Interventions

Braun et al., 

1999295 34 10 (29%) Active light 

(31%) 

Dim light 

(28%) 

 

Mitchell et al., 

2004297 57 17 weeks: 

9 (16%); 

43 weeks: 

16 (28%), 

70 weeks: 

23 (40%)

Crisis 

prevention 

17 weeks: 

(10%), 43 

weeks: (23%), 

70 weeks: 

(37%) 

Follow up 

17 weeks: 

(22%), 43 

weeks: (33%), 

70 weeks: (44%)

 

Esplen et al., 

1998296 58 8 (14%) Guided 

imagery 

(14%) 

Control 

(13%) 

 
64 

Table 14. Results from medication trials: bulimia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Beumont, 

Russell et al., 

1997244

Fluoxetine vs. 

placebo 

Outpatient 

Fair 

Eating: 

• BSQ 

• Bulimic 

episodes 

• EAT 

• EDE 

• Vomiting 

Biomarker: 

• Weight 

Psych: 

• HDRS 

Both groups decreased 

bulimic and vomiting 

episodes, ED concerns 

and symptoms; and 

worries about body 

shape at week 4. 

Both groups decreased 

bulimic and vomiting 

episodes; ED concerns 

and symptoms; worries 

about body shape; 

restraint, overeating, 

and concerns about 

eating, shape, and 

weight at week 8. 

Both groups decreased 

bulimic and vomiting 

episodes, restraint, 

overeating, and 

concerns about eating 

and shape at 3-month 

FU. Fluoxetine group 

increased weight at 3 

month FU. 

Fluoxetine associated with 

lower restraint, weight 

concern, and shape 

concern at week 8 

Significant difference on 

weight at 8 weeks with 

weight decreasing in 

fluoxetine group and 

increasing in placebo 

group. 

Fluoxetine group regained 

weight above baseline at 

FU while placebo group 

did not. 

Fichter et al., 

1991248

Fluoxetine vs. 

placebo 

Inpatient 

Good 

Eating: 

• Binge attacks 

• Binge urge 

• EDI 

• SIAB 

Biomarker: 

• Weight 

Psych: 

• CGI 

• HAM-D 

• SCL-90 

No statistics reported. No differences on any 

measures. 

No differences on any 

measures. 

BDI, Beck Depression Inventory; BITE, Bulimic Investigation Test Edinburgh; BMI, Body mass index; BSQ, Body Shape 

Questionnaire; CGI, Clinical Global Impression Scale; EAT, Eating Attitudes Test [EAT-26 items]; ED, Eating disorder; EDE, 

Eating Disorder Examination; EDI, Eating Disorders Inventory; FU, followup; HAM-A, Hamilton Anxiety Index; HAM-D (or 

HDRS), Hamilton Depression Rating Scale [HDRS-17 items, HDRS-21 items]; HRSD, Hamilton Rating Depression Scale; 

HSCL, Hopkins Symptom Check List (see SCL-90); kg, kilogram; PGI, Patient Global Impression; Psych, psychiatric and 

psychological; SCL, (Hopkins) Symptom Check List (SCL-90 items); SIAB, Structured Interview for Anorexia and Bulimia 

nervosa; STAI, Spielberger State-Trait Anxiety Inventory; tx, treatment; YBC-EDS, Yale-Brown-Cornell Eating Disorder Scale. 
65 

Table 14. Results from medication trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Fluoxetine BN 

Collaborative 

Study Group, 

1992249

Fluoxetine (20 

mg) vs. 

fluoxetine (60 

mg) vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Bingeing 

• Vomiting 

• EAT 

• EDI 

• Carbohydrate 

craving 

Biomarker: 

• Weight 

Psych: 

• HDRS 

No statistics reported. Fluoxetine (60 mg) 

associated with greater 

reductions in binge eating 

and vomiting than fluoxetine 

(20 mg) or placebo. 

Fluoxetine (60 mg and 20 

mg) associated with greater 

reductions in vomiting, 

weight, drive for thinness, 

bulimic intensity, 

carbohydrate craving, body 

dissatisfaction, and food and 

diet preoccupation than 

placebo. 

Fluoxetine (60 mg) 

associated with greater 

reductions in depressed 

mood, drive for thinness, 

oral control, and bulimia 

scores than placebo. 

No statistics reported. 

Goldstein, 

Wilson, 

Thompson et 

al., 1995250

Fluoxetine vs. 

placebo 

Outpatient 

Fair

Eating: 

• Binge eating 

• Vomiting 

• EDI 

Biomarker: 

• Weight 

Psych: 

• CGI 

• HRSD 

• PGI 

No statistics reported. Fluoxetine associated with 

greater median percentage 

reduction in vomiting (at 

weeks 1-10, 13, 16, and 

endpoint) and binge eating 

(at weeks 1-9, 13, 16, and 

endpoint); greater reduction 

in total bulimia symptoms, 

drive for thinness, global 

symptoms scores, and 

weight; greater tx response 

(≥ 50% improvement in 

bulimic episodes) 

No statistics reported. 

Kanerva, 

Rissanen, and 

Sarna, 1994252

Fluoxetine vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Bingeing 

• BITE 

• EAT 

• EDI 

Biomarker: 

• Weight 

Psych: 

• HDRS-17 

• HDRS-21 

• STAI 

At 4 weeks, fluoxetine 

group decreased 

anxious mood and 

state anxiety. 

No statistics reported. Fluoxetine associated with 

greater reduction in 

depressed and anxious 

mood, bulimia and food 

preoccupation over 8 

weeks. Difference in 

weight with decrease in 

fluoxetine group and 

increase in placebo group.
66 

Table 14. Results from medication trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Romano et al., 

2002254

Fluoxetine vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Bingeing 

• EDI 

• Relapse 

• Vomiting 

• YBC-EDS 

Biomarker: 

• BMI 

Psych: 

• CGI 

• HDRS 

Both groups 

worsened over the 

52-week extended tx 

period. 

No statistics reported. Fluoxetine group had 

smaller mean increases in 

vomiting, binge eating, 

total ED behavior, ritual, 

preoccupation and 

symptom severity. 

Relapse occurred less 

frequently in the first 3 

months of 52-week 

extended tx period. 

Fichter et al., 

1996247

Fichter et al., 

1997299

Fluvoxamine 

vs. placebo 

Inpatient and 

outpatient 

Fair 

Eating: 

• Abstinence 

• Bingeing 

• EDI 

• Relapse 

• SIAB 

• Urge to binge 

Biomarker: 

• BMI 

Psych: 

• CGI 

• HDRS 

• HSCL 

No statistics reported. Fluvoxamine associated with 

higher binge abstinence 

rate, reduced clinical 

severity, and lower relapse 

rate. 

Fluvoxamine superior in 

limiting increases in 

bulimic behavior (urge to 

binge, vomiting), global 

ED symptoms (SIAB total), 

EDI bulimia scores, fear of 

losing control, obsessivecompulsive symptoms, 

and, global severity during 

12 week post-discharge 

relapse prevention phase. 

Pope et al., 

1989255

Trazadone vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Binge 

frequency 

• EDI 

• Vomit 

frequency 

• Fear of eating 

Psych: 

• Self-control 

• Self-esteem 

• HAM-A 

• HAM-D 

Trazadone group 

decreased binge and 

purge frequencies 

and fear of eating at 6 

wks. 

Trazadone associated 

greater percent decrease in 

binge and vomit frequencies 

and decrease in fear of 

eating and increase in selfesteem. 

No statistics reported. 
67 

Table 14. Results from medication trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Hoopes et al., 

2003;251

Hedges et al., 

2003259

Topiramate vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Binge days 

• Bulimic 

intensity scale 

• Carbohydrate 

craving 

• EAT 

• EDI 

• Purge days 

• Remission 

Biomarker: 

• Weight 

Psych: 

• CGI 

• HAM-A 

• HAM-D 

• PGI 

No statistics reported. Topiramate associated with 

greater percentage reduction 

in weekly number of binge 

and purge days, 

carbohydrate craving score, 

bulimic intensity, lower mean 

global symptoms and 

symptom intensity; and 

greater mean weight 

reduction. 

Larger percentage of 

topiramate group achieved 

moderate (> 50% reduction) 

or marked (> 75% reduction) 

improvement in weekly 

binge/purge days. 

Topiramate superior to 

placebo in reducing 

uncontrolled eating, body 

dissatisfaction, dieting, 

food preoccupation,and 

anxious mood, and in 

increasing patient-rated 

percent improved. 

Kennedy et al., 

1993253

Brofaromine 

vs. placebo 

Outpatient 

Fair 

Eating: 

• Binge episodes 

• EAT-26 

• EDI 

• Non-binge 

meals 

• Vomiting 

episodes 

Biomarker: 

• BMI 

• Weight 

Psych: 

• HAM-A 

• HAM-D 

No statistics reported. Brofaromine associated with 

greater reduction in vomiting 

episodes. 

A greater percentage of 

brofaromine group lost > 1 

kg of weight. A greater 

percentage of placebo group 

gained > 1 kg of weight. 

No statistics reported 

Faris et al., 

2000246

Ondansetron 

vs. placebo 

Inpatient and 

outpatient 

Good 

Eating: 

• Binge-purge 

episodes 

• Normal meals 

• Time spent in 

BN behaviors 

Biomarker: 

• Weight 

Ondansetron group 

increased average 

number of normal 

meals, and decreased 

time spent engaging 

in BN behaviors at 

week 4. 

Ondansetron associated 

with lower binge/purge 

frequency at week 4. 

Ondansetron superior in 

reducing binge/vomit 

frequency and time spent 

engaging in BN behaviors 

and in increasing normal 

meals over 4 weeks. 
68 

Table 14. Results from medication trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Walsh et al., 

1991257

Desipramine 

vs. placebo 

Outpatient 

Fair 

Eating: 

• Binge episodes 

• BSQ 

• EAT 

• Remission 

• Vomiting 

episodes 

Biomarker: 

• BMI 

Psych: 

• BDI 

• HAM-D 

• SCL-90 

• Social 

adjustment 

scale 

• STAI 

No statistics reported. Desipramine associated with 

fewer binge and vomiting 

episodes/week, fewer ED 

symptoms and body shape 

concerns, lower BMI, fewer 

symptoms of depression, 

global symptoms, and 

obsessive/compulsiveness, 

less hostility and trait 

anxiety. 

No statistics reported. 

One study explored the efficacy of fluoxetine (60 mg/day) versus placebo in preventing 

relapse of BN over 52 weeks.254 Relapse rates were significantly lower for those receiving 

fluoxetine (33 percent) than for those receiving placebo (51 percent). However, dropout was 

substantial during the observation period (83 percent in the fluoxetine group and 92 percent in 

the placebo group). 

Drop-out rates in fluoxetine arms of these trials ranged from zero (in an inpatient study) to 50 

percent (three studies had greater than 40 percent dropout). In one study, dropout was greater in 

the fluoxetine than in the placebo group,244 in three studies placebo had greater attrition,249,250,254

and one inpatient study reported no dropout in either group.248

Fluvoxamine. To compare maintenance of therapeutic gains and prevention of relapse of BN 

after inpatient treatment, Fichter et al. compared fluvoxamine (average dose 182 mg/day) with 

placebo for 19 weeks.247 Patients treated with fluvoxamine reported fewer urges to binge, lower 

frequency of vomiting, and lower depression scores than those receiving placebo. Both groups 

gained weight, with no differences between groups. Fluovoxamine was associated with a lower 

relapse rate. However, attrition was high (51 percent for those on fluovoxamine and 14 percent 

for those on placebo). 

Trazodone. In a 6-week trial of trazodone (400 mg) versus placebo, trazodone led to 

significantly greater decreases in the frequency of binge eating and vomiting and decreased fear 

of eating.255 No differences in depression or anxiety were observed, although baseline levels 

were not indicative of severe depression. 

Tricyclic antidepressants. One 6-week trial of desipramine (200-300 mg/day) versus 

placebo found the active drug to be significantly more effective than placebo in decreasing binge 

eating, vomiting, and scores on the Eating Attitudes Test (EAT) and Body Shape Questionnaire 

(BSQ).257 Abstinence rates from binge eating and purging did not differ between active drug and 

placebo. Both self-reported depression and anxiety were significantly decreased in the 

desipramine group compared with the placebo group; clinician-rated depression did not differ 
69 

significantly. Patients in the desipramine group lost significantly more weight than those in the 

placebo group, who tended to gain weight. Dropout was 23 percent in the desipramine group and 

16 percent in the placebo group. 

Anticonvulsants. The single 10-week trial of the anticonvulsant topiramate (mean dose 100 

mg/day) led to significantly greater reductions than placebo in the number of binge/purge days 

reported and in body dissatisfaction, drive for thinness, and EAT scores.251,259 Abstinence rates 

from binge eating and purging were 22.6 percent for topiramate and 6 percent for placebo (not 

significantly different). Topiramate was associated with significant reductions in anxiety but not 

depression, and the topiramate group lost significantly more weight than the placebo group, who 

tended to gain weight. Dropout from topiramate treatment was 34 percent and 47 percent for 

placebo. 

MAOI. One 8-week trial of brofaromine (mean dose 175 mg/day) revealed no differences 

between the active drug and placebo on binge eating or psychological features of the eating 

disorder.253 Brofaromine did lead to significant reductions in vomiting. Abstinence from binge 

eating and from vomiting were measured independently and did not differ between groups; no 

differences were observed on depression or anxiety scores, weight change, or drop-out rates (21 

percent brofaromine and 24 percent placebo). 

5HT3 antagonist. In a small 4-week trial of ondansetron versus placebo—self-administered 

when patients had an urge to binge or vomit—the active drug led to significantly greater 

decreases than placebo in binge and vomit frequencies and time spent in bulimic behavior, and to 

significant increases in normal meals.246 The investigators did not measure depression or anxiety, 

and they found no differences in weight change. One patient dropped out from ondansetron, none 

from placebo. 

Summary of medication-only trials. Fluoxetine (60 mg/day) administered for 6 to 18 weeks 

has been shown in several fair- to good-rated trials to reduce the core bulimia symptoms of binge 

eating and purging and associated psychological features of the eating disorder in the short term. 

The 60 mg dose performs better than the 20 mg dose;249 it was also associated with prevention of 

relapse at 1 year in a study with considerable dropout.254 Considerable evidence exists for the use 

of 60 mg/day of fluoxetine to treat BN in the short term. Evidence for the long-term 

effectiveness of relatively brief medication treatment does not exist. The optimal duration of 

treatment and the optimal strategy for maintenance of treatment gains are unknown. 

Single studies provide preliminary evidence of the efficacy of two other second-generation 

antidepressants, namely trazodone255 and fluvoxamine.247 Likewise, evidence from single studies 

provides preliminary evidence of the efficacy of desipramine257 and topiramate.251 One 

preliminary trial of ondansetron, a 5HT3 antagonist and antiemetic, led to an intriguing decrease 

in binge eating and vomiting when patients could self-administer when they had urges to binge 

or purge.246 This innovative study requires replication. One trial of brofaromine, an MAOI, 

showed a significantly greater effect on reducing vomiting than placebo.253

When reported, abstinence rates in medication-only trials suggest that medication treatment 

leads to abstinence in a minority of individuals. This finding indicates that although bulimia 

symptoms improved, they nonetheless persisted. 

Drop-out rates in medication trials ranged from zero to 51 percent. No drug showed 

substantially greater attrition than others. 
70 

Medication Plus Behavioral Intervention Trials 

We present the six trials of medications plus behavioral interventions in Table 15. These 

trials used a variety of designs to determine the extent to which a combination intervention is 

superior to either medication or behavioral intervention alone. 

The total number of individuals enrolled in these combination trials was 1,895. The number 

of participants in the medication plus psychotherapy trials ranged from 71 to 120. No men 

participated in these trials. Participant ages ranged from 18 to 46. Three trials reported race or 

ethnicity of participants: 272 individuals were reported to be white, seven nonwhite, two 

Hispanic American, eight African American, and seven Asian. Five of these trials were 

conducted in the United States and one in Canada. 

Second-generation antidepressants and CBT. Three trials used fluoxetine as the drug 

intervention. Comparing fluoxetine (60 mg/day) to CBT only to fluoxetine (60 mg/day) plus 

CBT in a 12-week trial, Goldbloom et al. used intention-to-treat analyses but found no difference 

across groups on eating related-measures.261 In completers, all three interventions led to 

significant improvement in core bulimic symptoms; however, both combined treatment and CBT 

alone led to greater decreases than fluoxetine alone in objective and subjective binges and 

vomiting episodes. Abstinence rates, depression scores, and weight did not differ across groups. 

Dropout was highest in combined treatment (55 percent) compared to the fluoxetine (39 percent) 

and CBT only groups (35 percent). The investigators did not provide long-term followup data. 

Walsh et al. compared fluoxetine (60 mg/day) with placebo, each with or without self-help in 

the form of a cognitive-behavioral self-help book302 with instructions for use.265 Physicians and 

nurses in primary care provided the treatments. Fluoxetine (either alone or with self-help) was 

associated with significantly decreased objective binge episodes, vomiting, restrained eating, and 

depression. The self-help book had no independent effect. No differences emerged on weight 

change. Dropout was high: 54 percent in fluoxetine plus guided self-help to 88 percent in 

placebo plus guided self-help. 

Using the same design but a different self-help manual, also based on principles of CBT, and 

administering treatment from a specialized eating disorders program, Mitchell et al. found 

fluoxetine to be associated with a significantly greater decrease than placebo in vomiting 

episodes but not binge eating episodes.262 No significant differences emerged in abstinence rates 

or depression. At the end of treatment, the investigators reported no independent effect of selfhelp. Dropout was low: none in fluoxetine only and fluoxetine plus self-help, 5 percent in 

placebo only and placebo plus self-help. 

Tricyclic antidepressants and CBT. One complex trial compared desipramine treatment of 

different durations with or without CBT (16 versus 24 weeks) with CBT only.260 The 16-week 

combined treatment was better than drug only for decreasing binge eating and purging. Longer 

combined treatment was significantly better than drug only on binge eating, vomiting, dieting 

preoccupation, and hunger. Abstinence rates did not differ across groups. The authors did not 

report results concerning depression. Weight change did not differ significantly across groups. At 

1-year followup, the combined 24-week intervention and CBT alone were both better than the 

16-week drug only treatment in decreasing binge eating and vomiting. The 24-week combined 

treatment was also superior to 16-week drug only in decreasing binge frequency, dietary 

preoccupation, disinhibition, and hunger.300 In all but the medication-only group, between 78 

percent and 100 percent of individuals who were abstinent at the end of treatment remained 

abstinent at followup. The overall drop-out rate was 25 percent. 
71 

Table 15. Results from medication plus behavioral intervention trials: bulimia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant 

Differences Between 

Groups at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Goldbloom et 

al., 1997261

Fluoxetine vs. 

CBT vs. 

fluoxetine + 

CBT 

Outpatient 

Fair 

Eating: 

• Binge episodes 

• EDE 

• EDI 

• Vomiting 

episodes 

Biomarker: 

• Weight 

Psych: 

• BDI 

• RSE 

Decreased shape and 

weight concerns in the 

fluoxetine and the 

fluoxetine + CBT groups. 

At tx completion, CBT 

alone and fluoxetine + 

CBT associated with 

greater percent 

reduction in vomiting 

frequency, compared to 

fluoxetine alone. 

At 4 weeks post-tx, 

fluoxetine + CBT 

associated with fewer 

objective binge and 

vomit weekly episodes 

compared to fluoxetine 

alone. 

CBT associated with 

fewer subjective binge 

episodes compared to 

fluoxetine alone. 

Note: no sig diff in ITT 

analyses. 

No statistics reported. 

Mitchell et al., 

2001262

Fluoxetine vs. 

placebo vs. 

self-help + 

placebo vs. 

fluoxetine + 

self-help 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Binge eating 

• EDI 

• Fasting days 

• Vomiting 

Psych: 

• CGI 

• HAM-D 

• PGI 

No statistics reported. Fluoxetine, alone and 

with self-help, 

associated with greater 

percentage reduction in 

vomiting and greater 

clinician-rated and 

patient-rated clinical 

improvement, 

compared to self help 

plus placebo or 

placebo alone, at 

endpoint (16 week tx 

period). 

Self-help manual plus 

placebo or fluoxetine 

associated with greater 

percentage reduction in 

vomiting compared to 

placebo or fluoxetine 

with no self-help 

manual, at 4-week time 

point (after 2 weeks 

active tx). 

No statistics reported. 

BDI, Beck Depression Inventory; BES, Binge Eating Scale; BMI, body mass index; BSQ, Body Shape Questionnaire; CBT, 

cognitive behavior therapy; CGI, clinical global impression; EAT, Eating Attitudes Test; ED, eating disorders; EDE, eating 

disorders examination; EDI, eating disorder inventory; FU, followup; HAM-D, Hamilton Rating Score for Depression; ITT, 

intention-to-treat; IPT, interpersonal psychotherapy; PGI, patient global impression; Psych, psychiatric and psychological; RSE, 

Rosenberg Self-Esteem Questionnaire; SCL, (Hopkins) Symptom Checklist (SCL-53 items, SCL-90 items); TFEQ, Three Factor 

Eating Questionnaire; tx, treatment; vs., versus; YBC-ED, Yale-Brown-Cornell Eating Disorder Scale. 
72 

Table 15. Results from medication plus behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant 

Differences Between 

Groups at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Walsh et al., 

2004265

Fluoxetine vs. 

placebo vs. 

guided selfhelp vs. 

fluoxetine + 

guided selfhelp 

Outpatient 

Good 

Eating: 

• EDE (episodes 

of bulimia, 

laxative use, 

vomiting) 

• Restraint 

Biomarker: 

• BMI 

Psych: 

• BDI 

• SCL-53 

No statistics reported. Fluoxetine associated 

with fewer objective 

bulimic and vomiting 

episodes and fewer 

vomiting days per 

month, less restraint, 

less depressed mood, 

and a lower general 

symptom index 

compared to placebo. 

Fluoxetine only and 

placebo groups greater 

decrease in bulimic 

episodes than self-help 

groups. 

No statistics reported 

Agras et al., 

1992;260 and 

Agras et al., 

1994300

Desipramine 

(16 weeks) vs. 

desipramine 

(24 weeks) vs. 

desipramine + 

CBT (16 

weeks) vs. 

desipramine + 

CBT (24 

weeks) vs. 

CBT alone (24 

weeks) 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Bingeing 

• Dietary preoccupation 

• Disinhibition 

• EDE 

• Hunger 

• Purging 

• Recovery 

Biomarker: 

• Weight 

Psych: 

• BDI 

• RSE 

No statistics reported. No statistics reported. Desipramine + CBT 

superior to medication 

alone in reducing binge 

and purge frequency at 16 

and 32 weeks, and in 

reducing diet 

preoccupation over 16 

weeks. 

Desipramine + CBT 

superior to CBT alone in 

reducing hunger 

disinhibition over 24 

weeks, and superior to 

medication alone in 

reducing diet 

preoccupation at 16 

weeks. 

CBT alone superior to 

desipramine alone for 16 

or 24 wks in reducing 

binge and purge frequency 

at 16 wks. CBT alone or in 

combination with 

desipramine for 24 weeks, 

superior to desipramine for 

16 weeks in reducing 

binge frequency at 1 year 

FU. 

Desipramine + CBT for 24 

weeks superior to 

desipramine for 16 weeks 

in reducing binge 

frequency, hunger, 

disinhibition, and diet 

preoccupation at 1 year 

FU. 
73 

Table 15. Results from medication plus behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant 

Differences Between 

Groups at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Mitchell et al., 

2002263

IPT vs. 

fluoxetine (16 

weeks) or vs. 

fluoxetine (8 

weeks) 

followed by 

desipramine (8 

weeks) 

Outpatient 

Fair 

Eating: 

• Abstinence 

• BES 

• BSQ 

• EDE 

• Objective binges 

• Relapse 

• TFEQ 

Psych: 

• BDI 

No statistics reported. No differences on any 

measures. 

No statistics reported. 

Walsh et al., 

1997264 and 

Wilson et al., 

1999301

CBT + placebo 

vs. CBT + 

medication 

(desipramine 

only or 

desipramine 

followed by 

fluoxetine) vs. 

Supportive 

therapy + 

placebo vs. 

Supportive 

therapy + 

medication vs. 

Medication 

alone 

Outpatient 

Good 

Eating: 

• Bingeing 

• BSQ 

• EAT 

• EDE 

• Remittance 

• Vomiting 

Biomarker: 

• BMI 

• Weight 

Psych: 

• BDI 

• SCL-90 

All groups exhibited 

decreases in weekly 

bingeing and vomiting, 

EAT and BSQ scores, 

concerns about eating 

and eating restraint, 

global ED symptoms, and 

depressed mood. 

Weight and BMI 

decreased in 3 groups 

(CBT+ placebo, 

medication alone, and 

supportive therapy + 

medication). 

Anxiety decreased in 

each of the 3 groups 

receiving medication. 

Importance of shape and 

weight concerns 

decreased in two groups 

(CBT plus placebo and 

supportive therapy plus 

medication). 

No statistics reported. CBT groups combined 

superior to supportive 

therapy groups combined 

in reducing binge and 

vomit episode frequencies. 

Behavioral interventions 

plus medication superior 

to behavioral interventions 

alone in reducing binge 

frequency, EAT scores, 

depressed mood, weight, 

and in increasing 

remission rate. CBT plus 

medication superior to 

medication alone in 

reducing binge and vomit 

frequencies, EAT scores, 

body image, and 

increasing remission rate 

by self-report. Medication 

alone superior to CBT 

alone in reducing BMI and 

weight. Medication alone 

superior to supportive 

therapy plus medication in 

reducing binge and vomit 

frequency. 

Multiple drugs and CBT. Walsh et al. examined supportive psychotherapy, CBT, both with 

or without placebo and with or without medication, and medication alone in a five-group 16-

week comparison.264,301 They started patients on desipramine (mean dose 188 mg/day) and 

switched nonresponders to fluoxetine (60 mg/day) after 8 weeks. Analyses combining all arms of 

the study that included CBT versus all arms of the study that included supportive therapy 

indicated that CBT was superior to supportive therapy in reducing binge and vomit episode 

frequencies. Behavioral interventions plus medication were superior to behavioral interventions 

alone in reducing binge frequency, EAT scores, depressed mood, weight, and in increasing 

remission rate. 
74 

CBT plus medication was superior to medication alone in reducing binge and vomit 

frequencies, EAT scores, body image, and increasing remission rate by self-report. Medication 

alone was superior to CBT alone in reducing BMI and weight. Medication alone was superior to 

supportive therapy plus medication in reducing binge and vomit frequency. Medication led to 

significantly greater decreases in depression scores. CBT was associated with greater likelihood 

of remission. The overall drop-out rate was 34 percent. 

Mitchell et al. randomized patients who did not respond to CBT to either interpersonal 

psychotherapy or fluoxetine (60 mg/day), which could be switched to desipramine in those who 

did not achieve abstinence.263 No difference in abstinence was observed between the two groups. 

Overall, the sequential second-level treatment was associated with high dropout. 

Summary of medication plus psychotherapy trials. The combined medication plus 

behavioral intervention studies provide only preliminary evidence regarding the optimal 

combination of medication and psychotherapy or self-help. Given the variety of designs used and 

lack of replication, evidence remains weak. Combined CBT and fluoxetine and CBT alone led to 

greater decreases in binge eating and purging than fluoxetine alone in individuals who complete 

therapy.261 When delivered in the context of a specialist eating disorders program, both self-help 

and fluoxetine were associated with decreased vomiting; however, the addition of self-help to 

fluoxetine was not associated with increased efficacy.262 When these therapies were administered 

in a primary care setting, drop-out rates from fluoxetine (70 percent) and fluoxetine plus selfhelp (54 percent) were unacceptably high.265

The only study that looked at sequential treatment for individuals who did not respond to 

CBT revealed that the addition of interpersonal psychotherapy to fluoxetine (allowing the 

transition to desipramine) led to substantial attrition and minimal effects on subsequent 

abstinence rates. How best to treat individuals who do not respond to CBT or fluoxetine remains 

a major shortcoming of the literature. 

Behavioral Intervention Trials 

We report 13 psychotherapy-only trials, four self-help trials, one trial of light therapy, one of 

guided imagery, and one of crisis prevention. Summary outcomes data for the psychotherapy 

trials appear in Table 16. The total number of individuals enrolled in psychotherapy, self-help, 

and other trials was 1,462. From the studies that reported sex of participants, 1,064 women and 

two men participated. Across these 20 trials, participants ranged in age from 17 to 64 years. Six 

trials reported race and ethnicity of participants: in all, 410 patients were white; 22 nonwhite; 28 

Hispanic American; 26 Asian, Maori, or Pacific Islander; 10 African American; and 1 Native 

American. In no instance were results analyzed specifically by race or ethnicity group. Of the 20 

trials, seven were conducted in the United States, three each in Canada and the United Kingdom, 

one each in Australia, Austria, Germany, New Zealand, and Norway, and one two-site study in 

Germany and Australia, and one did not report location. 

Psychotherapy trials for bulimia nervosa. Cognitive Behavior Therapy. CBT focusing on 

cognitive and behavioral factors that maintain bulimic behaviors is the most widely studied 

intervention for BN. Eleven trials of various designs delivered CBT either individually or in 

group format. CBT was compared with interpersonal psychotherapy (IPT),269,276,287,288 with 

supportive expressive therapy,278 with nutritional counseling,280,283 and with exercise.283 One 

study compared individually with group-administered CBT.273 Several studies dismantled CBT 

by comparing complete CBT with behavioral therapy (BT) in the absence of a cognitive 

component,276 by comparing cognitive therapy only with exposure with response prevention 
75 

Table 16. Results from behavioral intervention trials: bulimia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Agras et al., 

2000269 and 

Wolk and 

Devlin, 2001268

CBT vs. IPT 

Outpatient 

Good 

Eating: 

• Bingeing 

• EDE 

• Purging 

• Remittance 

• Recovery 

Biomarker: 

• BMI 

Psych: 

• SCL-90R 

• Stage of 

change 

No statistics reported. CBT associated with 

higher percent remitted 

and percent recovered at 

end of tx (ITT analysis). 

In completers-only 

analysis, CBT associated 

with fewer objective 

binges and purges; less 

eating restraint; and less 

weight, shape, and eating 

concerns at the end of tx. 

Stage of change predicted 

improvement in IPT but 

not CBT. 

No statistics reported. 

Cooper and 

Steere, 

1995274

Cognitive 

therapy vs. 

exposure plus 

binge and 

purge 

response 

prevention 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Bulimic 

episodes 

• BSQ 

• EAT 

• EDE 

• Dietary 

restraint 

• Relapse 

• Vomiting 

episodes 

Biomarker: 

• Weight 

Psych: 

• BDI 

• PSE 

• MADRS 

• STAI 

No statistics reported. Relapse rate lower in 

cognitive therapy group 

among those who were 

abstinent from bingeeating at end of tx and at 

12 month FU. 

Cognitive therapy superior 

to exposure therapy in 

reducing vomiting and 

depression between 

baseline and 12 month 

FU. 

B-ERP, exposure with response prevention to pre-binge cues; BDI, Beck Depression Inventory; BMI, Body mass index; BN, 

bulimia nervosa; BSQ, Body Shape Questionnaire; BT, Behavioral Therapy; CBT, Cognitive Behavioral Therapy; CNT, 

Cognitive nutritional therapy; CT, Cognitive Therapy; DBT, dialectical behavior therapy; EAT, Eating Attitudes Test; ED, 

Eating disorder; EDE, Eating Disorder Examination (EDE-12 items); EDI, Eating Disorders Inventory; FU, follow-up; GAFS, 

Global Assessment of Functioning Symptoms; HDRS, Hamilton Depression Rating Scale; IIP, Inventory of Interpersonal 

Problems; IPT, interpersonal psychotherapy; ITT, intention-to-treat; MADRS, Montgomery and Asberg Depression Rating Scale; 

NT, nutritional therapy; P-ERP, exposure with response prevention to pre-purge cues; PSE, Present State Examination; Psych, 

psychiatric and psychological; RSE, Rosenberg Self-Esteem Scale; SCL-90, (Hopkins) symptom checklist (SCL-90 items, SFL90-R [SCL-90-revised]); STAI, Speilberger State-Trait Anxiety Inventory; SUDS, subjective units of distress; TFEQ, Three 

Factor Eating Questionnaire; tx, treatment. 
76 

Table 16. Results from behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Fairburn et al., 

1991;276

Fairburn, 

Jones et al., 

1993267 and 

Fairburn, 

Peveler et al., 

1993277

CBT vs. BT vs. 

IPT 

Outpatient 

Fair 

Eating: 

• EAT 

• EDE 

• Laxative 

misuse 

• Objective 

bulimic 

episodes 

• Vomiting 

Biomarker: 

• BMI 

Psych: 

• BDI 

• SCL-90 

• RSE 

No statistics reported. No statistics reported. Over 18 week tx period, 

CBT superior to BT and 

IPT in reducing eating 

restraint, weight concerns, 

and overall ED 

psychopathology; CBT 

superior to IPT in reducing 

vomiting; and CBT 

superior to BT in reducing 

shape concerns. 

Over 12-month FU, CBT 

superior to BT in 

improving abstinence. 

Wilfley et al., 

1993287

Group CBT 

vs. group IPT 

vs. waiting-list 

control 

Outpatient 

Fair 

Eating: 

• Binge frequency 

• EDE 

• TFEQ 

Psych: 

• BDI 

• IIP 

• RSE 

CBT and IPT decreased 

binge frequency at 1 year 

FU. 

No statistics reported. Group CBT and group IPT 

superior to waiting-list in 

reducing binge frequency, 

and disinhibition over 16 

weeks. 

Group IPT superior to 

waiting-list in reducing 

restraint over 16 weeks. 

Wilson et al., 

2002288

CBT vs. IPT 

Outpatient 

Fair 

Eating: 

• Binge eating 

• EDE 

• Recovery 

• Vomiting 

Psych: 

• IIP 

• RSE 

• Self- efficacy 

Both groups decreased 

shape and weight 

concerns at post-tx. 

CBT showed greater 

mean reduction in 

eating restraint by tx 

week 6, greater 

improvements in selfefficacy by tx week 10, 

and a higher 

percentage reduction in 

binge eating at post-tx. 

CBT superior in early (by 

week 6) improvement 

(reduction in frequency of 

vomit episodes) 

Garner et al., 

1993278

CBT vs. 

supportiveexpressive 

therapy 

Outpatient 

Fair 

Eating: 

• Binge episodes 

• EAT 

• EDE 

• EDI 

• Vomiting 

Biomarker: 

• Weight 

Psych: 

• BDI 

• Millon Inventory 

• RSE 

• SCL-90-R 

No statistics reported. No statistics reported. Over 18 week tx period, 

CBT superior in reducing 

dieting, food 

preoccupation, eating 

concerns, restraint, 

attitudes toward shape, 

bulimia behaviors, 

depressed mood, global 

symptoms, and symptoms 

of borderline personality 

disorder and dysthymia; 

and in improving selfesteem. 
77 

Table 16. Results from behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Hsu et al., 

2001280

CT vs. NT vs. 

CT+NT (CNT) 

vs. group 

support 

(control) 

Outpatient 

Fair 

Eating: 

• Bingeing 

• EDI 

• Meals/ week 

• Purging 

Psych: 

• HDRS 

No statistics reported. No statistics reported. CNT superior to NT alone 

and to group support in 

binge/purge abstinence 

and in reducing drive for 

thinness and BN 

symptoms. 

CT superior to NT in 

reducing BN symptoms 

and CT superior to group 

support in reducing drive 

for thinness. 

SundgotBorgen et al., 

2002283

Exercise vs. 

CBT vs. 

nutrition 

counseling vs. 

waiting-list vs. 

healthy 

controls 

Outpatient 

Fair 

Eating: 

• Binge frequency 

• EDI 

• Vomit frequency 

• Laxative abuse 

Biomarker: 

• Percent body fat 

Exercise group 

decreased percent 

body fat at post-tx and 

fat mass at 18-month 

FU. 

Body dissatisfaction lower 

in CBT compared to 

nutritional counseling 

group at post tx. 

Laxative use lower in 

exercise than CBT group 

at post tx. 

Vomit frequency, bulimia 

symptoms, and body 

dissatisfaction lower in 

CBT than nutritional 

counseling group at 6 

month FU. Drive for 

thinness and laxative 

abuse lower in exercise 

than CBT group, at 6 

month FU. 

Binge episodes lower in 

exercise than in CBT at 18 

month FU. 

No statistics reported. 

Chen et al., 

2003273

Individual CBT 

vs. group CBT 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Binge episodes 

• EDE-12 

• Laxative use 

• Over-exercising 

• Purge episodes 

Biomarker: 

• BMI 

Psych: 

• BDI 

• SCL-90 

• STAI 

No statistics reported. Higher rate of abstinence 

in individual CBT than 

group CBT at end of tx. 

Group CBT superior to 

individual CBT in reducing 

state anxiety. 
78 

Table 16. Results from behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Agras et al., 

1989266

Waiting-list vs. 

Self-monitoring 

vs. CBT vs. 

CBT+ 

response 

prevention 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Dieting urge 

• Food 

preoccupation 

• Purge/week 

Biomarker: 

• Weight 

Psych: 

• BDI 

Decreased 

purges/week in selfmonitoring, CBT, and 

CBT+ response groups 

at end of 4-month tx. 

CBT associated with 

higher abstinence rate 

compared to waiting-list at 

end of tx, and compared to 

self-monitoring and 

response prevention at 6 

month FU. 

CBT alone superior to 

waiting-list in reducing 

purging frequency, 

increasing purging 

abstinence and 

decreasing depressed 

mood, by end of 

treatment. 

CBT alone and CBT+ 

response prevention 

superior to waiting-list in 

reducing depressed mood 

by end of treatment. 

Bulik et al., 

1998;270 

Bulik et al., 

1998;271

Carter, 

McIntosh et 

al., 2003272

8 weeks CBT 

followed by 

B-ERP tx vs. 

P-ERP tx vs. 

relaxation 

training 

Outpatient 

Good 

Eating: 

• Abstinence 

• Bingeing 

• Clinician 

ratings (food 

restriction, 

body 

dissatisfaction 

• EDI 

• Laxative use 

• Purging 

• Vomiting 

Psych: 

• HDRS 

• GAFS 

• SUDS 

P-ERP and relaxation 

groups improved body 

dissatisfaction at 3 yr 

FU 

B-ERP associated with 

less drive for thinness, 

lower clinician-rated food 

restriction, body 

dissatisfaction, and 

depressed mood, lower 

subjective distress than 

relaxation training at 3 

year FU. 

P-ERP associated with 

fewer ED psychological 

and behavioral 

measures.than relaxation 

training at 3 year FU. 

B-ERP associated with 

less food restriction, 

higher GAFS score than 

relax training at 12 month 

FU. 

Relaxation superior to 

B-ERP in reducing 

depressed mood and 

clinician-rated body 

dissatisfaction from post-tx 

to 2 year FU. 

Relaxation superior to 

P-ERP in reducing ED 

psych and behavioral traits 

and depressed mood from 

post-tx to 3 year FU. 

Laessle et al., 

1991281

Nutritional 

management 

vs. stress 

management 

Outpatient 

Fair 

Eating: 

• Binge frequency 

• Calories/day 

• EAT 

• EDI 

• Vomit frequency 

Psych: 

• BDI 

• STAI 

No statistics reported. No difference on any 

measures. 

Nutritional management 

superior to stress 

management in increasing 

calorie consumption and 

decreasing binge 

frequency over first 3 

weeks of tx, and in 

increasing binge 

abstinence rate through 6 

and 12 months. 

Stress management 

superior to nutrition 

management in reducing 

trait anxiety over 3 months 

of tx. 
79 

Table 16. Results from behavioral intervention trials: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Safer et al., 

2001282

DBT vs. 

waiting-list 

Outpatient 

Good 

Eating: 

Binge episodes 

EDE 

Emotional eating 

scale 

Purge episodes 

Psych: 

BDI 

Positive and 

Negative Affect 

Schedule 

No statistics reported. DBT superior in post-tx 

abstinence rate 

DBT superior in reducing 

the number of binge and 

purge episodes measured 

in last 4 of 20 weeks of tx. 

only,274 and by exploring the additive efficacy of exposure with response prevention grafted onto 

a basis of cognitive therapy.271 Exposure with response prevention is defined as exposing 

individuals to their high-risk cues (e.g., prebinge cues or prepurge cues) and then preventing the 

response (e.g., binge eating or purging) until the urge to engage in the behavior subsides. 

In comparisons of individually administered CBT and IPT tailored for BN, CBT was 

associated with a significantly greater probability of remission than IPT269 and with greater 

decreases in vomiting and restraint269,276 and binge eating269 at the end of treatment. In one study 

at 1-year followup, these differences were no longer apparent.276 Neither CBT nor IPT led to 

greater improvements in mood or changes in weight. Changes in dietary restraint and in eating 

self-efficacy mediated change in binge and purge frequency.288 Being in the precontemplation 

stage of change was associated with failure to achieve remission at the end of treatment.268

When administered in group format, differences between CBT and IPT were less clear. Both 

group-administered treatments led to significantly greater decreases than waiting list on days 

binged, psychological features of the eating disorder, disinhibition, and restraint, with no 

differences observed between the active therapies.287

When compared directly, few differences emerged between group and individual 

administration of CBT. Both showed decreases in objective and subjective binge episodes, 

vomiting, laxative use, overexercise and EDI bulimia, drive for thinness, and body dissatisfaction 

subscale scores.273 Group CBT was associated with greater decreases in anxiety; individual CBT 

was associated with significantly higher rates of abstinence. From a cost-effectiveness 

perspective, the study concluded that group CBT was more economical, given the similarity of 

outcomes. 

In the dismantling studies, which attempted to parse out the effects of various components of 

CBT, the cognitive component emerged as critical to therapeutic outcome. Complete CBT led to 

better eating-related outcomes than BT,276 to lower relapse than exposure with response 

prevention only,274 and to greater abstinence than a self-monitoring only intervention.266

Two studies examined the additive efficacy of exposure with response prevention. Agras and 

colleagues found no additive benefit of exposure to CBT.266 Bulik et al. first treated all patients 

with a core of cognitive therapy and then explored the added efficacy of three augmentation 

strategies: exposure with response prevention to prebinge cues, exposure with response 

prevention to prepurge cues, and a relaxation therapy control.270 They found no evidence that 
80 

either exposure treatment led to greater improvement in binge eating and vomiting than the 

relaxation control. 

In other comparisons, cognitive therapy performed better than support only; adding a 

cognitive component to nutritional counseling led to a significantly greater decrease in drive for 

thinness than nutritional therapy alone.280 CBT was superior to nutritional counseling alone in 

improving core binge eating, vomiting, laxative use, and body dissatisfaction. CBT also led to 

significantly greater decreases than supportive-expressive therapy (a nondirective 

psychodynamically oriented treatment) in EDI bulimia, EAT scores, food preoccupation, eating 

concerns, and depression.278 Exercise therapy was superior to CBT at 18-month followup in 

improving drive for thinness, laxative abuse, and binge eating.283

Overall, dropout from CBT delivered individually or in group format ranged from 6 percent 

to 37 percent. Typical rates were about one-quarter of individuals randomized. 

Other behavioral interventions. A single study compared nutritional management (focusing 

on decreasing restraint, detailed nutritional self-monitoring, and stimulus control) to stress 

management (focusing on decreasing stressors that may trigger binge eating). Both treatments 

led to significant decreases in binge eating and vomiting; abstinence from binge eating was 

greater in nutritional management than stress management, although abstinence from vomiting 

did not differ. Stress management was associated with greater reductions in trait anxiety.281

Dialectical behavioral therapy (DBT). DBT focuses on emotional dysregulation as the core 

problem in BN with symptoms viewed as attempts to manage unpleasant emotional states. A 

small study showed that patients receiving DBT had significantly greater decreases in binge 

eating and purging than did those on a waiting list and that abstinence was greater at the end of 

treatment in the DBT than in the waiting list group.282

Self-help trials. We present self-help trials for BN in Table 17. In a direct 18-week 

comparison of guided self-help (manual including visits with nonspecialists in eating disorders to 

check on progress) with group CBT, both treatments significantly decreased binge eating, 

vomiting, laxative use, EDI bulimia, drive for thinness and body dissatisfaction.290 At 1-year 

followup, individuals in the self-help group showed greater reductions in vomiting and EDI 

bulimia. CBT was associated with greater reductions in drive for thinness over the treatment 

period and at followup. Both treatments significantly improved depression, with no differences 

between groups at the end of treatment; however, at followup, individuals in the self-help group 

had lower depression scores. Of those who completed treatment, a significantly greater number 

of individuals in the self-help group than in the CBT group were in remission for more than 2 

weeks at the end of treatment (74 percent versus 44 percent). No significant change was seen in 

weight, although those in the self-help condition weighed significantly more at 1 year. 

Carter et al. compared CBT-based self-help302with nonspecific self-help, focusing on selfassertion for women, with a waiting list control group in a 2-month trial.291 Both self-help 

approaches led to significant decreases in objective binge episodes and purging; the waiting list 

did not. CBT-based self-help was associated with greater reductions in reducing intense exercise 

than nonspecific self-help or waiting list. No change in depression was observed. Abstinence and 

weight values were not reported. 

To understand the feasibility and efficacy of self-help delivered in general practitioner (GP) 

offices, Durand and King compared GP-supported CBT-based self-help303 with specialist 

outpatient treatment.292 The duration of treatment was at the clinician’s discretion. Patients in 

both groups reported significant decreases in scores on the Bulimic Investigation Test Edinburgh 

(BITE) and Eating Disorders Examination (EDE) total; however, binge eating and vomiting did 
81 

Table 17. Results from self-help trials, no medication: bulimia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major 

Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Bailer et al., 

2004290

Guided self-help 

vs. group CBT 

Outpatient 

Fair 

Eating: 

• Binge 

frequency 

• EDI 

• Laxative use 

• Meal 

frequency 

• Recovery 

• Remittance 

• Vomit 

frequency 

Biomarker: 

• BMI 

Psych: 

• BDI 

No statistics reported. Higher meal frequency in 

self-help at post-tx. 

Lower vomit frequency, 

depressed mood, laxative 

use, and bulimia 

symptoms, and higher 

BMI in self-help, at 1-year 

FU. 

Self-help superior to CBT in 

reducing bulimia symptoms 

over 18 weeks. 

CBT superior to self-help in 

reducing drive for thinness 

over tx and FU periods. 

Carter et al., 

2003291

CBT-based selfhelp vs. nonspecific self-help 

vs. waiting-list 

Outpatient 

Fair 

Eating: 

• Binge 

frequency 

• EDE 

• Exercise 

frequency 

• Purge 

frequency 

Psych: 

• BAI 

• BDI 

• IIP 

Both self-help groups 

decreased binge and 

purge frequencies. 

CBT-based self-help 

experienced a 

decrease in intense 

exercising. 

No differences on any 

measures. 

CBT-based self-help 

superior to non-specific selfhelp and to waiting-list in 

reducing intense exercising. 

Durand and King, 

2003292

General practice 

physician- based 

self-help vs. 

specialist-based 

self-help 

Outpatient 

Fair 

Eating: 

• BITE 

• Bulimic 

episodes 

• EDE 

• Vomit 

episodes 

Psych: 

• BDI 

• Patientrated 

severity 

No statistics reported. No differences on any 

measures. 

No differences on any 

measures. 

BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; BITE, Bulimic Investigation Text Edinborough; BMI, Body 

mass index; CBT, Cognitive Behavioral Therapy; EDE, Eating Disorder Examination; EDI, Eating Disorders Inventory; FU, 

followup; HDRS, Hamilton Depression Rating Scale [HDRS-17 items, HDRS-21 items]; IIP, Inventory of Interpersonal 

Problems; Psych, psychiatric and psychological; tx, treatment. 
82 

Table 17. Results from self-help trials, no medication: bulimia nervosa (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major 

Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Thiels et al., 

1998293

CBT vs. guided 

self-change 

Outpatient 

Fair 

Eating: 

• Binge 

abstinence 

• BITE 

• EDE 

• ED 

Awareness 

Test 

• Purge 

Abstinence 

Biomarker: 

• BMI 

Psych: 

• BDI 

• Self-esteem 

No statistics reported. Lower BITE scores in 

guided self-change group. 

No differences on any 

measures. 

not drop significantly. Both groups reported significant decreases in depression, but no treatment 

was superior. Weight change was not reported. Drop-out rates were similar across groups (24 

percent in the GP group and 18 percent in specialist care). 

A German study by Thiels et al. compared 16 weeks of CBT with guided self-change using a 

manual.293 Guided self-change included 16 sessions with a therapist encouraging use of the 

manual and addressing motivation, obstacles, and emergent crises. Significant decreases 

occurred in overeating, vomiting, BITE scores, and EAT scores for both groups combined. Only 

on BITE scores did the CBT group perform significantly better than the guided self-change 

group. Depression dropped in both treatment groups with no significant differences between 

groups. Dropout was 13 percent in CBT and 29 percent in guided self-change. 

Additional interventions for bulimia nervosa. We present other interventions for BN in 

Table 18. Three studies explored interventions that did not fit into our classification scheme: 

active light (such as that used to treat seasonal affective disorder), crisis prevention, and guided 

imagery.

Light therapy. In a small 8-week trial of 10,000 lux white light (active light) versus 50 lux 

red light (control), individuals in the active light group showed significantly greater decreases in 

binge eating than individuals in the control group.295 Mood improved in both groups but no 

additional differences were observed for any other eating disorder, psychological, or biomarker 

outcome. The investigators did not provide long-term follow-up data. Given the size of this trial 

and the absence of followup, results should be viewed as preliminary. 

Crisis prevention. Individuals who were abstinent after a trial of CBT were randomized to 

either a crisis prevention group in which they were able to contact their clinician to receive up to 

eight additional visits over 17 months if they felt their condition was deteriorating or a control 

follow-up-only group.297 The percentage of individuals who resumed binge eating and purging 

did not differ over the 17-month interval; however, none of the individuals in the crisis 

prevention group used any of their available calls despite the reappearance of bulimic symptoms. 
83 

Table 18. Results from other trials: bulimia nervosa 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time Within 

Groups 

Significant Differences 

Between Groups at 

Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Braun et al., 

1999295

Bright light 

therapy vs. dim 

light/placebo 

Outpatient 

Fair 

Eating: 

• Binge 

frequency 

• Meal frequency 

• Purge 

frequency 

• Seasonal 

patterns 

assessment 

questionnaire 

• YBC-EDS 

Psych: 

• BDI 

• HAM-D 

No statistics reported. No differences on any 

measures. 

Bright light superior to dim 

light (placebo) in reducing 

binge frequency over 3 

week tx. 

Mitchell et al., 

2004297

Crisis prevention 

vs. usual followup 

Outpatient 

Fair 

Eating: 

• Resumption of 

bingeing and/or 

purging after 

period of 

abstinence 

No differences on any 

measures. 

No differences on any 

measures. 

No differences on any 

measures. 

Esplen et al., 

1998296

Guided imagery 

vs. control 

(eating behavior 

journaling 

therapies) 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Binge 

frequency 

• EAT-26 

• EDI 

• Purge 

frequency 

No statistics reported. Higher abstinence rate in 

guided imagery 

compared to control 

group. 

Guided imagery superior 

to control in reducing 

binge and purge 

frequencies, drive for 

thinness, bulimia 

symptoms, and body 

dissatisfaction over 6 

week tx period. 

BDI, Beck Depression Inventory; EAT, Eating Attitudes Test (EAT-26 items); EDI, Eating Disorders Inventory; HAM-D, 

Hamilton Depression Rating Scale; Psych, psychiatric and psychological; tx, treatment; YBC-EDS, Yale-Brown-Cornell Eating 

Disorder Scale 

Guided imagery. Esplen et al. conducted a 6-week trial of patients in a guided imagery group 

and a control journaling group.296 Guided imagery was based on developing self-comforting in 

BN.304 Guided imagery led to a significantly greater decrease in measures of binge eating, 

purging, EDI bulimia, drive for thinness, and body dissatisfaction. At the end of treatment, 21 

percent of individuals in guided imagery and no individuals in the control condition were 

abstinent. Drop-out rates were comparable across groups.

Summary of behavioral interventions for bulimia nervosa. A large number of fair- to 

good-rated trials provide evidence that CBT administered individually or in group format is 

effective in reducing the core behavioral symptoms of binge eating and purging and 

psychological features of BN in both the short and the long term. One study suggests that CBT 

leads to more rapid reduction of symptoms than IPT.276 Another suggests that individual CBT 

confers no advantage over the more economical group CBT approach;273 although this finding is 

important for service delivery, it requires replication. The cognitive component of CBT appears 
84 

to be the active ingredient for change, as behavioral interventions alone are not as effective.274,276

Exposure with response prevention, either alone or as an added component to a core of cognitive 

therapy, offers no additional therapeutic advantage to basic CBT.270,272,274

Adding a cognitive component to nutritional intervention led to greater effectiveness in one 

study,280 and CBT led to better outcomes than a psychodynamically oriented supportiveexpressive therapy.278 Preliminary evidence suggests that DBT is effective and worth additional 

study for the treatment of BN.282

Four studies provided mixed evidence regarding the efficacy of self-help methods for BN. 

One German and one Austrian study provide support for guided self-help in comparison to group 

CBT290 and individually administered CBT.293 The nature of the self-help approach (CBT 

oriented versus nonspecific) did not lead to different outcomes.291 Preliminary evidence from the 

United Kingdom indicates that GPs can successfully deliver self-help.292 No self-help trials 

conducted in the United States met our inclusion criteria. Overall, especially in the absence of 

control conditions, few conclusions can be drawn regarding the efficacy of self-help approaches 

for BN. Moreover, the term self-help must be considered carefully as many of the interventions 

labeled self-help included considerable contact with providers. 

One report yielded preliminary evidence for treating BN with light leading to some shortterm decreases in binge eating.295 One study provided some support for guided imagery 

compared to journaling, although long-term maintenance of treatment effects is unknown.296

Crisis prevention approaches do not appear to be effective in the treatment of BN, based on one 

study, as patients do not avail themselves of the opportunity to contact their therapists when 

symptoms reemerge.297

Key Question 2: Harms of Treatment for Bulimia Nervosa 

Table 19 presents adverse events associated with treatments for BN. As reported in Chapter 

3, harms from second-generation antidepressants include the following: for fluoxetine, insomnia, 

nausea, asthenia, tremor, dizziness, rhinitis, sweating, urinary frequency, and sexual dysfunction; 

for fluvoxamine, nausea, dizziness and drowsiness.243 Adverse events associated with secondgeneration antidepressants in BN appear to be consistent with those observed in other 

disorders.253

Side effects of MAOI administration were nausea, sleep disturbance, and dizziness. No 

hypertensive crises were reported, although this danger should always be considered in patients 

who experience uncontrollable eating episodes.121

Key Question 3: Factors Associated With Treatment Efficacy 

Medication Trials 

A few medication trials for BN explored factors associated with outcome. Walsh et al. 

reported that patients with greater concern for body shape and weight and longer duration of 

illness had more favorable treatment responses.257 The Fluoxetine BN Collaborative Study group 

found that heavier patients had higher response rates in each treatment group.249

 
85 

Table 19. Adverse events reported: bulimia nervosa trials 

Intervention Adverse Event *† 

Medication Trials 

Fluoxetine vs. placebo244 Fluoxetine group: Insomnia, nausea, and shakiness 

significantly more common 

Placebo group: depression more common 

Fluoxetine vs. placebo248 Fluoxetine: significantly more trembling than placebo 

Fluoxetine 60mg (F60) vs. fluoxetine 20mg (F20) vs. 

placebo (PL)249 Side effects by treatment group: 

Insomnia: F60 (30); F20 (23); PL (10); (P < 0.001)

Nausea: F60 (28); F20 (20); PL (14); (P = 0.021) 

Asthenia: F60 (23); F20 (16); PL (11); (P = 0.039) 

Tremor: F60 (12); F20 (4); PL (0); (P < 0.001) 

Sweating: F60(7); F20 (4); PL (1); (P = 0.036) 

Urinary frequency: F60 (5); F20 (0); PL (2); (P = 0.012) 

Palpitation: F60(5); F20(1); PL(1); (P = 0.017) 

Yawn: F60 (5); F20(1); PL(1); (P = 0.017) 

Mydriasis: F60 (3); F20 (0); PL(0); (P = 0.018) 

Vasodilation: F60(1); F20 (4); PL (0); (P = 0.029) 

Fluoxetine (F) vs. placebo (PL)250 Side effects by treatment group: 

Insomnia: F (102); PL (19); (P < 0.05) 

Nausea: F (90); PL(13); (P < 0.001) 

Asthenia, F (63); PL (7); (P < 0.001) 

Anxiety: F (52); PL (9); (P < 0.05) 

Tremor: F (42); PL (2); (P < 0.001) 

Dizziness: F (37); PL (4); (P < 0.05) 

Yawning, F (36); PL (0); (P < 0.001) 

Sweating: F (28); PL (2); (P < 0.05) 

Decreased libido: F (19); PL (1); (P < 0.05) 

Depression: F (30); PL (19); (P < 0.05) 

Myalgia: F (14); PL (12); (P < 0.05) 

Emotional lability: F (8); PL (8); (P < 0.05) 

Conjunctivitis: F (1); PL (3); (P < 0.05) 

Fluoxetine vs. placebo252 Fluoxetine: hand tremor (5) 

Placebo: Palpitations (1) 

Fluoxetine vs. placebo254 Fluoxetine: rhinitis (24) 

Placebo: rhinitis (12); (P < 0.04) 

Fluvoxamine vs. placebo247,299 Fluvoxamine: nausea, dizziness and drowsiness 

significantly more common in patients receiving 

fluvoxamine 

Fluvoxamine: Drop outs due to general side effects (8) 

Trazodone vs placebo255 Trazodone significantly more dizziness and drowsiness 

than placebo 

Topiramate vs. placebo251,259 Topiramate: Dropouts (1) facial rash and irritability 

Placebo: Dropouts (2) 

Brofaromine vs. placebo253 Brofaromine: nausea (2); sleep disturbance, nausea, 

dizziness 

Placebo: headache (1); dry mouth, nausea 

Ondansetron vs. placebo246 No adverse events observed 

Desipramine vs. placebo257 NR 

CBT, cognitive behavioral therapy; DBT, dialectical behavioral therapy; NR: not reported 

* If no numbers appear in parentheses, authors had only listed adverse events but not reported the number of cases. 

† P values indicate differences between groups; they are reported with they are provided by the author. 
86 

Table 19. Adverse events reported: bulimia nervosa trials (continued) 

Intervention Adverse Event *†

Medication plus Behavioral Intervention Trials 

Fluoxetine vs. individual CBT vs. fluoxetine and individual 

CBT261 Fluoxetine: Dropouts due to side effects (4) 

Fluoxetine plus CBT: Dropouts due to side effects (2) 

Nature of side effects NR 

Fluoxetine vs. manual based self-help262 NR 

Fluoxetine plus guided self-help vs. placebo plus guided self 

help vs. fluoxetine vs. placebo265 NR 

Desipramine 16 wks vs. despipramine 24 wks vs. desipramine 

16 wks plus CBT vs. CBT only260,300

NR 

Interpersonal psychotherapy vs. antidepressant (fluoxetine 

replaced by desipramine if no effect) in CBT nonresponders263 NR 

CBT plus medication vs. CBT plus placebo vs. Supportive 

therapy plus med vs. supportive therapy plus placebo264,301

NR 

Behavioral Intervention Trials 

CBT vs. Interpersonal psychotherapy269 9 withdrawn from treatment: 7 severe depression, 1 acute 

onset of panic disorder 

CBT vs. exposure response prevention274 NR 

CBT vs. Behavior therapy vs. interpersonal 

psychotherapy267,276,277 Behavior therapy: Drop out (1) severe weight loss 

Group CBT vs. group Interpersonal psychotherapy vs. waiting 

list control287 NR 

CBT vs. interpersonal psychotherapy288 NR 

CBT vs. supportive-expressive therapy278 NR 

Cognitive therapy vs. nutritional therapy280 NR 

CBT vs. physical exercise vs. nutritional counseling283 Exercise: injury (1) 

Individual CBT vs. Group CBT273 Alcohol abuse (2), AN (1), visual hallucinations (1). No 

indication of which group these participants were in. 

CBT vs. CBT plus response prevention vs. self-monitoring vs. 

waiting-list266 NR 

CBT plus exposure with response prevention to pre-binge cues 

vs. CBT plus exposure to response prevention with pre-purge 

cues vs. CBT plus relaxation training270-272

NR 

Nutritional management vs. stress management281 NR 

DBT vs. waiting list282 NR 

Self-help Trials 

Guided self-help vs. group CBT290 NR 

Self-help manual vs. waiting list control291 NR 

Self-help intervention vs. clinic intervention292 NR 

CBT vs. guided self-change sessions293 NR 

Other Trials 

Active light vs. placebo dim light295 No adverse events observed 

Crisis prevention vs. follow up297 NR 

Guided imagery vs. control296 NR 
87 

Behavioral Intervention Trials 

Behavioral interventions in BN provided better and reasonably consistent information about 

factors associated with treatment response. Several investigators reported two factors as 

associated with poor outcome: high frequency of binge eating270,272,274,298,301 and longer duration 

of illness.274,298

Evidence was mixed or contradictory for other factors. Higher body dissatisfaction was 

associated with both poorer270 and better outcome.277 With respect to weight, a history of obesity 

was reported as a positive prognostic indicator270 and as a predictor of dropout.278 Better 

outcomes or more rapid response were associated with higher baseline depression, lower severity 

of binge eating,287 and greater attitudinal disturbance at baseline.277 Positive response was 

reported to be associated with a history of obesity, a history of alcoholism, and high scores for 

self-directedness270 and self-control.280 Poorer outcomes were associated with greater food 

restriction, higher depression, higher drive for thinness and bulimia scores on the EDI, and 

greater cue reactivity,270 low self-esteem,277 and precontemplation stage of change.268

Self-help Trials 

Factors associated with positive response to self help included higher EDI perfectionism 

scores, higher Dimensional Assessment of Personality Pathology (DAPP) compulsivity scores, 

higher DAPP intimacy problem scores, and lower cognitive behavior knowledge scores.291

Other Interventions Trials 

Higher soothing receptivity and ability to tolerate aloneness were associated with more 

positive outcomes in guided imagery therapy.296

Key Question 4: Treatment Efficacy by Subgroups 

The total number of individuals enrolled in the 18 trials of drugs or drug plus behavioral 

interventions was 1,941. Of those 67 were men. No studies reported differential outcome by age. 

Thirteen studies failed to report the race or ethnicity of participants. Of those that did, 793 

participants were identified as white, 57 as nonwhite, 33 as Asian, 12 as Hispanic American, and 

eight as African American. Of the 18 trials, 12 were conducted in the United States. No study 

analyzed results separately by sex or by race or ethnicity. Based on these results, we conclude 

that no information exists regarding differential efficacy of medication only or combined 

medication plus behavioral interventions for BN by sex, gender, age, race, ethnicity, or cultural 

group. 

The total number of individuals enrolled in behavioral intervention or other intervention trials 

was 1,462. Of those, two were men. Of the 18 trials, 14 failed to reported race or ethnicity of 

participants. From the remaining four trials, 410 subjects were identified as white; 22 as 

nonwhite; 28 Hispanic-American; 26 as Asian; Maori or Pacific Islander; 19 as AfricanAmerican or Afro-Caribbean; and one as Native American. In no instance did the investigators 

analyze results separately by race or ethnic group. No data exist regarding differential efficacy of 

behavioral interventions for BN by sex, gender, age, race, ethnicity, or cultural group. 

89 

Chapter 5. Results: Binge Eating Disorder

This chapter presents results of our literature search and our findings for the four key 

questions (KQs) pertaining to binge eating disorder (BED). KQ 1 sought evidence for the 

efficacy of various treatments or combinations of treatments for BED. KQ 2 sought evidence of 

harms associated with the treatment or combination of treatments for BED. KQ 3 addressed 

factors associated with the efficacy of treatment for BED. KQ 4 addressed whether the efficacy 

of treatment for BED differs by sex, gender, age, race, ethnicity, or cultural groups. We report 

first on specific details about the yields of the literature searches and characteristics of the 

studies, then on literature pertaining to treatment (KQ 1, KQ 2, and KQ 3). Summary tables 

presenting findings grouped by selected outcomes appear at the end of this chapter. 

Overview of Included Studies 

For each included BED study, detailed evidence tables appear in Appendix C.†† We report 

first on medication trials (Evidence Table 10), then combined medication and behavioral 

interventions (Evidence Table 11), behavioral interventions only (Evidence Table 12), self-help 

interventions (Evidence Table 13), and other interventions (Evidence Table 14). Within each 

table, studies are listed alphabetically by author. For each study we report eating disorder-related 

outcomes, psychiatric and psychological outcomes (such as comorbid depression and anxiety), 

and biomarker outcomes including weight loss. 

We identified 26 studies addressing treatment efficacy for BED. Nine were medication-only 

trials.305-313 We rated four of these trials as good,305,307,309,312 and five as fair.306,308,310,311,313 One 

study of a medication no longer available in the United States (d-fenfluramine) is not discussed 

here.313 The medications studied included second-generation antidepressants,305-309 tricyclic 

antidepressants,310 an anticonvulsant,311 sibutramine,312 and d-fenfluramine.313 

Four trials combined medication with behavioral interventions using second-generation 

antidepressants,314,315 a tricyclic antidepressant,316 and orlistat.317 Of these, we rated two as 

good,315,317 one as fair,316 and one as poor.314

We identified eight behavioral-intervention-only studies. Of these, we rated one trial as 

good,318 three as fair,319-321 and four as poor.322-325 Of the four fair or good studies, three used 

some form of cognitive behavioral therapy (CBT) in comparison to other interventions318-320 and 

one used dialectical behavior therapy (DBT).321 

Three trials investigated various self-help methods.326-328 We rated one as good326 and two, 

which report on the same sample at two points in time, as fair.327,328 Finally, one trial involved 

exercise, rated as poor,329 and another examined virtual reality therapy, rated as fair.330 

Studies with a quality rating of “poor” are not discussed below. Reasons that these studies 

received this rating are presented in Table 20. Although each study was not deficient in all areas, 

the following are the most common concerns contributing to the low rating of studies: 

randomization (no description of protections against researchers’ influence, a fatal flaw in 

approach or the approach not described), assessors not being blinded or their blinding status 

not described, adverse events not described, the statistical analysis not including or not reporting 

whether a power analysis was conducted, a lack of necessary controls for confounding, and 

results not reported using an intention-to-treat approach. 

 

†† Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
90 
91 

Table 20. Reasons for poor quality ratings and number of trials with poor ratings: binge eating disorder 

Reasons Contributing to Poor Ratings 

Types of Intervention, Number of Times Flaw Was Detected, 

and Citations 

Research Aim 

Hypothesis not clearly described Medication-only trials: 0 

Psychotherapy trials: 0 

Study Population 

Characteristics not clearly described Medication-only trials: 0 

Psychotherapy trials: 0 

No specific inclusion or exclusion criteria Medication-only trials: 0 

Psychotherapy trials: 0 

Randomization 

Protections against influence not in place Medication-only trial: 1314

Psychotherapy trials: 3322-324

Approach not described Medication-only trials: 0 

Psychotherapy trials: 1324

Whether randomization had a fatal flaw not 

known 

Medication-only trials: 0 

Psychotherapy trials: 4322-325

Comparison group(s) not similar at baseline Medication-only trials: 0 

Psychotherapy trials: 0 

Blinding 

Study subjects Medication-only trials: 1314

Psychotherapy trials: 0 

Investigators Medication-only trials: 1314

Psychotherapy trials: 0 

Outcomes assessors Medication-only trial: 1314

Psychotherapy trials: 4322-325

Interventions 

Interventions not clearly described Medication-only trials: 0 

Psychotherapy trials: 0 

No reliable measurement of patient compliance Medication-only trials: 0 

Psychotherapy trials: 2322,323

Outcomes 

Results not clearly described Medication-only trials: 0 

Psychotherapy trials: 0 

Adverse events not reported Medication-only trials: 0 

Psychotherapy trials: 3322-324
92 

Table 20. Reasons for poor quality ratings and number of trials with poor ratings: binge eating disorder 

(continued) 

Reasons Contributing to Poor Ratings 

Types of Intervention, Number of Times Flaw Was Detected, 

and Citations 

Statistical Analysis 

Statistics inappropriate Medication-only trials: 0 

Psychotherapy trials: 1325

No controls for confounding (if needed) Medication-only trials: 0 

Psychotherapy trials: 2323,325 

Intention-to-treat analysis not used Medication-only trials: 0 

Psychotherapy trials: 3323-325 

Power analysis not done or not reported Medication-only trial: 1314

Psychotherapy trials: 3322-324

Results 

Loss to followup 26% or higher or not reported Medication-only trials: 0 

Psychotherapy trials: 1325

Differential loss to followup 15% or higher or 

not reported 

Medication-only trials: 0 

Psychotherapy trials: 2324,325

Outcome measures not standard, reliable, or 

valid in all groups 

Medication-only trials: 0 

Psychotherapy trials: 0 

Discussion 

Results do not support conclusions, taking 

possible biases and limitations into account 

Medication-only trials: 0 

Psychotherapy trials: 0 

Results not discussed within context of prior 

research 

Medication-only trials: 0 

Psychotherapy trials: 0 

External validity: population not representative 

of US population relevant to these treatments 

Medication-only trials: 0 

Psychotherapy trials: 0 

Funding/sponsorship not reported Medication-only trial: 1314

Psychotherapy trials: 0 

Participants 

Of the 19 studies rated fair or good, 14 were conducted in the United 

States,305-309,311,315-318,320,321,327,328 and one each in Brazil,312 Germany,319 Italy,330

Switzerland,310and the United Kingdom.326 Five studies failed to report the age of participants; of 

the remainder, all focused on individuals 18 years of age or older (range, 18 to 65 years). With 

respect to sex, 1,132 individuals participated in fair or good clinical trials (984 women and 87 

men; for 61 subjects, sex was not reported). 
93 

Six studies failed to report the race or ethnicity of participants. Of those that did, 775 

participants were identified as white, 48 as nonwhite, 20 as African American, 12 as Hispanic 

American, and one as Native American. Drop-out rates from treatment trials appear in Table 21. 

Key Question 1: Treatment Efficacy 

Medication-only Trials 

We report eight randomized controlled double-blind trials of medications (Table 22).305-312 A 

total of 413 individuals enrolled in medication-only trials. Based on studies that reported sex (all 

except one study),311 322 women and 25 men participated in medication-only BED trials. The 

number of participants in the medication trials ranged from 20 to 85. The age of participants 

ranged from 18 to 60 years. Five trials reported the race of participants: 234 individuals were 

reported to be white and 29 nonwhite. Six trials were conducted in the United States,305-309,311

one in Brazil,312 and one in Switzerland.310

Second-generation antidepressants. Fluoxetine. One trial compared fluoxetine (average 

dose 71.3 mg/day) with placebo in 60 individuals meeting the Diagnostic and Statistical Manual 

for Psychiatric Disorders-Version IV (DSM IV) criteria for BED with three or more binges per 

week for 6 months and higher than 85 percent ideal body weight (IBW) in a 6-week flexible dose 

trial.305 Fluoxetine significantly decreased binges per week, severity of illness, and clinicianrated depression scores. It was associated with less weight gain than the placebo, although both 

groups gained weight during treatment. The investigators failed to report abstinence rates and 

long-term followup. Dropout was 57 percent in the fluoxetine group and 23 percent in the 

placebo group. Any inferences made from this study must be made with extreme caution because 

of the very high and differential attrition rate. 

Other second-generation antidepressants. A 9-week trial compared fluvoxamine (50-300 

mg/day) with placebo in 85 patients with BED, at least three binge eating episodes per week for 

6 months, and higher than 85 percent of the midpoint of their ideal weight for height. Using 

intention-to-treat analyses, the investigators showed that patients on fluvoxamine had a 

significantly greater rate of reduction in binge frequency than those on placebo; however, the 

remission rate did not differ between groups.306 The rate of improvement in severity of illness 

but not in depression was greater in the fluvoxamine group than in the placebo group. 

Fluvoxamine led to a greater rate of reduction of body mass index (BMI); however, BMI at 

endpoint was not reported so the clinical significance of the weight change could not be 

evaluated. The investigators failed to report long-term followup. Overall dropout was 21 percent. 

In a 12-week trial of fluvoxamine (average dose 239 mg/day) versus placebo in 20 patients 

with DSM-IV BED, investigators observed no differences between fluvoxamine and placebo on 

binge eating frequency, although both groups combined showed decreases in binge frequency at 

the end of treatment.307 Both groups combined had significant decreases in shape and weight 

concerns with no differences between them. Self-reported depression decreased similarly for 

both. Neither group showed significant weight change with treatment. The investigators failed to 

report long-term followup. Overall dropout was 20 percent. 

McElroy et al. compared 6 weeks of sertraline (mean dose 187 mg/day) with placebo in 34 

individuals with DSM-IV BED, at least three binge episodes per week for 6 months, and greater 

than 85 percent of IBW.309 Sertraline led to greater reduction in binges per week but not with 

complete remission when rated categorically. It was also associated with increased reduction in 
94 

Table 21. Dropout rates for randomized controlled trials: binge eating disorder 

Author 

Total 

Enrollment, 

N 

Total 

Dropouts, 

N (%) 

G1 Treatment (% 

Dropout) 

G2 Treatment 

(% Dropout) 

G3 Treatment 

(% Dropout) 

G4 

Treatment (% 

Dropout) 

Medication Trials 

Arnold et al., 2002305 60 24 (40%) Fluoxetine (57%) Placebo (23%) 

Hudson et al., 

1998306 85 18 (21%) Fluoxetine (NR) Placebo (NR) 

Pearlstein et al., 

2003307 25 5 (20%) Fluvoxamine (NR) Placebo (NR) 

McElroy et al., 

2000309 34 8 (24%) Sertaline (28%) Placebo (19%) 

McElroy et al., 

2003308 38 7 (18%) Citalopram (16%) Placebo (21%) 

Laederach-Hoffman 

et al., 1999310 31 2 (7%) Imipramine (7%) Placebo (6%) 

McElroy et al., 

2003311 61 26 (43%) Topiramate (47%) Placebo (39%) 

Appolinario et al., 

2003312 60 12 (20%) Sibutramine (23%) Placebo (17%) 

Medication plus Behavioral Intervention Trials 

Grilo, Masheb, and 

Wilson, 2005315 108 22 (20%) Placebo 

(15%) 

Fluoxetine (22%) CBT + placebo 

(21%) 

CBT + 

fluoxetine 

(23%) 

Agras et al., 1994316 109 24 (22%) Weight loss 

therapy (27%)

CBT + Weight 

loss (17%) 

CBT + Weight 

loss + 

desipramine 

(23%) 

Grilo, Masheb, and 

Salant, 2005317 50 11 (22%) Orlistat + 

CBT (24%) 

Placebo + CBT 

(20%) 

 

Behavioral Interventions 

Gorin, Le Grange, 

and Stone, 2003320 94 32(34%) Standard 

CBT (NR) 

Standard CBT 

with spouse 

involvement (NR) 

Waiting list 

control (NR) 

Hilbert and TuschenCaffier, 2004319 28 4 (14%) CBT with a 

body 

exposure 

component 

(14%) 

CBT with a 

cognitive 

restructuring 

component 

focused on body 

image (14%) 

 

Wilfley et al., 2002318 162 29 (18%) CBT (20%) Interpersonal 

psychotherapy 

(16%) 

 

Telch, Agras, and 

Linehan, 2001321 44 10 (23%) Dialectical 

behavior 

therapy (18%)

Waiting list 

control (27%) 

 

CBT, cognitive behavioral therapy; G, group; N, number; NR, not reported. 
95 

Table 21. Dropout rates for randomized controlled trials: binge eating disorder (continued) 

Author 

Total 

Enrollment, 

N 

Total 

Dropouts, 

N (%) 

G1 Treatment (% 

Dropout) 

G2 Treatment 

(% Dropout) 

G3 Treatment 

(% Dropout) 

G4 

Treatment (% 

Dropout) 

Self-help 

Carter and Fairburn, 

1998326 72 9 (12%) Guided selfhelp (24%) 

Pure self-help 

(0%) 

Waiting list 

control (4%) 

Peterson et al., 

1998328 50 

(to active 

treatment) 

8 (16%) Therapist-led 

(13%) 

Partial self-help 

(11%) 

Structured selfhelp (27%) Waiting list 

control (0%) 

Peterson et al., 

2001327 51 7 (14%) Therapist-led 

(NR) 

Partial self-help 

(NR) 

Structured selfhelp (NR) 

Riva et al., 2002330 20 0 (0%) Virtual Reality 

(0%) 

Psych-nutritional 

group (0%) 

 
96 

Table 22. Results from medication trials: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Arnold et al., 

2002305

Fluoxetine vs. 

placebo 

Outpatient 

Good 

Eating: 

• Abstinence 

• Binge eating 

Biomarker: 

• BMI 

• Weight 

Psych: 

• CGI 

• HAM-D 

No statistics reported Fluoxetine associated with 

lower illness severity and 

depressed mood, and less 

weight gain. 

Fluoxetine superior in reducing 

binge frequency, illness severity, 

and depressed mood, and in 

controlling weight and BMI gain 

over 6 weeks. 

Hudson et al., 

1998306

Fluvoxamine 

vs. placebo 

Outpatient 

Fair 

Eating: 

• Binge eating 

• Remission 

Biomarker: 

• BMI 

Psych: 

• CGI 

• HDRS 

No statistics reported No statistics reported Fluvoxamine superior in 

reducing binge frequency, 

clinical severity, and BMI over 9 

weeks. 

Pearlstein et 

al., 2003307

Fluvoxamine 

vs. placebo 

Outpatient 

Good 

Eating: 

• Binge eating 

• EDE 

Biomarker: 

• Weight 

Psych: 

• BDI 

• HAM-D 

• SCL-90 

No statistics reported No statistics reported No differences on any measures

McElroy et al., 

2003311

Topiramate vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Binge eating 

• YBOCS-BE 

Biomarker: 

• BMI 

• Weight 

Psych: 

• CGI 

• HDRS 

No statistics reported No statistics reported. Topiramate superior in reducing 

binge frequency, illness severity, 

eating-related obsessions, 

compulsions, BMI, and weight 

over 14 weeks. 

BDI, Beck Depression Inventory; BES, Binge Eating Scale; BMI, body mass index; CGI, Clinical Global Impressions; EDE, 

Eating Disorders Examination; FU, followup; HAM-D, Hamilton Depression Inventory; HDRS, Hamilton Depression Rating 

Scale; Psych, psychiatric and psychological; SCL-90, (Hopkins) Symptom Check List; SDS, Self-rating Depression Scale; vs., 

versus; YBOCS-BE, Yale-Brown Obsessive Compulsive Scale (modified for binge eating). 
97 

Table 22. Results from medication trials: binge eating disorder (continued) 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

McElroy et al., 

2003308

Citalopram vs. 

placebo 

Outpatient 

Fair 

Eating: 

• Binge eating 

• YBOCS-BE 

Biomarker: 

• BMI 

• Weight 

Psych: 

• CGI 

• HAM-D 

No statistics reported Citalopram asscociated with 

greater reduction in 

frequency of binge days, 

BMI, and weight. 

Citalopram superior to placebo 

in the rate of reduction in 

frequency of binges, illness 

severity, binge eating related 

obsessions and compulsions, 

and weight over 6 weeks. 

LaederachHoffman et al., 

1999310

Imipramine vs. 

placebo (with 

dietary and 

psychological 

counseling 

Outpatient 

Fair 

Eating: 

• Binge eating 

Biomarker: 

• BMI 

• Waist-hip ratio 

weight 

Psych: 

• HAM-D 

• SDS 

Imipramine decreased 

binge frequency and 

depressed mood over 8 

weeks, and decreased 

depressed mood and 

weight at 32 week FU. 

No statistics reported Imipramine superior to placebo 

in decreasing binge frequency, 

depressed mood, and body 

weight over 8 weeks of active tx, 

and 32-week FU. 

McElroy, 

Casuto et al., 

2000309

Sertraline vs. 

placebo 

Outpatient 

Good 

Eating: 

• Binge eating 

Biomarker: 

• BMI 

Psych: 

• CGI 

• HDRS 

No statistics reported No statistics reported Sertraline superior to placebo in 

reducing binge frequency, illness 

severity, and BMI, and in 

increasing global improvement 

over 6 weeks. 

Appolinario et 

al., 2003312

Sibutramine 

hydrochloride 

vs. placebo 

Outpatient 

Good 

Eating: 

• BES 

• Binge eating 

• Remission 

Biomarker: 

• Weight 

Psych: 

• BDI 

No statistics reported Sibutramine associated with 

less depressed mood. 

Sibutramine superior to placebo 

in reducing binge frequency and 

severity. 

Difference in weight at end of 

treatment with weight 

decreasing over treatment 

period in the sibutramine group 

but increasing in the placebo 

group. 

severity of illness but not with depression scores. The drug also led to greater reductions in 

weight; however, the investigators failed to report BMI at endpoint so the clinical significance of 

the weight change is unclear. The investigators failed to present long-term follow-up data. 

Dropout was 28 percent in the sertraline group and 19 percent in the placebo group. 

In a 6-week trial of citalopram (40-60 mg/day) versus placebo in 38 individuals with BED, 

with three or more binge episodes per week for 6 months and more than 85 percent of IBW, the 

active drug led to a significantly greater rate of decrease of binge eating and binge eating days; 

however, the percentage of individuals remitted when measured categorically did not differ 
98 

significantly.308 The citalopram group showed greater reductions in clinician-rated obsession and 

compulsion scores and in severity of illness and depression scores. The BMI rate of change was 

significantly greater in the citalopram group; patients lost on average 2.7 kg and those on placebo 

gained 5.2 kg during treatment. Although the rate of change data suggested more rapid response 

in the citalopram group, differences between the groups over time were not significant for the 

core outcome variables of binges per week or severity of illness. Dropout was 16 percent in the 

citalopram group and 21 percent in the placebo group. 

Tricyclic antidepressants. Laederach-Hoffman et al. augmented standard bi-weekly diet 

counseling and psychological support with either impiramine (25 mg three times a day) or 

placebo in 31 individuals with DSM-IV BED and BMI greater than 27.5.310 Significantly greater 

reductions in binge eating episodes and Hamilton Depression Rating Scale (HAM-D) scores 

occurred in the impiramine group at 8 and 32 weeks. Body weight was significantly reduced in 

the imipramine group at 8 and 32 weeks (mean reduction of 2.1 kg at 8 weeks and 5.0 kg at 32 

weeks); the placebo group gained weight. Abstinence rates were not reported. Low doses of 

imipramine when delivered in the context of psychological support and diet counseling led to 

maintenance of decreased binge eating, depression, and weight. Dropout was between 6 percent 

and 7 percent in both groups. 

Anticonvulsants. One 14-week trial compared topiramate (average dose 212 mg/day) with 

placebo in 61 individuals with BED, BMI greater than 30, and a score greater than 15 on the 

Yale-Brown Obsessive Compulsive Scale for Binge Eating (YBOCS-BE).311 Patients receiving 

topiramate experienced a significantly greater rate of change and a significantly greater 

percentage reduction in binge episodes, binge days per week, and YBOC-BE. Severity of illness, 

but not depression scores, showed greater improvement in the topiramate group. Topiramate led 

to significantly greater and clinically meaningful weight loss (5.9 kg) than placebo (1.2 kg). No 

follow-up data were provided. The investigators failed to report abstinence rates or endpoint 

values, so estimating the magnitude of clinical significance of differences is difficult. Dropout 

was 47 percent in the topiramate group and 39 percent in the placebo group. 

Sibutramine. A 12-week comparison of sibutramine (15 mg/day) with placebo in 60 

individuals with DSM-IV BED and a Binge Eating Scale (BES) score of greater than or equal to 

17 indicated that sibutramine produced significant decreases in binge days per week and BES 

scores than placebo.312 Sibitramine was also associated with a significant decrease in selfreported depression scores over the course of treatment. At week 12, the sibutramine group had 

lost on average 7.4 kg whereas the placebo group gained weight (a significant difference). The 

authors did not report abstinence rates or provide long-term follow-up data. Dropout was 23 

percent in the sibutramine group and 17 percent in the placebo group. 

Summary of medication-only trials. Treating BED in overweight individuals has two 

critical outcomes—decrease in binge eating and decrease in weight. Although not all BED 

studies explicitly sampled on the basis of weight, all focused on overweight individuals. Four 

selective serotonin reuptake inhibitors (SSRIs)—one serotonin, dopamine, and norepinephrine 

uptake inhibitor; one tricyclic antidepressant; one anticonvulsant; and one appetite suppressant—

have been studied in BED. In short-term trials, SSRIs appear to lead to greater rates of reduction 

in target eating, psychiatric and weight symptoms, and severity of illness. However, in the 

absence of clear endpoint data, and in the absence of data regarding abstinence from binge 

eating, we cannot judge the magnitude of the clinical impact of these interventions. Moreover, 

lacking follow-up data after drug discontinuation, we do not know whether observed changes in 

binge eating, depression, and weight persist. 
99 

Low-dose imipramine as an augmentation strategy to standard dietary counseling and 

psychological support is associated with decreases in binge eating and weight that persist after 

discontinuation of the medication. This finding suggests a potentially promising pairing worth 

further investigation. 

Both sibutramine and topiramate yielded promising results in terms of weight reduction for 

patients with BED: clinically significant reductions in BMI over the short term. The authors of 

these reports did not supply remission rates. Additional research is required to track patients after 

drug discontinuation to determine whether observed changes in eating behavior and weight 

persist. 

Several studies reported rate of change of symptoms rather than actual differences in groups 

in change over time including endpoint values. Although rate of change is of interest, endpoint 

measures, including consistently defined abstinence rates, are critical to evaluate the clinical 

status of participants at the end of treatment. 

Overall, drop-out rates were between 16 percent and 57 percent in the medication trials for 

BED. The high placebo response in BED is noteworthy. 

Medication Plus Behavioral Intervention Trials 

We present three trials of medications plus psychotherapy in Table 23.315-317 The total 

number of individuals enrolled in these combination trials was 267 (237 women and 30 men). 

The number of participants in these combination trials ranged from 50 to 109. Age ranged 

from 21 to 65 years. Of these three trials, two reported the race or ethnicity of participants: 140 

individuals were reported as white, 12 as African American, and six as Hispanic American.315,317

The United States was the site of all three trials. 

Second-generation antidepressants and CBT. Grilo et al. compared fluoxetine (60 mg/day) 

with placebo, both with and without CBT, in a 16-week trial.315 Treatment groups receiving CBT 

reported greater reductions in binge episodes, eating and shape concerns, disinhibition, and 

depression and greater remission rates than did the medication-only or placebo groups. Weight 

loss did not differ across groups; the authors did not report within-group weight loss over time. 

Dropout between groups was comparable (between 15 percent and 23 percent). 

Tricyclic antidepressants and CBT. Agras et al. compared the effects of weight-loss 

treatment, CBT, and desipramine in 109 individuals with DSM IV BED. They randomly 

allocated participants to 9 months of weight-loss-only therapy, 3 months of CBT followed by 6 

months of weight-loss therapy, or 3 months of CBT followed by 6 months of weight-loss therapy 

and desipramine (300 mg/day).316 Groups receiving CBT showed significant reduction in binge 

eating at 12 weeks but not at any later follow-up point. Likewise, any observed differences on 

self-report measures of eating pathology were no longer significantly different at 36 weeks. 

Changes in depression scores did not differ across groups. Initial weight loss was greater in the 

weight-loss therapy group. At 3-month followup, the greatest weight loss was seen in the group 

including CBT and desipramine (average reduction of 4.8 kg from baseline). Dropout from acute 

treatment was comparable across groups: from 27 percent in the weight-loss therapy group to 17 

percent in the CBT plus weight-loss therapy group. 

Orlistat and CBT. In a 12-week trial of orlistat (120 mg three times/day) with CBT and 

placebo with CBT in 50 individuals with DSM-IV BED and BMI > 30, the orlistat group had 

greater remission rates at the end of treatment but not at 2-month followup.317 The authors 

reported no differences in any other eating-related or depression measures. Individuals in the 

orlistat group experienced greater initial weight loss (-3.5 kg) than those in the placebo group 
100 

Table 23. Results from medication plus behavioral intervention trials: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Grilo, Masheb, 

Salant, 2005317

CBT + orlistat 

vs. CBT + 

placebo 

Outpatient 

Good 

Eating: 

• EDE 

• Remission 

Biomarker: 

• Weight loss 

Psych: 

• BDI 

No statistics reported Greater percentage of CBT 

+ orlistat group remitted and 

achieved at least 5 percent 

weight loss over 12 weeks. 

Group difference in weight 

loss maintained at 2-month 

FU 

CBT + orlistat superior in total 

weight loss and in percent 

weight loss to post-tx over 12 

weeks. 

Agras et al., 

1994316

Weight loss 

therapy vs. 

CBT+weight 

loss therapy vs. 

CBT+weight 

loss therapy + 

desipramine 

Outpatient 

Fair 

Eating: 

• Binge eating 

• TFEQ 

Biomarker: 

• Weight 

Psych: 

• BDI 

No statistics reported No statistics reported CBT plus weight loss (with or 

without desipramine) superior 

to weight loss alone in 

reducing binge frequency over 

12 weeks. 

Significant difference between 

groups at 12 wks in change in 

weight over time with weight 

decreasing in weight loss 

group and increasing in CBT 

groups. By 3 month FU, CBT 

plus desipramine superior to 

CBT without desipramine in 

reducing weight. 

Grilo, Masheb, 

Wilson, 2005315

Fluoxetine vs. 

placebo vs. 

CBT + placebo 

vs. CBT + 

fluoxetine 

Outpatient 

Good 

Eating: 

• Binge eating 

• BSQ 

• EDE 

• Remission 

• TFEQ 

Biomarker: 

• BMI 

Psych: 

• BDI 

No statistics reported No statistics reported CBT groups superior to 

placebo and fluoxetine alone 

in decreasing binge 

frequency, eating and shape 

concerns, global eating score, 

disinhibition, and rate of 

remission. 

CBT + fluoxetine superior to 

placebo alone and fluoxetine 

alone in decreasing weight 

concerns and hunger; superior 

to fluoxetine alone in reducing 

depressed mood and dietary 

restraint; superior to placebo 

in decreasing body 

dissatisfaction. 

CBT + placebo superior to 

placebo alone and fluoxetine 

alone in decreasing 

depressed mood; superior to 

fluoxetine alone in decreasing 

dietary restraint, weight 

concerns, and body 

dissatisfaction. 

BDI, Beck Depression Inventory; BMI, Body mass index; BSQ, Body Shape Questionnaire; CBT, Cognitive Behavioral 

Therapy; EDE, Eating Disorders Examination; FU, followup; Psych, psychiatric and psychological; TFEQ, Three Factor Eating 

Questionnaire; Tx, treatment, vs., versus. 

(-1.6 kg), but that loss was not maintained at followup; at followup, however, the orlistat group 

was more likely to have achieved a weight loss of 5 percent or more. Dropout (about 20 percent) 

was comparable between groups.
101 

Summary of medication plus psychotherapy trials. Adding CBT conferred benefit on 

remission rate, but not weight loss, over fluoxetine alone or placebo alone in one trial.315 Adding 

CBT to orlistat was associated with a greater decrease in weight during treatment, although this 

does not appear to be maintained at followup.317 In one trial, adding desipramine to CBT and 

weight loss therapy led to greater maintenance of weight loss over time.316 Combining 

medication and CBT may improve both binge eating and weight loss, although sufficient 

trialshave not been done to determine definitively which medications are best at producing and 

maintaining weight loss. Moreover, the optimal duration of medication treatment for sustained 

reductions in binge eating and maintenance of weight loss has not yet been addressed 

empirically. 

Behavioral Intervention Trials 

We identified eight behavioral intervention-only trials (Table 24),318-325 three trials of selfhelp (Table 25),326-328 and one trial each of exercise and virtual reality (Table 26).329,330 

In behavioral intervention trials, CBT tailored for BED was the most commonly tested 

therapeutic approach; one study used DBT. The total number of individuals enrolled in 

psychotherapy, self-help, exercise, and virtual reality trials was 481 (449 women and 32 men). 

Of the eight trials identified, participants ranged in age from 18 to 65 years. Six trials reported 

the race and ethnicity of participants: in all, they involved 401 persons identified as white, 19 

individuals as nonwhite, eight as African American or Afro-Caribbean, six as Hispanic 

American, one as Native American, and one as Asian. In no instance were results analyzed 

specifically by race or ethnic group. Of the eight trials, five were conducted in the United States 

and one each in Germany, the United Kingdom, and Italy. 

Behavioral intervention trials for binge eating disorder. CBT. A 12-week trial of standard 

CBT tailored for BED compared with CBT and spousal involvement and with a waiting list 

control group in 94 individuals with a BMI of 25 or more showed that both active CBT groups 

had significant reductions in days binged, BMI, disinhibition, hunger, depression, and selfesteem than the controls and were more likely to be abstinent from binge eating at the end of 

treatment. Adding spousal involvement did not produce significantly greater improvements than 

standard CBT.320 Both CBT groups had significantly lower depression scores and BMI, but they 

did not differ from each other. The average BMI decrease from baseline to followup was 0.11 for 

CBT and 0.77 for CBT with spousal involvement, suggesting that CBT alone, with or without a 

spouse participating, did not yield substantial weight change. Overall, dropout was 34 percent. 

Hilbert et al. studied 5 months of group CBT with body exposure treatment and group CBT 

with cognitive restructuring of negative body cognitions in 28 women with BED, using a broad 

inclusion criterion of at least one binge per week.319 Both groups showed decreases in binge 

eating, psychological aspects of binge eating, self-report binge eating scores, and decreases in 

self-report depression, but differences between groups were not statistically significant. Neither 

group experienced significant weight loss. Dropout was 14 percent in each group. 

Looking at the efficacy of group psychotherapy, Wilfley et al. compared group CBT with 

group IPT in 20 sessions with 3 additional individual sessions in 162 individuals with BED and 

BMI levels between 27 and 48.318 Both therapies led to significant decreases in the number of 

days binged at the end of treatment and at 4-month followup. CBT led to greater improvements 

in Eating Disorders Examination Restraint scores at all time points. At 12 months, the groups did 

not differ in abstinence (CBT, 72 percent; IPT, 70 percent), severity of illness, or depression; 

both treatments led to significant reductions in these parameters. No participants in either group 
102 

Table 24. Results from behavioral intervention trials, no medication: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Gorin et al., 

2003320

Group-based 

CBT vs. CBT 

with spouse 

involvement vs. 

waiting list 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Binge eating 

• TFEQ 

Biomarker: 

• BDI 

Psych: 

• BMI 

No statistics reported Higher percent abstinent in 

CBT groups compared to 

waiting list. 

CBT (with and without 

spouse involvement) 

superior to waiting list in 

decreasing number of 

binge days, disinhibition, 

hunger, depressed mood, 

and BMI over 12 weeks. 

Hilbert and 

Tuschen-Caffier, 

2004319

CBT+exposure 

vs. 

CBT+cognitive 

interventions for 

image 

disturbance 

Outpatient 

Fair 

Eating: 

• Binge eating 

• Body Satisfaction 

• EDE 

• Negative 

automatic 

thoughts 

• Recovery 

Biomarker: 

• BMI 

Psych: 

• BDI 

Binge frequency, 

depressed mood, shape 

and weight concerns, 

body dissatisfaction, and 

restraint decreased in 

both groups over time. 

No differences in percent 

recovered. 

No differences on any 

measures. 

Wilfley et al., 

2002318

CBT vs. IPT 

Outpatient 

Good 

Eating: 

• Abstinence 

• Binge eating 

• EDE 

Biomarker: 

• BMI 

Psych: 

• GSI 

• SCL-90 

Both interventions 

associated with 

decreased number of 

binge days and eating 

restraint at post-tx, 4- 

and 8-month FU. 

Both tx associated with 

decreased GSI total 

scores; shape, weight, 

and eating concerns, 

restraint, and depressed 

mood at post-tx. 

Less restraint in CBT at 

post-tx and 4-month FU. 

CBT superior in 

decreasing eating 

restraint at post-tx and 4, 

8, and 12 month FU. 

BDI, Beck Depression Inventory; BES, Binge Eating Scale; BMI, body mass index; CBT, Cognitive Behavioral Therapy; DBT, 

Dialectical Behavior Therapy; EDE, Eating Disorders Examination; EES, Emotional Eating Scale; FU, followup; GSI, General 

Severity Index (derived from BSI); PANAS, Positive and Negative Affect Schedule; Psych, psychiatric and psychological; RSE, 

Rosenberg Self-Esteem Scale; SCL-90, (Hopkins) Symptom Check ListTFEQ, Three Factor Eating Questionnaire; Tx, treatment, 

vs. versus. 
103 

Table 24. Results from behavioral intervention trials, no medication: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Telch et al., 

2001321

DBT vs. waiting 

list 

Outpatient 

Fair 

Eating: 

• BES 

• Binge eating 

• EDE 

• EES 

Biomarker: 

• Weight 

Psych: 

• BDI 

• PANAS 

• RSE 

No statistics reported No statistics reported DBT superior to waiting 

list control in decreasing 

number of binge episodes 

and binge days, binge 

severity, and weight, 

shape, and eating 

concerns. 
104 

Table 25. Results from self-help trials, no medication: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Carter and 

Fairburn, 1998326

Guided self-help 

vs. non-guided 

self-help vs. 

waiting list 

Outpatient 

Good 

Eating: 

• Abstinence 

• Binge eating 

• EDE 

Biomarker: 

• BMI 

• Weight 

Psych: 

• BSI 

• GSI 

Both self-help groups 

decreased binge 

eating, GSI, and EDE 

global at 12-week posttx. 

Guided self-help only 

decreased eating 

restraint at post-tx. 

Both self-help groups 

associated with higher 

abstinence rates, less binge 

eating, and lower GSI, EDE 

global and restraint scores, 

compared to waiting list at 

post-tx. 

Guided self-help associated 

with less restraint and binge 

eating at 3 month FU and 

with less binge eating at 6 

month FU compared to nonguided self-help. 

Guided self-help superior 

to non-guided self-help 

and waiting list in 

reducing eating restraint 

over 12 weeks. 

Peterson et al., 

1998328

Therapist-led 

group CBT vs. 

partial self-help 

group CBT vs. 

structured selfhelp group CBT 

vs. waiting list 

Outpatient 

Fair 

Eating: 

• Abstinence 

• BES 

• Binge eating 

• BSQ 

• Eating Behavior-IV 

• TFEQ 

Biomarker: 

• BMI 

Psych: 

• HDRS 

• RSE 

No statistics reported Abstinence rates for binge 

eating higher in each of the 

CBT groups compared to 

waiting list 

CBT groups superior to 

waiting list in decreasing 

objective and total binge 

episodes/week, hours 

spent binge eating/week, 

binge severity, 

disinhibition, and hunger 

over 8 weeks. 

Peterson et al., 

2001327

Therapist-led 

group CBT vs. 

partial self-help 

group CBT vs. 

structured selfhelp group CBT 

Outpatient 

Fair 

Eating: 

• Abstinence 

• Binge eating 

• BSQ 

• TFEQ 

Biomarker: 

• BMI 

Psych: 

• BDI 

• HDRS 

No statistics reported Abstinence from total binge 

episodes higher in 

structured self-help group 

versus therapist-led selfhelp and partial self-help 

groups. 

No differences on any 

measures 

BDI, Beck Depression Inventory; BES, Binge Eating Scale; BMI, Body mass index; BSI, Brief Symptom Inventory; BSQ, Body 

Shape Questionnaire; CBT, Cognitive Behavioral Therapy; EDE, Eating Disorders Examination; FU, followup; GSI, General 

Severity Index (derived from BSI); HDRS, Hamilton Depression Rating Scale; Psych, psychiatric and psychological; RSE, 

Rosenberg Self-Esteem Scale; TFEQ, Three Factor Eating Questionnaire; Tx, treatment, vs., versus. 
105 

Table 26. Results from other trials: binge eating disorder 

Source, 

Treatment, 

Setting, and 

Quality Score 

Major Outcome 

Measures 

Significant Change 

Over Time 

Within Groups 

Significant Differences 

Between Groups 

at Endpoint 

Significant Differences 

Between Groups in 

Change Over Time 

Riva et al., 2002 

Virtual realitybased tx for body 

image vs. CBTbased psychonutritional group 

therapy 

Inpatient 

Fair 

Eating: 

• Abstinence 

• BIAQ 

• BSS 

• CDRS 

• DIET 

• FRS 

• WELSQ 

Psych: 

• STAI 

Virtual reality tx 

associated with increased 

ideal body score and 

WELSQ total score, and 

decreased state anxiety. 

No statistics reported Virtual reality tx superior 

to psycho-nutritional tx in 

increasing WELSQ total 

score and in decreasing 

state anxiety and 

overeating. 

BMI, Body mass index; BIAQ, Body Image Avoidance Questionnaire; BSS, Body Satisfaction Scale; CBT, cognitive behavioral 

therapy; CDRS, Contour Drawing Rating Scale; DIET, Dieter’s Inventory of Eating Temptations; FRS, Figure Rating Scale; 

Psych, psychiatric and psychological; STAI, Spielberger State-Trait Anxiety Inventory; Tx, treatment; WELSQ, Weight Efficacy 

Life-style Questionnaire. 

experienced reductions in BMI across treatment or follow-up periods. Dropout was 20 percent in 

CBT and 16 percent in IPT.

Dialectical behavioral therapy. Twenty weeks of DBT led to greater reduction in binge days, 

binge episodes, weight concern, shape concern, and eating concern than did being in a waiting 

list control group in 44 women with DSM-IV BED.321 Depression and anxiety scores did not 

differ. The authors did not report whether DBT was associated with significant change in weight, 

although no differences in weight loss emerged between groups during treatment. Dropout was 

18 percent in the DBT group and 55 percent in the waiting list group. 

Self-help trials. Carter and Fairburn compared guided self-help using a book302 combined 

with six to eight sessions with a facilitator with self-help-only using the same book in the 

absence of a facilitator and with waiting list controls in 72 women with BED with weekly 

binges.326 Both self-help approaches were more efficacious than the control arm in reducing the 

mean number of binge days and improving abstinence and cessation rates and EDE scores. At 

the end of treatment, both self-help groups showed significantly greater reductions in clinical 

severity than the control group. No group reported significant weight loss at any point. 

Comparisons of the two self-help groups yielded no differences in eating, depression, or BMI 

measures at any follow-up point. Dropout was 24 percent from guided self-help and 4 percent 

from the control group; self-help-only had no dropouts. 

In a four-group comparison, Peterson et al. compared therapist-led self-help, partial self-help, 

structured self-help, and waiting list controls in 61 individuals with DSM IV BED.328 In 

therapist-led self-help, a doctoral-level therapist led both the psychoeducational component and 

group discussion; in the partial self-help group, participants viewed a 30-minute 

psychoeducational videotape and then participated in a therapist-led discussion; and in the 

structured self-help group, subjects viewed the 30-minute psychoeducational videotape and then 

led their own 30-minute discussion. All self-help groups performed better than controls on 

objective binges, total binges, hours spent bingeing, and self-reported eating attitudes. For 

abstinence rates, all self-help groups (68 percent to 87 percent) were better than controls (12.5 

percent). The groups did not differ in depression scores or BMI changes. Dropout was higher in 
106 

the structured self-help group (27 percent) than in the therapist-led (13 percent) and partial (11 

percent) self-help groups. 

The second report on this sample compared therapist-led self-help, partial self-help, and 

structured self-help in 51 individuals with DSM-IV BED.327 All three approaches led to 

significant decreases in objective binges, hours spent bingeing, and body dissatisfaction. 

Structured self-help led to significantly greater abstinence at the end of treatment but not at 

followup. Depression scores decreased over time but not differentially across groups. BMI 

changes did not differ across groups; the authors did not report whether significant decreases 

occurred within groups, but the numerical changes appeared to be minimal. Dropout was not 

reported. 

Additional interventions for binge eating disorder. In an inpatient trial, Riva et al. 

compared virtual reality therapy to psychonutritional control in 20 women with DSM IV BED.330

Virtual reality therapy uses interactive three-dimensional visualization, a head-mounted display, 

and data gloves to modify body image perceptions. In this very small study with a large number 

of outcome measures, the investigators compared seven sessions of virtual reality plus a lowcalorie diet and physical training with psychonutritional CBT, a low-calorie diet, and physical 

training. Virtual reality showed significant improvements in weight efficacy and diet scores. 

Abstinence did not differ significantly between groups and was 100 percent in each, most likely 

secondary to intensive inpatient treatment. Dropout was not reported. 

Summary of behavioral interventions for binge eating disorder. Investigators most 

frequently chose to study CBT. However, no basic trial comparing individually administered 

CBT with waiting list, treatment as usual, or a second therapy was rated as fair or good. 

The three fair- or good-rated trials that incorporated CBT provided treatment for between 12 

weeks and 5 months. Collectively, these trials indicated two main findings. First, CBT is 

effective in reducing either the number of binge days or the actual number of reported binge 

episodes. Second, in comparison to waiting list controls, it leads to greater rates of abstinence 

when administered either individually or in group format, and this abstinence persists for up to 4 

months post treatment. CBT also improves the psychological aspects of BED such as ratings of 

restraint, hunger, and disinhibition. Results are mixed as to whether CBT improves self-rated 

depression in this population. In all three studies CBT did not lead to decreases in weight. 

Whether the successful treatment of BED with CBT is associated with less weight gain (as 

opposed to actual weight loss) over time in individuals with BED has not yet been adequately 

addressed. Similarly, DBT (one trial) is associated with decreases in binge eating and 

psychological aspects of the disorder but not with definitive change in depression or anxiety or 

apparent weight loss. 

Although CBT and DBT decrease binge eating and related psychological features of the 

disorder, they have no observable impact on the important outcome variable of weight loss. This 

is a somewhat puzzling finding as one would expect decreases in binge eating to be associated 

with weight loss. The reason for no weight loss is unclear. It is possible that calories previously 

consumed as binges may be distributed over nonbinge meals; or, how patients label binges and 

nonbinge meals may change with treatment. In any case, despite reported changes in eating 

patterns, little demonstrable weight change is achieved. 

Self-help (three trials) is efficacious in decreasing binge days, binge eating episodes, and 

psychological features associated with BED. It also leads to greater abstinence from binge eating 

when compared to individuals randomized to a waiting list control condition; short-term 

abstinence rates approximate those seen in face-to-face psychotherapy trials. No self-help trials 
107 

led to significant decreases in self-rated depression scores or weight in comparison to waiting list 

controls. Virtual reality therapy must be viewed as experimental; the intensive inpatient 

treatment associated with this trial invariably affects the perfect abstinence rates observed in both 

treatment groups. Observing any added efficacy of virtual reality therapy is difficult at best. 

Overall dropout rates in behavioral interventions for BED were between 11 percent and 27 

percent in active treatment groups. 

Key Question 2: Harms of Treatment for Binge Eating 

Disorder 

Table 27 presents adverse events associated with BED treatments. For the trials using 

second-generation antidepressants, we refer to a recently completed report on the comparative 

effectiveness and tolerability of second-generation antidepressants (see Chapter 3).243 In the BED 

clinical trials, the commonly reported side effects in trials involving fluoxetine were sedation, 

dry mouth, headache, nausea, insomnia, diarrhea, fatigue, increased urinary frequency, and 

sexual dysfunction. With fluvoxamine adverse events that occurred significantly more frequently 

than with placebo included insomnia, nausea, and abnormal dreams. Additional commonly 

reported adverse events included headache, asthenia, depression, dizziness, somnolence, dry 

mouth, nervousness, and decreased libido. Patients treated with sertraline experienced insomnia 

at a significantly greater rate than those receiving placebo; citalopram was associated with more 

reports of sweating and fatigue than placebo. For tricyclic antidepressants, 24 percent of 

individuals treated with desipramine discontinued treatment because of side effects. For 

imipramine, only anticholinergic effects (constipation, dry mouth, blurred vision) were reported 

more frequently in active drug than placebo participants. In the topiramate trial, six of 30 patients 

dropped out because of adverse events including headache, parasthesias, and amenorrhea. 

Individuals treated with sibutramine experienced significantly more constipation than those 

treated with placebo. Gastrointestinal events were reported more often in individuals receiving 

orlistat than in those receiving placebo. 

No direct adverse events were reported for any psychotherapy trials for BED. In the DBT 

trial, three individuals required treatment for depression during the follow-up period. 

Key Question 3: Factors Associated With Treatment Efficacy 

Few studies reported on factors associated with efficacy of treatment in BED. Early 

abstinence from binge eating was associated with significantly greater weight loss in one 

study.316 In one self-help trial, higher initial self-esteem was associated with poorer outcome; 

however, the effect was small, accounting for 6 percent of the variance in outcome.326 

Key Question 4: Treatment Efficacy by Subgroups 

The total number of individuals enrolled in the 12 drug or medication plus behavioral 

intervention trials was 680; of those, 55 were men. The age range of participants was reported in 

eight of the 12 studies; no study reported differential outcome by age. Of the seven studies that 

did report race or ethnicity, 374 participants were identified as white, 29 as nonwhite, 12 as 

African American, and six as Hispanic-American. Ten trials were conducted in the United States. 

No study analyzed results separately by sex, gender, race, or ethnicity. Based on these results, we 
108 

Table 27. Adverse events reported: binge eating disorder trials 

Intervention Adverse Events Reported 

Medication Trials* H

Fluoxetine versus placebo305 Fluoxetine group: sedation (5), dry mouth (11), headache (9), nausea (7), 

insomnia (7), diarrhea (6), fatigue (6), increased urinary frequency (4), sexual 

dysfunction (4). 

Both groups: hand and foot swelling, palpitations, and apathy; (P = NS) 

Fluvoxamine versus placebo306 Fluvoxamine group: insomnia, headache, nausea, asthenia, depression, 

dizziness, somnolence, abnormal dreams, dry mouth, nervousness, and 

decreased libido. Insomnia, nausea, and abnormal dreams significantly more 

common in fluvoxamine than placebo. 

Fluvoxamine versus placebo307 Fluvoxamine group: sedation (8); nausea (4); dry mouth (4); decreased libido 

(3) 

Placebo group: sedation (3); nausea (1); dry mouth (3); decreased libido (0) 

(P = NR) 

Sertraline versus placebo309 Sertraline group: insomnia (7) 

Placebo group: insomnia (1) (P = 0.04) 

Citalopram versus placebo308 Citalopram group: sweating (9) (P = 0.008); fatigue (5) (P = 0.05) 

Placebo group: sweating (1); fatigue (0) 

Also reported: dry mouth, headache, diarrhea, nausea, sedation, insomnia, 

sexual dysfunction 

Imipramine versus placebo310 Imipramine group: skin eruptions and an aversion to tablet intake (1) 

anticholinergic effects (7) 

Placebo group: hunger, sweating, palpitations, arrhythmia, and general 

malaise (1); anticholinergic effects (3); (P < 0.05) 

Topiramate versus placebo311 Topiramate group: headache, paresthesias and amenorrhea 

Placebo: leg cramps, sedation and testicular soreness 

Sibutramine hydrochloride versus 

placebo312 Sibutramine: dry mouth (22); headache (6); constipation (7) 

Placebo: dry mouth (3); headache (14); constipation (0) (P < 0.01) 

All other adverse events did not differ significantly (i.e., nausea, insomnia, 

sudoresis, lumbar pain, depressive mood, flu syndrome, malaise, others) 

(P = NS) 

Medication Plus Behavioral Intervention 

Placebo versus fluoxetine versus 

CBT + placebo versus CBT + 

fluoxetine315

NR 

Weight loss treatment versus 

CBT versus desipramine316 8 subjects discontinued desipramine because of side effects 

Orlistat plus CBT versus Placebo 

plus CBT317 Orlistat + CBT: significantly more gastrointestinal events 

Behavioral Interventions 

Standard CBT versus CBT with 

spouse involvement versus 

waiting list control320

NR 

CBT + exposure versus CBT + 

cognitive interventions for body 

image disturbances319

NR 

CBT versus IPT318 NR 

Dialectical behavioral therapy 

versus waiting list control321 3 women in DBT group were treated with either psychotherapy or medication for a 

major depressive episode. 

CBT, cognitive behavioral therapy; IPT, interpersonal psychotherapy; NR, not reported; NS, not significant, vs., versus. 

* If no numbers appear in parentheses, authors had only listed adverse events but not reported the number of cases. 

H P values indicate differences between groups, they are reported when provided by author. 
109 

Table 27. Adverse events reported: binge eating disorder trials (continued) 

Intervention Adverse Events Reported 

Self-help 

Guided self-help versus pure selfhelp versus waiting list control326 NR 

Therapist-led versus partial selfhelp versus structured self-help 

versus waiting list control328

NR 

Therapist-led versus partial selfhelp versus structured self-help327 NR 

Other Behavioral Interventions 

Virtual reality based treatment 

versus psychonutritional 

control330

No adverse events observed 

conclude that no information exists about differential efficacy of pharmacotherapy interventions 

for BED by sex, age, gender, race, ethnicity, or cultural group. 

The total number of individuals enrolled in psychotherapy, self-help, or other behavioral 

trials was 532; of those, 32 were men. Participants ranged in age from 18 to 64. No studies 

looked at BED treatment for children or adolescents. From the trials that reported race or 

ethnicity, participants included 450 whites, 19 nonwhites, eight African Americans or AfroCaribbeans, six Hispanic-Americans, one Native American, and one Asian. In no instance did 

the investigators analyze results separately by race or ethnic group. No data exist regarding 

differential efficacy of psychotherapeutic treatment for BED by sex, age, gender, race, ethnicity, 

or cultural group. 

109 

Chapter 6. Outcomes of Eating Disorders 

This chapter presents the results of our literature search and findings for key questions (KQs) 

5 and 6. KQ 5 asks what factors are associated with outcomes among individuals with the 

following eating disorders: anorexia nervosa (AN), bulimia nervosa (BN), and binge eating 

disorder (BED). KQ 6 asks whether outcomes for each of these disorders differ by sex, gender, 

age, race, ethnicity, or cultural groups. 

We report our results separately for each disease in three main sections of this chapter. Use 

of the term “significant” means that differences over time or between groups were statistically 

significant at least at the P < 0.05 level. 

We include literature that discusses more than one disease if findings do not combine 

individuals with different eating disorders. The review focuses on four main outcomes categories 

of interest: those related to eating, those involving psychiatric or psychological variables, those 

measured by biomarkers (e.g., weight, menstruation), and death. Many studies were conducted 

outside the United States, including Germany, England, Scotland, Sweden, China, Japan, New 

Zealand, and Australia. For that reason, we note in many cases below the setting (city, country) 

of the studies to emphasize the extent to which this literature is not directly generalizable to US 

populations and reflects variations across locales. 

We include summary tables containing information on outcomes for studies that we rated fair 

or good. Similar to text, tables group studies by design: cohort (following a group of individuals, 

with the disease, identified from the community) or case series (following a group of individuals, 

with the disease, who received treatment) and whether a nondisease comparison group is 

followed as well. Articles that discuss results from the same study (the same sample for the same 

amount of time) are grouped in the same row. Finally, within these categories, we list studies 

alphabetically by author. 

Six of the 62 outcomes articles we identified presenting outcomes for individuals with AN, 

BN, or BED received a quality rating of “poor;” Table 28 documents the reasons why these 

studies received this rating. Although each study was not deficient in all areas, common concerns 

contributing to a low rating included the following: a study involved only participants from one 

eating disorder program in one location or lacked a description of the location; the study did not 

have a comparison group; the statistical analysis did not include a power analysis or the authors 

did not report that they conducted any power analyses; the statistical analysis did not have 

necessary controls for confounding; and outcome assessors were not blinded to study group or 

blinding status was not described. As in earlier chapters, we do not discuss these studies further 

in the text. 

For each included study, detailed evidence tables appear in Appendix C.‡‡ Evidence Table 15 

contains the included articles for AN outcomes; Evidence Table 16, articles for BN outcomes; 

and Evidence Table 17, articles for BED outcomes. Within each table, studies are listed 

alphabetically. Studies with outcomes for individuals with both AN and BN are in evidence 

tables for both diseases. To answer KQ 6, we used the literature that met our inclusion criteria 

and was relevant to answer KQ 5. 

 

‡‡ Appendixes cited in this report are provided electronically at 

http://www.ahrq.gov/downloads/pub/evidence/pdf/eatingdisorders/eatdis.pdf. 
110 

Table 28. Outcome studies: reasons for poor quality ratings and number of poor ratings by disease type 

Reasons Contributing to 

Poor Ratings Types of Disease, Number of Times Flaw Was Detected, and Citations 

Research Aim 

Hypothesis not clearly 

described 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Study Population 

Characteristics not clearly 

described 

Anorexia Nervosa: 1331

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

No specific inclusion or 

exclusion criteria 

Anorexia Nervosa: 2331,332

Bulimia Nervosa: 1333 

Binge Eating Disorder: 0 

Study groups not 

comparable to each other 

and/or to non-participants 

with regard to confounding 

factors or characteristics 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Eating Disorder Diagnosis Method 

Used independent clinician 

diagnosis or method used 

not reported 

Anorexia Nervosa: 2331,334

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

None used to diagnose 

patients similar in 

treatment/disease and 

comparison groups 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Study Design 

Participants drawn from a 

treatment program in one 

city or area not reported 

Anorexia Nervosa: 5332,334-337

Bulimia Nervosa: 1333 

Binge Eating Disorder: 0 

No comparison group Anorexia Nervosa: 6332

331,334-337

Bulimia Nervosa: 1333 

Binge Eating Disorder: 0 
111 

Table 28. Outcome studies: reasons for poor quality ratings and number of poor ratings by disease type 

(continued) 

Reasons Contributing to 

Poor Ratings Types of Disease, Number of Times Flaw Was Detected, and Citations 

Statistical Analysis 

Statistics inappropriate Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

No controls for 

confounding (if needed) 

Anorexia Nervosa: 4331,332,335,336

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Power analysis not done or 

not reported 

Anorexia Nervosa: 5331,332,334-336

Bulimia Nervosa: 1333 

Binge Eating Disorder: 0 

Results/Outcome Measurement 

Outcome assessor not 

blinded or not reported 

Anorexia Nervosa: 3331,332,337

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Outcome measures not 

standard, reliable, or valid 

in all groups 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Interpretation of statistical 

tests inappropriate 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

External Validity 

Population not 

representative of US 

population relevant to 

these treatments 

Anorexia Nervosa: 2331,336

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Discussion 

Results do not support 

conclusions, taking 

possible biases and 

limitations into account 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

Results not discussed 

within context of prior 

research 

Anorexia Nervosa: 0 

Bulimia Nervosa: 0 

Binge Eating Disorder: 0 

 
112 

Anorexia Nervosa 

Our discussion of AN outcomes includes 38 articles exclusively discussing individuals with 

AN3,7,177,331,332,334-366 and seven articles discussing individuals with both AN and BN.367-373 First 

we discuss results for KQ 5, then KQ 6. 

Key Question 5: Factors Associated with Outcomes 

Eating-related outcomes. Table 29 presents outcomes from studies rated fair or good; we 

discuss factors associated with outcomes in the text. Types of studies include prospective cohort 

with a nondisease comparison group and case series with and without a nondisease comparison 

group. 

Many studies evaluate eating-related outcomes based on the general Morgan-Russell (M-R) 

scale or some modification of the scale, which evaluates weight (and menstruation in females), 

or the average M-R scale, which is a composite rating of subscales measuring nutritional status, 

mental status, sexual adjustment, menstrual functioning, and socioeconomic status. General scale 

categories are defined as good—normal body weight and regular menstruation—intermediate, 

amenorrhea or low body weight (i.e., weight less than 85 percent of average body weight 

[ABW]); and poor—amenorrhea and low body weight (i.e., less than 85% ABW). 

Prospective cohort studies with comparison groups. We included one prospective cohort 

study with outcomes for individuals with AN in our review that reported results in several 

articles, after participants were followed for 5 years345,356 and 10 years.349,352,362 AN participants 

were 51 residents of Göteborg, Sweden (including three males), born in 1970, who had been 

diagnosed with AN as adolescents. Comparisons were Göteborg residents matched to the AN 

group by age, sex, and school attended. Data from all articles discussing this study did not match 

exactly; therefore, we caution readers about ostensible trends across time based on data from 

different studies. 

At 5-year followup, approximately one-half of the individuals with AN were considered 

recovered: 59 percent had no eating disorder (ED) diagnosis and 41 percent had a good outcome 

according to M-R scale criteria. However, 6 percent still had AN and the remainder had other 

eating disorders including BN (22 percent) and EDNOS (14 percent). The AN group also 

remained significantly more symptomatic than the nondisease comparison group on several 

measures such as dietary restriction, concern about body weight, worry about appearance, and 

Eating Attitudes Test (EAT) scores. 

By 10 years, the M-R scale outcomes had improved. One-half of the cohort who had AN at 

baseline had a good outcome (49 percent); the percentage of the group with a poor outcome had 

declined from 24 percent at 5 years to 10 percent at 10 years. Still, 27 percent had an ED 

diagnosis at followup. 

Case series studies with comparison groups. One case series study with a nondisease 

comparison group discussed results in two articles, Bulik et al.342 and Sullivan et al.350 For this 

study, investigators recontacted 70 women 12 years after referral for treatment (inpatient, 

outpatient, or assessment) for AN at one facility in Christchurch, New Zealand. The AN group 

was not limited to those with adolescent onset of the disease. The comparison group (N = 98) 

resided in the same city and was matched by age. Although 30 percent of individuals with AN at 

baseline were fully recovered, 21 percent continued to have an eating disorder at followup, with 

10 percent continuing to meet Diagnostic and Statistical Manual, version III, Revised 
113 

Table 29. Eating-related outcomes: anorexia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Prospective Cohort, Comparison Group 

Gillberg et al., 1994345

(Good) 

Råstam et al., 1995356

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 5 

ED dx at FU: AN: 6%; BN: 22%; EDNOS: 14%; None: 59% 

Recovered (M-R scale): 47% 

M-R outcomes: Good: 41%; Intermediate: 35%; Poor: 24% 

Nilsson et al., 1999362

(Good) 

Råstam et al., 2003349

(Good) 

Wentz et al., 2001352

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 10 

ED dx at FU: AN: 6%; BN: 4%; EDNOS: 18%; Any ED: 27% 

M-R outcomes: Good: 49%; Intermediate: 41%; Poor: 10% 

Case Series, Comparison Groups 

Bulik et al., 2000342

(Good) 

Sullivan et al., 1998350

(Good) 

New Zealand 

Cases: 70 

Comparisons: 98 

Years followed (mean): 12 

Recovery outcomes: Fully: 30%, Partially: 49%, Chronically ill (current 

AN, BN or EDNOS): 21%, AN only: 10% 

Halmi et al., 19917

(Fair) 

USA 

Cases: 62 

Comparisons: 62 

Years followed (mean): 10 

ED dx at FU: AN: 3%, BN: 3%, Normal weight bulimia: 23%, EDNOS: 

39%, No ED: 27%, Unknown: 5% 

Case Series, No Comparison Groups 

Ben-Tovim et al., 

2001367 

(Good) 

Australia 

Cases: 92 

Years followed (mean): 5 

ED dx at FU: AN: 21%, BN: 5%, EDNOS: 9%, No ED: 59%, Unknown: 

2%, Deceased: 3% 

M-R-H Outcomes: Good: 34%, Intermediate: 54%, Poor: 13% 

Dancyger et al., 

1997353 

(Fair) 

USA 

Cases: 52 

Years followed (mean): 10 

Recovered: 31%, Good: 13%, Intermediate: 21%, Poor: 35% 

Deter et al., 1994343 

(Fair) 

Germany 

Cases: 75 

Years followed, mean (range): 11.8 (9-19) 

Good: 54%; Intermediate: 25% Poor:11%, Deceased: 11% 

AN: 17% 

Eckert et al., 1995338 

(Fair) 

USA 

Cases: 76 

Years followed, mean (range): 9.6 (8.5 – 10.5) 

Recovered: 24%, Good: 26%, Intermediate: 32%, Poor: 12%, Deceased: 

7% 

ED dx at FU: No ED: 24%, EDNOS: 36%, BN: 22%, AN: 9%, AN/BN: 3% 

AN, anorexia nervosa; ANBP, anorexia nervosa binge eating and/or purging subtype; ANR, anorexia nervosa restricting subtype; 

BED, binge eating disorder; BN,bulimia nervosa; Dx, diagnosis; ED, eating disorder; EDE, Eating Disorder Examination; EDI, 

Eating Disorder Inventory; EDNOS, eating disorder-not otherwise specified; FU, followup; M-R scores: Morgan and Russell 

Scale; M-R-H Scale, Morgan-Russell-Hayward Scale; SIAB, Structured Interview for Anorexia and Bulimia Nervosa; Tx, 

treatment; USA, United States of America. 
114 

Table 29. Eating-related outcomes: anorexia nervosa (continued) 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Eddy et al., 2002 

(Fair) 

USA 

Cases: 136 

Years followed, median (range): 8 (8-12) 

Full recovery (by subtype): Restricting pure: 46%, Restricting not pure: 

22%, Binge/purge:39% 

Relapse from full recovery (by subtype): Restricting pure: 31%, 

Restricting not pure: 47%, Binge/purge: 68% 

Restricting subtype crossover to binge/purge subtype: 52% 

Fichter et al., 1999339

(Good) 

Germany 

Cases: 95 

Years followed (mean): 6.2 

M-R outcomes: Good: 27%, Intermediate: 25%, Poor: 42% 

Deceased: 6% 

ED dx at FU: AN: 27%, BN: 17%, EDNOS: 2%, No ED: 55% 

Halvorsen et al., 

2004366 

(Fair) 

Norway 

Cases: 51 

Year followed, mean (range): 8.8 (3.5 – 14.5) 

M-R outcomes: Good: 80%, Intermediate: 16%, Poor: 4% 

No ED: 82%, AN: 2%, BN: 2%, EDNOS: 14% 

Herzog et al., 1996370

(Good) 

USA 

Cases: 76 

Years followed (mean): 4 

Full recovery (no symptoms for ≥ 8 wks): ANR: 8%; ANBP: 17% 

Partial recovery (symptom reduction): ANR: 54%; ANBP: 81% 

Herzog, Schellberg et 

al., 1997359 

(Fair) 

Germany 

Cases:69 

Years followed, mean: 11.7 

Average time to first recovery: 5.8 years 

Herzog et al., 1999369

(Good) 

USA 

Cases: 136 

Years followed: Up to 11 (median = 7.5) 

Full recovery (no symptoms for ≥ 8 wks): ANR: 34%; ANBP: 32% Partial 

recovery (symptom reduction): ANR: 83%; ANBP: 82% 

No remission: ANR: 17%; ANBP: 18% 

Relapse after full recovery: 40% 

Isager et al., 1985340

(Fair) 

Denmark 

Cases: 142 

Years followed, mean (range): 12.5 (4 – 22) 

Average annual hazard rate of relapse: 3% 

Lee et al., 2003347

(Fair) 

Lee et al., 2005363

(Fair) 

Hong Kong 

Cases: 74 

Years followed: 9 

M-R scale outcomes: Good: 62% (typical: 52.6%; atypical: 89.47%), 

Intermediate: 33% (typical: 42.11%; atypical: 5.26%), Poor: 5% (typical: 

5.26%, atypical: 5.26%) 

ED dx at FU: No ED: 46% (typical: 40.68%; atypical: 57.14%), AN: 15%, 

BN: 20% (typical: 25.42%; atypical: 4.76%), EDNOS: 19% (typical: 

15.25%; atypical: 28.57%) 

Löwe et al., 2001348

(Fair) 

Germany 

Cases: 63 

Years followed (mean): 21.3 

Full recovery: 51%, Partial recovery: 21%, Poor (including death): 26%, 

Unknown: 2% 

Morgan et al., 1983355

(Fair) 

United Kingdom 

Cases: 78 

Years followed, mean (range): 5.8 (4 – 8.5) 

M-R Outcomes: Good: 58%, Intermediate: 19%, Poor: 19%, 

Deceased: 1%, unknown: 3%
115 

Table 29. Eating-related outcomes: anorexia nervosa (continued) 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Strober et al., 1997341

(Fair) 

USA 

Cases: 93 

Years followed (range): 10 – 15 

Full recovery: 76%, Partial recovery: 86% 

Dx of chronically ill at FU: AN restricting: 3%, AN binge eating: 1%, 

BN: 10% 

Tanaka et al., 2001351

(Fair) 

Japan 

Cases: 61 

Years followed, mean (range): 8.3 (4.0 – 17.7) 

M-R outcomes: Good: 51%, Intermediate: 13%, Poor: 25%, 

Deceased: 11% 

(DSM III-R) criteria for AN. The AN group also continued to exhibit worse eating-related 

outcomes through other measures. Controlling for age and current AN status, individuals in the 

AN group reported higher scores on the Eating Disorder Inventory (EDI) drive for thinness and 

perfectionism subscales and the Three Factor Eating Questionnaire Scale (TFEQ) cognitive 

restraint and hunger subscales. Similarly, Halmi et al., in a separate US study, found that almost 

30 percent of the AN group were recovered at followup.7

 

Case series studies with no comparison groups. Among case series studies with no 

comparison group, we reviewed three studies limited to patients with adolescent AN 

onset.341,366,369,370 Among a mix of 51 former outpatients and inpatients who were followed from 

3.5 to 14.5 years in Norway, Halvorsen et al. found that three-quarters of participants no longer 

had an ED and had a good M-R general scale outcome score.366 Without controlling for the 

length of followup, patients who no longer had an ED were significantly less likely to be 

depressed or suffer from an anxiety disorder, with the exception of obsessive-compulsive 

disorder, which did not differ across groups. 

Similarly, after following 95 patients for 10 to 15 years in the US who had all received 

inpatient treatment, Strober et al. found that three-quarters of participants had achieved full 

recovery (free of any symptoms of AN and BN for 8 consecutive weeks).341 Significant 

predictors of chronic AN (intermediate or poor outcome) were an extreme compulsive drive to 

exercise and a history of poor social relating preceding onset of illness. Significant predictors of 

a longer time to recovery were a more hostile attitude towards one’s family and extreme 

compulsivity in daily routines. In both models, early onset of disease was not a significant 

predictor. 

Using survival analysis, D. Herzog et al. found that a shorter duration of the intake AN 

episode was a significant predictor of recovery after four years. Other variables in the model that 

were not significant predictors included age at ED onset, bulimic behaviors, impulse-control 

behaviors, current depression, and other Axis I disorders.370 Again, at 7-year followup, the D. 

Herzog study found a shorter duration of intake episode and higher percentage of ABW at intake 

predicted both a shorter time to full recovery and a shorter time to partial recovery.369 

D. Herzog and colleagues compared outcomes for restricting and for binge/purge subtypes of 

AN. Not all had received inpatient treatment. At up to 4-year followup, the authors found that the 

percentage of patients who were fully recovered (asymptomatic for at least 8 consecutive weeks) 

was greater in the AN-binge/purge subtype (17 percent) than in the AN-restricting subtype (8 

percent).370 Corresponding to these descriptive differences, the AN-binge/purge group was 
116 

significantly more likely to have recovered fully than the AN-restricting group (relative risk 

[RR], 4.6; 95% confidence interval [CI], 0.98-21.9). A much larger percentage achieved partial 

recovery (did not meet full criteria for AN but still experienced substantial symptomatology); 81 

percent in the binge/purge subtype and 54 percent in the restricting group. At 7-year followup, 

differences between the groups in the percentage that had recovered had diminished; 

approximately one-third in both subgroups had fully recovered and more than 80 percent had 

partially recovered.369 Forty percent of patients relapsed after first recovery. After following the 

group for 8 years, differences in duration of disease and ABW predicted being in the binge/purge 

subtype but measures of impulsivity including a history of alcohol abuse, drug abuse, 

kleptomania, suicidality, or borderline personality did not.177 

Through 8-year followup, crossover between the restricting and binge/purge subtypes was 

high. Of those with the restricting subtype 52 percent changed to the binge/purge subtype, with 

most of the crossover occurring in the first 5 years of followup.177 In contrast, Strober et al. 

found a lower rate of crossover (29 percent); the median time to onset of binge eating was 24 

months.341

The remaining case series studies discussing eating-related outcomes are not limited to a 

sample of patients with adolescent onset of AN. First we report outcomes based on M-R scale 

criteria because they are the most common measures across studies. 

A group of females who had all received inpatient treatment in Heidelberg, Germany, were 

followed up at several points in time. After 6 years, only 27 percent had a good M-R scale 

outcome, 25 percent had an intermediate outcome, and 42 percent had a poor outcome.339

However, at later followup points, more than 40 percent of living patients had good 

outcomes.338,339,353,354 

Among 74 women, 72 percent of whom had received inpatient treatment for AN, followed 

for an average of 9 years in Hong Kong, bivariate analyses comparing an M-R outcome of good 

and Shapiro Control Inventory measures found that a good M-R outcome was associated with a 

better overall general sense of control, a greater positive sense of control, and a lower negative 

sense of control.347,363 A better M-R outcome was also associated with an initial diagnosis of 

atypical AN (no fat phobia). Using descriptive analyses, Tanaka et al. found, for patients who all 

had received inpatient treatment, that a good versus poor M-R outcome was associated with 

younger age at referral, younger age at admission, higher body mass index (BMI) at followup, 

higher minimum BMI, better menstrual functioning, and better mental state and psychosocial 

measures.351 

Morgan and colleagues used bivariate analyses to report on UK patients followed from 4 to 

8.5 years, one-half of whom had been hospitalized.355 They reported that lower general M-R 

outcome scores were associated with longer duration of food difficulties and longer duration of 

amenorrhea. Poorer average M-R outcome scores were associated with a longer duration of food 

difficulties, a longer duration of amenorrhea, greater family hostility towards the patient, a 

disturbed relationship between the patient and family, and personality difficulties. 

Ben-Tovim et al. examined the characteristics of the Morgan-Russell-Hayward Scale (M-RH scale), a modification of the M-R scale, after adding items related to binge eating and vomiting 

to a subscale concerning dietary and eating patterns, body concern, and body weight.367 Using 

multivariate analyses, the authors found that total M-R-H Scale outcomes were significantly 

related to the dietary and eating patterns, body concern, and body weight subscale mentioned 

above. Other subscales measuring menstrual pattern, mental state, psychosexual state, and work 

and family relations were not significant in the model. Significant predictors in a second model, 
117 

predicting the same outcome, included subscale 2 at baseline of the disability adjustment scale 

(measuring overall behavior and social role functioning), the Flinders Medical Centre Symptom 

Score at baseline (measuring ED symptoms), the Body Attitudes Questionnaire Subscales 

(measuring a range of body-related attitudes), attractiveness at 6 months, and lastly, change in 

the salience of weight and shape over the first 6 months of treatment. 

Studies also examined diagnostic outcomes, including the persistence of eating disorders 

over time. Results varied greatly across studies and were not related to length of time to 

followup. The percentage of individuals who continued to have an AN diagnosis at followup 

ranged from 9 percent to 29 percent across studies, an EDNOS diagnosis from 2 percent to 36 

percent, and no eating disorder from 24 percent to 59 percent of participants.338,339,363,367,374 

W. Herzog and colleagues measured change over time in the likelihood of first recovery in 

the Heidelberg case series, after following patients for a mean of 11.7 years.359 The average 

patient had a first recovery in 5.8 years, with a greater likelihood of recovering in the first 6 years 

than later. Significant predictors of first recovery in multivariate models were lower serum 

creatinine levels at baseline, less purging behavior, and the interaction of less purging and fewer 

social disturbances as measured by the Anorexia Nervosa Symptom Score (ANSS). 

Löwe et al. followed this same group of patients for 21 years.348 Among the 63 patients, 51 

percent showed a good outcome and full recovery, 21 percent were partially recovered, and 26 

percent had a poor outcome and 2 percent were unknown. Poor long-term outcome (at 21 years 

since inpatient admission) was related to low BMI, severe psychological symptoms and social 

problems, higher EDI perfectionism and interpersonal trust scores, and lower hemoglobin and 

alkaline phosphatase levels (at 12 years since inpatient admission). 

After following this group of patients for 12 years, both Deter and W. Herzog343 (N = 84, 

including deceased patients) and Deter et al.365 (N = 70) found that the persistence of AN 

symptoms was predicted by older age at onset, more somatic symptoms, more laxative use, low 

albumin levels, and a high value on a global prognosis score developed from the ANSS.343,365

Baseline factors associated with relapsing versus having a persistent disorder include being 

younger, having a shorter disease duration, and less vomiting.343

Eckert et al. found, in descriptive analyses in a group of patients who had received inpatient 

treatment, that recovered patients were less likely to have major affective disorder, anxiety 

disorders, and phobias.338

Isager and colleagues measured relapse rates (lost 15 percent or more of weight gained 

during course of treatment in a year’s time) among 151 patients (93 percent female) who had 

received treatment (inpatient or outpatient) in Copenhagen, Denmark.340 After following patients 

from 4 to 22 years, they found patients were experiencing a 3 percent average annual hazard rate 

of relapse. Relapse was greater among those whose duration of therapeutic contact was less than 

1 year. 

Other factors related to these types of outcomes include the following. Factors associated 

with poor Psychiatric Scale Ratings for AN outcomes in the Fichter and Quadflieg study 

included binge eating in the month before treatment, other mental illness diagnoses before 

treatment, and lower body weight at the end of treatment.339 In research conducted by Lee and 

colleagues, a group of atypical AN patients scored better at followup on the Eating Attitudes 

Test – 26 and the Eating Disorders Evaluation Questionnaire.347,363 Typical versus atypical AN 

patients at followup had a lower sense of control in the domain of body and a stronger desire for 

control. 
118 

Psychiatric/psychological outcomes. Table 30 documents outcomes from eight studies with 

psychiatric and psychological outcomes. 

Prospective cohort studies with comparison groups. The one prospective cohort study that 

we reviewed followed individuals, at 5 and 10 years, with AN at baseline and compared them 

with a matched community comparison group in Göteborg, Sweden.346 At 5 years, the AN group 

was significantly more likely to have various personality disorders including obsessivecompulsive personality disorder, any Cluster C personality disorder (avoidant, dependent, 

obsessive-compulsive, or passive aggressive), any personality disorder, or two or more 

personality disorders as measured by the Structured Clinical Interview II for the DSM-IV (SCID 

II). In addition, individuals in the AN group had significantly greater rates of Asperger 

syndrome, any autistic-like condition, and empathy disorder than the comparison group. 

At 10 years,349,352,361,362 the AN group continued to be significantly more likely than the 

comparison group to currently have a personality disorder, Asperger syndrome disorder or 

autism spectrum disorder, and lifetime and current obsessive-compulsive disorder. The AN 

group was not more likely, however, to have an anxiety disorder, excluding obsessivecompulsive disorder. 

Ivarsson et al. examined depressive disorders in the AN and comparison groups in these 

cohorts at both 5- and 10-year followup.360 The AN group had a higher lifetime prevalence of 

depression. Being in the AN group was the only significant predictor of depressive disorder at 5-

year followup (odds ratio [OR], 7.7; 95% CI, 1.15-19.6). At 10 years, being in the AN group 

(OR, 4.03; 95% CI, 1.15-14.19) and having a depressive disorder at 5 years were significant 

predictors of current depressive disorder. The absence of a mood disorder was significantly 

associated with resolution of the eating disorder. 

Case series studies with comparison groups. Two studies followed individuals with AN who 

had received treatment and a comparison group. Both found higher rates of lifetime major 

depression and OCD among the AN group.7,342,350 The study in Christchurch, New Zealand, 

which followed women for 12 years, found, after controlling for age, significant differences in 

the lifetime prevalence of several psychological disorders including major depression, mood 

disorders, obsessive-compulsive disorder, anxiety disorders, and drug dependence.342,350 The 

study conducted by Halmi and colleagues also identified that significant differences in the rates 

of diagnosis of major depression and OCD continued to be true at 10-year followup in their AN 

case series.7

 

Case series studies with no comparison groups. Descriptively, Eddy et al. found that a 

history of drug abuse differed among AN subgroups; it was more likely among the binge/purge 

subtype (16 percent).177 Correspondingly, among patients who all had adolescent onset of AN, 

Strober et al., using stepwise regression, found that binge eating at treatment intake was the only 

significant predictor of the onset of a substance use disorder. Other variables included in the 

model, such as depression, anxiety, and weight, were not significant predictors.358

Also using stepwise regression, Dancyger et al. measured factors related to Minnesota 

Multiphasic Personality Inventory (MMPI) scores at 10-year followup on a population of women 

who had received inpatient treatment and were not limited to those with adolescent onset.353

Poorer overall outcomes were related to higher scores on three MMPI subscales: 

hypochondriasis, paranoia, and psychopathic deviate. 
119 

Table 30. Psychological outcomes: anorexia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Prospective Cohort Studies, Comparison Groups 

Gillberg et al., 

1995346 

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 5 

Diagnoses in AN group*: 

OCD: 30%, Any cluster C: 37%, any SCID personality disorder: 41%, 2 or 

more SCID personality disorders: 24%, Asperger syndrome: 12%, any 

autistic-like condition: 20%; empathy disorder: 30%; OCPD/AS/Autisticlike condition at both age 16 and 21: 45% 

Ivarsson et al., 

2000360 

(Good) 

Nilsson et al., 

1999362 

(Good) 

Råstam et al., 

2003349 

(Good) 

Wentz et al., 

2000361 

(Good) 

Wentz et al., 

2001352 

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 10 

Current diagnoses in AN group*: OCD:16%, axis I disorder (including ED): 

53% autism spectrum disorder: 18%, cluster C: 22%, 

Lifetime diagnoses in AN group*: Any affective disorder: 96% OCD: 35%, 

OCPD:55%, any anxiety disorder: 57%, Any Axis I (including and 

excluding ED): 100%, depressive disorder: 84%, cluster C: 63%, autism 

spectrum disorder: 24% 

Case Series, Comparisons Groups 

Bulik et al., 2000342

(Good) 

Sullivan et al., 

1998350 

(Good) 

New Zealand 

Cases: 70 

Comparisons: 98 

Years followed (mean): 12 

Lifetime diagnoses (controlling for age)*: 

Major depression: Cases: 51%; Comparisons: 36% 

Any mood disorder: Cases: 60%; Comparisons: 42%, 

Alcohol or any drug dependence: Cases: 30%; Comparisons: 12% 

OCD: Cases: 16%; Comparisons: 2% 

Separation anxiety disorder: Comparisons: 17%; Comparisons: 2% 

Overanxious disorder: Comparisons: 37%; Comparisons: 3% 

Any anxiety disorder: Comparisons: 60%; Comparisons: 33% 

Halmi et al., 19917

(Fair) 

USA 

Cases: 62 

Comparisons: 62 

Years followed: 10 

Lifetime diagnoses*: 

Major depression: Cases: 68%; Comparisons: 21% 

Dysthymia: Cases: 32%; Comparisons: 3% 

Obsessive-compulsive disorder: Cases: 25%; Comparisons: 6% 

Agoraphobia: Cases: 14%; Comparisons: 3% 

Social phobia: Cases: 32%; Comparisons: 3% 

Current diagnoses*: 

Major depression: Cases: 29%; Comparisons: 6% 

OCD: Cases: 11%; Comparisons: 2% 

*Difference between groups (P < 0.05) 

AN, anorexia nervosa; AS, Asperger syndrome; CD, compulsive disorder; ED, eating disorder; OCD, obsessive-compulsive 

disorder; OCPD, obsessive-compulsive personality disorder; sig, significant or significantly; SCID, Structured Clinical Inventory 

for DSM-IV; USA, United States of America. 
120 

Table 30. Psychological outcomes: anorexia nervosa (continued) 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Case Series, No Comparison Groups 

Eddy et al., 

2002177 

(Fair) 

USA 

Cases: 246 

Years followed (median): 8 

History of drug abuse at intake*: 

AN restricting pure: 0%; AN restricting not pure: 13%; AN binge purge: 

16% 

Halvorsen et al., 

2004366 

(Fair) 

Norway 

Cases: 51 

Years followed (mean): 8.8 

Diagnosis at followup: Depression: 22%; Anxiety (not OCD): 27%; OCD: 

2% 

Diagnoses at followup*: 

Depression: No ED group: 13%; ED group: 56% 

Anxiety disorder (no OCD): No ED group: 20%; ED group: 56% 

Löwe et al., 

2001348 

(Fair) 

Germany 

Cases: 63 

Years followed (mean): 21 

Mood disorders by Psychiatric Status Rating Scale outcomes*: 

Good: 8%; Intermediate: 31%; Poor: 38% 

Substance use disorders by Psychiatric Status Rating Scale outcomes*: 

Good: 5%; Intermediate: 6%; Poor: 50% 

Strober, Freeman 

et al., 1996358

(Good) 

USA 

Cases: 95 

Years followed: 10 

Substance use disorder: Abuse: 12%; Dependence: 7% 

Biomarker-measured outcomes. Table 31 contains study outcomes assessed with 

biomarkers. This category has very few studies primarily because many studies present 

measurement of weight and menstrual status through general M-R scale outcomes. These results 

are included among eating-related outcomes above. 

Prospective cohort studies with comparison groups. At 5 years, the study of the Göteborg, 

Sweden, cohort found that the AN group still weighed significantly less than the non-ED 

comparison group; more of the AN group was appreciably underweight than the comparison, and 

while only half of the AN group were near average body weight, nearly all of the comparison 

group were at that weight.344,345 Regular or cyclical menstruation was significantly less likely in 

the AN group, and a large percentage of the AN group had dysdiadochokinesis (an inability to 

execute rapidly alternating movements). 

At 10 years, various measures of weight, including direct measures in kilograms, ABW, and 

mean BMI (body mass index), did not differ significantly between groups.349,352,361 However, a 

significantly larger percentage of the AN group still did not have normal menstrual function and 

continued to demonstrate dysdiadochokinesis. 

Case series studies with comparison groups. The AN cohort in the Christchurch, New 

Zealand, study had significantly lower BMI than comparison participants when controlling for 

age and current AN status.344,345 Desired BMI was also lower in the chronically ill AN group 

than in recovered individuals or the comparison group. 

Case series studies with no comparison groups. Hebebrand et al. examined factors associated 

with BMI at 0 to 33.6 years followup.354 A BMI of less than 17.5 at followup (criterion cutoff for 

AN diagnosis) was related to lower BMI at referral, older age at referral, and younger age at 
121 

Table 31. Biomarker outcomes: anorexia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Prospective Cohorts, Comparison Groups 

Gillberg et al., 1994344 

(Good) 

Gillberg et al., 1994345 

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 5 

Near average body weight at FU*: Cases: 53%; Comparisons: 96% 

Extremely underweight:* Cases: 8%; Comparisons: 0% 

Regular or cyclical menstruation*: Cases: 50%; Comparisons: 90% 

Dysdiadochokinesis*: Cases: 20%; Comparisons: 2% 

Råstam et al., 2003349 

(Good) 

Wentz et al., 2000361 

(Good) 

Wentz et al., 2001352 

(Good) 

Sweden 

Cases: 51 

Comparisons: 51 

Years followed (mean): 10 

Mean weight: Cases: 62.3 kg; Comparisons: 63.7 kg 

Regular or cyclical menstruation*: Cases: 65%; Comparisons: 85% 

Dysdiadochokinesis*: Cases: 22%; Comparisons: 4% 

Case Series, Comparison Group 

Bulik, et al. 2000342 

(Good) 

Sullivan et al., 1998342 

(Good) 

New Zealand 

Cases: 70 

Comparisons: 98 

Years followed (mean): 12 

BMI*: Cases: 20.1 kg/m2

; Comparisons: 25.6 kg/m2

Case Series, No Comparison Group 

Eckert et al., 1995338 

(Fair) 

USA 

Cases: 76 

Years followed (range): 8.5 – 10.5 

ABW at FU: <85%: 23%; 85%-115%: 73%; >115%: 3% 

Regular menses: 48% 

Löwe et al., 2001348 

(Fair) 

Germany 

Cases: 63 

Years followed (mean): 21 

BMI by Psychiatric Status Rating Scale outcomes*: 

Good: 21.6; Intermediate: 19.7; Poor: 15.3 

*Difference between groups (P < 0.05). 

ABW, percentage of average body weight; BMI: body mass index; diff, different; FU, Followup; IBW, ideal body weight; kg, 

kilograms; sig, significant or significantly; USA, United States of America. 

followup; by contrast, age at disease onset was not a significant predictor. A higher BMI was 

also found to be significantly related to a better Psychiatric Status Rating Scale outcome at 

followup.348

Eckert et al. followed patients who had received inpatient treatment 10 years previously.338

Lower weight was associated with greater food faddishness, laxative abuse, body image 

disturbance, fear of getting fat, disturbance in sexual adjustment, worse psychological 

adjustment, disturbed menses, and other weight loss behavior.

Mortality outcomes. Table 32 summarizes results from studies of mortality and risk of 

suicide in individuals with AN. 

Prospective cohort studies with comparison groups. No deaths were reported in the Göteborg, 

Sweden, study through the 10-year followup. 

Case series with no comparison groups. All mortality data were obtained from case series 

studies without a comparison group. Several studies calculated standardized mortality ratios 
122 

Table 32. Mortality outcomes: anorexia nervosa 

Authors, Year 

Quality Score 

Country 

Sample Size Outcomes 

Case Series*, No Comparison Groups 

Birmingham et al., 

20053

 

(Fair) 

Canada 

Cases: 326 

Years followed (mean): 7 

Deaths: N=17 (Suicide: N=7, Pneumonia: N=2, Hypoglycemia: N=2, 

Liver disease: N=2, Cancer: N=2, Alcohol poisoning: N=1, Subdural 

hemorrhage: N=1) 

SMR: 10.5 

Crisp et al., 

1992357 

(Fair) 

England and 

Scotland 

Cases:168 

Years followed (mean): 22 

England: Deaths: N=4 (Anorexia: N=2; Suicide: N=1; Cancer: N=1) 

(SMR: 1.36 times more likely than women of same age, 1973 – 1989) 

Scotland: Deaths N=8 (Anorexia: N=3; Suicide: N=4; Cancer N=1) 

(SMR: 4.71 times more likely than women of same age, 1973 – 1979) 

Deter et al., 

1994343 

(Fair) and 

Herzog, Schellberg 

et al., 1997 

(Fair) 

Germany 

Cases: 75 at FU 

Years followed, mean (range): 11.8 (9 – 19) 

Deaths: N=9 (AN complications: N=7; Suicide: N=2) 

Eckert et al., 

1995338 

(Fair) 

USA 

Cases: 76 

Years followed, mean (range): 9.6 (8.5 – 10.5) 

Deaths: N=5 (all complications of AN; no suicides); SMR: 12.8 

Eddy et al., 

2002177 

(Fair) 

USA 

Cases: 136 

Years followed, median (range): 8 (8-12) 

Deaths by subtype: Restricting pure: 8%; Restricting not pure: 8%, 

Binge/purge: 6% 

History of suicidality by subtype: Restricting pure: 4%; Restricting not 

pure: 29%; Binge/purge: 27% 

Fichter et al., 

1999339 

(Good) 

Germany 

Cases: 95 

Years followed (mean): 6.2 

Deaths: N=6 (Traffic accident during exercise: N=1; Cardiac and renal 

failure: N=2; Hypocalcemia: N=2; Cardiac failure and cachexia: N=1) 

Franko et al., 

2004368 

(Good) 

USA 

Cases: 136 

Years followed (mean): 8.6 

Suicide attempts during study period: 22% 

Hebebrand et al., 

1997354 

(Fair) 

Germany 

Cases: 272 

Years followed, mean (range): 9.5, 0 – 33.6 

Deaths: N=12 (Emaciation: N=10, Suicide: N=2) 

Mortality rate by patient weight at referral: 

< 13 kg/m2

: 11%, ≥ 13 kg/m2: 0.6%; BMI < 13 at referral associated 

with higher likelihood of mortality 

Herzog et al., 

2000371 

(Fair) 

USA 

Cases: 110 

Years followed: 11 

Deaths: N=7 (Suicide: N=3; Acute alcohol intoxication: N=1; 

Cardiorespiratory failure, heptic failure, and cirrhosis: N=1; Cardiac 

arrhythmia and seizure disorder: N=1; Fungal pneumonia: N=1) 

SMR (all deaths): 9.6; SMR (suicide): 58.1 

AN, anorexia nervosa; FU, Followup; N, number; sig, significant; SMR, standardized mortality ratio; Tx, treatment; USA, United 

States of America. 

*In case series studies, sample size is as of the date of the analysis and therefore does not include deceased cases. 
123 

Table 32. Mortality outcomes: anorexia nervosa (continued) 

Authors, Year 

Quality Score 

Country 

Sample Size Outcomes 

Isager et al., 

1985340 

(Fair) 

Denmark 

Cases: 142 

Years followed, mean (range): 12.5 (4 – 22) 

Deaths N=9 (Suicide: N=6, Malnutrition: N= 2, 

Unknown: N=1) 

Keel et al., 2003372

(Fair) 

USA 

Cases: 136 

Years followed (mean): 8.6 

Deaths: N=11; SMR: 11.6 

Suicide: N=4; Suicide SMR: 56.9 

Lee et al., 2003347 

(Fair) 

Hong Kong 

Cases: 80 

Years followed (mean): 9 

Deaths: N=3 (Suicide: N=2, Emaciation: N=1); SMR: 10.5 

Löwe et al., 

2001348 

(Fair) 

Germany 

Cases: 63 at FU 

Years followed (mean): 21.3 

Deaths: N=14 (12 directly due to AN) 

Møller-Madsen et 

al., 1996364 

(Fair) 

Denmark 

Cases: 853 

Years followed, mean (range): 7.8 (< 1 – 17) 

Deaths: N=50 (AN complications: N=13, Natural causes: N=11, 

Suicide: N=18, Accidents: N=2, Unknown causes or could not be 

determined: N=4) 

SMR: Females: 9.2; SMR: Males: 8.2 

Females only < 1 year following treatment admission, SMR=30.5 

Patton, 1988373 

(Fair) 

United Kingdom 

Cases: 332 

Years followed (mean): 7.6 

Deaths: N = 11 (Suicide: N = 6; low weight: N = 5) 

Overall SMR: 6.01; Higher than expected 

SMR at 4-year FU: 5.76, Higher than expected 

SMR at 8-year FU: 2.70, Normal level 

Sullivan et al., 

1998350

(Good) 

New Zealand 

Cases: 70 

Years followed: 12 

Deaths: N = 1 (suidice) 

Tanaka et al., 

2001351 

(Fair) 

Japan 

Cases: 61 at FU 

Years followed, mean (range): 8.3 (4.0 – 17.7) 

Deaths: N=7 (Emaciation: N=3; Suicide: N=2; Murder: N=1; Burn: N=1) 

(SMR), allowing for comparison to the population based on age, sex, and time when the patient 

population was drawn. 

The SMRs were elevated in the AN groups and ranged from 9 to 13 across 

studies.3,338,347,364,371,372 In one study, SMRs were significantly elevated in a female patient 

population through 14 years of followup (ranging from 30.5 at less than 1 year followup to 

approximately 6 for the remainder of the period). The SMR was no longer significantly elevated 

after 14 years.364

Only in two studies conducted in the United Kingdom were the SMRs lower. Crisp et al. 

examined mortality among females more than 20 years after they had received treatment for AN 

in either London, England (1968 to1973), or Aberdeen, Scotland (1965 to 1973).357 In England, 

women with AN were 1.36 times more likely to die than women of the same age in England and 

Wales between 1973 and 1979. In Scotland, women with AN were 4.71 times more likely to die 

than women of the same age in Scotland during the same period. 

Patton and colleagues conducted a record review of 332 AN patients, mostly female (96 

percent), who had received treatment at Royal Free Hospital in the United Kingdom between 
124 

1971 and 1981.373 The SMR at 4-year followup was 5.76, which was a significant elevation; at 8-

year followup, the SMR was 2.7 (not significant). Predictors of mortality included weight less 

than 35 kilograms at presentation and more than one inpatient admission. 

In one study that followed patients for 8.6 years, significant predictors of death (controlling 

for age and duration of illness before intake) included greater severity of alcohol use disorders, 

greater severity of substance use disorders, worse social adjustment, and worse global 

assessment of functioning (GAF) scores. Predictors of shorter time to death included longer 

duration of illness at treatment intake, affective disorder hospitalization at intake, suicidality 

associated with mental illness other than an ED, substance abuse, and worse severity of alcohol 

use over the course of the illness.372 Descriptively, Isager et al. found that deceased patients were 

significantly more likely to have been hospitalized.340

Suicide was a common cause of death. Among the group of females with adolescent AN 

onset who received ED treatment at the Massachusetts General Hospital or other Boston area 

clinics the SMR was 58.1, significantly higher than that for the population as a whole.371 

Franko et al. reported predictors of suicide attempts among the women in the Boston 

cohort.368 Thirty percent of their patients had a history of suicide attempts before they entered the 

study; during the study, 22 percent of AN patients attempted suicide. A history of a suicide 

attempt at intake significantly predicted time to a future attempt in individuals with AN. Using 

multiple regression techniques, the authors determined that a first suicide attempt was predicted 

by a history of suicide attempts at intake, greater drug use, participation in individual therapy, 

use of neuroleptic medications, and older age at disease onset. 

A history of suicidality was significantly different among patient subtypes in one study – 

lower in the pure restricting group than other groups.177 However, the groups did not differ in 

rates of death at 8-year (median) followup. 

Several other case series studies that were discussed in relation to their eating, psychological, 

or biomarker outcomes reported deaths of patients during the followup period. These are 

summarized in Table 32. 

Summary of studies addressing KQ 5. One prospective cohort study following individuals 

who had AN and a healthy comparison group has been conducted. Limited to individuals with 

adolescent onset of their illness and comparisons in Göteborg, Sweden, this study found that, 

over a 10-year period, approximately one-half of the group had fully recovered; a small 

percentage continued to suffer from AN, and the remainder still had other eating disorders. The 

AN group no longer differed from the comparison group in terms of weight but these individuals 

continued to be more depressed than comparisons and to suffer from a variety of personality and 

obsessive-compulsive disorders, Asperger syndrome, and autism spectrum disorders. 

Two case series studies, which gathered followup measures from individuals who had 

received treatment for AN and a nondisease comparison group, were reviewed. They concluded 

that individuals with AN continued to be more likely to have eating and comorbid psychiatric 

diagnoses years after treatment. In one study, lower desired body weight and lower desired and 

actual BMI continued in the AN group, after controlling for current AN status. Individuals in the 

AN group were also more likely to be depressed and to suffer from mood and anxiety disorders. 

The second study, limited to psychiatric outcomes, found continued higher rates of major 

depression and obsessive-compulsive disorder. 

The remaining studies had no comparison groups. Rates of recovery and good outcomes 

varied across studies. Only a relatively small percentage of patients continued to be diagnosed 

with AN or BN at long-term followup, but many continued to have eating disorders, and relapse 
125 

rates were high. We did not find evidence that age of disease onset was related to disease 

chronicity. A relatively large percentage of patients cross over from the restricting subtype to the 

binge/purge subtype of the disease, but results are mixed concerning which subtype has better 

eating outcomes. 

Few studies examined psychiatric and psychological comorbidities independently of their 

relationship to eating disorder outcomes. Among those that did and had a comparison group, 

individuals with AN had a higher probability of having a depression and anxiety disorders 

diagnosis (including obsessive-compulsive disorder) than comparison individuals. Based on the 

results of one cohort study, individuals with AN may also be more likely to have Asperger 

syndrome or autism spectrum disorder. Among individuals with AN, substance abuse may be 

associated with binge eating. 

Through at least 5 years of followup, individuals with AN are more likely to weigh less than 

comparisons and evidence suggests that their desired weight is lower. We did not find similar 

predictors of continued low weight in the AN case series studies and so are unable to draw 

conclusions concerning these relationships. However, some evidence exists that lower weight at 

treatment presentation is related to poorer outcomes. 

The mortality risk is significantly greater among those diagnosed with AN than in the 

population as a whole. The risk of suicide is particularly pronounced, as is the risk of death early 

in the followup period. Increased risk is associated with alcohol and substance use disorders. 

Key Question 6: Outcome Difference by Sex, Gender, Age, Race, 

Ethnicity, or Cultural Group 

We examined whether AN outcomes differed by participants’ sex, gender, age, race, 

ethnicity, or cultural groups. We found insufficient evidence to evaluate differences by sex or 

gender. Males were included in only 19 of 38 reviewed studies and were never more than 10 

percent of the analysis sample in any one study. No study included any analyses examining 

differences controlling for sex or gender. 

No study that we reviewed provided outcomes based on the age of the participant at 

followup. Some studies limited participants to those whose AN onset was during adolescence, 

but none compared outcomes of those with adolescent onset to those with older onset. However, 

six studies did include a measure of age at disease onset. Whether this is a significant factor in 

the course of AN is of particular interest in the field. 

Results were mixed. Descriptively, Tanaka et al. found that a good M-R rating was related to 

younger age at referral;351 Deter and Herzog found that earlier onset of disease was a significant 

predictor of AN symptoms at 12-year followup.343 Suicide attempts were more likely among 

those whose disease began at an older age.368 In contrast, Strober et al. did not find age at onset 

to be a significant factor in predicting chronic AN (intermediate or poor outcomes) at 10- to 15-

year followup.341 It was also not a predictor of time to recovery after 4 years in the Heidelberg 

case series.370 Lastly, although Hebebrand et al. found age at onset not to be significantly related 

to lower BMI at followup,354 they reported that older age at referral and younger age at followup 

predicted worse outcome. 

Only two studies, both from the United States, reported the race or ethnicity of participants. 

Nonwhite subjects constituted 4 percent of the Boston, Massachusetts, case series368 and 7 

percent of the case series from the University of California at Los Angeles.341,358 
126 

Bulimia Nervosa 

Our discussion of BN outcomes includes 14 articles exclusively discussing individuals 

with BN70,333,375-385 and seven articles discussing individuals with both AN and BN.367-373 As 

above for AN, we first discuss results for KQ 5, then results for KQ 6. 

Key Question 5: Factors Associated with Outcomes 

Eating-related outcomes. Table 33 summarizes results from studies that report eatingrelated outcomes. The BN literature that met our inclusion criteria included only case series 

studies (i.e., no cohort studies). One study had a nondisease comparison group; all other studies 

had no comparison group. 

Case series studies with comparison groups. Female patients who had received inpatient 

treatment (N = 163), in Germany were followed for 12 years.378 The comparison group (N = 

202) included females ages 18 to 30 who had never received treatment for an eating disorder. 

The Structured Inventory for Anorexic and Bulimic Syndromes, Expert-Rating version (SIABEX) was used to compare eating disorder symptoms between cases and comparisons at 12 year 

followup. The BN group as a whole was significantly more symptomatic than the comparison 

group, as were individuals with BN who were considered to be recovered. 

As shown in Table 33, the BN group improved over time. At 2 years, 53 percent were 

considered recovered and did not have any ED diagnosis. At 6 years, the same was true of 67 

percent of the women and, at 12 years, of 66 percent of the women.378 However, even though 

recovery rates improved over time, total EDI scores were worse at 2- and 6-year followup than at 

discharge.70 

Lifetime psychiatric comorbidity predicted a significantly higher probability of having any 

eating disorder at 2- and 6-year followup. This variable was no longer significant at 12 years. In 

contrast, after 12 years, greater lifetime psychiatric comorbidity significantly predicted a higher 

probability of having a global eating disorder outcome as measured by the Psychiatric Status 

Rating Scale (PSR) (OR, 3.71; 95% CI, 1.16-11.91). A lifetime history of AN and older age at 

disease onset also predicted a worse PSR at 12 years.378

Case series studies with no comparison groups. Fairburn and colleagues conducted 5- and 6-

year followup assessments of females recruited for two psychotherapy trials in the United 

Kingdom.375-377,386 The investigators recruited 102 patients with BN through general practitioners 

and psychiatrists with no limitations on age at disease onset. 

After 5 years, by a variety of measures, the group had improved since baseline and had 

experienced a significant reduction, in the previous 3 months, in mean objective bulimic 

episodes, self-induced vomiting episodes, and laxative misuse.375 Eating Disorder Examination 

(EDE) interview measures that significantly improved included those measuring restraint, shape 

concern, weight concern, and eating concerns. 

Fairburn et al. examined whether outcomes differed between persistent disease (at least two 

episodes of behavior at one or both of last two assessments) and remitted disease (not engaged in 

any relevant behavior over past 3 months); they focused solely on binge eating or compensatory 

behaviors.377 The persistence of binge eating behavior was related to baseline duration of 

disturbed eating, overvaluation of shape and weight, and worse social adjustment. None of the 

tested baseline factors predicted compensatory behavior. However, binge eating and 

compensatory behaviors were significant predictors of each other. 
127 

Table 33. Eating-related outcomes: bulimia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Case Series, Comparison Groups 

Fichter and 

Quadflieg, 2004378 

(Fair) 

Germany 

Cases: 163 

Comparisons: 

202 

Years followed: 12 

Case diagnosis at 6 year FU: Recovered/no ED: 67%; AN: 4%; BN 

purge: 21%; BN nonpurging: 1%; BED: 1%; EDNOS: 1%;Deceased: 1% 

Case diagnosis at 12 year FU: Recovered/no ED: 66%; AN: 2%; BN 

purge: 10%; BN nonpurging: 1%; BED: 2%; EDNOS: 14%; Deceased: 

3% 

Case Series, No Comparison Groups 

Ben-Tovim et al., 

2001367 

(Good) 

Australia 

Cases: 86 

Years followed: 5 

Diagnosis at FU: AN: 1%; BN: 8%; EDNOS: 13%; No ED:74%; 

Unknown: 5%; Deceased: 0 

M-R-H Outcomes: Good: 76%; Intermediate: 19%; Poor: 2%; 

Unknown: 2% 

Fairburn et al., 

2000375 

(Good) 

Fairburn et al., 

2003377 

(Good) 

Stice and Fairburn, 

2003386 

(Fair) 

United Kingdom 

Cases: 92 

Years followed: 5 

Diagnosis at FU: BN: 15%; BED: 7%; AN: 1%; EDNOS: 32% 

Any DSM-IV ED: 49%; Remission: 35%; Relapse: 26% 

Fichter and 

Quadflieg, 199770 

(Fair) 

Germany 

Cases: 185 

Years followed (mean): 6.2 

Diagnosis at 2 years FU: AN: 2%; BN: 36%; EDNOS: 8%; No ED: 55% 

Diagnosis at 6 years FU: AN: 4%; BN: 21%; BED: 1%; EDNOS: 2%; No 

ED: 71% 

Herzog et al., 

1993380 

(Good) 

USA 

Cases: 96 

Years followed: 1 

First shift to subclinical BN diagnosis (loss of full criteria without 

considering duration): 86% 

Partial recovery: 71%; Full recovery: 56% 

Herzog et al., 

1996370 

(Good) 

USA 

Cases: 150 

Years followed: 4 

Partial recovery: 88%; Full recovery: 57% 

Herzog et al., 

1999369 

(Good) 

USA 

Cases at 

baseline: 110 

Years followed (Median): 7.5 

Full recovery: 74%; Partial recovery: 98%; 

Relapse after full recovery: 35% 

Jäger et al., 2004381 

(Fair) 

Germany 

Cases: 80 

Years followed: 8 

Diagnosis at FU: BN: 29%; EDNOS (bulimic): 9%; EDNOS (anorexic): 

1%; No ED diagnosis: 61% 

No binges per week at FU: 63% 

AN, anorexia nervosa; BED, binge eating disorder; BN, bulimia nervosa; DSM-IV, Diagnostic and Statistical Manual for Mental 

Disorders, Fourth Edition; ED, eating disorder; EDNOS, eating disorder not otherwise specified; FU, followup; M-R-H Scale, 

Morgan-Russell-Hayward Scale; USA, United States of America. 
128 

Table 33. Eating related outcomes: bulimia nervosa (continued) 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Keel et al., 1999384

(Fair) 

Keel, Mitchell, Davis 

et al., 2000383 

(Fair) 

Keel, Mitchell, Miller 

et al., 2000385 

(Fair) 

USA 

Cases: 173 

Years followed (mean): 11.5 

Diagnosis at FU: BN: 11%; AN:1%; BED: 1%; EDNOS: 19%; lifetime 

history of AN: 36%; lifetime history of BED: 11% 

Narrow definition of remission: Full: 42%, Partial: 28% 

Broad definition of remission: Full: 47%, Partial: 23% 

At 6-year followup, using multivariate analysis, Fairburn, Norman et al. determined that 

significant predictors of current AN or BN status (adjusted for the type of treatment received and 

the duration of followup) included paternal obesity (OR, 5.73; 95% CI, 1.56-21.1) and premorbid 

obesity (OR, 4.31; 95% CI, 1.35-13.7).376

Stice and Fairburn categorized their BN patients into dietary and dietary-depressive subtypes 

using cluster analysis.386 Compared with persons in the dietary subtype, those in the dietarydepressive subtype were significantly more likely to have lifetime psychiatric treatment for 

eating disorders at baseline and during followup, greater persistence of binge eating and 

compensatory behaviors, and diagnoses of major depression, panic disorder, obsessivecompulsive disorder, social phobia, generalized anxiety disorder, and agoraphobia. 

D. Herzog and colleagues examined eating-related outcomes for a group of female patients 

who sought treatment at Massachusetts General Hospital and other Boston area ED 

programs.369,370,380 The authors examined levels and predictors of full and partial recovery at 1, 4, 

and 7 years. Full recovery was defined as 8 consecutive weeks of being asymptomatic; partial 

recovery was defined as not meeting full criteria for AN or BN but still experiencing significant 

symptomatology. 

The percentage of the group that fully recovered increased over time. At 1 year, 56 percent 

were fully recovered;380 at 4 years, 57 percent were fully recovered;370 and at 7 years, 73 percent 

had achieved a full recovery at some point during followup.369 The trend was similar for partial 

recovery at some point during followup: 1 year, 71 percent;380 4 years, 91 percent;370 and 7 years, 

98 percent.369 Recovery was not, however, necessarily persistent even if it covers 8 consecutive 

weeks. By 7 years, 35 percent had relapsed after achieving a full recovery. 

The authors investigated predictors of recovery at each followup. At 1 year, ideal body 

weight (IBW) was not a significant predictor of time to partial recovery.380 Variables included in 

their models at both 4- and 7- year followup included duration of the current disorder episode, 

age at onset of the current eating disorder, age at onset of the first eating disorder, weight, binge 

and purge frequency, and the co-occurrence of various other disorders including those involving 

a lack of impulse control, depression, personality and any Axis I disorder. At both points, no 

significant predictors of recovery emerged from among these variables.369,370 

Ben-Tovim et al. analyzed results from 86 female BN patients who had been treated by an 

eating disorder specialist in Adelaide, South Australia, and followed for 5 years.367 Not all had 

inpatient stays and age at onset was not reported. Using multivariate analyses, they reported that 

total M-R-H scale outcomes were significantly related to subscales for dietary and eating 

patterns, body concern, and body weight rather than other subscales concerning menstrual 

pattern, mental state, psychosexual state or work and family relations. In a second multivariate 
129 

model, M-R-H total scores were predicted by overall behavior and social functioning at baseline, 

feeling fat at study recruitment, attractiveness at 6 months, and change in depression over the 

first 6 months. 

Jäger et al. compared outcomes of female patients who had received analytic inpatient and 

systemic outpatient treatment at a hospital in Germany.381 Over time, binges, bulimia severity, 

the number of episodes of food restriction, and EAT measures of bulimia and dieting 

significantly decreased in both treatment groups; in addition, the number of normal meals 

increased. The group receiving analytic inpatient treatment had a greater decline in the severity 

index and the number of restrictions than the group receiving systemic outpatient therapy. 

Keel and colleagues examined eating-related outcomes for 173 females with a mean of 11.5 

years following evaluation at the University of Minnesota’s Eating Disorders Clinic.383-385

Members of the group had participated in one of two previous treatment studies. A particular 

interest in this study was comparing results based on different definitions of remission. Defining 

remission as freedom from disordered eating for at least 6 months and the absence of undue 

influence of shape and weight on self-evaluation, the authors reported that 42 percent were in full 

remission and 28 percent in partial remission. Using a broader definition of remission, including 

absence of disordered eating for at least 8 weeks with no restrictions based on the influence of 

weight and shape, they reported 47 percent were in full remission and 23 percent were in partial 

remission.384 

The authors compared the relation between prognostic factors and two specifications of the 

outcome measure: categorical (full or partial remission vs. not in remission) and continuous (log 

of the number of months since last binge/purge episode).384,385 The two models showed little 

difference in results. Significant factors in relation to both outcome specifications included 

lifetime substance use, baseline substance use, current mood, substance use, and impulse control 

disorders, and results on a multidimensional personality questionnaire. Prognostic factors that 

were not statistically significant in relation to either outcome specification included age at onset, 

duration of symptoms at baseline, baseline depression or anxiety disorder, and lifetime mood or 

anxiety disorder. 

Keel et al. compared the association among six definitions of BN outcomes and a variety of 

other outcome measures and prognostic variables.383 Definitions of BN outcomes varied based 

on the duration of abstinence required for full remission or recovery, the number of categories in 

which outcomes were placed, and how the categories were combined. Full recovery ranged from 

47 percent to 38 percent based on the required duration of abstinence in the specification. Other 

outcomes that were significantly related to the eating disorder outcome in all specifications 

included depression, body image disturbance, impulse control, and social adjustment. The 

analysis did not identify any prognostic factors that were statistically significant in relation to all 

six eating disorder specifications. However, substance abuse was significant in four of six 

specifications, age of presentation in three specifications, and age of onset in two. 

Including 101 of the females from the University of Minnesota study discussed above, Keel 

et al. also examined the independence and relative strength of depression compared with bulimic 

symptoms in predicting body dissatisfaction at followup.382 Baseline depression was both 

independent of and superior to bulimic symptoms in predicting body dissatisfaction at followup, 

demonstrating a direct association between depression and body dissatisfaction that is 

independent of bulimic symptoms. 

Psychiatric/psychological outcomes. Table 34 summarizes results from studies reporting 

psychiatric/psychological outcomes. 
130 

Table 34. Psychological outcomes: bulimia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Case Series, Comparison Groups 

Fichter and 

Quadflieg, 2004378 

(Fair) 

Germany 

Cases: 163 at 12 

year followup 

Comparisons: 202 

Years followed: 12 

Psychiatric comorbidity at followup: 

Lifetime 79.7%; current: 41.1% 

Mood disorders: Lifetime: 69.0%; current: 16.5% 

Major depression: Lifetime: 58.2%; current: 10.8% 

Anxiety: Lifetime: 36.1%; current: 22.2% 

Substance use: Lifetime 36.1%; current: 14.6% 

Borderline personality disorder: 9.5% 

Case Series, No Comparison Groups 

Fichter and 

Quadflieg, 1997 

(Fair) 

Germany 

Cases: 185 

Years followed (mean): 6 

Psychiatric comorbidity at 2-year followup: 

Borderline personality disorder: 5%; Substance abuse: 24%; Mood 

disorders: 30%; Anxiety disorders: 13% 

Psychiatric comorbidity at 6-year followup: 

Borderline personality disorder: 4%; Substance abuse: 21%; Mood 

disorders: 46%; Anxiety disorders: 32% 

Stice and Fairburn, 

2003 

(Fair) 

United Kingdom 

Cases: 82 

Years followed: 5 

Psychiatric comorbidity at followup:* 

Major depression: Dietary: 61%; Dietary-depressive: 81% 

Panic disorder: Dietary: 15%; Dietary-depressive: 33% 

Obsessive-compulsive disorder: Dietary: 2%; Dietary-depressive: 25% 

Generalized anxiety disorder: Dietary: 11%; Dietary-depressive: 47% 

Agoraphobia: Dietary: 4%; Dietary-depressive: 36% 

*Difference between groups (P < 0.05). 

Prospective cohort studies with comparison groups. The Fichter and Quadflieg study that 

followed females with BN and a healthy comparison group recorded psychiatric comorbidities in 

the BN group only.70,378 In the first 6 years after treatment, general psychopathology, as 

measured by the Symptom Checklist 90-Revised (SCL-90), found that symptoms were worse at 

2-year followup but better at 6-year followup compared to the end of treatment.70 At 12 years, 80 

percent of patients had a lifetime psychiatric disorder, and 41 percent had a psychiatric disorder 

in the month before assessment. Half of the patients had suffered from a lifetime mood disorder 

or major depression and 36 percent had suffered from an anxiety or substance use disorder.378

Case series studies with no comparison groups. The Jäger et al. study that reported 8-year 

outcomes following either analytic inpatient or systemic outpatient treatment found that 

depression had declined in both groups381 but that the decline was greater in those who received 

inpatient treatment. 

Biomarker measured outcomes. Table 35 presents results from studies with outcomes 

assessed through various biomarkers. 

Case series studies with no comparison groups: Gendall et al. followed 82 females for 1 year 

who had participated in outpatient treatment trials in New Zealand.379 At followup, 

approximately 31 percent of the female participants had irregular menses. In multivariate 

analyses, irregular menses (irregular or absent menstrual cycles within the past 3 months) were 

significantly related to a greater maximum-minimum weight difference and current smoking. 
131 

Table 35. Biomarker outcomes: bulimia nervosa 

Authors, Year 

(Quality Score) 

Country 

Sample Size Outcomes 

Case Series, No Comparison Groups 

Fairburn et al., 

2000375 

(Good) 

England 

Cases: 92 

Years followed: 5 

Change over time: 

Weight: 69.8 kg, BMI: 25.5 

Fichter and Quadflieg, 

1997 

(Fair) 

Germany 

Cases: 185 

Years followed (mean): 6 

Weight at followup: Good (19<BMI<30): 74%; Intermediate (BMI 30-

40 or 17.5-19): 17%; Poor (BMI<17.5 or >40): 9% 

Gendall, Bulik et al., 

2000379 

(Good) 

New Zealand 

Cases: 82 

Years followed: 1 

Irregular menses: 30.5% 

Keel et al., 1999384 

(Fair) 

USA 

Cases: 173 

Years followed (mean): 11.5 

BMI: 22.1, Weight: 60.7 kg 

BMI, Body mass index, measured in kg/m2; USA, kg, kilograms; United States of America. 

Several studies reported improvements over time in weight measures. After 5 years, Fairburn 

and colleagues found that participants’ mean weight and BMI had increased.375 At 6-year 

followup, Fichter and Quadflieg found that 74 percent of their participants were in the good 

weight range.70 Similarly, Keel et al. measured differences in weight variables in 173 females 

followed for approximately 11 years.384 BMI, actual weight, desired weight, and highest weight 

all significantly increased over time. 

Mortality outcomes. Table 36 gives the results from studies that reported on either death or 

risk of suicide (or both) among individuals with BN. 

Case series studies with comparison groups. In the Fichter and Quadflieg study, 2.5 percent 

of the BN group were deceased at 12-year followup.378 The SMR was 2.36, not significantly 

different from the rate expected in the population matched by age and sex. 

Case series studies with no comparison groups. Franko et al. reported predictors of suicide 

attempts in a group of 110 women with BN who had been recruited because they sought 

treatment for eating disorders at Massachusetts General Hospital and other Boston area clinics.368

At baseline, 23 percent reported a history of suicide attempts before assessment, and 11 percent 

reported suicide attempts during the study. After approximately 9 years of followup, significant 

predictors of shorter time to first suicide attempt included receiving group therapy, receiving 

individual therapy, younger age at onset, a history of drug use disorder, paranoid personality 

disorder at intake, and greater severity of laxative use. 

In a companion study, D. Herzog et al. followed this same group of women in Boston for 11 

years to examine rates and causes of death.371 At the end of that time, none of the women were 

deceased. 

Keel et al. measured the mortality rates among 110 females, also recruited in Boston, in the 

same manner as Herzog et al., but the parameters of the recruitment dates differed somewhat. 

Participants were followed for a median of 9 years.372 One individual died during the followup 

period. The SMR of 1.3 was not significantly different from what would be expected in the 

population as a whole. 
132 

Table 36. Mortality outcomes: bulimia nervosa 

Authors, Year 

Quality Score 

Country 

Sample Size Outcomes 

Case Series Studies, Comparison Groups* 

Fichter and 

Quadflieg, 

2004378 

(Fair) 

Germany 

Cases: 163 at 12 year 

followup 

Comparisons: 202 

Years followed: 12 

BN Cases Deaths: 

2 year followup: 0 

6 year followup: 2 

12 year followup: 4, SMR: 2.36 

Franko et al., 

2004368 

(Good) 

USA 

Cases: 110 

Years followed: 8.6 

Suicide attempts: 11% 

Predictors of time to first suicide attempt (adjusted): 

Group therapy; Younger age at onset; History of drug use disorder; 

Individual therapy; Paranoid personality disorder; Greater severity of 

laxative use 

Herzog, et al., 

2000371 

(Fair) 

USA 

Cases: 110 

Years followed: 11 

Loss to followup deaths: 0 

Keel et al., 

2003372 

(Fair) 

USA 

Cases: 110 

Years followed (Median): 9 

Deaths: 1, SMR: 1.3 

Patton et al. 

1988373 

(Fair) 

USA 

Cases: 96 

Years followed: 4-15 

Deaths: N=3 (2 car accidents, 1 low weight) 

Crude mortality rate: 3.3, SMR: 9.38 

BN, bulimia nervosa; SMR, standardized mortality ratio; USA, United States of America. 

*In case series studies, sample size is as of the date of the analysis and therefore does not include deceased cases. 

Patton et al. measured mortality rates in patients in the United Kingdom who were followed 

for 4 to 15 years.373 Three patients died during the observation period, one from low weight. 

Again, the SMR was not statistically significant from what would be expected in the healthy 

population.

Summary of findings. All of the BN literature is case series, that is, studies that follow 

individuals over time who have received treatment. One study included a nondisease comparison 

group. Much of the emphasis in the BN literature concerned comparing various definitions of 

disease outcomes and diagnostic subtypes. Generally in these studies, more than half of the 

patients followed no longer had a BN diagnosis at the end of the study period. A substantial 

percentage continued to suffer from other eating disorders, but BN was not associated with an 

increased mortality risk. A limited number of analyses uncovered factors significantly associated 

with outcomes of this disease. Only depression was associated with worse outcomes consistently 

across studies. 

Key Question 6: Outcome Difference by Sex, Gender, Age, Race, 

Ethnicity, or Cultural Group 

In each of the BN outcomes studies except for Patton et al., all participants we reviewed were 

female.373 Four percent of the participants in the Patton et al. study were male; however, this 

study included both AN and BN populations, and the authors do not specify how many of the 

included males were in each disorder group. 
133 

Most studies did not report the race, ethnicity, or cultural group of the participants. Franko et 

al. reported that 4 percent of their sample was nonwhite, but they did not specify the distribution 

in the BN sample, relative to the AN sample.368 Johnson and colleagues reported that the modal 

race was white;333 Keel and colleagues reported that 1 percent of their sample was nonwhite.384

These investigators did not, however, report outcome differences by race, ethnicity, or cultural 

group. No outcome studies of BN controlled for the age of participants at entry; no studies were 

limited to individuals with adolescent onset of the disorder. We conclude that no evidence exists 

to determine whether outcomes for BN differ by any of these categories. 

Binge Eating Disorder 

Given the recent addition of the provisional criteria for BED to the psychiatric nomenclature, 

three studies met our inclusion criteria for this section. All three studies were case series.387-389

One study included a comparison group.389 One study was conducted in the United States (rated 

as fair),388 one in Germany (rated as fair),387 and one in Italy (rated as fair).389 

Key Question 5: Factors Associated with Outcomes 

In KQ 5 we address outcomes of BED and factors associated with outcomes. We partitioned 

outcomes into eating-related outcomes, psychological outcomes, and biomarker outcomes 

(largely weight change). 

Case series with comparison groups. The only case series with a comparison group 

explored a special population of individuals undergoing laparoscopic adjustable gastric 

banding.389 This is an important research question intended to determine whether individuals 

with BED who are obese are appropriate for bariatric surgery. In this large study of 130 BED 

patients versus 249 obese comparison individuals without BED, those with BED experienced 

more band adjustments and more pouch and esophageal dilatations than those without BED. The 

authors did not report on psychological outcomes. At 5 years, the groups did not differ on 

measures of either weight loss or weight regain. The authors did not report on any variations in 

disordered eating behavior that may have persisted after bariatric surgery. 

Case series without comparison groups. Fichter et al.387 followed 62 cases with BED for 6 

years; of these patients, 78 percent had no ED diagnosis, 6 percent continued to have a BED 

diagnosis, and a minority had developed BN or EDNOS over the followup interval. Over the 6-

year interval, depression, anxiety, and obsessionality measures also improved. The authors did 

not report whether changes observed in BMI over time were significant. No additional factors 

associated with outcome were reported. 

The second case series examined the impact of comorbid psychopathology and personality 

disorders on treatment outcome for BED.388 Individuals with cluster B personality disorders 

reported a greater number of binge days at 1-year followup. Neither binge frequency nor EDE 

global scores were related to other comorbid conditions. The authors did not report additional 

psychological or biomarker outcomes. 

Summary of studies addressing KQ 5. Only sparse evidence addresses factors associated 

with BED outcomes. The three included studies have vastly different designs and research 

questions; more importantly, their findings do not converge. 
134 

Key Question 6: Outcome Difference by Sex, Gender, Age, Race, 

Ethnicity, or Cultural Group 

KQ 6 addresses whether outcomes differ for BED by sex, gender, age, race, ethnicity, or 

cultural groups In all, 405 women and 134 men participated in outcome studies of BED. No 

study compared differential factors associated with outcome by sex or gender. 

Only one study reported ethnicity:388 151 whites, five blacks, four Hispanics, and two Native 

Americans. This study did not report any differential outcomes by ethnicity. 

All three studies were of adults. No outcome studies of BED in children have been 

performed. Nothing is known about differential outcome by age group. 

135 

Chapter 7. Discussion 

This chapter discusses our findings about anorexia nervosa (AN), bulimia nervosa (BN), and 

binge eating disorder (BED), which derive from our systematic review of literature for six key 

questions (KQs). Four KQs dealt with evidence about treatment issues (Chapters 3, 4, and 5): 

1. Efficacy of treatments or combination of treatments 

2. Harms associated with the treatment or combination of treatments 

3. Factors associated with the efficacy of treatment 

4. Differences in efficacy of treatment by sex, gender, age, race, ethnicity, or cultural 

group. 

Two other KQs covered the course and outcomes of these conditions (Chapter 6): 

5. Factors associated with outcomes among individuals with these conditions 

6. Differences in outcomes by sex, gender, age, race, ethnicity, or cultural group. 

Our report focused on randomized controlled trials (RCTs) for AN, BN, and BED and on 

outcomes studies that included sample sizes of 50 or greater and included at least 1 year of 

follow-up. All studies were published since 1980. 

In this chapter, we first review the quality of the literature and the strength of the evidence 

based on the outcomes of and treatment of eating disorders. The confidence that readers can have 

in our findings, conclusions, inferences, and research recommendations rests heavily on the 

quality of the research reviewed and the overall robustness of the evidence. We then discuss the 

major issues resolved (or not resolved) in treating and managing patients with these conditions, 

drawing as appropriate from the findings for all six questions. Following that section, we present 

our research recommendations. The chapter ends with a brief recapitulation of our conclusions. 

Critical Findings and Implications for 

Treatment of Eating Disorders 

In this section we review our main findings on treatments for AN, BN, and BED, with 

specific attention to medications only, behavioral or psychotherapy interventions only, 

combination approaches, and novel interventions. We also comment on issues relating to 

outcomes from the disorders, including mortality. Before presenting the findings, we document 

our approach to assessing the strength of these bodies of evidence. Interpreting our findings 

accurately requires appreciation of the considerable drawbacks to much of this literature. 

Quality of Literature and Strength of Evidence 

As described in Chapter 2 and documented in both evidence and summary tables, we first 

applied rigorous selection criteria for articles and assessed the quality of each study. We then 

evaluated the strength of the bodies of evidence available to address each KQ for each disorder. 

The possible grades in our scheme are as follows: 

I. Strong evidence. The evidence is from studies of strong design; results are both 

clinically important and consistent with minor exceptions at most; results are free 

from serious doubts about generalizability, bias, or flaws in research design. Studies 
136 

with negative results have sufficiently large samples to have adequate statistical 

power. 

II. Moderately strong evidence. The evidence is from studies of strong design, but some 

uncertainty remains because of inconsistencies or concern about generalizability, 

bias, research design flaws, or adequate sample size. Alternatively, the evidence is 

consistent but derives from studies of weaker design. 

III. Weak evidence. The evidence is from a limited number of studies of weaker design. 

Studies with strong design either have not been done or are inconclusive. 

IV. No published literature (for those situations in which no study addressed the 

question). 

For the four treatment KQs, we found 

the strength of the body of evidence to be 

of mixed quality that varied considerably 

across the three disorders (Table 37). For 

KQ 1, evidence for treatment efficacy, we 

judged the AN literature to be weak (III); 

the exception was for psychotherapy for 

adolescents with AN, for which more 

evidence was available yielding a moderate 

rating (II). The strongest treatment efficacy 

literature was for BN; we judged both 

medication and behavioral interventions as 

strong (I), although we gave self-help and 

other interventions only a weak rating (III). 

For BED, both medication and behavioral 

interventions were viewed as moderate (II) 

with self-help and other interventions as 

weak (III). 

Regarding harms of therapy (KQ 2), we 

gave strong ratings (I) to the literature on 

medication interventions for BN and BED. 

The evidence for harms of other 

interventions for all three disorders 

received ratings of either weak (III) or 

nonexistent (IV). Behavioral trials rarely 

reported harms associated with treatment. 

KQ 3 dealt with factors associated with 

or influencing therapeutic outcome. With 

the exception of behavioral interventions 

for BN, which we rated moderate (II), we rated the literature for all three disorders as weak (III). 

Very few well-designed studies addressed those factors that lead to good or poor outcome in 

clinical trials. 

Finally, KQ 4 addressed differences in treatment outcome by age, sex, gender, race, 

ethnicity, or cultural group. For all three disorders and all types of interventions, we rated the 

Table 37. Strength of evidence concerning four 

treatment key questions 

Interventions KQ 1 KQ 2 KQ 3 KQ 4 

Anorexia Nervosa 

Medication and Medication plus Behavioral Interventions 

 Adults III III III IV 

 Adolescents III III III IV 

Behavioral Interventions 

 Adults III IV III IV 

 Adolescents II IV III IV 

Bulimia Nervosa 

Medication and Medication plus Behavioral Interventions 

 All ages I I III IV 

Behavioral Interventions 

 All ages I IV II IV 

Self-help 

 All ages III IV III IV 

Other 

 All ages III IV III IV 

Binge Eating Disorder 

Medication and Medication plus Behavioral Interventions 

 Adult II I III IV 

Behavioral Interventions 

 Adult II IV III IV 

Self-help 

 Adult III IV III IV 

Other 

 Adult III IV III IV 
137 

literature as nonexistent (IV). The treatment literature for eating disorders has virtually ignored 

all these factors. 

As reported in Table 38, we found considerable evidence to address factors related to 

outcomes among individuals with AN and BN (KQ 5) and rated the evidence for both of these 

disorders as moderate (II). In contrast, the evidence available to address factors related to BED 

outcomes (KQ 5) was much more limited and, thus, weak (III). 

The AN outcomes literature includes one 

prospective cohort study (following individuals 

identified in the community) with a comparison group 

design and one case series study (following a 

treatment population) with a comparison group 

design. The remaining literature follows case series of 

patients without comparisons. Some studies use 

strong methodological designs that control for length 

of followup and the effect of independent predictors. However, results were not consistent across 

studies. 

The BN outcomes literature included no prospective cohort studies but did include several 

studies with strong methodological designs, including one case series study with a comparison 

group. However, partially because the literature is inconsistent in the methodology used to 

measure outcome, few factors were found to be consistently related to outcomes and so 

uncertainty remains. 

The BED literature included only three studies. Much of the data provided in these studies 

was descriptive and offered very limited information concerning factors related to outcomes. 

We used the body of literature that met our inclusion criteria for answering KQ 5 to address 

KQ 6 concerning differences in outcomes by sex, gender, age, race, ethnicity, or cultural group. 

We graded the AN literature as weak (III) and the BN and BED literature as nonexistent (IV). 

The AN literature had limited evidence discussing the effect of age of onset on outcomes, but 

results were not conclusive. The AN literature yielded no evidence to evaluate differences in 

outcomes by any other KQ 6 criteria. No study addressed any of these concerns for BN and 

BED. 

Our review supports and extends previous systematic reviews on treatment of eating 

disorders, including several Cochrane reports. Broadly, Cochrane reviews of AN treatment 

concur that the literature is weak, made no specific recommendations regarding AN treatment, 

and encouraged larger well-designed trials.390 For psychotherapy for BN and binge eating, a 

Cochrane review supported cognitive behavioral therapy (CBT) for BN, in individual or group 

format, and encouraged further study of self-help.391 For antidepressant treatment, Cochrane 

reviewers concluded that single antidepressant agents were clinically effective for BN in 

comparison to placebo, with greater remission rate but also greater dropouts. No differential 

effect regarding efficacy and tolerability among the various classes of antidepressants was 

reported.392 Examining combinations of psychotherapy and antidepressants for BN, another 

Cochrane review reported that combination treatments were superior to psychotherapy alone, 

that psychotherapy appeared to be more acceptable to participants, and that the addition of 

antidepressants to psychological treatments decreased the acceptability of the psychological 

intervention.393

In addition, guidelines from the National Institute of Clinical Effectiveness (NICE) in the 

United Kingdom (http://www.nice.org.uk/) concur that AN evidence is weak. The NICE authors 

Table 38. Strength of evidence concerning 

two outcomes key questions

Eating Disorder 

KQ 

5 KQ 6 

Anorexia nervosa II III 

Bulimia nervosa II IV 

Binge eating disorder III IV 
138 

assigned high grades to CBT for BN and BED and to antidepressants for BN. For both BN and 

BED, NICE recommended self-help as an initial treatment step. 

Managing Patients with Medication Alone 

Managing individuals with AN with medication only is inappropriate, based on evidence 

reviewed here. No pharmacological intervention for AN has a significant impact on weight gain 

or the psychological features of AN. Although mood may improve with tricyclic antidepressants, 

this outcome is not associated with improved weight gain. Moreover, medication treatment for 

AN is associated with high dropout rates, suggesting that the currently available medications are 

not acceptable to individuals with AN. 

For BN, good evidence indicates that fluoxetine (60 mg/day) reduces core bulimic symptoms 

of binge eating and purging and associated psychological features of the eating disorder in the 

short term. Based on two studies, the 60 mg dose performs better than lower doses and may 

contribute to decreased relapse at 1 year; however, patients do not tend to remain on the drug. 

Preliminary evidence exists for other second-generation antidepressants (trazodone and 

fluvoxamine), an anticonvulsant (topiramate), and a tricyclic antidepressant (desipramine). 

Preliminary evidence exists that monoamine oxidase inhibitors (MAOIs) are associated with 

decreased vomiting in the treatment of BN, although diet should be closely monitored. 

Medication trials for BED have focused primarily on overweight individuals with BED. In 

these individuals, desired outcomes are twofold: weight loss and abstinence from binge eating. 

The majority of medication research for BED reflects short-term trials. Preliminary efficacy has 

been shown for selective serotonin reuptake inhibitors (SSRIs), one serotonin, dopamine, and 

norepinephrine uptake inhibitor, one tricyclic antidepressant, one anticonvulsant, and one 

appetite suppressant. In the absence of abstinence data and long-term followup, however, we do 

not know whether observed changes in binge eating, depression, and weight persist. 

Managing Patients with Behavioral Interventions Alone 

For adult AN, we have tentative evidence that CBT reduces relapse risk for adults with AN 

after weight restoration has been accomplished. By contrast, we do not know the extent to which 

CBT is helpful in the acutely underweight state, as one study found that a manual-based form of 

nonspecific supportive clinical management was more effective than CBT and interpersonal 

psychotherapy (IPT) in terms of global outcomes during the acute phase. No replications of these 

studies exist. 

Family therapy as currently practiced has no supportive evidence for adults with AN and a 

comparatively long duration of illness. Overall, family therapy focusing on parental control of 

renutrition is efficacious in treating younger patients with AN; these approaches lead to clinically 

meaningful weight gain and psychological improvement. Although most studies of family 

therapy compared one variant of family therapy with another, two studies produced results 

suggesting that family therapy was superior to an individual therapy for adolescent patients with 

shorter duration of illness. 

For BN, evidence for CBT is strong. Although IPT is also as effective, at 1-year followup, 

based on one study, symptomatic change appears to be more rapid with CBT. This factor 

decreases the time that patients are exposed to the symptoms of BN. Dialectical behavioral 

therapy (DBT) and guided imagery both show preliminary promise for BN patients. 
139 

For BED, CBT decreases the target symptom of binge eating. It does not, as currently 

delivered, promote weight loss in overweight patients. DBT may hold promise for BED patients 

as well. 

Managing Patients with Combination Interventions 

Although many of the medication trials for AN were conducted within the context of basic 

clinical management, no study that systematically studied medication plus psychotherapy for AN 

met our inclusion criteria. 

For BN, the combined drug plus behavioral intervention studies provide only preliminary 

evidence regarding the optimal combination of medication and psychotherapy or self-help. 

Although some preliminary evidence exists for incremental efficacy with combined treatment, 

given the variety of designs used and lack of replication, evidence remains weak. 

For BED, the combination of CBT plus medication may improve both binge eating and 

weight loss outcomes. Sufficient trials have not been done to determine definitively which 

medications are best at producing and maintaining weight loss in this population. Moreover, the 

optimal duration of medication treatment for abstinence from binge eating and sustained weight 

loss has not yet been addressed empirically, yet weight-loss effects of medication are generally 

known to cease when the medication is discontinued.394

Managing Patients with Novel Interventions 

Across the three disorders, we found evidence of various innovative approaches that seem to 

hold promise, especially for conditions as complex as these eating disorders. Nonetheless, 

nothing can be said definitively because the trials were small and inconclusive. 

Reducing Mortality 

The AN outcomes literature clearly and consistently identified that the risk of death is 

significantly higher in the AN population than would be expected in the population in general. 

Life-threatening complications of the disease include not only those directly related to weight 

loss and other physical problems but also a significantly elevated risk of suicide. 

Studies were inconsistent concerning whether deceased patients had been included in the 

analysis sample at followup. Therefore, factors related to poor outcomes did not always include 

mortality risk. Several studies identified factors related to death versus all other outcomes. Only 

by including death with other outcome categories can we determine if factors related to death 

differ from factors related to other poor outcomes. 

Individuals with BN and BED were not identified as being at elevated risk of death. 

Methods and Other Deficiencies in Reviewed Studies and 

Recommendations to Overcome Them 

Sample Sizes, Attrition, and Statistical Power 

Adequate sample sizes. Especially in AN clinical trials, sample size was often insufficient to 

draw conclusions regarding differential efficacy across groups. Even when investigators did 

power calculations, they often did not plan an adequate allowance for attrition. Given this 

limitation, researchers using designs that contrasted one approach with another most commonly 
140 

observed no differences across interventions. This result was especially true in trials of 

behavioral interventions and even more so in those that included a large number of comparison 

groups. 

Accurate power analyses should be conducted before starting any study and presented in the 

methods section. Larger multisite studies should be conducted as a means of bolstering patient 

numbers. 

Subgroup analyses. Even in the face of small sample sizes, many authors conducted 

subgroup analyses on outcome variables, often in the absence of a priori hypotheses. In these 

small studies, the ability to discern even large differences between groups is limited, and some 

findings might arise by chance. Investigators must avail themselves of adequate statistical 

assistance to ensure against inappropriate analyses of this sort. 

Attrition. Loss to followup and dropout from clinical trials is especially problematic in AN 

studies.395 Individuals with AN are often in denial, deeply fearful of weight gain (which is the 

key treatment outcome), and hesitant to take medication. High attrition compromises the 

integrity of outcome data; differential attrition between treatment intervention groups and 

comparison (e.g., usual-care or placebo) groups is even more damaging. In light of high attrition, 

researchers often reported completer analyses rather than intention-to-treat analyses, and the 

former practice can bias results. 

Substantial attention needs to be paid to enhancing motivation for treatment in individuals 

with AN and to improving retention in clinical trials. Although dropout is somewhat lower in BN 

and BED studies than in AN studies, investigators should also address these factors in clinical 

trials for these disorders. 

Study Design and Statistical Analysis Issues 

In general, the eating disorders literature suffers from insufficient rigor with respect to 

statistical design and analysis in both the planning and conduct of trials. This leads to both gaps 

and inaccuracies in reporting and interpreting results. Minimally, these problems call into 

question the validity of the conclusions that can be drawn from individual studies. More broadly, 

it limits cross-study comparisons and the systematic accumulation of findings that stand the test 

of time and replication. Ultimately, these problems will hinder the advancement of effective 

treatments. 

Unclear randomization and allocation concealment. Randomization procedures were not 

of uniformly high standards in the AN, BN, and BED literatures. Many studies failed to report 

how investigators achieved randomization (if indeed they did achieve it). In many instances, 

clinical decisions interfered with the integrity of the randomization procedures. No studies 

reported procedures for allocation concealment. 

Trial design challenges. A common problem involves lack of attention to the within-subject 

repeated design inherent in intervention and treatment trials. For example, studies often indicate 

the use of repeated-measures analysis but then actually report analysis of posttreatment outcome 

data only using a paired t-test to identify treatment group differences. In some cases, 

investigators include baseline data as a covariate (which is not explicitly identical to using a 

repeated-measures model); in other cases, they do not take baseline data into account at all. 

In addition, authors sometimes compute a change (delta) score (posttreatment minus 

baseline) representing within-subject change over time. This is a reasonable (indeed, often 

preferable) analytic approach to understand pre-post differences. However, they then fail to 
141 

account for baseline differences that could result in misinterpretation of mean within-group delta 

scores; an example is when higher baseline values are associated with smaller delta scores. 

Overall, advances in this field demand more clarity in the description of analytical methods 

employed, including specifically the analytic models that have been determined a priori, and for 

the use of repeated measures models with appropriate inclusion of covariates. Attention to these 

recommendations should improve our ability to integrate information from disparate studies and 

to draw conclusions with higher yield with respect to the design and implementation of future 

interventions. 

Duration of treatment and absence of followup. Only a very few studies included a 

dimension of differential duration of treatment in their designs. Assuming that a medication trial 

that lasts weeks is likely to have long-lasting effects on symptoms that have been present often 

for many years is unrealistic. Realistic duration of treatment and longer followup of patients in 

clinical trials for AN, BN, and BED are essential. In addition, strategies to develop continuation 

and maintenance treatments have not yet been addressed in this field. They are a critical next 

step in both medication and psychotherapy research. 

Excessive diagnostic and outcome measures. The field of eating disorders has spawned an 

unusually large array of diagnostic and outcome assessment measures. The lack of consistency of 

measures renders comparisons across studies virtually impossible. This problem is an especially 

important barrier to standardizing measures of weight and weight change in outcome 

assessments and trials involving AN therapies, especially when age and sex corrections for body 

mass index (BMI) should be employed. Future efforts to refine and consolidate the number of 

measures would be a valuable contribution to the field. 

Researchers should be careful not to include too many outcome measures in their designs. 

They need to avoid having many outcome variables at the expense of the most important 

behavioral indicators. Excessive numbers of outcome measures, especially those that may be 

closely related, lead to a higher likelihood of Type I errors and an inevitable focus on the minor 

significant findings that do emerge. This is especially detrimental to understanding the efficacy 

of therapeutic regimens when those findings are not the most clinically relevant dimensions or 

when their relevance to recovery is unknown. 

Treatment of medical morbidities. Insufficient attention has been paid to addressing the 

optimal approach to treatment of serious long-term physical sequelae of AN and BN, most 

notably osteoporosis. We advise that measures of physical health issues be considered in the 

design of future trials. 

Sociocultural context. Although the facilitating nature of sociocultural forces such as 

emphasis on thinness and unhealthy dieting have long been acknowledged, few treatment or 

outcome studies have attempted to measure the impact of these pernicious contextual factors. 

Although these variables are less tractable (for study design and conduct) than more readily 

measured factors such as eating-disordered behaviors, depression, anxiety, or biomarkers, greater 

attention to developing effective methods to measure these contextual factors may reveal 

important and often overlooked factors that influence recovery. This in turn may open new 

avenues for prevention, community education, policy, and strategies for maintenance of 

treatment gains. 

Reporting Issues 

Lack of definition of stage of illness, remission, recovery, and relapse. For AN, BN, and 

BED, investigators did not apply consensus definitions of stage of illness, remission, recovery, 
142 

and relapse. Developing standardized definitions of these terms for each disorder and the means 

to evaluate them are high priorities for future research. Accomplishing this will require a 

concerted and orchestrated effort to bring researchers together to develop such definitions and 

reporting guidelines. 

Reporting change as reduction in behaviors rather than abstinence or remission. 

Especially in the BN and BED literature, researchers commonly reported outcomes such as 

percentage reduction in binge days, percentage reduction in binges, or amount of time spent 

binge eating. Although these are potential indicators of therapeutic change, when used alone they 

can be misleading because individuals with high weekly binge eating can reduce this behavior by 

even as much as 50 percent but still be highly symptomatic. Depending on the disorder and core 

behaviors being targeted, future studies should report either abstinence from binge eating, 

vomiting, and other compensatory behaviors or absence of binge days for a specified duration of 

time (at least 1 month but preferably longer). 

Statistical reporting. Frequently, authors do not report degrees of freedom, making it 

impossible to decipher the exact nature of the model being tested. Incomplete reporting of results 

derived from multivariate models is problematic. Authors should take care to report clearly any 

interaction, between-group, and within-group effects when they employ repeated designs. 

Statistically significant differences versus clinically meaningful differences. Across all 

three disorders attention to distinguishing between statistically significant and clinically 

meaningful differences is insufficient. For example, significant differences in weight gain in AN 

and in weight loss in BED may be observed; however, the extent to which group differences as 

small as 1 kg to 2 kg truly represent clinically meaningful differences is rarely addressed. 

Definitions of what constitutes clinically meaningful differences in eating disorders are required. 

This issue is even more complex when dealing with psychological features of the eating 

disorder or associated anxiety or depression. Although significant group differences may emerge 

in a parameter such as hunger, the extent to which this type of finding reflects improvement in 

the disorder and is a harbinger for remission remains unknown. 

Future Research Needs 

Gaps in the Literature for Interventions 

Gaps in the literature can be identified for the specific diseases and for broader issues of 

research across eating disorders. We first examine deficits in the evidence base for the main 

types of interventions (for one, two, or all three of the conditions), drawing on the points made 

above about the quality of articles or strength of evidence. We then turn to broader methods and 

related issues for the entire body of investigations in these conditions. 

Medications. Discovering new medications that target the core biological and psychological 

features of AN, address adverse medical sequelae such as osteoporosis, and enhance motivation 

and retention in medication trials are critically needed steps. As noted, fluoxetine offers some 

benefits for BN patients. Additional studies are required to determine the long-term effectiveness 

of relatively brief medication trials, the optimal duration of medication treatment, and the 

optimal strategy for maintenance of treatment gains. In addition, work to identify and test novel 

medications that decrease the urge to purge (e.g., with antiemetics) or reduce the extent to which 

binge eating and purging are experienced as reinforcing is also warranted. Medication trials 

should focus on achieving abstinence from binge eating and purging, not merely reducing the 
143 

frequency with which these behaviors occur. Efforts to improve retention in medication trials for 

BN are also warranted, as are additional studies combining medications and behavioral 

interventions. 

For BED medication questions, future investigations should take care to report specifically 

and separately on two outcomes – weight loss and abstinence from binge eating – because 

weight loss is less applicable to individuals with BED who are of normal weight. Future BED 

studies should clearly distinguish between normal weight and overweight participants and 

address whether treatment goals include both cessation of binge eating and weight loss. The 

impact of high placebo response should be considered in future trials and designs modified 

accordingly (e.g., sufficiently long placebo run-in phases). 

Across all three disorders, no effort has been made to study drug augmentation effects. All 

trials were monotherapy trials; only a few allowed sequential medication in nonresponders. 

Investigators should consider augmentation strategies in their future studies. 

Behavioral interventions. Strategies for enhancing CBT to change both binge eating and 

weight loss should be included in the next generation of behavioral studies. They should also 

focus on strategies for enhancing efficacy of CBT and how best to treat CBT nonresponders. On 

the basis of preliminary trials, DBT also deserves further study. 

Combination interventions. The absence of trials combining medications and behavioral 

interventions (e.g., psychotherapy) is a serious deficit in the AN literature, and it is striking given 

that treatment delivered in the community for AN patients is often some form of combination 

treatment. Future studies must address the efficacy of various combinations of treatments for 

individuals with AN. Future studies should further explore optimal combinations and how best to 

combine treatments for BN patients who do not respond to CBT or fluoxetine alone. For BED 

patients, the needed research centers more on which medications have the greatest efficacy for 

producing desired outcomes and the optimal duration of medication use. 

Novel and “borrowed” interventions. Research on innovative medications and behavioral 

treatments are warranted, especially given the state of treatment of AN. Medications studied to 

date have either focused on peripheral symptoms such as depression or anxiety or attempted to 

capitalize on medication side effects such as weight gain, with the aim of aiding weight 

restoration in AN. Of special importance will be trials of novel medications that target core 

biological and cognitive features of the disorders and that are also acceptable to patients. 

Similarly, psychotherapies applied to eating disorders have been borrowed from other fields 

such as depression (CBT and IPT), anxiety disorders (exposure with response prevention), and 

personality disorders (DBT). We should actively seek to further adapt psychotherapeutic 

interventions that are tailored to the unique core pathology of eating disorders (e.g., drive for 

thinness, body dissatisfaction, appetite dysregulation) and that are both efficacious and 

acceptable to the patients. New behavioral interventions that target motivation to change and 

encourage retention in treatment are required. Further dismantling of complex therapies such as 

CBT to determine the active therapeutic components is also warranted. 

Other fields are benefiting from the application of new information technologies to the 

treatment of illness. Adequately powered clinical trials that include the use of email, the Internet, 

personal digital assistants, text messaging, and other technological advances to enhance 

treatment will add to future treatment development. These approaches may be well suited to 

disorders marked by shame, denial, and interpersonal deficits and where availability of specialty 

care is limited. 
144 

Multidisciplinary interventions. Specialist inpatient and partial hospitalization treatment of 

AN often reflects a multidisciplinary approach: medicine, psychiatry, psychology, nutrition, 

family therapy, and sometimes additional disciplines such as recreational therapy and 

occupational therapy. The majority of treatment trials have been monotherapeutic. When they are 

multidisciplinary, the actual component of multidisciplinarity was rarely a variable on which 

patients were randomized. Studies that directly address the therapeutic benefits of and optimal 

approach to multidisciplinary treatment are required. 

Maintenance of gains after drug discontinuation. For all three disorders, investigators 

typically failed to provide adequate follow-up time for medication trials. This means they cannot 

determine the extent to which positive behavior changes seen during medication administration 

are maintained over time. At minimum, such studies should have at least 1 year of followup. 

Especially with BN and BED, for which evidence for the short-term efficacy of medication 

interventions exists, additional information on maintenance of treatment gains, prevention of 

relapse, and optimal duration of medication treatment are critical next phases for clinical trials. 

Gaps in the Literature for Certain Types of Patients 

Patients with anorexia nervosa. AN is a serious psychiatric illness. Treatment research on 

AN is particularly challenging given the characteristic denial of illness, high drop-out rates from 

treatment, and the limited population prevalence in any single catchment area. Despite the fact 

that this is the most challenging eating disorder to treat, our evidence base is scant. Studies tend 

to be small, inadequately powered, and hence inconclusive. Medications studied to date have 

either focused on peripheral symptoms such as depression or anxiety or attempted to capitalize 

on medication side effects such as weight gain, with the aim of aiding weight restoration in AN. 

Both medication and behavioral intervention trials tend to be derivative—using medications or 

behavioral interventions that are borrowed from other areas of medicine without focusing on the 

core symptoms of AN. 

We noted above some specific gaps related to medication and psychotherapy interventions. 

We reiterate here the urgency of more, and better, research on this disease. Trials of novel 

medications that target the core cognitive symptoms and biological processes of AN and medical 

sequelae are especially needed to move the field forward. 

The literature on AN has failed to distinguish sufficiently between interventions targeted at 

individuals before or after weight restoration and has failed to address the optimal approach to 

renutrition. Indeed, whether medication and behavioral interventions have different outcomes 

depending on weight status remains murky. Given that low weight and malnutrition can interfere 

with the efficacy of medication and the ability to process information in psychotherapy, the 

optimal timing of the administration of medications and therapy vis-a-vis weight restoration is a 

critical question that remains unaddressed. 

Patients with eating disorders not otherwise specified (EDNOS). Several treatment 

centers have reported that the majority of individuals who seek treatment for an eating disorder 

receive a diagnosis of EDNOS.88,89 EDNOS is a compound category illustrated in the Diagnostic 

and Statistical Manual, Version IV (DSM IV), by six examples including BED. Despite the 

patient characteristics that lead to this diagnosis, investigators appear to have ignored 

systematically those with EDNOS diagnoses. Given the preponderance of individuals with 

EDNOS diagnoses in treatment settings, this is a serious shortcoming of the literature. 

In part, this gap reflects the greater clarity and homogeneity that investigators can achieve in 

clinical trials when they recruit only individuals with clearly defined AN or BN. However, the 
145 

price of this clarity is generalizability and, ultimately, understanding the effectiveness of 

interventions tested. Although some trials have begun to expand inclusion criteria to reflect 

typical clinical practice, others have retained strict inclusion criteria. Only by further clarifying 

clinical syndromes within the current EDNOS category and investigating the optimal approach to 

treat these conditions will we be able to determine how best to treat the majority of treatmentseeking individuals. 

Improved epidemiologic data are required to determine whether the frequency with which 

EDNOS is seen in the clinic reflects population prevalence rates of the various eating disorders. 

In addition, active strides should be taken to characterize the syndromes that are captured under 

the heading of EDNOS and to determine the best way to treat conditions that exist under that 

umbrella diagnostic category. 

The need for additional attention to individuals with EDNOS was clearly shown through our 

review of the outcomes literature. EDNOS is a common outcome among individuals who 

formerly had AN or BN. However, virtually nothing is known about the persistence of these 

conditions. 

Age and lifespan orientation. The treatment literatures on AN, BN, and BED differ in how 

they examine differential therapeutic outcomes by age group. For all three disorders, a more 

thoughtful lifespan approach is required to determine optimal approaches from childhood 

through older adulthood. 

The AN literature is devoid of medication studies for adolescents; drug trials have focused 

exclusively on adults. Future medication trials should explore medication efficacy in adolescents 

and the differential efficacy of medications between adolescents and adults. 

In contrast, behavioral interventions have focused more on adolescent patients, possibly 

because of the existence of various family therapy models that are well suited to the context 

within which adolescent AN arises. Nonetheless, behavioral interventions should pay greater 

attention to the appropriateness of various approaches across the lifespan (including duration of 

illness) and of adaptations that depend on age of the patient. 

The extent to which CBT approaches to adolescent treatment of AN were adapted to match 

the developmental level of the patients is unknown. Likewise, approaches that are effective in 

adolescents may be inappropriate for adults, although developmentally appropriate adaptations 

may be worthy of study. For example, the relative efficacy of family therapy for adolescents with 

AN may signal the important role of the family. However, the family of relevance for an adult 

with AN may be her or his spouse and children rather than family of origin. Such permutations 

of the therapeutic approach have not yet been tested. 

For BN, most commonly older adolescent and adult patients received the same treatment and 

researchers made no effort to explore differential outcome by age group. Future studies that 

delve more into mechanisms of treatment response should take care to explore differential age 

effects. 

For BED, no medication or behavioral intervention trials exist for adolescents. No study 

enrolled patients younger than 18; many included individuals up to 65 without documenting age 

effects. The first step for BED research is to acquire epidemiologic data to determine the extent 

to which this disorder is a problem for adolescents. The second needed step is to explore 

differential outcomes by age. 

Males and females. Although males suffer from eating disorders, they are underrepresented 

in clinical trials of AN and BN. When included, their numbers are usually too small to be 
146 

analyzed separately. Clinical trials of BED often include a greater number of men; however, no 

study has reported on differential efficacy by sex. 

This situation can be remedied, first, by better studies comparing the phenomenology of AN, 

BN, and BED in males and females. Second, more extensive epidemiological data can provide 

more accurate estimates of the actual sex ratio in the population. Third, efforts should be 

expanded to explore differential treatment needs and outcomes in males and females across the 

age spectrum. Fourth, we have no data on whether treatment for eating disorders is best 

conducted in mixed-sex or single-sex environments. Fifth, multisite trials can be designed to 

increase sample size of male participants. 

We note that much of the literature to date deals with males and females (a construct related 

to sex and biology). Very little research, apparently, tries to deal with gender (a construct related 

to socialization and social roles). We believe that more attention to the difference between these 

ideas, and some effort to understand the impact of gender, and not simply sex, may be valuable 

in understanding treatment approaches and efficacy. 

Race and ethnicity. The majority of the literature on AN fails even to report the race and 

ethnicity of participants. All descriptions of participants should include this critical parameter. 

Although the more recent BN and BED literature has improved on this point, no studies of 

medication or behavioral interventions have addressed the issue of whether treatment efficacy 

differs by race or ethnic background. This is a serious omission in the literature. 

To remedy this shortcoming, we must collect adequate epidemiologic data to provide 

critically needed information about the frequency with which eating disorders occur across racial 

and ethnic groups. Such data would provide guidance for planning targeted recruitment in 

clinical trials and enable researchers to set priorities for approaches to incorporating race and 

ethnicity into both treatment and outcomes studies. In addition, further exploration of 

sociocultural factors (e.g., stigma) may also assist with understanding both underdetection and 

underrepresentation of racial and ethnic minorities in research studies. 

Underserved populations. The literature on AN, BN, and BED is devoid of any mention of 

specific issues of gay, lesbian, transsexual, or transgender individuals. These parameters should 

be systematically recorded in both treatment and outcome studies. 

Gaps in the Overall Evidence Base 

The United States’ contribution to the literature. The literatures on AN, BN, and BED are 

geographically imbalanced. Although the United States has contributed considerably to the 

literature on BN and BED, it has done much less on both the treatment and outcome literature for 

AN. Although outcome studies of AN may be more difficult in the United States because of the 

mobility of the population, large-scale multisite treatment trials are perhaps more feasible in the 

United States given the number of academic treatment centers, the generally shared language, 

and the size of the population base. The United States should expand its contribution to the 

global literature for the next phase of treatment studies, especially for AN. 

In addition, the unique racial and ethnic composition of the United States could assist with 

addressing the vacuum of information regarding differential treatment outcome by race and 

ethnicity across AN, BN, and BED. For the outcomes literature, the majority of literature for AN 

comes from outside of the United States. The extent to which data from outside the United States 

accurately reflect outcomes in the United States is unclear. 

Replication. The hallmark of good science is replication. One major weakness of the 

existing literature and a critical need for the future is replication. Once efficacious interventions 
147 

are identified, adequately powered replication studies should be supported to confirm their 

effectiveness. Results of such studies would need to be careful to report findings using measures 

and statistical techniques that would allow for direct comparisons across trials. 

Large multisite randomized controlled trials. The majority of eating disorders treatment 

studies are small, single-site trials. The average sample size of AN trials, 23, illustrates this point 

robustly. Future multisite trials will facilitate patient recruitment, enhance statistical power, 

enable meaningful subset analyses, buffer against high drop-out rates, and improve 

generalizability of results. Working in partnership with insurance companies to enable such trials 

in the current reimbursement milieu may be critical to success.

Generalizability and key treatment questions in the community. Clinical trials for AN in 

particular do not adequately reflect the type of treatment typically delivered in the community. 

Nor do clinical trials for AN address some of the key challenges facing clinicians who treat this 

disorder in inpatient and partial hospitalization or residential settings. 

For low-weight patients with AN, the first treatment challenge is weight restoration. 

Guidelines from the American Psychiatric Association (APA) suggest that individuals at 75 

percent of ideal body weight (IBW) or lower are candidates for inpatient weight restoration, 

although many other factors influence level of care decisions. When facilities are available, 

weight restoration occurs in hospital, followed by various levels of step-down marked by 

increasing autonomy and exposure to real-life eating and emotional situations. 

No clinical trials for AN address the optimal approach to inpatient weight restoration that can 

achieve the most lasting gain. This also includes nutritional trials of optimal approaches to 

renutrition. No studies address the accuracy of the recommendation for hospitalization at 75 

percent IBW. No studies address the optimal conditions under which a patient should be 

discharged from inpatient treatment and stepped down to less structured environments. Given the 

financial expense of prolonged inpatient hospitalizations and the toll on both patient and family, 

the conditions under which extended hospitalizations are superior to intensive outpatient 

management should be the focus of future studies. 

Harms of treatment. Trials of medication or behavioral interventions for patients with AN, 

BN, and BED do not routinely describe the degree of medical compromise or strategies to 

monitor for potential harm in malnourished patients. Indeed, behavioral intervention trials often 

completely overlook the fact that their interventions may have adverse effects on patients. 

Especially given the high drop-out rates from AN trials, behavioral interventions should pay 

greater attention to both physical and psychological harms associated with interventions. All 

studies should report adverse events associated with interventions with these disorders. In 

addition, with AN, researchers should determine, especially within medication trials, whether 

adverse events differ between the underweight and the weight-restored state. 

Issues in Outcomes Research

Outcomes research and treatment research. One serious gap in the evidence base about 

eating disorders is the absence of “cross talk” between the outcomes and the treatment 

literatures. Outcomes literature reveals intriguing problems that persist years after the onset of 

AN. One example is the presence of autism spectrum disorders reported in the Göteborg 

cohort.344-346,349,356 Such observations could provide critical information to individuals designing 

new interventions for AN. Targeting social information processing deficits, for example, could 

be one way to enhance AN treatment delivery. Paying greater attention to premorbid traits and 
148 

traits that persist after recovery or through persistent illness may help to enhance treatment 

efficacy by identifying new treatment targets. 

In addition, greater attention to demographic patterns in outcome studies such as typical age 

of recovery from AN may assist with better appraising where an individual entering treatment is 

in the course of her or his illness. This could assist with enhancing engagement in treatment and 

reducing the number of dropouts.

Prospective cohort studies and comparison groups. Virtually all the outcome results and 

relationships that we identified came from case series studies. This design limits generalizability 

beyond the specific treatment population being studied. Only one prospective cohort study has 

been conducted with individuals identified with AN; none has been done among persons with 

either BN or BED. Therefore, little evidence exists as to whether outcomes differ across 

treatment populations, individuals in the general population who suffer from these disorders, and 

those who may not meet threshold diagnostic criteria yet report symptoms or features of the 

disorders. 

Of particular interest would be studies that address factors associated with successful 

outcomes in AN or BN; these should explore trajectories of recovery and how current diagnostic 

nosology captures those trajectories. For example, an individual with AN who is assessed 5 years 

after the onset of that illness may be given a diagnosis of EDNOS; this pattern fails to 

acknowledge that the patient is on a recovery trajectory from AN. The appropriateness of 

receiving a diagnostic label (EDNOS) different from the original diagnosis (AN), rather than a 

specific indicator such as AN in partial remission, has yet to be addressed adequately in the 

literature. 

Tracing outcomes across diagnoses. Many individuals who at one time suffered from AN 

or BN continue to experience less severe eating disorders in later years. Use of dichotomous or 

simplistic measures of disease state is increasingly seen as uninformative. Additional research is 

needed that can sufficiently capture the factors associated with transitions in severity of eating 

disorder diagnoses. 

Statistical methods for outcomes research. Outcomes studies vary in their statistical 

sophistication. At their best, studies used multivariate techniques to control for the influence of 

various independent variables on outcomes; they may also employ survival analyses techniques 

to control for differences in the length of time that patients were followed. At their more 

rudimentary state, many studies simply presented descriptive comparisons between a series of 

prognostic factors and outcomes of interest, or they employed techniques more appropriate for 

exploratory research (e.g., stepwise regression). We encourage investigators doing outcomes 

research (as contrasted with trials) to plan from the outset on using advanced statistical and 

analytic methodological approaches. 

Impact of weight loss treatment on binge eating. Although not a focus of this review, with 

the ever-increasing obesity epidemic,396,397 an important area of study will be the impact of 

various weight loss treatments on binge eating and on the development of eating disorders and 

eating-disordered behaviors. Programs developed for obesity prevention and treatment in both 

children and adults should be carefully monitored to ensure that no untoward effects emerge that 

increase eating-disordered behaviors.398-401

Cost-effectiveness analyses. Only rarely has the cost-effectiveness of interventions for AN, 

BN, and BED been addressed. At some point, however, some medications, behavioral 

approaches, or combination therapies will appear to be efficacious in trials or effective in broader 

trials or observational studies. Then, clinicians, insurers, health plan administrators, and others 
149 

will want information on the relative cost-effectiveness of different therapeutic options. To 

provide information to address these questions, future studies should include data collection of 

costs and cost-effectiveness analyses in their designs. 

Conclusions 

The literature regarding treatment efficacy and outcomes for AN, BN, and BED is of highly 

variable quality. For AN, the literature on medications was sparse and inconclusive. No studies 

combining medication with behavioral interventions met inclusion criteria. Evidence suggests 

that specific forms of family therapy are efficacious in treating adolescents, and preliminary 

evidence suggests that CBT may reduce relapse risk for adults after weight restoration and that a 

manual-based form of nonspecific supportive clinical management may be effective in 

underweight adults. 

For BN, fluoxetine (60 mg/day) decreases the core bulimic symptoms of binge eating and 

purging and associated psychological features in the short term. CBT administered individually 

or in groups reduced core behavioral symptoms and psychological features in both the short and 

long term. How best to treat individuals who do not respond to CBT or fluoxetine remains 

unknown. 

In BED, CBT reduced binge eating and leads to greater rates of abstinence when 

administered either individually or in group format, persisting for up to 4 months after treatment; 

however, CBT does not lead to weight loss in individuals with BED. Medications may also play 

a role in the treatment of BED although further research addressing how best to achieve both 

abstinence from binge eating and weight loss in overweight patients is required. 

Higher levels of depression and compulsivity were associated with poorer outcomes in AN; 

increased mortality was associated with concurrent alcohol and substance use disorders. Only 

depression was consistently associated with poorer outcomes in BN; BN was not associated with 

an increased risk of mortality. Because of sparse data, we could reach no conclusions concerning 

BED outcomes. We uncovered weak to no evidence to address sociodemographic differences in 

either treatment or outcomes for any of these disorders. 

The quality of the literature about treatment efficacy and outcome for AN, BN, and BED is 

highly variable. In the treatment literature, the largest deficiency rests with treatment efficacy for 

AN; we rated this literature as the weakest. 

Future AN studies require large numbers of participants, multiple sites, clear delineation of 

the age of participants, and interventions that are tailored to the unique core pathology and 

medical sequelae of the illness. For BN, future studies should address novel treatments for the 

disorder, optimal duration of intervention, and optimal approaches for those who do not respond 

to medication or CBT. For BED, future studies require better explication of how best to target 

both binge eating and weight loss goals, optimal duration of intervention, and prevention of 

relapse. 

For all three disorders, exploring additional treatment approaches is warranted. In addition, 

research teams should pay greater attention to factors influencing outcome, harms associated 

with treatment, and differential efficacy by age, sex, gender, race, ethnicity, and cultural group. 

Consensus definitions of remission, recovery, and relapse are essential. For both treatment and 

outcome literature, greater attention is required to the presentations currently grouped under the 

heading of EDNOS. 

Outcome studies, especially for BN and BED, should emphasize population-based cohort 

studies with comparison groups and plan for adequate durations of follow-up. Ongoing 
150 

psychiatric epidemiology studies should routinely include assessments of eating disorders. 

Epidemiologic studies of BMI and obesity trends should include assessments of eatingdisordered behavior. Population-based studies should include measures of disability and 

impairment associated with eating disorders. For both future treatment and outcome studies, 

researchers must carefully attend to issues of statistical power, research design, and 

sophistication and appropriateness of statistical analyses. 

151 

References and Included Studies 

1. Hoek H, van Hoeken D. Review of the prevalence and 

incidence of eating disorders. Int J Eat Disord 

2003;34:383-96. 

2. Sullivan PF. Mortality in anorexia nervosa. Am J 

Psychiatry 1995;152:1073-4. 

3. Birmingham C, Su J, Hlynsky J, et al. The mortality 

rate from anorexia nervosa. Int J Eat Disord 

2005;38:143-6. 

4. Watson TL, Andersen AE. A critical examination of 

the amenorrhea and weight criteria for diagnosing 

anorexia nervosa. Acta Psychiatr Scand 

2003;108(3):175-82. 

5. Gendall K, Joyce P, Carter F, et al. The psychobiology 

and diagnostic significance of amenorrhea in anorexia 

nervosa. Fertility Sterility In Press. 

6. Wonderlich S, Lilenfeld L, Riso L, et al. Personality 

and anorexia nervosa. Int J Eat Disord 

2005;37(Suppl):568-71. 

7. Halmi K, Eckert E, Marchi P, et al. Comorbidity of 

psychiatric diagnoses in anorexia nervosa. Arch Gen 

Psychiatry 1991;48:712-8. 

8. Walters EE, Kendler KS. Anorexia nervosa and 

anorexic-like syndromes in a population-based female 

twin sample. Am J Psychiatry 1995;152:64-71. 

9. Bulik C, Sullivan P, Fear J, et al. Eating disorders and 

antecedent anxiety disorders: A controlled study. Acta 

Psychiatr Scand 1997;96:101-7. 

10. Kaye W, Bulik C, Thornton L, et al. Comorbidity of 

anxiety disorders with anorexia and bulimia nervosa. 

Am J Psychiatry 2004;161:2215-21. 

11. Sullivan PF, Bulik CM, Fear JL, et al. Outcome of 

anorexia nervosa. Am J Psychiatry 1998;155:939-46. 

12. Russell G. Anorexia nervosa and bulimia nervosa. In: 

Russell G, Hersov L, editors. Handbook of psychiatry 

4: the neuroses and personality disorders. Cambridge: 

Cambridge University Press;1983. 

13. Feighner J, Robins E, Guze S, et al. Diagnostic criteria 

for use in psychiatric research. Arch Gen Psychiatry 

1972;26:57-63. 

14. American Psychiatric Association. Diagnostic and 

statistical manual of mental disorders. Third Edition. 

3rd edition. Washington, DC: American Psychiatric 

Association Press; 1980. 

15. American Psychiatric Association. Diagnostic and 

statistical manual of mental disorders. Edition III-R. 

3rd, revised edition. Washington, DC: American 

Psychiatric Association Press; 1987. 

16. American Psychiatric Association. Diagnostic and 

statistical manual of mental disorders. Fourth Edition. 

Washington, D.C.: American Psychiatric Association 

Press; 1994. 

17. WHO. International statistical classification of 

diseases and related health problems, tenth revision. 

Geneva: World Health Organization; 1992. 

18. McKnight Investigators. Risk factors for the onset of 

eating disorders in adolescent girls: results of the 

McKnight longitudinal risk factor study. Am J 

Psychiatry 2003;160:248-54. 

19. Wittchen HU, Nelson CB, Lachner G. Prevalence of 

mental disorders and psychosocial impairments in 

adolescents and young adults. Psychol Med 

1998;28(1):109-26. 

20. Eagles J, Johnston M, Hunter D, et al. Increasing 

incidence of anorexia nervosa in the female population 

of northeast Scotland. Am J Psychiatry 

1995;152:1266-71. 

21. Jones D, Fox M, Babigan H, et al. Epidemiology of 

anorexia nervosa in Monroe County, New York: 1960-

76. Psychosom Medicine 1980;42:551-8. 

22. Lucas AR, Beard CM, O'Fallon WM, et al. Anorexia 

nervosa in Rochester, Minnesota: A 45-year study. 

Mayo Clin Proc 1988;63:433-42. 

23. Møller-Madsen S, Nystrup J. Incidence of anorexia 

nervosa in Denmark. Acta Psychiatr Scand 

1992;86:187-200. 

24. Szmukler G. The epidemiology of anorexia nervosa 

and bulimia. J Psychiat Res 1985;19:143-53. 

25. Willi J, Grossman S. Epidemiology of anorexia 

nervosa in a defined region of Switzerland. Am J 

Psychiatry 1983;140:564-7. 

26. Milos G, Spindler A, Schnyder U, et al. Incidence of 

severe anorexia nervosa in Switzerland: 40 years of 

development. Int J Eat Disord 2004;36:118-9. 

27. Hall A, Hay P. Eating disorder patient referrals from a 

population region 1977-1986. Psychol Med 

1991;21:697-701. 
152 

28. Hoek H, Bartelds A, Bosveld J, et al. Impact of 

urbanization on detection rates of eating disorders. Am 

J Psychiatry 1995;152:1272-8. 

29. Joergensen J. The epidemiology of eating disorders in 

Fyn County Denmark, 1977-1986. Acta Psychiatr 

Scand 1992;85:30-4. 

30. Nielsen S. The epidemiology of anorexia nervosa in 

Denmark from 1973-1987: a nationwide register study 

of psychiatric admission. Acta Psychiatr Scand 

1990;81:507-14. 

31. Willi J, Giacometti G, Limacher B. Update on the 

epidemiology of anorexia nervosa in a defined region 

of Switzerland. Am J Psychiatry 1990;147(11):1514-

7. 

32. Lucas AR, Beard CM, O'Fallon WM, et al. 50-year 

trends in the incidence of anorexia nervosa in 

Rochester, Minn.: a population-based study. Am J 

Psychiatry 1991;148:917-22. 

33. Gowers S, Crisp A, Joughin N, et al. Premenarcheal 

anorexia nervosa. J Child Psychol Psychiatry 

1991;32:515-24. 

34. Inagaki T, Horiguchi J, Tsubouchi K, et al. Late onset 

anorexia nervosa: two case reports. Int J Psychiatry 

Med 2002;32:91-5. 

35. Beck D, Casper R, Andersen A. Truly late onset of 

eating disorders: a study of 11 cases averaging 60 

years of age at presentation. Int J Eat Disord 

1996;20(4):389-95. 

36. Jacobi C, Hayward C, de Zwaan M, et al. Coming to 

terms with risk factors for eating disorders: application 

of risk terminology and suggestions for a general 

taxonomy. Psychol Bull 2004;130:19-65. 

37. Walsh B, Bulik C, Fairburn C et al. Defining eating 

disorders. Evans D, Foa E, Gur R et al. Treating and 

preventing adolescent mental health disorders: What 

we know and what we don't know. New York: Oxford 

University Press, The Annenberg Foundation Trust at 

Sunnylands, and the Annenberg Public Policy Center 

of the University of Pennsylvania;2005. 

38. Cnattingius S, Hultman C, Dahl M, et al. Very preterm 

birth, birth trauma, and the risk of anorexia nervosa 

among girls. Arch Gen Psychiatry 1999;56:634-8. 

39. Lilenfeld L, Kaye W, Greeno C, et al. A controlled 

family study of restricting anorexia and bulimia 

nervosa: comorbidity in probands and disorders in 

first-degree relatives. Arch Gen Psychiatry 

1998;55:603-10. 

40. Wade TD, Bulik CM, Neale M, et al. Anorexia 

nervosa and major depression: shared genetic and 

environmental risk factors. Am J Psychiatry 

2000;157(3):469-71. 

41. Klump KL, Miller KB, Keel PK, et al. Genetic and 

environmental influences on anorexia nervosa 

syndromes in a population-based twin sample. Psychol 

Med 2001;31(4):737-40. 

42. Kortegaard LS, Hoerder K, Joergensen J, et al. A 

preliminary population-based twin study of selfreported eating disorder. Psychol Med 

2001;31(2):361-5. 

43. Devlin B, Bacanu S, Klump K, et al. Linkage analysis 

of anorexia nervosa incorporating behavioral 

covariates. Hum Mol Genet 2002;11(6):689-96. 

44. Grice DE, Halmi KA, Fichter MM, et al. Evidence for 

a susceptibility gene for anorexia nervosa on 

chromosome 1. Am J Hum Genet 2002;70(3):787-92. 

45. Bergen AW, van den Bree MBM, Yeager M, et al. 

Candidate genes for anorexia nervosa in the 1p33-36 

linkage region: serotonin 1D and delta opioid receptor 

loci exhibit significant association to anorexia 

nervosa. Mol Psychiatry 2003;8:397-406. 

46. Slof-Op 't Landt M, van Furth E, Meulenbelt I, et al. 

Eating Disorders: From Twin Studies to Candidate 

Genes and Beyond. Twin Res Hum Genet 16:467-82. 

47. Kaye W, Frank G, Bailer U, et al. Neurobiology of 

anorexia nervosa: clinical implications of alterations 

of the function of serotonin and other neuronal 

systems. Int J Eat Disord 2005;37:S15-9. 

48. Barbarich N, Kaye W, Jimerson D. Neurotransmitter 

and imaging studies in anorexia nervosa: new targets 

for treatment. Curr Drug Targets CNS Neurol Disord 

2003;2:61-72. 

49. Kaplan A. Medical aspects of anorexia nervosa and 

bulimia nervosa. Kennedy SH. Handbook of eating 

disorders. Toronto: University of Toronto;1993:22-9. 

50. Katzman DK. Medical complications in adolescents 

with anorexia nervosa: a review of the literature. Int J 

Eat Disord 2005;37 Suppl:S52-9; discussion S87-9. 

51. Sharp C, Freeman C. The medical complications of 

anorexia nervosa. Br J Psychiatry 1993;162:452-62. 

52. Bulik C. Eating disorders in adolescents and young 

adults. Child Adolesc Psychiatr Clin N Am 

2002;11(2):201-18. 

53. Harris EC, Barraclough B. Excess mortality of mental 

disorder. Br J Psychiatry 1998;173:11-53. 
153 

54. Bulik C, Sullivan P, Fear J, et al. Fertility and 

reproduction in women with anorexia nervosa: a 

controlled study. J Clin Psychiatry 1999;2:130-5. 

55. Rigotti NA, Neer RM, Skates SJ, et al. The clinical 

course of osteoporosis in anorexia nervosa. A 

longitudinal study of cortical bone mass. J Am Med 

Assoc 1991;265(9):1133-8. 

56. Szmukler GI, Brown SW, Parsons V, et al. Premature 

loss of bone in chronic anorexia nervosa. Br Med J 

(Clin Res Ed) 1985;290(6461):26-7. 

57. Gendall K, Bulik C. The long term biological 

consequences of anorexia nervosa. Current Nutrition 

and Food Science in press. 

58. American Psychiatric Association Work Group on 

Eating Disorders. Practice guideline for the treatment 

of patients with eating disorders (revision). Am J 

Psychiatry 2000;157(1 Suppl):1-39. 

59. NICE. http://www.nice.org.uk/page.aspx?o=101239. 

National Institute for Clinical Excellence; 2004. 

60. Golden N, Katzman D, Kreipe R, et al. Eating 

disorders in adolescents: position paper of the Society 

for Adolescent Medicine. J Adolesc Health 

2003;33:496-503. 

61. American Academy of Pediatrics. Identifying and 

treating eating disorders. Pediatrics 2003;111:204-11. 

62. Beumont P, Hay P, Beumont D, et al. Royal 

Australian and New Zealand clinical practice 

guidelines for the treatment of anorexia nervosa. Aust 

N Z J Psychiatry 2004;38(9):659-70. 

63. Striegel-Moore RH, Leslie D, Petrill SA, et al. Oneyear use and cost of inpatient and outpatient services 

among female and male patients with an eating 

disorder: evidence from a national database of health 

insurance claims. Int J Eat Disord 2000;27(4):381-9. 

64. McKenzie JM, Joyce PR. Hospitalization for anorexia 

nervosa. Int J Eat Disord 1992;11:235-41. 

65. Matthias R. Care provision for patients with eating 

disorders in Europe: What patients get treatment 

where? Eur Eat Disord Rev 2005;13:159-68. 

66. Agras W, Brandt H, Bulik C, et al. Report of the 

National Institutes of Health Workshop on 

Overcoming Barriers to Treatment Research in 

Anorexia Nervosa. Int J Eat Disord 2004;35: 509-21. 

67. Anderson C, Bulik C. Gender differences in 

compensatory behaviors, weight and shape salience, 

and drive for thinness. Eating Behaviors 2003. 

68. Lewinsohn P, Seeley J, Moerk K, et al. Gender 

differences in eating disorder symptoms in young 

adults. Int J Eat Disord 2002;32:426-40. 

69. Woodside DB, Garfinkel PE, Lin E, et al. 

Comparisons of men with full or partial eating 

disorders, men without eating disorders, and women 

with eating disorders in the community. Am J 

Psychiatry 2001;158(4):570-4. 

70. Fichter MM, Quadflieg N. Six-year course of bulimia 

nervosa. Int J Eat Disord 1997;22(4):361-84. 

71. Braun DL, Sunday SR, Halmi KA. Psychiatric 

comorbidity in patients with eating disorders. Psychol 

Med 1994;24:859-67. 

72. Brewerton T, Lydiard R, Herzog D, et al. Comorbidity 

of Axis I psychiatric disorders in bulimia nervosa. J 

Clin Psychiatry 1995;56:77-80. 

73. Bulik C, Sullivan P, Joyce P, et al. Lifetime 

comorbidity of alcohol dependence in women with 

bulimia nervosa. Addict Behav 1997;22:437-46. 

74. Bushnell JA, Wells E, McKenzie JM, et al. Bulimia 

comorbidity in the general population and in the 

clinic. Psychol Med 1994;24:605-11. 

75. Herzog DB, Keller MB, Sacks NR, et al. Psychiatric 

comorbidity in treatment-seeking anorexics and 

bulimics. J Am Acad Child Adolesc Psychiatry 

1992;31(5):810-8. 

76. Perez M, Joiner TJ, Lewinsohn P. Is major depressive 

disorder or dysthymia more strongly associated with 

bulimia nervosa? Int J Eat Disord 2004;36:55-61. 

77. Bulik C, Klump K, Thornton L, et al. Alcohol use 

disorder comorbidity in eating disorders: a multicenter 

study. J Clin Psychiatry 2004;65:1000-6. 

78. Bulik C, Sullivan P, Carter F, et al. Temperament, 

character, and personality disorder in bulimia nervosa. 

J Nerv Ment Dis 1995;183:593-8. 

79. Fassino S, Amianto F, Gramaglia C, et al. 

Temperament and character in eating disorders: ten 

years of studies. Eat Weight Disord 2004;9:81-90. 

80. Steiger H, Gauvin L, Israël M, et al. Serotonin 

function, personality-trait variations, and childhood 

abuse in women with bulimia-spectrum eating 

disorders. J Clin Psychiatry 2004;65:830-7. 

81. Bulik C, Sullivan P, Kendler K. Heritability of bingeeating and broadly defined bulimia nervosa. Biol 

Psychiatry 1998;44(12):1210-8. 
154 

82. Wade T, Neale MC, Lake RIE, et al. A genetic 

analysis of the eating and attitudes associated with 

bulimia nervosa: Dealing with the problem of 

ascertainment. Behav Gen 1999;29:1-10. 

83. Bulik CM, Devlin B, Bacanu SA, et al. Significant 

linkage on chromosome 10p in families with bulimia 

nervosa. Am J Hum Genet 2003;72(1):200-7. 

84. Frank G, Bailer U, Henry S, et al. Neuroimaging 

studies in eating disorders. CNS Spectr 2004;9:539-

48. 

85. Walsh B, Devlin M. Eating disorders: progress and 

problems. Science 1998;280:1387-90. 

86. Mitchell J, Specker S, De Zwaan M. Comorbidity and 

medical complications of bulimia nervosa. J Clin 

Psychiatry 1991;52:13-20. 

87. Lasater L, Mehler P. Medical complications of 

bulimia nervosa. Eat Behav 2001;2:279-92. 

88. Fairburn C, Walsh B. Atypical eating disorders (eating 

disorders not otherwise specified). Fairburn C, 

Brownell K. Eating disorders and obesity: a 

comprehensive handbook. 2nd edition. New York: 

Guilford Press;2002:171-7. 

89. Turner H, Bryant-Waugh R. Eating disorders not 

otherwise specified (EDNOS): profiles of clients 

presenting at a community eating disorders service. 

Eur Eat Disord Rev 2003;12:18-26. 

90. Stunkard AJ. Eating patterns and obesity. Psychiat 

Quarterly 1959;33:284-95. 

91. Walsh B. Diagnostic criteria for eating disorders in 

DSM-IV: Work in progress. Int J Eat Disord 

1992;11:301-4. 

92. Spitzer RL, Yanovski S, Wadden T, et al. Binge eating 

disorders: its further validation in a multisite study. Int 

J Eat Disord 1993;13(2):137-53. 

93. Spitzer RL, Stunkard A, Yanovski S, et al. Binge 

eating disorder should be included in DSM- IV: A 

reply to Fairburn et al.'s " The classification of 

recurrent overeating: the binge eating disorder 

proposal". Int J Eat Disord 1993;13(2):161-9. 

94. Fairburn CG, Welch SL, Hay PJ. The classifaction of 

recurrent overeating: The "binge eating disorder" 

proposal. Int J Eat Disord 1993;13(2):155-9. 

95. Garfinkel P, Lin E, Goering P, et al. Bulimia nervosa 

in a Canadian community sample: prevalence and 

comparison of subgroups. Am J Psychiatry 

1995;152:1052-8. 

96. Sullivan PF, Bulik CM, Kendler KS. The 

epidemiology and classification of bulimia nervosa. 

Psychol Med 1998;28:599-610. 

97. Hay P. The epidemiology of eating disorder behaviors: 

An Australian community-based survey. Int J Eat 

Disord 1998;23:371-82. 

98. Basdevant A, Pouillon M, Lahlou N, et al. Prevalence 

of binge eating disorder in different populations of 

french women. Int J Eat Disord 1995;18:309-15. 

99. Spitzer RL, Devlin M, Walsh TB, et al. Binge eating 

disorder: A multisite field trail of the diagnostic 

criteria. Int J Eat Disord 1992;11(3):191-203. 

100. Bruce B, Agras WS. Binge eating in females: A 

population-based investigation. Int J Eat Disord 

1992;12(4):365-73. 

101. Bruce B, Wilfley D. Binge eating among the 

overweight population: a serious and prevalent 

problem. J Am Diet Assoc 1996;96(1):58-61. 

102. Yanovski S, Nelson J, Dubbert B, et al. Association of 

binge eating disorder and psychiatric comorbidity in 

obese subjects. Am J Psychiatry 1993;150:1472-9. 

103. Langer L, Warheit G, Zimmerman R. Epidemiological 

study of problem eating behaviors and related attitudes 

in the general population. Addict Behav 1992;16:167-

73. 

104. Warheit G, Langer L, Zimmerman R, et al. Prevalence 

of bulimic behaviors and bulimia among a sample of 

the general population. Am J Epidemiol 

1993;137:569-76. 

105. Bulik C, Sullivan P, Kendler K. Medical and 

psychiatric morbidity in obese women with and 

without binge eating. Int J Eat Disord 2002;32:72-8. 

106. Fairburn CG, Doll HA, Welch SL, et al. Risk factors 

for binge eating disorder: a community-based, casecontrol study. Arch Gen Psychiatry 1998;55(5):425-

32. 

107. Hudson J, Lalonde J, Pindyck L, et al. Familial 

aggregation of binge-eating disorder. Arch Gen 

Psychiatry in press. 

108. Reichborn-Kjennerud T, Bulik C, Tambs K, et al. 

Genetic and environmental influences on binge eating 

in the absence of compensatory behaviors: a 

population-based twin study. Int J Eat Disord 

2004;36:307-14. 

109. Branson R, Potoczna N, Kral J, et al. Binge eating as a 

major phenotype of melanocortin 4 receptor gene 

mutations. N Engl J Med 2003;348:1096-103. 
155 

110. Hebebrand J, Geller F, Dempfle A, et al. Binge-eating 

episodes are not characteristic of carriers of 

melanocortin-4 receptor gene mutations. Mol 

Psychiatry 2004;9:796-800. 

111. Brody ML, Walsh BT, Devlin MJ. Binge eating 

disorder: reliability and validity of a new diagnostic 

category. J Consult Clin Psychol 1994; 62(2):381-6. 

112. de Zwaan M, Mitchell J, Seim H, et al. Eating related 

and general psychopathology in obese females with 

binge-eating disorder. Int J Eat Disord 1994;15:43-52. 

113. Wilson G. Relation of dieting and voluntary weight 

loss to psychological functioning and binge-eating. 

Ann Intern Med 1993;119:727-30. 

114. Marcus MD, Wing RR, Hopkins J. Obese binge 

eaters: affect, cognitions and response to behavioral 

weight control. J Consult Clin Psychol 1988;56:433-9. 

115. Mussell M, Mitchell J, de Zwaan M, et al. Clinical 

characteristics associated with binge eating in obese 

females: a descriptive study. Int J Obes Rel Metab 

Disord 1996;20:324-31. 

116. Fichter MM, Quadflieg N, Brandl B. Recurrent 

overeating: an empirical comparison of binge eating 

disorder, bulimia nervosa, and obesity. Int J Eat 

Disord 1993;14(1):1-16. 

117. de Zwaan M, Nutzinger D, Schoenbeck G. Binge 

eating in overweight women. Comprehen Psychiatry 

1992;33:256-61. 

118. Wonderlich SA, de Zwaan M, Mitchell JE, et al. 

Psychological and dietary treatments of binge eating 

disorder: conceptual implications. Int J Eat Disord 

2003;34 Suppl:S58-73. 

119. Carter W, Hudson J, Lalonde J, et al. Pharmacologic 

treatment of binge eating disorder. Int J Eat Disord 

2003;34 :S74-88. 

120. Lask B, Bryant-Waugh. Anorexia Nervosa and 

Related Eating Disorders in Children and 

Adolescence. Hove, East Sussex, UK: Psychology 

Press; 2000. 

121. Hansen RA, Gartlehner G, Lohr KN, et al. Efficacy 

and safety of second-generation antidepressants in the 

treatment of major depressive disorder. Ann Intern 

Med 2005;143(6):415-26. 

122. West SL, King V, Carey TS et al. Systems to Rate the 

Strength of Scientific Evidence. Evidence Report, 

Technology Assessment No. 47. Rockville, Md.: 

Agency for Healthcare Research and Quality. AHRQ 

Publication No. 02-E016;2002. 

123. Greer N, Mosser G, Logan G, et al. A practical 

approach to evidence grading. Joint Commision J Qual 

Improv 2000;26:700-12. 

124. Vandereycken W. Neuroleptics in the short-term 

treatment of anorexia nervosa. A double-blind 

placebo-controlled study with sulpiride. Br J 

Psychiatry 1984;144:288-92. 

125. Slade P, Russell G. Awareness of body dimensions in 

anorexia nervosa: cross-sectional and longitudinal 

studies. Psychol Med 1973;3(2):188-99. 

126. Deter H, Herzog W. The anorexia nervosa symptom 

score: a multidimensional tool for evaluating the 

course of anorexia nervosa. in: W. Herzog, Deter HC, 

Vandereycken W, eds. The Course of Eating 

Disorders: Long-term Follow-Up Studies of Anorexia 

and Bulimia Nervosa. New York: Springer;1992:40-

52. 

127. Parloff M, Kelman HC, Frank JD. Comfort, 

effectiveness, and self-awareness as criteria for 

improvement in psychotherapy. Am J Psychiatry 

1954; 3:343-51. 

128. Probst M, Vandereycken W, Van Coppenolle H, et al. 

Body size estimation in eating disorder patients: 

testing the video distortion method on a life-size 

screen. Behav Res Ther 1995;33(8):985-90. 

129. Beck A, Ward C, Mendelson M, et al. An inventory 

for measuring depression. Arch Gen Psychiatry 

1961;4:561-71. 

130. Spitzer RL, Yanovski SZ, Marcus MD. Binge Eating 

Clinical Interview. Pittsburgh: HaPI Record; 1994. 

131. Gormally J, Black S, Datson S, et al. The assessment 

of binge eating severity among obese persons. Addict 

Behav 1982;7:47-55. 

132. Rosen JC, Srebnik D, Salzberg E, Wendt S. 

Development of a body image avoidance 

questionnaire. Psychol Assess 1991; 3:32-7. 

133. Henderson M, Freeman CP. Bulimic Investigation 

Test Edinburgh. Br J Psychiatry 1987; 150:18-24. 

134. Derogatis L, Melisaratos N. The brief symptom 

inventory: an introductory report. Psychol Med 

1983;13(3):595-605. 

135. Cooper P, Taylor M, Copper Z, et al. The 

development and validation of the Body Shape 

Questionnaire. Int J Eat Disord 1987;6:485-94. 

136. Dowson J, Henderson L. The validity of a short 

version of the Body Shape Questionnaire. Psychiatry 

Res 2001;102(3):263-71. 
156 

137. Slade P, Dewey ME, Newton T, Brodie D, Gundi K. 

The development and preliminary validation of the 

body satisfaction scale. Psychol Health 1990; 4:213-

20. 

138. Franko D, Zuroff D, Rosenthal F. Construct validation 

of the Bulimic Thoughts Questionnaire. Society of 

Behavioral Medicine. 1986. 

139. Achenbach T. Manual for the Child Behavior 

Checklist/4-18 and 1991 Profile. Burlington, VT: 

University of Vermont, Department of Psychiatry; 

1991. 

140. Crown S, Crisp AH. Manual of the Crown-Crisp 

Experiential Index. London: Hodder and Stoughton; 

1979. 

141. Kovacs M. The Children's Depression Inventory. 

Psychopharmacol Bull 1985; 21:995-8. 

142. Thompson M, Gray JJ. Development and validation of 

a new body-image assessment scale. J Personality 

Assess 1995;64(2):258-69. 

143. Guy W. Assessment Manual for Psychopharmacology 

- Revised (DHEW Publ No ADM 76-338). 1976. 

144. Welner Z, Reich W, Herjanic B, Jung K, Amado H. 

Reliability, validity, parent-child agreement studies of 

the diagnosis interview for children and adolescents 

(DICA). J Am Acad Child Adolesc Psychiatry 1987; 

26:694-53. 

145. Schlundt D, Zimering R. The Dieter's Inventory of 

Eating Temptations: A measure of weight control 

competence. Add Behav 1988; 13(2):151-64. 

146. Johnson C. Initial consultation for patients with 

bulimia and anorexia nevosa. Garner D, Garfinkel PE. 

Handbook of Psychotherapy for Anorexia and 

Bulimia. New York: Guilford Press;1997:19-51. 

147. Garner D, Olmsted M, Bohr Y, et al. The eating 

attitudes test: psychometric features and clinical 

correlates. Psychol Med 1982;12(4):871-8. 

148. Cooper Z, Cooper PJ, Fairburn CG. The validity of the 

eating disorder examination and its subscales. Br J 

Psychiatry 1989;154:807-12. 

149. Garner D, Olmsted MP, Polivy J. Development and 

validation of a multidimensional eating disorder 

inventory for anorexia nervosa and bulimia. Int J Eat 

Disord 1983;2:15-34. 

150. Garner D. Eating Disorder Inventory-2: Professional 

Manual. Odessa, FL: Psychological Assessment 

Resources, Inc; 1991. 

151. Olson D, Sprenkle D, Russel C. Circumplex model of 

marital and family systems I: Cohesion and 

adaptability dimensions, family types and clinical 

applications. Fam Process 1979; 18:3-28. 

152. Skinner H, Steinhauer P, Santa-Barbara J. Family 

Assessment Measure - III Manual. Toronto Canada: 

Multi Health System, 1995. 

153. Moos RH, MoosBS. Family Environment Scale 

Manual. Palo Alto, CA: Consulting Psychological 

Press; 1994. 

154. Frost R, Marten PA, Lahart C, et al. The dimensions 

of perfectionism. Cognitive Therapy and Research 

1990;14:449-68. 

155. Watson D, Friend R. Measure of socio-evaluative 

anxiety. J Consult Clin Psychol 1969; 33:448-57. 

156. Watson D, Friend R. Measurement of social 

evaluative anxiety. J Consult Clin Psychol 1969; 

33:448-57. 

157. Leary M. A brief version of the Fear of Negative 

Evaluation Scale. Personality Soc Psychol 1983; 

9:371-6. 

158. Stunkard A, Sørensen T, Schlusinger F. Use of the 

Danish Adoption Register for the study of obesity and 

thinness. Res Publ Assoc Res Mental Dis 1983; 

60:115-20. 

159. Goldberg S, Halmi K, Eckert E, et al. Pretreatment 

predictors of outcome in anorexia nervosa. J 

Psychiatry Res 1980;15:239-51. 

160. Hamilton M. The assessment of anxiety states by 

rating. Br J Med Psychol 1959; 32:50-5. 

161. Hamilton M. A rating scale for depression. J Neurol 

Neurosurg Psychiatry 1960; 23:56-62. 

162. Shor R, Orne EC. The Harvard Group Scale of 

Hypnotic Susceptibility, Form A. Palo Alto, 

California: Consulting Psychological Press; 1962. 

163. Luborsky. Principles of psychoanalytic psychotherapy. 

New York: Basic Books; 1984. 

164. Robin A, Foster S. Negotiating parent adolescent 

conflict: A behavioral family systems approach. New 

York: Guilford Press; 1989. 

165. Horowitz L, Rosenberg SE, Baer BA, Ureno G, 

Vilasenor VS. Inventory of Interpersonal Problems: 

Psychometric properties and clinical applications. J 

Consult Clin Psychol 1988; 56:885-92. 
157 

166. Craig A, Franklin J, Andrews G. A scale to measure 

locus of control of behaviour. Br J Med Psychol 

1984;57:173-80. 

167. Keller M, Lavori PW, Friedman B, et al. The 

longitudinal follow-up evaluation. Arch Gen 

Psychiatry 1987;44:540-8. 

168. Millon. Millon Clinical Multiaxial Inventory manual. 

3rd edition. Minneapolis, MN: Interpretive Scoring 

Systems; 1983. 

169. Dahlstrom W, Welsh GS, Dahlstrom LE. An MMPI 

Handbook, Vol. 1 Clinical Interpretation. Rev. edition. 

Minneapolis, MN: University of Minnesota Press; 

1972. 

170. Hodgson R, Rachman SJ. Obsessional-compulsive 

complaints. Behav Res Therapy 1977; 15:389-95. 

171. Morgan HG, Russell GF. Value of family background 

and clinical features as predictors of long-term 

outcome in anorexia nervosa: four-year follow-up 

study of 41 patients. 1975. 1975:355-71. 

172. Morgan H, Hayward AE. Clinical assessment of 

anorexia nervosa: the Morgan-Russell outcome 

assessment schedule. Br J Psychiatry 1988; 152:367-

71. 

173. Vandenberg S, Kuse A. Mental rotation, a group test 

of three-dimensional spatial ability. Percept Mot Skills 

1978;47:509-604. 

174. Robin A, Koepke T, Moye A. Multidimensional 

assessment of parent-adolescent relations. Psychol 

Assess 1990; 10:451-9. 

175. Dupuy H. The Psychological General Well-Being 

(PGWB) Index. Wenger N, Mattson ME, Furberg CD, 

Elinson J, eds. Assessment of quality of life in clinical 

trials of cardiovascular therapies. New York: Le 

Jacq;1984:170-83. 

176. Wing J, Cooper JE, Startorius N. The measurement 

and classification of psychiatric symptoms. Cambridge 

University Press; 1974. 

177. Eddy K, Keel P, Dorer D, et al. Longitudinal 

comparison of anorexia nervosa subtypes. Int J Eat 

Disord 2002;31(2):191-201. 

178. Yanovski S. Binge eating disorder: Current knowledge 

and future directions. Obes Res 1993;1:306-24. 

179. Rathus S. A 30-item schedule for assessing assertive 

behavior. Behav Therap 1973; 4:398-406. 

180. Rosenberg M. Society and the Adolescent Self-Image. 

Princeton, NJ: University Press; 1965. 

181. Endicott J, Spitzer RL. A diagnostic interview: the 

schedule for affective disorders and schizophrenia. 

Arch Gen Psychiatry 1978;35:837-44. 

182. Stanton A, Garcia M, Green S. Development and 

validation of the situation appetite measures. Add 

Behav 1990; 15(5):461-72. 

183. Weissman M, Bothwell S. Assessment of social 

adjustment by patient self-report. Arch Gen Psychiatry 

1976; 33:1111-5. 

184. Kinston W, Loader P. Eliciting whole-family 

interaction and a standardized clinical interview. J 

Fam Ther 1984; 6:347-63. 

185. Shapiro DJ, Potkin SG, Jin Y, Brown B, Carreon D, 

Wu J. Measuring the psychological construct of 

control. Discriminant, divergent, and incremental 

validity of the Shapiro Control Inventory and Rotter's 

and Wallstons' Locus of Control Scales. Int J 

Psychosom 1993; 40(1-4):35-46. 

186. First M, Spitzer RL, Gibbon M, Williams JBW. The 

structured clinical interview for DSM-IV Axis I 

Disorders. New York: State Psychiatric Institute, 

Biometrics Research Department; 1994. 

187. Zung W. A self-rating depression scale. Arch Gen 

Psychiatry 1965;12:63-70. 

188. Ware J, Snow K, Kosinski M, Gandek B. SF-36 

Health Survey: Manual and Interpretation Guide. 

1993. 

189. Fichter M, Elton M, Engel K, et al. Structured 

interview for anorexia and bulimia nervosa (SIAB): 

development of a new instrument for the assessment 

of eating disorders. Int J Eat Disord 1991;10:571-92. 

190. Angold A, Costello E, Messer S, et al. The 

development of a short questionnaire for use in 

epidemiological studies of depression in children and 

adolescents. Int J Meth Psychiat Res 1995;5:237-49. 

191. McConnaughy E, Prochaska J, Velicer W. Stages of 

change in psychotherapy: Measurement and sample 

profiles. Psychother: Theory Res Pract 

1983;20(3):368-75. 

192. Rosenthal N, Bradt TH, Wehr TA. Seasonal Pattern 

Assessment Questionnaire. Washington DC: National 

Institute of Mental Health; 1987. 

193. Spielberger C, Gorsuch R, Lushene R. Manual for the 

state-trait anxiety inventory. Palo Alto, CA: 

Consulting Psychologists Press; 1970. 
158 

194. Spielberger C. State-Trait Anger Expression 

Inventory. Tampa, FL: Psychological Assessment 

Resources, Inc., 1988. 

195. Wolpe J. Psychotherapy by reciprocal inhibition. 

Stanford, CA: Stanford University Press; 1958. 

196. Bagby M, Parker J, Taylor G. The twenty-item 

Toronto Alexithymia Scale - I. Item selection and 

cross-validation of the factor structure. J Psychosom 

Res 1994;38:23-32. 

197. Cloninger C, Svrakic DM, Przybeck TR. A 

psychobiological model of temperament and character. 

Arch Gen Psychiatry 1993;50(12):975-90. 

198. Stunkard A, Messick S. The three-factor eating 

questionnaire to measure dietary restraint, 

disinhibition and hunger. J Psychosom Res 1985; 

29:71-83. 

199. Wechsler D. Manual for the Wechsler Adult 

Intelligence Scale (WAIS). New York: Psychological 

Corporation, 1955. 

200. Clark M, Abrams D, Niaura RS. Self-efficacy in 

weight management. J Consult Clin Psychol 

1991;59:739. 

201. Boath E, Pryce A, Cox J. Social adjustment in 

childbearing women: the modified Work Leisure and 

Family Life Questionnaire. J Reproduct Infant Psychol 

1995;13(3-4):211-8. 

202. Sunday S, Halmi KA, Einhorn A. The Yale-BrownCornell Eating Disorder Scale: A new scale to assess 

eating disorders symptomatology. Int J Eat Disord 

1995; 18(3):237-45. 

203. McElroy SL, Arnold LM, Shapira NA, et al. 

Topirmate in the treatment of binge eating disorder 

associated with obesity: a randomized placebocontrolled trial. Am J Psychiatry 2003;160(2):255-61. 

204. Goodman W, Price L, Rasmussen S, et al. The YaleBrown Obsessive Compulsive Scale (Y-BOCS). Arch 

Gen Psychiatry 1989;46:1006-11. 

205. Achenbach T. Manual for the young adult self report 

and young adult behavior checklist. Burlington, VT: 

University of Vermont; 1997. 

206. Attia E, Haiman C, Walsh BT, et al. Does fluoxetine 

augment the inpatient treatment of anorexia nervosa? 

Am J Psychiatry 1998;155(4):548-51. 

207. Kaye WH, Nagata T, Weltzin TE, et al. Double-blind 

placebo-controlled administration of fluoxetine in 

restricting- and restricting-purging-type anorexia 

nervosa. Biol Psychiatry 2001;49(7):644-52. 

208. Halmi KA, Eckert E, LaDu TJ, et al. Anorexia 

nervosa. Treatment efficacy of cyproheptadine and 

amitriptyline. Arch Gen Psychiatry 1986;43(2):177-

81. 

209. Biederman J, Herzog DB, Rivinus TM, et al. 

Amitriptyline in the treatment of anorexia nervosa: a 

double-blind, placebo-controlled study. J Clin 

Psychopharmacol 1985;5(1):10-6. 

210. Klibanski A, Biller BM, Schoenfeld DA, et al. The 

effects of estrogen administration on trabecular bone 

loss in young women with anorexia nervosa. J Clin 

Endocrinol Metab 1995;80(3):898-904. 

211. Miller KK, Grieco KA, Klibanski A. Testosterone 

administration in women with anorexia nervosa. J Clin 

Endocrinol Metab 2005;90(3):1428-33. 

212. Hill K, Bucuvalas J, McClain C, et al. Pilot study of 

growth hormone administration during the refeeding 

of malnourished anorexia nervosa patients. J Child 

Adolesc Psychopharmacol 2000;10(1):3-8. 

213. Birmingham CL, Goldner EM, Bakan R. Controlled 

trial of zinc supplementation in anorexia nervosa. Int J 

Eat Disord 1994;15(3):251-5. 

214. Barbarich NC, McConaha CW, Halmi KA, et al. Use 

of nutritional supplements to increase the efficacy of 

fluoxetine in the treatment of anorexia nervosa. Int J 

Eat Disord 2004;35(1):10-5. 

215. Ruggiero GM, Laini V, Mauri MC, et al. A single 

blind comparison of amisulpride, fluoxetine and 

clomipramine in the treatment of restricting 

anorectics. Prog Neuropsychopharmacol Biol 

Psychiatry 2001;25(5):1049-59. 

216. Brambilla F, Draisci A, Peirone A, et al. Combined 

cognitive-behavioral, psychopharmacological and 

nutritional therapy in eating disorders. 2. Anorexia 

nervosa--binge-eating/purging type. 

Neuropsychobiology 1995;32(2):64-7. 

217. Fassino S, Leombruni P, Daga G, et al. Efficacy of 

citalopram in anorexia nervosa: a pilot study. Eur 

Neuropsychopharmacol 2002;12(5):453-9. 

218. Szmukler GI, Young GP, Miller G, et al. A controlled 

trial of cisapride in anorexia nervosa. Int J Eat Disord 

1995;17(4):347-57. 

219. Ricca V, Mannucci E, Paionni A, et al. Venlafaxine 

versus fluoxetine in the treatment of atypical anorectic 

outpatients: a preliminary study. Eat Weight Disord 

1999;4(1):10-4. 
159 

220. Birmingham CL, Gutierrez E, Jonat L, et al. 

Randomized controlled trial of warming in anorexia 

nervosa. Int J Eat Disord 2004;35(2):234-8. 

221. Eisler I, Dare C, Hodes M, et al. Family therapy for 

adolescent anorexia nervosa: the results of a controlled 

comparison of two family interventions. J Child 

Psychol Psychiatry 2000;41(6):727-36. 

222. Lock J, Agras WS, Bryson S, et al. A comparison of 

short- and long-term family therapy for adolescent 

anorexia nervosa. J Am Acad Child Adolesc 

Psychiatry 2005;44(7):632-9. 

223. Pike KM, Walsh BT, Vitousek K, et al. Cognitive 

behavior therapy in the posthospitalization treatment 

of anorexia nervosa. Am J Psychiatry 

2003;160(11):2046-9. 

224. McIntosh VV, Jordan J, Carter FA, et al. Three 

psychotherapies for anorexia nervosa: a randomized, 

controlled trial. Am J Psychiatry 2005;162(4):741-7. 

225. Channon S, de Silva P, Hemsley D, et al. A controlled 

trial of cognitive-behavioural and behavioural 

treatment of anorexia nervosa. Behav Res Ther 

1989;27(5):529-35. 

226. Treasure J, Todd G, Brolly M, et al. A pilot study of a 

randomised trial of cognitive analytical therapy vs 

educational behavioral therapy for adult anorexia 

nervosa. Behav Res Ther 1995;33(4):363-7. 

227. Crisp AH, Norton K, Gowers S, et al. A controlled 

study of the effect of therapies aimed at adolescent 

and family psychopathology in anorexia nervosa. Br J 

Psychiatry 1991;159:325-33. 

228. Dare C, Eisler I, Russell G, et al. Psychological 

therapies for adults with anorexia nervosa: randomised 

controlled trial of out-patient treatments. Br J 

Psychiatry 2001;178:216-21. 

229. Geist R, Heinmaa M, Stephens D, et al. Comparison 

of family therapy and family group psychoeducation 

in adolescents with anorexia nervosa. Can J Psychiatry 

2000;45(2):173-8. 

230. Robin AL, Siegel PT, Koepke T, et al. Family therapy 

versus individual therapy for adolescent females with 

anorexia nervosa. J Dev Behav Pediatr 

1994;15(2):111-6. 

231. Russell GF, Szmukler GI, Dare C, et al. An evaluation 

of family therapy in anorexia nervosa and bulimia 

nervosa. Arch Gen Psychiatry 1987;44(12):1047-56. 

232. Hall A, Crisp AH. Brief psychotherapy in the 

treatment of anorexia nervosa. Outcome at one year. 

Br J Psychiatry 1987;151:185-91. 

233. Pillay M, Crisp AH. The impact of social skills 

training within an established in-patient treatment 

programme for anorexia nervosa. Br J Psychiatry 

1981;139:533-9. 

234. Thien V, Thomas A, Markin D, et al. Pilot study of a 

graded exercise program for the treatment of anorexia 

nervosa. Int J Eat Disord 2000;28(1):101-6. 

235. le Grange D, Eisler I, Dare C, et al. Evaluation of 

family treatments in adolescent anorexia nervosa: a 

pilot study. Int J Eat Disord 1992;12(4):347-57. 

236. Robin AL, Siegel PT, Moye AW, et al. A controlled 

comparison of family versus individual therapy for 

adolescents with anorexia nervosa. J Am Acad Child 

Adolesc Psychiatry 1999;38(12):1482-9. 

237. Robin AL, Siegel PT, Moye A. Family versus 

individual therapy for anorexia: impact on family 

conflict. Int J Eat Disord 1995;17(4):313-22. 

238. Gowers S, Norton K, Halek C, et al. Outcome of 

outpatient psychotherapy in a random allocation 

treatment study of anorexia nervosa. Int J Eat Disord 

1994;15(2):165-77. 

239. Eisler I, Dare C, Russell G, et al. Family and 

individual therapy in anorexia nervosa. A 5-year 

follow-up. Arch Gen Psychiatry 1997;54(11):1025-30. 

240. Klerman G, Weissman M, Rounsaville B, Chevron E. 

Interpersonal Psychotherapy of Depression. New 

York, NY: Basic Books, Inc.; 1984. 

241. Fairburn CG. Interpersonal psychotherapy for bulimia 

nervosa. In: Klerman G, Weissman M, editors. New 

Applications of Interpersonal Psychotherapy. 

Washington, DC: American Psychiatric 

Press;1993:355-78. 

242. Lock J, le Grange D, Agras W, Dare C. Treatment 

manual for anorexia nervosa: A family-based 

approach. New York: Guilford Press; 2001. 

243. Gartlehner G, Hansen RA, Kahwati L et al. Drug class 

review on second generation antidepressants: Updated 

report. Chapel Hill, NC: Prepared by RTI-UNC 

Evidence-based Practice Center for The Agency for 

Healthcare Research and Quality;2005. 

244. Beumont PJ, Russell JD, Touyz SW, et al. Intensive 

nutritional counselling in bulimia nervosa: a role for 

supplementation with fluoxetine? Aust N Z J 

Psychiatry 1997;31(4):514-24. 

245. Carruba MO, Cuzzolaro M, Riva L, et al. Efficacy and 

tolerability of moclobemide in bulimia nervosa: a 

placebo-controlled trial. Int Clin Psychopharmacol 

2001;16(1):27-32. 
160 

246. Faris PL, Kim SW, Meller WH, et al. Effect of 

decreasing afferent vagal activity with ondansetron on 

symptoms of bulimia nervosa: a randomised, doubleblind trial. Lancet 2000;355(9206):792-7. 

247. Fichter MM, Kruger R, Rief W, et al. Fluvoxamine in 

prevention of relapse in bulimia nervosa: effects on 

eating-specific psychopathology. J Clin 

Psychopharmacol 1996;16(1):9-18. 

248. Fichter MM, Leibl K, Rief W, et al. Fluoxetine versus 

placebo: a double-blind study with bulimic inpatients 

undergoing intensive psychotherapy. 

Pharmacopsychiatry 1991;24(1):1-7. 

249. Fluoxetine Bulimia Nervosa Collaborative Study 

Group. Fluoxetine in the treatment of bulimia nervosa. 

A multicenter, placebo-controlled, double-blind trial. 

Fluoxetine Bulimia Nervosa Collaborative Study 

Group. Arch Gen Psychiatry 1992;49(2):139-47. 

250. Goldstein DJ, Wilson MG, Thompson VL, et al. Longterm fluoxetine treatment of bulimia nervosa. 

Fluoxetine Bulimia Nervosa Research Group. Br J 

Psychiatry 1995;166(5):660-6. 

251. Hoopes SP, Reimherr FW, Hedges DW, et al. 

Treatment of bulimia nervosa with topiramate in a 

randomized, double-blind, placebo-controlled trial, 

part 1: improvement in binge and purge measures. J 

Clin Psychiatry 2003;64(11):1335-41. 

252. Kanerva R, Rissanen A, Sarna S. Fluoxetine in the 

treatment of anxiety, depressive symptoms, and 

eating-related symptoms in bulimia nervosa. Nord J 

Psychiatry 1994;49(7):237-42. 

253. Kennedy SH, Goldbloom DS, Ralevski E, et al. Is 

there a role for selective monoamine oxidase inhibitor 

therapy in bulimia nervosa? A placebo-controlled trial 

of brofaromine. J Clin Psychopharmacol 

1993;13(6):415-22. 

254. Romano SJ, Halmi KA, Sarkar NP, et al. A placebocontrolled study of fluoxetine in continued treatment 

of bulimia nervosa after successful acute fluoxetine 

treatment. Am J Psychiatry 2002;159(1):96-102. 

255. Pope HGJr, Keck PEJr, McElroy SL, et al. A placebocontrolled study of trazodone in bulimia nervosa. J 

Clin Psychopharmacol 1989;9(4):254-9. 

256. Sundblad C, Landen M, Eriksson T, et al. Effects of 

the androgen antagonist flutamide and the serotonin 

reuptake inhibitor citalopram in bulimia nervosa: a 

placebo-controlled pilot study. J Clin 

Psychopharmacol 2005;25(1):85-8. 

257. Walsh BT, Hadigan CM, Devlin MJ, et al. Long-term 

outcome of antidepressant treatment for bulimia 

nervosa. Am J Psychiatry 1991;148(9):1206-12. 

258. Goldstein DJ, Wilson MG, Ascroft RC, et al. 

Effectiveness of fluoxetine therapy in bulimia nervosa 

regardless of comorbid depression. Int J Eat Disord 

1999;25(1):19-27. 

259. Hedges DW, Reimherr FW, Hoopes SP, et al. 

Treatment of bulimia nervosa with topiramate in a 

randomized, double-blind, placebo-controlled trial, 

part 2: improvement in psychiatric measures. J Clin 

Psychiatry 2003;64(12):1449-54. 

260. Agras WS, Rossiter EM, Arnow B, et al. 

Pharmacologic and cognitive-behavioral treatment for 

bulimia nervosa: a controlled comparison. Am J 

Psychiatry 1992;149(1):82-7. 

261. Goldbloom DS, Olmsted M, Davis R, et al. A 

randomized controlled trial of fluoxetine and cognitive 

behavioral therapy for bulimia nervosa: short-term 

outcome. Behav Res Ther 1997;35(9):803-11. 

262. Mitchell JE, Fletcher L, Hanson K, et al. The relative 

efficacy of fluoxetine and manual-based self-help in 

the treatment of outpatients with bulimia nervosa. J 

Clin Psychopharmacol 2001;21(3):298-304. 

263. Mitchell JE, Halmi K, Wilson GT, et al. A randomized 

secondary treatment study of women with bulimia 

nervosa who fail to respond to CBT. Int J Eat Disord 

2002;32(3):271-81. 

264. Walsh BT, Wilson GT, Loeb KL, et al. Medication 

and psychotherapy in the treatment of bulimia 

nervosa. Am J Psychiatry 1997;154(4):523-31. 

265. Walsh BT, Fairburn CG, Mickley D, et al. Treatment 

of bulimia nervosa in a primary care setting. Am J 

Psychiatry 2004;161(3):556-61. 

266. Agras WS, Schneider JA, Arnow B, et al. Cognitivebehavioral and response-prevention treatments for 

bulimia nervosa. J Consult Clin Psychol 

1989;57(2):215-21. 

267. Fairburn CG, Jones R, Peveler RC, et al. 

Psychotherapy and bulimia nervosa. Longer-term 

effects of interpersonal psychotherapy, behavior 

therapy, and cognitive behavior therapy. Arch Gen 

Psychiatry 1993;50(6):419-28. 

268. Wolk SL, Devlin MJ. Stage of change as a predictor of 

response to psychotherapy for bulimia nervosa. Int J 

Eat Disord 2001;30(1):96-100. 

269. Agras WS, Walsh T, Fairburn CG, et al. A multicenter 

comparison of cognitive-behavioral therapy and 
161 

interpersonal psychotherapy for bulimia nervosa. Arch 

Gen Psychiatry 2000;57(5):459-66. 

270. Bulik CM, Sullivan PF, Carter FA, et al. The role of 

exposure with response prevention in the cognitivebehavioural therapy for bulimia nervosa. Psychol Med 

1998;28(3):611-23. 

271. Bulik CM, Sullivan PF, Joyce PR, et al. Predictors of 

1-year treatment outcome in bulimia nervosa. Compr 

Psychiatry 1998;39(4):206-14. 

272. Carter FA, McIntosh VV, Joyce PR, et al. Role of 

exposure with response prevention in cognitivebehavioral therapy for bulimia nervosa: three-year 

follow-up results. Int J Eat Disord 2003;33(2):127-35. 

273. Chen E, Touyz SW, Beumont PJ, et al. Comparison of 

group and individual cognitive-behavioral therapy for 

patients with bulimia nervosa. Int J Eat Disord 

2003;33(3):241-54; discussion 255-6. 

274. Cooper PJ, Steere J. A comparison of two 

psychological treatments for bulimia nervosa: 

implications for models of maintenance. Behav Res 

Ther 1995;33(8):875-85. 

275. Davis R, McVey G, Heinmaa M, et al. Sequencing of 

cognitive-behavioral treatments for bulimia nervosa. 

Int J Eat Disord 1999;25(4):361-74. 

276. Fairburn C, Jones R, Peveler R, et al. Three 

psychological treatments for bulimia nervosa. A 

comparative trial. Arch Gen Psychiatry 

1991;48(5):463-9. 

277. Fairburn C, Peveler R, Jones R, et al. Predictors of 12-

month outcome in bulimia nervosa and the influence 

of attitudes to shape and weight. J Consult Clin 

Psychol 1993;61(4):696-8. 

278. Garner DM, Rockert W, Davis R, et al. Comparison of 

cognitive-behavioral and supportive-expressive 

therapy for bulimia nervosa. Am J Psychiatry 

1993;150(1):37-46. 

279. Griffiths RA, Hadzi-Pavlovic D, Channon-Little L. A 

controlled evaluation of hypnobehavioural treatment 

for bulimia nervosa: immediate pre-post treatment 

effects. Eur Eat Disord Rev 1994;2(4):202-20. 

280. Hsu LK, Rand W, Sullivan S, et al. Cognitive therapy, 

nutritional therapy and their combination in the 

treatment of bulimia nervosa. Psychol Med 

2001;31(5):871-9. 

281. Laessle RG, Beumont PJ, Butow P, et al. A 

comparison of nutritional management with stress 

management in the treatment of bulimia nervosa. Br J 

Psychiatry 1991;159:250-61. 

282. Safer DL, Telch CF, Agras WS. Dialectical behavior 

therapy for bulimia nervosa. Am J Psychiatry 

2001;158(4):632-4. 

283. Sundgot-Borgen J, Rosenvinge JH, Bahr R, et al. The 

effect of exercise, cognitive therapy, and nutritional 

counseling in treating bulimia nervosa. Med Sci Sports 

Exerc 2002;34(2): 190-5. 

284. Thackwray DE, Smith MC, Bodfish JW, et al. A 

comparison of behavioral and cognitive-behavioral 

interventions for bulimia nervosa. J Consult Clin 

Psychol 1993;61(4):639-45. 

285. Treasure JL, Katzman M, Schmidt U, et al. 

Engagement and outcome in the treatment of bulimia 

nervosa: first phase of a sequential design comparing 

motivation enhancement therapy and cognitive 

behavioural therapy. Behav Res Ther 1999;37(5):405-

18. 

286. Ventura M, Bauer B. Empowerment of women with 

purging-type bulimia nervosa through nutritional 

rehabilitation. Eat Weight Disord 1999;4(2):55-62. 

287. Wilfley DE, Agras WS, Telch CF, et al. Group 

cognitive-behavioral therapy and group interpersonal 

psychotherapy for the nonpurging bulimic individual: 

a controlled comparison. J Consult Clin Psychol 

1993;61(2):296-305. 

288. Wilson GT, Fairburn CC, Agras WS, et al. Cognitivebehavioral therapy for bulimia nervosa: time course 

and mechanisms of change. J Consult Clin Psychol 

2002;70(2):267-74. 

289. Crosby RD, Mitchell JE, Raymond N, et al. Survival 

analysis of response to group psychotherapy in 

bulimia nervosa. Int J Eat Disord 1993;13(4):359-68. 

290. Bailer U, de Zwaan M, Leisch F, et al. Guided selfhelp versus cognitive-behavioral group therapy in the 

treatment of bulimia nervosa. Int J Eat Disord 

2004;35(4):522-37. 

291. Carter JC, Olmsted MP, Kaplan AS, et al. Self-help 

for bulimia nervosa: a randomized controlled trial. Am 

J Psychiatry 2003;160(5):973-8. 

292. Durand MA, King M. Specialist treatment versus selfhelp for bulimia nervosa: a randomised controlled trial 

in general practice. Br J Gen Pract 2003;53(490):371-

7. 

293. Thiels C, Schmidt U, Treasure J, et al. Guided selfchange for bulimia nervosa incorporating use of a selfcare manual. Am J Psychiatry 1998;155(7):947-53. 
162 

294. Treasure J, Schmidt U, Troop N, et al. Sequential 

treatment for bulimia nervosa incorporating a self-care 

manual. Br J Psychiatry 1996;168(1):94-8. 

295. Braun DL, Sunday SR, Fornari VM, et al. Bright light 

therapy decreases winter binge frequency in women 

with bulimia nervosa: a double-blind, placebocontrolled study. Compr Psychiatry 1999;40(6):442-8. 

296. Esplen MJ, Garfinkel PE, Olmsted M, et al. A 

randomized controlled trial of guided imagery in 

bulimia nervosa. Psychol Med 1998;28(6):1347-57. 

297. Mitchell JE, Agras WS, Wilson GT, et al. A trial of a 

relapse prevention strategy in women with bulimia 

nervosa who respond to cognitive-behavior therapy. 

Int J Eat Disord 2004;35(4):549-55. 

298. Turnbull SJ, Schmidt U, Troop NA, et al. Predictors of 

outcome for two treatments for bulimia nervosa: short 

and long-term. Int J Eat Disord 1997;21(1):17-22. 

299. Fichter MM, Leibl C, Kruger R, et al. Effects of 

fluvoxamine on depression, anxiety, and other areas of 

general psychopathology in bulimia nervosa. 

Pharmacopsychiatry 1997;30(3):85-92. 

300. Agras WS, Rossiter EM, Arnow B, et al. One-year 

follow-up of psychosocial and pharmacologic 

treatments for bulimia nervosa. J Clin Psychiatry 

1994;55(5):179-83. 

301. Wilson GT, Loeb KL, Walsh BT, et al. Psychological 

versus pharmacological treatments of bulimia nervosa: 

predictors and processes of change. J Consult Clin 

Psychol 1999;67(4):451-9. 

302. Fairburn CG. Overcoming Binge Eating. New York: 

Guilford; 1995. 

303. Cooper P. Bulimia nervosa: a guide to recovery. 

London: Robinson; 1993. 

304. Esplen M, Garfinkel PE. Guided imagery treatment to 

promote self-soothing in bulimia nervos: a theoretical 

rationale. J Psychother Pract Res 1998;7:102-18. 

305. Arnold LM, McElroy SL, Hudson JI, et al. A placebocontrolled, randomized trial of fluoxetine in the 

treatment of binge-eating disorder. J Clin Psychiatry 

2002;63(11):1028-33. 

306. Hudson JI, McElroy SL, Raymond NC, et al. 

Fluvoxamine in the treatment of binge-eating disorder: 

a multicenter placebo-controlled, double-blind trial. 

Am J Psychiatry 1998;155(12):1756-62. 

307. Pearlstein T, Spurell E, Hohlstein LA, et al. A doubleblind, placebo-controlled trial of fluvoxamine in binge 

eating disorder: a high placebo response. Arch Women 

Ment Health 2003;6(2):147-51. 

308. McElroy SL, Hudson JI, Malhotra S, et al. Citalopram 

in the treatment of binge-eating disorder: a placebocontrolled trial. J Clin Psychiatry 2003;64(7):807-13. 

309. McElroy SL, Casuto LS, Nelson EB, et al. Placebocontrolled trial of sertraline in the treatment of binge 

eating disorder. Am J Psychiatry 2000;157(6):1004-6. 

310. Laederach-Hofmann K, Graf C, Horber F, et al. 

Imipramine and diet counseling with psychological 

support in the treatment of obese binge eaters: a 

randomized, placebo-controlled double-blind study. 

Int J Eat Disord 1999;26(3):231-44. 

311. McElroy SL, Arnold LM, Shapira NA, et al. 

Topiramate in the treatment of binge eating disorder 

associated with obesity: a randomized, placebocontrolled trial. Am J Psychiatry 2003;160(2):255-61. 

312. Appolinario JC, Bacaltchuk J, Sichieri R, et al. A 

randomized, double-blind, placebo-controlled study of 

sibutramine in the treatment of binge-eating disorder. 

Arch Gen Psychiatry 2003;60(11):1109-16. 

313. Stunkard A, Berkowitz R, Tanrikut C, et al. dfenfluramine treatment of binge eating disorder. Am J 

Psychiatry 1996;153(11):1455-9. 

314. Ricca V, Mannucci E, Mezzani B, et al. Fluoxetine 

and fluvoxamine combined with individual cognitivebehaviour therapy in binge eating disorder: a one-year 

follow-up study. Psychother Psychosom 

2001;70(6):298-306. 

315. Grilo CM, Masheb RM, Wilson GT. Efficacy of 

cognitive behavioral therapy and fluoxetine for the 

treatment of binge eating disorder: a randomized 

double-blind placebo-controlled comparison. Biol 

Psychiatry 2005;57(3):301-9. 

316. Agras WS, Telch CF, Arnow B, et al. Weight loss, 

cognitive-behavioral, and desipramine treatments in 

binge eating disorder: an additive design. Behavior 

Therapy 1994;25:225-38. 

317. Grilo CM, Masheb RM, Salant SL. Cognitive 

behavioral therapy guided self-help and orlistat for the 

treatment of binge eating disorder: a randomized, 

double-blind, placebo-controlled trial. Biol Psychiatry 

2005;57(10): 1193-201. 

318. Wilfley DE, Welch RR, Stein RI, et al. A randomized 

comparison of group cognitive-behavioral therapy and 

group interpersonal psychotherapy for the treatment of 

overweight individuals with binge-eating disorder. 

Arch Gen Psychiatry 2002;59(8):713-21. 
163 

319. Hilbert A, Tuschen-Caffier B. Body image 

interventions in cognitive-behavioural therapy of 

binge-eating disorder: a component analysis. Behav 

Res Ther 2004;42(11):1325-39. 

320. Gorin A, Le Grange D, Stone A. Effectiveness of 

spouse involvement in cognitive behavioral therapy 

for binge eating disorder. Int J Eat Disord 

2003;33(4):421-33. 

321. Telch CF, Agras WS, Linehan MM. Dialectical 

behavior therapy for binge eating disorder. J Consult 

Clin Psychol 2001;69(6):1061-5. 

322. Agras WS, Telch CF, Arnow B, et al. Does 

interpersonal therapy help patients with binge eating 

disorder who fail to respond to cognitive-behavioral 

therapy? J Consult Clin Psychol 1995;63(3):356-60. 

323. Eldredge KL, Stewart Agras W, Arnow B, et al. The 

effects of extending cognitive-behavioral therapy for 

binge eating disorder among initial treatment 

nonresponders. Int J Eat Disord 1997;21(4):347-52. 

324. Pendleton VR, Goodrick GK, Poston WS, et al. 

Exercise augments the effects of cognitive-behavioral 

therapy in the treatment of binge eating. Int J Eat 

Disord 2002;31(2):172-84. 

325. Riva G, Bacchetta M, Cesa G, et al. Six-month followup of in-patient experiential cognitive therapy for 

binge eating disorders. Cyberpsychol Behav 

2003;6(3):251-8. 

326. Carter JC, Fairburn CG. Cognitive-behavioral selfhelp for binge eating disorder: a controlled 

effectiveness study. J Consult Clin Psychol 

1998;66(4):616-23. 

327. Peterson CB, Mitchell JE, Engbloom S, et al. Self-help 

versus therapist-led group cognitive-behavioral 

treatment of binge eating disorder at follow-up. Int J 

Eat Disord 2001;30(4):363-74. 

328. Peterson CB, Mitchell JE, Engbloom S, et al. Group 

cognitive-behavioral treatment of binge eating 

disorder: a comparison of therapist-led versus selfhelp formats. Int J Eat Disord 1998;24(2):125-36. 

329. Levine MD, Marcus MD, Moulton P. Exercise in the 

treatment of binge eating disorder. Int J Eat Disord 

1996;19(2):171-7. 

330. Riva G, Bacchetta M, Baruffi M, et al. Virtual-realitybased multidimensional therapy for the treatment of 

body image disturbances in binge eating disorders: a 

preliminary controlled study. IEEE Trans Inf Technol 

Biomed 2002;6(3):224-34. 

331. Schork E, Eckert E, Halmi K. The relationship 

between psychopathology, eating disorder diagnosis, 

and clinical outcome at 10-year follow-up in anorexia 

nervosa. Compr Psychiatry 1994; 35:113-23. 

332. Gowers SG, Weetman J, Shore A, et al. Impact of 

hospitalisation on the outcome of adolescent anorexia 

nervosa. Br J Psychiatry 2000;176:138-41. 

333. Johnson C, Tobin DL, Dennis A. Differences in 

treatment outcome between borderline and 

nonborderline bulimics at one-year follow-up. Int J 

Eat Dis 1990;9(6):617-27. 

334. Herzog W, Deter HC, Fiehn W, et al. Medical findings 

and predictors of long-term physical outcome in 

anorexia nervosa: a prospective, 12-year follow-up 

study. Psychol Med 1997;27(2):269-79. 

335. Pinter O, Probst M, Vandereycken W, et al. The 

predictive value of body mass index for the weight 

evolution in anorexia nervosa. Eat Weight Disord 

2004;9(3):232-5. 

336. Saccomani L, Savoini M, Cirrincione M, et al. Longterm outcome of children and adolescents with 

anorexia nervosa: study of comorbidity. J Psychosom 

Res 1998;44(5):565-71. 

337. Tolstrup K, Brinch M, Isager T, et al. Long-term 

outcome of 151 cases of anorexia nervosa. The 

Copenhagen Anorexia Nervosa Follow-Up Study. 

Acta Psychiatr Scand 1985;71(4):380-7. 

338. Eckert ED, Halmi KA, Marchi P, et al. Ten-year 

follow-up of anorexia nervosa: clinical course and 

outcome. Psychol Med 1995;25(1):143-56. 

339. Fichter MM, Quadflieg N. Six-year course and 

outcome of anorexia nervosa. Int J Eat Disord 

1999;26(4):359-85. 

340. Isager T, Brinch M, Kreiner S, et al. Death and relapse 

in anorexia nervosa: survival analysis of 151 cases. J 

Psychiatr Res 1985;19(2-3):515-21. 

341. Strober M, Freeman R, Morrell W. The long-term 

course of severe anorexia nervosa in adolescents: 

survival analysis of recovery, relapse, and outcome 

predictors over 10-15 years in a prospective study. Int 

J Eat Disord 1997;22(4):339-60. 

342. Bulik CM, Sullivan PF, Fear JL, et al. Outcome of 

anorexia nervosa: eating attitudes, personality, and 

parental bonding. Int J Eat Disord 2000;28(2):139-47. 

343. Deter HC, Herzog W. Anorexia nervosa in a long-term 

perspective: results of the Heidelberg-Mannheim 

Study. Psychosom Med 1994;56(1):20-7. 
164 

344. Gillberg C, Råstam M, Gillberg IC. Anorexia nervosa: 

physical health and neurodevelopment at 16 and 21 

years. Dev Med Child Neurol 1994;36(7):567-75. 

345. Gillberg IC, Råstam M, Gillberg C. Anorexia nervosa 

outcome: six-year controlled longitudinal study of 51 

cases including a population cohort. J Am Acad Child 

Adolesc Psychiatry 1994;33(5):729-39. 

346. Gillberg IC, Råstam M, Gillberg C. Anorexia nervosa 

6 years after onset: Part I. Personality disorders. 

Compr Psychiatry 1995;36(1):61-9. 

347. Lee S, Chan YY, Hsu LK. The intermediate-term 

outcome of Chinese patients with anorexia nervosa in 

Hong Kong. Am J Psychiatry 2003;160(5):967-72. 

348. Löwe B, Zipfel S, Buchholz C, et al. Long-term 

outcome of anorexia nervosa in a prospective 21-year 

follow-up study. Psychol Med 2001;31(5):881-90. 

349. Råstam M, Gillberg C, Wentz E. Outcome of teenageonset anorexia nervosa in a Swedish community-based 

sample. Eur Child Adolesc Psychiatry 2003;12 Suppl 

1:I78-90. 

350. Sullivan PF, Bulik CM, Fear JL, et al. Outcome of 

anorexia nervosa: a case-control study. Am J 

Psychiatry 1998;155(7):939-46. 

351. Tanaka H, Kiriike N, Nagata T, et al. Outcome of 

severe anorexia nervosa patients receiving inpatient 

treatment in Japan: an 8-year follow-up study. 

Psychiatry Clin Neurosci 2001;55(4):389-96. 

352. Wentz E, Gillberg C, Gillberg IC, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

psychiatric disorders and overall functioning scales. J 

Child Psychol Psychiatry 2001;42(5):613-22. 

353. Dancyger IF, Sunday SR, Eckert ED, et al. A 

comparative analysis of Minnesota Multiphasic 

Personality Inventory profiles of anorexia nervosa at 

hospital admission, discharge, and 10-year follow-up. 

Compr Psychiatry 1997;38(3):185-91. 

354. Hebebrand J, Himmelmann GW, Herzog W, et al. 

Prediction of low body weight at long-term follow-up 

in acute anorexia nervosa by low body weight at 

referral. Am J Psychiatry 1997;154(4):566-9. 

355. Morgan HG, Purgold J, Welbourne J. Management 

and outcome in anorexia nervosa. A standardized 

prognostic study. Br J Psychiatry 1983;143: 282-7. 

356. Råstam M, Gillberg IC, Gillberg C. Anorexia nervosa 

6 years after onset: Part II. Comorbid psychiatric 

problems. Compr Psychiatry 1995;36(1):70-6. 

357. Crisp AH, Callender JS, Halek C, et al. Long-term 

mortality in anorexia nervosa. A 20-year follow-up of 

the St George's and Aberdeen cohorts. Br J Psychiatry 

1992;161:104-7. 

358. Strober M, Freeman R, Bower S, et al. Binge eating in 

anorexia nervosa predicts later onset of substance use 

disorder: a ten-year prospective, longitudinal followup of 95 adolescents. J Youth Adolesc 

1996;25(4):519-32. 

359. Herzog W, Schellberg D, Deter HC. First recovery in 

anorexia nervosa patients in the long-term course: a 

discrete-time survival analysis. J Consult Clin Psychol 

1997;65(1):169-77. 

360. Ivarsson T, Råstam M, Wentz E, et al. Depressive 

disorders in teenage-onset anorexia nervosa: a 

controlled longitudinal, partly community-based 

study. Compr Psychiatry 2000;41(5):398-403. 

361. Wentz E, Gillberg IC, Gillberg C, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

physical health and neurodevelopment. Dev Med 

Child Neurol 2000;42(5):328-33. 

362. Nilsson EW, Gillberg C, Gillberg IC, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

personality disorders. J Am Acad Child Adolesc 

Psychiatry 1999;38(11):1389-95. 

363. Lee S, Chan YY, Kwok K, et al. Relationship between 

control and the intermediate term outcome of anorexia 

nervosa in Hong Kong. Aust N Z J Psychiatry 

2005;39(3):141-5. 

364. Møller-Madsen S, Nystrup J, Nielsen S. Mortality in 

anorexia nervosa in Denmark during the period 1970-

1987. Acta Psychiatr Scand 1996;94(6):454-9. 

365. Deter HC, Schellberg D, Kopp W, et al. Predictability 

of a favorable outcome in anorexia nervosa. Eur 

Psychiatry 2005;20(2):165-72. 

366. Halvorsen I, Andersen A, Heyerdahl S. Good outcome 

of adolescent onset anorexia nervosa after systematic 

treatment. Intermediate to long-term follow-up of a 

representative county-sample. Eur Child Adolesc 

Psychiatry 2004;13(5):295-306. 

367. Ben-Tovim DI, Walker K, Gilchrist P, et al. Outcome 

in patients with eating disorders: a 5-year study. 

Lancet 2001;357(9264):1254-7. 

368. Franko DL, Keel PK, Dorer DJ, et al. What predicts 

suicide attempts in women with eating disorders? 

Psychol Med 2004;34(5):843-53. 

369. Herzog DB, Dorer DJ, Keel PK, et al. Recovery and 

relapse in anorexia and bulimia nervosa: a 7.5-year 
165 

follow-up study. J Am Acad Child Adolesc Psychiatry 

1999;38(7):829-37. 

370. Herzog DB, Field AE, Keller MB, et al. Subtyping 

eating disorders: is it justified? J Am Acad Child 

Adolesc Psychiatry 1996;35(7):928-36. 

371. Herzog DB, Greenwood DN, Dorer DJ, et al. 

Mortality in eating disorders: a descriptive study. Int J 

Eat Disord 2000;28(1):20-6. 

372. Keel PK, Dorer DJ, Eddy KT, et al. Predictors of 

mortality in eating disorders. Arch Gen Psychiatry 

2003;60(2):179-83. 

373. Patton GC. Mortality in eating disorders. Psychol Med 

1988;18(4):947-51. 

374. Herzog W, Deter HC. [Long-term follow-up: 

methodologic aspects in the interpretation of followup results. A presentation exemplified by anorexia 

nervosa]. 40. 1994:117-27. 

375. Fairburn CG, Cooper Z, Doll HA, et al. The natural 

course of bulimia nervosa and binge eating disorder in 

young women. Arch Gen Psychiatry 2000;57(7):659-

65. 

376. Fairburn CG, Norman PA, Welch SL, et al. A 

prospective study of outcome in bulimia nervosa and 

the long-term effects of three psychological 

treatments. Arch Gen Psychiatry 1995;52(4):304-12. 

377. Fairburn CG, Stice E, Cooper Z, et al. Understanding 

persistence in bulimia nervosa: a 5-year naturalistic 

study. J Consult Clin Psychol 2003;71(1):103-9. 

378. Fichter MM, Quadflieg N. Twelve-year course and 

outcome of bulimia nervosa. Psychol Med 

2004;34(8):1395-406. 

379. Gendall KA, Bulik CM, Joyce PR, et al. Menstrual 

cycle irregularity in bulimia nervosa. Associated 

factors and changes with treatment. J Psychosom Res 

2000;49(6):409-15. 

380. Herzog DB, Sacks NR, Keller MB, et al. Patterns and 

predictors of recovery in anorexia nervosa and bulimia 

nervosa. J Am Acad Child Adolesc Psychiatry 

1993;32(4):835-42. 

381. Jäger B, Liedtke R, Lamprecht F, et al. Social and 

health adjustment of bulimic women 7-9 years 

following therapy. Acta Psychiatr Scand 

2004;110(2):138-45. 

382. Keel PK, Mitchell JE, Davis TL, et al. Relationship 

between depression and body dissatisfaction in women 

diagnosed with bulimia nervosa. Int J Eat Disord 

2001;30(1):48-56. 

383. Keel PK, Mitchell JE, Davis TL, et al. Impact of 

definitions on the description and prediction of 

bulimia nervosa outcome. Int J Eat Disord 

2000;28(4):377-86. 

384. Keel PK, Mitchell JE, Miller KB, et al. Long-term 

outcome of bulimia nervosa. Arch Gen Psychiatry 

1999;56(1):63-9. 

385. Keel PK, Mitchell JE, Miller KB, et al. Predictive 

validity of bulimia nervosa as a diagnostic category. 

Am J Psychiatry 2000;157(1):136-8. 

386. Stice E, Fairburn CG. Dietary and dietary-depressive 

subtypes of bulimia nervosa show differential 

symptom presentation, social impairment, 

comorbidity, and course of illness. J Consult Clin 

Psychol 2003;71(6):1090-4. 

387. Fichter MM, Quadflieg N, Gnutzmann A. Binge 

eating disorder: treatment outcome over a 6-year 

course. J Psychosom Res 1998;44(3-4):385-405. 

388. Wilfley DE, Friedman MA, Dounchis JZ, et al. 

Comorbid psychopathology in binge eating disorder: 

relation to eating disorder severity at baseline and 

following treatment. J Consult Clin Psychol 

2000;68(4):641-9. 

389. Busetto L, Segato G, De Luca M, et al. Weight loss 

and postoperative complications in morbidly obese 

patients with binge eating disorder treated by 

laparoscopic adjustable gastric banding. Obes Surg 

2005;15(2):195-201. 

390. Hay P, Bacaltchuk J, Claudino A, et al. Individual 

psychotherapy in the outpatient treatment of adults 

with anorexia nervosa. Cochrane Database Syst Rev 

2003;(4):CD003909. DOI: 10.1002/14651858. 

391. Hay P, Bacaltchuk J, Stefano S. Psychotherapy for 

bulimia nervosa and binging. Cochrane Database Syst 

Rev 2004;(3 ):CD000562. DOI: 10.1002/14651858. 

392. Bacaltchuk J, Hay P. Antidepressants versus placebo 

for people with bulimia nervosa. Cochrane Database 

Syst Rev 2003;(4):CD003391. DOI: 

10.1002/14651858. 

393. Bacaltchuk J, Hay P, Trefiglio R. Antidepressants 

versus psychological treatments and their combination 

for bulimia nervosa. Cochrane Database Syst Rev 

2001;4:CD003385. DOI: 10.1002/14651858. 

394. Yanovski SZ, Yanovski JA. Obesity. N Engl J Med 

2002;346(8):591-602. 

395. Halmi KA, Agras WS, Crow S, et al. Predictors of 

treatment acceptance and completion in anorexia 
166 

nervosa: implications for future study designs. Arch 

Gen Psychiatry 2005;62(7):776-81. 

396. Mokdad AH, Bowman BA, Ford ES, et al. The 

continuing epidemics of obesity and diabetes in the 

United States. J Am Med Assoc 2001;286(10):1195-

200. 

397. Flegal KM, Carroll MD, Ogden CL, et al. Prevalence 

and trends in obesity among US adults, 1999-2000. 

JAMA 2002;288(14):1723-7. 

398. National Task Force on the Prevention and Treatment 

of Obesity. Dieting and the development of eating 

disorders in overweight and obese adults. Arch Intern 

Med 2000;160(17):2581-9. 

399. Butryn ML, Wadden TA. Treatment of overweight in 

children and adolescents: does dieting increase the risk 

of eating disorders? Int J Eat Disord 2005;37(4):285-

93. 

400. Wadden TA, Foster GD, Sarwer DB et al. Dieting and 

the development of eating disorders in obese women: 

results of a randomized controlled trial. 80. 2004:560-

8. 

401. Neumark-Sztainer D. Can we simultaneously work 

toward the prevention of obesity and eating disorders 

in children and adolescents? Int J Eat Disord 

2005;38(3):220-7. 

Appendix A. Exact Search Strings 

A-1

Search Strategy 

#3 Search "Eating Disorders"[MeSH] 17336

#4 Search "Eating Disorders"[MeSH] Field: All Fields, Limits: Randomized 

Controlled Trial 

467

#6 Search "Anorexia"[MeSH] OR "Anorexia Nervosa"[MeSH] 9631

#7 Search "Anorexia"[MeSH] OR "Anorexia Nervosa"[MeSH] Field: All Fields, 

Limits: Randomized Controlled Trial 

195

#11 Search "Bulimia"[MeSH] 3624

#12 Search "Bulimia"[MeSH] Field: All Fields, Limits: Randomized Controlled 

Trial 

210

#14 Search "Therapeutics"[MeSH] 1607160

#23 Search "Cognitive Therapy"[MeSH] OR "Family Therapy"[MeSH] OR "Drug 

Therapy"[MeSH] OR "Therapy, Computer-Assisted"[MeSH] 

289583

#34 Search "Randomized Controlled Trials"[MeSH] OR "Single-Blind 

Method"[MeSH] OR "Double-Blind Method"[MeSH] OR "Random 

Allocation"[MeSH] 

157518

#35 Search #3 AND #34 306

#36 Search #6 AND #34 146

#37 Search #11 AND #34 130

#39 Search #36 OR #7 272

#40 Search #38 OR #12 624

#41 Search #23 OR #14 1614410

#42 Search #41 AND #35 111

#43 Search #41 AND #36 45

#44 Search #41 AND #37 49

#45 Search relapse 130475

#48 Search "Recurrence"[MeSH] OR "Patient Readmission"[MeSH] 103204

#49 Search #48 AND #4 18

#50 Search #48 AND #6 95

#51 Search #48 AND #11 68

#54 Search "Outcome Assessment (Health Care)"[MeSH] OR "Treatment 

Outcome"[MeSH] OR "Outcome and Process Assessment (Health 

Care)"[MeSH] 

236323

#55 Search #54 AND #4 139

#56 Search #54 AND #6 341

#57 Search #54 AND #11 304

#58 Search "binge eating" 1240

#59 Search #58 AND #34 50

#60 Search #58 AND #41 335
A-2

#61 Search #58 AND #48 22

#65 Search #60 AND #59 2

#69 Search #12 OR #37 

274

#3 Search "Eating Disorders"[MeSH] 17336

#4 Search "Eating Disorders"[MeSH] Field: All Fields, Limits: Randomized 

Controlled Trial 

467

#6 Search "Anorexia"[MeSH] OR "Anorexia Nervosa"[MeSH] 9631

#7 Search "Anorexia"[MeSH] OR "Anorexia Nervosa"[MeSH] Field: All Fields, 

Limits: Randomized Controlled Trial 

195

#11 Search "Bulimia"[MeSH] 3624

#12 Search "Bulimia"[MeSH] Field: All Fields, Limits: Randomized Controlled 

Trial 

210

#14 Search "Therapeutics"[MeSH] 1607160

#23 Search "Cognitive Therapy"[MeSH] OR "Family Therapy"[MeSH] OR "Drug 

Therapy"[MeSH] OR "Therapy, Computer-Assisted"[MeSH] 

289583

#24 Search #3 AND #23 789

#25 Search #6 AND #23 463

#26 Search #11AND #23 0

#27 Search #11 AND #23 291

#34 Search "Randomized Controlled Trials"[MeSH] OR "Single-Blind 

Method"[MeSH] OR "Double-Blind Method"[MeSH] OR "Random 

Allocation"[MeSH] 

157518

#35 Search #3 AND #34 306

#36 Search #6 AND #34 146

#37 Search #11 AND #34 130

#39 Search #36 OR #7 272

#40 Search #38 OR #12 624

#41 Search #23 OR #14 1614410

#42 Search #41 AND #35 111

#43 Search #41 AND #36 45

#44 Search #41 AND #37 49

#45 Search relapse 130475

#48 Search "Recurrence"[MeSH] OR "Patient Readmission"[MeSH] 103204

#49 Search #48 AND #4 18

#50 Search #48 AND #6 95

#51 Search #48 AND #11 68

#54 Search "Outcome Assessment (Health Care)"[MeSH] OR "Treatment 

Outcome"[MeSH] OR "Outcome and Process Assessment (Health 

Care)"[MeSH] 

236323
A-3

#55 Search #54 AND #4 139

#56 Search #54 AND #6 341

#57 Search #54 AND #11 304

#58 Search "binge eating" 1240

#59 Search #58 AND #34 50

#60 Search #58 AND #41 335

#61 Search #58 AND #48 22

#65 Search #60 AND #59 25

#66 Search #48 AND #3 186

#67 Search #54 AND #3 680

#68 Search #54 AND #58 134

Extra Numbers 

#1 Search outcomes 96219 

#10 Search "Outcome Assessment (Health Care)"[MeSH] OR "Fatal 

Outcome"[MeSH] OR "Treatment Outcome"[MeSH] OR "Outcome 

and Process Assessment (Health Care)"[MeSH] OR "Weight 

Gain"[MeSH] OR "Osteoporosis"[MeSH] OR "Tooth 

Diseases"[MeSH] OR "Suicide"[MeSH] OR "Stomach 

Diseases"[MeSH] 

511077 

#17 Search "Randomized Controlled Trial"[Publication Type] OR 

"Randomized Controlled Trials"[MeSH] OR "Double-Blind 

Method"[MeSH] OR "Single-Blind Method"[MeSH] AND "Random 

Allocation"[MeSH] OR "Longitudinal Studies"[MeSH]OR 

Observational Study 

492971 
A-4

Harms Search 

#1 Search anorexia [mh] OR anorexia nervosa [mh] or bulimia [mh] or 

"binge eating disorder" [tw] OR eating disorders [mh] OR "binge 

eating" [tw] 

17671 

#2 Search coprophagia [mh] OR hyperphagia [mh] OR pica [mh] 2392 

#3 Search #1 NOT #2 15279 

#4 Search adverse effects [subheading] OR harms [tw] OR "side 

effects" [tw] OR "adverse effects" [tw] OR death [mh] OR drug 

hypersensitivity [mh] OR drug toxicity [mh] OR seizures [mh] 

1211380 

#5 Search #3 AND #4 1675 

#6 Search therapeutics [mh] OR therapy [subheading] 3923801 

#7 Search #5 AND #6 1228 

Other Terms Search 

#4 Search "Eating Disorders"[MeSH]OR "binge eating" [tw] 17669 

#8 Search ("Anorexia"[MeSH] OR "Anorexia Nervosa"[MeSH]) OR 

"Bulimia"[MeSH] OR "binge eating disorder" [tw] 

11821 

#9 Search #4 NOT #8 5848 

#10 Search #4 NOT #8 Field: All Fields, Limits: Randomized Controlled 

Trial 

99 

#15 Search ("Randomized Controlled Trial"[Publication Type] OR 

"Randomized Controlled Trials"[MeSH]) OR "Single-Blind 

Method"[MeSH] OR "Double-Blind Method"[MeSH] OR "Random 

Allocation"[MeSH] 

277468 

#16 Search #9 AND #15 133 

#17 Search #10 OR #16 133 

#18 Search longitudinal studies [mh] OR observational study [mh] 472680 

#20 Search #18 AND #9 291 

#21 Search #20 OR #16 400 

#27 Search "Cognitive Therapy"[MeSH] OR "Therapeutics"[MeSH] OR 

"Family Therapy"[MeSH] OR "Drug Therapy"[MeSH] OR 

"Therapy, Computer-Assisted"[MeSH] 

1640745 

#28 Search #27 AND #9 910 

#29 Search #28 NOT #8 910 

#30 Search #28 NOT #8 Field: All Fields, Limits: 5 Years 277 

#31 Search #28 NOT #30 633 

#32 Search #28 NOT #30 Field: All Fields, Limits: 10 Years 194 
A-5

#33 Search #31 NOT #32 439 

#37 Search "Recurrence"[MeSH] OR "Patient Readmission"[MeSH] 104066 

#38 Search #9 AND #37 49 

#45 Search ("Outcome Assessment (Health Care)"[MeSH] OR 

"Treatment Outcome"[MeSH] OR "Outcome and Process 

Assessment (Health Care)"[MeSH]) OR "Weight Gain"[MeSH] OR 

"Osteoporosis"[MeSH] OR "Tooth Diseases"[MeSH] OR 

"Suicide"[MeSH] OR "Stomach Diseases"[MeSH] 

494808 

#46 Search #9 AND #45 482 

#50 Search "Coprophagia"[MeSH] OR "Hyperphagia"[MeSH] OR 

"Pica"[MeSH] 

2392 

#51 Search #9 NOT #50 3922 

#52 Search #9 NOT #50 Field: All Fields, Limits: Randomized 

Controlled Trial 

70 

#53 Search #15 AND #51 Limits: Randomized Controlled Trial 70 

#54 Search #52 OR #53 Limits: Randomized Controlled Trial 70 

#55 Search #51 AND #18 Limits: Randomized Controlled Trial 15 

#56 Search #51 AND #18 Field: All Fields 236 
Appendix B. Sample Data Collection Forms 

B-1 

Eating Disorders Outcomes Quality Rating Form (__points) 

Author/Year: Reviewer: 

Article: 

1. Research Aim/Study Question

a. Hypothesis/objective of the study clearly described 

2 Good 

1 Fair 

0 Poor 

2. Study Population 

a. Study subjects’ characteristics clearly described 

2 Good 

1 Fair 

0 Poor 

 

b. Specific inclusion/exclusion criteria 

2 Yes 

0 No 

 

c. Study groups comparable to each other and/or to non-participants with regard to confounding 

factors or characteristics 

2 Good 

1 Fair 

0 Poor 

Exclude No comparisons 

 

3. Eating Disorder Diagnosis Method

a. Method used to diagnose individuals with an eating disorder 

2 Structured diagnostic interview 

1 Expert consensus diagnosis 

0 Independent clinician diagnosis 

 Other method___________________________________________ 

 1 Method NR 

 

b. Method used to diagnose patients similar in treatment/disease and comparison groups 

2 Yes 

0 No 

0 NR 

Exclude No comparisons 

 

4. Study Design

a. Area from which participants were drawn 

2 Community or catchment area 

1 Treatment programs in several cities 

0 Treatment program in one city 

 Other______________________________________ 

0 NR 

 

b. Study includes comparison group 

2 Yes 

1 No 

 
B-2 

5. Statistical Analysis 

a. Statistical tests appropriate 

2 Yes 

1 Partially 

0 No 

 

b. Statistical approach includes necessary controls for confounding such as multivariate analysis or 

stratification 

2 Yes 

0 No 

2 not necessary 

0 NR 

 

c. Power analysis conducted to determine the sample size needed to detect a sig difference in effect 

size for one or more outcomes 

2 Yes 

0 No 

0 NR 

 

6. Results/Outcome measurement

a. Outcome assessor blind to exposure or intervention status 

2 Yes 

0 No 

0 NR 

Exclude No comparisons 

 

b. Method of outcome assessment clearly defined, standard, valid, reliable, and applied equally to 

groups 

2 Good 

1 Fair 

0 Poor 

 

c. Interpretation of statistical tests appropriate 

2 Yes 

0 No 

1 Partially 

 

7. External Validity 

a. Study subjects comparable to the US population who would suffer from the eating disorder 

2 Yes 

0 No 

0 Cannot determine 

 

8. Discussion 

a. Study conclusions supported by results with possible biases and limitations taken into account 

2 Good 

1 Fair 

0 Poor 

 

b. Results discussed within the context of prior research 

2 Good 

1 Fair 

0 Poor 
B-3 

Quality Review Form for Eating Disorder RCTs 

Author, Year: _________________________________________________ Reviewer __________ 

Short title: _______________________________________________________________________ 

1. Research Aim/Study Question Yes No

1a. Is the hypothesis/aim/objective of the study clearly described? 4 0 

2. Study Population Yes Partially No

2a. Are study subjects’ characteristics clearly described, including 

comparisons of important confounders between groups? 4 2 0 

2b. Are specific inclusion/exclusion criteria provided? 4 2 0 

3. Randomization Yes No Unknown

3a. Were protections put in place to prevent researchers from 

(unconsciously or otherwise) influencing which participants are 

assigned to a given intervention group? 

4 0 0 

3b. Is there a description of the approach to randomization? 4 0 0 

3c. Is there a fatal flaw in the approach to randomization? 0 4 0 

Yes Partially No Unknown

3d. Are comparison groups similar at baseline? 4 2 0 0 

4. Blinding 

Yes No

Not 

Reported

 Not 

Applicable* 

4a. Are study subjects blinded to the intervention they 

received? 4 0 0 n/a 

4b. Are those administering the intervention blinded to the 

intervention received by the subjects? 4 0 0 n/a 

*(not able to blind participants to their study arm) 

Yes No NR

4c. Are outcome assessors blinded to the subject’s treatment arm? 4 0 0 

5. Interventions Yes No NR

5a. Are study interventions clearly described? 4 0 0 

Yes Partially No

Not 

Reported

5b. Is measurement of subjects’ compliance with the intervention(s) 

reliable? 4 2 0 0 

6. Outcomes Yes No Partially

6a. Are study results clearly described? 4 0 2 

6b. Are adverse events reported? 4 0 2 
B-4 

7. Statistical Analysis Yes No

7a. Is the statistical technique used to assess the main outcomes appropriate? 4 0 

Yes No

Not 

Necessary

 Not 

Reported

7b. Does the statistical technique include any necessary

controls for confounding? 4 0 4 0 

Yes Not 

Reported

No

7c. Are results evaluated using an intention to treat approach? 4 0 0 

7d. Did the researchers say they conducted a power analysis to determine 

the sample size needed to detect a significant difference in effect size 

for one or more outcomes?

4 0 0 

8. Results 

Low (10% 

or below) 

Fair 

(11%-25%)

 Poor 

(26% or 

above) 

Not 

Reported

8a. Is loss to follow-up 4 2 0 0 

Low 

(0-3% point 

difference)

Fair 

(>3 and less 

than 15% 

point 

difference)

Poor 

(15% point 

difference 

or greater) 

Not 

Reported

8b. Is differential loss to follow-up 4 2 0 0 

Yes Partially No

8c. Are the main outcomes measured using standard, valid and reliable 

methods which are applied equally to both groups? 4 2 0 

9. Discussion Yes Partially No

9a. Are study conclusions supported by the results with possible biases 

and limitations taken into account? 4 2 0 

Yes No

9b. Are the results discussed within the context of the prior research? 4 0 

10. External Validity 

Yes No 

Cannot 

Determine

10a. Are the subjects who participated in the study representative of the US 

population that would receive treatment for this condition? 4 0 0 

11. Funding/Sponsorship Yes No

11a. Are the sources of funding for the study listed? 4 0 
Appendix C. Evidence Tables 

C-1 

Acronyms, Abbreviations, and Definitions 

AA: African American 

ABW: percentage of avg body wt (matched for age, gender, and height) 

ADDM: adjustment disorder with depressed mood 

ads: advertisements 

aka: also known as

am: morning 

AN: anorexia nervosa

ANBP: anorexia nervosa with binge eating and/or purging 

ANCOVA: analysis of covariance 

ANSS: anorexia nervosa symptom score 

ANOVA: analysis of variance 

ANR: restricting anorexia nervosa 

AN-RDC: anorexia nervosa with concomitant major depression according to RDC 

ANSS: Anorexia Nervosa Symptom Score 

ASD: Autism spectrum disorder 

avg: average 

B-ERP: exposure with response prevention to pre-binge cues 

BAI: Beck Anxiety Inventory 

BAT: Body Attitudes Test 

BP: blood pressure 

BCE: bone collagen equivalents 

BD: body dissatisfaction 

BDI: Beck Depression Inventory 

BE: binge eating episode 

BEAQ: Binge Eating Adjective Checklist 

BED: binge eating disorder 

BES: Binge Eating Scale 

BF: body fat 

BFST: Behavioral family systems therapy 

BIAQ: Body Image Avoidance Questionnaire 

b.i.d.: twice a day 

BITE: Bulimic Investigation Test Edinburgh 

BMI: body mass index, measured in kg/m2 

BN: bulimia nervosa 

BPD: borderline personality disorder 

BSI: Brief Symptom Inventory 

BSQ: Body Shape Questionnaire 

BSS: Body Satisfaction Scale 

BT: Behavioral therapy 

CA: California 

CAT: cognitive analytical therapy 

CFT: conjoint family therapy 

CBCL: Child Behavior Checklist 

CBT: Cognitive-behavioral therapy 
C-2 

CBT-E: Cognitive-behavioral therapy with exposure 

CBT-C: Cognitive-behavioral therapy with cognitive interventions for treatment of body 

disturbance 

CCEI: Crown Crisp Experimental Index 

CDI: Children’s Depression Inventory 

CDRS: Contour Drawing Rating Scale 

CFT: conjoint family therapy 

CGI: Clinical Global Impression 

CGI-S score: Clinical Global Impressions-Severity of Illness scores: 1 = normal, 2 = borderline, 

3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most 

extremely ill. 

Chi-square: χ

2 

CI: confidence interval 

cm: centimeter 

CNT: cognitive nutritional therapy 

Co: company 

CR: clinician rating 

CT: Connecticut

CT: cognitive therapy 

CUE: physiological cue assessment 

d: day 

DBT: Dialectical Behavior Therapy 

DIET: Dieter’s Inventory of Eating Temptations Questionnaire 

Diff: Diff/Different 

DSM IV: Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition 

DSM III: Diagnostic and Statistical Manual for Mental Disorders, Third Edition 

DSM III-R: Diagnostic and Statistical Manual for Mental Disorders, Third Edition, Revised 

DT: drive for thinness 

Dx: diagnosis 

EAT: Eating Attitudes Test 

EB-IV: Diagnostic and Statistical Manual for Mental Disorders, eating behavior IV 

EBT: educational behavioral therapy 

ECG: electrocardiogram 

ECT: Experimental Cognitive Therapy 

ED: eating disorder 

EDE: Eating Disorders Examination 

EDE-Q: Eating Disorders Examination-Questionnaire 

EDI: Eating Disorder Inventory 

EDNOS: Eating disorder-not otherwise specified 

EE: expressed emotion 

EOIT: ego oriented individual therapy 

ERP: exposure with response prevention 

ES: effect size 

et al: et alia 

EWL: excess weightt loss 

EXRP: exposure with response prevention 
C-3 

F: F-statistic 

FAM-III: Family Assessment Measure 

FBNCSG: Fluoxetine bulima nervosa collaborative study group

FH: family history 

FL: Florida 

FNE: Fear of Negative Evaluation 

FRS: Figure Rating Scale 

FU: FU 

fx: function 

g: grams 

G: group 

GAF: Global Assessment of Functioning Scale 

GAF-S: Global Assessment of Functioning-Symptoms 

GAF-F: Global Assessment of Functioning-Functionging 

GCBT: group cognitive behavioral therapy 

GEE: Generalized estimating equation

GI: gastrointestinal 

GP: general practitioner 

GSI: General Severity Index 

HAM-A: Hamilton Rating Score for Anxiety

HAM-D: Hamilton Rating Score for Depression 

HBT: Hypnobehavioral therapy 

HDRS: Hamilton Depression Rating Scale (also HRSD: Hamilton Rating Scale for Depression) 

HM: hazard multiplier 

HRQ: Helping Relationship Questionnaire 

HS: High School 

HSCL: Hopkins Symptom Checklist

hr: hours 

ht: height 

Hx: history 

IBC: Interaction Behavior Code 

IBW: ideal body weight 

ICBT: individual cognitive behavioral therapy 

ICD: International Classification of Diseases 

IDDB: Insulin dependent diabetes mellitus 

IGF-1: 

IL: Illinois 

Inc.: Incorporated 

info: information 

IPT: Interpersonal psychotherapy 

ITT: intention to treat 

K2HPO4/cm3

: measure of bone mineral density (BMD) 

kcal: kilocalories

Kg: kilograms 

KS: Kansas 

l: liter 
C-4 

LAGB: laparoscopic adjustable gastric banding 

lb: pounds 

LIFE: Longitudinal Interval FU Evaluation 

Ltd.: limited

m: minutes 

MA: Massachusetts 

MADRS: Montgomery-Asberg Depression Rating Scale 

MANCOVA: multivariate analysis of covariance 

MANOVA: multivariate analysis of variance 

MAOI: monoamine-oxidase inhibitors 

max: maximum 

MD: Maryland 

MDD: major depressive disorder 

MDE: major depressive episode 

meds: medication(s) 

MET: Motivational Enhancement therapy 

mg: milligram 

Mg: micrograms

MI: Michigan 

Min: minimum 

MKAT: measurement of bone specific alkaline phosphatase 

mm Hg: millimeters mercury 

MMPI: Minnesota Multiphasic Personality Inventory 

MMPW: mean matched population wt 

mmol: millimole 

MN: Minnesota 

MOCI: Maudsley Obsessive Compulsive Inventory 

mo: month(s) 

M-R Scores: Morgan and Russell scale 

M-R-H Scale: Morgan-Russell-Hayward Scale 

N: number 

NA: not applicable 

NATO: North Atlantic Treaty Organization 

NBPD: non-borderline personality disorder 

neg: negative 

NG: nutritional groups 

NIH: National Institutes of health 

NIMH: National Institute of Mental Health 

NJ: New Jersey

nM: nanomole 

N: number 

NC: North Carolina 

NICHD: National Institute for Child Health and Development 

NM: New Mexico 

nmol: nanomile

NR: not reported 
C-5 

NS: not significant 

NSMT: Non-specific Self Monitoring 

NT: nutritional therapy 

NY: New York 

NYC: New York City 

OBE: objective binge episode 

OC: obsessive-compulsive 

OCD: obsessive-compulsive disorder 

OCPD: obsessive-compulsive personality disorder 

outpt: outpatient 

OR: odds ratio 

P: p-value 

P61: Patient’s gloval impression 

PA: Pennsylvania 

PARQ: Parent Adolescent Relationship Questionnaire 

P-ERP: exposure with response prevention to pre-purge cues 

PE: psychoeducation 

PGI: Patient Global Impression 

PICP: C-terminal propeptide of type 1 collagen 

pmol: picomole 

po: per os (by mouth) 

pos: positive 

PSE: Present State Exam 

PSR: Psychiatric Status Rating Scale 

psych: psychological or psychiatric 

PTSD: posttraumatic stress disorder 

QEWPR: Questionnaire on Eating and Wt Patterns - Revised 

RAN: restricting anorexia nervosa 

RCT: randomized controlled trial

RDC: Research Diagnostic Criteria 

RELAX: relaxation training 

rhGh: recombinant human growth hormone 

RI: Rhode Island 

RP: response prevention 

RM-ANOVA: repeated measures analysis of variance 

RSE: Rosenberg Self Esteem Inventory 

RSEQ: Rosenberg Self-Esteem Questionnaire 

SADS-C: Schedule for Affective Disorders and Schizophrenia-Change Version 

SAS: Social Adjustment Scale 

SCI: Shapiro Control Inventory 

SCID: Structured Clinical Interview for DSM IV 

SCL-90: Hopkins Symptom Checklist-90

SD: standard deviation 

SDS: Self-rating Depression Scale 

SE: standard error 

SEM: standara error of the mean 
C-6 

SES: socioeconomic status 

SF-36: Short-Form 36-item quality of life questionnaire 

• RP: role physical component score

• SF: social functioning component score

• Vit: vitality component score

SFT: Separated family therapy 

SIAB: Structured Interview for Anorexia Nervosa and Bulimic Syndromes 

Sig: significant 

SMFQ: Short Mood and Feeling Questionnaire 

SMR: Standardized Mortality Ratio 

SOC: stages of change 

SPAQ: Seasonal Patterns Assessment Questionnaire 

SR: Self-report 

SRQ: Three Factor Eating Questionnaire 

SRS: Self-Rating Depression Scale 

SSRI: selective serotonin reuptake inhibitor 

St: Saint 

STAI: State/Trait Anxiety Inventory 

STAXI: State Trait Anger Expression Inventory 

SUD: substance use disorder 

SUDS: Subjective units of distress 

sx: symptoms 

T: time 

t.i.d.: three times a day 

TAS-20: Toronto Alexithymia Scale 

TCA: tricyclic antidepressants 

TFEQ: Three Factor Eating Questionnaire 

TN: Tennessee 

TT3: total testosterone 

tx: treatment 

U: university 

UK: United Kingdom 

USA: United States 

UT: Utah 

UTB: Urge to binge 

UTP: Urge to purge 

VAS: visual analog scale 

vs: versus 

WAIS: Wechsler Adult Intelligence Scale 

WELSQ: Weight Efficacy Life Style Questionnaire 

WLFL: Work, Life and Family Leisure Questionnaire 

WI: Wisconsin 

wk: week 

wkly: weekly 

WPIC: Western Psychiatric Institute and Clinic 

wt: weight 
C-7 

X2: chi square 

YBC-ED: Yale-Brown-Cornell Eating Disorders Scale 

Y-BOCS: Yale-Brown Obsessive Compulsive Scale 

Y-BOCS-BE: Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating 

Yr: year 

Yrs: years
C-8 

Evidence Table 1. Medication trials for anorexia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Attia et al., 1998 

Setting: 

Inpatient research 

unit, NY, USA 

Enrollment period: 

NR 

Research objective: 

To determine whether 

fluoxetine was associated 

with greater wt gain and 

improved psychological 

functioning compared to 

placebo when combined 

with a structured inpatient 

program for AN. 

Groups: 

G1: Fluoxetine (N = 15) 

G2: Placebo (N = 16) 

Enrollment: 

• 33 enrolled 

• 1 drop out 

• 1 undetectable levels of 

meds 

• 1 unreliable selfreporter 

• 31 included in analyses 

Age, mean (SD): 

26.2 (7.4) 

G1: 29.1 (7.2) 

G2: 23.4 (6.4) 

(P < 0.03) 

Sex: 

Female:100% 

Race/ethnicity: 

NR 

Duration (yrs) of AN, 

mean (SD): 

8.0 (5.8) 

G1: NR 

G2: NR 

(P = NS) 

Wt, lb, mean (SD): 

92.0 (9.8) 

G1: NR 

G2: NR 

(P = NS) 

% of IBW, mean (SD): 

72.5 (5.3) 

G1: NR 

G2: NR 

(P = NS) 

BMI, mean (SD): 

15.0 (4.2) 

G1: NR 

G2: NR 

(P = NS) 
C-9 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, between 16-45 yrs 

old, receiving inpatient tx for 

AN. Met DSM IV criteria AC for AN, wt < 80% of IBW. 

Exclusion: 

Medically unstable, allergy 

to fluoxetine, alcohol or drug 

dependence in past 6 mo, 

bipolar disorder or psychotic 

disorder (current or lifetime), 

OCD with onset before AN. 

Inpatient tx: 

Seen 3-5 times/wk in 

individual therapy. Several 

group sessions. Random 

assignment occurred after 

patient was medically stable 

and after having reached 

65% IBW. 

G1: initiated at 20 mg/day 

and increased to 60 mg 

/day over 1 wk and was 

maintained unless side 

effects occurred. 

Patients continued with 

study until reached 90% 

IBW and remained at or 

above for 1 wk or for a max 

of 7 wks. 

Days of medical tx, mean 

(SD): 

G1: 36.1 (14.1) 

G2: 37.4 (13.8) 

(P = NS) 

Dose at termination 

mg/day, mean (SD): 

G1: 56.0 (11.2) 

G2: 58.7 (5.0) 

(P = NS) 

Paired t tests, ANCOVA, 

ANOVA 

Score: 

Good 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

Meds related insomnia 

and agitation in 1 patient 

and blurred vision in a 

second. 

Funding: 

Eli Lilly and Co 
C-10 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Anorexic Behavior Scale, mean (SD): 

G1: 49.0 (14.3) 

G2: 43.2 (11.2) 

Anorexic Behavior Scale, mean (SD): 

G1: 38.5 (11.6) (P < 0.05) 

G2: 39.7 (9.5) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EAT, mean (SD): 

G1: 53.8 (23.3) 

G2: 54.1 (19.5) 

EAT, mean (SD): 

G1: 37.1 (20.1) (P < 0.05) 

G2: 30.8 (17.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Attia et al., 1998 

(continued) 

CGI, ED, mean (SD): 

G1: 5.7 (1.0) 

G2: 5.8 (1.0) 

CGI, ED, mean (SD): 

G1:4.2 (1.4) (P < 0.05) 

G2: 4.1 (1.1) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-11 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI, Illness, mean (SD): 

G1: 5.3 (1.0) 

G2: 5.3 (1.2) 

CGI, Illness, mean (SD): 

G1: 4.1 (1.4) (P < 0.05) 

G2: 4.3 (1.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BDI mean (SD): 

G1: 24.3 (11.9) 

G2: 20.0 (7.2) 

BDI mean (SD): 

G1: 15.9 (11.3) (P < 0.05) 

G2: 14.0 (8.9) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

Wt, % of IBW, mean 

(SD): 

G1: 73.3 (5.8) 

G2: 71.8 (5.0) 

Wt, % of IBW, mean (SD): 

G1: 86.6 (6.3) (P < 0.05) 

G2: 87.4 (4.7) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Change in % of IBW, mean 

(SD): 

G1: 0.35 (0.17) (P = NS) 

G2: 0.42 (0.11) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

CGI, Global Improvement, 

mean (SD): 

G1: 2.5 (1.4) (P = NS) 

G2: 2.8 (1.5) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

 

BSQ mean (SD): 

G1: 129.9 (48.8) 

G2: 138.6 (35.1) 

BSQ mean (SD): 

G1: 109.3 (39.5) (P < 0.05) 

G2: 119.4 (31.5) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 

SCL-90, Depression, 

mean (SD): 

G1: 3.2 (0.9) 

G2: 2.8 (0.6) 

SCL-90, Depression, mean 

(SD): 

G1: 2.3 (1.0) (P < 0.05) 

G2: 2.2 (0.8) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

 

SCL-90, OC scale, mean 

(SD): 

G1: 2.5 (1.0) 

G2: 2.3 (0.9) 

SCL-90, OC scale, mean 

(SD): 

G1: 1.9 (1.0) (P < 0.05) 

G2: 1.7 (0.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 
C-12 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Yale Brown Cornell ED Scale, 

Preoccupation, mean (SD): 

G1: 11.1 (3.4) 

G2: 9.7 (2.3)

Yale Brown Cornell ED Scale, Preoccupation, 

mean (SD): 

G1: 8.1 (3.4) (P < 0.05) 

G2: 8.1 (2.3) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Yale Brown Cornell ED Scale, Ritual, 

mean (SD): 

G1: 9.9 (2.6) 

G2: 9.0 (2.7) 

Yale Brown Cornell ED Scale, Ritual, mean 

(SD): 

G1: 7.7 (2.9) (P < 0.05) 

G2: 6.7 (2.6) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Attia et al., 1998 

(continued) 

Yale Brown Cornell ED Scale, total, 

mean (SD): 

G1: 20.9 (5.7) 

G2: 18.7 (4.3) 

Yale Brown Cornell ED Scale, total, mean (SD): 

G1: 15.7 (6.1) (P < 0.05) 

G2: 14.8 (4.2) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-13 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL-90, Global symptom, 

mean (SD): 

G1: 2.4 (0.7) 

G2: 2.3 (0.6)

SCL-90, Global symptom, 

mean (SD): 

G1: 1.9 (0.8) (P < 0.05) 

G2: 1.8 (0.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 

 

 
C-14 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Barbarich, McConaha 

et al. 2004 

Setting: 

Eating Disorders 

programs at WPIC, 

Pittsburgh, PA and 

NY Hospital/Cornell 

Medical Center, NYC, 

USA. 

Enrollment period: 

NR 

Research objective: 

To determine if the use of 

supplements containing 

tryptophan and essential 

fatty acids would increase 

the efficacy of flouxetine in 

underwt AN subjects. 

Groups: 

G1: daily dietary 

supplements (N = 15) 

G2: Placebo (N = 11) 

Enrollment: 

• 26 enrolled and 

randomized 

• 9 completed full 

study 

Age, mean (SD): 

Mean: 23.0 (6.3) yrs 

G1: NR 

G2: NR 

(P = NR) 

Sex: 

Female: NR 

Race/ethnicity: 

NR 

Other characteristics: 

AN restricting type (N = 10) 

AN restricting and purging only 

(N = 6) 

AN Binge eating/purging type 

(N = 10) 

Characteristics for 

completers only: 

No sig diff between completers 

and drop outs on any 

measures except mean 

laxative abuse onset age (SD): 

Noncompleters: 16.3 (1.6) 

Completers: 21.3 (1.2); 

Diff between groups 

(P < 0.01) 

Measures, mean (SD): 

• Dieting start age: 16.9 

(5.2) 

• Age of onset: 17.3 (6.3) 

• Duration of ED: 8.4 (8.1) 

• Binge eating start: 17.8 

(6.9) 

• Laxative abuse start: 21.3 

(1.2) 

• Vomiting start age: 20.2 

(6.9) 

• Age: 25.7 (7.4) 

• Low BMI: 14.4 (1.4) 

• High BMI: 20.8 (2.3) 

• Perfectionism score (Frost 

multidimensional 

perfectionism scale): 87.8 

(28.4) 
C-15 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

NR 

Exclusion: 

NR 

Tx lasted 6 mos. All enrolled 

subjects started on a dose of 20 

to 40 mg of fluoxetine. Individual 

doses titrated throughout study. 

Dose at study end ranged from 

20 to 60 mg. Subjects wted at 

wkly intervals for the first 8 wks, 

at 2-wk intervals for 6 wks, and 

at 4 wk intervals for 12 wks. 

In addition, G1 received 2.3 g 

tryptophan taken in divided 

dosage in the am and pm, 1 

multivitamin/mineral capsule per 

day in the am, and 4 fish oil 

capsules per day in the am (600 

mg of docosahexanoic acid and 

180 mg of arachadonic acid). G2 

received equivalent number of 

inactive capsules 

Independent sample t-tests 

for measuring changes 

between groups. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

Double 

Adverse /events: 

NR 

Funding: 

NR 
C-16 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Barbarich, McConaha 

et al. 2003 

(continued) 

NR NR 
C-17 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Biomarkers 

Baseline Outcomes Baseline Outcomes 

Estimate is change over time 

(SE) 

Estimate is change over time 

(SE) 

STAI-Y: 

G1: 43.5 (17.6) 

G2: 54.5 (3.5) 

(P = NS) 

STAI – Y: 

G1: -7.8 (23.8) 

G2: -10.5 (0.7) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

NR Mean wt gain per wk: 

G1: 0.27 kg (0.3) 

G2: 0.10 kg (0.1) 

Diff between groups (P = NR) 

Diff between groups in change

over time (P = NS)

YBOCS: 

G1: 11.8 (14.2) 

G2: 12.0 (11.3) 

(P = NS) 

YBOCS: 

G1: -9.2 (12.9) 

G2: -6.5 (3.5) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 
C-18 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Biederman et al., 

1985 

Setting: 

Inpatient Eating 

Disorder Unit, 

Massachusetts 

General Hospital; 

Psychosomatic Unit, 

Children’s Hospital 

Medical Center, 

Boston, USA 

Enrollment period: 

Dates NR (2 yrs) 

Research objective: 

To investigate effect of 

amitriptyline on wt and 

psychiatric sx’s in AN. 

Groups: 

G1: Amitriptyline (N = 11) 

G2: Placebo (N = 14) 

Enrollment: 

• 25 patients enrolled 

• 5 outpatients and 11 

inpatients 

Age, mean (SD): 

G1: 18.4 (4.9) 

G2: 17.2 (4.3) 

Range: 11-27 

(P = NS) 

Sex: 

Female: NR 

Race/ethnicity: 

NR 

SES (range 1-5), mean 

(SD): 

G1: 2.4 (1.2) 

G2: 2.0 (1.4) 

(P = NS) 

Age onset (yrs) of AN, 

mean (SD): 

G1: 15.7 (1.2) 

G2: 16.1 (2.7) 

(P = NS) 

Duration (mos) of present 

episode, mean (SD): 

G1: 20.2 (16.7) 

G2: 25.2 (29.4) 

(P = NS) 
C-19 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx for AN per 

Feighner et al. (1972) 

and DSM III. All but 1 

patient met full criteria. 

Exclusion: 

Evidence of other 

medical disorders 

All received regular 

psychiatric and medical tx 

(supportive, nutritional rehab 

illitation, individual therapy, 

family intervention, and 

inpatients received behavior 

modification). Meds: dosage 

increased every other day by 

50 mg up to 3 mg/kg/day and 

a max dose of 175 mg/day 

unless adverse effects 

developed. Mean dose at wk 

5: 115 (31) mg/day; 2.8 (1.1 

mg/kg/day). Plasma levels 

varied among patients on the 

same dose of meds. 

T-tests to compare 

placebo and drug 

group Diffs. One-way 

ANOVA to determine 

whether diffs emerged 

in change scores 

across groups. 

Correlations between 

improvement and 

plasma levels of 

meds. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

Assessed wkly. 

G1: diaphoresis (N = 2; 18%), 

drowsiness (N = 6, 55%), dry 

mouth (N = 4; 36%), blurred vision 

(N = 1; 9%), urinary retention (N = 

1; 9%), hypotension (N = 2; 18%), 

leucopenia (N = 1; 9%) 

G2: Dry mouth (N = 2; 14%), 

palpitations (N = 1; 7%), dizziness 

(N = 2; 14%). No P-values reported

Funding: 

NIMH, Charlupski Foundation, 

Milton Fund, Jane Hilder Harris 

Foundation. 
C-20 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Biederman et al., 

1985 

(continued) 

Antibulimic effect (EAT-Bulimic factor): 

 < 30% response, N (%): 

G1: 2 (22%) 

G2: 8 (57%) 

30 to 50% response, N (%): 

G1: 1 (11%) 

G2: 1 (7%) 

>50% response, N (%): 

G1: 6 (67%) 

G2: 5 (36%) 

(P-values NR; described as NS) 
C-21 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Family Hx (FH): 

Depression (1st degree), N 

(%): 

G1: 6 (54%) 

G2: 6 (43%) 

AN-RDC (AN with 

concomitant depression), N 

(%): 

G1: 4 (36%) 

G2: 10 (71%) 

(P = NS) 

Generation-FH (depression or 

substance abuse in 2 or more 

consecutive generations) N 

(%): 

G1: 1 (10%) 

G2: 3 (21%) 

(P = NS) 

Antidepressant effect 

 (SADS-C): 

 < 30% response, N (%): 

G1: 8 (73%) 

G2: 6 (46%) 

30 to 50% response, N (%): 

G1: 3 (27%) 

G2: 5 (36%) 

>50% response, N (%): 

G1: 0 (0%) 

G2: 2 (14%) 

(P-values NR; described as NS)

Wt kg, mean (SD): 

G1: 38.2 (4.2) 

G2: 35.5 (5.8) 

(P = NS) 

Percent below ideal 

(wt for ht at baseline), 

mean (SD): 

G1: 25.0 (7.3) 

G2: 31.0 (6.2) 

(P = NS) 

Wt gain: 

 < 10%, N (%): 

G1: 8 (72%) 

G2: 8 (57%) 

10 to 30%, N (%): 

G1: 3 (27%) 

G2: 5 (36%) 

> 50%, N (%): 

G1: 0 (0%) 

G2: 1 (7%) 

(P-values NR; described 

as NS) 

Antianxiety effect (SADS-C):

< 30% response, N (%): 

G1: 9 (82%) 

G2: 8 (61%) 

30 to 50% response, N (%): 

G1: 2 (18%) 

G2: 3 (25%) 

>50% response, N (%): 

G1: 0 (0%) 

G2: 2 (15%) 

(P-values NR; described as NS)

Plasma levels: 

No correlation between 

plasma levels and any 

outcome variable. 

Antiobsessional effect 

(HSCL): 

< 30% response, N (%): 

G1: 9 (100%) 

G2: 12 (86%) 

30 to 50% response, N (%): 

G1: 0 (0%) 

G2: 1 (7%) 

>50% response, N (%): 

G1: 0 (0%) 

G2: 1 (7%) 

(P-values NR; described as NS)

 
C-22 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Biederman et al., 

1985 

(continued) 
C-23 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Global effect (Clinical Global; 

Global Severity Scale): 

< 30% response, N (%): 

G1: 6 (54%) 

G2: 9 (64%) 

30 to 50% response, N (%): 

G1: 4 (36%) 

G2: 4 (27%) 

> 50% response, N (%): 

G1: 1 (9%) 

G2: 1 (7%) 

(P-values NR; described as NS) 

 

Substance use disorder (1st 

degree), N (%): 

G1: 3 (27%) 

G2: 6 (43%) 

(P = NS) 

 

TCA used previous to study, N 

(%): 

G1: 1 (9%) 

G2: 2 (14%) 

(P = NS) 

 
C-24 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Birmingham, Goldner 

et al., 1994 

Setting: 

Inpatient eating 

disorders programs; 

St. Paul’s Hospital, 

Health Sciences 

Centre Hospital, and 

the University of 

British Columbia, 

Vancouver, British 

Columbia, Canada. 

Enrollment period: 

September 1988-

June 1991 

Research objective: 

To determine whether zinc 

supplementation of 

hospitalized AN patients 

would enhance their rate of 

recovery as measured by 

the rate of increase in their 

BMI. 

Groups: 

G1: zinc (N = 26) 

G2: placebo (N = 28) 

Enrollment: 

• 54 randomized 

• 35 patients completed 

G1: N = 16

G2: N = 19 

Age, mean (SD): 

G1: 20.6 (3.8) 

G2: 23.8 (6.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Hospitalizations, mean 

(SD): 

G1: 1.9 (1.6) 

G2: 2.1 (1.8) 

(P = NS) 

Yrs since dx, mean (SD): 

G1: 3.6 (2.0) 

G2: 3.8 (3.2) 

(P = NS) 
C-25 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, ≥ 15 yrs old, 

inpatient for AN tx 

Exclusion: 

NR 

Routine inpatient tx for AN 

including group and individual 

psychotherapy; psychiatric meds 

and enteral feeding was 

individualized. On day 7 of 

admission baseline measures 

collected. Patient began trial of 

14 mg of elemental zinc or 

placebo on day 8. The study of 

each patient was terminated 

when a 10% wt gain above 

baseline was achieved on 2 

consecutive biwkly wtings. 

Two-tailed tests. 

Mann-Whitney U to 

compare zinc and 

placebo groups. Chi 

square with Yates 

correction used to 

compare number of 

patients in each group

who received 

psychiatric meds 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

No adverse events reported 

Funding: 

Vancouver Foundation 
C-26 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Birmingham, Goldner 

et al., 1994 

(continued) 

NR NR 
C-27 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR BMI, mean (SD): 

G1: 15.6 (1.2) 

G2: 16.2 (1.8) 

(P = NS) 

Rate BMI gain/day, mean 

(SD): 

G1: 0.079 (0.07) (P = NR) 

G2: 0.039 (0.06) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.03) 

G1 greater than G2 

 % total body fat, mean

(SD): 

G1: 15.0 (5.5) 

G2: 15.0 (4.0) 

(P = NS)

Rate % body fat gain/day, 

mean (SD): 

G1: 0.18 (0.18) 

(P = NR) 

G2: 0.02 (0.27) 

(P = NR) 

Diff between groups 

(P = NR) 

Diff between groups in change 

over time 

(P = NS) 

 Total wt gain (kg), mean 

(SD): 

G1: 3.6 (2.0) (P = NR) 

G2: 2.6 (2.7) (P = NR) 

Diff between groups 

(P = NS) 

Diff between groups in change 

over time 

(P = NR) 
C-28 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Brambilla et al., 1995 

Setting: 

Outpatient, Center for 

Eating Disorders of 

the Dipartimento di 

Scienze 

Neuropsichiche 

Universita, Milan, Italy 

Enrollment period: 

NR 

Research objective: 

To determine if a 4-mo 

course of combined 

cognitive-behavioral, 

nutritional, and 

antidepressant therapy 

(amineptine or fluoxetine) 

results in positive clinical 

effects in patients with ANbinge-eating/purging 

subtype. 

Groups: 

G1: Fluoxetine (N = 6) 

G2: Amineptine (N = 7) 

Enrollment: 

N = 13 

Completed: 100%; N = 13 

Age, mean (SD) (range): 

23.1 (6.8) (17-43) 

G1: NR 

G2: NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Length of illness, yrs, 

mean (SD) (range): 4.6 

(3.9) (3 mos – 13 yrs) 

G1: NR 

G2: NR 

Amenorrheic, N: 

3 
C-29 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of AN per DSM III-R and 

IV criteria 

Exclusion: 

NR 

CBT, nutritional counseling, 

and pharmacotherapy 

G1: 60 mg/day of fluoxtine 

orally (p.o.) 

G2: 300 mg/day of 

aminepine (p.o.) 

Length of Treatment: 

4 mos 

Student t test and 

MANCOVA for repeated 

measures with time by 

group. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

None 

Funding: 

NR 
C-30 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI, Global Score, mean (SD): 

G1: 99.6 (31.6) 

G2: 82.3 (42.7) 

(P = NR) 

EDI, Global Score at 4 mos, mean (SD): 

G1: 74.0 (13.7) (P = NR) 

G2: 46.2 (16.4) (P = NR) 

Change over time (P = 0.02) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

BITE, symptoms mean (SD): 

G1: 19.7 (4.4) 

G2: 20.2 (6.4) 

(P = NR) 

BITE, symptoms at 4 mos, mean (SD): 

G1: 23.8 (3.6) (P = NR) 

G2: 18.8 (7.7) (P = NR) 

Change over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

BITE, gravity mean (SD): 

G1: 10.7 (6.0) G2: 12.0 (7.7) 

(P = NR) 

BITE, gravity at 4 mos, mean (SD): 

G1: 10.4 (4.8) (P = NR) 

G2: 12.0 (6.3) (P = NR) 

Change over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Binge eating (not defined), mean (SD): 

G1: 3.5 (2) 

G2: 4.1 (1) 

(P = NR) 

Binge eating, mean (SD): 

G1: 3.2 (1.8) (P = NS) 

G2: 4.4 (0.5) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Brambilla et al., 1995 

(continued) 

Vomiting (not defined), mean (SD): 

G1: 3.2 (2.3) 

G2: 3.6 (2.3) 

(P = NR) 

Vomiting, mean (SD): 

G1: 2.2 (1.8) (P = NS) 

G2: 1.8 (2.0) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-31 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HAM-D, mean (SD): 

G1: 19.7 (7.3) 

G2: 20.2 (5.6) 

(P = NR) 

HAM-D at 4 mos, mean 

(SD): 

G1: 11.2 (6.9) (P = NR) 

G2: 11.2 (7.8) (P = NR) 

Change over time (P = 0.002)

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

BMI, mean (SD): 

G1: 16.7 (2.2) 

G2: 16.3 (2.8) 

(P = NR) 

BMI, mean (SD) at 4 mo: 

G1: 21.1 (6.3) (P = NS) 

G2: 17.7 (2.6) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

HAM-A, mean (SD): 

G1: 85.7 (20.9) 

G2: 89.4 (11.2) 

(P = NR) 

HAM-A at 4 mos, mean 

(SD): 

G1: 50.4 (34.8) (P = NR) 

G2: 37.0 (31.0) (P = NR) 

Change over time (P = 0.001)

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

 
C-32 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fassino et al., 2002 

Setting: 

Single center; 

outpatient; Centre for 

Eating Disorders, 

Turin University; 

Turin, Italy 

Enrollment period: 

September 1, 1998 

through September 1, 

2000 

Research objective: 

To study the efficacy of 

citalopram (an SSRI) 

in the outpatient tx of 

AN restricting type 

Groups: 

G1: citalopram (N = 26) 

G2: waitlist control (N = 26) 

Enrollment: 

• 98 screened who were 

consecutively admitted AN 

patients 

• 52 met criteria for AN 

restricting type and were 

randomized 

• 39 participants (G1 = 19, 

G2 = 20) remained by wk 

12 

Open label study, no masking 

of observers 

Age, mean (SD): 

G1: 24.35 (5.38) 

G2: 25.23 (8.64) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age of onset, mean (SD): 

G1: 18.42 (4.16) 

G2: 17.69 (3.92) 

(P = NS) 

Duration of disease in yrs, 

mean (SD): 

G1: 5.69 (4.90) 

G2: 7.54 (8.19) 

(P = NS) 

Duration of amenorrhea in 

mos, mean (SD): 

G1: 15.81 (14.83) 

G2: 20.11 (25.35) 

(P = NS) 
C-33 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of AN restricting 

type; age 16-35; no 

psychopharmacologic 

tx within the mo 

preceding the 

beginning of the study 

or 6 wks without tx 

with fluoxetine (an 

exception was made 

for 4 subjects who 

were permitted to 

continue tx with 

lorazepam for anxietyrelated sxs); no 

estrogen-progesterone 

therapy for the last mo 

Exclusion: 

Psychiatric 

comorbidity; sensitivity 

to citalopram 

All randomized subjects were 

part of a waitlist group for 

entering an integrated, usual 

practice tx for AN; half of 

subjects randomized to 

citalopram group and half to 

waitlist control group. Over 12 wk 

tx, subjects in citalopram group

initiated on 10 mg/day of the 

drug and increased to 20 mg/day 

after 6 days of tx. Subjects in the 

control group also followed by 

periodic clinical assessment and 

the administration of 

questionnaires of interest. 

MANOVAs to assess 

the efficacy of 

citalopram versus 

waitlist control (at 

baseline and 12 wks); 

univariate analyses to 

assess within group

diffs on questionnaire 

measures (at baseline 

and 12 wks); multiple 

regression models to 

assess the effect of 

citalopram on the 

outcome variables 

while controlling for 

age, duration of 

disease, personality 

disorders, and BMI at 

baseline. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

None 

Adverse events: 

NR 

Funding: 

NR 
C-34 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Fassino et al., 2002 

(continued) 

EDI-2, mean (SD): 

Bulimia 

G1: 5.88 (6.71) 

G2: 3.31 (3.66) 

(P = NR) 

EDI-2, mean (SD): 

Bulimia 

G1: 2.26 (4.07) 

G2: 3.30 (3.67) 

Diff between groups (P = NR) 

Change over time from baseline to wk 12: 

G1: 3.62 (P = 0.005) 

G2: 0.01 (P = NS) 

Diff between groups in change over time (P = NR) 
C-35 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 14.46 (7.73) 

G2: 12.65 (6.39) 

(P = NR) 

BDI, mean (SD): 

G1: 7.31 (5.07) 

G2: 12.30 (9.02) 

Diff between groups (P = NR) 

Change over time from 

baseline to wk 12: 

G1: -7.15 (P = 0.001) 

G2: -0.35 (P = NS) 

Diff between groups in 

change over time (P = NR) 

BMI, kg/m2

, mean 

(SD): 

G1: 16.19 (0.81) 

G2: 15.62 (1.42) 

(P = NR) 

BMI, kg/m2

, mean (SD): 

G1: 17.47 (1.41) 

G2: 16.33 (1.68) 

Diff between groups (P = NR) 

Change over time from 

baseline to 12 wks: 

G1: 1.28 (P = 0.002) 

G2: 0.71 (P = 0.005) 

Diff between groups in 

change over time (P = NR) 

SCL-90, mean (SD): 

Depression: 

G1: 26.73 (11.56) 

G2: 23.69 (12.49) 

(P = NR) 

SCL-90, mean (SD): 

Depression: 

G1: 17.11 (9.39) 

G2: 22.55 (12.78) 

Diff between groups (P = NR) 

Change over time from 

baseline to wk 12: 

G1: - 9.62 (P = 0.001) 

G2: - 1.14 (P = NS) 

Diff between groups in 

change over time (P = NR) 

Wt, kg, mean (SD): 

G1: 43.48 (3.93) 

G2: 42.48 (4.60) 

(P = NR) 

Wt, kg, mean (SD): 

G1: 46.47 (5.33) 

G2: 43.92 (4.86) 

Diff between groups (P = NR) 

Change over time from 

baseline to 12 wks: 

G1: 2.99 (P = 0.003) 

G2: 1.44 (P = 0.007) 

Diff between groups in 

change over time (P = NR) 

Anxiety: 

G1: 17.38 (8.16) 

G2: 15.65 (9.26) 

(P = NR) 

Anxiety: 

G1: 12.74 (6.59) 

G2: 14.15 (8.78) 

Diff between groups (P = NR) 

Change over time from 

baseline to wk 12: 

G1: - 4.64 (P = 0.005) 

G2: - 1.50 (P = 0.054) 

Diff between groups in 

change over time (P = NR) 

 
C-36 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Halmi et al., 1986 

Setting: 

Inpatient, University of 

Minnesota Hospitals, 

Minneapolis; New 

York Hospital – 

Cornell Medical 

Center, Westchester 

Division, White Plains, 

USA 

Enrollment period: 

NR 

Research objective: 

To assess the effects of 

amitriptyline and 

cyproheptadine for the tx 

of AN in an inpatient 

setting. 

Groups: 

G1: amitriptyline (N = 23) 

G2: cyproheptadine (N = 24) 

G3: placebo (N = 25) 

Enrollment: 

• 72 randomly assigned 

• 54 completed: 

• G1: 16 

• G2: 18 

• G3: 20 

Age, mean (SD) (range): 

20.56 (5.1) (13 to) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age of onset of AN, mean 

(SD): 

17.44 (4.6) (12 to 30) 

Duration of illness, yrs, 

mean (SD) (range): 

2.9 (2.3) (4 mo to 10 yrs). 

Marital status, N: 

Never married: 65 

Divorced/Separated: 3 

Married: 4. 

Hollingshead social level 

score (SD): 2.0 (1.2) 

corresponding to hs grad 

and employment level 

between white-collar and 

administrative 

No hx of binge eating, N: 

39 
C-37 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III criteria for AN 

plus amenorrhea 

Exclusion: 

NR 

Baseline assessment on days 2 

and 5 of the 7 day pre-tx period, 

conducted wkly during tx until 

patient reached within 5% of a 

normal wt for age and height (Per 

Iowa Growth Chart and 1959 

Metropolitan Height-Wt Chart). 

Drug dosage was increased per 

discretion of the investigator to 

obtain max drug dosage 

(cyproheptadine: 32 mg; 

amitriptyline: 160 mg) at the end of 

the 2nd wk of tx. Patients 

maintained on highest tolerated 

dosage. 

During the 7 day pre tx: patients 

could choose their own food. 

During drug tx, patients received 

nutritious liquid product (Sustacal) 

diluted to 1 kcal/mL given in 6 

equal feedings which was the only 

source of nutrients for first 15 days 

of tx (allowed as much as they 

wanted). After 15 days, patients 

received 3 meals of a regular diet 

and evening snack (allowed as 

much as they wanted). 

Length of time in tx varied by 

speed of reaching target wt or 

withdrawal due to clinical 

deterioration. Max days: 90 

Computed “tx 

efficiency” = reciprocal 

of days to target wt X 

90 (max days of tx). 

Chi Square, 

hierarchical multiple 

regression controlling 

for hospital, pre-tx wt, 

drug intervention, and 

interactions, ANOVA 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: Physical 

symptoms during tx, mean: 

Day 7: 

Moderate: 

G1: 1.80 

G2: 1.83 

G3: 2.48 

Severe: 

G1: 0.29 

G2: 0.13 

G3: 0.36 

Day 21: 

Moderate: 

G1: 1.95 

G2: 0.91 

G3: 1.80 

Severe: 

G1: 0.14 

G2: 0 

G3: 0.28 

(P = NR) 

G1: drowsiness, excitement, 

confusion, increased motor 

activity, tachycardia, dry 

mouth, constipation 

G2: no pattern 

G3: drowsiness, excitement, 

increased motor activity. 

Funding: 

NIMH 
C-38 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Halmi et al., 1986 

(continued) 

Caloric Intake, mean (SD): 

Pre-tx wk: 

G1: 1802 (746) 

G2: 1934 (940) 

G3: 1746 (542) 

(P = NR) 

Caloric Intake, mean (SD): Treatment wk: 

G1: 2450 (1094) 

G2: 3023 (1103) 

G3: 2390 (844) 

Diff between groups 

(P < 0.04) G2 greater than G3 

Diff between groups 

(P < 0.06)G2 greater than G1 
C-39 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

Day 2: 

G1: 26.0 (9.2) 

G2: 21.7 (12.7) 

G3: 22.0 (10.8) 

(P = NR) 

Day 7: 

G1: 19.7 (11.9) 

G2: 15.7 (9.4) 

G3: 14.4 (8.6) 

(P = NR) 

BDI, mean (SD): Day 14: 

G1: 17.9 (10.4) 

G2: 12.9 (9.5) 

G3: 14.5 (9.3) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Day 28: 

G1: 13.1 (12.1) 

G2: 11.5 (9.4) 

G3: 13.6 (9.8) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Treatment efficiency, mean (SD) 

(N = 72): 

G1: 3.21 (2.85) 

G2: 3.07 (2.95) 

G3: 2.30 (3.45) 

Diff between groups (P = NS) 

Composite Depression 

Scores created from BDI and 

HSCL-90), mean (SD): 

Day 2: 

G1: 5.1 (1.0) 

G2: 4.7 (1.5) 

G3: 4.3 (1.2) 

(P = NR) 

Day 7: 

G1: 4.3 (1.3) 

G2: 3.8 (1.2) 

G3: 3.6 (1.0) 

(P = NR) 

Composite Depression 

Scores created from BDI and 

HSCL-90, mean (SD): 

Day 14: 

G1: 4.0 (1.1) 

G2: 3.6 (1.1) 

G3: 3.6 (1.0) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Day 28: 

G1: 3.6 (1.1) 

G2: 3.5 (1.2) 

G3: 3.5 (1.0) 

Diff between groups (interaction 

of G2 and wt gain vs G3, P < 

0.01). Cyproheptadine + wt 

gain associated with less 

depression compared to 

placebo. 

Days to Target Wt in patients 

achieving target wt, mean (SD): 

G1 (N = 17) 32.24 (17.37) 

G2 (N = 20) 36.50 (19.53) 

G3 (N = 16) 45.00 (18.34) 

Diff between G1 and G3 (P = 0.05)

G1 better than G3 

Diff between G1 and G2 (P < 0.05)

G2 better than G3 

Hamilton Rating Scale, mean 

(SD): 

Day 2: 

G1: 17.3 (10.0) 

G2: 19.6 (9.5) 

G3: 20.4 (7.8) 

(P = NR) 

Day 7: 

G1: 15.7 (6.9) 

G2: 17.1 (6.8) 

G3: 17.8 (6.9) 

(P = NR) 

Diff between groups over time 

(P = NR) 

Hamilton Rating Scale, mean 

(SD): 

Day 14: 

G1: 14.6 (6.8) 

G2: 13.4 (7.9) 

G3: 18.1 (7.8) 

Diff between groups (P < 0.005)

Diff between G2 and G3 

(P < 0.001) 

G2 better than G3 

Day 28: 

G1: 14.1 (6.9) 

G2: 13.2 (6.5) 

G3: 17.7 (8.5) 

Wt gain/day, kg, mean (SD): 

G1: 0.31 (0.17) 

G2: 0.30 (0.19) 

G3: 0.23 (0.12) 

Diff between groups (interaction of 

G2 and wt on day 7 of tx vs G3, P 

< 0.03). Greater day 7 wt gain on 

cyproheptadine associated with 

greater rate of wt gain over 28 

days compared to placebo 
C-40 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Halmi et al., 1986 

(continued) 

 
C-41 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Treatment Efficiency in AN 

subgroups, mean (SD): 

Bulimic (N = 33) 

G1: 4.99 (3.55) 

G2: 2.37 (1.78) 

G3: 3.65 (5.45) 

Diff between groups (P < 0.01) 

G1 better than G2 

 Nonbulimic (N = 39): G1: 2.06

(1.51)

G2: 4.23 (4.12) 

G3: 1.54 (1.21) 

Diff between groups (P < 0.01) 

G2 better than G3 

 Treatment Failures (did not 

gain 2 kg after 6 wks of tx), 

N: 

G1: 6 

G2: 4 

G3: 9 

(P = NR) 
C-42 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hill et al., 2000 

Setting: 

Inpatient at Children’s 

Hospital Medical 

Center, Cincinnati, 

Ohio, USA 

Enrollment period: 

NR; 28 days 

Research objective: 

To learn if rhGH improves the 

efficiency of tx protocols for 

malnourished AN patients 

who have 

medical/cardiovascular 

instability and require 

hospitalizations. 

Groups: 

G1: rhGH (N = 8) 

G2: placebo (N = 7) 

Enrollment: 

• 15 enrolled and 

completed 

Age, mean (SD): 

G1: 14.5 

G2: 15 

Range: 12-18 

Sex: 

Female: 

G1: N = 7 

G2: N = 7 

Race/ethnicity: 

NR 
C-43 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for AN; 

sigly malnourished ( < 

80% of IBW according 

to Frisancho’s 

standard criteria). 

Exclusion: 

Suicidal ideation; preexisting medical 

conditions unrelated to 

AN which could 

complicate nutritional 

rehabilitation (e.g., 

inflammatory bowel 

disease, chronic lung 

disease, cardiac 

disease). 

G1: rhGH (0.05 mg/kg 

subcutaneously) received daily 

until discharge for a max of 28 

days. 

G2: Placebo 

All patients received standard 

clinical care for AN. 

Comparison of mean 

responses between 

groups: two-sample t 

tests. Comparison of 

the median waiting 

time to achieve 

orthostasis between 

groups: log rank 

statistic. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Monitored and none were 

reported 

Funding: 

NIMH, the Genentech 

Foundation for Growth and 

Development, the NIH, and 

the Veterans Administration 
C-44 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Hill et al., 2000 

(continued) 

NR NR 
C-45 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR Wt (kg): 

G1: 38.3 

G2: 40.7 

(P = NS) 

Cardiovascular stability (2 

consecutive mornings that 

patient was no longer 

orthostatic by pulse; 

orthostasis: change in pulse 

from a supine to standing 

position of > 20 beats per 

minute): 

Estimate is diff in median time 

until patient no longer 

orthostatic 

G1: 17 days 

G2: 37 days 

Diff between groups (P < 0.02) 

 Median length of 

hospitalization: 

G1: 32 days 

G2: 39 days 

Diff between groups (P = NS) 

 Rate of wt gain: 

G1: 0.235 (0.077) kg/day 

G2: 0.166 (0.127) kg/day 

Diff between groups (P = NS) 
C-46 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design 

Patient 

Characteristics 

Author, yr: 

Kaye et al., 2001 

Setting: 

Single center; 

inpatient and 

outpatient; location: 

eating disorders tx 

program at Western 

Psychiatric Institute 

and Clinic, University 

of Pittsburgh Medical 

Center, Pittsburgh, 

PA, USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy 

and safety of fluoxetine 

(an SSRI) in the longterm relapse 

prevention (52 wks) 

among restricting-type 

AN patients following 

intensive cognitivebehavioral, and dietary 

inpatient intervention. 

Also examined effect 

of fluoxetine on core 

eating disorder 

symptoms, 

obsessionality, and 

depression. 

Groups: 

G1: fluoxetine (N = 16) 

G1A: fluoxetine completers (N = 10) 

G1B: fluoxetine drop-outs (N = 6) 

G2: placebo (N = 19) 

G2A: placebo completers (N = 3) 

G2B: placebo drop-outs (N = 16) 

Enrollment: 

• 95 screened who were admitted 

to the eating disorder inpatient 

unit 

• 39 enrolled and randomized 

(G1: N = 19; G2: N = 20) 

• 35 took fluoxetine or placebo for 

at least 30 days 

(G1: N = 16; G2: N = 19) 

• 13 completers remained at 1 yr 

FU 

(G1: N = 10; G2: N = 3) 

(P = 0.006) 

Age, mean (SD): 

G1: 23 (9) 

G2: 22 (6) 

(P = NS) 

G1A, G1B, G2A, G2B: 

NR

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age of onset (SD): 

G1: 16 (5) 

G2: 18 (5) 

(P = NS) 

G1A, G1B, G2A, G2B: 

NR 

(P = NS) 
C-47 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM IV criteria for 

AN (restricting and 

restricting and purging 

types) when they were 

underwt 

Exclusion: 

Hx of binge-eating; 

concurrent severe 

medical or 

neurological 

conditions; concurrent 

or previous 

schizophrenia; 

concurrent or recent 

(within last 12 mos) 

alcohol or substance 

dependence; use of 

psychotropic meds 

within a mo before 

entry (exception was 

alprazolam) 

Subjects were randomly assigned 

to either initiation on fluoxetine or 

placebo prior to discharge. They 

began at a dosage of 20 mg/day 

and were adjusted over the 52 

wks up to a max of 60 mg/day. 

Subjects evaluated every 4 wks 

after discharge (if status 

deteriorated sigly, then assessed 

every wk). Allowed to receive 

outpatient psychotherapy if they 

desired. 

Survival analysis; 

Repeated measures 

MANOVAs for tx 

completers and dropouts by condition, 

paired t-tests 

Score: 

Fair 

Intent to treat: 

No, data analyzed either on 

the sample of 35 who 

completed at least 30 days of 

tx or for those whom data 

available through the 1 yr FU 

(N = 13) 

Blinding: 

Double 

Adverse events: 

NR 

Funding: 

Eli Lilly Corporation, NIMH 
C-48 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

YBOCS-ED (SD): 

G1: 20.9 (11.2) 

G2: 20.5 (9.5) 

(P = NS) 

G1A: 21.2 (11.2) 

G1B: 20.3 (13.3) 

G2A: 25.7 (2.9) 

G2B: 19.5 (10.1) 

(P = NR) 

YBOCS-ED: 

Change from baseline to 1 yr: 

G1A: -8.4 (P < 0.05) 

G1B: 4.2 (P = NS) 

G2A: -14.3 (P = NS) 

G2B: 0.8 (P = NS) 

Diff between G1 and G2 (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Kaye et al., 2001 

(continued) 

 Abstinence/remission rates: 

NR 
C-49 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS (SD): 

G1: 13.7 (10.7) 

G2: 13.9 (10.4) 

(P = NS) 

G1A: 13.4 (9.7) 

G1B: 14.3 (13.1) 

G2A: 4.0 (5.3) 

G2B: 15.8 (10.0) 

(P = NR) 

HDRS (SD): 

Change from baseline to 1 yr:

G1A: -8.2 (7.9) (P < 0.01) 

G1B: 0.3 (8.1) (P = NS) 

G2A: 1.7 (2.1) (P = NS) 

G2B: -3.5 (10.5) (P = NS) 

Diff between G1 and G2 

(P = NS) 

Diff between groups in change 

over time (P = NS) 

%ABW at entry (SD): 

G1: 89 (6) 

G2: 89 (7) 

(P = NS) 

G1A: 88 (7) 

G1B: 92 (5) 

G2A: 89 (12) 

G2B: 90 (6) 

(P = NS) 

%ABW (SD): 

Change from baseline to 

1 yr: 

G1A: 5.3 (5.3) (P < 0.01) 

G1B: -1.2 (3.3) (P = NS) 

G2A: 11.2 (11.9) (P = NS) 

G2B: -0.2 (6.7) (P = NS) 

Diff between G1 and G2 

(P = NS) 

Diff between groups in 

change over time (P = NS)

HAM-A (SD): 

G1: 11.3 (7.5) 

G2: 11.2 (6.4) 

(P = NS) 

G1A: 10.6 (1.7) 

G1B: 12.5 (4.4) 

G2A: 5.3 (3.9) 

G2B: 12.3 (1.5) 

(P = NR) 

HAM-A: 

Change from baseline to 1 yr:

G1A: -5.1 (P < 0.01) 

G1B: -0.8 (P = NS) 

G2A: -2.0 (P = NS) 

G2B: -2.4 (P = NS) 

Diff between G1 and G2 

(P = NS) 

Diff between groups in change 

over time (P = NS) 

Low lifetime %ABW (SD): 

G1: 70 (8) 

G2: 73 (7) 

(P = NS) 

G1A, G1B, G2A, G2B: NR 

(P = NS) 

Y-BOCS (SD): 

G1: 15.0 (10.1) 

G2: 14.3 (7.7) 

(P = NS) 

G1A: 16.8 (9.6) 

G1B: 12.0 (11.2) 

G2A: 8.0 (8.5) 

G2B: 15.5 (7.2) 

(P = NR) 

Y-BOCS (SD):Change from 

baseline to 1 yr: 

G1A: -8.6 (12.7) (P < 0.10) 

G1B: 8.6 (7.2) (P < 0.10) 

G2A: -1.0 (5.6) (P = NS) 

G2B: -1.6 (6.9) (P = NS) 

Diff between G1 and G2 

(P = NS) 

Diff between groups in change 

over time (P = NS) 

High lifetime %ABW (SD): 

G1: 110 (24) 

G2: 112 (16) 

(P = NS) 

G1A, G1B, G2A, G2B: NR 

(P = NS) 
C-50 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Klibanski et al., 1995 

Setting: 

Single center; 

inpatient evaluation, 

otherwise outpatient 

location: General 

Clinical Research 

Center and Eating 

Disorders Unit, 

Massachusetts 

General Hospital; 

Boston, MA, USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy 

and safety of estrogen 

and progestin 

replacement therapy 

for reducing bone loss 

in patients with AN at 

6-mo intervals over an 

avg of 1.5 yrs. 

Groups: 

G1: estrogen/progestin (N = 22) 

G2: control (N = 26) 

Enrollment: 

• 48 women were enrolled and 

randomized who were 

recruited from the hospital’s 

Eating Disorders Clinic and 

from psychiatrists in the 

community 

• 44 completers 

G1: N = 19 

G2: N = 25 (P = NR) 

Age, mean (SD): 

G1: 23.7 (7.2) 

G2: 25.8 (6.6) 

Range: 16.3-42.5 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-51 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women who met DSM 

III-R criteria for AN 

Exclusion: 

Other illnesses; taking 

meds that could 

impact bone density 

(e.g., thyroid hormone, 

antiseizure meds, or 

glucocorticoids) 

Enrolled subjects were 

randomized either to the estrogen 

or non-meds control group. Tx 

included Premarin (0.625 mg, 

days 1-25), Provera (5 mg, days 

16-25) or oral contraceptive. 

Biochemical indicators including 

bone density and serum hormone 

levels assessed at 6-mo intervals 

for an avg of 1.5 yrs. No 

psychosocial measures assessed.

All participants also took 1500 mg 

calcium. 

Students t-tests and 

Fisher’s Exact Test 

used to evaluate 

between group diffs 

on the primary 

variables of interest 

including logtransformed spinal 

bone density. 

ANCOVAs used to 

test for interactions 

between the clinical 

and biochemical 

variables in affecting 

bone density changes 

over time. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

Depression: 

G1: N = 1 

G2: N = 0 

(P = NR) 

Hyperlipidemia: 

G1: N = 1 

G2: N = 0 

(P = NR) 

Funding: 

NIH and Rubenstein 

Foundation 
C-52 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Klibanski et al., 1995 

(continued) 

NR NR 
C-53 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR Wt, kg mean (SD): 

G1: 43.03 (7.3) 

G2: 41.0 (5.6) 

(P = NR) 

Wt, kg mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

% IBW, mean (SD): 

G1: 72 (9) 

G2: 72 (8) 

(P = NS) 

%IBW, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

% Body fat, mean (SD): 

G1: 15 (5) 

G2: 14 (4) 

(P = NS) 

% Body fat, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

Bone density, mg 

K2HPO4/cm3

 mean (SD): 

G1: 124 (25) 

G2: 134 (28) 

Bone density, mg 

K2HPO4/cm3 mean (SD): 

G1: 128 (26) 

G2: 132 (31) 

Diff between groups in 

change over time (P = NS) 

Serum hormone levels, 

mean (SD): 

Ethinyl estradiol, pmol/L:

G1: 81 (29) 

G2: 77 (44) 

(P = NS) 

Serum hormone levels, 

mean (SD): 

G1: NR 

G2: NR 

(P = NS) 

Testosterone, nmol/L: 

G1: 1.2 (0.7) 

G2: 1.5 (0.8) 

(P = NS) 

Unbound Testosterone, 

pmol/L: 

G1: 14 (7) 

G2: 16 (10) 

(P = NS) 

IGF-1, U/L: 

G1: 223 (102) 

G2: 229 (89) 

(P = NS) 

TT3, nmol/L: 

G1: 1.5 (0.3) 

G2: 1.6 (0.4) 

(P = NS) 

 Remission/Recovery = 

85% IBW and 

spontaneous return of 

menses: 

G1: N = 2 

G2: N = 6 

(P = NS) 
C-54 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Miller et al., 2005 

Setting: 

MA General Hospital, 

Boston, USA 

Enrollment period: 

NR 

Research objective: 

Investigate effectiveness of 

low-dose testosterone 

replacement in increasing 

bone formation, depression 

and spatial abilities of 

women with AN and relative 

androgen deficiency. 

Groups: 

G1: Testosterone (N = 24) 

G2: Placebo (N = 9) 

Enrollment: 

• 38 women were 

enrolled in the study. 

• 5 dropped out, resulting 

in 33 participants. 

• 33 individuals 

randomized to receive 

testosterone or 

placebo. 

Age, mean (SD): 

G1: 25 (1) 

G2: 22 (1) 

Range: 18-50 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mos since last menstrual 

period (SEM): 

G1: 20 (5) 

G2: 14 (6) 

Bone Mineral Density at 

L4, mg/cc of K2 HPO4 

(SEM): 

G1: 126 (5) 

G2: 135 (6) 
C-55 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women; aged 18-50 yrs; 

DSM IV criteria for AN; < 

85%IBW; amenorrhea for at 

least 3 mos; all psychiatric 

manifestations of AN; serum 

free testosterone level < 

median of reference range 

for premenopausal women; 

no oral contraceptives, 

progesterone derivatives, 

glucocorticoids, anabolic 

agents or any meds known 

to affect bone metabolism 

within 3 mos before study 

enrollment; no fracture 

within one yr of 

participation. 

Exclusion: 

NR 

Doses of 150 and 300 μg 

transdermal testosterone 

(Patches) administered to 

two groups on group given 

placebo for a period of 3 

wks. 

Antidepressant use allowed, 

no sig diff in use between 

G1 and G2 at baseline. 

ANOVA to compare 

baseline characteristics and 

Wilcoxon rank-sums test for 

non-normal distributions 

Repeated measures 

ANOVA for biomarkers and 

mood. Data from two meds 

groups combined for 

analysis on tx effects after 

determining that there was 

no statistically sig diff 

between groups. For 

analysis of cognitive 

abilities, ANCOVA was 

used. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

Participants and 

investigators were blind to 

group assignment. 

Adverse events: 

Mild skin irritation at the 

patch site (G1 = 3, 

G2 = 1). 1 participant in 

G1 with a hx of affective 

disorder reported 

increased depression and 

anxiety after 10 days of tx. 

Other side effects included 

increased fatigue and 

vertigo (G2 = 1), nausea 

(G2 = 1) and life 

threatening wt loss (G2 = 

1, G1 = 1) 

Funding: 

NIH 
C-56 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Miller et al., 2005 

(continued) 

NR NR 
C-57 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI (SEM): 

G1: 12 (2) 

G2: 14 (3) 

BDI (SEM): 

G1: 15.1 (2.6) 

G2: 19.3 (5.2) 

Diff between groups (P = 0.02) 

Diff between groups in change 

over time (P = 0.03) 

%IBW (SD): 

G1: 76.9 (1.6) 

G2: 75.6 (2.5) 

BMI: 

G1: NR 

G2: NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.02) 

 Free testosterone, 

pmol/liter (SEM): 

G1: 8.9 (1.1) 

G2: 9.1 (1.2) 

Free testosterone, pmol/liter

(SEM): 

G1: 26.7 (3.0) 

G2: 8.9 (1.5) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.0001) 

G1 greater increase than G2 

BDI in depressed 

subgroup (score > 10): 

G1: 20.4 (2.1) 

G2: 19.8 (3.8)

BDI in depressed subgroup: 

G1: 15.1 (2.6) 

G2: 19.3 (5.2) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.02) 

G1 better than G2 

Total testosterone, 

nmol/liter (SEM): 

G1: 0.9 (0.4) 

G2: 0.9 (0.3) 

Total testosterone, 

nmol/liter (SEM): 

G1: 2.4 (0.2) 

G2: 0.8 (0.1) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.0001) 

G1 greater increase than G2

 Estradiol, nmol/liter 

(SEM): 

G1: 0.07 (0.007) 

G2: 0.07 (0.01) 

Estradiol, nmol/liter (SEM): 

G1: 0.07 (0.009) 

G2: 0.06 (0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 SHBG, nmol/liter (SEM): 

G1: 113.9 (14.1) 

G2: 103.6 (20.1) 

SHBG, nmol/liter (SEM): 

G1: 114.1 (14.3) 

G2: 116.1 (16.0) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 Dehydroepiandrosterone 

Sulphate, nmol/liter 

(SEM): 

G1: 341 (26) 

G2: 354 (37) 

Dehydroepiandrosterone 

Sulphate, nmol/liter (SEM): 

G1: 338 (33) 

G2: 394 (53) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-58 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Miller et al., 2005 

(continued) 

NR NR 
C-59 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 IGF-I, nmol/liter (SEM): 

G1: 30 (3) 

G2: 26 (4) 

IGF-I, nmol/liter (SEM): 

G1: 32 (4) 

G2: 28 (5) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 PICP, μg/liter (SEM): 

G1: 132 (12) 

G2: 119 (19) 

PICP, μg/liter during drug 

administration (SEM): 

G1: NR 

G2: NR 

Diff between groups (P = NR) 

diff between groups in change 

over time (P = 0.02) 

 Osteocalcin, μg/liter 

(SEM): 

G1: 13.9 (1.7) 

G2: 11.1 (2.0) 

Osteocalcin, μg/liter (SEM): 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

 Bone Specific Alkaline 

Phosphatase, μkat/liter 

(SEM): 

G1:.38 (.02) 

G2:.37 (.04) 

Bone Specific Alkaline 

Phosphatase, μkat/liter 

(SEM): 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

 N-telopeptide, nM BCE 

(SEM): 

G1: 16 (1) 

G2: 18 (3) 

N-telopeptide, nM BCE 

(SEM): 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-60 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Ruggiero et al., 2001 

Setting: 

Inpatient Endocrinology 

Department, Istituto 

Auxologico, Milan 

University Hospital, 

Milan, Italy 

Enrollment period: 

March 1997 to 

November 1998 

Research objective: 

Compare amisulpride, 

clomipramine, and fluoxetine 

in treating AN and improving 

attitudes toward wt gain, 

eating, body shape and fear 

of fatness. 

Groups: 

G1: clomipramine (N = 13) 

G2: fluoxetine (N = 10) 

G3: amisulpride (N = 12) 

Enrollment: 

Participants selected from a 

larger population of 164 ED 

patients treated in the 

endocrinology department. 

Age, mean (SD): 

G1: 23.69 (4.57) 

G2: 24.50 (5.06) 

G3: 24.33 (5.76) 

(P = NR) 

Sex: 

NR 

Height: mean cm (SD): 

G1: 160.00 (9.17) 

G2: 160.40 (6.59) 

G3: 163.42 (4.03) 

(P = NR) 

Race/ethnicity: 

NR 
C-61 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of restricting type 

AN according to DSM 

IV, severe underwt 

condition needing 

urgent wt restoration, 

capacity to cooperate 

according to current 

health. 

Exclusion: 

Being younger than 17 

yrs, not consenting, 

not completing 

refeeding tx, not 

speaking Italian with 

sufficient fluency, 

showing clear 

psychiatric comorbidity 

such as, depression, 

anxiety or obsessivecompulsive disorder 

and delusional body 

image related thinking. 

Meds management done within 

the context of the 3-mo refeeding 

tx offered on the unit. G1 treated 

with clomipramine at a mean 

dosage of 57.69 mg/d (SD = 

25.79). G2 treated with fluoxetine 

at a mean dosage of 28 mg/d (SD 

= 10.32) and G3 treated with 

amisulpride at a mean dosage of 

50 mg/d (SD = 0). 

ANOVA and Tukey’s 

honestly sig diff were 

used to compare 

percentage wt 

increases of the 3 

groups. T-tests used 

for paired data to 

compare absolute wt 

values of each group. 

The McNemar test for 

present/absent 

dichotomous variables 

used for the variables 

of wt phobia, body 

image, amenorrhea, 

bingeing and purging. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

NR 
C-62 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Bingeing 

G1: 0 

G2: 0 

G3: 0 

Bingeing: 

G1: 0 

G2: 40% 

G3: 25% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Purging: 

G1: 0 

G2: 0 

G3: 0

Purging: 

G1: 0 

G2: 30% 

G3: 25% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Ruggiero et al., 2001 

(continued) 

Abstinence/Remission: 

NR 
C-63 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Wt phobia: 

G1: 61.53% 

G2: 60% 

G3: 91.66% 

(P = NR) 

Wt Phobia: 

G1: 30.76% 

G2: 50% 

G3: 75% 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wt in kgs (SD): 

G1: 37.62 (9.80) 

G2: 40.90 (6.98) 

G3: 38.42 (8.33) 

(P = NR) 

Wt in kgs (SD): 

G1: 38.84 (9.38) (P = NS) 

G2: 42.75 (7.54) (P = 0.04) 

G3: 42.66 (10.09) (P = 0.01) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Body Image 

Disturbance: 

G1: 46.15% 

G2: 50% 

G3: 75% 

(P = NR) 

Body Image Disturbance: 

G1: 30.76% 

G2: 30% 

G3: 66.66% 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

BMI: 

G1: 14.69 

G2: 15.97 

G3: 14.44 

(P = NR) 

BMI: 

G1: 15.17 

G2: 16.70 

G3: 16.03 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 Amenorrhea: 

G1: 84.61% 

G2: 70% 

G3: 91.66% 

(P = NR) 

Amenorrhea: 

G1: 53.84% 

G2: 70% 

G3: 66.66% 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)
C-64 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Szmukler et al., 1995 

Setting: 

Two inpatient tx 

centers for AN 

Australia 

Enrollment period: 

NR 

Research objective: 

Test effectiveness of 

cisapride in treating gastric 

and psychological features 

associated with AN 

Groups: 

G1: Cisapride (N = 16) 

G2: Placebo (N = 13) 

Enrollment: 

• Consecutive inpatients 

at tx centers for AN 

• Patients recruited soon 

after admission; 

however, meds trial 

started on avg 9 days 

after admission 

• 50 patients invited to 

participate in the study 

and 34 agreed. 

• Of these, 5 did not 

progress beyond 2 wks. 

• Gastric emptying 

patterns in 10 normal 

female controls 

(university students and 

staff) also studied over 

2 time periods 

Age, mean (SE): 

G1: 21.5 (0.8) 

G2: 22.5 (2.0) 

Diff between groups 

(P = NS) 

Sex: 

NR 

Race/ethnicity: 

NR 

Height, cms (SE): 

G1: 163.5 (1.7) 

G2: 166.5 (1.4) 

Diff between groups 

(P = NS) 

Duration of illness, mos 

(SE): 

G1: 39.5 (11.4) 

G2: 23.5 (4.8) 

Diff between groups 

(P = NS) 
C-65 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

current AN, aged 18-

40 yrs. Eligible if they 

had bulimic symptoms 

as long as the criteria 

for current AN still met. 

Exclusion: 

Concurrent illness that 

would affect gastric 

emptying. 

Cisapride, 10 mg orally, three times 

daily. Patients were all expected to 

consume between 2500 to 3500 

kCal per day. At entry to the trial, 

patients were asked to fast 

overnight, given a meal and 

measures of gastric emptying, lag 

and subjective states were 

evaluated. A full blood examination 

was also done. 

Slopes representing 

change over time for 

each patient using the 

least squares method. 

The slopes for change 

were correlated 

among the variables. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

Yes 

Adverse events: 

One patient reported loose 

motions without abdominal 

pain. 

Funding: 

Janssen-Cilag patienty Ltd. 
C-66 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Szmukler et al., 1995 

(continued) 

NR NR 
C-67 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI (SE): 

G1: 28.6 (2.6) 

G2: 26.5 (3.2)

Change in BDI (SE): 

G1: - 9.0 (2.6)

G2: - 6.8 (3.6) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NS)

Wt, kg (SE): 

G1: 40.5 (1.7) 

G2: 41.6 (1.8)

Change in Wt, kg (SE): 

G1: 5.1 (0.5) 

G2: 5.7 (0.6) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS)

Visual Analog 

Scale (SE): 

Miserable: 

G1: 56 (10) 

G2: 33 (8)

Change in Visual Analog Scale 

(SE): 

Miserable: 

G1: - 15 (12) 

G2: - 4 (12) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS)

 

Tense: 

G1: 54 (9) 

G2: 35 (8)

Tense: 

G1: - 17 (10) 

G2: - 6 (11) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS)

 

Bloated: 

G1: 57 (9) 

G2: 58 (9) 

Bloated: 

G1: - 16 (11) 

G2: - 7 (7) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS)

 

Fat: 

G1: 59 (9) 

G2: 55 (8)

Fat: 

G1: - 20 (11) 

G2: 0 (7) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS)

 

Hot: 

G1: 23 (8) 

G2: 27 (8) 

Hot: 

G1: - 7 (9) 

G2: 1 (8) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

 

Hungry: 

G1: 8 (3) 

G2: 32 (8) 

(P < 0.01)

Change in Hunger: 

G1: 27 (10) 

G2: - 9 (7) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.02)

 
C-68 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Szmukler et al., 1995 

(continued) 

Global Improvement in Eating Symptoms (SE): 

G1: 2.50 (0.27) 

G2: 3.38 (0.18) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G1 better than G2 
C-69 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 
C-70 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Vandereycken, 1984 

Setting: 

Inpatient at the 

University Psychiatric 

Center St-Jozef in 

Kortenberg, Belgium 

Enrollment period: 

NR 

Research objective: 

To investigate the use of 

sulpiride in AN 

Groups: 

G1: sulpiride – placebo 

sequence (N = 9) 

G2: placebo – sulpiride 

sequence (N = 9) 

Enrollment: 

NR 

Age, yrs, mean (SD): 

G1: 23.2 (6.5) 

G2: 23.7 (9.6) 

(P = NS) 

Sex: 

Female: 

G1: 100% 

G2: 100% 

Race/ethnicity: 

NR 

Duration of illness (mos), 

mean (SD): 

G1: 51.8 (49.2) 

G2: 74.9 (106.9) 

(P = NS) 
C-71 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female dx of AN 

(DSM III criteria), no 

additional drug tx 

(except hypnotics) 

Exclusion: 

NR 

Double-blind cross-over design. 

After 1 wk baseline, patients began 

2 meds periods of 3 wks each. 13 

patients received daily dose of 300 

mg (100 mg t.i.d.) and 5 received 

400 mg (200 mg b.i.d.). Inpatient tx 

as usual. 

Inter-group

comparison (MannWhitney U-test) 

Evidence table only 

contains outcomes 

prior to cross-over. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

None reported 

Funding: 

Drug and placebo provided by 

Laboratoire Delagrange, 

Belgium 
C-72 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Vandereycken, 1984 

(continued) 

EAT, mean (SD): 

Preoccupation with eating/body wt: 

G1: 50.9 (26.0) 

G2: 31.0 (17.2) 

(P = 0.05) 

G2 lower than G1 

AN Behavior, mean (SD): 

Nurse observation: 

G1: 17.7 (6.7) 

G2: 18.7 (5.5) 

(P = NS) 

Psychiatrist observation: 

G1: 10.7 (6.9) 

G2: 9.5 (7.7) 

(P = NS) 

EAT, mean (SD): 

Preoccupation with eating/body wt: 

G1: 39.0 (27.2) (P = NR) 

G2: 17.8 (8.9) (P = NR) 

Diff between groups (P = 0.03) 

G2 lower than G1 

Diff between groups in change over time (P = NR)

AN Behavior, mean (SD): 

Nurse observation: 

G1: 15.1 (5.6) (P = NR) 

G2: 14.1 (4.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Psychiatrist observation: 

G1: 12.2 (9.3) (P = NR) 

G2: 7.0 (6.2) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)
C-73 

Evidence Table 1. Medication trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BAT, mean (SD): 

G1: 42.6 (11.4) 

G2: 30.4 (12.8) 

(P = 0.05) 

BAT, mean (SD): 

G1: 36.8 (12.9) (P = NR) 

G2: 27.7 (8.1) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wt (kg), mean (SD): 

G1: 40.4 (4.6) 

G2: 38.3 (4.3) 

(P = NS) 

Wt vs ideal wt (%) (SD): 

G1: 71.6 (8.2) 

G2: 67.6 (7.2) 

(P = NS) 

Wt vs premorbid wt (%) 

(SD): 

G1: 70.7 (5.9) 

G2: 69.9 (6.4) 

(P = NS) 

Wt change (g/day) during 

1-wk pre-tx phase, mean 

(SD): 

G1: 86.4 (126.8) 

G2: 141.0 (115.5) 

(P = NS) 

Wt change (g/day), mean 

(SD): 

G1: 153.8 (91.0) (P = NR) 

G2: 92.6 (49.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-74 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Ricca et al., 1999 

Setting: 

Outpatient ED clinic, 

Italy 

Enrollment period: 

June 1, 1997 – April 

31, 1998 

Research objective: 

To compare the efficacy of 

venlafaxine and fluoxetine in 

the tx of atypical AN when 

combined with CBT. 

Groups: 

G1: Fluoxetine (N = 13) 

G2: Venlafaxine (N = 13) 

Enrollment: 

• 26 Enrolled 

• 24 completed (1 drop

out in each group) 

Age, mean (SD): 

19.0 (3.7) 

G1: 19.1 (3.6) 

G2: 18.9 (3.8) 

(P = NS) 

Sex: 

Female: 100%

Race/ethnicity: 

NR 

Marital Status, N: 

Unmarried: 

G1: 9 

G2: 7 

Married: 

G1: 2 

G2: 3 

Separated/Divorced: 

G1: 1 

G2: 2 

(P = NR) 

Education, N: 

Junior HS: 

G1: 4 

G2: 3 

Senior HS: 

G1: 8 

G2: 9 

Employment Status, N: 

Unemployed: 

G1: 0 

G2: 1 

Employed: 

G1: 4 

G2: 5 

Student: 

G1: 8 

G2: 6 

(P = NR) 

Axis I Dx per SCID for 

DSM III-R: 

Dysthymia: 

G1: 4 

G2: 4 
C-75 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Atypical AN defined as 

all DSM IV criteria 

except one and criteria 

for other ED not 

fulfilled. Atypical AN = 

all criteria for AN 

except: 1) amenorrhea 

2) wt loss (body wt 

above the dx 

threshold). 

Exclusion: 

Illiteracy, mental 

retardation, concurrent 

medical condition that 

would preclude use of 

antidepressants, 

psychotropic drugs in 

the previous 2 mo 

(except for low doses 

of anxiolytic or 

hypnotic compounds). 

G1: 40 mg/day 

G2: 75 mg/day 

Both had CBT provided wkly on an 

outpt basis. 

Tx: 6 mo 

Paired and unpaired 

student’s t test, 

Wilcoxon, MannWhitney U 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

No 

Adverse events, 2 stopped 

tx N: 

G1: 1 nausea 

G2: 1 constipation 

Funding: 

NR 
C-76 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Ricca et al., 1999 

(continued) 

 Adjustment disorder with 

depressed mood (ADDM) 

G1: 2 

G2: 3 

OCD: 

G1: 1 

G2: 1 

Diff between groups (P = NR) 
C-77 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-78 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE, restraint, mean (SD): 

G1: 3.17 (1.23) 

G2: 3.40 (1.26) 

(P = NR) 

EDE, restraint, mean (SD): 

G1: 2.57 (1.15) 

Diff over time (P < 0.05) 

G2: 2.74 (0.85) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE, eating concerns, mean (SD): 

G1: 3.14 (1.47) 

G2: 3.12 (2.12) 

(P = NR) 

EDE, eating concerns, mean (SD): 

G1: 2.66 (1.07) 

Diff over time (P = 0.05) 

G2: 2.65 (1.76) 

Diff over time (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE, wt concerns, mean (SD): 

G1: 2.85 (1.46) 

G2: 3.40 (1.73) 

(P = NR) 

EDE, wt concerns, mean (SD): 

G1: 2.54 (1.25) 

Diff over time (P = 0.05) 

G2: 3.08 (1.41) 

Diff over time (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Ricca et al., 1999 

(continued) 

EDE, shape concerns, mean (SD): 

G1: 3.62 (1.04) 

G2: 3.88 (1.77) 

(P = NR) 

EDE, shape concerns, mean (SD): 

G1: 3.16 (0.86) diff over time (P < 0.01) 

G2: 3.48 (0.89) diff over time (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-79 

Evidence Table 2. Medication plus behavioral intervention trials for anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 12.50 (8.75) 

G2: 16.25 (9.32): 

(P = NR) 

BDI, mean (SD): 

G1: 7.25 (4.27) 

Diff over time (P < 0.01) 

G2: 7.67 (3.96) 

Diff over time (P < 0.001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

BMI, mean (SD): 

G1: 15.84 (0.46) 

G2: 15.67 (0.59) 

(P = NS) 

BMI, mean (SD): 

G1: 18.7 (1.1) 

Diff over time (P < 0.001) 

G2: 18.3 (1.3) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

STAI-State, mean (SD): 

G1: 41.00 (8.06) 

G2: 45.17 (9.02) 

(P = NR) 

STAI-State, mean (SD): 

G1: 51.08 (9.94) 

Diff over time (P = 0.001) 

G2: 38.00 (4.88) 

Diff over time (P < 0.001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.001)

G1 increased in state anxiety 

while G2 decreased 

 

STAI-Trait, mean (SD): 

G1: 44.17 (9.16) 

G2: 50.25 (10.0) 

(P = NR) 

STAI-Trait, mean (SD): 

G1: 45.50 (8.47) 

Diff over time (P = NS) 

G2: 39.67 (4.83) 

Diff over time (P < 0.001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.001) 

G1 showed no change while 

G2 decreased in trait anxiety 

 
C-80 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa 

Study Description Objective Design Patient Characteristics 

Author, year: 

Birmingham et al., 2004 

Setting: 

Inpatient 

Vancouver, British 

Columbia, Canada 

Enrollment period: 

NR 

Research objective: 

To determine if warming 

therapy increases the rate 

of weight gain in patients 

with AN. 

Groups: 

G1: Warming treatment (N = 10) 

G2: Control (N = 11) 

Enrollment: 

Assessed: N = 32 

Enrolled: N = 21 

Completed: N = 18 

G1: 10 

G2: 8 

Age, mean (SD): 

Total Sample: 28.4 (6.6) 

G1: 26.4 (4.8) 

G2: 30.2 (7.6) 

(P = NS) 

Sex: 

Female = 100% 

Race/ethnicity: 

NR 

Length of AN, yrs, mean 

(SD): 

Total Sample: 13.6 (6.7)

G1: 11.7 (7.1)

G2: 15.0 (6.3)

(P = NS) 
C-81 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, between the ages 

of 17 – 50, admitted to the 

eating disorders inpatient 

unit at St. Paul’s Hospital. 

Exclusion: 

Gravid, male gender, age 

over 50, diabetes mellitus, 

untreated hypothyroidism, 

use of beta blockers. 

All subjects wore a warming 

vest on their chest for 3 hr a 

day for 21 days. All vests 

were plugged in. Wearing 

the vest required the subject 

to remain within the radius 

of the power cord. 

G1: Vests were set 

permanently at medium 

heat. 

G2: Vests were set 

permanently in the off 

position. 

Descriptive Statistics 

Statistical tests used = NR 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

Patient blinded. 

Researcher or Assessor 

Blinding = NR 

Adverse events: 

NR 

Funding: 

NR 
C-82 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, year: 

Birmingham et al., 

2004 

(continued) 

NA NA 
C-83 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NA NA BMI, mean (SD): 

Total sample: 17.7 (2.8) 

G1: 17.5 (3.2) 

G2: 17.9 (2.4) 

(P = NS) 

BMI, mean (SD): 

Total sample: 18.4 (2.9) 

G1: 18.0 (3.6) 

G2: 18.8 (2.1) 

Diff over time (P = NR) 

Diff between groups (P = 

NS) 

Diff between groups in 

change over time (P = 

NR) 

Change in BMI, mean 

(SD): 

Total sample: 0.59 (1.2) 

G1: 0.60 (1.2) 

G2: 0.58 (1.1) 

Diff over time (P = NR) 

Diff between groups (P = 

NS) 

Diff between groups in 

change over time (P = 

NR) 
C-84 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Channon et al., 1989 

Setting: 

Outpatient ED Clinic 

of the Maudsley 

Hospital, London, UK 

Enrollment period: 

NR 

Research objective: 

To investigate the 

effectiveness of an outpt 

CBT tx for AN and compare 

it to BT alone, and control 

for “usual care.” 

Groups: 

G1: CBT (N = 8) 

G2: BT (N = 8) 

G3: Control (N = 8) 

Enrollment: 

• 34 referred 

• 24 met criteria and 

enrolled 

• Dropouts, N: G1: 0; G2:

1; G3: 2. 

3 dropped out during 

FU and still provided 

assessment data 

(included in analysis) 

Age, mean (SD): 

G1: 21.63 (5.88) 

G2: 24.13 (5.77) 

G3: 25.75 (7.19) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age of Onset, mean (SD): 

G1: 16.50 (3.82) 

G2: 21.38 (6.21) 

G3: 17.88 (4.36) 

(P = NS) 

Duration of illness, yrs: 

mean (SD): 

G1: 5.13 (4.85) 

G2: 3.13 (1.73) 

G3: 7.75 (6.09) 

(P = NS) 

Previous hospitalization, 

% yes: 

G1: 50.0 

G2: 12.5 

G3: 37.5 

(P = NS) 

Binge eating % yes: 

G1: 25.0 

G2: 50.0 

G3: 12.5 

(P = NS) 

Vomiting % yes: 

G1: 37.5 

G2: 75.0 

G3: 37.5 

(P = NS) 

Laxative use, % yes: 

G1: 0.0 

G2: 37.5 

G3: 25.0 

(P = NS) 
C-85 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx AN per Russell’s 

(1983) classification; 

bulimic features 

accepted as long as 

also met Russell’s dx 

Exclusion: 

NR 

Four assessments: 1) PreTx, 

2) after 6 mo of tx (18 

sessions), 3) after 6 mo FU 

(6 booster sessions), 4) after 12 

mo FU. 

G1: Self-monitoring and daily 

food planning; information, 

education. Identification of 

dysfunctional thoughts and 

challenging them. 

G2: Daily diary, self-monitoring, 

daily planning. Construction of 

graded hierarchies of feared 

foods and situations and graded 

exposure. Relaxation and 

distraction techniques. 

G3: 1/2 hour tx session, eclectic 

therapy 

Repeated measures 

ANOVA with 

appropriate contrasts 

for parametric tests; 

nonparametric tests 

for diff scores for 

clinical ratings and 

self-reports. No 

means given, only F 

statistics and P 

values. 

Comparisons: 

G1 vs. G2 

(G1 + G2) vs. G3 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

2 patients in G1, 1 patient in G2 

and 4 patients in G3 hospitalized 

for severe and progressive wt loss

Funding: 

Bethlem-Maudsley Research 

Fund 
C-86 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

NR Post Treatment 

EDI, drive for thinness: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDI, body dissatisfaction: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDI, bulimia: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

M-R all scales: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Preferred wt: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

6 Mo FU: 

EDI, drive for thinness: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Channon et al., 1989 

(continued) 

EDI, body dissatisfaction: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-87 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measure Biomarkers 

Baseline Outcomes Baseline Outcomes 

Post-tx: 

BDI: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

BMI, mean (SD): 

G1: 14.85 (1.10) 

G2: 16.06 (1.42) 

G3: 14.90 (1.49) 

(P = NS) 

Post Treatment: 

BMI 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NR) 

MOCI: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

6 mo: 

M-R menstrual: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between G1 and G2 (P < 0.05) 

G2 > G1 

Diff between G1+G2 and G3 (P = NS) 

Diff between groups in change over 

time (P = NR)

6-mo FU: 

M-R, Psychosexual functioning: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups G1 and G2 

(P < 0.02) 

G1 > G2 

Diff between groups G1+G2 and G3 

(P = NS) 

Diff between groups in change over time 

(P = NR) 

1 yr FU: 

BMI 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups 

(P = NS) 

Diff between groups in change over 

time (P = NR)

M-R mental state: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

M-R Menstual: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.0002) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NR)

1 yr FU: 

MOCI: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

 
C-88 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

1 Yr FU: 

EDI, drive for thinness: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.05) 

Diff between G1 and G2 (P = NS) 

Diff between (G1+G2) vs G3 (P < 0.03) 

G3 better than G1 or G2 

Diff between groups in change over time (P = NR) 

M-R Nutritional: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.0001) 

Diff between G1 and G2 (P = NS) 

Diff between G1+G2 and G3 (P < 0.04) 

G1 + G2 > G3 

Diff between groups in change over time (P = NR) 

Author, yr: 

Channon et al., 1989 

(continued) 

Preferred wt: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.03) 

Diff between groups G1 and G2 (P < 0.04) G2 > G1 

Diff between groups in change over time (P = NR) 
C-89 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measure Biomarkers 

Baseline Outcomes Baseline Outcomes 

M-R Psychosexual: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff over time (P < 0.03) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

 

M-R mental state: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 

 

M-R social: 

G1: NR (P = NR) 

G2: NR (P = NR) 

G3: NR (P = NR) 

Diff between G1 and G2 (P = NS) 

Diff between G1+G2, G3 

(P < 0.04) 

G3> G1 + G2 

Diff between groups in change over time 

(P = NR) 

 
C-90 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Crisp, Norton et al., 

1991 

Companion article: 

Gowers, Norton et al., 

1994 

Setting: 

Inpatient and 

outpatient; St. George’s 

Hospital; London, 

England, UK 

Enrollment period: 

1983-1987 

Research objective: 

Compare three different forms 

of tx and “no tx” for individuals 

with AN at one-yr FU. 

Groups: 

G1: Inpatients (N = 30) 

G2: Outpatient individual and 

family psychotherapy and 

dietary counseling (N = 20) 

G3: Group psychotherapy (N 

= 20) 

G4: No further tx by research 

team (N = 20) 

Enrollment: 

• Patients comprised of 

successive referrals who 

fulfilled criteria 

• 90 patients randomized 

• Those who refused tx 

were defined as noncompliers (they were 

considered for FU 

analyses within their 

respective groups) 

Compliers: 

G1: (N = 18) 

G2: (N = 18) 

G3: (N = 17) 

G4: (N = 20) 

Age, mean (SD): 

G1: 23.2 (4.9) 

G2: 21.2 (5.1) 

G3: 19.7 (2.6) 

G4: 21.9 (4.5) 

(P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset (SD): 

G1: 19.8 (4.7) 

G2: 18.4 (3.9) 

G3: 17.4 (1.9) 

G4: 17.4 (3.2) 

(P = NR) 

Duration of illness (SD): 

G1: 41.0 (30.17) 

G2: 33.4 (25.9) 

G3: 27.5 (25.8) 

G4: 53.5 (52.9) 

(P = NR) 
C-91 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Diagnosed with AN 

(according to DMS-III 

R criteria), females, 

had AN for less than 

ten yrs and lived within 

outpatient reach of 

services (≤ 40 miles). 

Exclusion: 

None reported 

G1: Inpatient tx including wt 

restoration to the mean-matched 

popwt at age of AN onset, wkly 

individual family and group

therapy, dietary counseling and 

occupational therapy. Inpatient tx 

followed by 12 sessions of 

outpatient tx involving patient and 

family. 

G2: 12 sessions (of 1-1.5 hours 

duration) of outpatient 

individual/family therapy over 

several mos. Decision about how 

much depended on needs of the 

patient. 

G3: 10 outpatient group therapy 

meetings with partient and 10 

separate meetings for parents at 

mo intervals. 

Dietary counseling and advice 

part of inpatient tx and offered on 

4 occasions to the two outpatient 

conditions. 

G4: referred back to family doctor 

or local consultant with details of 

assessment along with advice on 

further management. In G4, 6 

patients had no tx, 6 had inpatient 

tx, 5 had outpatient hospital tx, 3 

had at least wkly contact with doc 

No psychotropic drugs provided to 

any participants 

ANOVAs and 

ANCOVAs for testing 

between group diffs at 

randomization; Paired 

t tests to test within 

and between group

diffs at 1 and 2 yr FU. 

All values scores at 

one-yr FU. 

Morgan and Russell 

scales used to 

evaluate nutritional 

status, menstrual 

status, and mental 

state 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

One patient in outpatient tx 

group died as a result of her AN 

prior to tx beginning. 

Funding: 

Marks and Spencer plc, St. 

George’s Hospital Special 

Trustees and Worshipful 

Company of Grocers 
C-92 

 Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Nutrition score (SE): 

G1: 4.7 (0.4) 

G2: 5.3 (0.4) 

G3: 5.0 (0.5) 

G4: 5.0 (0.3) 

Nutrition score (SE): 

One yr FU: 

G1: 7.3 (0.6) (P < 0.01) 

G2: 8.1 (0.6) (P < 0.01) 

G3: 8.3 (0.7) (P < 0.01) 

G4: 6.4 (0.7) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Crisp, Norton et al., 

1991 

(continued) 

Morgan-Russell Global score (SE): 

G1: 3.5 (0.2) 

G2: 3.9 (0.3) 

G3: 3.8 (0.4) 

G4: 3.5 (0.3) 

Global Score (SE): 

One-yr FU: 

G1: 5.5 (0.6) (P < 0.01) 

G2: 6.4 (0.6) (P < 0.01) 

G3: 6.2 (0.7) (P < 0.05) 

G4: 5.6 (0.7) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-93 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Mental state (SE): 

G1: 5.6 (0.4) 

G2: 5.4 (0.6) 

G3: 5.8 (0.5) 

G4: 4.2 (0.6) 

G1 vs G4 (P < 0.05) 

Diff between groups all other 

comparisons (P = NS) 

Mental State (SE): 

One yr FU: 

G1: 6.1 (0.9) (P = NS)

G2: 7.3 (0.8) (P < 0.05) 

G3: 6.5 (0.8) (P = NS) 

G4: 5.5 (0.8) (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Menstruation (SE): 

G1: 0.4 (0.2) 

G2: 0.2 (0.2) 

G3: 0.8 (0.6) 

G4: 0.6 (0.4) 

Menstruation (SE): 

One-yr FU: 

G1: 4.5 (1.0) (P < 0.01) 

G2: 4.4 (1.1) (P < 0.01) 

G3: 5.7 (1.5) (P < 0.05) 

G4: 4.6 (0.3) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Mental state (SE): 

G1: 5.6 (0.4) 

G2: 5.4 (0.6) 

G3: 5.8 (0.5) 

G4: 4.2 (0.6) 

G1 vs G4: (P ≤ 0.05) 

Diff between groups all other 

comparisons (P = NS) 

Mental state (SD): 

2-yr FU (SD)*: 

G2: 7.2 (3.4) (P < 0.05) 

G4: 5.5 (4.1) (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Wt, in kgs (SD): 

G1: 40.8 (6.1) 

G2: 40.3 (3.8) 

G3: 40.2 (6.0) 

G4: 41.0 (6.1) 

Wt gain in kgs: 

G1: 9.6 

G2: 9.0 

G3: 10.1 

G4: 3.2 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.01) 

G4 < G1, G2, G3 

 Menstruation (SE): 

G1: 0.4 (0.2) 

G2: 0.2 (0.2) 

G3: 0.8 (0.6) 

G4: 0.6 (0.4) 

Menstruation (SD): 

2-yr FU (SD)*: 

G2: 6.1 (4.7) (P < 0.001) 

G4: 5.2 (5.7) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-94 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Dare et al., 2001 

Setting: 

Outpatient eating 

disorder program in 

Maudsley Hospital, UK 

Enrollment period: 

NR 

Research objective: 

Compare two forms 

of individual 

psychodynamic tx’s 

for adult AN with 

family therapy and 

controlled “routine” 

tx. 

Groups: 

G1: Focal psychotherapy (N = 21) 

G2: Family therapy (N = 22) 

G3: Cognitive-analytic therapy (N = 22) 

G4: ‘Routine’ tx (N = 19) 

Enrollment: 

• Sequential referrals to the 

outpatient service were recruited for 

the study. 

• Patients were assessed and given 

information about the four kinds of 

tx. 

• Patients were interviewed with 

partners or family members 

following this and randomly 

allocated to one tx (total = 84) 

• Of the original 84 patients, 4 failed 

to attend the first tx session, 6 

dropped out within the first 2 mos of 

tx and another 19 dropped out 

during the rest of tx. 

• From the original sample, 61 came 

for FU interviews at one yr. Some 

information was obtained by phone 

for an additional 9 patients. 

• 82 female; 2 male 

Age, mean (SD): 

G1: 26.7 (6.4) 

G2: 26.6 (7.6) 

G3: 27.2 (7.6) 

G4: 24.3 (4.5) 

(P = NS) 

Sex: Females 

G1: 100% 

G2: 91% 

G3: 100% 

G4: 100% 

(P = NS) 

Race/ethnicity: 

NR 

Age at onset (SD): 

G1: 18.8 (4.2) 

G2: 20.5 (7.5) 

G3: 19.9 (4.1) 

G4: 16.6 (4.1) 

(P = NS) 

Duration of illness (SD): 

G1: 6.7 (5.9) 

G2: 5.8 (4.9) 

G3: 6.7 (7.6) 

G4: 6.1 (5.0) 

(P = NS) 

Bingeing daily: 

G1: 10% 

G2: 9% 

G3: 23% 

G4: 11% 

(P = NS) 

Bingeing > = wkly: 

G1: 5% 

G2: 5% 

G3: 5% 

G4: 26% 

(P = NS) 

Bingeing < wkly: 

G1: 10% 

G2: 9% 

G3: 0% 

G4: 0% 

(P = NS) 
C-95 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV for AN, 18 or 

older at the time of 

entry into trial 

Exclusion: 

If mental or physical 

state at assessment 

was considered so 

dangerous as to 

require hospitalization 

e.g., serious suicidal 

risk, extremely low wt 

(usually BMI < 12), 

hypoglycaemia, 

syncope or severe 

electrolyte disturbance 

(Potassium < 2.5 

mMol/l; sodium < 130 

mMol/l). 

G1 Focal psychoanalytic therapy 

which is a standardized form of timelimited psychoanalytic therapy. A 

doctor, social worker, and 

psychologist conducted therapy. 

Sessions lasted 50 m and occurred 

wkly for 1 yr. 

G2 Family therapy, focuses on ED as 

problem of family life. Sessions were 

1 hour to 1 hour 15 mins in duration 

and scheduled by negotiation 

between once a wk and once every 3 

wks. Therapists saw patients, partner 

or spouse or parents for most of the 

sessions but individual contact was 

allowed at a max of once every 3 

attendances. Same therapists as for 

G1. 

G3 Cognitive analytic therapy which 

combines elements of cognitive 

therapy and brief focused 

psychodynamic therapy. Sessions 

were 50 m and occurred wkly for the 

first 20 wks and then moly for 3 mos. 

Therapists were members of the ED 

team. 

G4 ‘Routine’ tx which consisted of 

low-contact outpatient management 

with no specific psychotherapies 

used. Patients attended 30-minute 

sessions with a trainee psychiatrist. 

Categorical data were 

analyzed using the 

Fisher exact 

probability test. 

ANCOVAs used to 

analyze continuous 

data, controlling for 

initial scores. T-tests 

used to compare pre 

and post scores. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

12 patients required 

hospitalization during the 

course of tx and 1 patient in 

G4 died. 

Funding: 

Leverhulme Foundation and 

Mental Health Research Fund
C-96 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Dare et al., 2001 

(continued) 

 Bingeing never: 

G1: 76% 

G2: 77% 

G3: 73% 

G4: 63% 

(P = NS) 

Vomiting daily: 

G1: 19% 

G2: 9% 

G3: 27% 

G4: 11% 

(P = NS) 

Vomiting < wkly: 

G1: 5% 

G2: 0% 

G3: 0% 

G4: 5% 

(P = NS) 

Vomiting never: 

G1: 62% 

G2: 68% 

G3: 55% 

G4: 63% 

(P = NS) 

Living arrangements: 

Family of origin: 

G1: 52% 

G2: 59% 

G3: 41% 

G4: 47% 

Spouse/cohabiting: 

G1: 14% 

G2: 27% 

G3: 32% 

G4: 21% 

Alone: 

G1: 33% 

G2: 14% 

G3: 27% 

G4: 32% 

Previous tx: 

Outpatient: 

G1: 48% 

G2: 27% 

G3: 41% 

G4: 26% 
C-97 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-98 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Dare et al., 2001 

(continued) 

 Single inpatient: 

G1: 19% 

G2: 32% 

G3: 18% 

G4: 26% 

Repeat inpatient: 

G1: 5% 

G2: 23% 

G3: 18% 

G4: 32% 

Any tx: 

G1: 71% 

G2: 82% 

G3: 77% 

G4: 84% 
C-99 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-100 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Dare et al., 2001 

(continued) 

Morgan-Russell Assessment Schedule-A 

(nutritional status) (SD): 

Total: 2.4 (1.8) 

One-yr FU: 

Morgan-Russell Assessment ScheduleA (nutritional status) (SD): 

Total: 4.3 (2.8) (P = 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NR) 
C-101 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline 

Outcomes Baseline Outcomes 

Morgan-Russell 

Assessment Schedule-C 

(Mental state) (SD): 

Total: 10.1 (2.5) 

One-yr FU: 

Morgan-Russell 

Assessment Schedule-C 

(Mental state) (SD): 

Total: 9.8 (3.0) (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Morgan-Russell 

Assessment 

Schedule-B 

(Menstrual scale) 

(SD): 

Total: 1.1 (2.8) 

At one-yr FU: 

Morgan-Russell Assessment 

Schedule-B (Menstrual scale) 

(SD): 

Total: 3.4 (4.7) (P = 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

 Baseline BMI (SD):

G1: 15.0 (1.6) 

G2: 15.2 (1.5) 

G3: 16.0 (1.7) 

G4: 15.3 (1.6) 

Total: 15.4 (1.6) 

At one yr FU: 

BMI (SD):

Total: 16.5 (2.4) (P = 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.03) 

Diff between G1 and G4 (P = 0.02) 

Diff between G2 and G4 (P = 0.05) 

Diff between G3 and G4 (P = NS) 

 One-yr FU no longer meeting 

criterion for AN (by DSM IV): 

Recovered 1 yr (wt > 85% ABW, 

menstruation returned and no 

bulimic symptoms): 

G1: 14% 

G2: 14% 

G3: 14% 

G4: 0% 
C-102 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Dare et al., 2001 

(continued) 

 
C-103 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Sig improved (wt > 85% 

ABW, no menstruation 

and/or occasional 

bulimic symptoms): 

G1: 19% 

G2: 23% 

G3: 14% 

G4: 5% 

Diff between groups; 3 

specialty tx’s vs. routine 

tx (P = 0.01) 

G2 vs G4 (P = 0.02) 

G1 vs G4 (P = 0.03) 

G3 vs G4 (P = NS) 

Diff between groups in 

change over time 

(P = NR) 
C-104 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Gowers, Norton et al., 

1994 

Companion article: 

Crisp, Norton et al., 

1991 

Setting: 

Inpatient and 

outpatient; St. George’s 

Hospital; London, 

England, UK 

Enrollment period: 

1983-1987 

Research objective: 

To compare long-term 

(i.e., 1 and 2-yr) 

outcomes of a combined 

individual-family therapy 

versus assessment-only 

control for treating 

symptoms of AN 

Groups: 

G2: Outpatient individual and 

family psychotherapy and dietary 

counseling (N = 20) 

G4: No further tx by research 

team Assessment-only (N = 20) 

Enrollment: 

• Patients comprised of 

successive referrals who 

fulfilled criteria 

• 90 patients randomized 

• Those who refused tx were 

defined as non-compliers 

(they were considered for FU 

analyses within their 

respective groups) 

Age, mean (SD): 

G1: 23.2 (4.9) 

G2: 21.2 (5.1) 

G3: 19.7 (2.6) 

G4: 21.9 (4.5) 

(P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset (SD): 

G1: 19.8 (4.7) 

G2: 18.4 (3.9) 

G3: 17.4 (1.9) 

G4: 17.4 (3.2) 

(P = NR) 

Duration of illness (SD): 

G1: 41.0 (30.17) 

G2: 33.4 (25.9) 

G3: 27.5 (25.8) 

G4: 53.5 (52.9) 

(P = NR) 
C-105 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Diagnosed with AN 

(according to DMS-III R 

criteria), females, had AN 

for less than ten yrs, and 

lived within outpatient reach 

of services (≤ 40 miles). 

Exclusion: 

None reported 

G1: Inpatient tx including wt 

restoration to the meanmatched popwt at tage of 

AN onset, wkly individual 

family and group therapy, 

dietary counseling and 

occupational therapy. 

Inpatient tx followed by 12 

sessions of outpatient tx 

involving the patient and the 

family. 

G2: 12 sessions (of 1-1.5 

hours duration) of outpatient 

individual/family therapy 

over several mos. Decision 

about how much depended 

on needs of patient. 

G3: 10 outpatient group

therapy meetings with 

patient and 10 separate 

meetings for parents at 

monthly intervals. 

Dietary counseling and 

advice part of inpatient tx 

and offered on 4 occasions 

to the two outpatient 

conditions. 

G4: Referred back to family 

doctor or local consultant 

with details of assessment 

along with advice on further 

management. In G4, 6 

patients had no tx, 6 had 

inpatient tx, 5 had outpatient 

hospital tx, 3 had at least 

wkly contact with physician 

No psychotropic drugs 

provided to any participants 

ANOVAs and ANCOVAs 

for testing between group

diffs at randomization; 

Paired t tests to test within 

and between group diffs at 

1 and 2 yr FU. All values 

are scores at one-yr FU. 

Morgan and Russell scales 

used to evaluate nutritional 

status, menstrual status, 

and mental state 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

One patient in outpatient 

tx group died as a result of 

her AN prior to tx 

beginning. 

Funding: 

Marks and Spencer plc, 

St. George’s Hospital 

Special Trustees and 

Worshipful Company of 

Grocers 
C-106 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Nutrition (SE): 

G1: 4.7 (0.4) 

G2: 5.3 (0.4) 

G3: 5.0 (0.5) 

G4: 5.0 (0.3) 

Nutrition (SE): 

2-yr FU (SD): 

G2: 9.2 (2.7) (P < 0.001) 

G4: 7.1 (3.1) (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P = NS) 

Abstinence/Remission by 2 yrs: 

G2: 20% 

G4: 10% 

Diff between groups (P = NR) 

Author, yr: 

Gowers, Norton et al., 

1994 

(continued) 

Morgan-Russell Global score (SE): 

G1: 3.5 (0.2) 

G2: 3.9 (0.3) 

G3: 3.8 (0.4) 

G4: 3.5 (0.3)

Morgan-Russell Global score (SD): 

Two-yr FU: 

G2: 7.5 (2.8) (P < 0.001) 

G4: 6.2 (3.2) (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change over time 

(P = NS) 
C-107 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Wt, in kgs (SD): 

G1: 39.5 (5.9) 

G2: 41.0 (3.4) 

G3: 40.2 (6.4) 

G4: 41.0 (6.1) 

Wt, kg (SD): 

1-yr FU: 

G2: 48.76 (6.2) (P = NR) 

G4: 43.92 (8.0) (P = NR) 

Diff between groups (P < 0.05) 

G2 > G4 

Diff between groups in change 

over time (P = NR) 

Wt, kg (SD): 

2-yr FU (SD): 

G2: 52.51 (8.5) (P = NR); G4: 

46.24 (8.6) (P = NR) 

Diff between groups (P < 0.05) 

G2 > G4 

Diff between groups in change 

over time (P < 0.01) G2 > G4

BMI (SD): 

G2: 15.52 (1.4) 

G4: 15.84 (1.7) 

BMI (SD): 

1-yr FU: 

G2: 18.97 (2.0) (P = NR) 

G4: 16.93 (2.8) (P = NR) 

Diff between groups (P < 0.05) 

G2 > G4 

Diff between groups in change 

over time (P = NR) 

2-yr FU: 

G2: 20.09 (2.8) (P = NR) 

G4: 17.83 (3.2) (P = NR) 

Diff between groups (P < 0.01) 

G2 > G4 

Diff between groups in change 

over time (P = NR) 
C-108 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hall and Crisp, 1987 

Setting: 

Outpatient, UK 

Enrollment period: 

NR 

Research objective: 

Compare effect of 

outpatient brief 

individual and family 

psychotherapy or 

dietetic advice on wt 

and eating behavior 

among outpatients with 

AN at one yr FU. 

Groups: 

G1: Psychotherapy group (N = 15) 

G2: Dietary advice group (N = 15) 

Enrollment: 

• 30 participants selected from 

consecutive referrals to one of 

the authors. 

• Referrals initially screened by 

postal questionnaire and those 

meeting criteria were 

interviewed along with their 

families. 

Age, mean: 

G1: 19.55 

G2: 19.57 

(P = NS) 

Social class: 

Group I and II: 

G1: 12 

G2: 13 

Group III: 

G1: 3

G2: 2

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Height, cms: 

G1: 161.7 

G2: 162.3 

(P = NS) 

Age at onset of illness, 

mean: 

G1: 17.07 

G2: 17.53 

(P = NS) 

Age at onset of 

amenorrhea: 

G1: 17.77 

G2: 17.90 

(P = NS) 

Duration of illness, mos: 

G1: 29.7 

G2: 24.5 

(P = NS) 

Duration of amenorrhea, 

mos: 

G1: 27.5 

G2: 20.1 

(P = NS) 

Number having previous 

tx: 

G1: 10 

G2: 8 

(P = NS) 

Mean wt at onset of dieting 

(kg): 

G1: 52.50 

G2: 55.42 

(P = NS) 
C-109 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Diagnostic criteria for 

primary AN, aged 13-

27, from social classes 

I-III, unmarried, wting 

less than 85% of 

matched population 

mean wt, had 

amenorrhea, had been 

ill for 6 – 72 mos and 

willing to attend 

outpatient tx. 

Exclusion: 

None reported 

G1: 12 one hour sessions at one to 

two wkly intervals. Proportion of 

individual psychodynamic therapy 

and family therapy depended on 

clinical judgment, practicability and 

the willingness of the family to be 

involved. Patients seen by a 

dietitian for 4 15-minute interviews. 

G2: 12 one-hour sessions at wkly 

or fortnightly intervals. Family was 

seen with the participant on some 

occasions. All participants were 

seen by psychotherapist for four 

15-minute interviews. 

No description 

provided 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

No 

Adverse events: 

One patient in G1 deteriorated 

after tx ended and had to be 

hospitalized. 2 patients in G2 

hospitalized. 

Funding: 

NR 
C-110 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Hall and Crisp, 1987 

(continued) 

NR NR 
C-111 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Global clinical score: 

G1: 5.7 

G2: 6.3 

One-yr FU: 

Global clinical score: 

G1: 8.8 (P < 0.001) 

G2: 7.8 (P < 0.01) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Wt, kgs: 

G1: 41.00 

G2: 39.54 

One yr FU: 

Wt, kgs: 

G1: 45.1 (P = NS) 

G2: 46.0 (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-112 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

McIntosh et al., 2005 

Setting: 

Outpatient setting in 

Christchurch, New 

Zealand 

Enrollment period: 

NR 

Research objective: 

Examine effectiveness of 

CBT, interpersonal 

psychotherapy and control tx 

(nonspecific supportive 

clinical management) in 

treating AN on an outpatient 

basis. 

Groups: 

G1: CBT (N = 19) 

G2: Interpersonal 

psychotherapy (N = 21) 

G3: Nonspecific supportive 

clinical management (N = 16)

Enrollment: 

Recruitment included 

referrals from health 

professionals, self-referrals 

and family referrals. 

400 individuals inquired 

about study. 

135 interviewed and 78 

deemed eligible. 

56 consented to participate 

and were randomly assigned 

to one of three tx’s. 

35 completed therapy 

(attending 15 of 20 

sessions). 

Age, mean (SD): 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Comorbid dx of panic 

disorder: 

G1: 26% 

G2: 0 

G3: 19% 

Diff between groups (P < 0.05)

G1 > G2 and G3 

Comorbid dx of BN: 

G1: 63%

G2: 31% 

G3: 19% 

Diff between groups (P < 0.05)

G1 > G2 and G3 
C-113 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; of age 17-40 

yrs; current primary 

AN; included DSM IV 

wt criterion (BMI < 

17.5) and more lenient 

wt criterion (BMI, 17.5-

19.0); could be 

receiving stable dose 

of a psychotropic med 

with no change in AN 

symptoms 

Exclusion: 

BMI < 14.5; current 

severe major 

depression; 

psychoactive 

substance 

dependence; major 

medical or 

neurological illness; 

developmental 

learning disorder; 

cognitive impairment; 

bipolar I disorder; 

schizophrenia; chronic 

refractory course of 

AN 

Therapy in all 3 groups consisted 

of 20 hour-long manual-based 

sessions conducted over a min 

of 20 wks. 

CBT: working on entrenched 

food restriction and avoidance 

patterns. 

Interpersonal psychotherapy: 

based on IPT for depression and 

BN. 

Nonspecific supportive clinical 

management: aimed at 

mimicking outpatient tx that 

could be offered in usual clinical 

practice and combined features 

of supportive psychotherapy and 

clinical management. Information 

provided about wt maintenance 

strategies, energy requirements 

and relearning to eat normally. 

Pairwise comparisons 

among groups made 

using Mann-Whitney 

U test. Repeated 

measures ANOVA 

was used for 

secondary and tertiary 

outcome variables to 

measure change over 

time. Pairwise least 

significance tests 

used for FU 

comparisons. Logistic 

regression used to 

examine 

independence of tx 

effects. Nonparametric KruskalWallis test used to 

compare global AN 

measure values. 

Created a 4 patient 

global AN rating scale: 

4: meets full criteria 

for AN, min improved 

from baseline in wt, 

BMI, EDE but min 

improvement in EDI; 

3: not full AN but 

having features of 

eating disorders, 

gained wt, min 

changes on EDE, 

considerable 

symptoms on EDI; 2: 

few features of eating 

disorders, “much 

improved”, 1: no sig 

features of ED, min 

symptoms on EDI and 

EDE 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

Reported only for those who 

dropped out. Of these, 4 

hospitalized (one died) for wt 

loss or medical complications 

of AN. 

Funding: 

Health Research Council of 

New Zealand 
C-114 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-Restraint (SD): 

Total sample: 3.9 (1.3) 

EDE-Restraint (SD): 

G1: 2.8 (1.7) 

G2: 4.0 (1.5) 

G3: 2.1 (1.7) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.01) 

Diff between 2 groups in change over time (P < 0.05) 

G1 and G3 > G2 

EDE-Eating concerns (SD): 

Total sample: 2.8 (1.3) 

EDE-Eating concerns: 

G1: 1.7 (1.7) 

G2: 2.5 (1.2) 

G3: 1.8 (1.6) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE-wt concerns (SD): 

Total sample: 3.1 (1.7) 

EDE-wt concerns: 

G1: 2.5 (1.2) 

G2: 1.8 (1.5) 

G3: 1.8 (1.5) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE-shape concerns (SD): 

Total sample: 3.8 (1.3) 

EDE-shape concerns: 

G1: 2.7 (1.5) 

G2: 3.1 (1.7) 

G3: 2.6 (2.0) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDI-Drive for thinness (SD): 

Total sample: 11.7 (5.4) 

EDI-Drive for thinness: 

G1: 7.9 (6.5) 

G2: 9.5 (5.6) 

G3: 6.8 (7.5) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDI-Bulimia (SD): 

Total sample: 3.1 (4.0) 

EDI-Bulimia: 

G1: 1.5 (4.0) 

G2: 2.6 (3.2): G3: 1.8 (2.5) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

McIntosh et al., 2005 

(continued) 

EDI-Body dissatisfaction (SD): 

Total sample: 7.7 (7.0) 

EDI-Body dissatisfaction: 

G1: 5.8 (6.9) 

G2: 7.3 (7.6) 

G3: 7.7 (9.5) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Global outcome – rating of 1: 

G1: 5% 

G2: 0 

G3: 25% 
C-115 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline 

Outcomes Baseline Outcomes 

Global assessment of 

functioning (SD): 

Total sample: 48.8 (5.6) 

Global assessment of 

functioning (SD): 

G1: 53.2 (9.5) 

G2: 51.1 (7.2) 

G3: 60.7 (13.9) 

(P = NR) 

Change over time 

Diff between groups in 

change over time (P < 0.02) 

Diff between 2 groups in 

change over time (P < 0.05) 

G3 better than G1 or G2 

Wt, in kgs: 

Total sample: 46.6 (3.9) 

Wt, in kgs: 

G1: 48.6 (5.5) 

G2: 49.0 (8.5) 

G3: 50.4 (7.3) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

HDRS (SD): 

Total sample: 12.6 (6.9) 

HDRS (SD): 

G1: 6.9 (7.8) 

G2: 9.9 (7.3) 

G3: 6.8 (7.1) 

(P = NR) 

Diff between groups in 

change over time (P = NS) 

BMI (SD): 

Total sample: 17.3 (1.1) 

BMI (SD): 

G1: 18.1 (1.9) 

G2: 18.1 (3.1) 

G3: 18.8 (2.1) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Body fat (SD): 

Total sample: 18.9% 

(3.4) 

Body fat (SD): 

G1: 22.0% (5.3) 

G2: 20.7% (6.6) 

G3: 22.1% (5.9) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-116 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

McIntosh et al., 2005 

(continued) 

 Global outcome – rating of 2: 

G1: 26% 

G2: 10% 

G3: 31% 

Global outcome – rating of 3: 

G1: 16% 

G2: 24% 

G3: 6% 

Global outcome – rating of 4 (Poor): 

G1: 53% 

G2: 67% 

G3: 38% 

(P = NR) 

Diff between groups in change over time 

G3 > G2 (P < 0.02) 

G3 vs G1 (P = NS) 

G2 vs G1 (P = NS) 
C-117 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-118 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Pike et al., 2003 

Setting: 

Outpatient, New York 

State Psychiatric 

Institute, USA 

Enrollment period: 

NR 

Research objective: 

Assessed the efficacy of 

CBT vs. nutritional 

counseling in the 

posthospitalization tx of AN 

among outpatient adults. 

Groups: 

G1: CBT (N = 18) 

G2: Nutritional counseling 

(N = 15) 

Enrollment: 

• 43 met initial eligibility 

criteria 

• 33 randomly assigned 

to tx immediately before 

their first session which 

was scheduled within 1 

wk of hospital discharge 

• Random assignment 

based on an adaptive 

stratification procedure 

• Dropout before session 

10: G1: 0; G2: 3 

Age, mean (SD): 

G1: 26.1 (6.2) 

G2: 24.3 (6.9) 

(P = NS) 

Range: 18-45 

Sex: 

Female: 100% 

Race/ethnicity: 

G1: NR% 

G2: NR% 

Age at illness onset (SD): 

G1: 17.4 (5.2) 

G2: 16.5 (3.1) 

(P = NS) 

Duration of illness (SD): 

G1: 7.6 (5.9) 

G2: 7.3 (5.8)

(P = NS) 

Previous hospitalizations 

(SD): 

G1: 1.8 (2.6) 

G2: 1.1 (1.2) 

(P = NS) 

Percent restricting type 

AN (N): 

G1: 56% (10) 

G2: 40% (6) 

(P = NS) 
C-119 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV dx of AN, 

successfully 

completed inpatient tx 

(defined as 

achievement of at 

least 90% IBW based 

on 1959 Metropolitan 

Life Insurance Tables) 

for a min of two wks, 

normalization of 

eating, resolution of 

acute medical 

problems and living 

within commuting 

distance of the 

hospital. 

Exclusion: 

NR 

Both tx’s consisted of 50 individual 

therapy sessions delivered over 

one yr. CBT and nutritional 

counseling based on manuals 

created by K. Pike. CBT focused 

on cognitive and behavioral 

features associated with 

maintenance of eating pathology 

and used a schema-based 

approach. Nutritional counseling 

was psychoeducational and 

supportive and focused on dietary 

analyses and balanced meal 

planning. Both txs conducted by 

PhD licensed, experienced 

psychologists. Participation 

terminated if subject’s wt fell below 

BMI of 17.5 for > 10 days or if 

medical status compromised by 

exacerbation of AN pathology to 

the extent that inpatient care 

required or exacerbation of noneating disorder pathology requiring 

alternative care. 

Participants monitored wkly. 

Allowed to continue with 

psychopharmacological tx started 

before study. 

T-tests conducted to 

compare baseline 

characteristics 

between of two 

groups. Kaplan Meier 

survival analyses 

done to compare 

time to relapse for 

the participants in the 

two tx groups. 

Relapsing not 

defined 

Full recovery defined 

using EDE as: good 

outcome, eating 

attitudes and wt 

concerns < 1 SD 

above mean of 

comprison group

without ED, binge 

eating or purging had 

to be absent. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NR 

Adverse events: 

Reasons for participants 

dropping out of tx or relapsing: 

wt loss, increased suicidality 

and in most cases, these were 

referred for inpatient tx or 

alternative tx. 

Funding: 

NIMH 
C-120 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

NR Time to relapse (sessions/wks): 

G1: 43.79 (2.9) 

G2: 27.21 (5.9) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.004) 

Number of participants relapsing: 

G1: 22% 

G2: 53% 

Diff between groups (P = NS) 

Overall tx failure (relapse + dropout): 

G1: 22% (4 of 18) 

G2: 73% (11 of 15) 

Diff between groups (P < 0.003) 

Diff between groups in change over time (P = NR) 

Morgan-Russell criteria for “good outcome”: 

G1: 44% (8 of 18) 

G2: 7% (1 of 15) 

Diff between groups (P < 0.02) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Pike et al., 2003 

(continued) 

“Full Recovery” 

G1: 17% 

G2: 0% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Good vs fair/poor/other outcome 

Psychotropic med vs not 

G1 (P < 0.04) On med superior to no med

G2 (P = 0.39)

AN subtype 

G1: (P = NS) 

G2: (P = NS) 
C-121 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Treatment logic: 

G1: 11.8 (3.0) 

G2: 10.61 (3.3) 

NR BMI (SD): 

G1: 16.0 (2.1 

G2: 15.2 (1.5) 

(P = NS) 

NR 

Treatment relevance: 

G1: 10.6 (3.6) 

G2: 10.0 (2.8) 

 

Expectation of success: 

G1: 10.2 (3.0) 

G2: 11.6 (2.5) 

 
C-122 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Pillay and Crisp, 1981 

Setting: 

Inpatient unit, 

London, UK 

Enrollment period: 

NR 

Research objective: 

To investigate impact of 

a social skills program 

within a longer tx 

approach to AN. 

Groups: 

G1: Social skills/social 

anxiety reduction (N = 11) 

G2: placebo nonspecific 

therapy (N = 12) 

Enrollment: 

• 33 patients enrolled 

• 9 patients (8 from G2) 

dropped out and 

replaced by other 

patients. 

• 1 excluded 

Completed 

G1: 11 

G2: 12 

1 yr FU 

G1: 10 

G1: 12 

Age, mean (SD): 

G1: 23.6 (8.2) 

G2: 23.8 (7.8) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Married (N = 5): 

G1: 2 

G2: 3 

(P = NS) 

Single (N = 18): 

G1: 9 

G2: 9 

Social class, 1 or 2 (N = 9): 

G1: 4 

G2: 5 

(P = NS) 

3/4/5 (N = 14): 

G1: 7 

G2: 7 

(P = NS) 

Ht, cm, mean (SD) (N = 

162.6 [5.3]): 

G1: 162.7 (5.6) 

G2: 162.5 (5.1) 

(P = NS) 

Vomiters (N = 10): 

G1: 6 

G2: 4 

(P = NS) 

Wks as inpatient, mean 

(SD): 

G1: 17.4 (4.8) 

G2: 16.3 (4.7) 

(P = NS) 

WAIS equivalent score, 

mean (SD): 

G1: 106.0 (9.8) 

G2: 106.6 (14.0) 

(P = NS) 
C-123 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

NR 

Exclusion: 

NR 

Initial bed rest, 3000 kcal/day, 

individual, milieu, and family 

therapy. 

G1: 12 sessions of social 

skills/social anxiety tx (approach 

behavior). 

G2: 12 sessions non-specific 

counseling 

Intervention provided during 4 mo 

inpatient tx 

Assessments: admission, post = 

target wt + 4 wks FU = 1 yr 

Chi square 2 tailed 

group comparisons 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

St George’s Medical Research 

Committee 
C-124 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Pillay and Crisp, 1981 

(continued) 

NR NR 
C-125 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 

Wt, kg, mean (SD):

G1: 41.0 (5.7) 

G2: 40.2 (7.5) 

(P = NS) 

Post tx: 

Wt, kg, mean (SD) 

G1: 54.4 (3.6) (P = NR) 

G2: 54.1 (5.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 % Wt increase, mean (SD) 

G1: 34.5 (15.5) (P = NR) 

G2: 37.1 (18.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 (CCEI, mean (SD): 

Anxiety 

G1: 11.1 (3.5 

G2: 10.8 (3.6) 

(P = NS) 

CCEI, mean (SD): 

Anxiety 

G1: 8.9 (3.5) (P = 0.05) 

G2: 10.2 (4.6) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

1 Yr FU: 

Wt, kg, mean (SD) 

G1: 48.0 (7.1) (P = NR) 

G2: 47.4 (7.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Phobic Anxiety 

G1: 5.2 (4.3) 

G2: 4.3 (3.2) 

(P = NS) 

Phobic Anxiety 

G1: 4.4 (3.2) (P = NS) 

G2: 5.3 (3.7) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

FU Wt as % MMPW, mean (SD):

G1: 84.6 (11.7) (P = NR) 

G2: 83.1 (10.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Obsessionality 

G1: 11.6 (2.1) 

G2: 8.8 (3.4) 

(P = NS) 

Obsessionality 

G1: 9.9 (1.5) (P = NS) 

G2: 7.9 (3.1) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Depression 

G1: 10.3 (4.2) 

G2: 8.4 (3.9) 

(P = NS)

Depression 

G1: 7.1 (3.8) (P = 0.01) 

G2: 9.0 (4.0) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Total Score 

G1: 56.0 (15.8) 

G2: 49.3 (14.1) 

(P = NS) 

Total Score 

G1: 43.4 (14.7) (P = 0.01) 

G2: 44.2 (16.4) (P = NS) 

(P = NR) 

Diff between groups in change 

over time (P = NR) 

 
C-126 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Pillay and Crisp, 1981 

(continued) 

 
C-127 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

1 yr FU: 

CCEI, mean (SD) 

Anxiety 

G1: 9.4 (4.3) (P = 0.05) 

G2: 8.8 (3.9) (P = 0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Phobia 

G1: 3.7 (3.3) (P = NS) 

G2: 4.3 (3.2) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Obsessionality 

G1: 10.3 (3.4) (P = NS) 

G2: 7.1 (2.8) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Depression 

G1: 7.5 (5.3) (P < 0.05) 

G2: 7.0 (4.0) (P < 0.04) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 

Total Score: FU 

G1: 44.2 (18.4) (P < 0.05) 

G2: 39.6 (14.4) (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 
C-128 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics

Author, yr: 

Thien et al., 2000 

Setting: 

St. Paul’s Hospital 

EDs Outpatient clinic, 

Canada 

Enrollment period: 

July 1997 

Research objective: 

To determine whether an 

AN patient’s quality of life 

is improved by being 

placed on a graded 

exercise program while 

not reducing gain of 

percent body fat or BMI. 

Groups: 

G1: Graded Exercise (N = 8) 

G2: Control (N = 8) 

Enrollment: 

• 16 enrolled 

• 12 completed 

• G1: 3/8 drop out 

• G2: 1/8 drop out 

Age, mean (SD): 

G1: 29.0 (4.4) 

G2: 36.1 (7.9) 

Diff between groups (P = 0.05) 

% female: 

G1: 100%

G2: 86% 

Race/ethnicity: 

NR 
C-129 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 17-45, DSM IV 

criteria of AN. 

Exclusion: 

NR 

Patients followed as usual, every 2-3 

wks for 3 mo. G1: patients seen by 

occupational therapist who reviewed 

and adjusted level of exercise based 

on a graded protocol. Patients 

remained at each level of activity for 

at least 1 wk and progression to the 

next level determined by team. G2: 

patients encouraged to limit exercise. 

Nonpaired two-tailed 

t-tests. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NA 

Funding: 

NR 
C-130 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Thien et al., 2000 

(continued) 

NR NR 
C-131 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SF-36, mean (SD): 

G1: 58.8 (13.9) 

G2: 53.3 (14.5) 

(P = NS) 

Change in SF-36, mean 

(SD): 

G1: 6.6 (7.0) (P = NR) 

G2: -12.0 (25.5) (P = NR) 

Diff between groups in 

change over time (P = NS) 

BMI, kg/m2

, mean (SD): 

G1: 20.26 (1.8) 

G2: 17.2 (1.6) 

(P = 0.02) 

Change in BMI, mean 

(SD): 

G1: 1.0 (1.3) (P = NR) 

G2: 0.8 (1.1) (P = NR) 

Diff between groups 

(P = NS) 

SF-36, RP, mean (SD): 

G1: 55.0 (37.1) 

G2: 50.0 (47.9) 

(P = NS) 

Change in SF-36, RP, mean 

(SD): 

G1: 25.0 (35.4) (P = NR) 

G2:-10.7 (53.7) (P = NR) 

Diff between groups (P = NS)

%Body fat, mean (SD): 

G1: 21.0 (2.9) 

G2: 16.7 (4.9) 

(P = 0.05)

Change in %Body fat, 

mean (SD): 

G1: 0.9 (2.1) (P = NR) 

G2: 0.5 (2.6) (P = NR) 

Diff between groups 

(P = NS)

SF-36, SF, mean (SD): 

G1: 72.5 (18.5) 

G2: 62.5 (14.4) 

(P = NS)

Change SF-36, SF, mean 

(SD): 

G1: 5.0 (18.9) (P = NR) 

G2: -19.6 (27.8) (P = NR) 

Diff between groups in 

change over time (P = 0.05)

 

SF-36, Vit, mean (SD): 

G1: 37.0 (28.2) 

G2: 39.3 (24.4) 

(P = NS) 

Change in SF-36, Vit, mean 

(SD): 

G1: 5.0 (25.7) (P = NR) 

G2: -2.8 (32.3) (P = NR) 

Diff between groups in 

change over time (P = NS) 

 

SF-36, sum of 3 scales, 

mean (SD): 

G1: 54.8 (20.1) 

G2: 50.6 (22.5) 

(P = NS)

Change in SF-36, sum of 3 

scales, mean (SD): 

G1: 11.7 (19.5) (P = NR) 

G2: -11.0 (34.2) (P = NR) 

Diff between groups in 

change over time (P = NS) 

 
C-132 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Treasure et al., 1995 

Setting: 

Outpatients from the 

Eating Disorder Clinic 

at the Maudsley 

Clinic, London, UK 

Enrollment period: 

NR 

Research objective: 

To compare EBT and CAT 

for adult AN. 

Groups: 

G1: EBT (N = 16) 

G2: CAT (N = 14) 

Enrollment: 

• 38 Assessed 

• 32 met criteria 

• 30 enrolled (1 refused, 

1 lost more wt and was 

excluded) 

• completed 20 sessions: 

G1: N = 10 

G2: N = 10 

Age, mean (SD) (range): 

G1: 25.3 (7) (18-39)

G2: 24.7 (5) (18-35) 

(P = NR) 

Sex: 

Female (N): 29 

Race/ethnicity: 

NR 

Age onset, yrs, mean 

(SD) (range): 

G1: 20.8 (5) (12-34) 

G2: 20.4 (5) (17-30) 

(P = NR) 

% wt loss, mean (SD) 

(range): 

G1: 28.9 (8) (20-24) 

G2: 25.5 (7) (18-42) 

(P = NR) 

Height, meters, mean 

(SD) (range): 

G1: 1.67 (0.80) (1.55-1.3*) 

G2: 1.66 (0.09) (1.5-1.85) 

* error in paper*

(P = NR) 

Duration amenorrhea, 

mos, mean (SD) (range): 

G1: 50.1 (60) (6-224) 

G2: 63.1 (77) (6-264) 

(P = NR) 

Premorbid wt, kg, mean 

(SD) (range): 

G1: 60.3 (10) (44-80) 

G2: 56.5 (8) (46-77) 

(P = NR) 

Bulimic episodes, N: 

G1: 4/16 

G2: 5/14 

(P = NR) 
C-133 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

ICD-10 dx for AN, > 18 

yrs old. 

Exclusion: 

Inpatient tx because of 

extreme, rapid wt loss 

with other severe sx. 

20 wkly, 50 minutes sessions. 

G1: monitor intake, goals to 

increase amt and range of food, 

wt/shape discussed, information re: 

nutrition and ED. G2: manual of 

Ryle (1990). Integrates 

psychodynamic factors with 

behavioral factors, transference, 

reformulate and interpret problems.

FU assessments at end of tx and 3 

mo intervals up to 1 yr. 

Mann-Whitney-U 

t-tests 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

None reported 

Funding: 

Mental Health Foundation and 

the Society for Research into 

AN (aka: Eating Disorders 

Association) 
C-134 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Treasure et al., 1995 

(continued) 

 Vomiting, N: 

G1: 7/16 

G2: 7/14 

(P = NR) 

Laxatives, N: 

G1: 4/16 

G2: 5/14 

(P = NR) 

Previous 

hospitalizations, N: 

G1: 6/16 

G2: 3/14 

(P = NR) 
C-135 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-136 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Treasure et al., 1995 

(continued) 

M-R, Nutrition, mean (SD) (range): 

G1: 6.2 (4.0) (0-12) (P = NR) 

G2: 7.1 (2.8) (3-12) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

M-R, avg score mean (SD) (range): 

G1: 6.4 (2.8) (1.8-11.7) 

G2: 7.3 (2.7) (3.3-11) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Bulimia Nervosa, N (%): 

G1: 3 (19) (P = NR) 

G2: 2 (14) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Good outcome (body wt maintained within 15% 

of ABW), N (%): 

G1: 5 (31) (P = NR) 

G2: 6 (42) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Intermediate outcome (body wt increased to 

within 15% of ABW with persistent 

amenorrhea), N (%): 

G1: 3 (19) (P = NR) 

G2: 5 (36) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Poor outcome ( < 15% ABW), N (%): 

G1: 8 (50) (P = NR) 

G2: 3 (22) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-137 

Evidence Table 3. Behavioral intervention trials for adults with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes – 1 yr 

Self rated improvement, mean 

(SD) (range): 

G1: 1.7 (0.9) (0-3) 

Diff between groups (P = NR) 

G2: 2.4 (0.5) (2-3) (P = NR) 

Diff between groups (P = 0.045) 

Diff between groups in change 

over time (P = NR) 

Wt, kg, mean (SD) 

(range): 

G1: 42.2 (4) (34-50) 

G2: 42.9 (5) (34-51) 

Wt, kg, mean (SD) (range): 

G1: 47 (7) (33-58) (P = NR) 

G2: 50 (6) (34-59) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

BMI, mean (SD) (range): 

G1: 15.0 (1.0) (12.5-17.3)

G2: 15.6 (2.1) (13-17.5)

BMI mean (SD) (range): 

G1: 17.4 (3.0) (12.3-20.7) (P = NR) 

G2: 18.5 (2.1) (14.1-21.8) (P = NR)

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

 Wt gain, kg, mean (SD) (range): 

G1: 6.7 (5.2) (-1 -14) (P = NR) 

G2: 6.9 (4.3) (-8-16) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-138 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Eisler et al., 2000 

Setting: 

Outpatient at a 

postgraduate 

psychiatric teaching 

hospital in London, 

UK. Some patients 

may be inpatient at 

the hospital’s eating 

disorder unit for some 

portion of the study 

Enrollment period: 

NR 

Research objective: 

To compare the efficacy of 

two forms of outpatient 

family intervention for AN; 

conjoint family therapy 

(CFT) and separated family 

therapy (SFT). 

Groups: 

G1: CFT (N = 19) 

G2: SFT (N = 21) 

Enrollment: 

• 57 referrals to the 

hospital (14 did not 

meet dx criteria) 

• 40 enrolled 

• 36 completed at least 3 

mos of tx 

Age, mean (SD): 

15.5 yrs (1.6) 

Sex: 

Female (N): 39 of 40 

Race/ethnicity: 

NR 

Social class based on 

father’s occupation: 

I-II: Professional (65%) 

III-IV: Skilled (22%) 

VI-VIII: Unskilled (13%) 

Family structure: 

Nuclear (70%) 

Adoptive (5%) 

Single (10%) 

Reconstituted (15%)

Age of AN onset (SD): 

14.5 yrs (1.6) 

Duration of illness (mos): 

12.9 (9.4) 

M-R Scales (SD): 

A (Nutritional): 3.3 (1.8) 

B (Menstrual): 1.8 (3.0) 

C (Mental State): 7.1 (2.0) 

D (Psychosexual): 7.0 (3.7) 

E (Psychosocial): 8.0 (2.9) 

Avg: 5.5 (1.7) 
C-139 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Adolescents, met DSM IV or 

ICD-10 criteria for AN 

Exclusion: 

None 

One yr of CFT or SFT with 

assessments independent 

of the research team 

conducted at 3, 6, and 12 

mos. Assessments included 

patient and family interviews 

and self-report 

questionnaires. Frequency 

of sessions dictated by 

clinical need and similar in 

both txs. Generally, families 

were seem wkly during the 

early stages of tx, gradually 

increasing to every 3 to 4 

wks (mean number of 

sessions = 16.4 (8.9) for 

CFT and 15.5 (6.8) for 

SFT). CFT sessions lasted 

1 hour; in SFT the individual 

and parental sessions each 

lasted 45 m. 

ANCOVA, G1 vs. G2, 

taking duration of illness, 

previous tx, and wt and the 

T1 values of each measure 

as covariates. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

Medical Research Council 

(UK) 
C-140 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Bulimic symptoms: 

> wkly (25%) 

< wkly (22.5%) 

Never (52.5%) 

Bulimic symptoms (scale 0-12, 12 = 

normal with no symptoms) (SD): 

7.7 (5.1) 

Change in bulimic symptoms: 

G1: - 2.2 (6.4) (P = NR) 

G2: - 2.9 (4.5) (P = NR) 

Change over time (P = 0.01) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDI (SD): 

56.2 (33.9) 

Change in EDI: 

G1: - 32.3 (25.9) (P = NR) 

G2: - 21.8 (27.2) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G1 better than G2 

Author, yr: 

Eisler et al., 2000 

(continued) 

EAT (SD): 

47.7 (25.7)

Change in EAT: 

G1: - 26.8 (20.8) (P = NR) 

G2: - 29.2 (24.9) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-141 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Depression (SD): 

2.9 (3.2) 

Change in Depression (SD): 

G1: - 5.6 (4.5) (P = NR) 

G2: - 4.2 (5.7) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.02) 

G1 better than G2 

Lowest wt (kg): 

38.5 (6.2) 

Current wt (kg): 

40.0 (6.4) 

Change in Wt (kg): 

G1: + 6.4 (6.2) (P = NR) 

G2: + 9.8 (6.7) (P = NR) 

Change over time (P = 0.001)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Obsessionality (SD): 

8.3 (3.4) 

Change in Obsessionality 

(SD): 

G1: - 2.7 (2.8) (P = NR) 

G2: - 1.2 (3.5) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.03) 

G1 better than G2 

%ABW: 

74.3 (9.8) 

Change in %ABW: 

G1: + 10.2 (11.3) (P = NR) 

G2: + 15.0 (11.0) (P = NR) 

Change over time (P = 0.001)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 Change in BMI: 

G1: + 2.4 (2.5) (P = NR) 

G2: + 3.6 (2.4) (P = NR) 

Change over time (P = 0.001)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

SMFQ (SD): 

26.5 (13.3)

Change in SMFQ (SD): 

G1: 16.5 (16.5) (P = NR) 

G2: 8.0 (11.5) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.01) 

G1 better than G2 

 

MOCI (SD): 

6.2 (3.6)

Change in MOCI (SD): 

G1: - 2.8 (3.8) (P = NR) 

G2: - 2.4 (4.0) (P = NR) 

Change over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 
C-142 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Eisler et al., 1997 

Companion article: 

Russell et al., 1987 

Setting: 

Output tx: Maudsley 

Hospital, London, 

UK 

Enrollment period: 

NR 

Research objective: 

To determine the long 

term benefit of family 

versus individual 

therapy in AN after 5 

yrs. 

Groups: 

G1: Family Therapy (N = 41) 

G2: Individual Therapy (N = 39) 

Enrollment: 

Of 80 original participants 

• Followed at 3 yrs: N = 77 

• Followed at 5 yrs: N = 73 

Age, mean (SD): 

17.9 (6.4) 

(P = NS) 

Age at end of trial, mean 

(SD): 

21.8 (7.1) 

(P = NS) 

Duration of illness, y, mean 

(SD): 

3.8 (3.1) 

Diff between groups (P = NS) 

Wt on admission, % ABW, 

mean (SD): 

69.6 (13.0) 

(P = NS) 

Wt on discharge, % ABW, 

mean (SD): 

89.5 (7.1) 

(P = NS) 

Duration of index hospital 

stay, wk, mean: 

10.4 

G1: 8.8 

G2: 12.1* 

(P = NR) 

Subgroup 1: 

G1: 8.6 

G2: 11.8 

Diff between groups (P < 0.05) 

Subgroup 2: 

G1: 8.2 

G2: 13.0 

Diff between groups (P < 0.02) 

Previous admissions, N, 

mean: 1.5 

Diff between groups (P = NS) 

Sex, N: 

Male: 7 

Female: 73 

Diff between groups (P = NS) 

Race/ethnicity: 

NR 

Marital status, N: 

Single: 69 

Married: 8 

Separated/divorced: 3 

(P = NS) 
C-143 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

AN: DSM III criteria; 

self-induced wt loss 

through avoidance of 

fattening foods, 

excessive exercise, 

and self-induced 

vomiting or purging 

(but did not follow 

binge eating); idea that 

fatness is dreadful 

state; specific 

endocrine disorder 

(amenorrhea or in 

males sexual 

interest/potency lost). 

BN: DSM III-R 

preoccupation with 

food and episodes of 

gross overeating; 

counteract fattening 

effects of food by 

vomiting, purging, or 

starvation; 

psychopathology 

similar to AN; hx of 

previous overt or minor 

episode of AN. 

Exclusion: 

NR 

Upon reaching a near-healthy body 

wt and being discharged from 

inpatient tx, patients randomly 

assigned to conditions which were 

delivered on outpatient basis for 

one yr. Tx lasted 1 hour at least 

fortnightly for first 3 mos, then once 

every three wks for a total of 1 yr 

from date of discharge. 

G1: Family therapy: Included all 

members of the household. Tasks: 

family cooperation, organization 

(communication, rules), 

interventions (management, 

cooperation, support, consistency) 

G2: Nonspecific form of individual 

therapy: supportive, educational, 

problem-centered 

Antidepressant drug use allowed 

for both groups. 

Amount of sessions, mean (SD): 

G1: 10.5 (8.9) 

G2: 15.9 (8.5) 

Diff between groups (P < 0.01) 

For subjects missing 

5-yr data, 3-yr data 

substituted in 

analyses 

Chi square, Fisher 

exact probability test, 

student t tests 

Eating outcome 

categories: 

Good: body wt 

maintained within 15% 

of the ABW and 

menstrual cycles 

regular. 

Intermediate: body wt 

risen to within 15% of 

ABW but amenorrhea 

persists. 

Poor: body wt < 15% 

below ABW or bulimic 

sx have developed 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

Deaths, N: 3 

Funding: 

Medical Research Council, UK
C-144 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Eisler et al., 1997 

(continued) 

Category of outcome at 5 years, N: 

Subgroup 1: 

Total Subgroup: 

Good: 13 

Intermediate: 2 

Poor: 6 

G1: Good: 9 

Intermediate: 0 

Poor: 1 

G2: Good: 4 

Intermediate: 2 

Poor: 5 

Diff between groups Good vs Intermediate + Poor 

(P < 0.02) G1 > G2 

Diff between groups in change over time (P = NR) 

Subgroup 2: 

Total Subgroup: Good: 4 

Intermediate: 5 

Poor: 10 

G1: Good: 3 

Intermediate: 1 

Poor: 6 

G2: Good: 1 

Intermediate: 4 

Poor: 4 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Subgroup 3: 

Total subgroup: Good: 6 

Intermediate: 4 

Poor: 4 

G1: Good: 2 

Intermediate: 2 

Poor: 3 

G2: Good: 4 

Intermediate: 2 

Poor: 1 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-145 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

M-R scales: mental state at 

5 years, mean (SD): 

Subgroup 1: 

G1: 12.0 (0.0) 

G2: 11.5 (1.4) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Subgroup 2: 

G1:9.1 (3.8) 

G2: 9.5 (2.1) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Subgroup 3: 

G1: 9.7 (2.1) 

G2: 12.0 (0.0) 

Diff between groups (P ≤

0.05) G2 > G1 

Diff between groups in 

change over time (P = NR) 

Subgroup 4: 

G1: 8.0 (3.0) 

G2: 10.2 (2.1) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Wt, % ABW at 5 years, mean 

(SD): 

Subgroup 1: 

G1: 103.4 (13.2) 

G2: 94.4 (16.8) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 2: 

G1: 86.9 (11.9) 

G2: 95.7 (11.5) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 3: 

G1: 93.7 (18.0) 

G2: 97.5 (9.0) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 4: 

G1: 93.4 (8.9) 

G2: 98.9 (8.8) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

M-R scales: Psychosexual 

adjustment at 5 years mean

(SD): 

Subgroup 1: 

G1: 10.5 (2.1) 

G2: 9.2 (2.2) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Subgroup 2: 

G1: 8.5 (3.0) 

G2: 8.1 (3.0) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

M-R scales: menstrual 

functioning at 5 years, mean 

(SD): 

Subgroup 1: 

G1: 12.0 (0.0) 

G2: 7.0 (5.1) 

Diff between groups (P ≤ 0.05) 

G1 > G2 

Diff between groups in change 

over time (P = NR) 

Subgroup 2: 

G1: 3.4 (5.9) 

G2: 4.5 (5.0) diff between 

groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-146 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Subgroup 4: 

Total subgroup: Good: 3 

Intermediate: 6 

Poor: 10 

G1: Good: 0 

Intermediate: 4 

Poor: 5 

G2: Good: 3 

Intermediate: 2 

Poor: 5 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Eisler et al., 1997 

(continued) 

M-R scales: nutritional status at 5 years, mean 

(SD): 

Subgroup 1: 

G1: 9.4 (1.8) 

G2: 8.7 (2.8) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Subgroup 2: 

G1: 7.4 (4.4) 

G2: 7.2 (3.3) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Subgroup 3: 

G1: 7.6 (4.8) 

G2: 9.2 (2.0) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Subgroup 4: 

G1: 6.2 (2.5) 

G2: 7.4 (4.2) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-147 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Subgroup 3: 

G1: 6.0 (4.3) 

G2: 10.1 (1.4) 

Diff between groups (P ≤ 0.05) 

G2 better than G1. 

Diff between groups in change 

over time (P = NR) 

Subgroup 4: 

G1: 8.5 (4.1) 

G2: 9.0 (3.3) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 3: 

G1: 7.4 (5.4) 

G2: 11.3 (1.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 4: 

G1: 8.5 (5.4) 

G2: 7.5 (5.4) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

M-R scales: social adjustment 

mean at 5 years (SD): 

Subgroup 1: 

G1: 11.1 (1.2) 

G2: 10.2 (1.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 2: 

G1: 9.6 (2.1) 

G2: 8.7 (2.9) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 3: 

G1: 8.8 (3.0) 

G2: 10.5 (1.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 4: 

G1: 7.0 (2.5) 

G2: 9.5 (3.0) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-148 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Eisler et al., 1997 

(continued) 

 
C-149 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline 

Outcomes Baseline Outcomes 

M-R scales: avg outcome at 5 

years, mean (SD): 

Subgroup 1: 

G1: 11.0 (0.4) 

G2: 9.3 (2.1) 

Diff between groups (P ≤ 0.05) 

G1 better than G2 

Diff between groups in change 

over time (P = NR) 

Subgroup 2: 

G1:7.6 (3.0) 

G2: 7.6 (2.5) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Subgroup 3: 

G1: 7.8 (2.8) 

G2: 10.6 (1.0) 

Diff between groups (P ≤ 0.05) 

G2 better than G1 

Diff between groups in change 

over time (P = NR) 

Subgroup 4: 

G1: 7.6 (2.7) 

G2: 8.5 (2.8) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-150 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Geist et al., 2000 

Setting: 

Inpatient/Outpatient 

Adolescent Eating 

Disorders Unit, The 

Hospital for Sick 

Children, Toronto, 

Canada 

Enrollment period: 

2.5 yrs (dates not 

reported) 

Research objective: 

Comparison of family 

therapy and family group

psychoeducation for 

adolescent inpatients 

(who later became 

outpatients) with AN 

Groups: 

G1: Family Therapy (N = 12) 

G2: Family Group

Psychoeducation (N = 13) 

Enrollment: 

• 120 assessed and 

admitted to inpatient 

program 

• 61 met study criteria 

• 36 refused to participate 

• 25 enrolled and 

completed 

Age, mean (SD): 

G1: 14.3 (1.5) 

G2: 14.9 (1.7) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Dx: 

RAN (excluding amenorrhea 

criteria) (N = 19) 

EDNOS (restricting) (N = 3) 

Study criterion only (N = 3) 
C-151 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Admitted for inpatient tx, 

current wt < 90% of IBW 

(modification of DSM IV AN 

dx requiring < 85%) and 

self-imposed food restriction 

indicating onset or 

maintenance of low wt. 

Exclusion: 

< 12 and > 17.4 yrs of age, 

male, chronic medical 

condition, immediate suicide 

risk, presented with 

psychotic features, 

unavailable over the study 

period, receiving individual 

or family therapy in the 

community or could not 

communicate in English. 

G1: 8 sessions of family 

therapy (every two wks). 

Sessions were 45 m, 

attended by patients, 

parents, and siblings. 

Therapists were social 

workers and 1 psychiatrist. 

G2: 8 sessions of family 

psychoeducation every 2 

wks. Classes were 90 m, 

led by a dietitian, 

occupational therapist and 

psychiatric nurse. First 45 

m, patients and parents 

together. Second 45 

minutes separate. Both txs 

lasted 4 mo. 

All participants received 

standard medical and 

psychosocial tx. Once 

patients medically stable 

and met target wts, 

discharged to outpatient 

unit. Remainder of sessions 

carried out on outpatient 

basis. 

Two-way multivariate 

MANOVA and ANOVA 

repeated measures. 

Patients completed post tx 

assessment after 16 wks 

(T2) using same measures 

as beginning of tx (T1). 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

5 participants readmitted 

to inpatient program 

during the study and 

another 6 later readmitted 

after the study was 

completed. 

Funding: 

Physician Services Inc. 
C-152 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Geist et al., 2000 

(continued) 

EDI measures, mean (SD): 

Drive for thinness: 

G1: 11.1 (5.8) 

G2: 13.7 (6.2) 

(P = NR) 

Body Dissatisfaction: 

G1: 9.1 (6.6) 

G2: 11.0 (5.0) 

(P = NR) 

Bulimia: 

G1: 1.2 (1.3) 

G2: 1.9 (1.6) 

(P = NR) 

EDI measures, mean (SD): 

Drive for thinness: 

G1: 12.3 (7.5) (P = NR) 

G2: 13.3 (7.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Body Dissatisfaction: 

G1: 10.6 (9.2) (P = NR) 

G2: 12.2 (6.1) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Bulimia: 

G1: 1.2 (2.0) (P = NR) 

G2: 2.5 (2.6); (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-153 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CDI, mean (SD): 

G1: 11.8 (6.6) 

G2: 14.0 (4.7) 

(P = NR) 

CDI, mean (SD): 

G1: 12.2 (7.4) (P = NR) 

G2: 15.4 (4.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Wt: 

G1: 41.1 kg (7.0) 

G2: 41.1 kg (6.3) 

(P = NS) 

BSI, global severity, mean 

(SD): 

Patient: 

G1: 1.3 (0.6) 

G2: 1.4 (0.9) 

(P = NR) 

Mother: 

G1: 0.7 (0.8) 

G2: 0.6 (0.5) 

(P = NR) 

Father: 

G1: 0.7 (0.7) 

G2: 0.4 (0.3) 

(P = NR) 

BSI, global severity, mean 

(SD): 

Patient 

G1: 1.2 (0.7) (P = NR) 

G2: 1.2 (0.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Mother: 

G1: 0.6 (0.5) (P = NR) 

G2: 0.6 (0.5) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Father: 

G1: 0.4 (0.4) (P = NR) 

G2: 0.3 (0.2) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

IBW, %: 

G1: 77.7% 

G2: 77.2% 

(P = NR) 

IBW, %: 

G1: 91.4% (P = NR) 

G2: 96.3% (P = NR) 

Change over time (P < 0.0001)

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

FAM III, mean (SD): 

G1: 48.3 (7.3) 

G2: 50.9 (10.8) 

(P = NR) 

FAM III, mean (SD): 

G1: 52.2 (8.5) (P = NR) 

G2: 55.8 (7.7) (P = NR) 

Change over time (P = 0.02) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-154 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

le Grange et al., 1992 

Setting: 

Outpatient ED clinic; 

UK 

Enrollment period: 

NR 

Research objective: 

To assess, in adolescents 

with AN, the efficacy of 

conjoint family therapy in 

which the whole family is 

seen together versus 

separate session, family 

counseling in which parents 

and adolescents seen 

separately. 

Groups (N = 18): 

G1: Family Therapy 

(conjoint) (N = NR) 

G2: Family Counseling 

(separate) (N = NR) 

Enrollment: 

18 consecutively referred 

from Department of 

Children and Adolescents, 

Bethlem Royal and 

Maudsley Hospital, 

randomized and enrolled 

Duration of Illness: 

< 3 yrs 

Age, mean (SD): 

15.33 (1.81) 

Range: 12-17 

Sex (N): 

Female: 16 

Male: 2 

Race/ethnicity: 

NR 

Duration of Illness, mean 

mo (SD): 

13.7 (8.38) 

DSM III-R for BN: 

G1: 1 

G2: 3 
C-155 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Meet DSM III-R criteria for 

AN; < 18 yrs old; duration of 

illness < 3 yrs 

Exclusion: 

Medical risk or risk of 

suicide requiring 

hospitalization; comorbid 

major psychiatric disorder 

Both txs included wkly 

sessions, gradually spread 

out as they progressed to 

32 wks; both txs first 

address wt gain, then 

include family in tx of EDrelated issues 

G1: whole family in all tx 

sessions; G2: separate 

sessions between parents 

and therapist, and patient 

and therapist. 

Avg # of tx sessions, 6 

mos, mean (SD): 

G1: 8.6 (4.12) 

G2: 9.3 (4.37) 

(P = NR) 

Comparisons made 

between group and within 

group; further 

methodological details: NR 

Assessments at baseline, 

16 wks, and 32 wks, 

including patient’s 

biological and 

psychological variables and 

family interaction variables. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

NR 

Funding: 

NR 
C-156 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EAT scores, mean (SD): 

G1: 36.9 (27.6) 

G2: 35.3 (22.8) 

(P = NS) 

End-of-tx (32 wks): 

EAT scores, mean (SD): 

G1: 16.6 (12.1) (P = 0.01) 

G2: 15.6 (9.5) (P = 0.01) 

Diff between groups (P = NR) 

Diff between group in change over time (P = NS) 

Author, yr: 

le Grange et al., 1992 

(continued) 

M-R scores, avg outcome score, 

mean (SD): 

G1: 3.9 (1.7) 

G2: 4.8 (1.5) 

(P = NS) 

M-R scores, mean (SD): 

G1: 7.3 (2.0) (P = 0.01) 

G2: 8.8 (1.4) (P = 0.01) 

Diff between groups (P = NR) 

Diff between group in change over time (P = NS) 
C-157 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 

Wt (% ABW), mean 

(SD): 

G1: 75.9% (8.8) 

G2: 80.5% (5.3) 

(P value is not reported 

because inconsistent 

between table and text) 

End-of-tx (32 wks): 

Wt (% ABW), mean (SD): 

G1: 89.1% (13.5) (P = 0.006) 

G2: 100.4% (9.1) (P = 0.0001)

(P = NR) 

Diff between group in change 

over time (P = NS) 
C-158 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Lock et al., 2005 

Setting: 

Outpatient clinic for 

child and adolescent 

eating disorders, 

Stanford University 

School of Medicine, 

Stanford, CA, USA.

Enrollment period: 

September 1999 to 

April 2002 

Research objective: 

To determine the optimal 

length of family tx for 

adolescents with AN. 

Groups: 

G1: Long-term tx (N = 42) 

G2: Short-term tx (N = 44) 

Enrollment: 

• 241 assessed for 

eligibility 

• 155 excluded (100 not 

meeting study criteria; 

55 refusing 

participation) 

• 86 (61%) randomized 

• G1: 3 lost to FU, 7 

discontinued 

intervention; G2: 5 lost 

to FU, 2 discontinued 

intervention 

Age, mean (SD): 

G1: 15.2 (1.7) 

G2: 15.2 (1.6) 

(P = NS) 

Sex, N (%): 

Female 

G1: 38 (91%) 

G2: 39 (89%) 

Race/ethnicity, N (%): 

Asian 

G1: 2 (5%) 

G2: 6 (14%) 

White 

G1: 32 (76%) 

G2: 32 (73%) 

Hispanic 

G1: 6 (14%) 

G2: 4 (9%) 

Native American 

G1: 0 (0%) 

G2: 1 (2%) 

Other 

G1: 2 (5%) 

G2: 1 (2%) 

(P = NS) 

Duration of Eating 

Problem, mos (SD): 

G1:12.0 (9.9) 

G2: 11.3 (10.4) 

(P = NS) 

Hospitalization before tx, 

N (%): 

G1: 14 (34%) 

G2:12 (27%) 

(P = NS) 

Previous tx, N (%): 

G1: 36 (90%) 

G2: 39 (89%) 

(P = NS) 

Intact families, N (%) 

G1: 31 (74%) 

G2: 36 (82%) 

(P = NS) 
C-159 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for AN, 

though some partially 

wt restored 

participants entered; 

for postmenarchal 

females, those who 

had missed a min of 

one menstrual period 

instead of the three 

required by DSM IV 

criteria. 

Exclusion: 

Severe physical health 

problems likely to 

affect wt or psychiatric 

illnesses that would 

interfere with tx (e.g., 

psychosis); those who 

had failed family tx 

using the model 

employed in the study; 

use of psychotherapy 

in addition to that 

offered in the study 

protocol; (Psychotropic 

meds used to treat 

common comorbid 

psychiatric illnesses 

allowed.) 

Randomized to either a short-term 

(10 sessions over 6 mos) or longterm tx (20 sessions over 12 mos). 

ED variables were evaluated at 6 

mos and 1 yr using the EDE and 

YBC-ED. 

Manual-based txs (Dare and Eisler, 

1997) conducted on an outpatient 

basis. In G2, sessions held wkly for 

7 wks, then moly for 2 mos, and a 

final session at the 6 mos. In G1, 

sessions first held wkly for 7 wks, 

then biwkly through session 13, 

and finally, seven sessions were 

moly until the 1yr mark. 

All questionnaires were completed 

by the participants at home. 

 

Repeated measures 

for each subject; 

Effect sizes are 

reported using the 

mean diff between 

groups divided by the 

pooled within-group

SD; In a post hoc 

analysis, linear 

regression model was 

employed (using 1 yr 

FU data as the 

dependent measure 

and controlling for 

baseline values.) 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Yes 

Adverse events: 

Brief hospitalization for 

medical instability was needed 

for participants in both groups 

(22% overall; G1: 21%, G2:

10%); One participant dropped 

out due to need for other 

psychiatric tx. 

Funding: 

NIH Career Development 

Award 
C-160 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Lock et al., 2005 

(continued) 

 Purgers, N (%): 

G1: 9 (21%) 

G2: 7 (16%) 

(P = NS) 

Restrictors, N (%): 

G1: 33 (79%) 

G2: 37 (84%) 

(P = NS) 
C-161 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-162 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

All comparisons refer to intent-to-treat 

outcomes: 

EDE-Eating Concerns, mean (SD): 

G1: 1.04 (1.33) 

G2: 1.35 (1.13) 

(P = NS) 

EDE-Eating Concerns, mean (SD) 

6mos: 

G1: 0.75 (1.00) (P = NS) 

G2: 0.86 (1.01) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1 yr: 

G1: 0.52 (0.83) (P = NS) 

G2: 0.71 (0.92) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDE-Restraint, mean (SD): 

G1: 2.64 (1.96) 

G2: 2.76 (1.97) 

(P = NS)

EDE-Restraint, mean (SD) 

6mos: 

G1: 1.64 (1.70) (P = NS) 

G2: 1.84 (1.77) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1 yr: 

G1: 1.42 (1.63) (P = NS) 

G2: 1.62 (1.80) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Lock et al., 2005 

(continued) 

EDE-Shape Concerns, mean (SD): 

G1: 2.41 (1.67) 

G2: 2.61 (1.73) 

(P = NS)

EDE-Shape Concerns, mean (SD) 

6mos: 

G1: 1.96 (1.55) (P = NS) 

G2: 2.25 (1.63) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1 yr: 

G1: 1.76 (1.69) (P = NS) 

G2: 2.08 (1.70) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-163 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BMI, kg/m2, mean (SD): 

G1: 17.3 (1.5) 

G2: 17.0 (1.3) 

(P = NS) 

BMI, kg/m2, mean (SD): 

6 mos: 

G1:19.0 (1.8) (P = NS) 

G2:19.0 (2.3) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

1 yr: 

G1: 19.5 (2.1) (P = NS) 

G2: 19.5 (2.2) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 Wt (kg), mean (SD): 

G1: 46.7 (7.2) 

G2: 44.6 (5.5) 

(P = NS) 

Wt (kg), mean (SD): 

6mos: 

G1: 51.4 (7.5) (P = NS) 

G2: 50.6 (8.1) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

1 yr: 

G1: 53.2 (8.0) 

G2: 52.0 (7.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-164 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE- Wt Concerns, mean (SD): 

G1: 1.96 (1.52) 

G2: 2.32 (1.51) 

(P = NS) 

EDE-Wt Concerns, mean (SD) 

6mos: 

G1: 1.62 (1.48) (P = NS) 

G2: 2.01 (1.50) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1 yr: 

G1: 1.39 (1.44) (P = NS) 

G2: 1.97 (1.60) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

YBC-ED-Total score, mean (SD): 

G1: 12.2 (8.4) 

G2: 13.4 (7.9) 

(P = NS)

YBC-ED-Total Score, mean (SD) 

6mos: 

G1: 8.8 (6.6) (P = NS) 

G2: 10.9 (9.7) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1 yr: 

G1: 6.4 (6.4) (P = NS) 

G2: 9.2 (9.6) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Lock et al., 2005 

(continued) 

A secondary analysis of moderators of 

outcome found: 

• For BMI, YBC-ED-total score moderated 

outcome in favor of longer tx (G1) for those with 

the most severe symptoms (P = 0.008). 

• For global EDE, those with non-intact families 

did better in longer tx (P = 0.004). 

Sx Remission: 

• Using DSM IV BMI criterion (BMI < 17.5) only, 

96% of the sample remitted at the end of tx 

• Using criterion of BMI = 20 and a global EDE 

score within 2 SDs of normal, 67% would be 

considered remitted.
C-165 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-166 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Robin et al., 1999 

Setting: 

Outpt tx, MI, USA 

Enrollment period: 

1988-19947 

Research objective: 

To compare the 

effectiveness of behavioral 

family systems therapy 

(BFST) with ego-oriented 

individual therapy (EOIT) in 

adolescents with AN. 

Groups: 

G1: BFST (N = 19) 

G2: EOIT (N = 18) 

Enrollment: 

• 120 telephone 

screened 

• 60 intake interviews 

• 56 met criteria 

• 41 enrolled 

• 37 completed (G1: 19 

G2: 18) 

1 yr FU: 

N = 30 

Age, mean (SD): 

G1: 14.9 (P = NR) 

G2: 13.4 (P = NR) 

(P < 0.05) 

Sex: 

Female: 100% 

Race/ethnicity, N: 

White: 35 

Middle Eastern: 2 

Hollingshead 4-factor 

index: SES, mean (SD): 

G1: 45.7 (13.6) 

G2: 47.9 (12.0) 

(P = NS) 

Developed AN within 

previous 12 mos: 

100% 

Wt, lbs, mean: 

G1: 86.5 

G2: 86.8 

(P = NS) 

Height, inches, mean: 

G1: 63 

G2: 61 

(P = NS) 

Comorbidity assessed 

via DSM III Diagnostic 

Interview for Children 

and Adolescents: 

Mood disorder: 54% 

Anxiety: 13% 
C-167 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; age 11-20; 

DSM III-R criteria for 

AN, residing at home 

with 1 or both 

parents. 

Exclusion: 

NR 

G1: Family seen conjointly, parents 

placed in control of eating, cognitive 

restructuring, behavioral 

interventions to change family 

interactions. Met wkly for mean of 72 

m. 

G2: Adolescent seen individually, 

emphasis on building ego strength 

and uncovering dynamics blocking 

eating, parents seen collaterally. 

Adolescents met wkly for 45 m. 

Parents met bimonthly for mean of 

54 m. 

G1 + G2: medical and dietary 

regimen. 

Therapy length, mean mo (range):

15.9 (12-18). Wkly for the first half, 

bimoly thereafter. Post-assessment 

at termination 

FU at 12 mos. 

Diet: Balanced based on diabetic 

exchange, starting with 1200 cal/day 

and adjusted upward to permit 1 lb 

st gain/wk. 

Hospitalizations, N: If < 75% of 

ideal wt and/or had cardiac 

problems, received refeeding 

program and assigned therapy. 

Discharged when exceeded 80% of 

target wt, no other medical distress, 

and gaining wt on regular basis. 

G1: 11 

G2: 5 

Psychoactive meds prescribed, N: 

G1: 2 

G2: 2 

Due to OCD, MDD after wt gain 

Univariate and 

Multivariate repeatedmeasures ANOVAs. 

Chi squares. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NIMH 
C-168 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Robin et al., 1999 

(continued) 

EAT, Teen, mean (SD): 

G1: 32.6 (15.6) 

G2: 20.6 (15.6) 

EAT, Teen, mean (SD): post 

G1: 11.2 (13.6) 

G2: 7.9 (9.6) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EAT, Teen, mean (SD): FU 

G1: 8.1 (10.0) 

G2: 4.7 (6.1) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-169 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline 

Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 19.4 (12.3) 

G2: 11.3 (10.5) 

BDI, mean (SD): Post 

G1: 8.5 (8.4)

G2: 5.4 (9.0)

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

FU 

G1: 10.5 (11.0)

G2: 2.7 (4.7)

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI, mean (SD): 

G1: 15.2 (1.8) 

G2: 16.6 (2.1) 

BMI, mean (SD): Post 

G1: 19.9 (1.9) 

G2: 18.9 (1.9) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.001) 

G1 > than G2 

BMI, mean (SD): FU 

G1: 20.7 (2.7) 

G2: 19.8 (3.1) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.02) 

 Attained target wt, %: Post: 

G1: 66.7 

G2: 68.8 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Attained target wt, %: FU: 

G1: 80.0 

G2: 68.8 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

 Attained 25 percentile BMI for 

age, %: Post: 

G1: 84.2 

G2: 82.4 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Attained 25 percentile BMI for 

age, %: FU: 

G1: 86.7 

G2: 93.3 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)
C-170 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Robin et al., 1999 

(continued) 

 
C-171 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Attained 50th percentile BMI 

for age, %: Post: 

G1: 52.6 

G2: 41.2 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Attained 50th percentile BMI 

for age, %: FU: 

G1: 66.7 

G2: 46.7 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

 Resumed/Began 

menstruation, %, post: 

G1: 94 

G2: 64.4 

Change over time (P = NR) 

Diff between groups (P < 0.03) 

Diff between groups in change 

over time (P = NR) 

Resumed/Began 

menstruation, %, FU: 

G1: 92.9 

G2: 80 

Change over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)
C-172 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Robin et al., 1994 

Companion article: 

Robin, Siegel and 

Moye, 1995 

Setting: 

One site: outpatient 

and inpatient hospital 

setting, USA 

Enrollment period: 

NR 

Research objective: 

Compare the effectiveness 

of BFST to EOIT on wt gain, 

eating attitudes, family 

measures, ego functioning, 

depression, internalizing 

behavior and other 

psychometric measures in 

adolescents with AN, 

restricting sub-type. 

Groups: 

G1: BFST (N = 12) 

G2: EOIT (N = 12) 

Analysis in article 

presented on 22 

completers only 

Enrollment: 

• Referred by 

pediatricians, school 

personnel, 

psychologists, and 

social workers. 

• Phone screen with 

parent 

• Randomization to G1 or 

G2 

• Comprehensive intake 

interview and pediatric 

medical exam 

• Enrolled (N = 24) after 

confirmation of dx 

• Completed (N = 22) 

Drop-outs: 

G1 = 1 

G2 = 1 

Age, mean (SD): 

G1: 14.7 (2.7) 

G2: 13.9 (2.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 100% 

SES (Hollingshead), 

mean (SD): 

G1: 44.5 (15.4) 

G2: 44.5 (15.4) 

(P = NS) 

Target Wt (lbs), mean 

(SD): 

G1: 116.7 (10.7)

G2: 108.3 (20.5)

(P = NS) 
C-173 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of AN (restricting 

type) by DSM III-R 

criteria; onset within 

last 12 mos; lives at 

home with one or both 

parents; adolescent 

aged 12-19 

Exclusion: 

NR 

6 hr pre-assessment 

Randomized to BFST (G1) or 

EOIT (G2) 

Therapists (5) dedicated to 1 tx 

modality- standardized 

12-18 mos of tx determined by 

case with amount of therapy time 

equalized across modes 

6-9 mos of tx wkly, then 6-9 mos 

of tx bimoly 

diet to gain 1 lb wt /wk 

Inpatient re-feeding if < 75% IBW 

until 80% or more of target wt., no 

other sig problems and gaining wt. 

Participants also hospitalized for 

sig cardiac or neurologic problems

G2: collateral sessions for parents

6-hr post-assessment (includes 

physical) 

FU (Planned) at 12, 30 and 48 mo 

post-tx 

2x2 group (BFST vs 

EOIT) x time (Pre vs 

post) repeated 

measures ANOVA 

with Bonferroni 

correction for multiple 

comparison 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

Patients hospitalized for an 

avg of 26.4 days: 

BFST: 5 

EOIT: 3 

Funding: 

NIMH 
C-174 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Robin, Siegel and 

Moye, 1995 

Companion article: 

Robin et al., 1994 

Setting: 

One site: outpatient 

and inpatient hospital 

setting, USA 

Enrollment period: 

NR 

Research objective: 

In an adolescent AN, 

restricting sub-type 

population, compare the 

impact of behavioral family 

systems therapy (BFST) vs. 

ego-oriented individual 

therapy (EOIT) on family 

interactions including 

communication, problemsolving, warmo/hostility 

using self-report and 

observational measures of 

conflict and negative 

communication concerning 

eating and non-eating 

issues at end of tx and 1-yr 

FU. 

Groups: 

G1: BFST (N = 12) 

G2: EOIT (N = 12) 

G3: BFST at FU (N = 11) 

G4: EOIT at FU (N = 9) 

Enrollment: 

• Referred by 

pediatricians, school 

personnel, 

psychologists, and 

social workers. 

• Phone screen with 

parent 

• Randomization to G1 or 

G2 

• Comprehensive intake 

interview and pediatric 

medical exam 

• Enrolled (N = 24) after 

confirmation of dx 

• Completed (N = 22) 

Age, mean (SD): 

G1: 14.7 (2.7) 

G2: 13.9 (2.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 100% 
C-175 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of AN (restricting 

type) by DSM III-R 

criteria; onset within 

last 12 mos; lives at 

home with one or both 

parents; adolescent 

aged 12-19 

Exclusion: 

NR 

6 hr pre-assessment 

Randomized to BFST (G1) or 

EOIT (G2) 

Therapists (5) dedicated to 1 tx 

modality- standardized 

12-18 mos of tx determined by 

case with amount of therapy time 

equalized across modes 

6-9 mos of tx wkly, then 6-9 mos 

of tx bimoly 

diet to gain 1 lb wt /wk 

Inpatient re-feeding if < 75% IBW 

until 80% or more of target wt., no 

other sig problems and gaining wt. 

Participants also hospitalized for 

sig cardiac or neurologic problems

G2: collateral sessions for parents

6-hr post-assessment (includes 

physical) 

FU (Planned) at 12, 30 and48 mo 

post-tx 

6-hr post-assessment (includes 

physical) 

12 mo FU assessment 

t-tests to determine 

initial diffs between 

groups at preassessment 

2x2 group (BFST vs 

EOIT) x time (Pre vs 

post) repeated 

measures ANOVA 

orthogonal, repeated 

measures linear 

contrasts with tx 

condition as the 

grouping factor: 

Contrast I = preassessment vs. FU; 

Contrast II = postassessment vs. FU 

Bonferroni correction 

for multiple 

comparisons. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

Patients hospitalized for an 

avg of 26.4 days: 

BFST: 5 

EOIT: 3 

Funding: 

NIMH 
C-176 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EAT, mean (SD): Adolescent 

G1: 33.3 (16.7) 

G2: 18.0 (14.7) 

(P = NR) 

EAT, mean (SD): Adolescent 

G1: 7.2 (7.8) (P = NR) 

G2: 4.1 (7.9) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Robin, Siegel and 

Moye 1995 

(continued) 

EAT, mean (SD): Mother 

G1: 42.8 (10.9) 

G2: 36.3 (15.8) 

(P = NR) 

EAT, mean (SD): Mother 

G1: 6.0 (6.8) (P = NR) 

G2: 12.6 (11.8) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

 EAT, mean (SD): Father 

G1: 41.3 (12.6) 

G2: 36.6 (15.9) 

(P = NR) 

EAT, mean (SD): Father 

G1: 12.6 (16.9) (P = NR) 

G2: 20.4 (14.4) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

 Eating Conflict (T scores) from PARQ, 

mean (SD): Adolescent 

G1: 76.4 (21.7) 

G2: 74.0 (16.1) 

(P = NS) 

Eating Conflict (T scores) from PARQ, mean 

(SD):Adolescent 

G1: 55.0 (16.6) (P = NR) 

G2: 59.5 (21.1) (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

 Eating Conflict (T scores) from PARQ, 

mean (SD): Mother 

G1: 88.5 (17.6) 

G2: 96.3 (18.1) 

(P = NS) 

Eating Conflict (T scores) from PARQ, mean 

(SD): Mother 

G1: 52.0 (13.9) (P = NR) 

G2: 58.8 (17.1) (P = NR) 

Diff over time (P < 0.001)(P = NR) 

Diff between groups in change over time (P = NS) 

 Eating Conflict (T scores) from PARQ, 

mean (SD): Father 

G1: 76.7 (19.1) 

G2: 86.1 (20.1) 

(P = NS) 

Eating Conflict (T scores) from PARQ, mean 

(SD): Father 

G1: 46.8 (11.5) (P = NR) 

G2: 52.3 (22.0) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-177 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BSQ, mean (SD): 

G1: 106.0 (40.3) 

G2: 69.3 (47.1) 

(P = NR) 

BSQ, mean (SD): 

G1: 53.1 (42.8) (P = NR) 

G2: 43.4 (38.9) (P = NR) 

Diff over time (P < 0.001) 

(P = NR) 

Diff between groups in 

change over time (P = NS) 

Wt (lbs), mean (SD): 

G1: 85.4 (12.7) 

G2: 91.0 (23.1) 

(P = NS) 

EDI, mean (SD): 

Body dissatisfaction 

G1: 10.4 (8.3) 

G2: 9.8 (7.8) 

(P = NR) 

EDI, mean (SD): 

Body dissatisfaction 

G1: 6.5 (9.2) (P = NR) 

G2: 8.8 (9.9) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

BMI (kg/m2

), mean (SD)

G1: 15.0 (1.4) 

G2: 16.3 (2.8) 

(P = NS) 

%Underwt, mean (SD): 

G1: 26.9 (8.3) 

G2: 16.4 (10.6) 

(P < 0.05) 

BMI (kg/m2), mean (SD): 

G1: 20.1 (1.1) (P = NR) 

G2: 19.0 (1.4) (P = NR) 

Diff over time (P < 0.001) 

(P = NR) 

Diff between groups in change 

over time (P < 0.01) 

G1 better than G2 

≥ 50thpercentile BMI for age 

G1: 73% 

G2: 45% 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Menstruating at postassessment 

G1: 89% 

G2: 60% 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

BDI, mean (SD): 

G1: 21.4 (11.3) 

G2: 12.1 (12.8) 

(P = NR) 

BDI, mean (SD): 

G1: 6.7 (8.0) (P = NR) 

G2: 6.2 (10.9) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

 
C-178 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures (continued) 

Study Description Baseline Outcomes 

Interaction Behavior Code (IBC) of 

Conflict During Discussion of 

Adolescent’s Eating/Wt Problem: 

Negative communication, mean (SD): 

Adolescent 

G1: 6.1 (3.5) 

G2: 7.5 (4.5) 

(P = NS) 

IBC Of Conflict OverEating: 

Negative communication, mean (SD): 

Adolescent 

G1: 2.2 (1.9) (P = NR) 

G2: 3.9 (2.4) (P = NR) 

Diff over time (P < 0.003) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Negative communication, mean (SD): 

Mother 

G1: 5.5 (3.3) 

G2: 4.1 (2.5) 

(P = NS) 

Negative communication, mean (SD): Mother 

G1: 1.4 (1.4) (P < 0.002) 

G2: 3.4 (4.3) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.04) 

G1 better than G2 

Negative communication, mean (SD): 

Father 

G1: 6.1 (4.1) 

G2: 6.4 (3.7) 

(P = NS) 

Negative communication, mean (SD): Father 

G1: 3.4 (3.5) 

G2: 3.5 (3.0) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Positive communication, mean (SD): 

Adolescent 

G1: 1.3 (1.0) 

G2: 0.9 (0.6) 

(P = NS) 

Positive communication, mean (SD): Adolescent

G1: 2.3 (1.2) 

G2: 1.7 (1.6) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Positive communication, mean (SD): 

Mother 

G1: 1.6 (1.4) 

G2: 2.5 (1.3) 

(P = NS) 

Positive communication, mean (SD): Mother 

G1: 3.1 (1.6) (P < 0.005) 

G2: 2.2 (1.3) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Author, yr: 

Robin, Siegel and 

Moye 1995 

(continued) 

Positive communication, mean (SD): 

Father 

G1: 1.2 (1.2) 

G2: 1.3 (0.8) 

(P = NS) 

Positive communication, mean (SD): Father 

G1: 3.5 (1.4) 

G2: 2.6 (0.9) 

Diff over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-179 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 FU: 

BMI (kg/m2

): 

G3: 21.5 (2.7) (P = NR) 

G4: 19.3 (2.2) (P = NR) 

Diff over time 

• vs. pre-tx (P < 0.001) 

• vs. post-tx (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (Pre-tx: P < 0.004) 

G3 better than G4 

 Achieved target wt (postassessment) 

G1: 64% 

G2: 64% 

Diff between groups (P = NS) 

Achieved target wt (FU) 

G3: 82% 

G4: 50% 

Diff between groups (P = NS) 

 Menstruating (at postassessment) 

G1: 89% 

G2: 60% 

G3: 90% 

G4: 73% 

Diff between groups (P = NS) 

Menstruating (at FU) 

G3: 100% 

G4: 100% 

Diff between groups (P = NS) 
C-180 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures (continued) 

Study Description Baseline Outcomes 

Author, yr: 

Robin, Siegel and 

Moye 1995 

(continued) 

1 yr FU: 

Eating Conflict (T scores) from PARQ, mean 

(SD): 

Adolescent: 

G3: 56.0 (21.8) (P = NR) 

G4: 55.6 (14.2) (P = NR) 

Change over time 

• vs. pre-tx (P < 0.006) 

• vs. post-tx (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Mother: 

G3: 54.0 (16.3) (P = NR) 

G4: 65.9 (13.0) (P = NR) 

Change over time 

• vs. pre-tx (P < 0.001) 

• vs. post-tx (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Father: 

G3: 53.3 (16.8) (P = NR) 

G4: 59.9 (18.0) (P = NR) 

Change over time 

• vs. pre-tx (P < 0.001) 

• vs. post-tx (P < 0.02) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-181 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-182 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Russell et al., 1987 

Companion article: 

Eisler et al., 1997 

Setting: 

Outpt tx: Maudsley 

Hospital, London, 

UK 

Enrollment period: 

NR 

Research objective: 

To compare family 

therapy with 

individual supportive 

therapy in AN and 

BN. 

Groups: 

G1: Family Therapy (N = 41) 

G2: Individual Therapy (N = 39) 

Enrollment: 

Following inpatient stay, 

patients randomly assigned 

after determined to be in 1 of 4 

subgroups: 

1) AN, age of onset ≤ 18 yrs 

and duration < 3 yrs (N = 21) 

2) AN, onset ≤ 18 yrs and 

duration > 3 yrs (N = 15) 

3) AN, onset ≥ 19 yrs (N = 21) 

4) BN (N = 23) 

• Randomized: N = 80 

• Analyzed: N = 73 (did not 

begin tx: G1: 5, G2: 2) 

• Dropout/Tx Refusers, N: 28 

Subgroup 1: 

G1: 1 

G2: 7 

(P < 0.02) 

Subgroup 2: 

G1: 3 

G2: 4 

(P = NR) 

Subgroup 3: 

G1: 4 

G2: 0 

(P < 0.05) 

Subgroup 4: 

G1: 7 

G2: 2 

(P = NR) 

Diff between subgroups (P = 

NS) 

Age at onset, mean (SD): 

17.9 (6.4) 

(P = NS) 

Age at entry to trial, mean 

(SD): 

21.8 (7.1) 

(P = NS) 

Duration of illness, y, mean 

(SD): 

3.8 (3.1) 

(P = NS) 

Wt on admission, % ABW, 

mean (SD): 

69.6 (13.0) 

(P = NS) 

Wt on discharge, % ABW, 

mean (SD): 

89.5 (7.1) 

(P = NS) 

Duration of index hospital 

stay, wk, mean: 

10.4 

G1: 8.8 

G2: 12.1* 

(P = NR) 

Subgroup 1: 

G1: 8.6 

G2: 11.8 

(P < 0.05) 

Subgroup 2: 

G1: 8.2 

G2: 13.0 

(P < 0.02) 

Previous admissions, N, 

mean: 1.5 

(P = NS) 

Sex, N 

Male: 7 

Female: 73 

(P = NS) 

Race/ethnicity: 

NR 

Marital status, N: 

Single: 69 

Married: 8 

Separated/divorced: 3 

(P = NS) 
C-183 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

AN: DSM III criteria; 

self-induced wt loss 

through avoidance of 

fattening foods, 

excessive exercise, 

and self-induced 

vomiting or purging 

(not following binge 

eating); idea that 

fatness is a dreadful 

state; specific 

endocrine disorder 

(amenorrhea or in 

males sexual 

interest/potency lost). 

BN: DSM III-R 

preoccupation with 

food and episodes of 

gross overeating; 

counteract fattening 

effects of food by 

vomiting, purging, or 

starvation; 

psychopathology 

similar to AN; hx of 

previous overt or minor 

episode of AN. 

Exclusion: 

NR 

Upon reaching near-healthy body 

wt and being discharged from 

inpatient tx, patients were 

randomly assigned to conditions 

which were delivered on an outpt 

basis for one yr. Tx lasted 1 hour 

at least fortnightly for first 3 mos, 

then once every three wks for a 

total of 1 yr from date of 

discharge. 

G1: Family therapy: Included all 

members of the household. 

Tasks: family cooperation, 

organization (communication, 

rules), interventions 

(management, cooperation, 

support, consistency) 

G2: Nonspecific form of individual 

therapy: supportive, educational, 

problem-centered 

Antidepressant drug use allowed 

for both groups. 

Number of sessions, mean 

(SD): 

G1: 10.5 (8.9) 

G2: 15.9 (8.5) 

(P < 0.01) 

t-tests, Fisher’s exact 

probability test. 

Mulitivariate analyses 

and ANCOVAs 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

N/A 

Adverse events: 

NR 

Funding: 

Medical Research Council, UK
C-184 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Russell et al., 1987 

(continued) 

 Social Class, N: 

I: 23 

II: 28 

III: 21 

IV: 6 

V: 2 

Diff between groups (P = NS) 

Living with: 

Parents: 60 

Spouse/cohabitant: 12 

Alone: 8 

Diff between groups (P = NS) 

Distance from hospital, km, 

N: 

< 24: 28 

25 – 80: 28 

81 – 240: 16 

> 240: 8 

Diff between groups (P = NS) 
C-185 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

AN: DSM III criteria; 

self-induced wt loss 

through avoidance of 

fattening foods, 

excessive exercise, 

and self-induced 

vomiting or purging 

(not following binge 

eating); idea that 

fatness is a dreadful 

state; specific 

endocrine disorder 

(amenorrhea or in 

males sexual 

interest/potency lost). 

BN: DSM III-R 

preoccupation with 

food and episodes of 

gross overeating; 

counteract fattening 

effects of food by 

vomiting, purging, or 

starvation; 

psychopathology 

similar to AN; hx of 

previous overt or minor 

episode of AN. 

Exclusion: 

NR 
C-186 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Russell et al., 1987 

(continued) 

M-R Scales, Nutritional Status, mean 

(SD): Subgroup 1: 

G1: 0.7 (1.0) 

G2: 1.3 (1.4) 

(P = NS) 

M-R Scales, Nutritional Status at one year, mean 

(SD): Subgroup 1: 

G1: 9.6 (1.7) 

G2: 5.2 (3.3) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001)

G1 better than G2 

 Subgroups 2-4: 

Data not shown 

Diff between groups in change over time (P = NS) 

 Readmission rate, N (%): 22 

G1: 9 (25) 

G2: 13 (35) 

Diff between groups (P = NS) 
C-187 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

M-R Scales, Mental 

State, mean (SD): 

Subgroup 1: 

G1: 10.0 (2.8) 

G2: 8.7 (3.0) 

Diff between groups 

(P = NS) 

Subgroup 4: 

G1: 9.8 (2.9) 

G2: 7.6 (3.0) 

Diff between groups 

(P = NS) 

M-R Scales, Mental State 

mean (SD): 

Subgroup 1: 

G1: 12.0 (0.0) 

G2: 10.2 (2.1) 

Diff between groups (P = NR) 

Diff between groups over time 

(P = NS) 

Subgroup 4: 

G1: 9.3 (2.8) 

G2: 10.8 (2.7) 

Diff between groups (P = NR) 

Diff between groups over time 

(P < 0.001) 

G2 > G1 

Subgroups 2-3: 

G1: NR 

G2: NR 

Diff between groups in change 

over time (P = NS) 

ABW at discharge, %, 

mean (SD): 

Subgroup 1: 

G1: 89.4 (6.9) 

G2: 88.4 (8.1) 

Diff between groups 

(P = NR) 

Subgroup 2: 

G1: 91.3 (4.9) 

G2: 92.1 (6.4) 

Diff between groups 

(P = NR) 

Subgroup 3: 

G1: 84.9 (8.8) 

G2: 86.6 (6.7) 

Diff between groups 

(P = NR) 

Subgroup 4: 

G1: 91.2 (8.3) 

G2: 87.8 (4.9) 

Diff between groups 

(P = NR) 

ABW at one year, %, 

mean (SD): 

Subgroup 1: 

G1: 92.8 (8.4) 

G2: 80.1 (15.1) 

Diff between groups 

(P = NR) 

Diff between groups in 

change over time (P < 0.01)

G1 better than G2 

Subgroup 2: 

G1: 81.7 (9.0) 

G2: 80.3 (15.3) 

Diff between groups 

(P = NR) 

Diff between groups in 

change over time (P = NS) 

Subgroup 3: 

G1: 71.1 (8.3) 

G2: 79.9 (13.1) 

Diff between groups 

(P = NR) 

Diff between groups in 

change over time (P < 0.03)

G2 better than G1. 

Subgroup 4: 

G1: 989.0 (13.1) 

G2: 86.2 (11.5) 

Diff between groups 

(P = NR) 

Diff between groups in 

change over time (P = NS) 
C-188 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Russell et al., 1987 

(continued) 

 
C-189 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

M-R Scales, Psychosexual 

adjustment, mean (SD): 

Subgroup 1: 

G1: 6.3 (3.2) 

G2: 5.6 (2.4) 

Diff between groups 

(P = NS) 

M-R Scales, Psychosexual 

adjustment at one year, 

mean (SD): 

Subgroup 1: 

G1: 9.4 (3.0) 

G2: 6.3 (1.8) 

Diff between groups 

(P = NR) 

Diff between groups over 

time (P < 0.05) 

G1 better than G2. 

Subgroups 2-4: 

G1: NR 

G2: NR 

Diff between groups in 

change over time (P = NS) 

Wt maintenance >85% ABW 

from discharge to post tx at 

one year, N: 

Subgroup 1: 

G1: 5/10 

G2: 1/11 

Diff between groups (P < 0.05)

Subgroup 2: 

G1: 4/10 

G2: 3/9 

Diff between groups (P = NS) 

Subgroup 3: 

G1: 1/7 

G2: 2/7 

Diff between groups (P = NS) 

Subgroup 4: 

G1: 6/9 

G2: 5/10 

Diff between groups (P = NS) 

 M-R Scales, Menstrual 

function, mean (SD): 

Subgroup 1: 

G1: 0.0 (0) 

G2: 0.0 (0) 

Diff between groups 

(P = NS) 

M-R Scales, Menstrual 

function at one year, mean 

(SD): Subgroup 1: 

G1: 5.5 (6.0) 

G2: 0.8 (2.5) 

Diff between groups (P = NR) 

Diff between groups over time 

(P < 0.02) 

G1 better than G2. 

Subgroups 2-4: 

G1: NR 

G2: NR 

Diff between groups in change 

over time (P = NS) 
C-190 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Russell et al., 1987 

(continued) 

 
C-191 

Evidence Table 4. Behavioral intervention trials for adolescents with anorexia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

M-R Scales, Socioeconomic 

status, mean (SD): 

Subgroup 1: 

G1: 9.2 (2.1) 

G2: 8.1 (3.5) 

(P = NS) 

M-R Scales, 

Socioeconomic status at 

one year, mean (SD): 

Subgroup 1: 

G1: 10.8 (1.9) 

G2: 7.4 (3.4) 

Diff between groups (P = NR)

Diff between groups over 

time (P < 0.03) 

G1 better than G2 

Subgroups 2-4: 

G1: NR 

G2: NR 

Diff between groups in 

change over time (P = NS) 

 M-R scales outcome at one 

year, N: 

Subgroup 1: 

G1: Good: 6 

Intermediate: 3 

Poor: 1 

G2: Good: 1 

Intermediate: 1 

Poor: 9 

Diff between good and 

combined intermediate and 

poor (P = 0.02) 

Diff between poor and 

combined intermediate and 

good (P < 0.002) 

Subgroup 2: 

G1: Good: 2 

Intermediate 2: Poor: 6 

G2: Good: 2 

Intermediate 1: Poor: 6 

Diff between groups (P = NS) 

Subgroup 3: 

G1: Good: 0 

Intermediate: 1 

Poor: 6 

G2: Good: 2 

Intermediate: 1 

Poor: 4 

Diff between groups (P = NS) 

Subgroup 4: 

G1: Good: 0 

Intermediate: 1 

Poor: 8 

G2: Good: 1 

Intermediate: 2 

Poor: 7 

Diff between groups (P = NS) 

M-R Scales, Avg outcome. 

mean (SD): 

Subgroup 1: 

G1: 5.5 (1.3) 

G2: 4.8 (1.4) 

Diff between groups (P = NS) 

M-R Scales, Avg Outcome 

at one year, mean (SD): 

Subgroup 1: 

G1: 9.7 (2.0) 

G2: 5.7 (2.0) 

Diff between groups (P = NR)

Diff between groups over 

time (P < 0.01). G1 better 

than G2. 

Subgroups 2-4: 

G1: NR 

G2: NR 

Diff between groups in 

change over time (P = NS) 

 
C-192 

Evidence Table 5. Medication trials for bulimia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Beumont et al., 1997 

Setting: 

University-based 

outpatient clinics, 

Australia 

Enrollment period: 

NR 

Research objective: 

Efficacy of nutritional 

counseling in treating BN and 

whether improvement is 

maintained. Examine 

additional benefit of 

fluoxetine. 

Groups: 

G1: Fluoxetine (N = 34) 

G2: Placebo (N = 33) 

Enrollment: 

Participants recruited from 

two university-affiliated tx 

centers and from tertiary 

referrals from other 

psychiatric units. 

• Consecutive patients who 

met criteria were offered 

participation and asked 

for consent. 

• Participants received 

defined nutritional 

counseling program each 

wk (for 8 wks) in a oneone setting and randomly 

allocated to fluoxetine or 

placebo. 

• After initial interview, 

placebo washout period 

for 7-10 days. 

• 49 participants completed 

tx 

• Of these, 40 took part in 

the final FU assessment 

(G1: 17; G2: 23) 

Age, mean (SD): 

G1: 24.2 (4.5) 

G2: 25.1 (5.8) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-193 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women; at least 18 yrs old; 

fulfilled DSM III-R criteria for 

BN; within normal, healthy 

wt range with BMI between 

20 and 25. 

Exclusion: 

Use of appetite suppressant 

or monoamine oxidase 

inhibitor within 2 wks of 

starting study or other 

psychotropic meds within 

one wk; presence of 

medical illness, psychosis 

or suicidal ideation; hx of 

drug abuse, bipolar 

depression, mania or 

hypomania; pregnancy, 

lactation or being of child 

bearing age, not using 

medically accepted means 

of contraception; previous 

participation in any 

fluoxetine study or use of 

fluoxetine in last 5 wks; 

electrolyte levels outside 

normal range. 

All participants received 

nutritional counseling for 8 

wks from same dietitian, 

along with random 

allocation to fluoxetine or 

placebo. Fluoxetine group: 

20 mg 3 times a day with 

initial placebo washout 

period for 7-10 days. After 

washout, participants began 

trial and seen wkly until 

active tx ceased. FU 

assessments were made 4 

wks after meds was 

stopped and 8 wks after 

that. The participants were 

all seen by the same 

research nurse, general 

practitioner and dietitian. 

Mann-Whitney U tests, ttests, median tests and chisquared tests used to test 

Diffs. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Insomnia, nausea, and 

shakiness sig more 

common in G1. 

Depression more common 

in G2. Tiredness and 

headaches present 

equally in both groups. 

Funding: 

Eli Lilly of Australia 
C-194 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Total number of bulimic episodes, mean 

(SD): 

G1: 10.1 (10.1)

G2: 6.1 (5.6) 

(P = NS) 

Wk 4: 

Total number of bulimic episodes, mean (SD): 

G1: 1.9 (3.4) (P < 0.0001) 

G2: 1.5 (2.4) (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Wk 8: 

Mean total number of bulimic episodes (SD): 

G1: 1.6 (3.21) (P < 0.0001) 

G2: 1.2 (2.0) (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

3 mo FU: 

Total number of bulimic episodes, mean (SD): 

G1: 2.2 (3.8) (P < 0.003) 

G2: 1.0 (3.3) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Vomiting episodes per wk, mean (SD): 

G1: 8.8 (7.4) 

G2: 7.3 (6.5) 

(P = NS) 

Wk 4: 

Vomiting episodes per wk, mean (SD): 

G1: 3.2 (7.4) (P = 0.0001) 

G2: 2.8 (3.6) (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Wk 8: 

Vomiting episodes per wk, mean (SD): 

G1: 1.2 (3.0) (P = 0.0001) 

G2: 2.3 (3.3) (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

3 mo FU: 

Vomiting episodes per wk, mean (SD): 

G1: 2.5 (4.6) (P = 0.009) 

G2: 2.3 (3.3) (P = 0.003) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Author, yr: 

Beumont et al., 1997 

(continued) 

BSQ, mean (SD): 

G1: 142 (288) 

G2: 137 (26) 

(P = NS) 

Wk 4: 

BSQ, mean (SD): 

G1: NR (P < 0.0001) 

G2: NR (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Wk 8: 

BSQ: 

G1: NR (P < 0.001) 

G2: NR (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)
C-195 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Wt, kgs, mean (SD): 

G1: 60.5 (6.2) 

G2: 60.9 (6.9) 

Wk 4: 

Wt, kgs: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.03) 

G1 > wt loss than G2 

Wk 8: 

Wt, kgs: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.03) 

G1 > wt loss than G2 

3 mo FU: 

Wt increase, kgs, above 

baseline mean: 

G1: 2.4 (P < 0.01) 

G2: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

HDRS, mean (SD): 

G1: 11 (5) 

G2: 11.8 (4.4) 

(P = NS)

HDRS, mean (SD): 

G1: 5.3 (5.5) (P = NS) 

G2: 6.8 (6.4) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in 

change over time (P = NR) 

 
C-196 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

 Wk 8: 

Abstinence from binge eating: 

G1: 69.6% 

G2: 61.5% 

Diff between groups (P = NS) 

3 mo FU: 

Abstinence from binge eating: 

G1: 35.7% 

G2: 60.9% 

EAT score, mean (SD): 

G1: 49 (17) 

G2: 40 (15) 

(P = 0.04) 

Wk 4: 

EAT score: 

G1: NR (P < 0.005) 

G2: NR (P < 0.005) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Wk 8: 

EAT score: 

G1: NR (P < 0.005) 

G2: NR (P < 0.005) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EAT score: 

G1: NR 

G2: NR 

Author, yr: 

Beumont et al., 1997 

(continued) 

EDE – Restraint, mean (SD): 

G1: 3.5 (1.5) 

G2: 3.4 (1.4) 

(P = NS)

Wk 8: 

EDE – Restraint, mean (SD): 

G1: 1.0 (1.3) (P < 0.05) 

G2: 2.0 (1.4) (P < 0.05) 

Diff between groups (P < 0.03) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EDE – Restraint, mean (SD): 

G1: 1.7 (1.7) (P < 0.05) 

G2: 1.7 (1.8) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-197 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-198 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE – Overeating, mean (SD): 

G1: 2.4 (0.8) 

G2: 2.1 (1.0) 

(P = NS)

Wk 8: 

EDE – Overeating, mean (SD): 

G1: 0.9 (1.0) (P < 0.05) 

G2: 1.2 (1.0) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EDE – Overeating, mean (SD): 

G1: 1.4 (1.3) (P < 0.05) 

G2: 1.0 (1.1) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE – Eating Concern, mean (SD): 

G1: 3.1 (1.4) 

G2: 2.7 (1.6) 

(P = NS)

Wk 8: 

EDE – Eating Concern, mean (SD): 

G1: 1.1 (1.2) (P < 0.05) 

G2: 1.4 (1.2) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EDE – Eating Concern, mean (SD): 

G1: 1.6 (1.7) (P < 0.05) 

G2: 1.4 (1.5) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Beumont et al., 1997 

(continued) 

EDE – Shape Concern, mean (SD): 

G1: 3.7 (1.3) 

G2: 3.9 (1.2) 

(P = NS)

Wk 8: 

EDE – Shape Concern, mean (SD): 

G1: 2.0 (1.3) (P < 0.05) 

G2: 2.9 (1.5) (P < 0.05) 

Diff between groups (P < 0.03) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EDE – Shape Concern, mean (SD): 

G1: 3.0 (1.5) (P < 0.05) 

G2: 2.6 (1.6) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-199 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-200 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Beumont et al., 1997 

(continued) 

EDE – Wt Concern, mean (SD): 

G1: 3.0 (1.5) 

G2: 3.0 (1.5) 

(P = NS)

Wk 8: 

EDE – Wt Concern, mean (SD): 

G1: 1.2 (0.8) 

G2: 2.4 (1.6) 

Diff between groups (P < 0.03) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

3 mo FU: 

EDE – Wt Concern, mean (SD): 

G1: 2.0 (1.7) (P = NS) 

G2: 2.2 (1.6) (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-201 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-202 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Carruba et al., 2001 

Setting: 

3 Eating Disorder 

Units, Italy 

Enrollment period: 

6 consecutive mos 

Research objective: 

To examine the efficacy and 

tolerability of the MAOI-A 

moclobemide versus 

placebo in the tx of BN. 

Groups: 

G1: Moclobemide (N = 28) 

G2: Placebo (N = 24) 

Enrollment: 

• 78 (of 103 patients 

seen in 3 ED Units) 

recruited 

• 77 met criteria after 

placebo run-in phase 

• 52 completed trial 

Drop outs: 

G1: 10 (4 adverse events) 

G2: 15 (5 adverse events) 

Age, mean (SE) (range): 

G1: 25.65 (0.78) (19-36) 

G2: 25.15 (0.9) (18-40) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-203 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 18 to 40; DSM IV 

criteria for BN 

Exclusion: 

Hypersensitivity to MAOIs; 

neurological disorders; hx of 

schizophrenia, bipolar (I or 

II), suicide attempts, recent 

substance abuse; current dx 

of major depressive 

episode, high suicidal risk, 

unstable or uncontrolled 

medical diseases, clinically 

sig ECG; BMI < 17 or > 27; 

received psychotropic meds 

in past 4 wks 

Pre-screening with HAM-D, 

BITE, EDI, and TFEQ 

Initial 1-wk single-blind run 

in phase to identify and 

exclude placebo responders 

(i.e., 50% reduction of binge 

eating). 

Randomization: 

G1: 400mg for 1 wk, 600mg 

wk 2-6 

G2: NR 

Daily diaries to record binge 

eating, purging, or nonpurging compensatory 

behaviors. 

6 wkly sessions to collect 

diaries, record blood 

pressure, evaluate change 

in sx, effects, compliance, 

and to complete 

questionnaires. 

Between-group diffs in 

outcomes assessed 

using an unspecified 

parametric test for 

numerical variables and 

a non-parametric test 

for categorical 

variables. 

Efficacy and safety 

frequency data 

evaluated using a nonparametric test, and 

psychometric data 

compared using 

ANOVA. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events, N (%): 

G1: respiratory infectious 

disease, 3 (7.9%); vertigo, 2 

(5.3%); derealization crisis, 1 

(2.6%); headache, 1 (2.6%); 

skin rash, 1 (2.6%); sleep

disturbances, 1 (2.6%). 

G2: headache, 2 (5.2%); 

sleep disturbances, 3 (7.8%); 

abdominal pain, 1 (2.6%); 

attention difficulty, 1 (2.6%); 

chest pain, 1 (2.6%); 

constipation, 1 (2.6%); 

palpitations, 1 (2.6%); renal 

colic, 1 (2.6%) 

Funding: 

Roche 
C-204 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Pre-Placebo Run-in (N = 78): 

Binge Episodes, wkly, mean (SE): 

G1: 6.24 (1.04) 

G2: 6.46 (0.96) 

(P = NS) 

Post-Treatment: 

Binge Episodes, wkly, mean (SE): 

G1: 4.84 (0.79) (P = NR) 

G2: 3.61 (0.97) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Vomiting Episodes, wkly, mean (SE): 

G1: 4.80 (1.03) 

G2: 5.69 (1.29) 

(P = NS) 

Vomiting Episodes, wkly, mean (SE): 

G1: 4.44 (1.06) (P = NR) 

G2: 4.15 (1.24) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

BITE-Sx, mean (SE) (range): 

G1: 24.19 (0.56) (15-28) 

G2: 24.08 (0.64) (15-28) 

(P = NS) 

BITE-Sx, mean (SE): 

G1: 22.46 (0.93) (P = NR) 

G2: 21.86 (0.83) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

BITE-Severity, mean (SE) (range): 

G1: 11.69 (0.78) (3-20) 

G2: 12.43 (0.80) (3-31) 

(P = NS) 

BITE-Severity, mean (SE): 

G1: 9.26 (0.56) (P = NR) 

G2: 9.43 (0.81) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDI mean (SE): 

G1: 98.4 (6.3) 

G2: 83.4 (6.3) 

(P = NR) 

EDI mean (SE): 

G1: 87.6 (6.7) (P = NR) 

G2: 66.0 (6.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

TFEQ-1, restriction, mean (SE): 

G1: 13.32 (0.82) 

G2: 13.04 (0.81) 

(P = NR) 

TFEQ-1, restriction, mean (SE): 

G1: 13.04 (0.86) (P = NR) 

G2: 13.72 (0.94) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

TFEQ-2, disinhibition, mean (SE): 

G1: 12.92 (0.37) 

G2: 11.95 (0.51) 

(P = NR) 

TFEQ-2, disinhibition, mean (SE): 

G1: 12.56 (0.48) (P = NR) 

G2: 10.95 (0.56) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Carruba, Cuzzolaro et 

al., 2001 

(continued) 

TFEQ-3, hunger, mean (SE): 

G1: 10.28 (0.60) 

G2: 8.22 (0.79) 

(P = NR) 

TFEQ-3, hunger, mean (SE): 

G1: 9.84 (0.71) (P = NR) 

G2: 8.22 (0.83) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-205 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Pre-Placebo Run-In (N = 

78): 

HAM-D, mean (SE) (range): 

G1: 8.14 (0.90) (2-22) 

G2: 9.43 (1.28) (1-22) 

(P = NS) 

HAM-D, mean (SE): 

G1: 6.22 (0.99) (P = NR) 

G2: 6.26 (1.26) (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Pre-Placebo Run-in (N = 

78): 

Ht, cm (SE) (range): 

G1: 165.28 (1.04) (150-179) 

G2: 163.56 (0.87) (153-173) 

(P = NS) 

Wt, kg, mean (SE) (range): 

G1: 55.76 (1.36) (41-75) 

G2: 55.14 (1.3) (42-76) 

(P = NS) 

BMI, kg/m2 (SE) (range): 

G1: 20.35 (0.43) (17-26) 

G2: 20.49 (0.41) (17-26) 

(P = NS) 

Post-tx (N = 52): 

Wt, kg, mean (SE): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups 

Diff between groups (P = NR)

BMI, kg/m2 (SE): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups 

Diff between groups (P = NR)
C-206 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Faris, et al., 2000 

Setting: 

Outpatient setting, 

Dept of Psychiatry, U 

of Minnesota, 

Minneapolis, MN, 

USA 

Enrollment period: 

NR 

Research objective: 

RCT investigating use of 

ondansetron for participants 

with severe BN 

Groups: 

G1: Ondansetron (N = 14) 

G2: Placebo (N = 12) 

Enrollment: 

• 43 screened 

• 29 selected for initial 

assessment 

• 28 completed baseline 

study 

• 26 completed single 

blind placebo wk and 

randomized 

• 25 completed tx 

Age, mean (SD): 

Total: 29.1 (6) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of BN (SD): 

Total: 11.8 yrs (6.6) 
C-207 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Females, aged 18 or 

older not receiving any 

tx, bingeing followed 

by self-induced 

vomiting a min of 7 

times a wk for at least 

6 mos with a definite 

feeling of lack of 

control over the 

behavior, not engaged 

in other methods of 

purging, such as 

laxative or diuretic use, 

more than twice per 

wk in the past mo 

(more stringent than 

DSM IV BN criteria), 

BMI:17.5-23.5 kg/m2

, 

normal blood counts, 

electrolyte 

concentrations, liver 

function tests, 

electrocardiograms 

and physical 

examinations, not 

pregnant, no serious 

diagnosed medical 

condition, not suicidal 

or psychotic, no 

current or previous dx 

of schizophrenia or 

bipolar disorder, no 

problem with drug or 

alcohol abuse in the 6 

mos prior to study 

initiation, had not 

taken any 

psychoactive meds in 

6 wks before study 

began. 

Exclusion: 

Those who developed 

psychiatric or physical 

symptoms requiring 

medical tx 

One capsule (4 mg of drug or 

placebo) whenever urge to binge-eat 

or vomit. Should first try to restrain 

themselves for 30 min. If urges 

constant or not clearly defined, take 

doses 30 minutes before eating. Up

to 6 doses per day, could alter timing 

to max perceived effect for 4 wks. 

Maintains daily meal pattern record, 

research assistants contacted 

participants to create backup of same 

info, met once a wk with a 

psychiatrist to evaluate compliance 

and any side effects. 

Repeated measures 

analysis of variance 

(RM-ANOVA) with 

Huynh-Feldt 

corrections for sig. 

levels. Between-group

effects examined 

using contrast 

analyses. To control 

for diff in groups in 

baseline values, data 

subjected to an 

ANCOVA with values 

during the single-blind 

placebo wk entered as 

covariates. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Participants evaluated but 

none reported. One patient 

dropped out due to injury but 

no information about injury 

provided. 

Funding: 

Mark A Nugent Research 

Foundation 
C-208 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge-purge episodes in baseline wk 

for total sample, mean (SD): 

16.5 (7) 

During single-blind placebo wk, 

coupled binge-eating and vomiting 

episodes/a wk, mean (SD): 

G1: 12.8 (5.0) 

G2: 13.4 (9.9) 

(P = NR) 

Binge/vomit frequency during 4th wk, mean (SD): 

G1: 6.5 (3.9) (P = NR) 

G2: 13.2 (11.6) (P = NR) 

Diff between groups (P < 0.0001) 

Diff between groups in change over time (P < 0.001)

G1 better than G2 

Number of “normal meals” consumed: 

G1: NR 

G2: NR 

(P = NR) 

Number of “normal meals” consumed: 

G1: NR (P = 0.03) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.03) 

G1 better than G2 

Author, yr: 

Faris et al., 2000 

(continued) 

Time spent engaging in bulimic 

behaviors: 

G1: NR 

G2: NR 

(P = NR) 

Time spent engaging in bulimic behaviors: 

G1: NR (P = 0.04) 

G2: NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G1 less than G2 
C-209 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR BMI, kg/m2

, mean (SD): 

Total sample: 21.6 (2.5) 

 Wt, at single blind 

placebo wk, kg, mean: 

G1: 60.3 

G2: 60.1 

(P = NR) 

Wt after wk 4, kg, mean: 

G1: 60.4 (P = NR) 

G2: 60.8 (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-210 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fichter et al., 1996 

Companion article: 

Fichter et al., 1997 

Setting: 

Roseneck Hospital, 

Prien, Germany 

Enrollment period: 

December 1989 to 

March 1992 

Research objective: 

Compare fluvoxamine with 

placebo in maintaining 

improvement and preventing 

relapse in bulimic symptoms 

after tx with psychotherapy. 

Groups: 

G1 = Fluvoxamine group 

G2 = Placebo group 

Enrollment: 

• 257 patients admitted to 

inpatient unit between 

December 1989 and 

March 1992 

• 81 fulfilled inclusion 

criteria and randomly 

assigned to meds or 

placebo at admission to 

inpatient program. 

• 72 patients who had 

responded sufficiently to 

inpatient tx (9 were 

excluded as they were 

bingeing > 5 times/wk) 

began the tx. 

The study had three phases; 

inpatient tx phase, followed 

by a maintenance/outpatient 

tx phase and lastly, a 4-wk 

off-meds/placebo phase. 

Age, yrs, mean (SD): 

G1: 25.2 (4.9) 

G2: 23.7 (5.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset, yrs, mean 

(SD): 

G1: 19 (3) 

G2: 19 (4) 

Binge episodes in the mo 

prior to admission, mean 

(SD): 

G1: 16 (15) 

G2: 15 (15) 

Marital status, never 

married: 

G1: 81% 

G2: 86% 

Hx of depression: 

G1: 43% 

G2: 49% 

Hx of anxiety disorder: 

G1: 41% 

G2: 31% 

Hx of obesity: 

G1: 14% 

G2: 11% 

Hx of alcohol abuse: 

G1: 19% 

G2: 17% 

Hx of suicide attempts: 

G1: 27% 

G2: 23% 
C-211 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Between 18 and 50, 

DSM III-R BN of at 

least 6 mos duration 

prior to admission, 

body wt between 85% 

and 125% of IBW, 

inpatient 

improvements of 4 

points on clinical 

global impression – 

severity of illness scale 

during inpatient 

admission; 5 or fewer 

binges in the last wk of 

inpatient tx. 

Meds very rarely or in 

very low doses (i.e., 

low doses of 

psychoactive 

substances on a 

herbal basis or 

homeopathic dosages; 

up to 1 gm per night of 

chloralhydrate for 

sleep; 50 mg or less of 

isopromethazine; 1 mg 

in injection form of 

fluspirilene for crisis; 

50 mg or less of 

amitriptyline; normal 

dose of 

benzodiazepines for 

less than 5 days or 

when taken in low or 

avg dosage, i.e., about 

5 mg of diazepam a 

day). 

Identical capsules containing either 

50 mg of fluvoxamine or a lactose 

filler as a replacement; started at one 

capsule in the morning about 3 wks 

before the end of inpatient tx; 

stepwise increases every 3-4 days; 

usual dosage increased by one 

capsule and if tolerated, dose 

increased to a max of 300 mg of 

fluvoxamine by end of tx. Participants 

in placebo group received an avg of 

4.4 capsules a day. Avg dose 182 ± 

4.1mg. 

Participants who took 

meds in the off-meds 

phase included in the 

examination but 

excluded from 

analyses related to 

the off-meds phase. 

Repeated measures 

MANOVA’s for diffs 

between placebo and 

meds groups. 

ANOVA’s for main 

diffs across all three tx 

phases. Chi-square 

tests for 

nonparametric data. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

1 patient in G2 had to be 

admitted to the hospital. 1 

patient from G2 

complained of side 

effects. 8 patients from 

G1 dropped out due to 

side effects. Common 

side effects included 

nausea, dizziness and 

drowsiness (more 

common in the patients 

receiving fluvoxamine). 

Funding: 

NR 
C-212 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fichter et al., 1996 

(continued) 

 
C-213 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Exclusion: 

Pregnant or lactating, 

serious medial 

conditions, psychosis 

or acute suicidal 

ideation, seizures, 

insulin-dependent 

diabetes or if used 

other psychoactive 

meds, appetite 

suppressants or other 

relevant meds within 2 

wks prior to entering 

meds part of study. 

Avg or high dose of 

concurrent 

psychoactive meds 

over more than 4 days 

during the study also 

excluded. 

 
C-214 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Values obtained immediately 

before discharge. 

Values obtained 12 wks post-discharge. 

Urge to binge: binge frequency 

previous wk, mean: 

G1: 0.9 

G2: 1.0 

(P = NR)

Urge to binge: binge frequency previous wk, mean: 

G1: 1.9 (P = NR) 

G2: 3.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

SIAB-Bulimia, mean: 

G1: 1.2 

G2: 0.8 

(P = NR)

SIAB-Bulimia, mean: 

G1: 1.8 (P = NR) 

G2: 2.2 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

SIAB-total, mean: 

G1: 1.3 

G2: 1.1 

(P = NR)

SIAB-total, mean: 

G1: 1.6 (P = NR) 

G2: 1.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2

EDI-total score, mean: 

G1: 0.73 

G2: 0.60 

(P = NR) 

EDI-total score, mean: 

G1: 0.78 (P = NR) 

G2: 0.86 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDI-Bulimia, mean: 

G1: 0.47 

G2: 0.22 

(P = NR) 

EDI-Bulimia, mean: 

G1: 0.40 (P = NR) 

G2: 0.61 (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.01) 

G1 better than G2 

SIAB-expert rating: fasting, 

mean: 

G1: 0.9 

G2: 1.0 

(P = NR) 

SIAB-expert rating: fasting, mean: 

G1: 0.7 (P = NR) 

G2: 1.4 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Author, yr: 

Fichter et al., 1996 

(continued) 

SIAB-expert rating: qualitative 

food reduction, mean N: 

G1: 1.2 

G2: 0.9 

(P = NR) 

SIAB-expert rating: qualitative food reduction, mean: 

G1: 0.8 (P = NR) 

G2: 1.0 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-215 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Global assessment, mean: 

G1: 3.0 

G2: 2.8 

(P = NR) 

Global assessment, mean: 

G1: 3.3 (P = NR) 

G2: 4.1 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P < 0.01) 

G1 better than G2 

BMI, kg/m2, mean: 

G1: 20.7 

G2: 20.2 

(P = NS) 

BMI, kg/m2, mean: 

G1: 21.4 (P = NR) 

G2: 20.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-216 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

SIAB-expert rating: vomiting, 

mean: 

G1: 1.3 

G2: 0.6 

(P = NR) 

SIAB-expert rating: vomiting, mean: 

G1: 1.8 (P = NR) 

G2: 2.0 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Fear to lose control over eating 

behavior, mean: 

G1: 97 

G2: 97 

(P = NR) 

Fear to lose control over eating behavior, mean: 

G1: 98 (P = NR) 

G2: 187 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.01) 

G1 better than G2 

Urge to binge in last 7 days in 

VAS, mean: 

G1: 138 

G2: 118 

(P = NR) 

Urge to binge in last 7 days in VAS, mean: 

G1: 147 (P = NR) 

G2: 195 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Severity of Eating Disorder- patient rating: 

Diff between groups in change over time (P < 0.05) 

Severity of Eating Disorder – expert rating: 

Diff between groups in change over time (P < 0.05) 

Figure Consciousness and Body Image: 

Diff between groups in change over time (P = NS) 

“Deterioration” (increase) in severity of bulimic 

symptoms: 

G1: 10% (P = NR) 

G2: 46% (P = NR) 

“Deterioration” (increase) in number of binges in 

previous wk: 

G1: 111% (P = NR) 

G2: 270% (P = NR) 

Abstinence from bingeing: 

G1: NR 

G2: NR 

Diff between groups (P < 0.05) 

G1 better than G2

Abstinence from vomiting: 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Author, yr: 

Fichter et al., 1996 

(continued) 

“Deterioration” (increase) in SIAB-bulimia: 

G1: 50% (P = NR) 

G2: 175% (P = NR) 
C-217 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-218 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Fichter et al., 1996 

(continued) 

Relapse (defined as score of 5 or more on CGI 

severity) before end of the relapse prevention phase:

G1: 8.1% (P = NR) 

G2: 31.4% (P = NR) 

Diff between groups (P < 0.05) 

G1 better than G2 

Diff between groups in change over time (P = NR) 
C-219 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-220 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fichter et al., 1997 

Companion article: 

Fichter et al., 1996 

Setting: 

Roseneck Hospital, 

Prien, Germany 

Enrollment period: 

December 1989 to 

March 1992 

Research objective: 

Compare fluvoxamine with 

placebo on depression, 

anxiety and other areas of 

psychopathology among 

individuals with BN after 

inpatient tx with 

psychotherapy. 

Groups: 

G1 = Fluvoxamine group 

G2 = Placebo group 

Enrollment: 

• 257 patients admitted to 

inpatient unit between 

December 1989 and 

March 1992 

• 81 fulfilled inclusion 

criteria and were 

randomly assigned to 

meds or placebo at 

admission to the inpatient 

program. 

• 72 patients who 

responded sufficiently to 

inpatient tx and began 

the tx. (9 were excluded 

as they were bingeing > 5 

times/wk) 

• Out of 72 patients who 

began tx, 24 dropped out 

or excluded because of 

low fluvoxamine levels. 

The study had three phases; 

inpatient tx phase, followed 

by a maintenance/outpatient 

tx phase and lastly, a 4-wk 

off-meds/placebo phase. 

Age, yrs, mean (SD): 

G1: 25.2 (4.9) 

G2: 23.7 (5.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset, yrs, mean 

(SD): 

G1: 19 (3) 

G2: 19 (4) 

Binge episodes in the mo 

prior to admission, mean 

(SD): 

G1: 16 (15) 

G2: 15 (15) 

Marital status, never 

married: 

G1: 81% 

G2: 86% 

Hx of depression: 

G1: 43% 

G2: 49% 

Hx of anxiety disorder: 

G1: 41% 

G2: 31% 

Hx of obesity: 

G1: 14% 

G2: 11% 

Hx of alcohol abuse: 

G1: 19% 

G2: 17% 

Hx of suicide attempts: 

G1: 27% 

G2: 23% 
C-221 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Years of age between 18 

and 50, DSM III-R BN of at 

least 6 mos duration prior to 

admission, body wt between 

85% and 125% of IBW, 

inpatient improvements of 4 

points on clinical global 

impression – severity of 

illness scale during inpatient 

admission; 5 or fewer 

binges in the last wk of 

inpatient tx. 

Meds very rarely or in very 

low doses (i.e., low doses of 

psychoactive substances on 

a herbal basis or 

homeopathic dosages; up to 

1 gm per night of 

chloralhydrate for sleep; 50 

mg or less of 

isopromethazine; 1 mg in 

injection form of fluspirilene 

for crisis; 50 mg or less of 

amitriptyline; normal dose of 

benzodiazepines for less 

than 5 days or when taken 

in low or avg dosage, i.e., 

about 5 mg of diazepam a 

day). 

Patients dispensed identical 

capsules containing either 

50 mg of fluvoxamine or a 

lactose filler as a 

replacement; started at one 

capsule in the morning 

about 3 wks before end of 

inpatient tx; stepwise 

increases every 3-4 days; 

usual dosage increased by 

one capsule and if tolerated, 

increased to a max of 300 

mg of fluvoxamine by end of 

tx. Placebo group received 

an avg of 4.4 capsules a 

day. Avg dose 182 ± 4.1mg.

MANOVA’s for the relapse 

prevention phase and two 

factorial ANOVA’s for each 

of the 3 phases (only 

completer for last phase). 

Mann Whitney U tests for 

examining relapses. T-tests 

were used to look at diffs in 

side effect duration and 

severity and use of 

subsequent tx. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

1 patient in G2 had to be 

admitted to the hospital. 1 

patient from G2 

complained of side effects. 

8 patients from G1 

dropped out due to side 

effects. Common side 

effects included nausea, 

dizziness and drowsiness 

(more common in 

fluvoxamine group). 

Funding: 

NR 
C-222 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fichter et al., 1997 

(continued) 

 
C-223 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Exclusion: 

Pregnant or lactating, 

serious medial conditions, 

psychosis or acute suicidal 

ideation, hx of seizures, 

insulin-dependent diabetes 

or if used other 

psychoactive meds, 

appetite suppressants or 

other relevant meds within 2 

wks prior to entering meds 

part of study. Avg or high 

dose of concurrent 

psychoactive meds over 

more than 4 days during the 

study also excluded. 

 
C-224 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Values obtained immediately before 

discharge. 

Values obtained 12 wks post-discharge. 

Urge to binge: binge frequency 

previous wk, mean: 

G1: 0.9 

G2: 1.0 

(P = NR)

Urge to binge: binge frequency previous wk, 

mean: 

G1: 1.9 (P = NR) 

G2: 3.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

SIAB-Bulimia, mean: 

G1: 1.2 

G2: 0.8 

(P = NR)

SIAB-Bulimia, mean: 

G1: 1.8 (P = NR) 

G2: 2.2 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

SIAB-total, mean: 

G1: 1.3 

G2: 1.1 

(P = NR)

SIAB-total, mean: 

G1: 1.6 (P = NR) 

G2: 1.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2

EDI-total score, mean: 

G1: 0.73 

G2: 0.60 

(P = NR) 

EDI-total score, mean: 

G1: 0.78 (P = NR) 

G2: 0.86 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDI-Bulimia, mean: 

G1: 0.47 

G2: 0.22 

(P = NR) 

EDI-Bulimia, mean: 

G1: 0.40 (P = NR) 

G2: 0.61 (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.01) 

G1 better than G2 

Author, yr: 

Fichter et al., 1997 

(continued) 

SIAB-expert rating: fasting, mean: 

G1: 0.9 

G2: 1.0 

(P = NR) 

SIAB-expert rating: fasting, mean: 

G1: 0.7 (P = NR) 

G2: 1.4 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 
C-225 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI Severity, mean: 

G1: 3.1 

G2: 3.0 

(P = NS) 

CGI Severity, mean: 

G1: 3.3 (P = NR) 

G2: 3.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P < 0.05) 

G1 better than G2 

BMI, kg/m2, mean: 

G1: 20.7 

G2: 20.2 

(P = NS) 

BMI, kg/m2, mean: 

G1: 21.4 (P = NR) 

G2: 20.7 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

HDRS, mean: 

G1: 12.3 

G2: 10.1 

(P = NS)

HDRS, mean: 

G1: 13.2 (P = NR) 

G2: 15.0 (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS)

 

Hopkins Symptom 

Checklist Depression, 

mean: 

G1: 1.9 

G2: 1.7 

(P = NS)

Hopkins Symptom 

Checklist depression, 

mean: 

G1: 1.9 (P = NR) 

G2: 2.0 (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS)

 

Hopkins Symptom 

Checklist Anxiety, mean: 

G1: 1.7 

G2: 1.8 

(P = NS)

Hopkins Symptom 

Checklist Anxiety, mean: 

G1: 1.7 (P = NR) 

G2: 1.9 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS)

 

Hopkins Symptom 

Checklist ObsessionsCompulsions, mean: 

G1: 1.8 

G2: 1.7 

(P = NS)

Hopkins Symptom 

Checklist ObsessionsCompulsions, mean: 

G1: 1.8 (P = NR) 

G2: 2.1 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P < 0.05) 

G1 better than G2

 
C-226 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

SIAB-expert rating: qualitative food 

reduction, mean N: 

G1: 1.2 

G2: 0.9 

(P = NR) 

SIAB-expert rating: qualitative food reduction, 

mean: 

G1: 0.8 (P = NR) 

G2: 1.0 (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

SIAB-expert rating: vomiting, mean: 

G1: 1.3 

G2: 0.6 

(P = NR) 

SIAB-expert rating: vomiting, mean: 

G1: 1.8 (P = NR) 

G2: 2.0 (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Fear to lose control over eating 

behavior, mean: 

G1: 97 

G2: 97 

(P = NR) 

Fear to lose control over eating behavior, mean: 

G1: 98 (P = NR) 

G2: 187 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.01) 

G1 better than G2 

Urge to binge in last 7 days in VAS, 

mean: 

G1: 138 

G2: 118 

(P = NR) 

Urge to binge in last 7 days in VAS, mean: 

G1: 147 (P = NR) 

G2: 195 (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.05) 

G1 better than G2 

Severity of Eating Disorder- patient rating: 

Diff between groups in change over time (P < 0.05) 

Severity of Eating Disorder – expert rating: 

Diff between groups in change over time (P < 0.05) 

Figure Consciousness and Body Image: 

Diff between groups in change over time (P = NS) 

Author, yr: 

Fichter et al., 1997 

(continued) 

“Deterioration” (increase) in severity of bulimic 

symptoms: 

G1: 10% (P = NR) 

G2: 46% (P = NR) 

“Deterioration” (increase) in number of binges in 

previous wk: 

G1: 111% (P = NR) 

G2: 270% (P = NR) 
C-227 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-228 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Abstinence from bingeing: 

G1: NR 

G2: NR 

Diff between groups (P < 0.05) 

G1 better than G2

Abstinence from vomiting: 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

“Deterioration” (increase) in SIAB-bulimia: 

G1: 50% (P = NR) 

G2: 175% (P = NR) 

Author, yr: 

Fichter et al., 1997 

(continued) 

Relapse (defined as score of 5 or more on CGI 

severity) before end of the relapse prevention 

phase: 

G1: 8.1% (P = NR) 

G2: 31.4% (P = NR) 

Diff between groups (P < 0.05) 

G1 better than G2 

Diff between groups in change over time (P = NR) 
C-229 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-230 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fichter et al., 1991 

Setting: 

Inpatient clinic; Klinik 

Roseneck, Prien, 

Germany 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

fluoxetine (60mg) versus 

placebo in the tx of individuals 

with BN already receiving 

intensive inpatient behavioral 

psychotherapy. 

Groups: 

G1: Fluoxetine (N = 20) 

G2: Placebo (N = 20) 

Enrollment: 

• 40 randomized 

• 39 analyzed 

(G1: 19; G2: 20), with I 

exclusion 

• 0 drop outs 

Age, mean (SD): 

G1: 26.5 (NR) 

G2: 24.6 (NR) 

(P = NS) 

Sex, N: 

Female: 39 

Male: 1 

Race/ethnicity: 

NR 

Age of onset of eating 

disorder, yrs, mean (SD): 

G1: 16.6 (NR) 

G2: 16.2 (NR) 

(P = NS) 

Hx of AN, N (%): 

G1: 10/20 (50%) 

G2: 10/20 (50%) 

(P = NS) 

Laxative abuse, past wk, N 

(%): 

G1: 4/20 (30%) 

G2: 1/20 (35%) 

(P = NR) 
C-231 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of BN (DSM III-R); 

inpatient status 

Exclusion: 

Pregnancy; serious suicidal 

risks, medical risks or 

disorders; schizophrenia, hx 

of seizures or drug/alcohol 

addiction; PreTx with longacting neuroleptics 

In 10 balanced blocks of 4, 

40 patients with BN 

randomly assigned to 60mg 

fluoxetine or placebo; in 

addition to meds, all 

participants continued in 

intensive inpatient care—a 

broad spectrum, behavioral 

tx program. 

After a 3-7 day washout 

period, received a 60 

mg/day dose of fluoxetine or 

placebo for 35 days; no 

other psychotropic meds 

given, except for 

chloralhydrate and 

benzodiazepines, if 

necessary. 

Repeated-measures 

ANOVA 

Self-report measures 

regarding and clinically 

administered ratings, 

and biometric 

measures made one wk 

before tx start, and on 

days, 7, 14, 21, 28, 35. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

One patient excluded due to 

undetectable fluoxetine 

plasma levels at all 

measurement points; G1 

reported sig more “trembling” 

than G2 (P = 0.02); No sig 

diffs observed for numbness, 

nausea, body tingling, “mind 

going blank, hot and cold 

spells, trouble getting breath, 

heart racing, pains in heart, 

nervousness or shaking, 

heartache or restlessness, 

trouble concentrating, anxiety, 

poor appetite, sweating, 

elevated systolic and diastolic 

blood pressure, elevated 

pulse rate, reduced white 

blood count, reduced 

hemoglobin, increased liver 

enzymes and creatinine, and 

changes in serum potassium. 

Funding: 

NR 
C-232 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI, Bulimia, mean (SD) 

G1: 10.2 (5.3) 

G2: 9.9 (3.5) 

(P = NS) 

End of tx: 

EDI, Bulimia, mean (SD) 

G1: 3.0 (4.8) (P = NR) 

G2: 4.0 (4.8) (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDI, Drive for thinness, mean,\ (SD) 

G1: 12.3 (5.4) 

G2: 11.0 (4.7) 

(P = NS)

EDI, Drive for thinness, mean (SD) 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

EDI, Total score, mean (SD): 

G1: 82.7 (32.5) 

G2: 76.9 (28.9) 

(P = NS)

EDI, Total score, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDI, Body Dissatisfaction, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

SIAB-Global rating, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Urge to binge, past wk, mean (SD): 

G1: 2.51 (1.20) 

G2: 2.64 (0.83) 

(P = NS)

Urge to binge, past wk, mean (SD): 

G1: 1.37 (0.90) (P = NR) 

G2: 1.54 (0.95) (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Binge attacks, past wk, mean (SD): 

G1: 5.63 (9.10) 

G2: 8.85 (7.99) 

(P = NS)

Binge attacks, past wk, mean (SD): 

G1: 3.00 (4.77) (P = NR) 

G2: 6.60 (6.94) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Fichter et al., 1991 

(continued) 

Anxiety, loss of control over eating 

(0-4), mean (SD): 

G1: 2.7 (1.4) 

G2: 1.9 (1.0) 

(P = 0.05)

Anxiety, loss of control over eating (0-4), mean 

(SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-233 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HAM-D, total score, 

mean (SD): 

G1: 13.3 (5.6) 

G2: 14.1 (7.0) 

(P = NS) 

End of tx: 

HAM-D, total score, mean 

(SD): 

G1: 8.3 (5.0) (P = NR) 

G2: 11.1 (7.4) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Wt, kg, mean (SD): 

G1: 56.8 (12.3) 

G2: 54.7 (11.1) 

(P = NS) 

Wt, kg, mean (SD): 

G1: 55.3 (9.1) (P = NR) 

G2: 55.0 (10.1) (P = NR) 

Diff over time (P = 0.05) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

SCL-90, depression, 

mean (SD): 

G1: 1.7 (0.9) 

G2: 1.8 (0.8) 

(P = NS) 

SCL-90, depression (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 

SCL-90, anxiety, mean 

(SD): 

G1: 1.0 (0.8) 

G2: 1.3 (1.0) 

(P = NS) 

SCL-90, anxiety, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-234 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: Abstinence NR 

Fichter et al., 1991 

(continued) 

NR 

The following selected SIAB items were reported 

over time within both groups (means: NR): 

• Compulsive eating behavior (P = NS) 

• Compulsive thoughts about eating(P = NS) 

• Ideal of slimness (P = 0.001) 

• Fasting (P = 0.001) 

• Body image disturbance (P = 0.05) 

• Induced vomiting (P = 0.01) 

• Laxative abuse (P = NS) 

No sig diff between groups, or sig diff between 

groups in change over time were reported for any of

these items 
C-235 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 CGI-Severity of illness, mean 

(SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

CGI-Change over time, mean 

(SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

CGI-Therapy effectiveness, 

mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

CGI-Risk index, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-236 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fluoxetine BN 

Collaborative Study 

Group, 1992 

Comparison 

articles: 

Goldstein, 1995 and 

Goldstein, 1999 

Setting: 

13 Outpatient centers 

in the U.S. and 

Canada 

Enrollment period: 

NR 

Research objective: 

To compare the efficacy 

and safety of two doses 

of fluoxetine in the tx of 

BN 

Groups: 

G1: Placebo (N = 129) 

G2: Fluoxetine 20 mg (N = 129) 

G3: Fluoxetine 60 mg (N = 129) 

Enrollment: 

• 442 screened 

• 387 randomized (129 

assigned to each group) 

• 270 after 8 wks 

Age, mean (SD): 

G1: 27.7 (8.0) 

G2: 27.4 (7.2) 

G3: 26.4 (6.2) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 

G1: 98% 

G2: 95% 

G3: 97% 

(P = NS) 

BMI, kg/m2

, mean (SD): 

G1: 22.6 (3.3) 

G2: 22.7 (4.2) 

G3: 22.4 (3.2) 

(P = NS) 

BN behaviors (self-report): 

Vomiting (83%) 

Laxative abuse (60%) 

Diuretic abuse (22%) 

Fasting (13%) 

Strict dieting or exercising 

(27%) 
C-237 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, met DSM III-R 

criteria for BN; ≥ 3 

binge eating episodes 

per wk for at least 6 

mos; age 18+; 

between 85%-130% of 

midpoint of IBW for ht. 

Exclusion: 

Pregnant or lactating; 

serious medical 

illness; psychosis; 

acute suicidal ideation; 

initial serum potassium 

level < 3.0 mmol/L; 

used psychoactive 

meds 2 wks prior to 

enrollment; initiated 

some other form of tx 

for BN (e.g., 

psychotherapy or 

behavior therapy) 1 

mo prior to enrollment; 

1 wk placebo 

responders (i.e., 75% 

improvement or had < 

3 bulimic episodes per 

wk). 

1 wk of single-blind placebo admin, 

followed by random assignment to 

placebo, 20 mg fluoxetine, or 60 mg 

of fluoxetine for 8 wks. 

Participants seen wkly for recording 

of wt, blood pressure, resting pulse, 

and oral temperature. Administered 

HDRS, EDI, EAT, and 2 visual analog 

scales for measuring carbohydrate 

craving and bulimic intensity. 

Subjects recorded number of daily 

binge eating and purging episodes in 

diary, which were totaled at wkly visit. 

Clinicians subjectively rated subject’s 

global improvement during each visit. 

Med compliance assessed by 

capsule count (# dispensed - # 

returned). 

Tx responders: at least 50% 

improvement in binge-eating and 

vomiting frequency. Med noncompliance: taking < 80% of 

recommended dosage by endpoint. 

ANOVAs on rank 

transformed data for 

continuous efficacy 

and safety variables; 

Pairwise comparisons 

using Fisher’s least 

sig diff; CochranMantel-Haenszel 

mean score test for 

bulimic response data; 

Pearson’s X2

 tests for 

subject dispositional 

and adverse event 

data; Spearman’s 

rank correlation 

coefficients for 

efficacy versus drug 

plasma concentration 

correlations; multiple 

logistic regressions for 

predicting response to 

fluoxetine. 

Score: 

Fair 

Intent to treat: 

Analyses not performed on 

initial randomized sample of 

387 but on those who returned 

for at least 1 visit after 

randomization (N = 382). 

Blinding: 

Double 

Adverse events: 

Insomnia (P < 0.001) 

Nausea (P = 0.021) 

Asthenia (P = 0.039) 

Tremor (P < 0.001) 

Sweating (P = 0.036) 

Urinary frequency (P = 0.012) 

Palpitation (P = 0.017) 

Yawn (P = 0.017) 

Mydriasis (P = 0.018) 

Vasodilation (P = 0.029) 

All events greater in the active 

vs placebo groups. No sig diff 

among groups for adverse 

events being the reason why 

participants discontinued the 

study. 

Funding: 

Eli Lilly and Company 
C-238 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge episodes/wk, mean (SD): 

G1: 11.0 (8.0) 

G2: 8.0 (5.0) 

G3: 11.0 (10.0) 

(P = NR) 

Median % reduction in binges/wk: 

G1: 33% (P = NR) 

G2: 45% (P = NR) 

G3: 67% (P = NR) 

Diff between groups (P ≤ 0.003) 

G3 better than G2 and G1 

Diff between groups in change over time (P = NR) 

Wkly median % change in binges/wk (wks 1-7): 

G1, G2, G3 data shown in figure 

Diff between groups (P < 0.005) 

G3 better than G1 

Diff between groups in change over time (P = NR) 

% ≥ 50% improved in binges/wk at end of tx: 

G1: 43% (P = NR) 

G2: 49% (P = NR) 

G3: 63% (P = NR) 

Diff between groups (P ≤ 0.003) 

G3 better than G1 and G2 

Diff between group in change over time (P = NR) 

Binge Abstinence (full remission): 

G1, G2, G3 shown in figure 

Diff between groups (P = NR)

Author, yr: 

Fluoxetine BN 

Collaborative Study 

Group, 1992 

(continued) 

Vomiting episodes/wk, mean (SD): 

G1: 11.0 (14.0) 

G2: 9.0 (10.0) 

G3: 11.0 (14.0) 

(P = NR) 

Median % reduction vomiting/wk: 

G1: 5% (P = NR) 

G2: 29% (P = NR) 

G3: 56% (P = NR) 

Diff between groups (P ≤ 0.04) 

G3 and G2 better than G1 (P = 0.003) 

G3 better than G2 

Diff between groups in change over time (P = NR) 

Wkly median % change in vomiting/wk 

frequency (wks 1-7): 

G1, G2, G3 shown in figure 

Diff between groups (P < 0.005) 

G3 better than G1 

Diff between groups in change over time (P = NR) 

% ≥ 50% improved in tx vomiting/wk at end of 

tx: 

G1: 26% (P = NR) 

G2: 45% (P = NR) 

G3: 57% (P = NR) 

Diff between groups (P = 0.021) 

G3 and G2 better than G1 (P = 0.011) 

G3 better than G2 

Vomiting Abstinence (full remission): 

G1, G2, G3 shown in figure 

Diff between groups (P = NR)
C-239 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS total score, mean 

(SD): 

G1: 11.8 (7.7) 

G2: 11.9 (7.3) 

G3: 11.9 (7.3) 

(P = NS) 

Change HDRS total score, 

median: 

G1: -3.0 (P = NR) 

G2: -4.0 (P = NR) 

G3: -5.0 (P = NR) 

Diff between groups (P = 0.033)

G3 better than G1 

Diff between groups in change 

over time (P = NR) 

% med non-compliance at 8 

wks: 

G1: 16.3% 

G2: 13.2% 

G3: 20.2% 

(P = NS) 

Wt, kg, mean (SD): 

G1: 61.1 (9.8) 

G2: 60.3 (10.9) 

G3: 60.4 (9.2) 

(P = NS) 

Change in wt, kg, median: 

G1: 0.0 (P = NR) 

G2: -0.5 (P = NR) 

G3: -1.6 (P = NR) 

Diff between groups (P = 0.013)

G3 and G2 better than G1 

Diff between groups in change 

over time (P = NR) 
C-240 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Fluoxetine BN 

Collaborative Study 

Group, 1992 

(continued) 

EAT total score, mean (SD): 

G1: 35.0 (13.3) 

G2: 32.5 (12.4) 

G3: 31.5 (12.5) 

(P = NS) 

Change in EAT Total Scale, median: 

G1: -4.0 (P = NR) 

G2: -8.5 (P = NR) 

G3: -8.5 (P = NR) 

Diff between groups (P = 0.006) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NR) 

Change in EAT diet preoccupation, median: 

G1: -2.0 (P = NR) 

G2: -5.0 (P = NR) 

G3: -4.0 (P = NR) 

Diff between groups (P = 0.011) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NR) 

Change in EAT food preoccupation, median: 

G1: -2.0 (P = NR) 

G2: -4.0 (P = NR) 

G3: -5.0 (P = NR) 

Diff between groups (P = 0.016) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NR) 

Change in EAT oral control, median 

G1: 0.0 (P = NR) 

G2: 0.0 (P = NR) 

G3: 0.0 (P = NR) 

Diff between groups (P = 0.005) 

G3 better than G1 

Diff between groups in change over time (P = NS) 

Change EDI drive for thinness, median: 

G1: -1.5 (P = NR) 

G2: -2.0 (P = NR) 

G3: -3.0 (P = NR) 

Diff between groups (P = 0.008) 

G3 better than G1 

Diff between groups in change over time (P = NS) 

Change EDI Bulimia, median: 

G1: -3.0 (P = NR) 

G2: -4.0 (P = NR) 

G3: -5.0 (P = NR) 

Diff between groups (P = 0.003) 

G3 better than G1 

Diff between groups in change over time (P = NS) 

Change EDI body dissatisfaction, median: 

G1: 0.0 (P = NR) 

G2: -2.0 (P = NR) 

G3: -3.0 (P = NR) 

Diff between groups (P = 0.027) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NS)
C-241 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-242 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Bulimic intensity (SD): 

G1: 7.2 (2.0) 

G2: 6.8 (1.8) 

G3: 6.6 (2.1) 

(P = NS) 

Change bulimic intensity, median: 

G1: -1.0 (P = NR) 

G2: -2.0 (P = NR) 

G3: -2.0 (P = NR) 

Diff between groups (P = 0.035) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NR) 

Author, yr: 

Fluoxetine BN 

Collaborative Study 

Group, 1992 

(continued) 

Carbohydrate craving (SD): 

G1: 7.0 (2.3) 

G2: 6.8 (2.4) 

G3: 6.7 (2.4) 

(P = NS)

Change carbohydrate craving, median: 

G1: -1.0 (P = NR) 

G2: -2.0 (P = NR) 

G3: -2.0 (P = NR) 

Diff over time between (P = 0.017) 

G3 and G2 better than G1 

Diff between groups in change over time (P = NR)
C-243 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-244 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, year: 

Goldstein et al., 1999 

Companion article: 

Goldstein et al., 1995 

and Fluoxetine BN 

Collaborative Study 

Group, 1992 

Setting: 

15 outpatient psychiatry 

clinics in the US (See 

Goldstein, Wilson, 

Thompson et al., 1995) 

Enrollment period: 

NR 

See Goldstein et al., 

1995 for specific details 

from original RCTs. 

Data from Fluoxetine 

Bulimia Nervosa 

Collaboration Study 

Group, 1992 unknown. 

Research objective: 

Retrospective analyses of 

data obtained from two 

previous RCTs assessing 

the effectiveness and safety 

of fluoxetine in treating the 

primary and associated 

symptoms of BN. This study 

aimed to evaluate whether 

improvements in bingeeating and vomiting were 

independent of depression 

status at baseline. 

Groups: 

G1: Fluoxetine 60 mg-Hi 

depressed-8-wk trial 

G2: Fluoxetine 20 mg-Hi 

depressed-8-wk trial 

G3: Placebo-Hi depressed-8-

wk trial (N = 61) 

G4: Fluoxetine 60mg-Lo 

depressed-8-wk trial 

G5: Fluoxetine 20 mg-Lo 

depressed-8-wk trial 

G6: Placebo-Lo depressed-8-

wk trial (N = 66) 

G7: Fluoxetine 60 mg-Hi 

depressed 16-wk trial 

G8: Placebo-Hi depressed-16-

wk trial (N = 39) 

G9: Fluoxetine 60 mg-Lo 

depressed-16-wk trial 

G10: Placebo-Lo depressed16-wk trial (N = 61) 

G11: Fluoxetine 60 mgdepressed-8-wk trial 

G12: Fluoxetine 20 mgdepressed-8-wk trial 

G13: Placebo-depressed-8-wk 

trial (N = 47) 

G14: Fluoxetine 60 mgnondepressed-8 wk trial 

G15: Fluoxetine 20 mgnondepressed-8 wk trial 

G16: Placebo-nondepressed8-wk trial (N = 73) 

G17: Fluoxetine 60 mgdepressed-16-wk trial 

G18: Placebo-depressed-16-

wk trial (N = 22) 

G19: Fluoxetine 60 mgnondepressed-16-wk trial 

G20: Placebo-nondepressed16-wk trial (N = 73)

Enrollment: 

Participants were male and 

female outpatients at each of 

the 15 centers. Details 

regarding the recruiting 

methods were not reported 

Age, mean (SD): 

NR 

Sex: 

NR 

Race/ethnicity: 

NR 
C-245 

Evidence Table ?. Goldstein, Wilson, Ascroft et al., 1999 (ID JB/) (BN) (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Males and Females 

who met DSM-IIIR 

criteria for BN; at least 

3 vomiting episodes 

per week after binge 

eating for at least six 

months; age 18 and 

older. 

Exclusion: 

Previous participation 

in a fluoxetine study; 

had taken fluoxetine 

within 5 wks before 

enrollment or had a 

cumulative lifetime 

fluoxetine dose of 

more than 140 mg; 

pregnant or lactating; a 

medically unstable 

condition; psychosis; 

acute suicidal ideation; 

a history of seizures; a 

diagnosis of AN; a 

diagnosis of organic 

brain disease; an 

allergy to fluoxetine or 

a history of severe 

allergies or multiple 

adverse drug 

reactions; 

hypertension treated 

with guanethidine, 

reserpine, clinidine, or 

methyldopa; having 

used MAOI’s within 

two wks of enrollment 

or who anticipated 

using an MAOI within 

5 wks of study 

completion; use of 

lithium, tryptophan or 

any other psychoactive 

agent in the wk prior to 

enrollment; had 

initiated some other 

form of treatment for 

BN within 1 month 

prior to enrollment; 2 

wk placebo 

responders (i.e. 75% 

reduction in the 

number of vomiting 

episodes or had < 3 

vomiting episodes per 

wk). 

1 wk drug-free pre-screen 

period followed by 2 wks of 

single-blind placebo run-in 

administration, followed by 

random assignment (1:3) to 

placebo or 60 mg of 

fluoxetine for 16 wks. 

Subjects were seen by a 

physician and/or study 

coordinator weekly during the 

initial placebo lead-in phase, 

were seen every other week 

for the first four wks of the 

double-blind phase, and then 

monthly. Subjects completed 

a bulimic activity diary (i.e. 

recording the number of 

weekly vomiting and bingeeating episodes) and were 

administered a HRSD, EDI, 

and Patient’s Global 

Impression (PGI) scales at 

each visit. Clinicians 

subjectively rated the 

subject’s global improvement 

during each visit. 

Tx responders were defined 

as those who met the criteria 

of at least 50% improvement 

in binge-eating and vomiting 

frequency. 

For each RCT, subjects 

stratified by median 

depression scores on the 

HRSD (i.e.12). Baseline dx 

of current depression or hx 

of depression as assessed 

via patient history also used 

to stratify subjects for 

another set of analyses per 

RCT. 

Analyses included ANOVAs 

to assess sig between group

diffs in change of median 

frequencies of binge eating 

and vomiting from baseline 

to endpoint. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

NR 

Funding: 

Eli Lilly 
C-246 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, year: 

Goldstein et al., 1999 

(continued) 

Baseline data reported in companion 

articles 

For 8-wk trial stratified by median HRSD: 

Binge-eating (median % improvement): 

G1: ~75% (P = NR) 

G2: ~28% (P = NS) 

G3: ~40% (P = NR) 

G4: ~61% (P = NR) 

G5: ~48% (P = NS) 

G6: ~19% (P = NR) 

Diff between groups in change over time 

G1 > G3 (P = 0.03) 

G1 > G2 (P = 0.00) 

G4 > G6 (P = 0.02) 

G4 = G5 (P = NS) 

Vomiting (median % improvement): 

G1: ~65% (P = NR) 

G2: ~21% (P = NS) 

G3: ~15% (P = NR) 

G4: ~48% (P = NR) 

G5: ~50% (P = 0.014) 

G6: ~13% (P = NR) 

Diff between groups in change over time 

G1 > G2 (P = 0.01) 

G1 > G3 (P = 0.002) 

G4 = G5 (P = NS) 

G4 > G6 (P = 0.003) 

For 16-wk trial stratified by median HRSD: 

Binge-eating (median % improvement): 

G7: ~42% (P = NR) 

G8: ~12% (P = NR) 

G9: ~50% (P = NR) 

G10: ~22% (P = NR) 

Diff between groups in change over time 

G7 > G8 (P = 0.042) 

G9 > G10 (P = 0.002) 

Vomiting (median % improvement): 

G7: ~50% (P = NR) 

G8: ~18% (P = NR) 

G9: ~51% (P = NR) 

G10: ~30% (P = NR) 

Diff between groups in change over time 

G7 > G8 (P = 0.03) 

G9 > G10 (P = 0.002)
C-247 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

None reported None reported 
C-248 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, year: 

Goldstein et al., 1999 

(continued) 

For 8-wk trial stratified by current or hx of 

depression: 

Binge-eating (median % improvement): 

G11: ~71% (P = NR) 

G12: ~30% (P = NR) 

G13: ~38% (P = NR) 

G14: ~67% (P = NR) 

G15: ~53% (P = NR) 

G16: ~32% (P = NR) 

Diff between groups in change over time 

G11 > G13 (P = 0.04) 

G14 > G16 (P = 0.005) 

G12 = G13 (P = NS) 

G15 = G16 (P = NS) 

G11 > G12 (P = 0.02) 

G14 > G15 (P = 0.03) 

Vomiting (median % improvement): 

G11: ~63% (P = NR) 

G12: ~29% (P = NR) 

G13: ~15% (P = NR) 

G14: ~55% (P = NR) 

G15: ~31% (P = NR) 

G16: ~12% (P = NR) 

Diff between groups in change over time 

G11 > G13 (P = 0.005) 

G14 > G16 (P = 0.0004) 

G12 = G13 (P = NS) 

G15 = G16 (P = NS) 

G11 = G12 (P = NS) 

G14 > G15 (P = 0.04) 

For 16-wk trial stratified by current or hx of 

depression: 

Binge-eating (median % improvement): 

G17: ~48% (P = NR) 

G18: ~5% (P = NR) 

G19: ~50% (P = NR) 

G20: ~20% (P = NR) 

Diff between groups in change over time 

G17 > G18 (P = 0.005) 

G19 > G20 (P = 0.01) 

Vomiting (median % improvement): 

G17: ~53% (P = NR) 

G18: ~8% (P = NR) 

G19: ~50% (P = NR) 

G20: ~29% (P = NR) 

Diff between groups in change over time 

G17: > G18 (P = 0.001) 

G19: > G20 (P = 0.005) 
C-249 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-250 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Goldstein et al., 1995 

Companion article: 

Fluoxetine Bulimia 

Nervosa Collaborative 

Study Group, 1992 

and Goldstein et al., 

1999 

Setting: 

15 outpatient 

psychiatry clinics in 

the US 

Enrollment period: 

NR 

Research objective: 

As an extension of a 

previous 8-wk RCT (see 

Fluoxetine Bulimia Nervosa 

Collaborative Study Group, 

1992), the primary aim was 

to assess the efficacy and 

safety of fluoxetine versus 

placebo in improving 

principal symptoms of BN 

(i.e., binge eating and 

purging behavior) during a 

16-wk, double blind RCT. 

Secondary aims: evaluating 

improvements in selfreported depression, eating 

dysregulation and both 

patient and clinician-rated 

global psychiatric 

impressions. 

Groups: 

G1: Fluoxetine (N = 296) 

G2: Placebo (N = 102) 

Enrollment: 

Male and female 

outpatients at 15 centers. 

Details regarding the 

recruiting methods not 

reported 

• 483 enrolled 

• 398 randomized at a 

ratio of 3:1 (fluoxetine: 

placebo) 

• 225 completers 

G1: 59.5% 

G2: 48% 

(P = 0.045) 

Age, yrs, median (range): 

G1: 27 (17 - 63) 

G2: 26 (17 - 61) 

(P = NS) 

Sex: 

% Female 

G1: 95.3 

G2: 99.0 

(P = NS) 

Race/ethnicity: 

% White 

G1: 96.6 

G2: 97.1 

(P = NS) 

Fasting days/wk median 

(range): 

G1: 0 (0 - 7) 

G2: 0 (0 - 7) 

(P = NS) 

Diuretic abuse days/wk 

median (range): 

G1: 0 (0 - 14) 

G2: 0 (0 - 8) 

(P = NS) 

Laxative abuse days/wk 

median (range): 

G1: 0 (0 - 14) 

G2: 0 (0 - 9) 

(P = NS) 

BN Behavior: 

Bingeing 

G1: 100 % 

G2: 99.0% 

(P = NS) 

Vomiting 

G1: 99.0% 

G2: 100% 

(P = NS) 

Laxative use 

G1: 11.8% 

G2: 16.6% 

(P = NS) 

Diuretic use 

G1: 6.9% 

G2: 7.4% 

(P = NS) 

Fasting 

G1: 14.7% 

G2: 17.9% 

(P = NS) 
C-251 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM III-R criteria 

for BN; 3 vomiting 

episodes per wk after 

binge eating for at 

least 6 mos; age 18 

and older. 

Exclusion: 

Previous participation 

in a fluoxetine study; 

had taken fluoxetine 

within 5 wks before 

enrollment or had a 

cumulative lifetime 

fluoxetine dose of 

more than 140 mg; 

pregnant or lactating; 

medically unstable 

condition; psychosis; 

acute suicidal ideation; 

hx of seizures; dx of 

AN; a dx of organic 

brain disease; allergy 

to fluoxetine or hx of 

severe allergies or 

multiple adverse drug 

reactions; 

hypertension treated 

with guanethidine, 

reserpine, clinidine, or 

methyldopa; having 

used MAOI’s within 2 

wks of enrollment or 

who anticipated using 

an MAOI within 5 wks 

of study completion; 

use of lithium, 

tryptophan or any 

other psychoactive 

agent in the wk prior to 

enrollment; had 

initiated some other 

form of tx for BN within 

1 mo prior to 

enrollment; 2 wk 

placebo responders 

(i.e., 75% reduction in 

the number of vomiting 

episodes or had < 3 

vomiting episodes per 

wk). 

1 wk drug-free pre-screen period 

followed by 2 wks of single-blind 

placebo run-in administration, 

followed by random assignment (1:3) 

to placebo or 60 mg of fluoxetine for 

16 wks. 

Subjects were seen by a physician 

and/or study coordinator wkly during 

initial placebo lead-in phase, seen 

every other wk for first four wks of 

double-blind phase, and then moly. 

Subjects completed bulimic activity 

diary (i.e., recording number of wkly 

vomiting and binge-eating episodes) 

and administered HRSD, EDI, and 

PGI scales at each visit. Clinicians 

subjectively rated subject’s global 

improvement during each visit. 

Tx responders defined as those who 

met criteria of at least 50% 

improvement in binge-eating and 

vomiting frequency. 

ANOVAs on rank 

transformed data for 

continuous efficacy 

and safety variables 

using Bonferroni 

correction for 

controlling Type I 

error; Pearson’s X2

and Mantel-Haenszel 

X2

 tests for linear 

associations in 

conjunction with 

computing confidence 

intervals for odds 

ratios for comparing 

among bulimic 

responder and nonresponder groups; 

Pearson’s X2

 tests for 

subject dispositional 

and adverse event 

data. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events (%

reporting):

Insomnia: 

G1: 34.5 

G2: 18.6 

(P ≤ 0.05) 

Nausea: 

G1: 30.4 

G2: 12.7 

(P ≤ 0.001) 

Asthenia: 

G1: 21.3 

G2: 6.9 

(P ≤ 0.001) 

Anxiety: 

G1: 17.6 

G2: 8.8 

(P ≤ 0.05) 

Tremor: 

G1: 14.2 

G2: 2.0 

(P ≤ 0.001) 

Dizziness: 

G1: 12.5 

G2: 3.9 

(P ≤ 0.05) 

Yawning: 

G1: 12.2 

G2: 0.0 

(P ≤ 0.001) 

Sweating: 

G1: 9.5 

G2: 2.0 

(P ≤ 0.05) 

Decreased Libido: 

G1: 6.4 

G2: 1.0 

(P ≤ 0.05) 

Depression: 

G1: 10.1 

G2: 18.6 

(P ≤ 0.05) 
C-252 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Goldstein et al., 1995 

(continued) 

 > 1 Purging Behavior: 

G1: 27.5% 

G2: 32.8% 

(P = NS) 
C-253 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

 Myalgia: 

G1: 4.7 

G2: 11.8 

(P ≤ 0.05) 

Emotional lability: 

G1: 2.7 

G2: 7.8 

(P ≤ 0.05) 

Conjunctivitis: 

G1: 0.3 

G2: 2.9 

(P ≤ 0.05) 

Funding: 

Eli Lilly 
C-254 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Vomiting episodes/wk, 

median (range): 

G1: 9 (1 - 94) 

G2: 9 (0 - 225) 

(P = NS) 

% Change in vomiting episodes/wk, median: 

G1, G2: data shown in figure 

Diff between groups (P < 0.017) 

G1 better than G2 through wk 10, and during wk 13 and 16 

Diff between groups in change over time (P = NR) 

Vomiting days/wk, median 

(range): 

G1: 6 (0 - 15) 

G2: 5.5 (0 - 12) 

(P = NS) 

Change in vomiting episodes/wk at endpoint, median 

(range): 

G1: -4 (-64 - 34) (P = NR) 

G2: -2 (-55 - 58) (P = NR) 

Diff between groups (P < 0.0005) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

% Change in vomiting episodes/wk at endpoint, median: 

G1: -50 (P = NR) 

G2: -21 (P = NR) 

Diff between groups (P < 0.0001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Vomiting Remission: 

G1: 19% 

G2: 12% 

(P = NR) 

Vomiting Treatment Responders (≥ 50% improvement): 

G1: 53.1% 

G2: 35.0% 

Diff between groups (P = 0.002) 

G1 better than G2 

Author, yr: 

Goldstein et al., 1995 

(continued) 

Binge-eating episodes/wk, 

median (range) 

G1: 9 (0 - 68) 

G2: 9.5 (1 - 150) 

(P = NS) 

Change in binge-eating episodes/wk, median: 

G1, G2: data shown in figure 

Diff between groups (P < 0.01) 

G1 better than G2 through wk 9, and during wk 13 and 16 

Diff between groups in change over time (P = NR) 

Change in binge-eating episodes/wk at endpoint, median 

(range): 

G1: -4 (-59 - 30) 

G2: -2 (-143 - 40) 

Diff between groups (P < 0.0003) 

G1 better than G2 

Diff between groups in change over time (P = NR) 
C-255 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HRSD, median: 

G1: 10 

G2: 8.5 

(P = NS) 

Change in HRSD, median 

(Range): 

G1: -4 (-20 - 20) (P = NR) 

G2: -3 (-27 - 9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wt, kg, median (range):

G1: 58 (39 - 132) 

G2: 58 (43 - 96) 

(P = NS) 

Change in wt, kg, median: 

G1: -0.45 (P = NR) 

G2: 0.16 (P = NR) 

Diff between groups (P = 0.001)

G1 better than G2 

Diff between groups in change 

over time (P = NR) 

CGI, median (range): 

G1: 5 (3 - 7) 

G2: 5 (3 - 7) 

(P = NS)

CGI, median (range): 

G1: 2 (1 - 6) (P = NR) 

G2: 3 (1 - 6) (P = NR) 

Diff between groups (P < 0.0001) 

G1 better than G2 

Diff between groups in change 

over time (P = NR)

 

PGI: 

G1: NR 

G2: NR 

(P = NR)

PGI, median (range): 

G1: 2 (1 - 6) (P = NR) 

G2: 3 (1 - 5) (P = NR) 

Diff between groups (P < 0.0001) 

G1 better than G2 

Diff between groups in change 

over time (P = NR)

 
C-256 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge-eating days/wk, 

median (range): 

G1: 6 (0 - 15) 

G2: 6 (1 - 12) 

(P = NS) 

% Change in binge-eating episodes/wk at endpoint, median:

G1: -50 (P = NR) 

G2: -18 (P = NR) 

Diff between groups (P < 0.0002) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Binge-eating Remission (%): 

G1: 18.3% 

G2: 12.0% 

Diff between groups (P = NR) 

Binge-eating Treatment Responder (≥ 50% improvement): 

G1: 51.4% 

G2: 36.0% 

Diff between groups (P = 0.008) 

G1 better than G2) 

EDI Total: 

G1: NR 

G2: NR 

Change in EDI Total, median: 

Total: 

G1: -21 (P = NR) 

G2: -12 (P = NR) 

Diff between groups (P = 0.006) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

EDI Bulimia: 

G1: NR 

G2: NR 

Change in EDI Bulimia, median: 

G1: -6 (P = NR) 

G2: -3 (P = NR) 

Diff between groups (P = 0.003) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

EDI Drive for Thinness: 

G1: NR 

G2: NR 

Change in EDI Drive for Thinness, median: 

G1: -3 (P = NR) 

G2: -1 (P = NR) 

Diff between groups (P = 0.040) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Goldstein et al., 1995 

(continued) 

EDI Body Dissatisfaction: 

G1: NR 

G2: NR 

Change in EDI Body Dissatisfaction, median: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-257 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-258 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design 

Patient 

Characteristics 

Author, yr: 

Hedges et al., 2003 

Companion article: 

Hoopes et al., 2003 

Setting: 

Idaho and UT 

Outpatient 

Enrollment period: 

4/1999 to 12/2000 

Research objective: 

To investigate 

topiramete’s effect on 

psychological 

symptoms associated 

with disordered 

eating. 

Groups: 

G1: Topiramate (N = 34) 

G2: Placebo (N = 34) 

Enrollment: 

• Randomized (N = 69) 

• Discontinued after washout: 

Total Sample (N = 1) 

G1 (N = 1) 

G2 (N = 0) 

• Evaluable for safety and received 

at least 1 dose of study med: 

Total (N = 68) 

G1 (N = 34) 

G2 (N = 34) 

• Returned for at least 1 postbaseline assessment (included in 

ITT): 

Total (N = 64) 

G1 (N = 31) 

G2 (N = 33) 

• Discontinued tx: 

Total (N = 28) 

G1 (N = 12) 

G2 (N = 16) 

• Completed: 

Total (N = 40) 

G1 (N = 22) 

G2 (N = 18) 

(P = NR) 

Age, yrs, mean (SD): 

G1: 29.0 (9.7) 

G2: 29.6 (8.1) 

(P = NS) 

Sex: 

Female, N: 

G1: 33 

G2: 34 

(P = NS) 

Race/ethnicity: 

NR 

Wt, kg (mean): 

G1: 61.5 

G2: 67.4 

(P = NR) 
C-259 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age: 16 – 50; DSM IV 

criteria for BN for at 

least 6 mo. 

Exclusion: 

Recent hx of clinically 

sig suicidality, 

substance abuse, 

bipolar I or II, major 

depressive, anxiety, or 

personality disorder 

that could have 

interfered with 

assessments. Hx of 

nephrolithiasis. 

Currently pregnant or 

lactating. Use of 

psychoactive meds 

within 2 wks prior to 

the study other than 

occasional use of 

short-acting sedatives 

for sleep. Dx of AN, 

BMI of ≤ 17, serum 

potassioum level < 3.0 

mmol/L. Patients were 

not permitted to initiate 

psychotherapy during 

the study, but were 

allowed to be 

randomized if 

psychotherapy had 

been started 3 mo 

prior to the study. 

2 to 4 wk screening and washout 

period during which baseline values 

established. 

Study med: 25 mg or 100 mg tablets 

of topiramate or placebo. Topiramate 

started at 25 mg/day for the first wk 

and titrated by 25 to 50 mg/wk until 

max tolerated dose, complete or 

near-complete efficacy, or max daily 

dose of 400 mg achieved. Once this 

level was achieved, patients 

continued at that dose through wk 10. 

Patients allowed 1 reduction in dose 

during titration period if they 

experienced side effects. 

Patients seen wkly for 10 wks and 

then tapered from study meds and 

offered option to continue into a 40 

wk open label extension. 

Topiramate dose, mean (range): 100 

mg/day (25 – 400 mg/day). 

% change from 

baseline compared by 

a Wilcoxon rank sum 

test; ANCOVA; 

Cochran-MantelHaenszel test 

stratified by site 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events, N (%): 

Fatigue: 

G1: 11 (32%) 

G2: 8 (24%) 

Flulike symptoms: 

G1: 10 (29%) 

G2: 6 (18%) 

Paresthesia: 

G1: 8 (24%) 

G2: 2 (6%) 

Hypoesthesia: 

G1: 7 (21%) 

G2: 1 (3%) 

Nausea: 

G1: 6 (18%) 

G2: 3 (9%) 

Constipation: 

G1: 5 (15%) 

G2: 2 (6%) 

Difficulty with 

Concentration: 

G1: 5 (15%) 

G2: 2 (6%) 

Nervousness: 

G1: 4 (12%) 

G2: 2 (6%) 

Headache: 

G1: 4 (12%) 

G2: 5 (15%) 

Diff between groups in all 

adverse effects (P = NR) 

Funding: 

Ortho-McNeil Pharmaceutical, 

Inc. 
C-260 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI: Bulimia/uncontrollable 

overeating, mean (SD): 

G1: 10.4 (5.0) 

G2: 11.5 (5.1) 

(P = NS) 

EDI: Bulimia/uncontrollable overeating, mean 

(SD): 

G1: 5.9 (5.5) 

G2: 10.3 (6.8) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.005)

G1 better than G2 

EDI: Body dissatisfaction: mean (SD): 

G1: 16.7 (8.2) 

G2: 19.1 (8.7) 

(P = NS)

EDI: Body dissatisfaction: mean (SD): 

G1: 14.2 (8.5) 

G2: 19.9 (8.5)

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.007)

G1 better than G2 

EDI: Drive for thinness, mean (SD): 

G1: 14.1 (5.6) 

G2: 16.2 (4.0) 

(P = NS)

EDI: Drive for thinness, mean (SD): 

G1: 10.9 (5.7) 

G2: 15.3 (4.4) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.002)

G1 better than G2 

EAT: Bulimia/food preoccupation, 

mean (SD): 

G1: 11.5 (4.3) 

G2: 12.4 (3.9) 

(P = NS)

EAT: Bulimia/food preoccupation, mean (SD): 

G1: 7.9 (5.2) 

G2: 10.9 (5.2) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.19) 

G1 better than G2 

EAT: Dieting, mean (SD): 

G1: 18.3 (8.3) 

G2: 22.5 (7.5) 

(P = NS)

EAT: Dieting, mean (SD): 

G1: 15.2 (9.0) 

G2: 20.6 (8.1) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.031)

G1 better than G2 

EAT: Oral control, mean (SD): 

G1: 2.8 (3.4) 

G2: 3.3 (3.5) 

(P = NS)

EAT: Oral control, mean (SD): 

G1: 2.5 (3.1) 

G2: 2.8 (3.4) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Hedges et al., 2003 

(continued) 

EAT: Total score, mean (SD): 

G1: 32.5 (12.8) 

G2: 37.8 (12.0) 

(P = NS)

EAT: Total score, mean (SD): 

G1: 25.6 (14.6) 

G2: 33.8 (13.6) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.022)

G1 better than G2 
C-261 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Change in HAM– A, mean: 

G1: -4.0 

G2: -1.7 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = 0.046)

G1 better than G2 

Change in HAM– D, mean: 

G1: -2.9 

G2: -1.3 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

PGI, % improved: 

G1: 61.3% 

G2: 36.4% 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = 0.004)

G1 better than G2 

Change in PGI, %, mean: 

G1: 

No change: 38.7% 

Minimally improved: 25.8% 

Much improved: 22.6% 

Very much improved: 12.9% 

G2: 

No change: 63.6% 

Minimally improved: 30.3% 

Much improved: 6.1% 

Very much improved: 0% 

 
C-262 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hoopes et al., 2003 

Companion article: 

Hedges et al., 2003 

Setting: 

Idaho and UT 

Outpatient, USA 

Enrollment period: 

4/1999 to 12/2000 

Research objective: 

To assess the efficacy and 

safety of topiramate in BN 

Groups: 

G1: Topiramate (N = 34) 

G2: Placebo (N = 34) 

Enrollment: 

• Randomized (N = 69) 

• Discontinued after 

washout: 

Total (N = 1) 

G1 (N = 1) 

G2 (N = 0) 

• Evaluable for safety 

and received at least 

1 dose of study med: 

Total (N = 68) 

G1 (N = 34) 

G2 (N = 34) 

• Returned for at least 

1 post-baseline 

assessment (included 

in ITT): 

Total (N = 64) 

G1 (N = 31) 

G2 (N = 33) 

• Discontinued tx: 

Total (N = 28) 

G1 (N = 12) 

G2 (N = 16) 

• Completed: 

Total (N = 40) 

G1 (N = 22) 

G2 (N = 18) 

Age, yrs, mean (SD): 

G1: 29.0 (9.7) 

G2: 29.6 (8.1) 

(P = NS) 

Sex: 

Female, N: 

G1: 33 

G2: 34 

(P = NS) 

Race/ethnicity: 

NR 

Reported Self-induced 

vomiting, N (%): 

64 (100) 

(P = NS) 

Reported Laxative use, N 

(%): 

13 (20.3%) 

(P = NS) 

Reported diuretic use, N 

(%): 

5 (7.8%) 

(P = NS) 

Reported fasting, N (%): 

11 (17.2%) 

(P = NS) 
C-263 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age: 16 – 50; DSM IV 

criter for BN for at 

least 6 mo. 

Exclusion: 

Recent hx of clinically 

sig suicidality, 

substance abuse, 

bipolar I or II, major 

depressive, anxiety, or 

personality disorder 

that could interfere 

with assessments. Hx 

of nephrolithiasis. 

Currently pregnant or 

lactating. Use of 

psychoactive meds 

within 2 wks prior to 

the study other than 

occasional use of 

short-acting sedatives 

for sleep. Dx of AN, 

BMI of ≤ 17, serum 

potassioum level < 3.0 

mmol/L. Patients not 

permitted to initiate 

psychotherapy during 

the study, but allowed 

to be randomized if 

psychotherapy had 

been started 3 mo 

prior to study. 

Participants underwent 2 to 4 wk 

screening and washout period 

during which baseline values 

established. 

Study med provided as 25 mg or 

100 mg tablets of topiramate or 

placebo. Topiramate started at 25 

mg/day for first wk and was then 

titrated by 25 to 50 mg/wk until max 

tolerated dose, complete or nearcomplete efficacy, or max daily 

dose of 400 mg achieved. Once 

this level was achieved, patients 

continued at that dose through wk 

10. Patients allowed 1 reduction in 

dose during the titration period if 

they experienced side effects. 

Patients seen wkly for 10 wks and 

then tapered from study meds and 

offered the option to continue into a 

40 wk open label extension. 

Topiramate dose, mean (range): 

100 mg/day (25 – 400 mg/day). 

Wilcoxon rank sum 

test, ANCOVA, 

Cochran-MantelHaenszel test 

stratified by site 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

G1: 1 drop out due to nausea 

G2: 2 drop outs due to facial 

rash and irritability. 

No serious adverse events, 

generally mild/moderate in 

nature, resolved with time or 

dose reduction. 

N (%): 

Fatigue: 

G1: 11 (32) 

G2: 8 (24) 

Influenza-like symptoms: 

G1: 10 (29) 

G2: 6 (18) 

Paresthesia: 

G1: 8 (24) 

G2: 2 (6) 

Hypoesthesia: 

G1: 7 (21) 

G2: 1 (3) 

Nausea: 

G1: 6 (18) 

G2: 3 (9) 

Constipation: 

G1: 5 (15) 

G2: 2 (6) 

Difficulty with concentration/ 

attention: 

G1: 5 (15) 

G2: 2 (6) 

Headache: 

G1: 4 (12) 

G2: 5 (15) 

Nervousness: 

G1: 4 (12) 

G2: 2 (6) 

(P = NR)

Funding: 

Ortho-McNeil Pharmaceutical, 

Inc. 
C-264 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Hoopes et al., 2003 

(continued) 

Binge and/or Purge days per wk, 

mean (SD): 

G1: 5.0 (1.6) 

G2: 5.1 (1.5) 

(P = NS) 

Change in binge/purge days per wk, %, mean: 

G1: -44.8% 

G2: -10.7% 

Diff between groups (P = 0.004) 

G1 better than G2) 

Diff between groups in change over time (P = NR) 

Achieved at least moderate improvement (≥ 50% 

reduction) in number of binge and/or purge days, 

N (%): 

G1: 16/31 (51.6%) 

G2: 8/33 (24.2%) 

Diff between groups (P = 0.012) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Achieved marked improvement (≥ 75% reduction) 

or complete remission of binge and/or purge 

days, N (%): 

G1: 9/31 (29.0%) 

G2: 2/33 (6.1%) 

Diff between groups (P = 0.021) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Remission of binge and/or purge days, N (%): 

G1: 7/31 (22.6%) 

G2: 2/33 (6.1%) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Binge days per wk, mean (SD): 

G1: 4.8 (1.7) 

G2: 4.7 (1.7) 

(P = NS) 

Binge episodes per wk, mean (SD): 

G1: 10.8 (10.4) 

G2: 11.3 (10.7) 

(P = NS) 

Change in binge days per wk, %, mean: 

G1: -48.2% 

G2: -17.7% 

Diff between groups (P = 0.015) 

G1 better than G2) 

Diff between groups in change over time (P = NR) 

Achieved at least moderate improvement in 

number of binge days, N (%): 

G1: 19/31 (61.3%) 

G2: 10/33 (30.3%) 

Diff between groups (P = 0.032) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Change in wkly binge frequency, %, mean: 

G1: -49.2% 

G2: -28.0% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NRS) 
C-265 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI-S, mean (SD): 

G1: 4.9 (0.7) 

G2: 4.6 (0.7) 

(P = NS) 

CGI-S, mean (SD): 

G1: 3.7 (1.4) 

G2: 4.3 (1.1) 

Diff between groups (P = 0.022) 

G1 better than G2 

Diff between groups in change over 

time (P = NR) 

Wt, kg, mean (SD): 

G1: 61.3 (10.3) 

G2: 65.9 (14.2) 

(P = NS) 

Change in wt, kg (lb), mean: 

G1: -1.8 (-4.0) 

G2: 0.2 (0.4) 

Diff between groups (P = 0.004)

G1 better than G2) 

Diff between groups in change 

over time (P = NR) 

CGI–I, mean (SD): 

G1: NR 

G2: NR 

CGI–I, mean (SD): 

G1: 2.8 (1.3) 

G2: 3.6 (1.0) 

Diff between groups (P = 0.004) 

G1 better than G2 

Diff between groups in change over 

time (P = NR) 

 
C-266 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Purge days per wk, mean (SD): 

G1: 4.8 (1.9) 

G2: 4.8 (1.6) 

(P = NS) 

Purge episodes per wk, mean (SD): 

G1: 13.3 (13.5) 

G2: 12.4 (13.0) 

(P = NS) 

Change in purge days per wk, %, mean: 

G1: -43.4% 

G2: -16.6% 

Diff between groups (P = 0.016) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Achieved at least moderate improvement in 

number of purge days per wk, N (%): 

G1: 16/31 (51.5%) 

G2: 8/33 (24.2%) 

Diff between groups (P = 0.021) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Change in wkly purge frequency, %, mean: 

G1: -49.8% 

G2: -21.6% 

Diff between groups (P = 0.016) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Bulimic Intensity Scale Score, mean 

(SD): 

G1: 7.1 (1.6) 

G2: 7.4 (1.8) 

(P = NS) 

Change in Bulimic Intensity Scale Score, %, 

mean: 

G1: -37% 

G2:- 14% 

Diff between groups (P = 0.007) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Hoopes et al., 2003 

(continued) 

Carbohydrate Craving Scale score, 

mean (SD): 

G1: 7.0 (2.6) 

G2: 7.3 (2.4) 

(P = NS) 

Change in Carbohydrate Craving Scale score, %:

G1: -43% 

G2: -16% 

Diff between groups (P = 0.011) 

G1 better than G2 

Diff between groups in change over time (P = NR) 
C-267 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-268 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Kanerva, Rissanen, 

and Sarna, 1995 

Setting: 

Single center; 

outpatient; location: 

Department of 

Psychiatry and 

Adolescent Psychiatry 

of Helsinki University 

Central Hospital; 

Helsinki, Finland 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy and 

safety of fluoxetine (an 

SSRI) versus placebo in the 

tx of BN and its effect on 

associated eating-related 

attitudes, depression, and 

anxiety symptoms. 

Groups: 

G1: fluoxetine (N = 24) 

G2: placebo (N = 26) 

Enrollment: 

• Potential subjects 

recruited through letters 

sent out to somatic and 

mental healthcare 

departments of hospital 

• 50 enrolled 

• 46 completers (G1: 22; 

G2: 24; P = NR) 

Age, yrs, mean: 

Total Sample: 25.2 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-269 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; met DSM III-R 

criteria for BN; age 

15+; BMI; ≥16 

Exclusion: 

Pregnancy; lactation; 

inadequate 

contraception; major 

somatic or psychiatric 

illness (e.g., recent 

drug or alcohol abuse, 

severe depression or 

suicidal features, 

recent or concurrent 

use of other 

psychotropic drugs 

such as lithium or 

MAOIs); previous tx 

with fluoxetine; 

concurrent psychiatric 

tx 

All subjects went through single-blind 

placebo run-in phase for first wk of 

study. Subjects then randomized to 

either 60 mg of fluoxetine or placebo 

for 8 wks. 

Mann-Whitney U test 

to assess between 

group diffs on 

continuous variables 

of interest and 

Fisher’s exact test to 

evaluate between 

group diffs on the 

categorical variables 

being studied at 

baseline, 4 wks and at 

8 wks of tx. Repeated 

measures ANOVA for 

diffs between groups 

at mid-tx (4 wks) and 

post-tx (8 wks) 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

Heart palpitations (G2: N = 1) 

Worsening hand tremor (G1:

N = 5) 

Funding: 

Eli Lilly and Company grant 

Helsinki University Central 

Hospital 
C-270 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges/wk, mean (SD): 

G1: 9.2 (NR) 

G2: 10.5 (NR) 

(P = NR) 

End of Treatment (8 wks): 

Binges/wk, mean (SD): 

G1: 5.3 (P = NR) 

G2: 5.7 (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Abstinence/Remission: 

NR

BITE, mean (SD): 

G1: 24.3 (2.3) 

G2: 23.9 (3.5) 

(P = NR)

BITE, mean (SD): 

G1: 22.3 (4.3) (P = NR) 

G2: 22.1 (5.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EAT Dieting mean (SD): 

G1: 14.6 (7.2) 

G2: 16.2 (7.6) 

(P = NR)

EAT Dieting, mean (SD): 

G1: 11.9 (7.0) (P = NR) 

G2: 14.1 (7.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EAT Bulimia and Food 

Preoccupation, mean (SD): 

G1: 10.5 (4.0) 

G2: 10.5 (4.1) 

(P = NR)

EAT Bulimia and Food Preoccupation, mean 

(SD): 

G1: 6.3 (4.0) (P = NR) 

G2: 8.2 (4.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.033)

G1 better than G2

EAT Oral Control, mean (SD): 

G1: 3.4 (2.8) 

G2: 3.6 (3.1) 

(P = NR)

EAT Oral Control, mean (SD): 

G1: 2.9 (2.2) (P = NR) 

G2: 3.0 (2.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EAT Total Score, mean (SD): 

G1: 40.3 (15.6) 

G2: 42.5 (16.4) 

(P = NR)

EAT Total Score, mean (SD): 

G1: 29.6 (13.3) (P = NR) 

G2: 35.9 (16.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EDI Drive for Thinness, mean (SD): 

G1: 10.7 (5.2) 

G2: 13.6 (4.8) 

(P = NR)

EDI Drive for Thinness, mean (SD): 

G1: 9.2 (5.3) (P = NR) 

G2: 11.6 (5.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Kanerva, Rissanen, 

and Sarna, 1995 

(continued) 

EDI Bulimia, mean (SD): 

G1: 11.4 (2.6) 

G2: 12.9 (4.3) 

(P = NR)

EDI Bulimia, mean (SD): 

G1: 6.7 (4.8) (P = NR) 

G2: 7.4 (4.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-271 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS-21, mean (SD): 

G1: 12.2 (4.6) 

G2: 11.7 (5.8) 

(P = NR) 

At mid-tx (4 wks): 

HDRS-21, mean (SD): 

G1: 7.4 (4.7) (P = NR) 

G2: 10.9 (5.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0062) 

G1 better than G2 

End of Treatment (8 wks): 

HDRS-21, mean (SD): 

G1: 7.1 (5.1) (P = NR) 

G2: 9.5 (5.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.05) 

G1 better than G2 

Wt, kg, mean (SD):

G1: 62.2 (15.4) 

G2: 63.0 (17.0) 

(P = NR) 

End of Treatment (8 wks): 

Wt, kg, mean (SD): 

G1: 61.2 (12.9) (P = NR) 

G2: 65.7 (16.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.023) 

G1 better than G2 

HDRS-17, mean (SD): 

G1: 9.3 (4.5) 

G2: 9.4 (4.9) 

(P = NR)

At mid-tx (4 wks): 

HDRS-17, mean (SD): 

G1: 5.9 (4.2) (P = NR) 

G2: 8.9 (4.6) (P = NR) 

Within group change from 

baseline (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.030) 

G1 better than G2 

End of Treatment (8 wks): 

HDRS-17, mean (SD): 

G1: 5.5 (4.3) (P = NR) 

G2: 7.7 (4.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

 

HDRS-Depression mean 

(SD): 

G1: 5.3 (2.6) 

G2: 5.1 (2.4) 

(P = NR)

At mid-tx (4 wks): 

HDRS-Depression, mean (SD):

G1: 2.2 (1.9) (P = NR) 

G2: 4.9 (2.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0002) 

G1 better than G2 

End of Treatment (8 wks): 

HDRS-Depression, mean (SD):

G1: 2.0 (2.0) (P = NR) 

G2: 4.2 (2.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0003) 

G1 better than G2

 
C-272 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI Body Dissatisfaction, mean (SD):

G1: 12.8 (9.9) 

G2: 16.4 (7.9) 

(P = NR)

EDI Body Dissatisfaction mean (SD): 

G1: 10.3 (9.4) (P = NR) 

G2: 14.6 (8.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Kanerva, Rissanen, 

and Sarna, 1995 

(continued) 

EDI Total Score, mean (SD): 

G1: 69.4 (22.5) 

G2: 80.5 (26.1) 

(P = NR)

EDI Total Score, mean (SD): 

G1: 50.0 (23.7) (P = NR) 

G2: 61.9 (22.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-273 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS-Anxiety mean (SD): 

G1: 2.3 (1.1) 

G2: 1.8 (1.0) 

(P = NR)

At mid-tx (4 wks): 

HDRS-Anxiety, mean (SD): 

G1: 1.1 (1.0) (P = 0.0004) 

G2: 2.0 (1.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

End of Treatment (8 wks): 

HDRS-Anxiety, mean (SD): 

G1: 1.2 (1.2) (P = NR) 

G2: 1.8 (1.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0013) 

G1 better than G2

 

Spielberger State Anxiety 

mean (SD): 

G1: 50.3 (11.8) 

G2: 45.8 (11.4) 

(P = NR)

At mid-tx (4 wks): 

Spielberger State Anxiety, 

mean (SD): 

G1: 39.8 (8.3) (P = 0.0004) 

G2: 48.2 (10.7) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR)

End of Treatment (8 wks): 

Spielberger State Anxiety, 

mean (SD): 

G1: 42.5 (8.3) (P = NR) 

G2: 44.5 (11.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0004) 

G1 better than G2

 
C-274 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Kennedy et al., 1993 

Setting: 

The Toronto Hospital, 

Outpatient, Canada 

Enrollment period: 

NR 

Research objective: 

Evaluate efficacy of 

Brofaromine on eating 

behavior and attitude towards 

wt shape and 

psychopathology in women 

with BN. 

Groups: 

G1: Brofaromine (N = 19) 

G2: Placebo (N = 17) 

Enrollment: 

• 110 women screened 

and 38 enrolled. 

• All participants completed 

single-blind placebo 

phase during which binge 

eating and vomiting 

episodes recorded. 

• Individuals who reported 

fewer than 3 binge 

episodes a wk or 

experienced a 50% 

reduction in binge 

frequency were removed 

from study. 

• 2 participants dropped 

during the single blind 

washout phase. 

• 4 dropped out of each tx 

group after 4 wks 

Age, yrs, mean (SD): 

G1: 27.6 (6.7) 

G2: 25.9 (6.4) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of illness, yrs, 

mean (SD): 

G1: 14.3 (15.3) 

G2: 13.8 (10.1) 

Diagnostic comorbidity, %:

Major Depression: 

Current: 

G1: 26% 

G2: 24% 

Past: 

G1: 63% 

G2: 47% 

Dysthymic Disorder: 

Current: 

G1: 5% 

G2: 6% 

Past: 

G1: 5% 

G2: 12% 

Substance abuse: 

Current: 

G1: 0 

G2: 0 

Past: 

G1: 21% 

G2: 18% 

Panic with Agoraphobia: 

Current: 

G1: 0 

G2: 0 

Past: 

G1: 5% 

G2: 12% 

Panic without 

Agoraphobia: 

Current: 

G1: 0 

G2: 12% 
C-275 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women, 18-40 yrs, 

met DSM III-R criteria 

for BN who engaged in 

vomiting as the 

primary method of 

purging. 

Exclusion: 

Wt < 85% or > 125% 

of statistical avg for 

age and height; use of 

any psychotropic meds 

in the preceding 4 wks; 

presence of suicidal 

ideation, substance 

abuse or medical 

instability (including 

aserum potassium of < 

3 μmol/liter). 

Both groups received identical 

looking capsules. Dosing started at 

25 mg and increased on days 4, 7, 

11, 15 and 19 to reach max permitted 

dose of 200 mg [mean = 175 mg, 

range 75 to 200 mg] given in a twice 

daily regimen. Clinicians could omit 

dose increment due to reported side 

effects. 

After randomization, participants 

assessed once every 2 wks for 

remainder of the 8-wk trial. Sessions 

lasted 10 to 20 m and included 

review of symptom changes, adverse 

events, and compliance. 

Repeated measures 

ANCOVA for binge, 

purge and meal 

completion data. 

Binge and purge data 

log transformed prior 

to analysis. Only 

completers included in 

analyses. Baseline 

values included as 

covariates for eating 

and psychological 

measures. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

2 individuals in G1 experienced 

intolerable side effects (nausea) 

and dropped out and 1 

individual from G2 reported 

headaches and dropped out. 

Common side effects included 

sleep disturbance, nausea and 

dizziness among G1 

participants. Headache, dry 

mouth, and nausea were 

common side effects for G2. 

Funding: 

Ciba-Geigy Canada and 

Ontario Mental Health 

Foundation 
C-276 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Kennedy et al., 1993 

(continued) 

 Past: 

G1: 0 

G2: 12% 

Generalized Anxiety: 

Current: 

G1: 5% 

G2: 0 

Past: 

G1: 0 

G2: 0 

Social Anxiety: 

Current: 

G1: 11% 

G2: 0 

Past: 

G1: 11% 

G2: 0 

Simple phobia: 

Current: 

G1: 16% 

G2: 0 

Past: 

G1: 11% 

G2: 0 

Obsessive-compulsive 

disorder: 

Current: 

G1: 0 

G2: 6% 

Past: 

G1: 0 

G2: 6% 

Somatoform pain disorder:

Current: 

G1: 0 

G2: 6% 

Past: 

G1: 0 

G2: 0 
C-277 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-278 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge eating episodes/wk, mean 

(SD): 

G1: 9.1 (5.7) 

G2: 8.8 (3.7) 

(P = NS) 

Binge eating episodes/wk, mean (SD): 

G1: 3.5 (3.0) (P = NR) 

G2: 4.4 (3.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Vomiting episodes/wk, mean (SD): 

G1: 10.2 (12.9) 

G2: 7.5 (6.5) 

(P = NS)

Vomiting episodes/wk, mean (SD): 

G1: 2.6 (3.0) (P = NR) 

G2: 5.7 (6.3) (P = NR) 

Diff between groups (P < 0.02) 

G1 better than G2 

Diff between groups in change over time (P = NS)

Non-binge meals/wk, mean (SD): 

G1: 8.8 (6.9) 

G2: 14.1 (5.5) 

(P < 0.02)

Non-binge meals/wk, mean (SD): 

G1: 11.6 (6.5) (P = NR) 

G2: 17.9 (2.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P < 0.04) 

G2 better than G1 at wk 8 only

EAT-26, mean (SD): 

G1: 36.5 (12.4) 

G2: 34.6 (14.9) 

(P = NS)

EAT-26, mean (SD): 

G1: 24.4 (15.3) (P = NR) 

G2: 23.9 (15.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

EDI-Body Dissatisfaction, mean (SD):

G1: 18.4 (9.2) 

G2: 19.4 (9.6) 

(P = NS)

EDI-Body Dissatisfaction, mean (SD): 

G1: 19.5 (9.9) (P = NR) 

G2: 18.3 (9.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

EDI-Bulimia, mean (SD): 

G1: 14.3 (4.8) 

G2: 13.6 (3.3) 

(P = NS)

EDI-Bulimia, mean (SD): 

G1: 5.9 (5.9) (P = NR) 

G2: 7.9 (5.3) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Kennedy et al., 1993 

(continued) 

EDI-Drive for thinness, mean (SD): 

G1: 15.7 (4.6) 

G2: 14.4 (6.2) 

(P = NS)

EDI-Drive for thinness, mean (SD): 

G1: 13.5 (6.1) (P = NR) 

G2: 12.4 (5.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-279 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HAM-D, mean (SD): 

G1: 14.5 (8.7) 

G2: 12.4 (8.7) 

(P = NS) 

HAM-D, mean (SD): 

G1: 7.5 (6.7) (P = NR) 

G2: 6.8 (7.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Wt, kg, mean (SD): 

G1: 70.2 (18.6) 

G2: 62.8 (10.9) 

(P = NS) 

Wt, kg, mean (SD): 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Change in Wt (%): 

> 1 kg wt loss: 

G1: 53% 

G2: 12% 

Diff between groups (P = NR) 

G1 better than G2 

> 1 kg wt gain: 

G1: 32% 

G2: 53% 

Diff between groups (P = NR) 

G1 better than G2 

Chi-square (P < 0.05) 

HAM-A, mean (SD): 

G1: 13.4 (7.9) 

G2: 11.3 (8.8) 

(P = NS) 

HAM-A, mean (SD): 

G1: 7.6 (7.8) (P = NR) 

G2: 5.9 (6.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS)

BMI, kg/m2, mean 

(SD): 

G1: 26.2 (6.5) 

G2: 24.2 (4.8) 

(P = NS)

BMI, kg/m2

, mean (SD): 

G1: NR 

G2: NR
C-280 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Abstinence from vomiting, %: 

Wk 4: 

G1: 56% 

G2: 27% 

End of tx: 

G1: 44% 

G2: 20% 

(P = NS)

Author, yr: 

Kennedy et al., 1993 

(continued) 

Abstinence from bingeing, %: 

Wk 4: 

G1: 31% 

G2: 7% 

End of tx: 

G1: 19% 

G2: 13% 

(P = NS)
C-281 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-282 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Pope et al., 1989 

Setting: 

Outpatients of a 

teaching hospital in 

the USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

trazodone compared to 

placebo and its adverse 

effects in BN 

Groups: 

G1: Trazodone (N = 23) 

G2: Placebo (N = 23) 

Enrollment: 

• 56 recruited and 

entered 2 wk placebo 

washout period 

• 10 eliminated during 

placebo period (5 drop

outs, 1 reduced sx, 1 

sickness, 3 lab 

abnormalities) 

• 46 randomized (N = 23 

each condition) 

• 42 completed at least 4 

wks of tx 

• G1 (N = 20) (1 

hospitalized for alcohol 

dependence, 2 did not 

return after baseline) 

• G2 (N = 22) (1 

developed medical 

condition and was 

withdrawn_ 

• 5 terminated on or after 

wk 4 and termination 

scores were based on 

14-day period before 

termination day 

Age, yrs, mean (SD): 

Total sample: 26.0 

G1: 25.7 (N = 20) 

G2: 26.2 (N = 22) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

% IBW, mean: 

Total: 98.3 

G1: 98.4 

G2: 98.2 

(P = NS) 

Duration of bulimic 

symptoms, yrs, mean: 

Total: 7.4 

G1: 6.8 

G2: 7.9 

(P = NS) 

SCID Current major 

depression, N: 

Total: 10 (24%, 3 of which 

were bipolar) 

G1: 6 

G2: 4 

SCID Hx of AN, N: 

Total: 6 
C-283 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN (at least 3 binge 

episodes per wk and 

duration of 3 mos, as 

opposed to 2 per wk 

and for only 3 mos); 

age: 18-55; wt 

between 80% and 

140% of IBW; use of 

vomiting as principal 

method of purging 

Exclusion: 

No sig medical 

disorder; pregnant, at 

risk for pregnancy, 

nursing; taking meds 

with psychotropic 

effects; psych med 

within 14 days of 

baseline; 

investigational meds 

within 28 days of 

baseline; active 

suicidal ideation, 

current drug/alcohol 

abuse, psychotic 

symptoms; hx of drug 

hypersensitivity; hx of 

failure to respond to an 

adequate trial of 

antidepressants or 

ECT; starting any 

other nonpharmacological 

therapy within 2 mo 

before or after 

baseline. 

2 wk placebo wash out. Randomized 

to trazodone (50 mg) or placebo and 

instructed to raise the dose by 1 

tablet every second day to a max of 8 

tablets (trazodone 400 mg). Allowed 

to raise dose more slowly or take < 8 

if side effects. 

6 wks of active drug phase and seen 

at wks 2, 4, 6. Assessment at 

baseline and wk 6 

Wilcoxon rank sum, 2-

tailed for frequency fx of 

binge eating between 

groups. Diff. in 

proportions between 

groups assessed by 

Fisher’s exact test, 2-

tailed. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

Sig more patients on 

trazodone than on placebo 

suffered dizziness, 29% vs. 

4% (P = 0.042) and 

drowsiness, 52% vs. 17% 

(P = 0.025) 

Funding: 

Bristol-Myers 

Pharmaceuticals and NIMH
C-284 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Current frequency of binges/wk: 

G1: 11.3 

G2: 12.8

(P = NS) 

Current frequency of binges/wk: 

G1: data in graph (P < 0.05) 

G2: data in graph (P = NS)

% change in Binge Eating: 

G1: 31% reduction 

G2: 21% increase 

Diff between groups (P < 0.001) 

G1 better than G2 

Remission of Binge Eating, N (%): 

G1: 2 (10%) 

G2: 0 

(P = NR) 

Current frequency of vomiting/wk: 

G1: NR 

G2: NR

(P = NR) 

Current frequency of vomiting/wk: 

G1: data in graph (P < 0.05) 

G2: data in graph (P = NS) 

% change in vomiting frequency: 

G1: NR 

G2: NR 

Diff between groups (P < 0.001) 

G1 better than G2 

Author, yr: 

Pope et al., 1989 

(continued) 

 Self-Report measures: 

Fear of Eating: 

G1: NR (P < 0.05) 

G2: NR (P = NS) 

Diff between groups (P = 0.007) 

G1 better than G2 

Self -control: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

Self-esteem: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = 0.009) 

Global Improvement: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

Preoccupation with food: 

Data NR 

G1 = G2 

Diff between groups (P = NS) 

Intensity of binges: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

Self-control regarding food: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 
C-285 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 No relation between 

blood trazodone plasma 

levels and degree of 

clinical improvement. 

Data NR 

HAM-D (mean): 

Total sample: 12.4 

G1: NR 

G2: NR 

HAM-D: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

 

HAM-A (mean): 

Total sample: 9.8 

G1: NR 

G2: NR 

HAM-A: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NS) 

 

 Patient-rating of 

effectiveness of tx (4 patient 

Likert scale): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = 0.04) 

G1 better than G2 

 
C-286 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Romano et al., 2002 

Setting: 

16 sites in USA (NY, 

MA, CA, MD, IL, NM, 

UT, NC, TN, PA, FL, 

WI, KS); Outpatient, 

USA 

Enrollment period: 

NR 

Research objective: 

Evaluate fluoxetine versus 

placebo in preventing 

relapse of BN over one yr 

Groups: 

G1: Fluoxetine (N = 76) 

G2: Placebo (N = 74) 

Enrollment: 

• 265 in initial screening 

• 1 wk no-therapy 

screening phase 

• 232 received singleblind acute therapy (60 

mg/day of fluoxetine) 

• After 8 wks of acute tx, 

150 responders 

randomly assigned to 

60 mg/day of fluoxetine 

or placebo (doubleblind therapy) 

• Nonresponders and 

patients unable to 

tolerate 60 mg/day 

were discontinued 

Age, yrs, mean (SD): 

G1: 29.5 (7.0) 

G2: 30.0 (9.3) 

(P = NS) 

Sex: 

Female: 

G1: 97% 

G2: 98.6% 

(P = NS) 

Race/ethnicity: 

Caucasian: 

G1: 93% 

G2: 88% 

(P = NS) 
C-287 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Male and female 

outpatients, at least 18 yrs 

old with a psychiatric dx of 

BN, purging type (as 

defined by DSM IV). 

Purging must included selfinduced vomiting. 

Exclusion: 

Participated in a prior 

fluoxetine study or taken 

fluoxetine within 5 wks 

before enrollment or 

previously treated with 60 

mg/day of fluoxetine for 

longer than 8 wks. Coexisting schizophrenia or 

bipolar disorder, moodcongruent or incongruent 

psychotic features, serious 

suicidal risk, organic brain 

disease, hx of seizures, 

medically unstable 

condition or hx of an 

alcohol and/or other 

substance abuse disorder 

within 3 mos before 

enrollment. Also, patients 

who had used a 

monoamine oxidase 

inhibitor within 2 wks 

before enrollment had used 

other investigational drugs 

or psychoactive meds 

within 4 wks before 

enrollment had received 

CBT within 4 wks of 

enrollment or who planned 

to begin a structured, 

focused therapy at any 

time during the study were 

excluded. 

After one-wk of no-therapy 

screening, patients assigned to 

acute, single blind tx with 60 

mg/day of fluoxetine. During 

screening and acute tx phase 

patients seen by the 

investigators each wk. Dosage 

adjustment allowed in first 2 wks 

at clinician’s discretion if patient 

unable to tolerate 60 mg initially. 

To be considered a “tx 

responder” at the end of acute 

period, patients must have 

experienced a decrease of ≥

50% in frequency of vomiting 

episodes during at least 1 of 2 

preceding wks compared to 

baseline. 

After 8 wks of acute tx, tx 

responders randomly assigned 

to receive 60 mg of fluoxetine or 

placebo for up to 52 wks. Study 

meds packaged in blister packs 

that contained 20 mg of 

fluoxetine capsules or matching 

placebo capsules. At each visit, 

patients returned the blister 

pack so that remaining capsules 

could be counted. Patients who 

missed meds for 5 consecutive 

days or who failed to attend 

visits within stated periods were 

deemed noncompliant and 

withdrawn from study. During 

52-wk double blind therapy 

phase, visits occurred at 2-wk 

intervals during first 8 wks and 

at 4-wk intervals after that. The 

primary efficacy measure was 

change in the number of 

vomiting episodes per wk. 

Time to relapse 

curves estimated for 

each tx group and a 

two sided log rank test 

used to compare time 

to relapse 

distributions. Tx diffs 

assessed with 

Fisher’s exact test for 

categorical variables 

and student’s t test for 

continuous variables. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Rhinitis: 

G1: 31.6% 

G2: 16.2% 

(P < 0.04) 

Unwanted Pregnancy: 

G1: 2.6% 

G2: 4.1% 

(P = NR) 

Funding: 

Eli Lilly and Co. 
C-288 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description 

Baseline and at Random 

Assignment Outcomes 

Vomiting episodes/wk, mean (SD): 

G1: 12.1 (8.7) 

G2: 14.0 (11.7) 

(P = NS) 

Vomiting episodes/wk at random 

assignment, mean (SD): 

G1: 4.1 (5.5) 

G2: 4.5 (6.1) 

(P = NS) 

Change in vomiting episodes/wk, mean (SD): 

G1: 2.92 (7.08) 

G2: 4.82 (8.43) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001)

G1 better than G2 (less increase after random 

assignment) 

Binge eating episodes/wk, mean 

(SD): 

G1: 10.3 (7.7) 

G2: 12.5 (10.1) 

(P = NS) 

Binge eating episodes/wk at random 

assignment, mean (SD): 

G1: 3.0 (4.8) 

G2: 3.9 (5.1) 

(P = NS) 

Change in Binge eating episodes/wk, mean (SD): 

G1: 2.47 (6.58) 

G2: 4.11 (6.70) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.02) 

G1 better than G2 (less increase after random 

assignment) 

EDI total, mean (SD): 

G1: 76.6 (26.9) 

G2: 78.4 (29.9) 

(P = NS) 

EDI total at random assignment, 

mean (SD): 

G1: 37.0 (22.0) 

G2: 39.1 (27.2) 

(P = NS) 

Change in EDI total, mean (SD): 

G1: 7.79 (25.49) 

G2: 17.41 (24.45) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Romano et al., 2002 

(continued) 

Relapse rate, %: 

3 mos: 

G1: 19% 

G2: 37% 

Diff between groups (P < 0.04) 

G1 better than G2 

6 mos: 

G1: 29% 

G2: 43% 

(P = NS) 

12 mos: 

G1: 33% 

G2: 51% 

(P = NS) 

Two sided log rank test applied to Kaplan-Meier 

survival function (P < 0.02) 

G1 better than G2 

Abstinence/Remission: 

NR
C-289 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI severity score: 

G1: 4.5 (0.6) 

G2: 4.5 (0.7) 

(P = NS) 

CGI severity at 

random assignment: 

G1: 2.9 (1.0) 

G2: 2.9 (0.9) 

(P = NS) 

CGI severity mean change score 

(SD): 

G1: 0.45 (1.33) 

G2: 0.97 (1.21) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.004) 

G1 deteriorated less than G2 

CGI Improvement severity mean 

change score (SD): 

G1: 0.77 (1.43) 

G2: 1.37 (1.39) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.009) 

G1 deteriorated less than G2 

BMI: 

G1: 22.5 (3.9) 

G2: 23.0 (3.8) 

(P = NS) 

BMI at random 

assignment: 

G1: NR 

G2: NR 

(P = NR) 

BMI: 

G1: NR 

G2: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

HDRS: 

G1: 10.5 (6.1) 

G2: 10.5 (5.9) 

(P = NS) 

HDRS at random 

assignment: 

G1: 4.6 (3.9) 

G2: 6.1 (5.3) 

(P = NS) 

HDRS mean change score (SD): 

G1: 2.03 (5.66) 

G2: 3.23 (6.60) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

 

 Patient’s global impression mean 

change score (SD): 

G1: 0.72 (1.54) 

G2: 1.37 (1.49) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.03) 

G1 deteriorated less than G2 

 
C-290 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Eating Related Measures 

Author, yr: 

Romano et al., 2002 

(continued) 

Yale-Brown Cornell ED Scale (YBCEDS) score, mean (SD): 

G1: 18.8 (4.1) 

G2: 18.3 (5.1) 

(P = NS) 

YBC EDS at random assignment, 

mean (SD): 

G1: 9.4 (4.8) 

G2: 9.4 (5.4) 

(P = NS) 

Change in YBC EDS, mean (SD): 

G1: 2.92 (7.91) 

G2: 7.38 (6.80) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.002) 

G1 better than G2 (less increase after random 

assignment) 

Change in YBC EDS preoccupation, mean (SD): 

G1: 1.53 (3.82) 

G2: 3.63 (3.74) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.008) 

G1 better than G2 (less increase after random 

assignment) 

Change in YBC EDS ritual, mean (SD): 

G1: 1.35 (4.51) 

G2: 3.75 (3.79) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.008) 

G1 better than G2 (less increase after random 

assignment) 
C-291 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-292 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Sundblad et al., 2005 

Setting: 

Single center 

Outpatient, Sweden 

Enrollment period: 

NR 

Research objective: 

Comparison of efficacy 

of four txs for BN: 

flutamide (androgen 

antagonist) vs 

citalopram (SSRI) vs 

combination of 

flutamide and 

citalopram, vs placebo. 

Groups: 

G1: Flutamide (N = 9) 

G2: Citalopram (N = 15) 

G3: Flutamide + Citalopram (N = 10) 

G4: Placebo (N = 12) 

Enrollment: 

• Individuals recruited through 

advertisements 

• Patients randomized to one of 4 

conditions once consent obtained 

• Dropouts during tx (G1 = 3; G2 = 

3; G3 = 2; G4 = 2) 

Age, yrs, mean: 

G1: 29 

G2: 26 

G3: 25 

G4: 28 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Wt, kgs, mean: 

G1: 58 

G2: 61 

G3: 61 

G4: 61 
C-293 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for for 

BN, purging type, 

irregular menstruation 

allowed 

Exclusion: 

Age ≤ 18 yrs; other 

mental disorders 

Initial dose of flutamide (250 mg/day) 

and citalopram (20mg/day) titrated 

within 2 wks to final doses of 500 

mg/day and 40 mg/day, respectively. 

Subjects received no formal 

psychotherapy; supportive and 

educative therapy kept to a min. Tx 

lasted for 12 wks. 

T-tests were used to 

evaluate within-group

changes in symptom 

severity from baseline 

to end of tx. 2-sided 

Mann-Whitney U tests 

used to compare 

global effect of tx vs 

placebo on change in 

BN symptoms. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

2 cases of elevated serum 

aminotrans-ferase in 

flutamide-tx group; both 

normalized after tx withdrawal. 

Nausea most common side 

effect for citalopram; dry skin 

most common for flutamide 

participants. 

Funding: 

H Lundbeck AB, Sweden and 

Swedish Medical Research 

Council 
C-294 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BN symptom VAS, mean (SD): 

G1: 52.0 (16.0) 

G2: 54.1 (13.9) 

G3: 44.5 (10.4) 

G4: 52.3 (17.2) 

(P = NR) 

BN symptom VAS, mean (SD): 

G1: 29.5 (27.2) (P = 0.04) 

G2: 31.6 (22.6) (P = 0.003) 

G3: 26.4 (16.3) (P = 0.005) 

G4: 46.9 (21.9) (P = NS) 

Diff between groups 

G1, G2, G3 vs. G4 (P = NR) 

G1+G3 < G4 (P = 0.03) 

G2+G3 < G4 (P = 0.03) 

Diff between groups in change over time (P = NR) 

% reduction BN VAS, mean (SD): 

G1: 46 (15) (P = NR)

G2: 41 (12) (P = NR)

G3: 41 (11) (P = NR)

G4: 8 (10) (P = NR) 

Diff between groups 

G1, G3 > G4 (P = 0.04) 

G1+G3 < G4 (P = 0.02) 

G2+G3 < G4 (P = 0.03) 

Author, yr: 

Sundblad et al., 2005 

(continued) 

Binge eating episodes per wk, mean 

(SD): 

G1: 6.1 (1.8) 

G2: 6.6 (3.4) 

G3: 6.4 (2.1) 

G4: 8.0 (3.8) 

(P = NR)

Binge eating episodes per wk (SD): 

G1: 3.0 (3.0) (P = 0.01) 

G2: 4.9 (3.9) (P = NS) 

G3: 2.9 (2.0) (P = 0.0007) 

G4: 6.7 (5.9) (P = NS) 

Diff between groups 

G1, G2, G3 vs. G4 (P = NR) 

G1+G3 < G4 (P = 0.02) 

G2+G3 < G4 (P = NS) 

Diff between groups in change over time (P = NR) 

% reduction binge episodes, mean (SD): 

G1: 54 (40) (P = NR)

G2: 21 (88) (P = NR)

G3: 54 (28) (P = NR)

G4: 15 (47) (P = NR) 

Diff between groups 

G3 > G4 (P = 0.04) 

G1, G2 (P = NS) 

G1+G3 < G4 (P = 0.01) 

Diff between groups in change over time (P = NR)
C-295 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Global Rating of Sadness: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = NR) 

Diff between groups in change 

(reduction) over time (P < 0.05)

G2 and G3 better than G4 

G2 vs G4 (P = NS) 

Global Rating of Anxiety: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = NR) 

Diff between groups in change 

(reduction) over time (P < 0.05)

G2 and G3 better than> G4 

G2 vs G4 (P = NS) 

 
C-296 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Sundblad et al., 2005 

(continued) 

Vomiting episodes, per wk, mean (SD):

G1: 8 (4) 

G2: 9 (7) 

G3: 7 (3) 

G4: 9 (3) 

(P = NR)

Vomiting episodes per wk, mean (SD): 

G1: 4 (4) (P = 0.01) 

G2: 6 (6) (P = NS) 

G3: 3 (3) (P = 0.0007) 

G4: 7 (5) (P = NS) 

Diff between groups 

G1, G2, G3 vs. G4 (P = NR) 

G1+G3 < G4 (P = NS) 

G2+G3 < G4 (P = NS) 

Diff between groups in change over time (P = NR) 

% reduction vomiting episodes, mean (SD): 

G1: 45 (56) (P = NR)

G2: 28 (46) (P = NR)

G3: 52 (36) (P = NR)

G4: 31 (37) (P = NR) 

Diff between groups (P = NS) 

BN symptom improvement, %: 

G1: Enormously (22%), Much (22%), Somewhat 

(33%), No change (11%), Deterioration (11%) 

G2: Enormously (20%), Much (20%), Somewhat 

(33%), No change (27%), Deterioration (0%)

G3: Enormously (10%), Much (40%), Somewhat 

(20%), No change (20%), Deterioration (10%)

G4: Enormously (0%), Much (8%), Somewhat 

(17%), No change (50%), Deterioration (25%) 

Global BN symptom change vs. placebo, 

Mann-Whitney U: 

G1: 23.5 (P = 0.03) 

G2: 35.5 (P = 0.008) 

G3: 28.5 (P = 0.04)
C-297 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-298 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Walsh et al., 1991 

Setting: 

Outpatient, New York, 

USA 

Enrollment period: 

NR 

Research objective: 

Compare antidepressant 

desipramine with placebo in 

treating BN and examine 

long-term efficacy of drug. 

Groups: 

G1: placebo (N = 38) 

G2: desipramine (N = 40) 

Enrollment: 

• 217 individuals had 

screening interviews 

• 98 entered study (56 did 

not meet entry criteria, 46 

refused and 17 who did 

not FU after screening) 

• Patients first entered into 

a 2-wk single-blind 

placebo washout phase 

• 10 patients dropped after 

washout phase because 

they had reduced binge 

eating by 75% or more or 

were binge eating less 

than twice a wk. 

• 8 patients dropped out. 

• 80 patients entered the 

double-blind trial. 

• Completers: 

• 2 patients did not 

return after 

assignment and are 

not included in 

analyses 

• G1: 32/38 

• G2: 31/40 

Age, yrs, mean (SD): 

G1: 25.7 (5.6) 

G2: 24.8 (4.5) 

(P = NS) 

Height, inches, mean (SD): 

G1: 65.0 (2.7) 

G2: 65.4 (2.1) 

(P = NS) 

Wt, lbs, mean (SD): 

G1: 132.4 (17.8) 

G2: 136.2 (16.1) 

(P = NS) 

Sex: 

Female: 

G1: 100% 

G2: 100% 

(P = NS) 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 22.0 (2.3) 

G2: 22.4 (1.9) 

(P = NS) 

Duration of illness, yrs, 

mean (SD): 

G1: 6.6 (4.5) 

G2: 6.7 (3.6) 

(P = NS) 

Hx of AN: 

23.1% 

Current Depression: 

51.3% 
C-299 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for BN for 

at least 1 yr, only women 

between the ages of 18 and 

45 whose wt was 85%-

120% of their IBW 

(according to Metropolitan 

Life Insurance Company 

tables) 

Exclusion: 

Acute or chronic medical 

conditions; judged to be 

acutely suicidal; currently 

being treated with 

psychotropic meds; had 

abused drugs or alcohol in 

the past yr or had previous 

adequate trial of 

antidepressant meds (min 

of 200 mg of desipramine 

for at least 3 wks or 

equivalent meds doses). 

During the first wk of tx, 

dose of desipramine 

gradually raised to 200 

mg/day (four 50 mg tablets) 

or the equivalent dose of 

placebo. If tolerated, this 

dose was continued for 

three wks. Four wks after 

randomization, patients who 

continued to binge eat had 

dose raised to 300 mg/day. 

Tx lasted for 6 wks. After 

the 6 wk tx, patients who 

had been randomly 

assigned to placebo and 

had not improved were 

offered open trial of 

desipramine. 

To enter the maintenance 

phase, patients required to 

have achieved reduction of 

50% or more in binge 

frequency in the last two 

wks of the tx phase 

compared to baseline. 

Patients who met this 

criterion were continued on 

desipramine for another 16 

wks. 

Patients who had not 

relapsed during 

maintenance phase, offered 

to participate in the 

discontinuation phase. Here 

patients randomly assigned 

to either continue taking the 

same dose of meds or 

switch to placebo. Meds 

tapered to placebo over two 

wks. 

Student’s t test was used to 

compare groups. 

Score: 

Fair 

Intent to treat: 

Used termination data for 

those who completed 

initial 6 wks and those 

who discontinued before 

initial 6 wks. 

Blinding: 

Initially participants were 

in a single blind washout 

phase and the tx 

component was double 

blinded. 

Adverse events: 

NR 

Funding: 

NIMH 
C-300 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge episodes/wk, mean (SD): 

G1: 8.3 (5.4) 

G2: 8.1 (4.6) 

(P = NS) 

Binge episodes/wk, mean (SD): 

G1: 8.6 (7.2) (P = NR) 

G2: 4.3 (3.9) (P = NR) 

Diff between groups (P < 0.001) 

G2 better than G1 

Diff between groups in change over time (P = NR) 

Vomiting episodes/wk, mean (SD): 

G1: 13.0 (16.7) 

G2: 10.8 (12.7) 

(P = NS)

Vomiting episodes/wk, mean (SD): 

G1: 13.3 (17.5) (P = NR) 

G2: 7.8 (14.4) (P = NR) 

Diff between groups (P = 0.02) 

G2 better than G1 

Diff between groups in change over time (P = NR)

Eating Attitudes Test, mean (SD): 

G1: 39.6 (15.2) 

G2: 39.8 (16.9) 

(P = NS)

Eating Attitudes Test, mean (SD): 

G1: 37.7 (15.1) (P = NR) 

G2: 29.9 (16.0) (P = NR) 

Diff between groups (P = 0.03) 

G2 better than G1 

Diff between groups in change over time (P = NR)

Body Shape Questionnaire, mean 

(SD): 

G1: 135.3 (28.3) 

G2: 148.7 (35.6) 

(P = NS)

Body Shape Questionnaire, mean (SD): 

G1: 120.5 (34.2) (P = NR) 

G2: 101.6 (36.6) (P = NR) 

Diff between groups (P = 0.02) 

G2 better than G1 

Diff between groups in change over time (P = NR)

Author, yr: 

Walsh et al. 1991 

(continued) 

 Remission rate: 

G1: 7.9% 

G2: 12.5% 

Diff between groups (P = NS)
C-301 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HAM-D, mean (SD): 

G1: 7.3 (4.6) 

G2: 8.3 (4.6) 

(P = NS) 

HAM-D, mean (SD): 

G1: 6.5 (5.1) (P = NR) 

G2: 6.0 (4.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

BMI, mean (SD) kg/m2: 

G1: 22.0 (2.3) 

G2: 22.4 (1.9) 

(P = NS) 

BMI, mean (SD) kg/m2: 

G1: 22.3 (2.5) (P = NR) 

G2: 22.0 (1.9) (P = NR) 

Diff between groups (P = 0.001)

G2 better than G1 

Diff between groups in change 

over time (P = NR) 

BDI, mean (SD): 

G1: 15.0 (11.1) 

G2: 10.4 (7.3) 

(P = 0.04)

BDI, mean (SD): 

G1: 13.0 (11.0) (P = NR) 

G2: 9.2 (7.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

 

SCL-90 Global 

Symptom index, mean 

(SD): 

G1: 2.1 (0.7) 

G2: 1.9 (0.5) 

(P = NS)

SCL-90 Global Symptom 

index, mean (SD): 

G1: 2.0 (0.7) (P = NR) 

G2: 1.6 (0.4) (P = NR) 

Diff between groups (P = 0.009) 

G2 better than G1 

Diff between groups in change 

over time (P = NR)

 

SCL-90 Anxiety scale, 

mean (SD): 

G1: 2.0 (0.8) 

G2: 1.9 (0.6) 

(P = NS)

SCL-90 Anxiety scale, mean 

(SD): 

G1: 1.9 (0.8) (P = NR) 

G2: 1.7 (0.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

 

SCL-90 Depression 

scale, mean (SD): 

G1: 2.5 (1.0) 

G2: 2.3 (0.8) 

(P = NS)

SCL-90 Depression scale, 

mean (SD): 

G1: 2.5 (0.9) (P = NR) 

G2: 1.9 (0.7) (P = NR) 

Diff between groups (P = 0.007) 

G2 better than G1 

Diff between groups in change 

over time (P = NR)

 

SCL-90 

Obsessive/Compulsive 

scale, mean (SD): 

G1: 2.2 (1.0) 

G2: 2.0 (0.7) 

(P = NS)

SCL-90 

Obsessive/Compulsive scale, 

mean (SD): 

G1: 2.1 (1.0) (P = NR) 

G2: 1.6 (0.6) (P = NR) 

Diff between groups (P = 0.003) 

G2 better than G1 

Diff between groups in change 

over time (P = NR)

 

SCL-90 Hostility scale, 

mean (SD): 

G1: 1.9 (0.9) 

G2: 1.7 (0.8) 

(P = NS)

SCL-90 Hostility scale, mean 

(SD): 

G1: 2.1 (1.0) (P = NR) 

G2: 1.6 (0.6) (P = NR) 

Diff between groups (P = 0.02) 

G2 better than G1 

Diff between groups in change 

over time (P = NR)

 
C-302 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Walsh et al. 1991 

(continued) 

 
C-303 

Evidence Table 5. Medication trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

STAI – State, mean (SD): 

G1: 51.5 (14.3) 

G2: 48.1 (12.2) 

(P = NS)

STAI – State, mean (SD): 

G1: 49.3 (14.3) (P = NR) 

G2: 45.5 (12.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

 

STAI – Trait, mean (SD): 

G1: 54.3 (10.3) 

G2: 51.9 (10.5) 

(P = NS)

STAI – Trait, mean (SD): 

G1: 54.1 (11.6) (P = NR) 

G2: 46.5 (10.2) (P = NR) 

Diff between groups (P = 0.01) 

G2 better than G1 

Diff between groups in change 

over time (P = NR)

 
C-304 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 1992 

Companion article: 

Agras, Rossiter et al., 

1994 

Setting: 

Outpatient, ED Clinic; 

location: Stanford, CA, 

USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

desipramine, CBT and 

their combination in the 

tx of women with BN. 

Groups (N = 71): 

G1: desipramine, 16 wks (N = 12)

G2: desipramine, 24 wks (N = 12)

G3: desipramine, 16 wks, plus 

CBT (N = 12) 

G4: desipramine, 24 wks, plus 

CBT (N = 12) 

G5: CBT only (N = 23) 

Enrollment: 

• 100 recruited from university 

ED clinic and media, then 

interviewed 

• 11 met exclusion criteria; 18 

withdrew 

• 71 met criteria and 

participated 

Meds Drop-out rate: 

• 6 wks (12.2%) 

• 16 wks (14.6%) 

• 24 wks (17%) 

CBT Drop-out rate 

(4.3%) 

Age, yrs, mean (SD): 

29.6 (8.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Marital Status (%): 

Married: 32% 

Single: 56.3% 

Divorced: 8.5% 

Separated: 2.8% 

Education (%): 

Graduated HS: 5.6% 

Completed some HS: 1.4% 

Graduated college: 56% 

Completed some college: 36.7% 

Age of onset of BE, yrs, mean 

(SD): 

19.9 (5.7) 

Age of onset of purging, yrs, 

mean (SD): 

20.7 (5.9) 

Frequency of bingeing/wk, mean 

(SD): 

7.5 (5.7) 

Frequency of purging/wk, mean 

(SD): 

9.2 (6.9) 

Ideal wt, kg, mean (SD): 

53.7 (5.8) 

Baseline wt, kg, mean (SD): 

59.9 (9.1) 

Prior AN Dx: 

22% 
C-305 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 18-65; met DSM 

III-R criteria for BN; no 

concurrent medical 

condition that would 

preclude use of 

antidepressants; no 

evidence of conduction 

disturbance on ECG 

Exclusion: 

Current AN, drug or 

alcohol abuse, 

psychosis, or 

depression with 

suicidal risk of 

sufficient severity to 

preclude use of 

antidepressants on an 

outpatient basis. 

Participants randomized to one of 

5 groups: desipramine continued 

for 16 or 24 wks; individual CBT; 

combined CBT with drug tx for 16 

or 24 wks. 

For individuals randomized to 

drug tx, dose began at 25 mg/day 

for 3 days, increased by 50 mg 

increments every 3-5 days to a 

max of 300 mg, responsecontingent. At 6 wks, serum levels 

assessed, drug increased to 350 

mg/day, as needed. 

Participants seen wkly for first 4 

wks, then at wks 6, 8, 12, 16 (for 

those withdrawn per tx), then 18, 

20, 24, for those continuing, per tx 

group. 

CBT was administered in 15, 

individual, 50 min, wkly sessions, 

and FU included sessions at wks 

20, 24 and 28. 

Assessments were collected at 

baseline, wks 16 and 24; bingeing 

and purging frequency also 

assessed at wk 32. 

Two primary (binge 

and purge 

frequencies) and 5 

secondary factors 

subjected to a 

repeated measures 

ANCOVA for three 

groups (med alone, 

CBT and combined) at 

16 wks; similarly, an 

ANCOVA was used to 

assess diff between 5 

groups at 32 wks for 

primary measures, 

and at 24 wks for 

secondary measures. 

Two-tailed test for sig 

was used throughout. 

When sig time X 

group effect found, 

post hoc tests carried 

out and Bonferroni 

correction applied, 

resulting in an 

adjusted sig level of P 

< 0.005. 

Score: 

Fair 

Intent to treat: 

Yes, for analysis of primary 

outcomes; secondary analyses 

used “completers” only. 

Blinding: 

N/A 

Adverse events: 

“side effects” of meds reported; 

further detail: NR 

Funding: 

National Institute of Mental 

Health 
C-306 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras et al., 1992 

(continued) 

Binges, past 7 days, mean (SD): 

G1: 5.5 (4.6) 

G2: 5.9 (5.1) 

G3: 7.5 (3.4) 

G4: 9.3 (5.8) 

G5: 8.7 (7.2) 

(P = NS) 

Binges, past 7 days, mean (SD): 

16 wks: 

G1: 3.5 (6.1) (P = NR) 

G2: 3.4 (3.5) (P = NR) 

G3: 2.4 (3.1) (P = NR) 

G4: 1.7 (1.5) (P = NR) 

G5: 1.5 (2.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.005)

G5 better than G1+G2 (P < 0.005) 

G3+G4 better than G1+G2 (P < 0.004) 

24 wks: 

G1: 3.7 (7.1) (P = NR) 

G2: 2.7 (2.8) (P = NR) 

G3: 2.1 (2.8) (P = NR) 

G4: 2.3 (4.7) (P = NR) 

G5: 2.8 (5.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

32 wks: 

G1: 6.2 (13.7) (P = NR) 

G2: 3.3 (3.9) (P = NR) 

G3: 3.2 (4.2) (P = NR) 

G4: 1.0 (3.0) (P = NR) 

G5: 2.5 (3.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.02) 

G4 better than G1 (P < 0.004) 

GG4 better than G2 (P < 0.005) 
C-307 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 Wt (kg): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

G5: NR 

(P = NR) 

Wt (kg): 

32 wks 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

G5: NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)
C-308 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras et al., 1992 

(continued) 

Purges, past 7 days, mean (SD): 

G1: 9.7 (9.4) 

G2: 6.3 (4.9) 

G3: 8.3 (4.3) 

G4: 11.7 (5.9) 

G5: 10.1 (7.7) 

(P = NS) 

Purges, past 7 days, mean (SD): 

16 wks: 

G1: 4.7 (8.6) (P = NR) 

G2: 3.9 (3.8) (P = NR) 

G3: 2.6 (3.2) (P = NR) 

G4: 1.2 (2.7) (P = NR) 

G5: 1.7 (2.7) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.004)

G5 better than G1+G2 (P < 0.004) 

G3 better than G1+G2 (P < 0.003) 

Purges, past 7 days, mean (SD) (continued): 

24 wks: 

G1: 5.0 (10.8) (P = NR) 

G2: 2.9 (3.0) (P = NR) 

G3: 2.7 (4.2) (P = NR) 

G4: 1.7 (4.7) (P = NR) 

G5: 2.7 (5.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

32 wks: 

G1: 6.2 (13.7) (P = NR) 

G2: 3.4 (4.1) (P = NR) 

G3: 3.2 (4.3) (P = NR) 

G4: 1.1 (3.0) (P = NR) 

G5: 2.2 (3.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G4 better than G1 (P < 0.005) 
C-309 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-310 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Hunger/disinhibition, mean (SD): 

G1: 10.0 (2.3) 

G2: 9.6 (2.3) 

G3: 11.1 (2.1) 

G4: 11.0 (2.1) 

G5: 10.1 (3.2) 

(P = NS) 

Hunger/disinhibition, mean (SD): 

16 wks: 

G1: 7.4 (2.1) (P = NR) 

G2: 7.9 (2.7) (P = NR) 

G3: 9.1 (3.6) (P = NR) 

G4: 6.0 (3.4) (P = NR) 

G5: 8.6 (3.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Diff between groups in change over time (P = NS) 

24 wks: 

G1: 8.7 (2.5) (P = NR) 

G2: 7.4 (1.7) (P = NR) 

G3: 11.1 (2.1) (P = NR) 

G4: 6.3 (3.2) (P = NR) 

G5: 8.3 (3.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G4 better than G5 (P < 0.005) 

Dietary Preoccupation, mean (SD): 

G1: 14.0 (4.8) 

G2: 13.4 (5.4) 

G3: 15.3 (3.0) 

G4: 15.9 (3.0) 

G5: 14.1 (4.3) 

(P = NS) 

Dietary Preoccupation, mean (SD): 

16 wks: 

G1: 9.7 (4.5) (P = NR) 

G2: 10.4 (6.7) (P = NR) 

G3: 10.5 (7.1) (P = NR) 

G4: 5.5 (2.9) (P = NR) 

G5: 9.3 (5.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.01) 

G3+G4 better than G1+G2 (P < 0.005)

24 wks: 

G1: 8.9 (4.1) (P = NR) 

G2: 7.5 (5.6) (P = NR) 

G3: 10.7 (7.1) (P = NR) 

G4: 5.9 (6.2) (P = NR) 

G5: 9.5 (6.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 1992 

(continued) 

Abstinence from bingeing: 

NR 

Abstinence from bingeing %: 

16 wks: 

G1 + G2: 35% 

G3 + G4: 65% 

G5: 50% 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

24 wks: NR

32 wks: 

G1 + G2: 42% 

G3 + G4: 74% 

G5: 55% 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-311 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-312 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras et al., 1992 

(continued) 

Abstinence from purging %: 

NR 

Abstinence from purging: 

16 wks: 

G1 + G2: 33% 

G3 + G4: 64% 

G5: 48% 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

24 wks: 

NR

32 wks: 

NR
C-313 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-314 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras, Rossiter et al., 

1994 

Companion article: 

Agras et al., 1992 

Setting: 

Outpatient, ED Clinic; 

location: USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

desipramine, CBT and their 

combination in the tx of 

women with BN at 1 yr FU. 

Groups: 

G1: desipramine, 16 wks 

G2: desipramine, 24 wks 

G3: desipramine, 16 wks, 

plus CBT 

G4: desipramine, 24 wks, 

plus CBT 

G5: CBT only 

Enrollment: 

• 100 recruited from 

university ED clinic and 

media, then interviewed 

• 71 met criteria and 

participated 

• 11 met exclusion criteria; 

18 withdrew 

• 61 completed FU 

Age, mean (SD): 

29.6 (8.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Marital Status (%): 

Married: 32% 

Single: 56.3% 

Divorced: 8.5% 

Separated: 2.8% 

Education (%): 

Graduated HS: 5.6% 

Completed some HS: 1.4% 

Graduated college: 56% 

Completed some college: 36.7% 

Age of onset of BE, yrs, mean 

(SD): 

19.9 (5.7) 

Age of onset of purging, yrs, 

mean (SD): 

20.7 (5.9) 

Frequency of bingeing/wk, 

mean (SD): 

7.5 (5.7) 

Frequency of purging/wk, 

mean (SD): 

9.2 (6.9) 

FU Ideal wt, kg, mean (SD): 

122.8 (55.3) 

FU wt, kg, mean (SD): 

136.5 (61.4) 
C-315 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 18-65; met DSM III-R 

criteria for BN; no 

concurrent medical 

condition that would 

preclude use of 

antidepressants; no 

evidence of conduction 

disturbance on ECG 

Exclusion: 

Current AN, drug or alcohol 

abuse, psychosis, or 

depression with suicidal risk 

of sufficient severity to 

preclude use of 

antidepressants on an 

outpatient basis. 

Participants randomized to 

one of 5 groups: 

desipramine continued for 

16 or 24 wks; individual 

CBT; CBT combined with 

drug tx for 16 or 24 wks. 

For individuals randomized 

to drug tx, dose began at 25 

mg/day for 3 days, 

increased by 50 mg 

increments every 3-5 days 

to a max of 300 mg, 

response-contingent. At 6 

wks, serum levels 

assessed, and drug was 

increased to 350 mg/day, as 

needed. 

Participants seen wkly for 

first 4 wks, then at wks 6, 8, 

12, 16 (for those withdrawn 

per tx), then 18, 20, 24, for 

those continuing, per tx 

group. 

CBT administered in 15, 

individual, 50 min, wkly 

sessions, and FU included 

sessions at wks 20, 24 and 

28. 

Assessments collected at 

baseline, wks 16 and 24; 

bingeing and purging 

frequency also assessed at 

wk 32. 

Repeated ANCOVA for 5 

groups to 1 yr FU using the 

baseline value as the 

covariate. Patients 

descriptively classified as 

recovered or not recovered, 

defined by abstinence from 

both bingeing and purging 

for a 3-mo period. 

Score: 

Fair 

Intent to treat: 

Yes, for analysis of 

primary outcomes; 

secondary analyses used 

“completers” only. 

Blinding: 

NA 

Adverse events: 

“side effects” of meds; 

further detail: NR 

Funding: 

National Institute of Mental 

Health 
C-316 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges/wk, mean (SD): 

G1: 5.3 (6.2) 

G2: 7.4 (5.4) 

G3: 7.4 (3.6) 

G4: 7.9 (6.2) 

G5: 8.4 (6.8) 

Binges/wk, mean (SD): 

72 wks: 

G1: 5.8 (10.2) (P = NR) 

G2: 2.4 (3.6) (P = NR) 

G3: 3.4 (4.6) (P = NR) 

G4: 3.1 (7.7) (P = NR) 

G5: 2.6 (3.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.03) 

G4 better than G1 (P < 0.02) 

G5 better than G1 (P < 0.02) 

Purges/wk, mean (SD): 

G1: 9.4 (10.9) 

G2: 7.8 (5.2) 

G3: 8.3 (4.5) 

G4: 10.0 (6.4) 

G5: 10.2 (7.5)

Purges/wk, mean (SD): 

72 wks: 

G1: 5.6 (14.3) (P = NR) 

G2: 2.6 (3.6) (P = NR) 

G3: 3.1 (4.6) (P = NR) 

G4: 2.9 (5.2) (P = NR) 

G5: 2.2 (3.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Diff between groups in change over time (P = NS)

Hunger/disinhibition, mean (SD): 

G1: 10.8 (2.6) 

G2: 10.0 (2.4) 

G3: 11.4 (2.0) 

G4: 10.0 (1.5) 

G5: 10.5 (3.2)

Hunger/disinhibition, mean (SD): 

72 wks: 

G1: 9.5 (2.5) (P = NR) 

G2: 6.3 (2.5) (P = NR) 

G3: 8.8 (3.7) (P = NR) 

G4: 6.1 (2.2) (P = NR) 

G5: 8.5 (3.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.01) 

G4 better than G1 (P < 0.01)

Dietary Preoccupation, mean (SD): 

G1: 13.1 (4.4) 

G2: 11.2 (5.1) 

G3: 15.5 (4.2) 

G4: 15.3 (3.2) 

G5: 14.5 (4.2)

Dietary Preoccupation, mean (SD): 

72 wks: 

G1: 8.7 (3.7) (P = NR) 

G2: 5.1 (3.1) (P = NR) 

G3: 9.9 (6.8) (P = NR) 

G4: 3.2 (2.6) (P = NR) 

G5: 7.1 (5.3) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.03) 

G4 better than G1 (P < 0.001)

Author, yr: 

Agras, Rossiter et al., 

1994 

(continued) 

Restraint, mean (SD): 

G1: 12.3 (5.1) 

G2: 11.4 (4.6) 

G3: 11.2 (4.2) 

G4: 13.7 (4.2) 

G5: 12.0 (4.4)

Restraint, mean (SD): 

72 wks: 

G1: 12.6 (3.2) (P = NR) 

G2: 11.3 (5.3) (P = NR) 

G3: 11.9 (5.2) (P = NR) 

G4: 12.6 (4.7) (P = NR) 

G5: 13.2 (4.5) (P = NR) 

(P = NR) 

Diff between groups in change over time (P = NR) 

Diff between groups in change over time (P = NR)
C-317 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 15.0 (12.1) 

G2: 12.6 (10.5) 

G3: 14.0 (7.7) 

G4: 18.6 (4.1) 

G5: 14.3 (7.0) 

(P = NR) 

BDI, mean (SD): 

72 wks: 

G1: 10.0 (7.5) (P = NR) 

G2: 5.1 (5.3) (P = NR) 

G3: 9.7 (8.9) (P = NR) 

G4: 4.4 (4.6) (P = NR) 

G5: 10.3 (13.1) (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR) 

NR NR 

RSE, mean (SD): 

G1: 3.6 (1.7) 

G2: 3.3 (2.1) 

G3: 3.5 (1.7) 

G4: 3.3 (0.8) 

G5: 3.8 (1.4)

RSE, mean (SD): 

G1: 2.6 (1.7) (P = NR) 

G2: 1.8 (0.9) (P = NR) 

G3: 3.0 (1.8) (P = NR) 

G4: 2.0 (1.5) (P = NR) 

G5: 2.4 (1.9) (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR)

 
C-318 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras, Rossiter et al., 

1994 

(continued) 

Post-tx: 

Recovered, abstinence from bingeing and 

purging for prior 3 mos, N (%): 

G1: 5 (45%) (P = NR) 

G2: 5 (45%) (P = NR) 

G3: 5 (50%) (P = NR) 

G4: 5 (56%) (P = NR) 

G5: 9 (41%) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Not recovered, N (%) 

G1: 6 (55%) (P = NR) 

G2: 4 (44%) (P = NR) 

G3: 5 (50%) (P = NR) 

G4: 4 (44%) (P = NR) 

G5: 13 (59%) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

72-wk FU: 

Maintained Recovery, N (%): 

G1: 1/5 (20%) (P = NR) 

G2: 5/5 (100%)) (P = NR) 

G3: 4/5 (80%) (P = NR) 

G4: 5/5 (100%) (P = NR) 

G5: 7/9 (78%) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Additional recovered, N (%) 

G1: 1/6 (17%) (P = NR) 

G2: 1/4 (25%) (P = NR) 

G3: 0/5 (0%) (P = NR) 

G4: 2/4 (50%) (P = NR) 

G5: 5/13 (38%) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-319 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-320 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design 

Patient Characteristics 

N = 38 (completers) 

Author, yr: 

Goldbloom et al., 

1997 

Setting: 

Eating Disorders 

Program – Toronto 

Hospital, Canada 

Enrollment period: 

2 yrs 

Research objective: 

To compare fluoxetine, 

individual CBT, and 

fluoxetine plus individual 

CBT in the tx of BN. 

Groups: 

G1: Fluoxetine (N = 23) 

G2: CBT (N = 24) 

G3: Fluoxetine+CBT (N = 29)

Enrollment: 

N = 76 (approximately 13% 

of all initial consultations for 

ED conducted during the 

recruitment period) 

Completed at least 14 wks, 

N (%): 

G1: 14 (60.9) 

G2: 16 (66.7) 

G3: 13 (43.8) 

(P = NS) 

Completed and provided 

post assessment data, N: 

G1: 12 

G2: 14 

G3: 12 

Age, yrs, mean (SD): 

25.8 (5.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BMI, mean (SD): 

23.0 (2.5) 

Past highest BMI, mean 

(SD): 

25.8 (3.6) 

Past lowest BMI, mean 

(SD): 

19.8 (2.2) 

Previous Dx of AN: 

Total sample: 15.8% 

G1: N = 1 

G2: N = 3 

G3: N = 2 

Current mood disorders: 

Total sample: 13.2% 

G1: N = 2 

G2: N = 0 

G3: N = 3 

Lifetime mood disorder, 

N: 

G1: 8 

G2: 8 

G3: 6 

Anxiety disorders: 

10.5% 

Substance use disorders: 

5.3% 

Personality disorders: 

Total sample: 18.4% 

Cluster A (G1 = 1; G2 = 0; 

G3 = 0) 

Cluster B (G1 = 1; G2 = 1; 

G3 = 1) 

Cluster 3 (G1 = 3; G2 = 0; 

G3 = 2) 

No diffs between groups on 

any characteristics. 
C-321 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, age: 18-45; 

85-125% matched 

population mean wt; 

DSM III-R dx of BN; 

binge and vomit at 

least twice per wk per 

EDE; min 6 mo 

duration of illness. 

Exclusion: 

Ongoing 

pharmacotherapy or 

psychotherapy or use 

of MAOIs within 2 wks 

prior to the onset of 

study tx; immediate 

suicide risk or 

psychosis; medical 

contraindications to 

drug tx; previous 

exposure to research 

txs. 

Assessment: Baseline, 6 wks, end 

of tx, 4 wk FU 

G1: Met with psychiatrist individually 

once per wk for 4 wks and then 

biwkly for 12 wks (total = 10 

sessions). Sessions < 10 m and 

focused on meds issues. Prescribed 

60 mg per day, adjusted if side 

effects emerged. 

G2: Met with psychologist wkly for 16 

wks. Sessions were 1 hr based on 

Fairburn’s manual. 

G3: Met separately with 

pharmacotherapists and 

psychotherapists as described above; 

involved greater frequency of 

professional contacts than either tx 

alone. 

Non-parametric chi 

square to compare 

sociodemographic 

variables. ANCOVA 

for 4-wk post tx 

symptom variables 

(controlling for pre-tx 

measures). Repeated 

measures MANOVA 

to compare change in 

primary and 

secondary 

psychological 

variables between 

groups. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

No 

Adverse events: 

Dropped out because of 

side effects, N: 

G1: 4 

G3: 2 

Funding: 

Eli Lilly Canada Inc. 
C-322 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Note: ITT ANCOVA analyses (N = 76) found no sig 

diffs between groups on any measures. 

At Treatment Completion: 

Reduction in objective binge frequency, %, 

mean: 

G1: 70% 

G2: 80% 

G3: 87% 

Diff between groups (P = NS)

Reduction in vomiting episodes, %, mean: 

G1: 37.4% 

G2: 79.2% 

G3: 82.4% 

Diff between groups (P < 0.05) 

G2 and G3 better than G1

Objective binges, mean (SD): 

G1: 21.0 (12.2) 

G2: 33.6 (29.5) 

G3: 29.6 (16.5) 

(P = NS)

4 Wks Post-tx: 

Objective binges, mean (SD): 

G1: 10.0 (15.9) (P = NR) 

G2: 7.4 (16.6) (P = NR) 

G3: 1.8 (3.3) (P = NR) 

Diff between groups (P = NS) 

Diff between G3 and G1 (P < 0.03) 

G3 better than G1 

Diff between groups in change over time (P = NR)

Subjective binges, mean (SD): 

G1: 6.3 (9.6) 

G2: 3.2 (5.5) 

G3: 9.7 (14.3) 

(P = NS)

Subjective binges, mean (SD): 

G1: 10.7 (13.3) (P = NR) 

G2: 1.9 (3.8) (P = NR) 

G3: 4.7 (6.2) (P = NR) 

Diff between groups (P = 0.046) 

Diff between G2 and G1 (P < 0.02) 

G2 better than G1 

Diff between groups in change over time (P = NR)

Vomit episodes, mean (SD): 

G1: 24.6 (20.4) 

G2: 41.8 (34.4) 

G3: 30.9 (29.7) 

(P = NS)

Vomit episodes, mean (SD): 

G1: 17.3 (27.2) (P = NR) 

G2: 9.0 (16.8) (P = NR) 

G3: 3.3 (4.5) (P = NR) 

Diff between groups (P = NS) 

Diff between G3 and G1 (P < 0.03) 

G3 better than G1 

Diff between groups in change over time (P = NR)

Author, yr: 

Goldbloom et al., 

1997 

(continued) 

EDE dietary restraint, mean (SD): 

G1: 3.8 (1.0) 

G2: 3.1 (1.5) 

G3: 3.7 (1.5) 

(P = NS)

EDE dietary restraint, mean (SD): 

G1: 2.3 (1.5) (P = NR)

G2: 1.6 (1.6) (P = NR) 

G3: 1.6 (1.8) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)
C-323 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 16.3 (9.4) 

G2: 18.4 (11.5) 

G3: 14.8 (13.0) 

(P = NS) 

4 Wks Post-tx: 

BDI, mean (SD): 

G1: 13.6 (15.3) (P = NS) 

G2: 13.8 (14.2) (P = NS)

G3: 7.5 (9.0) (P = NS) 

Diff over time (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Wt, lbs, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

(P = NR) 

4 Wks Post-tx: 

Change in wt, lbs, mean 

(SD): 

G1: -2.0 (10.0) (P = NR) 

G2: 5.0 (7.7) (P = NR) 

G3: 3.2 (7.3) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

RSE, mean (SD): 

G1: NR 

G2: NR

G3: NR 

(P = NR) 

RSE, mean (SD): 

G1: 13.6 (15.3) (P = NR) 

G2: 13.8 (14.2) (P = NR)

G3: 7.5 (9.0) (P = NR) 

Diff over time (P < 0.000) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR) 

 
C-324 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE shape concern, mean (SD): 

G1: 4.1 (1.0) 

G2: 3.0 (1.8) 

G3: 3.7 (1.7) 

(P = NS)

EDE shape concern, mean (SD): 

G1: 2.8 (1.8) (P = NR) 

G2: 2.3 (2.0) (P = NS) 

G3: 2.3 (1.9) (P = NR) 

Diff over time (P < 0.0001), sig reductions in G1 

and G3 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

EDE wt concern mean (SD): 

G1: 3.4 (1.4) 

G2: 2.6 (1.9) 

G3: 3.3 (1.8) 

(P = NS)

EDE wt concern, mean (SD): 

G1: 2.1 (1.4) (P = NR) 

G2: 1.8 (2.2) (P = NS) 

G3: 1.8 (1.7) (P = NR) 

Diff over time (P < 0.0001), sig reductions in G1 

and G3 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

EDI Drive for thinness: 

G1: NR 

G2: NR 

G3: NR 

(P = 0.013) 

G2 diff than G1 and G3

EDI Drive for thinness: 

G1 (P = NR) 

G2 (P = NR) 

G3 (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

Abstinent (no binges or vomit episodes in 4 

wks post tx), %, mean: 

G1: 17% 

G2: 43% 

G3: 25% 

Diff between groups (P = NS)

Subthreshold ( < 2 binge or vomit episodes/wk 

in 4 wks posttx), %, mean: 

G1: 25% 

G2: 21% 

G3: 50% 

Diff between groups (P = NS)

Author, yr: 

Goldbloom et al., 

1997 

(continued) 

Threshold (2+ binge or vomit episodes per wk 

in the 4 wks post tx), %, mean: 

G1: 58% 

G2: 36% 

G3: 25% 

Diff between groups (P = NS)
C-325 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-326 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Mitchell et al., 2002 

Setting: 

Outpatient, NY, NJ, 

Minnesota, USA 

Enrollment period: 

NR 

Research objective: 

To investigate effect of 

meds management vs. 

IPT on abstinence rates in 

patients previously 

treated unsuccessfully 

with CBT (see Agras et 

al., 2000). 

Groups: 

G1: IPT (N = 31) 

G2: Antidepressant meds 

(fluoxetine; replaced with 

desipramine in those who did not 

achieve abstinence) (N = 31) 

Enrollment: 

• 847 contacted clinics 

• 258 interviewed 

• 194 enrolled in initial CBT tx 

study (NY:77; Minnesota: 79; 

NJ: 38) 

• 62 of those who remained 

symptomatic after CBT tx 

enrolled in current study (NY: 

22; Minnesota: 28; NJ: 12) 

Completers (N = 37): 

G1: 21 

G2: 16 

Drop outs (N = 25): 

G1: 10 

G2: 15 

Diff between sites (P = NS) 

Diff between groups (P = NS) 

Completed FU (N = 33): 

G1: 18 

G2: 15 

Drop out FU (N = 4): 

G1: 3 

G2: 1 

Age, yrs, mean (SD): 

G1: 28.0 (7.3) 

G2: 27.1 (6.3) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 23.2 (3.7) 

G2: 21.9 (2.5) 

(P = NS) 

Duration of bingeing, yrs, 

mean (SD): 

G1: 11.0 (6.7) 

G2: 10.4 (7.1) 

(P = NS) 

Duration of purging, yrs, 

mean (SD): 

G1: 10.7 (6.7) 

G2: 8.9 (6.3) 

(P = NS) 

Hx of AN, %: 

G1: 29 

G2: 36 

(P = NS) 

Hx of depression, %: G1: 

45 

G2: 64 

(P = NS) 

Current depression, %: 

G1: 26 

G2: 26 

(P = NS) 

Personality Disorder, %: 

G1: 42 

G2: 54 

(P = NS) 

Hx of substance abuse, %: 

G1: 13 

G2: 16 

(P = NS) 
C-327 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Adult women who met 

DSM III-R criteria for 

BN with purging by 

self-induced vomiting 

at least 2 times per wk 

for 3 mo. 

Exclusion: 

Substance 

dependence in last 6 

mo, hx of psychosis 

CBT (20 session, 16 wk) 

Those with active bulimic sx (purging) 

at the end of CBT tx randomized. 

G1: 20 sessions of IPT over 16 wks 

(developed by Klerman et al., 1984; 

modified by Fairburn, 1993), 

delivered by same therapist as 

previous CBT tx. 

G2: fluoxetine (60 mg/day; reduced if 

not well tolerated). For those who did 

not achieve abstinence at 60 mg over 

8 wks, fluoxetine discontinued and 

desipramine initiated, beginning at a 

dose of 50 mg/day with subsequent 

increases to a max of 300 mg/day. 

Timeline: CBT: Wk 1-16; IPT/Meds: 

Wk 17 - 33. Post Assessment: wk 33 

- 34; IPT discontinued at wk 33 and 

no further tx until FU. Med maintained 

at the same dosage until FU and was 

then discontinued. FU: wk 60 

Two-way ANCOVA 

(Site x Tx) using 

baseline values as 

covariate. 

For binary outcomes, 

multiple logistic 

regression with site 

and tx as independent 

measures. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

McKnight Foundation 
C-328 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Objective binges, median (SD): 

G1: 4.0 

G2: 5.0 

(P = NR) 

Abstinence, 34 wks, N (%): 

G1: 5/31 (16.1) 

G2: 3/31 (9.7) 

(P = NS) 

Abstinence, 60 wks, N (%): 

Of those abstinent at 34 wks, N (%): 

G1: 2/5 (40) 

G2: 3/3 (100) 

Of those not abstinent at wk 34, N (%): 

G1: 3/26 (11.5) 

G2: 0/28 (0.0) 

Relapse, 60 wks, N (%): 

G1: 3/5 (60) 

G2: 0/3 (0.0) 

EDE restraint, mean (SD): 

G1: 2.0 (1.3) 

G2: 2.6 (1.5) 

(P = NR)

EDE restraint, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

EDE Wt Concerns, mean (SD): 

G1: 2.5 (1.3) 

G2: 2.4 (1.5) 

(P = NR)

EDE Wt Concerns, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

EDE Shape Concerns, mean (SD): 

G1: 2.9 (1.4) 

G2: 2.8 (1.5) 

(P = NR)

EDE Shape Concerns, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

EDE Eating Concerns, mean (SD): 

G1: 1.3 (0.9) 

G2: 1.9 (1.4) 

(P = NR)

EDE Eating Concerns, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

BES, mean (SD): 

G1: 17.7 (9.9) 

G2: 20.8 (10.4) 

(P = NR)

BES, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

TFEQ – Restraint, mean (SD): 

G1: 12.5 (4.1) 

G2: 13.8 (4.4) 

(P = NR)

TFEQ – Restraint, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

Author, yr: 

Mitchell et al., 2002 

(continued) 

TFEQ – Disinhibition, mean (SD): 

G1: 9.6 (3.2) 

G2: 9.9 (3.4) 

(P = NR)

TFEQ – Disinhibition, mean (SD): 

G1: NR 

G2: NR 

(P = NR)
C-329 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 9.9 (8.4) 

G2: 11.8 (10.0) 

(P = NR) 

BDI, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

 

RSE, mean (SD): 

G1: 23.6 (7.5) 

G2: 23.7 (6.0) 

(P = NR)

RSE, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

 
C-330 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ – Hunger, mean (SD): 

G1: 6.8 (3.5) 

G2: 7.7 (3.3) 

(P = NR)

TFEQ – Hunger, mean (SD): 

G1: NR 

G2: NR 

(P = NR)

Author, yr: 

Mitchell et al., 2002 

(continued) 

Bulimic Thoughts Questionnaire, mean 

(SD): 

G1: 49.1 (16.8) 

G2: 50.0 (17.4) 

(P = NR)

Bulimic Thoughts Questionnaire, mean (SD): 

G1: NR 

G2: NR 

(P = NR)
C-331 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 
C-332 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Mitchell et al., 2001 

Setting: 

Outpatient University 

of Minnesota Hospital 

eating disorders 

program, USA 

Enrollment period: 

NR 

Research objective: 

To examine the singular 

and combined effects of 

fluoxetine and a self-help

manual on suppressing 

bulimic behaviors in BN. 

Groups: 

G1: Placebo only (N = 22) 

G2: Fluoxetine Only (N = 26) 

G3: Placebo and Self-Help

Manual (N = 22) 

G4: Fluoxetine and SelfHelp Manual (N = 21) 

Enrollment: 

N = 91 

Endpoint (at least 1 postrandomization 

measurement), N: 

Total sample: 89 

G1: 21 

G2: 26 

G3: 22 

G4: 20 

Wk 4 (evaluable data at wk 

4), N: 

Total sample: 83

G1: 18 

G2: 25

G3: 21 

G4: 19 

Age, yrs, mean (SD) 

(range): 

Total sample: 26.6 (7.1) 

(18-46) 

G1: 23.8 (6.1) 

G2: 26.6 (7.1) 

G3: 26.8 (6.9) 

G4: 29.3 (7.8) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

White, N (%): 

G1: 21 (95.5) 

G2: 25 (100) 

G3: 22 (100) 

G4: 20 (95.2) 

(P = NS) 

Height, cm, mean (SD): 

G1: 165.1 (6.9) 

G2: 162.6 (7.0) 

G3: 164.3 (5.7) 

G4: 162.7 (7.0) 

(P = NS) 

Wt, kg, mean (SD): 

G1: 60.7 (7.8) 

G2: 59.5 (13.9) 

G3: 61.2 (10.5) 

G4: 56.4 (6.8) 

(P = NS) 

Smoking, Yes, N (%): 

G1: 11 (50) 

G2: 8 (30.8) 

G3: 7 (31.8) 

G4: 3 (14.3) 

(P = NS) 

Alcohol Use, Yes, N (%): 

G1: 12 (54.5) 

G2: 15 (57.7) 

G3: 13 (59.1) 

G4: 10 (47.6) 

(P = NS) 
C-333 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, at least 18 yrs 

old, at least 85% of 

IBW, DSM III-R criteria 

for BN and binge 

eating/vomiting 3 times 

per wk for last 6 mos, 

Exclusion: 

Currently receiving 

pharmacotherapy or 

psychotherapy; 

medical condition that 

would preclude safe 

outpt tx, hx of 

hypersensitivity to 

fluoxetine, prior 

exposure to fluoxetine 

in a total amt > 140 mg 

or within preceding 5 

wks before entering 

study. 

 

Baseline: interview, exam, 

assessment instruments. Instructed 

to self-monitored tx and return to the 

clinic in 2 wk to reassess admission 

criteria. 

Randomized into single blind for 2 

wks. Participants who reported < 75% 

improvement in the number of 

vomiting episodes were then 

randomized. 

Patients seen wkly for 4 wks and then 

every other wk for 12 wks (by RA) 

and every other wk for 12 wks (by 

investigator). 

Meds: 60 mg/day fluoxetine for 16 

wks. 

Manual: instructed to follow daily 

assignments. 14 readings/homework 

assignments equaling 1 hr each 

night: normalizing eating, behavioral 

strategies, cognitive restructuring, 

body image, relapse prevention. 

Baseline comparisons 

– one way ANOVA 

Chi squares and 

Fisher exact test 

Two-way ANOVA 

Cochran-MantelHaenszel for response 

rates 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

First 2 wks: Single 

Remainder: NR 

Adverse events: 

NR 

Funding: 

Dista Pharmaceuticals 

NIMH 

McKnight Foundation 
C-334 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Episodes of vomiting, mean (SD): 

G1: 11.77 (6.67) 

G2: 16.81 (27.72) 

G3: 13.86 (10.81) 

G4: 12.43 (6.92) 

(P = NS) 

Days of vomiting, mean (SD): 

G1: 5.59 (1.65) 

G2: 5.65 (1.60) 

G3: 6.09 (1.66) 

G4: 6.05 (1.36) 

(P = NS)

At Wk 4 (after 2 wks of active tx): 

Vomiting, % decrease from baseline, mean (SD):

G1: 21.8 (48.1) (P = NR) 

G2: 46.1 (39.5) (P = NR) 

G3: 31.5 (66.4) (P = NR) 

G4: 66.7 (28.9) (P = NR) 

Diff between groups (P = 0.012) 

G2+G4 better than G1+G3 

Diff between groups (P = 0.033) 

G3+G4 better than G1+G2 

At Endpoint: 

Vomiting, % decrease from baseline, mean (SD):

G1: 22.8 (56.1) (P = NR) 

G2: 52.8 (50.7) (P = NR) 

G3: 50.2 (55.0) (P = NR) 

G4: 66.7 (31.2) (P = NR) 

Diff between groups (P = 0.043) 

G2+G4 better than G1+G3 

Episodes of binge eating, mean (SD): 

G1: 9.45 (5.34) 

G2: 11.58 (6.74) 

G3: 11.91 (10.70) 

G4: 11.29 (5.87) 

(P = NS)

Days of binge eating, mean (SD): 

G1: 5.45 (1.68) 

G2: 5.96 (1.40) 

G3: 5.73 (1.78) 

G4: 6.10 (1.37) 

(P = NS)

At Wk 4 (after 2 wks of active tx): 

Binge eating, % decrease from baseline, mean 

(SD): 

G1: 26.9 (62.1) (P = NR) 

G2: 43.4 (36.2) (P = NR) 

G3: 35.4 (66.0) (P = NR) 

G4: 61.6 (31.5) (P = NR) 

Diff between groups (P = NS)

At Endpoint: 

Binge eating, % decrease from baseline, mean 

(SD): 

G1: 32.4 (66.7) (P = NR) 

G2: 50.3 (52.6) (P = NR) 

G3: 59.7 (39.6) (P = NR) 

G4: 66.8 (29.9) (P = NR) 

Diff between groups (P = NS)

Author, yr: 

Mitchell et al., 2001 

(continued) 

Days of fasting, mean (SD): 

G1: 1.18 (2.20) 

G2: 0.54 (1.07) 

G3: 0.59 (1.74) 

G4: 0.48 (1.03) 

(P = NS)

At Endpoint: 

Days of fasting, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

(P = NR) 

Diff between groups in change over time (P = NS)
C-335 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HAM-D, mean (SD): 

G1: 10.91 (5.89) 

G2: 8.85 (6.83) 

G3: 10.14 (7.01) 

G4: 8.10 (6.56) 

(P = NS) 

At Endpoint: 

HAM-D: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

 

CGI Severity, mean (SD): 

G1: 4.82 (0.59) 

G2: 4.69 (0.62) 

G3: 4.82 (0.66) 

G4: 5.00 (0.77) 

(P = NS)

CGI Improvement: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = 0.029)

G2+G4 better than G1+G3

 

Patient’s Global Improvement 

Scales (PGI): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = 0.036)

G2+G4 better than G1+G3

 
C-336 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI total score, mean (SD): 

G1: 72.11 (14.59) 

G2: 66.79 (16.21) 

G3: 68.74 (18.48) 

G4: 58.11 (15.14) 

(P = NS)

At Endpoint: 

EDI total score, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Mitchell et al., 2001 

(continued) 

Abstinence rates: 

G1: NR 

G2: 16% 

G3: 24%

G4: 26% 

(P = NS)
C-337 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-338 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Walsh et al., 2004 

Setting: 

Primary care clinics, 

Connecticut and 

Manhattan, NY, USA 

Enrollment period: 

March 1998 – 

October 2001 

Research objective: 

To evaluate relative and 

combined benefits of 

fluoxetine and guided selfhelp for BN in a primary 

care setting. 

Groups: 

G1: Fluoxetine and guided 

self-help (N = 24) 

G2: Placebo and guided self 

help (N = 25) 

G3: Fluoxetine only (N = 20) 

G4: (Placebo only; N = 22) 

Enrollment: 

• 227 contacted clinic and 

met phone screening 

• 101 chose to come for in 

person screening 

• 91 met criteria and were 

randomized 

• Completed tx, N (%): 28 

(30.8%); G1: 11; G2: 3; 

G3: 6; G4: 8. 

• Diff in attrition 

• fluoxetine (G1 + G3) vs 

placebo (G2 + G4) 

(P = 0.02); G1/G3 had 

less attrition) 

• Guided self-help (G1 + 

G2) vs pills only (G3 + 

G4) (P = NS) 

Age, yrs, mean (SD): 

30.6 (7.8) 

Duration of BN, yrs, mean 

(SD): 

12.0 (7.9) 

Met full DSM IV criteria 

for BN, N (%): 

76 (83.5) 

Received previous tx, N 

(%): 

28 (32.2) 

Sex: 

Female: 100% 

Race/ethnicity, N (%): 

Caucasian: 84 (92.3) 

Hispanic: 5 (5.5) 

Asian: 1 (1.1) 

African American: 1 (1.1) 

Comorbidty, N (%): 

MDD: 30 (33.3) 

Past MDD: 28 (31.1) 
C-339 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Modified DSM IV 

criteria: included 

“moderately” large 

amounts of food during 

binges, and binge at 

least once per wk for 3 

mos. Woman, age 18-

60, BMI > 17.5 

Exclusion: 

Pregnant, substantial 

medical illness, 

psychotropic drug use, 

meds known to 

influence shape or wt, 

previously received 

course of 60 mg/day of 

fluoxetine for at least 4 

wks, received CBT, 

adverse reaction to 

fluoxetine, currently in 

other psychological 

/psychiatric tx, 

substantial alcohol or 

substance abuse or 

dependence in the last 

6 mo, other serious 

psychiatric dx requiring 

immediate tx or 

actively suicidal. 

Physicians were internists with limited 

experience in ED. Nurses had no 

specialized training in ED. Physicians 

and nurses received brief ( < 2 hr) 

training in BN, guided self-help, and 

fluoxetine tx for BN. 

• Initial visit – met with physician for 

hx, exam, meds. patient returned 2 

wks later for evaluation. All patients 

scheduled for 4 additional 15 

minutes visit at moly intervals. 

• Med conditions –60 mg /day 

• Guided self help – received selfhelp book and instructions during 

initial visit. In addition to moly 

physician visits, met with nurse for 

6 – 8 30 minutes sessions. First 4 

were wkly during the first mo; 5th – 

6th moly; 7 – 8th optional in the 3rd 

or 4th mo. Focused on encouraging 

patients to progress through selfhelp manual. 

ANCOVA. 

Proportional odds 

polytomous logistic 

regression 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

NIDDK, 

Welcome Trust, 

Eli Lilly and Company 
C-340 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline 

Outcomes 

EDE interview, mean (SD): 

Objective bulimic episodes/mo:

G1: 27.42 (23.88) 

G2: 27.80 (25.64)

G3: 24.20 (22.60) 

G4: 23.95 (15.57) 

(P = NS) 

EDE interview, mean (SD): 

Objective bulimic episodes/mo: 

G1: 16.83 (24.65) (P = NR) 

G2: 26.92 (26.79) (P = NR) 

G3: 17.25 (23.93) (P = NR) 

G4: 20.09 (19.64) (P = NR)

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 better than G2+G4 (P = 0.03) 

Diff between groups in change over time (P = NR) 

Subjective Bulimic 

Episodes/mo: 

G1: 17.58 (25.19) 

G2: 15.84 (22.37) 

G3: 16.25 (16.06) 

G4: 15.09 (18.85) 

(P = NS)

Subjective Bulimic Episodes/mo: 

G1: 14.25 (23.54) (P = NR) 

G2: 13.88 (20.79) (P = NR) 

G3: 3.70 (7.80) (P = NR) 

G4: 6.68 (12.73) (P = NR) 

Diff between groups G1+G2 worse than G3+G4 (P = 0.01)

Diff between groups G1+G3 vs G2+G4 (P = NS) 

Diff between groups in change over time (P = NR)

Days of vomiting/mo: 

G1: 20.29 (9.62) 

G2: 20.12 (9.18) 

G3: 18.80 (9.36) 

G4: 17.55 (9.01) 

(P = NS)

Days of vomiting/mo: 

G1: 11.83 (11.86) (P = NR) 

G2: 20.00 (9.63) (P = NR) 

G3: 11.55 (10.60) (P = NR) 

G4: 13.68 (10.63) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 better than G2+G4 (P = 

0.004) 

Diff between groups in change over time (P = NR)

Episodes of vomiting/mo: 

G1: 38.04 (25.08) 

G2: 44.16 (56.14) 

G3: 34.30 (29.34) 

G4: 26.32 (18.09) 

(P = NS)

Episodes of vomiting/mo: 

G1: 21.04 (27.08) (P = NR) 

G2: 46.12 (56.75) (P = NR) 

G3: 19.85 (25.80) (P = NR) 

G4: 21.32 (20.89) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 better than G2+G4 (P = 

0.002) 

Diff between groups in change over time (P = NR)

Episodes of laxative use/mo: 

G1: 2.54 (6.67) 

G2: 3.64 (8.15) 

G3 (4.70 (10.20) 

G4: 3.45 (7.66) 

(P = NS) 

Episodes of laxative use/mo: 

G1: 2.25 (6.60) (P = NR) 

G2: 2.36 (6.42) (P = NR) 

G3: 3.90 (9.48) (P = NR) 

G4: 3.05 (6.55) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 vs G2+G4 (P = NS) 

Diff between groups in change over time (P = NR)

Author, yr: 

Walsh et al., 2004 

(continued) 

Restraint rating for past mo: 

G1: 5.00 (2.00) 

G2: 5.16 (1.99) 

G3: 5.20 (1.67) 

G4: 5.24 (1.58) 

(P = NS)

Restraint rating for past mo: 

G1: 3.67 (2.62) (P = NR) 

G2: 4.92 (2.08) (P = NR) 

G3: 3.90 (2.65) (P = NR)

G4: 4.19 (2.75) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 better than G2+G4 (P = 0.03) 

Diff between groups in change over time (P = NR)
C-341 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 19.74 (11.85) 

G2: 19.56 (11.64) 

G3: 18.40 (9.65) 

G4: 18.41 (9.15) 

(P = NS) 

BDI, mean (SD): 

G1: 12.52 (11.77) (P = NR) 

G2: 17.24 (11.74) (P = NR) 

G3: 12.25 (10.38) (P = NR) 

G4: 15.95 (11.23) (P = NR) 

Diff between groups G1+G2 

vs G3+G4 (P = NS) 

Diff between groups G1+G3 

better than G2+G4 (P = 0.01) 

Diff between groups in 

change over time (P = NR) 

BMI, kg/m2, mean (SD): 

G1: 21.79 (3.40) 

G2: 22.78 (4.33) 

G3: 24.29 (5.49) 

G4: 24.00 (3.72) 

(P = NS)

BMI, kg/m2, mean (SD): 

G1: 21.68 (3.47) (P = NR) 

G2: 22.61 (4.49) (P = NR) 

G3: 24.58 (6.46) (P = NR) 

G4: 23.89 (4.08) (P = NR) 

Diff between groups G1+ G2 

vs G3+G4 (P = NS)

Diff between groups G1+ G3 

vs G2+G4 (P = NS) 

Diff between groups in 

change over time (P = NR) 

SCL-53, mean (SD): 

G1: 1.36 (0.80)

G2: 1.49 (0.93) 

G3: 1.26 (0.77) 

G4: 1.20 (0.69) 

(P = NS)

SCL-53, mean (SD): 

G1: 1.03 (0.88) (P = NR) 

G2: 1.36 (0.88) (P = NR) 

G3: 0.95 (0.77) (P = NR) 

G4: 1.22 (0.85) (P = NR) 

Diff between groups G1+G2 

vs G3+G4 (P = NS)

Diff between groups G1+G3 

better than G2+G4 (P = 0.02) 

Diff between groups in 

change over time (P = NR)

 
C-342 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline 

Outcomes 

EDE questionnaire, mean (SD): 

Objective bulimic episodes /mo: 

G1: 20.70 (15.46)

G2: 17.92 (16.19) 

G3: 16.65 (12.82) 

G4: 15.48 (10.78) 

(P = NS)

EDE questionnaire, mean (SD) 

Objective bulimic episodes /mo: 

G1: 10.13 (13.14) (P = NR) 

G2: 13.88 (15.97) (P = NR) 

G3: 8.10 (9.09) (P = NR) 

G4: 9.91 (10.03) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 vs G2+G4 (P = NS) 

Diff between groups in change over time (P = NR)

Subjective Bulimic Episodes/mo: 

G1: 10.19 (8.84) 

G2: 10.45 (10.32) 

G3: 8.95 (9.23)

G4: 7.45 (8.61) 

(P = NS)

Subjective Bulimic Episodes/mo: 

G1: 9.00 (20.85) (P = NR) 

G2: 7.91 (9.29) (P = NR) 

G3: 3.11 (5.92) (P = NR) 

G4: 4.14 (5.38) (P = NR) 

Diff between groups G1+G2 vs G3+ G4 (P = NS) 

Diff between groups G1+G3 vs G2+ G4 (P = NS) 

Diff between groups in change over time (P = NR)

Days of vomiting/mo: 

G1: 20.74 (9.12) 

G2: 19.32 (9.42) 

G3: 18.30 (10.19) 

G4: 17.32 (8.95) 

(P = NS)

Days of vomiting/mo: 

G1: 10.33 (10.93) (P = NR) 

G2: 17.20 (10.98) (P = NR) 

G3: 11.15 (10.63) (P = NR) 

G4: 12.45 (10.00) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 better than G2+G4 (P = 0.04) 

Diff between groups in change over time (P = NR)

Days of laxative use/mo: 

G1: 2.70 (6.55) 

G2: 4.32 (8.78) 

G3: 4.89 (10.11)

G4: 3.77 (8.12) 

(P = NS)

Days of laxative use/mo: 

G1: 2.21 (6.47) (P = NR) 

G2: 2.88 (7.32) (P = NR) 

G3: 2.70 (7.60) (P = NR) 

G4: 2.95 (6.60) (P = NR) 

Diff between groups G1+G2 vs G3+G4 (P = NS) 

Diff between groups G1+G3 vs G2+G4 (P = NS) 

Diff between groups in change over time (P = NR)

Author, yr: 

Walsh et al., 2004 

(continued) 

Remission (absence of bingeing, vomiting, or laxative 

use for 1 mo) (N, %): 

Diff between groups G1+ G2 (6, 12.2%) vs G3+G4 

(4, 9.5%) (P = NS) 

Diff between groups G1+G3 (7, 15.9%) vs G2+G4 

(3, 6.4%) (P = NS)
C-343 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-344 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wilson et al., 1999 

Companion article: 

Walsh et al., 1997 

Setting: 

Outpatient New York 

State Psychiatric Unit, 

Columbia University, 

USA 

Enrollment period: 

NR 

Research objective: 

Examine effect of therapeutic 

alliance, predictive factors 

and time course of change on 

psychological and 

pharmacological tx of BN. 

Groups: 

G1: CBT + Meds (N = 23) 

G2: CBT + Placebo (N = 25) 

G3: Supportive therapy + 

Meds (N = 22) 

G4: Supportive therapy + 

placebo (N = 22) 

G5: Meds only (N = 28) 

Enrollment: 

• Recruitment through 

advertisements in media 

• Individuals screened on 

telephone using EDE and 

SCID (DSM III-R) 

• 209 met with psychiatrist 

who confirmed dx and did 

physical 

• Eligible participants 

entered single-blind 

washout phase for 7-10 

days 

• 120 who continued to 

meet criteria randomly 

assigned to one of the 

groups 

Age, yrs, mean (SD): 

G1: 26.1 (5.7) 

G2: 25.8 (4.4) 

G3: 28.0 (5.3) 

G4: 26.9 (4.3) 

G5: 24.3 (4.5) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity, %: 

White: 83% 

African American: 6% 

Hispanic: 6% 

Asian: 5% 

(P = NS) 

Duration of BN, yrs, mean 

(SD): 

G1: 7.26 (5.8) 

G2: 8.0 (4.0) 

G3: 9.55 (5.3) 

G4: 7.55 (3.7) 

G5: 7.36 (4.3) 

(P = NS) 

Current major depression, 

%: 

G1: 17% 

G2: 24% 

G3: 23% 

G4: 9% 

G5: 29% 

(P = NS) 

Past AN, %: 

G1: 17% 

G2: 36% 

G3: 32% 

G4: 27% 

G5: 32% 

(P = NS) 
C-345 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Meet DSM III-R criteria 

for BN for at least 1 yr; 

had to use selfinduced vomiting as 

compensatory 

mechanism; Female 

between ages 18-45; 

wt between 80-120% 

of IBW 

Exclusion: 

Medically ill; possible 

cardiac conduction 

disease; pregnant; 

abused alcohol or 

drugs in past yr; 

appeared acutely 

suicidal; prior adverse 

reaction to 

desipramine or 

fluoxetine 

Combination of therapy and meds or 

placebo, except for the ‘Meds only’ 

group. Both CBT and supportive 

therapy designed to include 20 

sessions over 16 wks. ‘Meds only’ 

group expected to attend 16 sessions 

over 16 wks. 

CBT: based on manual (Wilson, 

1989) derived from Fairburn et al. 

CBT included: self-monitoring, 

triggers, cognitive restructuring, 

coping strategies, problem solving, 

and dysfunctional cognitions. 

Supportive therapy: modified version 

of a manual-based approach 

(Fairburn et al.); aspects of tx that 

were similar to CBT eliminated. 

Meds: desipramine (up to 300 

mg/day avg dose 188 mg/day) first 

for 8 wks. If binge frequency not 

reduced by at least 75% or if 

intolerable side effects occurred, 

desipramine tapered and 

discontinued over next 2 wks and 

given fluoxetine (up to 60 mg/day avg 

dose 55 mg/day). 

Placebo: same rules followed (8 wks 

of tx and if no 75% reduction in binge 

freq or side effects, tapering and 

discontinuation and switch to 

fluoxetine placebo). 

In the first wk of tx, dose of 

desipramine increased to 200 mg/day 

and if tolerated, continued for 3 wks. 

If needed, dose increased to 300 

mg/day. Fluoxetine started at 60 

mg/day with the option to lower the 

dose to minimize side effects. 

Logistic regression 

analyses for outcomes 

of remission and 

completion of tx and 

regression for 

termination frequency. 

Survival analyses 

comparing variables 

among the tx’s. 

Repeated measures 

ANOVA’s. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double, within groups 

receiving psychological tx 

Adverse events: 

NR 

Funding: 

NIMH; Eli Lilly; Marion Merrell 

Dow 
C-346 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Logistic Regression Analyses: 

Likelihood of remission, predictor variable, odds ratio 

[95% CI]: 

CBT (G1+G3), OR = 4.81 [1.32-17.53] (P = 0.02), CBT 

increased likelihood of remission 

HRQ, OR = NR (P = NR), higher therapeutic alliance 

increased likelihood of remission 

Predictors of Worse Outcome (end of tx binge and 

vomit frequencies): 

Higher baseline binge and vomit frequencies (P = 0.0001) 

CBT assignment (P = 0.02) 

Positive hx of AN (P = 0.05) 

Positive hx of substance abuse (P = 0.04) 

Author, yr: 

Wilson et al., 1999 

(continued) 

Binges/wk, mean (SD): 

G1: 7.29 (4.8) 

G2: 7.22 (4.0) 

G3: 7.92 (5.6) 

G4: 6.18 (3.6) 

G5: 8.32 (7.5) 

(P = NS)

Survival Analyses, hazard ratio [95% CI]: 

Binge eating: 

G1+G2 better than G3+G4, HR = 1.88 [1.08-3.26], 

especially if baseline BSQ or eating restraint were low 

• If BSQ < 140, HR = 3.54 [1.57-8.00] 

• If BSQ > 140, HR = 1.04 [0.52-2.10] 

• Low EDE restraint, HR = 3.37 [1.45-7.81] 

• High EDE restraint, HR = 1.12 [0.55-2.28] 

Repeated Measures ANOVA: 

Binge eating, overall: 

Diff between groups G1+G2 better than G3+G4 (P = 0.003)

Diff between groups in change over time, quadratic effect: 

G1+G2 better than G3+G4 in initial binge reduction 

(P = 0.05); G1+G3 vs. G2+G4 (P = NS) 

Binge eating (wks 1-3): 

Diff between groups (P = NS) 

Diff between groups in change over time, linear effects: 

G1+G2 better than G3+G4 (P = 0.001) 

G1+G3 vs. G2+G4 (P = NS) 

Binge eating (wks 4-16): 

Diff between groups (P = NR) 

Diff between groups in change over time, cubic effect: 

G1+G3 better than G2+G4 (P = 0.03)
C-347 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR Helping Relationship

Questionnaire (Therapeutic 

Alliance), mean (SD): 

*error in paper

G1: 23.58 (4.56) 

G2: 19.74 (8.60) 

G3: 18.76 (7.81) 

G4: 20.55 (7.94) 

G5: 15.09 (7.79) 

Diff between groups (P = NS)

Diff between groups in 

change over time 

G1 vs. G2 (P = NR) 

G3 vs. G4 (P = 0.03) 

*text states higher 

therapeutic alliance (higher 

HRQ) with meds vs. placebo 

within supportive tx and 

higher alliance with placebo 

vs. meds within CBT. 

NR NR 
C-348 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wilson et al., 1999 

(continued) 

Vomiting episodes/wk, mean (SD): 

G1: 10.8 (13) 

G2: 10.8 (12) 

G3: 10.6 (9) 

G4: 11.9 (13) 

G5: 10.5 (11) 

(P = NS)

Survival Analyses, hazard ratio [95% CI]: 

Vomiting: 

G1+G2 better than G3+G4, HR = 4.73 [2.21-

10.10], especially if baseline BDI was high 

• If BDI < 20, HR = 2.91 [1.25-6.79] 

• If BDI > 20, HR = 29.34 [4.72-182.15] 

G1+G3 better than G2+G4, HR = 2.01 [1.04-

3.89], especially if baseline BDI was high 

• BDI < 20 subgroup, HR = 1.22 [0.55-2.70] 

• BDI > 20 subgroup, HR = 6.79 [2.90-15.88] 

Repeated Measures ANOVA: 

Vomiting, overall: 

Diff between groups: 

G1+G2 better than G3+G4 (P = 0.002) 

G1+G3 better than G2+G4 (P = 0.04) 

Vomiting (wks 1-3): 

Diff between groups G1+G3 better than G2+G4 

Diff between groups (P = 0.04) 

Vomiting (wks 4-16): 

Diff between groups (P = NR) 

Diff between groups in change over time, 

quadratic effect: G1+G3 better than G2+G4 (P = 

0.03) 

For CBT, early responders remained superior to 

others over the course of tx. 

For supportive therapy, improvement in early 

responders deteriorated.

Time to remission: 

G1+G3 vs. G2+G4 (P = NS)
C-349 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-350 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Walsh et al., 1997 

Companion article: 

Wilson et al., 1999 

Setting: 

Outpatient New York State 

Psychiatric Unit, Columbia 

University, USA 

Enrollment period: 

NR 

Research objective: 

Compare supportive 

therapy with CBT and 

see if meds tx 

(desipramine, or 

desipramine followed by 

fluoxetine in meds nonresponders) adds to tx 

efficacy for BN. 

Groups: 

G1: CBT + Meds (N = 23) 

G2: CBT + Placebo (N = 25) 

G3: Supportive therapy + 

Meds (N = 22) 

G4: Supportive therapy + 

placebo (N = 22) 

G5: Meds only (N = 28) 

Enrollment: 

• Recruitment through 

advertisements in media 

• Individuals screened on 

telephone using EDE and 

SCID (DSM III-R) 

• 209 individuals met with 

psychiatrist who 

confirmed dx and did 

physical 

• Eligible participants 

entered single-blind 

washout phase for 7-10 

days 

• 120 who continued to 

meet criteria were 

randomly assigned to one 

of the groups 

Drop outs: 

Overall: 34% 

Meds only group: 43% 

Psychotherapy groups: 32% 

(P = NS) 

Age, yrs, mean (SD): 

G1: 26.1 (5.7) 

G2: 25.8 (4.4) 

G3: 28.0 (5.3) 

G4: 26.9 (4.3) 

G5: 24.3 (4.5) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity, %: 

White: 83% 

African American: 6% 

Hispanic: 6% 

Asian: 5% 

(P = NS) 

Duration of BN, yrs, 

mean (SD): 

G1: 7.26 (5.8) 

G2: 8.0 (4.0) 

G3: 9.55 (5.3) 

G4: 7.55 (3.7) 

G5: 7.36 (4.3) 

(P = NS) 

Current major 

depression, %: 

G1: 17% 

G2: 24% 

G3: 23% 

G4: 9% 

G5: 29% 

(P = NS) 

Past AN, %: 

G1: 17% 

G2: 36% 

G3: 32% 

G4: 27% 

G5: 32% 

(P = NS) 
C-351 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN for at least 1 yr; 

had to use selfinduced vomiting as 

compensatory 

mechanism; Female: 

between ages 18-45; 

wt between 80-120% 

of IBW 

Exclusion: 

Medically ill; possible 

cardiac conduction 

disease; pregnant; 

abused alcohol or 

drugs in past yr; 

appeared acutely 

suicidal; prior adverse 

reaction to 

desipramine or 

fluoxetine 

Combination of therapy and meds or 

placebo, except for the ‘Meds only’ 

group. Both CBT and supportive 

therapy designed to include 20 

sessions over 16 wks. Those receiving

‘meds only’ expected to attend 16 

sessions over 16 wks. 

CBT based on a manual (Wilson, 

1989) derived from Fairburn et al., 

Components of CBT included: selfmonitoring, triggers, cognitive 

restructuring, coping strategies, 

problem solving, and dysfunctional 

cognitions. 

Supportive therapy: modified version 

of a manual-based approach 

(Fairburn et al.); aspects of the tx that 

were similar to CBT eliminated. 

Participants receiving meds received 

desipramine (up to 300 mg/day avg 

dose 188 mg/day) first for 8 wks. If 

binge frequency not reduced by 

≥ 75% or if intolerable side effects 

occurred, the desipramine was 

tapered and discontinued over the 

next 2 wks and patients were then 

given fluoxetine (up to 60 mg/day avg 

dose 55 mg/day). The same rules 

were followed for those receiving 

placebo (8 wks of tx and if no 75% 

reduction in binge freq or side effects, 

tapering and discontinuation and 

switch to fluoxetine placebo). 

In the first wk of tx, the dose of 

desipramine was increased to 200 

mg/day and if tolerated, this was 

continued for 3 wks. If needed, the 

dose was increased to 300 mg/day. 

Fluoxetine was started at 60 mg/day 

with the option to lower the dose to 

minimize side effects. 

ANOVA for 

continuous variables 

and logistic 

regressions for 

categorical variables 

to examine diffs 

between pre and post 

tx levels. Odds ratio 

values were tested 

with chi square tests. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double, within groups 

receiving 

psychological tx 

Adverse events: 

NR 

Funding: 

NIMH; Eli Lilly; Marion 

Merrell Dow 
C-352 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges/wk, mean (SD): 

G1: 7.29 (4.8) 

G2: 7.22 (4.0) 

G3: 7.92 (5.6) 

G4: 6.18 (3.6) 

G5: 8.32 (7.5) 

(P = NS) 

Binges/ wk, mean (SD): 

G1: 0.95 (1.6) (P < 0.05) 

G2: 2.56 (3.3) (P < 0.05) 

G3: 3.57 (3.1) (P < 0.05) 

G4: 3.32 (4.0) (P < 0.05) 

G5: 2.59 (3.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 better than G3+G4 (P = 0.0005) 

G1+G3 better than G2+G4 (P = 0.05) 

G1 better than G5 (P = 0.04) 

G3 vs. G5 (P = NS) 

Vomiting episodes/wk, mean (SD):

G1: 10.8 (13) 

G2: 10.8 (12) 

G3: 10.6 (9) 

G4: 11.9 (13) 

G5: 10.5 (11) 

(P = NS)

Vomiting episodes/wk, mean (SD): 

G1: 1.1 (2) (P < 0.05) 

G2: 5.6 (15) (P < 0.05) 

G3: 5.5 (5) (P < 0.05) 

G4: 7.5 (10) (P < 0.05) 

G5: 3.7 (5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 better than G3+G4 (P = 0.0002) 

G1+G3 vs. G2+G4 (P = NS) 

G1 better than G5 (P = 0.01) 

G3 vs. G5 (P = NS)

EAT, mean (SD): 

G1: 45.0 (13) 

G2: 42.3 (16) 

G3: 45.8 (16) 

G4: 39.9 (16) 

G5: 40.9 (20) 

(P = NS)

EAT, mean (SD): 

G1: 19.1 (12) (P < 0.05) 

G2: 24.5 (17) (P < 0.05) 

G3: 28.1 (13) (P < 0.05) 

G4: 28.7 (23) (P < 0.05) 

G5: 27.8 (21) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 better than G3+G4 (P = 0.005) 

G1+G3 better than G2+G4 (P = 0.01) 

G1 better than G5 (P = 0.01) 

G3 vs. G5 (P = NS)

Author, yr: 

Walsh et al., 1997 

(continued) 

BSQ, mean (SD): 

G1: 137 (29) 

G2: 132 (32) 

G3: 132 (30) 

G4: 127 (31) 

G5: 135 (38) 

(P = NS)

BSQ, mean (SD): 

G1: 87 (36) (P < 0.05) 

G2: 94 (36) (P < 0.05) 

G3: 94 (35) (P < 0.05) 

G4: 104 (39) (P < 0.05) 

G5: 106 (47) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 better than G5 (P = 0.05) 

G3 vs. G5 (P = NS)
C-353 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 10.9 (6) 

G2: 11.7 (10) 

G3: 15.9 (12) 

G4: 14.3 (9) 

G5: 14.5 (8) 

(P = NS) 

BDI, mean (SD): 

G1: 4.4 (5) (P < 0.05) 

G2: 6.8 (7) (P < 0.05) 

G3: 6.7 (7) (P < 0.05) 

G4: 10.2 (11) (P < 0.05) 

G5: 8.2 (9) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 better than G2+G4 

(P = 0.04) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS) 

BMI, kg/m2

, 

mean (SD): 

G1: 21.6 (2.2) 

G2: 22.1 (2.1) 

G3: 21.7 (2.3) 

G4: 21.7 (2.2) 

G5: 22.3 (2.1) 

(P = NS) 

BMI, kg/m2, mean (SD): 

G1: 21.5 (2.1) (P = NR) 

G2: 22.6 (2.3) (P < 0.05) 

G3: 21.2 (2.5) (P < 0.05) 

G4: 22.1 (2.2) (P = NR) 

G5: 21.7 (2.3) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 worse than G3+G4 (P = 0.02) 

G1+G3 better than G2+G4 (P = 0.005) 

G1 worse than G5 (P = 0.01) 

G3 vs. G5 (P = NS) 

SCL-90 Global 

Symptom index, 

mean (SD): 

G1: 1.83 (0.6) 

G2: 1.69 (0.5) 

G3: 1.88 (0.6) 

G4: 1.66 (0.3) 

G5: 1.73 (0.4) 

(P = NS)

SCL-90 Global Symptom index, mean 

(SD): 

G1: 1.39 (0.4) (P < 0.05) 

G2: 1.47 (0.5) (P < 0.05) 

G3: 1.51 (0.5) (P < 0.05) 

G4: 1.51 (0.5) (P = NR) 

G5: 1.41 (0.4) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

Wt (lb), mean 

(SD): 

G1: 126 (15) 

G2: 130 (11) 

G3: 133 (17) 

G4: 130 (15) 

G5: 131 (17) 

(P = NS)

Wt (lb), mean (SD): 

G1: 125 (15) (P = NR) 

G2: 133 (11) (P < 0.05) 

G3: 131 (18) (P < 0.05) 

G4: 133 (13) (P = NR) 

G5: 128 (16) (P < 0.05) 

G1+G2 (+1.13 lb) worse than G3+G4 

(-1.29 lb) (P = 0.03) 

G1+G3 (-1.54 lb) better than G2+G4 

(+1.49 lb) (P = 0.007) 

G1 worse than G5 (P = 0.02) 

G3 vs. G5 (P = NS)

SCL-90 

Depression 

Index, mean 

(SD): 

G1: 2.16 (0.8) 

G2: 20.01 (0.8) 

G3: 2.38 (0.9) 

G4: 20.07 (0.6) 

G5: 2.25 (0.7) 

(P = NS)

SCL-90 Depression Index, mean (SD):

G1: 1.47 (0.5) (P < 0.05) 

G2: 1.74 (0.7) (P = NR) 

G3: 1.75 (0.7) (P < 0.05) 

G4: 1.83 (0.8) (P = NR) 

G5: 1.73 (0.8) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 better than G2+G4 (P = 0.05) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

 
C-354 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE binges/mo, mean (SD): 

G1: 28.8 (23) 

G2: 28.1 (22) 

G3: 33.4 (21) 

G4: 21.8 (12) 

G5: 36.8 (35) 

(P = NS)

EDE binges/mo, mean (SD): 

G1: 2.5 (5) (P < 0.05) 

G2: 6.6 (14) (P < 0.05) 

G3: 13.2 (15) (P < 0.05) 

G4: 10.6 (18) (P < 0.05) 

G5: 6.1 (14) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 better than G3+G4 (P = 0.001) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G5 better than G3 (P = 0.03)

EDE vomiting episodes/mo, mean 

(SD): 

G1: 38.7 (27) 

G2: 45.9 (69) 

G3: 39.3 (29) 

G4: 41.6 (48) 

G5: 45.4 (38) 

(P = NS)

EDE vomit episodes/mo, mean (SD): 

G1: 3.4 (6) (P < 0.05) 

G2: 7.6 (17) (P < 0.05) 

G3: 16.8 (16) (P < 0.05) 

G4: 25.4 (43) (P < 0.05) 

G5: 8.9 (13) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 better than G3+G4 (P = 0.0001) 

G1+G3 vs. G2+G4 (P = NS) 

G1 better than G5 (P = 0.04) 

G5 better G3 (P = 0.03)

EDE importance of shape and wt, 

mean (SD): 

G1: 8.43 (2.4) 

G2: 8.56 (2.9) 

G3: 9.45 (2.5) 

G4: 8.95 (2.5) 

G5: 9.55 (2.2) 

(P = NS)

EDE importance of shape and wt, mean (SD): 

G1: 7.11 (3.2) (P = NR) 

G2: 6.81 (3.6) (P < 0.05) 

G3: 6.25 (3.3) (P < 0.05) 

G4: 7.71 (3.2) (P = NR) 

G5: 8.45 (2.7) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G5 better than G3 (P = 0.01)

Author, yr: 

Walsh et al., 1997 

(continued) 

EDE shape concern, mean (SD): 

G1: 3.74 (1.2) 

G2: 3.59 (1.3) 

G3: 3.78 (1.4) 

G4: 3.52 (1.2) 

G5: 3.99 (1.3) 

(P = NS)

EDE shape concern, mean (SD): 

G1: 2.18 (1.4) (P = NR) 

G2: 2.27 (1.3) (P = NR) 

G3: 2.47 (1.5) (P = NR) 

G4: 2.52 (1.5) (P = NR) 

G5: 2.80 (1.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)
C-355 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL-90 Anxiety 

Index, mean (SD): 

G1: 1.83 (0.7) 

G2: 1.57 (0.6) 

G3: 1.66 (0.6) 

G4: 1.56 (0.5) 

G5: 1.55 (0.5) 

(P = NS)

SCL-90 Anxiety Index, mean (SD): 

G1: 1.31 (0.4) (P < 0.05) 

G2: 1.37 (0.5) (P = NR) 

G3: 1.37 (0.5) (P < 0.05) 

G4: 1.41 (0.5) (P = NR) 

G5: 1.29 (0.4) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

 
C-356 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE wt concern, mean (SD): 

G1: 3.53 (1.1) 

G2: 3.47 (1.4) 

G3: 3.69 (1.5) 

G4: 3.36 (1.2) 

G5: 3.37 (1.4) 

(P = NS)

EDE wt concern, mean (SD): 

G1: 2.06 (1.4) (P = NR) 

G2: 1.99 (1.4) (P = NR) 

G3: 1.98 (1.5) (P = NR) 

G4: 2.38 (1.7) (P = NR) 

G5: 2.44 (1.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1+G2 vs. G3+G4 (P = NS) 

G1+G3 vs. G2+G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

EDE restraint, mean (SD): 

G1: 3.21 (1.2) 

G2: 3.13 (1.2) 

G3: 3.28 (1.3) 

G4: 2.93 (1.5) 

G5: 3.59 (1.4) 

(P = NS)

EDE restraint, mean (SD): 

G1: 1.15 (1.2) (P < 0.05) 

G2: 1.43 (1.4) (P < 0.05) 

G3: 2.06 (1.6) (P < 0.05) 

G4: 1.68 (1.6) (P < 0.05) 

G5: 2.15 (1.5) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1 + G2 vs. G3 + G4 (P = NS) 

G1 + G3 vs. G2 + G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

EDE overeating, mean (SD): 

G1: 3.26 (0.5) 

G2: 3.18 (0.6) 

G3: 3.32 (0.7) 

G4: 2.99 (0.6) 

G5: 3.18 (0.6) 

(P = NS)

EDE overeating, mean (SD): 

G1: 1.37 (1.1) (P = NR) 

G2: 1.73 (1.3) (P = NR) 

G3: 2.17 (1.3) (P = NR) 

G4: 1.91 (1.2) (P = NR) 

G5: 1.49 (10.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1 + G2 vs. G3 + G4 (P = NS) 

G1 + G3 vs. G2 + G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

Author, yr: 

Walsh et al., 1997 

(continued) 

EDE eating concern, mean (SD): 

G1: 2.45 (1.6) 

G2: 2.36 (1.4) 

G3: 2.49 (1.3) 

G4: 2.31 (1.3) 

G5: 2.58 (1.2) 

(P = NS)

EDE eating concern, mean (SD): 

G1: 0.84 (1.0) (P < 0.05) 

G2: 0.77 (0.9) (P < 0.05) 

G3: 1.36 (1.6) (P < 0.05) 

G4: 1.32 (1.4) (P < 0.05) 

G5: 1.17 (0.8) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1 + G2 vs. G3 + G4 (P = NS) 

G1 + G3 vs. G2 + G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)
C-357 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-358 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE global score, mean (SD): 

G1: 3.23 (0.7) 

G2: 3.15 (0.7) 

G3: 3.31 (0.9) 

G4: 3.02 (1.3) 

G5: 3.34 (0.7) 

(P = NS)

EDE global score, mean (SD): 

G1: 1.52 (0.9) (P < 0.05) 

G2: 1.65 (0.9) (P < 0.05) 

G3: 2.01 (1.1) (P < 0.05) 

G4: 1.96 (1.2) (P < 0.05) 

G5: 2.01 (0.9) (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time 

G1 + G2 vs. G3 + G4 (P = NS) 

G1 + G3 vs. G2 + G4 (P = NS) 

G1 vs. G5 (P = NS) 

G3 vs. G5 (P = NS)

Remission of self-report binge eating and vomiting, 

N (%): 

G1: 11/23 (48) (P = NR) 

G2: 5/25 (20) (P = NR) 

G3: 2/22 (9) (P = NR) 

G4: 3/22 (14) (P = NR) 

G5: 6/28 (21) (P = NR) 

Diff between groups 

G1+G2 vs. G3+G4, OR = 4.3 [1.4-13.3] (P = 0.01) 

G1+G3 vs. G2+G4 (P = NR) 

G1 vs. G5, OR = 3.7 [1.1-12.5] (P = 0.04) 

G3 vs. G5 (P = NR)

Author, yr: 

Walsh et al., 1997 

(continued) 

Remission of EDE binge eating and vomiting, N 

(%): 

G1: 9/18 (50) (P = NR) 

G2: 3/16 (19) (P = NR) 

G3: 3/17 (18) (P = NR) 

G4: 2/17 (12) (P = NR) 

G5: 5/20 (25) (P = NR) 

Diff between groups 

G1+G2 vs. G3+G4, OR = 3.3 [1.0-10.9] (P = 0.06) 

G1+G3 vs. G2+G4, OR = 2.7 [1.0-7.5] (P = 0.07) 

G1 vs. G5 (P = NR) 

G3 vs. G5 (P = NR)
C-359 

Evidence Table 6. Medication plus behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-360 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 1989 

Setting: 

Single center; 

outpatient; location: 

Department of 

Psychiatry and 

Behavioral Sciences 

and the Behavioral 

Medicine Program, 

Stanford University 

School of Medicine; 

Stanford, CA, USA 

Enrollment period: 

NR 

Research objective: 

To compare the efficacy of 

three, 4-mo long 

psychological txs (selfmonitoring of binge-eating 

and purging only, CBT, CBT + 

response prevention of 

purging behavior) versus a 

waitlist control for reducing 

BN symptoms. Another 

primary objective was to 

assess whether the addition 

of a purging-related response 

prevention component to the 

CBT tx would yield additional 

reductions in purging 

frequency. 

Groups: 

G1: waitlist (N = 19) 

G2: self-monitoring (N = 19) 

G3: CBT (N = 22) 

G4: CBT + response 

prevention (N = 17) 

Enrollment: 

• 119 recruited through 

media advertisements 

and through referrals 

from health care workers 

were screened 

• 77 were enrolled and 

randomized. 

• 67 remained at 4 mo 

post-tx (G1 = 18, 

G2 = 16, G3 = 17, 

G4 = 16) 

(P = NS) 

Age, yrs, mean (SD): 

Total Sample: 

29.2 (8.6) (range: 18-61 yrs) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-361 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN; Female; ages 18-

65 

Exclusion: 

Concurrent 

psychological or 

pharmacological tx for 

BN; concurrent DSM 

III-R dx of AN, 

schizophrenia, 

unipolar or bipolar 

affective disorder, drug 

abuse, or alcoholism; 

pregnancy; abnormal 

serum potassium; 

major medical 

disorders such as 

hepatic disease, renal 

disease, or major 

cardiac disease. 

77 enrolled subjects randomized to 

one of four conditions which were 

administered over a 4-mo period 

(i.e., 1-hour long per session, up to 

14 sessions). In each of the three 

tx conditions, subjects met 

individually with Ph.D. level 

psychologists. Assessments 

conducted at baseline, 6 wks, 4 

mos for all groups and 6 mo FU for 

the three tx conditions only. 

Repeated measures 

ANOVAs to evaluate 

between group diffs in 

changes in primary 

(e.g., purging 

frequency) and 

secondary (e.g., 

depression, dieting 

attitudes, maturity 

attitudes, and food 

preoccupation) 

continuous outcome 

measures over the 

course of tx at three 

different time points 

(i.e., baseline, 6 wks, 

4 mos). Scheffe posthoc analyses used to 

interpret sig 

interaction effects. 

Chi-square analyses 

used to assess 

between group diffs 

on categorical 

measures or 

percentage diffs in 

variables of interest. 

The secondary 

measures were 

created through 

principal components 

analysis of standard 

depression, anxiety, 

and eating-related 

self-report measures. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NIMH 
C-362 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Purges/wk, mean (SD): 

G1: 13.8 (8.4) 

G2: 12.3 (8.3) 

G3: 11.1 (6.0) 

G4: 12.2 (8.3) 

(P = NS) 

Purges/wk, mean (SD): 

At 4 mos 

G1: 13.6 (10.7) (P = NS) 

G2: 4.6 (6.2) (P < 0.01) 

G3: 2.8 (6.3) (P < 0.001) 

G4: 5.8 (10.3) (P < 0.04) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.02) 

G3 better than G1 (P < 0.05) 

G2, G4 vs. G1 (P = NS) 

At 6-mo FU (% purge reduction): 

G1: NA 

G2: 50% 

G3: 80% 

G4: 50% 

Diff between groups (P = NR) 

Abstinence of Purging: 

At 4 mos 

G1: 5.8% 

G2: 23.5% 

G3: 56.3% 

G4: 31.2% 

Diff between groups (P < 0.05) 

G3 greater than G1 (P < 0.01) 

G2, G4 vs. G1 (P = NS) 

At 6-mo FU 

G1: NA 

G2: 18% 

G3: 59% 

G4: 20% 

Diff between groups (P < 0.005) 

G3 greater than G2 and G4 

Food Preoccupation, mean (SD): 

G1: 11.4 (4.4) 

G2: 11.8 (3.6) 

G3: 10.4 (3.4) 

G4: 10.9 (4.3) 

(P = NS) 

Food Preoccupation, mean (SD): 

At 4 mos 

G1: 9.2 (4.7) (P = NR) 

G2: 8.0 (5.7) (P = NR) 

G3: 2.5 (4.5) (P = NR) 

G4: 4.0 (4.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

At 6-mo FU 

(P = NR) 

Author, yr: 

Agras et al., 1989 

(continued) 

Dieting urges, mean (SD): 

G1: 14.4 (6.3) 

G2: 17.7 (6.8) 

G3: 16.8 (4.3) 

G4: 15.5 (6.3) 

(P = NS) 

Dieting urges, mean (SD): 

At 4 mos 

G1: 13.1 (5.4) (P = NR) 

G2: 14.0 (8.0) (P = NR) 

G3: 8.5 (7.1) (P = NR) 

G4: 10.2 (6.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

At 6-mo FU 

(P = NR) 
C-363 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 19.5 (7.6)

G2: 19.6 (10.2) 

G3: 18.2 (6.7) 

G4: 19.1 (9.4) 

(P = NS) 

BDI, mean (SD): 

At 4 mos 

G1: 18.8 (8.3) (P = NR) 

G2: 13.5 (10.2) (P = NR) 

G3: 7.1 (7.7) (P = NR) 

G4: 9.2 (7.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

G3, G4 better than G1 (P < 0.05)

G2 vs. G1 (P = NS) 

Wt, kg, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

(P = NS) 

Change in Wt, kg, mean 

(SD): 

At 4 mos 

G1: -2.01 (P = NR) 

G2: +1.64 (P = NR) 

G3: +0.48 (P = NR) 

G4: +3.49 (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-364 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras, et al., 1989 

(continued) 

Maturity, mean (SD): 

G1: 7.1 (4.2) 

G2: 6.3 (5.4) 

G3: 5.8 (4.2) 

G4: 6.9 (5.4) 

(P = NS)
C-365 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-366 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wilson et al., 2002 

Setting: 

2 tx sites: 

Stanford University, 

Palo Alto, CA; 

Columbia University, 

NY, NY, USA 

Outpatient 

Quality-control center: 

Oxford University, USA 

Enrollment period: 

NR 

Research objective: 

To investigate the mechanism 

by which CBT vs. IPT 

improves BN symptomatology 

by examining three potential 

mediating factors and their 

time course of action: 

• reduction in dietary 

restraint 

• change in self-efficacy 

• modification of 

dysfunctional attitudes 

about body wt and shape 

Groups enrolled: 

G1: CBT (N = 110) 

G2: IPT (N = 110) 

Enrollment: 

Potential subjects referred to 

outpatient tx facilities 

Randomized (N = 220) 

G1: 110 (NY = 54; CA = 56) 

G2: 110 (NY = 56; CA = 54) 

Drop-outs: 

G1: 31 

G2: 25 

Analyses based on 

‘complete’ data set: 

Post-tx: N = 154 

FU: N = 129 

Age, yrs, mean (SD): 

G1: 28.3 (7.0) 

G2: 27.9 (7.5) 

(P = NS) 

Sex: 

Female: NR 

Race/ethnicity N (%): 

White: 

G1: 87 (79) 

G2: 81 (74) 

(P = NR) 

Hispanic: 

G1: 11 (10) 

G2: 14 (13) 

(P = NR) 

African American: 

G1: 7 (6) 

G2: 7 (6) 

(P = NR) 

Asian: 

G1: 4 (4) 

G2: 7 (6) 

(P = NR) 

American Indian: 

G1: 1 (1) 

G2: 0 (0) 

(P = NR) 

Duration of Binge Eating, 

mean (SD): 

G1: 11.5 (7.5) 

G2: 11.4 (7.6) 

(P = NS) 

Duration of Purging, mean 

(SD): 

G1: 10.0 (7.2) 

G2: 9.7 (6.4) 

(P = NS) 

Hx of AN, N (%): 

G1: 26 (24) 

G2: 26 (24) 

(P = NR) 

Lifetime major depression, 

N (%): 

G1: 54 (49) 

G2: 63 (57) 

(P = NR) 
C-367 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN 

Exclusion: 

Severe medical or 

psychiatric condition 

(e.g., psychosis), 

current AN, current 

psych tx of any type, 

use of any meds 

known to affect eating 

or wt, pregnancy, 

previous exposure to 

adequate trial of CBT 

or IPT for BN. 

CBT and IPT: 19 individual 50-

minutes therapy sessions conducted 

over 20 wks as 2x/wk for 2 wks, 

wkly for 12 wks, at 2-wk intervals for 

6 wks. 

G1: manualized CBT (Fiarburn, 

Marcus, and Wilson, 1993) 

G2: manualized IPT (Fairburn, in 

Garner and Garfinkel, 1997) 

Questionnaires to evaluate dietary 

restraint, body and wt concerns 

(EDE-Q (Fairburn and Beglin, 1994), 

self-efficacy (Rosenberg, 1979, and 

study-defined SE), interpersonal 

problems (IIP), and therapeutic 

alliance (Helping Relationship

Questionniare (Laborsky, 1984) 

were administered at pre-tx, wk 4 

(HRQ only) and mid-tx (wk 10). 

Every 2 wks, subjects reported 

vomiting frequency and rated wt and 

shape dissatisfaction, and conscious 

food restriction over past 7 days. 

FU (at least 8 mos post-tx) 

Stratification of 

sample on hx of AN 

Randomization by 

Efron’s biased coin 

method at Stanford 

Data Center 

Multiple linear or 

logistic regression to 

test the model: Effect 

= B1 (main tx effect) + 

B2 (main mediator 

effect) + B3 

(interactive effect) 

Tx outcomes included: 

proportion of subjects 

recovered (no 

bingeing or purging in 

previous 28 days), 

proportion of subjects 

remitted (bingeing or 

purging < 2x/wk in 28 

days), frequency of 

bingeing/purging 

episodes post-tx and 

at FU co-varying for 

pre-tx base rates. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

9 withdrawn from tx, 8 of 

which received meds: 7 for 

severe depression, 1 for an 

acute onset of panic disorder. 

Funding: 

NR 
C-368 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wilson et al., 2002 

(continued) 

Post-tx 

Reduction in Vomiting, %: 

G1: 80%

G2: 52% 

(P = 0.00) 

Reduction in Binge Eating, %: 

G1: 80% 

G2: 44% 

(P = 0.017) 

Improvement in EDE Shape Concerns: 

G1: (P < 0.01) 

G2: (P < 0.01) 

(P = NS) 

Improvement in EDE Wt Concerns: 

G1: (P ≤ 0.01) 

G2: (P = 0.001) 

(P = NS) 

Change in EDE Restraint, wk 4, mean (SD): 

G1: -1.9 (1.9) (P = NR) 

G2: -1.3 (1.9) (P = NR) 

(P = 0.04) 

G1 better than G2 

Change in EDE Restraint, wk 6, mean (SD): 

G1: -2.2 (2.1) (P = NR) 

G2: -1.2 (1.7) (P = NR) 

(P < 0.01) 

G1 better than G2 

Recovered, N: 

G1: 29 

G2: 5 

(P = NR) 

Mediator Analyses: 

Binge Eating Frequency: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Tx Main Effect (P < 0.05) 

Tx Effect on Wk 4 Dietary Restraint (P < 0.01) 

Tx Effect on Wk 6 Dietary Restraint (P < 0.01) 

Tx Effect on Wk 10 Self-Efficacy in Response to Food Cues (P < 0.05) 

Tx X Dietary Restraint Effect (P = NS) 

Tx X Self-Efficacy Effect (P = NS) 
C-369 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Post-tx: 

Rosenberg Self-Esteem: 

G1: NR (P = NR) 

G2: NR (P = NR) 

(P = NS) 

Inventory of Interpersonal 

Problems: 

G1: NR (P = NR) 

G2: NR (P = NR) 

(P = NS) 

Change in Self-efficacy 

over eating behavior, wk 

10, mean (SD): 

G1: 2.1 (1.8) (P = NR) 

G2: 0.9 (1.8) (P = NR) 

(P < 0.01) 

G1 better than G2 

Change in Self-efficacy 

over negative affect, wk 10, 

mean (SD): 

G1: 2.8 (2.5) (P = NR) 

G2: 1.9 (2.7) (P = NR) 

(P = 0.04) 

G1 better than G2 

Change in Self-efficacy 

over shape and wt, wk 10, 

mean (SD): 

G1: 1.3 (1.6) (P = NR) 

G2: 0.6 (1.6) (P = NR) 

(P = 0.03) 

G1 better than G2 

Suitability of tx, mean (SD):

G1: 12.2 (2.9) (P = NR) 

G2: 13.1 (2.3) (P = NR) 

(P = 0.03) 

G2 better than G1 

 
C-370 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wilson et al., 2002 

(continued) 

Purge Frequency: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Tx Main Effect (P < 0.01) 

Tx Effect on Wk 4 Dietary Restraint (P < 0.05) 

Tx Effect on Wk 6 Dietary Restraint (P < 0.01) 

Tx Effect on Wk 10 Self-Efficacy in Response to Food Cues (P < 0.01) 

Tx Effect on Wk 10 Self-Efficacy in Response to Shape/Wt Cues (P < 0.05) 

Tx Effect on Wk 10 Self-Efficacy in Response to Negative Affect (P < 0.05) 

Tx X Dietary Restraint Effect (P = NS) 

Tx X Self-Efficacy Effect (P = NS) 

AT FU: 

Reduction in Vomiting, %: 

G1: 61%

G2: 62% 

(P = NS) 

Reduction in Binge Eating, %: 

G1: 72% 

G2: 70% 

(P = NS) 

Remained Recovered, N (%): 

G1: 19 of 29 (66%) 

G2: 4 of 5 (80%) 

(P = NR) 

Previously Remitted, Recovered, N (%): 

G1: 5 of 15 (33%) 

G2: 7 of 19 remitted (34%) 

(P = NR) 

Newly Recovered, N (%): 

G1: 2 

G2: 6 

(P = NR) 

Mediator Analyses: 

Binge Eating Frequency: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Tx Main Effect (P = NS) 

Tx Effect on Wk 4 Dietary Restraint (P < 0.05) 

Tx X Dietary Restraint Effect (P = NS) 
C-371 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-372 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 2000 

Companion article: 

Wolk and Devlin, 2001 

Setting: 

Two outpatient tx sites: 

Stanford University, 

Stanford, California; 

Columbia University, 

NY.; USA; Oxford 

University, UK served 

as an independent 

quality control center 

Enrollment period: 

NR 

Research objective: 

To test whether IPT might be 

as efficacious as CBT in the 

tx of women with BN. 

Groups: 

G1: CBT (N = 110) 

G2: IPT (N = 110) 

Enrollment: 

• Participants recruited via 

advertisement and 

physician referral 

• 923 contacted by phone; 

584 screened out primarily 

due to not meeting BN dx 

criteria, meds use, and/or 

disinterest 

• 220 enrolled and 

randomized (110 at each 

tx site) 

• 9 withdrawn (6 CBT) 

• 27% (of 211) did not 

complete tx (N = 57): 

G1: 31 (28%) and G2: 26 

(24%) 

• 154 completed tx 

• 129 completed tx and FU

G1: (N = 65) 

G2: (N = 64) 

Age, yrs, mean (SD): 

G1: 28.3 (7.0) 

G2: 27.9 (7.5) 

(P = NS) 

Sex: 

Female: NR 

Race/ethnicity N (%): 

White: 

G1: 87 (79) 

G2: 81 (74) 

(P = NR) 

Hispanic: 

G1: 11 (10) 

G2: 14 (13) 

(P = NR) 

African American: 

G1: 7 (6) 

G2: 7 (6) 

(P = NR) 

Asian: 

G1: 4 (4) 

G2: 7 (6) 

(P = NR) 

American Indian: 

G1: 1 (1) 

G2: 0 (0) 

(P = NR) 

Duration of binge eating, 

mean (SD): 

G1: 11.5 (7.5) 

G2: 11.4 (7.6) 

(P = NS) 

Duration of purging, mean 

(SD): 

G1: 10.0 (7.2) 

G2: 9.7 (6.4) 

(P = NS) 

Hx of AN, N (%): 

G1: 26 (24) 

G2: 26 (24) 

(P = NR) 

Lifetime major depression, 

N (%): 

G1: 54 (49) 

G2: 63 (57) 

(P = NR) 
C-373 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM III-R criteria 

for BN, dx using SCID 

Exclusion: 

Severe physical or 

psychiatric condition 

that would interfere 

with tx; current AN; 

current 

psychotherapeutic tx 

of any type; all 

psychotropic meds; 

pregnancy; having 

received adequate trial 

of CBT or IBT for BN 

prior to study 

19, 50 minutes sessions of CBT or 

IPT over 20 wks; Tx occurred 

2x/wk in first 2 wks, wkly for next 

12 wks, at 2 wk intervals for 

remaining 6 wks; sessions 

audiotaped, and 20% randomly 

selected and monitored by the 

quality control site. 

CBT focused on shape, wt, and 

eating behaviors; IPT focused on 

non-eating/wt-related personal 

issues; tx conducted by doctoral 

level psychologist or psychiatrist. 

Assessments were taken at 

baseline, end-of-tx, 4-, 8-and 12-

mos FU. 

A power analysis was 

calculated for the 

primary outcome 

variables. For the 

primary analysis, 

logistic regression 

analyses performed at 

end of tx and at 1yr 

FU, using site and tx 

as independent 

variables. A 

secondary ANCOVA 

(with baseline value 

as the covariate) used 

to test for tx diffs in 

“completers only”. Not 

normally-distributed 

data (bingeing, 

purging) were square 

root transformed prior 

to analysis. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

9 withdrawn from tx, 8 of 

which received meds: 7 for 

severe depression, 1 for an 

acute onset of panic disorder. 

Funding: 

NIMH and Wellcome Trust 

Principal FellowshiP grant 
C-374 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 2000 

(continued) 

 Current major depression, 

N (%): 

G1: 22 (20) 

G2: 25 (23) 

(P = NR) 

Lifetime substance 

abuse/dependence, N (%): 

G1: 29 (26) 

G2: 22 (20) 

(P = NR) 
C-375 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-376 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras et al., 2000 

(continued) 

Values for total sample (N = 220): 

EDI measures: 

Objective binges/28days, median: 

G1: 24.5 

G2: 25.5 

(P = NS) 

Purges/28days, median: 

G1: 33.0 

G2: 49.0 

(P = 0.003) 

Restraint, mean (SD): 

G1: 3.4 (1.3) 

G2: 3.5 (1.2) 

(P = NS) 

Shape Concerns, mean (SD): 

G1: 3.7 (1.3) 

G2: 3.8 (1.2) 

(P = NS) 

Wt. Concerns, mean (SD): 

G1: 3.4 (1.4) 

G2: 3.4 (1.5) 

(P = NS) 

Eating Concerns, mean (SD): 

G1: 2.4 (1.4) 

G2: 2.9 (1.4) 

(P = 0.02) 

Global Score, mean (SD): 

G1: 3.2 (1.0) 

G2: 3.3 (0.9) 

(P = NS) 

Intent-to-treat analysis: 

End-of-tx: 

Recovered (no binge or purge in past 28 

days), N (%): 

G1: 32 (29%) 

G2: 7 (6%) 

Diff between groups (P < 0.001) 

G1 better than G2 

Remitted (binge or purge < 2/wk in past 28 

days), N (%): 

G1: 53 (48%) 

G2: 31 (28%) 

Diff between groups (P = 0.003) 

G1 better than G2 

Of participants recovered at end-of-tx: 

Recovered at FU, N (%): 

G1: 21/32 (66%) 

G2: 4/7 (57%) 

Diff between groups (P = NS) 

Of participants remitted (but not recovered) 

at end-or-tx: 

Remitted at FU, N (%): 

G1: 6/21 (29%) 

G2: 8/24 (33%) 

Diff between groups (P = NS) 

Of remaining participants at end of tx: 

Recovered at FU, N (%): 

G1: 4/57 (7%) 

G2: 7/79 (9%) 

Diff between groups (P = NR) 
C-377 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Completer Analyses: 

SCL-90-R, mean (SD): 

G1: 1.1 (0.6) 

G2: 1.1 (0.7) 

(P = NS) 

Completer Analyses: 

SCL-90-R, mean (SD): 

End-of-tx: 

G1: 0.5 (0.5) (P = NR) 

G2: 0.5 (0.5) (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

4-mo FU: 

G1: 0.5 (0.4) (P = NR) 

G2: 0.6 (0.6) (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NRS)

8-and 12-mo FU: 

G1: 0.5 (0.6) (P = NR) 

G2: 0.5 (0.6) (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NR) 

Completer Analyses:

BMI, kg/m2, mean (SD):

G1: 23.0 (5.0) 

G2: 23.0 (4.8) 

(P = NS) 

Completer Analyses: 

BMI, kg/m2, mean (SD): 

End-of-tx: 

G1: 23.3 (4.9) (P = NR) 

G2: 23.0 (4.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

4-mo FU: 

G1: 23.3 (5.1) (P = NR) 

G2: 23.2 (4.9) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR)

8-and 12-mo FU: 

G1: 23.3 (4.9) (P = NR) 

G2: 22.9 (4.1) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-378 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Completer Analyses: 

EDE – Objective binges/28days, 

median (interquartile range): 

G1: 20.0 (32) 

G2: 23.5 (27) 

(P = NS) 

Completer Analyses: 

EDE – Objective binges/28days, median 

(interquartile range): 

End of tx: 

G1: 0 (5) (P = NR) 

G2: 5 (23.5) (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 0 (5) (P = NR) 

G2: 6 (20) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- or 12-mo FU: 

G1: 0 (10) (P = NR) 

G2: 2 (17.5) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 2000 

(continued) 

EDE – Purges/28days, median: 

G1: 30.0 (32) 

G2: 42.0 (54) 

(P = 0.001)

EDE – Purges/28days, median: 

End of tx: 

G1: 1.0 (8) (P = NR) 

G2: 13.5 (32.35) (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 1.0 (8.5) (P = NR) 

G2: 9.5 (35) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 3.0 (14.5) (P = NR) 

G2: 7.0 (27.5) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-379 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-380 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE – Restraint, mean (SD): 

G1: 3.4 (1.3) 

G2: 3.3 (1.3) 

(P = NS)

EDE – Restraint, mean (SD): 

End of tx: 

G1: 1.4 (1.3) (P = NR) 

G2: 2.1 (1.4) (P = NR) 

Diff between group (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 1.3 (1.3) (P = NR) 

G2: 2.1 (1.5) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 1.4 (1.5) (P = NR) 

G2: 1.8 (1.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE – Wt Concerns, mean (SD): 

G1: 3.2 (1.4) 

G2: 3.2 (1.5) 

(P = NS)

EDE – Wt Concerns, mean (SD): 

End of tx: 

G1: 1.8 (1.2) (P = NR) 

G2: 1.9 (1.4) (P = NR) 

Diff between group (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 1.7 (1.2) (P = NR) 

G2: 2.0 (1.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 1.8 (1.3) (P = NR) 

G2: 1.9 (1.3) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 2000 

(continued) 

EDE – Shape Concerns, mean (SD): 

G1: 3.5 (1.2) 

G2: 3.5 (1.4) 

(P = NS) 

EDE – Shape Concerns, mean (SD): 

End of tx: 

G1: 2.1 (1.3) (P = NR) 

G2: 2.1 (1.4) (P = NR) 

Diff between group (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 1.8 (1.2) (P = NR) 

G2: 2.1 (1.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 1.9 (1.4) (P = NR) 

G2: 2.0 (1.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-381 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-382 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE – Eating Concerns, mean (SD): 

G1: 2.2 (1.3) 

G2: 2.6 (1.3) 

(P = NS) 

EDE – Eating Concerns, mean (SD): 

End of tx: 

G1: 0.7 (0.8) (P = NR) 

G2: 1.1 (1.1) (P = NR) 

Diff between group (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 0.6 (0.9) (P = NR) 

G2: 1.0 (1.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 0.8 (1.2) (P = NR) 

G2: 0.9 (1.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE – Global Score, mean (SD): 

G1: 3.0 (0.9) 

G2: 3.1 (0.9) 

(P = NS)

EDE – Global Score, mean (SD): 

End of tx: 

G1: 1.4 (0.9) (P = NR) 

G2: 1.8 (1.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

4-mo FU: 

G1: 1.3 (0.9) (P = NR) 

G2: 1.8 (1.1) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

8- and 12-mo FU: 

G1: 1.4 (1.1) (P = NR) 

G2: 1.6 (1.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 2000 

(continued) 

Reduction of Binge Eating by end-of-tx: 

G1: 86% 

G2: 51% 

Diff between groups (P = 0.01) 

G1 better than G2 

Reduction of Purging by end-of-tx: 

G1: 84% 

G2: 50% 

Diff between groups (P = 0.001) 

G1 better than G2 
C-383 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-384 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

Companion article: 

Carter et al., 2003 and 

Bulik, Sullivan, Joyce et 

al., 1998 

Setting: 

Outpatient, 

Christchurch, New 

Zealand 

Enrollment period: 

NR 

Research objective: 

• To determine whether 

addition of ERP to a core 

of CBT leads to greater 

clinical improvement and 

lower risk of relapse. 

• To compare efficacy of 2 

forms of ERP (ERP to 

pre-binge cues and ERP

to pre-purge cures). 

• To determine whether 

ERP assists with 

preventing relapse. 

Groups: 

G1: exposure to pre-binge 

cues (B-ERP) (N = 37) 

G2: exposure to pre-purge 

cues (P-ERP) (N = 35) 

G3: relaxation training 

(RELAX) (N = 39) 

Enrollment: 

• 135 began CBT tx 

• 116 completed CBT 

• 111 randomized to one of 

the study arms 

• 106 completed 

• 95 completed 6 mo FU 

(86% of those 

randomized) 

• 105 completed 12 mo FU 

(95% of those 

randomized) 

Drop-outs: 

G1: 2 

G2: 2 

G3: 1 

Age, yrs, mean (SD): 

26.1 (6.1) 

Sex: 

Female: 100% 

BMI, kg/m2

, mean (SD): 

22.4 (2.5) 

Race/ethnicity: 

White: 91% 

Maori, Pacific Island, and 

Asian: 6%

Duration of BN, yrs (SD): 

6.7 (5.8) 

Prior BN or Psych 

Treatment: 

73.6% 

Lifetime comorbidity: 

Mood: 70.4% 

Anxiety: 61.5% 

Alcohol use disorders: 48.1%

AN: 25.0% 

Marital Status: 

Never married or “de facto 

relationship”: 62.2% 

Currently employed: 

59.3% 

Education, yrs, mean (SD): 

13.1 (2.6) 
C-385 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; age 17-45; 

current primary DSM 

III-R dx of BN 

Exclusion: 

Current AN, current 

obesity (BMI>30 

kg/m2

), current severe 

major depression with 

severe suicidal 

ideation or requiring 

immediate tx with 

antidepressants, 

current severe medical 

illness or severe 

medical complications 

of BN, or the current 

use of psychoactive 

meds and 

unwillingness to 

undergo a supervised 

drug wash-out period. 

All individuals received 8 sessions of 

CBT (2 first wk, then wkly) based on 

manuals. 

Randomized groups: 

2 wks of sessions twice per wk, then 

4 wkly sessions; at least 2 

performed outside office; min of 50 

minutes but lasted until arousal 

approached baseline (50 m – 3 h). 

G1: B-ERP 

G2: P-ERP 

G3: (RELAX) 

Binge and purge 

outcomes: logistic 

regression controlling 

for mid-tx measure 

(end of CBT). 

Clinician rated food 

restriction and body 

dissatisfaction 

outcomes: ordinal 

logistic regression. 

Continuous outcomes: 

ANCOVA with main 

effects of 

experimental tx, 

relevant measures at 

end of CBT as 

covariates. 

All analyses compare 

B-ERP and P-ERP to 

RELAX (reference 

category). 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Post-tx assessor was blinded 

to tx 

Adverse events: 

NR 

Funding: 

New Zealand Health Research 

Council and New Zealand 

Lottery Grants Board 
C-386 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

Abstinence, prior 2 wks: 

Baseline: 

All groups 0% 

Mid-tx: 

G1: 38% 

G2: 23% 

G3: 21% 

(P = NS) 

Abstinence, prior 2 wks: 

Post-tx: 

G1: 66% (P = NR) 

G2: 45% (P = NR) 

G3: 47% (P = NR) 

6 mo FU: 

G1: 53% (P = NR) 

G2: 43% (P = NR) 

G3: 51% P = NR) 

12 mo FU: 

G1: 65% (P = NR) 

G2: 44% (P = NR) 

G3: 43% (P = NR) 

Abstinence (Clinician Rated), Odds ratio 

[95% CI] vs. G3: 

Post-tx: 

G1: OR = 2.15 [0.65, 7.08] (P = NS) 

G2: OR = 0.89 [0.28, 2.80] (P = NS) 

6 mo FU: 

G1: OR = 0.95 [0.34, 2.67] (P = NS) 

G2: OR = 0.67 [0.23, 1.98] (P = NS) 

12 mo FU: 

G1: OR = 2.59 [0.85, 7.92] (P = NS) 

G2: OR = 1.11 [0.38, 3.25] (P = NS) 
C-387 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS, mean (SD): 

Baseline: 

G1: 7.9 (5.5) 

G2: 7.7 (5.4) 

G3: 10.1 (5.3) 

Mid-tx: 

G1: 4.4 (4.3) (P = NR) 

G2: 5.7 (5.7) (P = NR) 

G3: 7.5 (5.6) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

HDRS, mean (SD): 

Post-tx: 

G1: 2.6 (3.1) (P = NR) 

G2: 4.9 (6.0) (P = NR) 

G3: 6.7 (6.0) (P = NR) 

6 mo FU: 

G1: 3.1 (3.1) (P = NR) 

G2: 6.4 (6.5) (P = NR) 

G3: 5.8 (5.1) (P = NR) 

12 mo FU: 

G1: 3.2 (3.0) (P = NR) 

G2: 5.2 (5.5) (P = NR) 

G3: 6.8 (7.6) (P = NR) 

HDRS (Clinician Rated), 

Regression coefficient [95% 

CI] vs. G3: 

Post tx: 

G1: -1.35 [-2.46, -0.25] 

(P = 0.02) 

G1 better than G3 

G2: -0.55 [-1.66, 0.56] (P = NS) 

6 mo FU: 

G1: -1.41 [-3.51, 0.69] (P = NS) 

G2: 1.36 [-1.04, 3.75] (P = NS) 

12 mo FU: 

G1: -2.10 [-4.81, 0.62] (P = NS) 

G2: -1.09 [-3.70, 1.51] (P = NS) 
C-388 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Bingeing absent prior 2 wks: 

Baseline: 

All groups 0% 

Mid-tx: 

G1: 51% 

G2: 34% 

G3: 36% 

(P = NS) 

Bingeing absent prior 2 wks: 

Post-tx: 

G1: 66% (P = NR) 

G2: 61% (P = NR) 

G3: 58% (P = NR) 

6 mo FU: 

G1: 6253% (P = NR) 

G2: 61% (P = NR) 

G3: 69% P = NR) 

12 mo FU: 

G1: 68% (P = NR) 

G2: 56% (P = NR) 

G3: 57% (P = NR) 

Bingeing absent (Clinician Rated), Odds ratio 

[95% CI] vs. G3: Post-tx: 

G1: OR = 1.36 [0.44, 4.22] (P = NS) 

G2: OR = 1.50 [0.49, 4.64] (P = NS) 

6 mo FU: 

G1: OR = 0.72 [0.24, 2.19] (P = NS) 

G2: OR = 0.80 [0.25, 2.53] (P = NS) 

12 mo FU: 

G1: OR = 1.64 [0.56, 4.76] (P = NS) 

G2: OR = 1.09 [0.39, 3.03] (P = NS) 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

Binges/2 wks, mean (SD): 

Baseline: 

G1: 11.7 (10.5) 

G2: 9.3 (11.4) 

G3: 8.6 (9.1) 

Mid-tx: 

G1: 2.6 (4.3) (P = NR) 

G2: 2.7 (3.5) (P = NR) 

G3: 2.3 (3.2) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Binges/2 wks, mean (SD): 

Post-tx: 

G1: 1.3 (2.4) (P = NR) 

G2: 1.8 (4.1) (P = NR) 

G3: 1.8 (3.1) (P = NR) 

6 mo FU: 

G1: 1.1 (2.6) (P = NR) 

G2: 3.0 (6.4) (P = NR) 

G3: 1.2 (2.7) (P = NR) 

12 mo FU: 

G1: 1.7 (3.5) (P = NR) 

G2: 2.1 (4.4) (P = NR) 

G3: 1.6 (2.4) (P = NR) 
C-389 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

GAFS, mean (SD): 

Baseline: 

G1: 56.2 (6.4) 

G2: 55.8 (6.7) 

G3: 55.3 (6.8) 

Mid-tx: 

G1: 65.4 (8.4) (P = NR) 

G2: 65.0 (8.2) (P = NR) 

G3: 62.2 (9.9) (P = NR)

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

GAFS, mean (SD): 

Post-tx: 

G1: 72.6 (9.7) (P = NR) 

G2: 69.0 (10.0) (P = NR) 

G3: 67.8 (10.1) (P = NR) 

6 mo FU: 

G1: 72.0 (9.2) (P = NR) 

G2: 67.3 (10.6) (P = NR) 

G3: 67.0 (11.2) (P = NR) 

12 mo FU: 

G1: 73.6 (11.1) (P = NR) 

G2: 67.6 (12.1) (P = NR) 

G3: 65.3 (12.7) (P = NR) 

GAFS (Clinician Rated), 

Regression coefficient [95% 

CI] vs. G3: 

Post tx: 

G1: 1.54 [-0.41, 3.50] 

(P = NS) 

G2: -0.12; CI: [-2.10, 1.87] 

(P = NS) 

6 mo FU: 

G1: 3.49 [-1.05, 8.02] 

(P = NS) 

G2: 0.02 [-4.66, 4.70] 

(P = NS) 

12 mo FU: 

G1: 5.34 [0.16, 10.5] 

(P = 0.05) G1 better than G3 

G2: 1.17 [-3.83, 6.17] 

(P = NS) 

 
C-390 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Purging absent prior 2 wks: 

Baseline: 

All groups 0% 

Mid-tx: 

G1: 46% (P = NR) 

G2: 31% (P = NR) 

G3: 28% (P = NR) 

Diff between groups (P = NS) 

Purging absent prior 2 wks: 

Post-tx: 

G1: 69% (P = NR) 

G2: 55% (P = NR) 

G3: 50% (P = NR) 

6 mo FU: 

G1: 56% (P = NR) 

G2: 50% (P = NR) 

G3: 57% (P = NR) 

12 mo FU: 

G1: 68% (P = NR) 

G2: 47% (P = NR) 

G3: 46% (P = NR) 

Purging absent (Clinician Rated), Odds ratio 

[95% CI] vs. G3: 

Post-tx: 

G1: OR = 2.11 [0.64, 6.94] (P = NS) 

G2: OR = 1.10; [0.35, 3.42] (P = NS) 

6 mo FU: 

G1: OR = 0.73 [0.25, 2.09] (P = NS) 

G2: OR = 0.61 [0.21, 1.83] (P = NS) 

12 mo FU: 

G1: OR = 2.13 [0.72, 6.27] (P = NS) 

G2: OR = 0.94 [0.33, 2.61] (P = NS) 

Total purges per 2 wks, mean (SD): 

Baseline: 

G1: 14.4 (11.3) 

G2: 11.0 (13.3) 

G3: 12.4 (11.8) 

Mid-tx: 

G1: 3.9 (6.0) (P = NR) 

G2: 3.5 (4.6) (P = NR) 

G3: 7.0 (13.3) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Total purges per 2 wks, mean (SD): 

Post-tx: 

G1: 2.0 (4.5) (P = NR) 

G2: 2.8 (5.2) (P = NR) 

G3: 5.6 (10.9) (P = NR) 

6 mo FU: 

G1: 1.5 (2.8) (P = NR) 

G2: 3.8 (6.2) (P = NR) 

G3: 5.3 (10.5) (P = NR) 

12 mo FU: 

G1: 3.2 (8.2) (P = NR) 

G2: 3.2 (5.0) (P = NR) 

G3: 5.6 (12.1) (P = NR)

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

Vomiting episodes/2 wks, mean (SD): 

Baseline: 

G1: 12.3 (10.9) 

G2: 10.0 (13.4) 

G3: 10.3 (10.8) 

Mid-tx: 

G1: 3.4 (5.3) (P = NR) 

G2: 3.4 (4.7) (P = NR) 

G3: 5.5 (11.8) (P = NR) 

Diff over time (P = NR) 

Vomiting episodes/2 wks, mean (SD): 

Post-tx:

G1: 1.9 (4.5) (P = NR) 

G2: 2.4 (4.6) (P = NR) 

G3: 4.4 (9.8) (P = NR) 

6 mo FU: 

G1: 1.5 (2.8) (P = NR) 

G2: 3.7 (6.2) (P = NR) 

G3: 3.7 (8.6) (P = NR) 

12 mo FU: 

G1: 3.1 (8.2) (P = NR) 

G2: 3.0 (4.9) (P = NR) 

G3: 4.5 (11.7) (P = NR) 
C-391 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-392 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Laxative use episodes/2 wks, mean (SD): 

Baseline: 

G1: 2.1 (5.3) 

G2: 1.0 (2.9) 

G3: 2.1 (4.4) 

Mid-tx: 

G1: 0.5 (1.5) (P = NR) 

G2: 0.1 (0.4) (P = NR) 

G3: 1.5 (5.1) (P = NR) 

Diff between groups (P = NS) 

Laxative use episodes/2 wks, mean (SD): 

Post-tx:

G1: 0.1 (0.5) (P = NR) 

G2: 0.5 (2.4) (P = NR) 

G3: 1.2 (3.7) (P = NR) 

6 mo FU: 

G1: 0.0 (0.0) (P = NR) 

G2: 0.1 (0.3) (P = NR) 

G3: 1.7 (5.4) (P = NR) 

12 mo FU: 

G1: 0.2 (0.6) (P = NR) 

G2: 0.3 (1.0) (P = NR) 

G3: 1.1 (3.4) (P = NR) 

Peak Subjective Units of Distress (CUE), 

regression coefficient [95% CI] vs. G3: 

Post-tx: 

G1: -0.30 [-0.47, -0.12] (P = 0.001) 

G1 better than G3 

G2: -0.11 [-0.29, 0.07] (P = NS) 

Peak Urge To Binge (CUE), regression 

coefficient [95% CI] vs. G3: 

Post-tx: 

G1: -0.20 [-0.40, 0.005] (P = NS) 

G2: -0.17 [-0.38, 0.00] (P = NS) 

Peak Urge To Purge (CUE), regression 

coefficient [95% CI] vs. G3: 

Post-tx: 

G1: -0.18 [-0.39, 0.04] (P = NS) 

G2: 0.05 [-0.17, 0.27] (P = NS) 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

Food restriction (Clinician Rated), Odd ratio 

[95% CI] vs. G3: 

Post-tx: 

G1: OR = 0.39 [0.16, 1.01] (P = 0.05) 

G1 better than G3 

G2: OR = 1.00 [0.41, 2.47] (P = NS) 

6 mo FU: 

G1: OR = 1.11 [0.44, 2.83] (P = NS) 

G2: OR = 1.54 [0.58, 4.10] (P = NS) 

12 mo FU: 

G1: OR = 0.30 [0.12, 0.80] (P = 0.02) 

G1 better than G3 

G2: OR = 0.44 [0.17, 1.10] (P = NS) 
C-393 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-394 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

EDI drive for thinness, mean (SD): 

Baseline: 

G1: 14.4 (4.7) 

G2: 14.3 (5.0) 

G3: 13.4 (4.7) 

Mid-tx: 

G1: 9.3 (6.0) (P = NR) 

G2: 8.5 (5.2) (P = NR) 

G3: 9.4 (6.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

EDI drive for thinness, mean (SD): 

Post-tx: 

G1: 5.6 (5.7) (P = NR) 

G2: 6.6 (5.6) (P = NR) 

G3: 7.8 (6.6) (P = NR) 

6 mo FU: 

G1: 4.4 (5.1) (P = NR) 

G2: 6.8 (5.4) (P = NR) 

G3: 5.3 (6.2) (P = NR) 

12 mo FU: 

G1: 7.1 (6.1) (P = NR) 

G2: 5.5 (5.9) (P = NR) 

G3: 6.6 (5.9) (P = NR) 

EDI drive thinness, regression coefficient 

[95% CI] vs. G3: 

Post-tx: 

G1: -1.40 [-2.52, -0.28] (P = 0.01) 

G1 better than G3 

G2: -0.38 [-1.49, 0.73] (P = NS) 

6 mo FU: 

G1: -0.86 [ -3.37, 1.64] (P = NS) 

G2: 1.89 [-0.73, 4.51] (P = NS) 

12 mo FU 

G1: -0.43 [-3.68, 2.82] (P = NS) 

G2: 0.04 [-3.06, 3.15] (P = NS) 
C-395 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-396 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

EDI bulimia, mean (SD): 

Baseline: 

G1: 9.5 (4.1) 

G2: 8.7 (5.5) 

G3: 10.1 (4.3) 

Mid-tx: 

G1: 3.2 (4.3) (P = NR) 

G2: 3.8 (3.8) (P = NR) 

G3: 4.4 (4.5) (P = NR) 

Diff over time (P = NR) 

EDI bulimia, mean (SD): 

Post-tx: 

G1: 1.5 (3.0) (P = NR) 

G2: 1.6 (2.9) (P = NR) 

G3: 3.3 (3.5) (P = NR) 

6 mo FU: 

G1: 1.0 (1.8) (P = NR) 

G2: 1.8 (3.6) (P = NR) 

G3: 1.7 (3.0) (P = NR) 

12 mo FU: 

G1: 2.6 (4.6) (P = NR) 

G2: 3.1 (4.9) (P = NR) 

G3: 3.1 (4.9) (P = NR) 

EDI bulimia, regression coefficient [95% CI] 

vs. G3: 

Post-tx: 

G1: -0.60 [-1.23, 0.02] (P = 0.06) 

G1 better than G3 

G2: -0.77 [-1.38, -0.16] (P = 0.01) 

G2 better than G3 

6 mo FU: 

G1: -0.32 [-1.69, 1.06] (P = NS) 

G2: -0.07 [-1.50, 1.36] (P = NS) 

12 mo FU: 

G1: -0.71 [-3.54, 2.11] (P = NS) 

G2: 0.44 [-2.25, 3.13] (P = NS) 
C-397 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-398 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Carter 

et al., 1998 

(continued) 

EDI body dissatisfaction, mean (SD): 

Baseline: 

G1: 18.9 (7.3) 

G2: 18.0 (7.4) 

G3: 18.0 (8.0) 

Mid-tx: 

G1: 13.3 (8.1) (P = NR) 

G2: 13.4 (7.7) (P = NR) 

G3: 15.0 (8.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

EDI body dissatisfaction, mean (SD): 

Post-tx: 

G1: 10.8 (8.9) (P = NR) 

G2: 12.1 (8.2) (P = NR) 

G3: 12.3 (7.8) (P = NR) 

6 mo FU: 

G1: 8.0 (8.3) (P = NR) 

G2: 13.4 (8.8) (P = NR) 

G3: 10.6 (7.6) (P = NR) 

12 mo FU: 

G1: 12.2 (8.4) (P = NR) 

G2: 11.3 (9.3) (P = NR) 

G3: 13.3 (9.2) (P = NR) 

EDI body dissatisfaction, regression 

coefficient [95% CI] vs. G3: 

Post-tx: 

G1: -0.44 [-1.70, 0.82] (P = NS) 

G2: 0.71 [-0.54, 1.96] (P = NS) 

6 mo FU: 

G1: -0.29 [-3.58, 3.00] (P = NS) 

G2: 3.96 [0.54, 7.37] (P = 0.03) 

G1 better than G3 

12 mo FU: 

G1: 0.93 [-2.93, 4.79] (P = NS) 

G2: 0.79 [CI: -2.89, 4.46] (P = NS) 

Body dissatisfaction (Clinician Rated), Odd 

ratio [95% CI] vs. G3: 

Post-tx: 

G1: OR = 0.32 [0.13, 0.83] (P = 0.02) 

G1 better than G3 

G2: OR = 1.46 [0.58, 3.72] (P = NS) 

6 mo FU: 

G1: OR = 1.04 [0.42, 2.54] (P = NS) 

G2: OR = 1.16 [0.44, 3.01] (P = NS) 

12 mo FU: 

G1: 0.74 [0.30, 1.84] (P = NS) 

G2: 0.45 [0.18, 1.13] (P = NS) 
C-399 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-400 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Bulik, Sullivan, Joyce et 

al., 1998 

Companion article: 

Bulik, Sullivan, Carter 

et al.,1998 and Carter 

et al., 2003 

Setting: 

University of 

Canterbury, New 

Zealand 

Enrollment period: 

NR 

To examine predictors of 

outcome from BN 1 yr after 

completion of CBT by 

partitioning predictors 

temporally into lifetime 

(including personality), PreTx, 

and posttx categories. 

Groups: 

G1: exposure to pre-binge 

cues (B-ERP) (N = 37) 

G2: exposure to pre-purge 

cues (P-ERP) (N = 35) 

G3: relaxation training 

(RELAX) (N = 39) 

Enrollment: 

Enrolled (N = 135) 

Randomized (N = 111) 

Completed tx (N = 106) 

Completed 12-mo FU (N = 

101) 

Age, yrs, mean (SD): 

26.5 (6.13) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 91% 

Maori, Pacific Island, and 

Asian: 6%

Duration of BN, yrs, mean 

(SD): 

6.7 (5.8) 

Lifetime comorbidity: 

Mood: 70.4% 

Anxiety: 61.5% 

Alcohol use disorders: 48.1%

AN: 25.0% 

Marital Status: 

Never married or “de facto 

relationship”: 62.2% 

Currently employed: 

59.3% 

Education, yrs, mean (SD): 

13.1 (2.6) 
C-401 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, age: 17 to 45 

yrs, primary DSM III-R 

dx of BN 

Exclusion: 

Current AN; current 

obesity (BMI > 30); 

current severe major 

depression, medical 

illness, or medical 

complications of BN; 

current use of 

psychoactive meds; 

unwilling to undergo a 

supervised drug washout period. 

8 sessions of CBT (2 first wk, then 

wkly) based on manuals. 

Randomized groups: 

2 wks of sessions twice per wk, 

then 4 wkly sessions; at least 2 

performed outside office; sessions 

lasted until arousal approached 

baseline (min, 50 min, max, 3 

hours). 

G1: B-ERP 

G2: P-ERP 

G3: RELAX 

FU interview inquired about 2 wk 

episodes throughout the 6 mos. 

The mean frequency of bingeing 

and purging per episode in the 3 

mos before the 1 yr FU was 

calculated. 

Univariate logistic 

regression, stepwise 

logistic regression 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Post-tx assessor was blinded, 

however FU assessor blinding 

is NR. 

Adverse events: 

NR 

Funding: 

Original study: New Zealand 

Health Research Council and 

New Zealand Lottery Grants 

Board 
C-402 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Joyce 

et al., 1998 

(continued) 

Met DSM III-R criteria for BN in the mo before 1 yr FU: 

17% 

Bingeing and Purging Episodes, past 3 mos: 

Category 1 (none): 38% 

Category 2 (not more than 2/wk on avg): 45% 

Category 3 (2 or more/wk on avg): 16% 

Reported additional tx between end of tx and 1 yr FU: 

Category 1: 2.6% 

Category 2: 6.7% 

Category 3: 37.5% 

Diff between groups (P = 0.002) 

Poor outcome at 1 yr FU (Predicted by lifetime hx and 

personality), odds ratio [95% CI]: 

G1: 0.32 [0.12 – 0.91]

G2: NR

G3: NR 

Predicting 1 Yr Outcome with demographics, lifetime hx, and 

personality: 

Univariate Model, predictor, mean (SD) or %, odds ratio [95% 

CI]: 

Self-directedness: 24.6 (8.20), 0.94 [0.89 – 0.98] (P < 0.05), 

higher self-directedness predicts better outcome. 

Age, yrs: 26.5 (6.13), 0.97 [0.91 – 1.03] (P = NS) 

BMI min: 18.6 (2.46), 0.95 [0.81 – 1.10] (P = NS) 

Hx of obesity: 8.8%, 2.60 [0.71 – 9.56] (P = NS) 

Prior inpatient tx: 9.9%, 0.04 [0.80 – 3.57] (P = NS) 

Duration of BN, yrs: 6.82 (6.07), 0.96 [0.91 – 1.03] (P = NS) 

Lifetime AN: 24.3%, 1.09 [0.46 – 2.60] (P = NS) 

Lifetime major depression: 52.5%, 1.15 [0.55 – 2.41] (P = NS) 

Lifetime alcohol dependence: 42.6%, 0.81 [0.38 – 1.72] (P = NS) 

Lifetime anxiety disorder: 43.6%, 1.21 [0.57 – 2.56] (P = NS) 

Novelty seeking: 21.6 (6.33), 1.00 [0.94 – 1.06] (P = NS) 

Harm avoidance: 20.7 (6.89), 1.03 [0.98 – 1.09] (P = NS) 

Reward dependence: 15.8 (4.36), 1.03 [0.95 – 1.12] (P = NS) 

Persistence: 4.82 (1.98), 1.06 [0.88 – 1.29] (P = NS) 

Cooperativeness: 34.1 (5.77), 1.01 [0.95 – 1.06] (P = NS) 

Self-transcendence: 11.1 (5.66), 1.00 [0.94 – 1.07] (P = NS) 

Total cluster A personality symptoms: 4.12 (3.45), 

1.02 [0.91 – 1.14] (P = NS) 

Total cluster B symptoms: 7.35 (4.96), 1.07 [0.99 – 1.16] (P = NS) 

Total cluster C symptoms: 6.36 (4.64), 1.02 [0.94 – 1.10] (P = NS)

Borderline personality disorder: NR, 1.29 [0.55 – 3.04] (P = NS) 

Stepwise Model, predictor, odds ratio [95% CI]: 

Hx of Obesity: 7.88 [1.42 – 43.64] (P < 0.05), hx of obesity 

increased odds of poor outcome 

Lifetime hx of alcohol dependence: 0.26 [0.12 – 0.68] (P < 0.05), 

hx of alcohol dependence decreased odds of poor outcome 

Self-directedness: 0.92 [0.87 – 0.98] (P < 0.05), increased selfdirectedness decreased the odds of poor outcome 
C-403 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-404 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Joyce 

et al., 1998 

(continued) 

Predicting 1 Yr Outcome with Pre-tx Status: 

Univariate model, predictor, mean (SD) or %, odds ratio [95% CI]: 

GAFS: 55.6 (6.66), 0.91[0.86 – 0.97] (P < 0.05), lower GAFS predicted 

poorer outcome 

EDI, bulimia: 9.61 (4.78), 1.15 [1.05 – 1.25] (P < 0.05), higher EDI 

bulimia scores predicted poorer outcome 

Major depression, past mo: 23%, 3.54 [1.39 – 9.01] (P < 0.05) 

Greater current major depression predicted poorer outcome 

Binges past 2 wks: 10.6 (11.5), 1.03 [0.99 – 1.06] (P = NS) 

Total purges per 2-wk period: 14.7 (20.8), 1.03 [1.00 – 1.06] (P = NS) 

Food restriction (quartiles: 3 = 24%; 2 = 29%; 1 = 33%; 0 = 14%): 1.29 

[0.88 – 1.88] (P = NS) 

Body dissatisfaction (quartiles: 3 = 37%; 2 = 35%; 1 = 24%; 0 = 4%): 

0.97 [0.64 – 1.49] (P = NS) 

HDRS: 8.75 (5.39), 1.07 [0.99 – 1.15] (P = NS) 

EDI drive for thinness: 14.3 (4.64), 1.09 [1.00 – 1.19] (P = NS) 

EDI body dissatisfaction: 18.9 (7.50), 1.03 [0.98 – 1.08] (P = NS) 

Peak SUDS: 1.67 (0.83), 1.45 [0.68 – 3.12] (P = NS) 

Peak urge to binge: 2.44 (0.50), 1.68 [1.05 – 2.69] (P = NS) 

Peak urge to purge: 2.04 (0.95), 1.34 [0.89 – 1.98] (P = NS) 

Alcohol dependence, past mo: 16%, 1.16 [0.42 – 3.18] (P = NS) 

Stepwise model, predictor, odds ratio [95% CI]: 

GAFS: 0.93 [0.86 – 0.99] (P < 0.05), increased GAFS increased odds 

of a good outcome 

EDI bulimia: 1.16 [1.06 – 1.27] (P < 0.05), increased EDI bulimia scale 

increased the odds of poor outcome 

Major depression, past mo: 2.80 [1.04 – 7.52] (P < 0.05), presence of 

major depression at PreTx increased the odds of poor outcome Body 

dissatisfaction (quartiles): 0.67 [0.41 – 1.08] (P = NS) 
C-405 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-406 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Bulik, Sullivan, Joyce 

et al., 1998 

(continued) 

Predicting 1 Yr Outcome with Post-tx Status: 

Univariate model, predictor, mean (SD) or %, odds ratio [95% CI]: 

Binges past 2 wks: 1.58 (3.24), 1.30 [1.11 – 1.51] (P < 0.05), higher 

binge frequency predicted poorer outcome. 

Food restriction (quartiles: 3 = 5%; 2 = 15%; 1 = 34%; 0 = 46%): 2.45 

[1.51 – 3.96] (P < 0.05) 

Greater food restriction predicted poorer outcome 

Body dissatisfaction (quartiles: 3 = 11%; 2 = 24%; 1 = 52%; 0 = 13%): 

3.25 [1.89 – 5.58] (P < 0.05) 

Greater body dissatisfaction predicted poorer outcome 

GAFS: 69.6 (9.85), 0.90 [0.86 – 0.95] (P < 0.05), lower GAFS predicted 

poorer outcome 

HDRS: 5.15 (5.64), 1.11 [1.04 – 1.20] (P < 0.05), higher HDRS 

predicted poorer outcome 

EDI drive for thinness: 6.69 (6.08), 1.15 [1.07 – 1.24] (P < 0.05), higher 

EDI drive for thinness predicted poorer outcome 

EDI bulimia: 2.23 (3.26), 1.23[1.09 – 1.40] (P < 0.05), higher EDI 

bulimia scores predicted poorer outcome 

Peak SUDS: 1.68 (0.83), 1.79 [1.09 – 2.94] (P < 0.05), higher peak 

SUDS predicted poorer outcome 

Peak urge to binge: 0.79 (0.92), 2.11 [1.34– 3.34] (P < 0.05), higher 

peak urge to binge predicted poorer outcome 

Peak urge to purge: 0.80 (0.98), 2.81 [1.76 – 4.47] (P < 0.05), higher 

peak urge to purge predicted poorer outcome 

EDI body dissatisfaction: 11.9 (8.22), 1.05 [1.00 – 1.10] (P = NS) 

Total purges per 2-wk period: 3.67 (8.03), 1.10 [1.03 – 1.18] (P = NS) 

Stepwise model, odds ratio [95% CI]: 

Binges past 2 wks: 1.23 [1.06 – 1.42] (P < 0.05), higher binge 

frequency predicted poorer outcome 

Food restriction (quartiles): 2.35 [1.38 – 4.01] (P < 0.05) 

Greater food restriction predicted poorer outcome 

Peak urge to binge: 2.06 [1.24 – 3.43] (P < 0.05) 

Greater urge to binge predicted poorer outcome 
C-407 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-408 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Carter et al., 2003 

Companion article: 

Bulik, Sullivan, Carter 

et al., 1998 and Bulik, 

Sullivan, Joyce et al., 

1998 

Setting: 

Outpatient, 

Christchurch, New 

Zealand 

Enrollment period: 

NR 

To evaluate 3-yr outcome of 

an RCT that compared the 

additive efficacy of exposure 

based behavioral txs versus 

non-exposure based 

behavioral txs with a core of 

CBT. 

Groups: 

G1: exposure to pre-binge 

cues (B-ERP) (N = 37) 

G2: exposure to pre-purge 

cues (P-ERP) (N = 35) 

G3: relaxation training 

(RELAX) (N = 39) 

Enrollment: 

Completed 3 yr FU (N = 113) 

• G1: Completed B-ERP and 

3 yr FU (N = 23) 

• G2: Completed P-ERP and 

3 yr FU (N = 27) 

• G3: Completed RELAX 

and 3 yr FU (N = 30) 

• G4: Completed CBT and 

BT interventions and 3 yr 

FU (N = 92) 

• G5: Completed CBT and 3 

yr FU but not BT (N = 15) 

• G6: Completed 3 yr FU but 

not CBT or BT (N = 6) 

Age, yrs, mean (SD): 

26.1 (6.1) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 91% 

Maori, Pacific Island 

Asian: 6% 
C-409 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; age 17-45; 

current primary DSM 

III-R dx of BN 

Exclusion: 

Current AN, current 

obesity (BMI>30 

kg/m2

), current severe 

major depression with 

severe suicidal 

ideation or requiring 

immediate tx with 

antidepressants, 

current severe medical 

illness or severe 

medical complications 

of BN, or the current 

use of psychoactive 

meds and 

unwillingness to 

undergo a supervised 

drug wash-out period. 

8 sessions of CBT (2 first wk, then 

wkly) based on manuals. 

Randomized groups: 

2 wks of sessions twice per wk, then 

4 wkly sessions; at least 2 

performed outside office; min of 50 

minutes but lasted until arousal 

approached baseline (50 minutes– 3 

h). 

G1: B-ERP 

G2: P-ERP 

G3: (RELAX) 

Non-parametric 

(Kruskal-Wallis) 

ANOVA to evaluate 

outcomes in groups 

defined by tx 

completion (G4, G5, 

G6). Chi-square tests 

to compare eatingrelated dx at FU in G4 

vs. G5 vs. G6. 

Separate series of 

repeated measures 

ANOVAs to evaluate 

outcomes in groups 

that completed CBT 

and BT (series 1: G1 

vs. G3; series 2: G2 

vs. G3). 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Assessor, at post-tx only. 

Adverse events: 

NA 

Funding: 

Health Research Council of 

New Zealand and the New 

Zealand Lottery Grants Board 
C-410 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge frequency, past 2 wks, median 

(range): 

NR 

Binge frequency, past 2 wks, median (range): 

Post-tx: 

G1: 0.0 (0.0 – 10.0) (P = NR) 

G2: 0.0 (0.0 – 20.0) (P = NR) 

G3: 0.0 (0.0 – 12.0) (P = NR) 

3 Yr FU: 

G1: 0.0 (0.0 – 20.0) (P = NR) 

G2: 0.0 (0.0 – 12.0) (P = NR) 

G3: 0.0 (0.0 – 28.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 0.0 (0.0 – 28.0) (P = NR) 

G5: 0.0 (0.0 – 4.0) (P = NR) 

G6: 5.5 (1.0 – 30.0) (P = NR) 

Diff between groups (P < 0.05) 

G1 and G2 better than G6 

Vomiting frequency, past 2 wks, 

median (range): 

NR 

Vomit frequency, past 2 wks, median (range): 

Post-tx: 

G1: 0.0 (0.0 – 10.0) (P = NR) 

G2: 0.0 (0.0 – 20.0) (P = NR) 

G3: 0.0 (0.0 – 12.0) (P = NR) 

3 Yr FU: 

G1: 0.0 (0.0 – 20.0) (P = NR) 

G2: 0.0 (0.0 – 12.0) (P = NR) 

G3: 0.0 (0.0 – 42.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 0.0 (0.0 – 42.0) (P = NR) 

G5: 0.0 (0.0 – 6.0) (P = NR) 

G6: 5.5 (1.0 – 30.0) (P = NR) 

Diff between groups (P < 0.05) 

G4 and G5 better than G6 

Author, Yr: 

Carter et al., 2003 

(continued) 

Purge frequency, past 2 wks, median 

(range): 

NR 

Purge frequency, past 2 wks, median (range): 

Post-tx: 

G1: 0.0 (0.0 – 10.0) (P = NR) 

G2: 0.0 (0.0 – 20.0) (P = NR) 

G3: 0.0 (0.0 – 25.0) (P = NR) 

3 Yr FU: 

G1: 0.0 (0.0 – 20.0) (P = NR) 

G2: 0.0 (0.0 – 12.0) (P = NR) 

G3: 0.0 (0.0 – 42.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 0.0 (0.0 – 42.0) (P = NR) 

G5: 0.0 (0.0 – 6.0) (P = NR) 

G6: 5.5 (1.0 – 35.0) (P = NR) 

Diff between groups (P < 0.05) 

G4 and G5 better than G6
C-411 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HRDS, median (range): 

NR 

HDRS, median (range): 

Post-tx: 

G1: 2.0 (0.0 –14.0) (P = NR) 

G2: 3.0 (0.0 – 24.0) (P = NR) 

G3: 7.0 (0.0 – 19.0) (P = NR) 

3 Yr FU: 

G1: 2.0 (0.0 – 19.0) (P = NR) 

G2: 6.0 (0.0 – 23.0) (P = NR) 

G3: 4.0 (0.0 – 18.0) (P = NR) 

Diff between groups (P = 0.008)

G1 better than G3 

Diff between groups in change 

over time (P = 0.02) 

G3 better than G1 (G1 benefit 

at post-tx not maintained at FU)

Diff between groups in change 

over time (P = 0.03), 

G3 better than G2 (G2 NS 

advantage at post-tx and G3 

NS advantage at FU) 

G4: 3.5 (0.0 – 23.0) (P = NR) 

G5: 4.0 (0.0 – 31.0) (P = NR) 

G6: 7.0 (0.0 – 20.0) (P = NR) 

Diff between groups (P = NS) 

 

GAF, median (range): 

NR 

GAF median (range): 

Post-tx: 

G1: 75.0 (51.0-88.0) (P = NR) 

G2: 70.0 (52.0 – 85.0) (P = NR)

G3: 70.0 (50.0 – 82.0) P = NR) 

3 Yr FU: 

G1: 70.0 (45.0 – 90.0) (P = NR)

G2: 68.0 (40.0 – 90.0) (P = NR)

G3: 64.0 (50.0 – 90.0) (P = NR)

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

G4: 68.5 (40.0 – 49.0) (P = NR)

G5: 74.0 (55.0 – 89.0) (P = NR)

G6: 51.0 (35.0 – 65.0) (P = NR)

Diff between groups (P < 0.05) 

G4 and G5 better t han G6

 
C-412 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Dieting, median (range): 

NR 

Dieting, median (range): 

Post-tx: 

G1: 0.0 (0.0 – 28.0) (P = NR) 

G2: 1.0 (0.0 – 28.0) (P = NR) 

G3: 2.0 (0.0 – 42.0) (P = NR) 

3 Yr FU: 

G1: 3.0 (0.0 – 42.0) (P = NR) 

G2: 0.0 (0.0 – 42.0) (P = NR) 

G3: 5.5 (0.0 – 42.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 3.5 (0.0 – 42.0) (P = NR) 

G5: 0.0 (0.0 – 28.0) (P = NR) 

G6: 28.0 (0.0 – 42.0) (P = NR) 

Diff between groups (P < 0.05) 

G4 and G5 better than G6

Body dissatisfaction, median (range):

NR 

Body dissatisfaction, median (range): 

Post-tx: 

G1: 5.0 (0.0 – 28.0) (P = NR) 

G2: 14.0 (0.0 – 42.0) (P = NR) 

G3: 12.0 (0.0 – 42.0) (P = NR) 

3 Yr FU: 

G1: 8.0 (0.0 – 42.0) (P = NR) 

G2: 3.0 (0.0 – 42.0) (P = NR) 

G3: 3.5 (0.0 – 42.0) (P = NR) 

Diff over time (P = 0.005) 

G2 and G3 better at FU 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.02) 

G3 better than G1 (benefit of G1 at post-tx not 

maintained at FU) 

G4: 4.0 (0.0 – 42.0) (P = NR) 

G5: 2.0 (0.0 – 28.0) (P = NR) 

G6: 17.0 (10.0 – 42.0) (P = NR) 

Diff between groups (P = NS) 

Author, Yr: 

Carter et al., 2003 

(continued)

EDI Drive for thinness, median 

(range): 

NR 

EDI Drive for thinness, median (range): 

Post-tx: 

G1: 4.0 (0.0 – 17.0) (P = NR) 

G2: 6.0 (0.0 – 17.0) (P = NR) 

G3: 4.0 (0.0 – 19.0) (P = NR) 

3 Yr FU: 

G1: 1.0 (0.0 – 23.0) (P = NR) 

G2: 2.0 (0.0 – 19.0) (P = NR) 

G3: 2.0 (0.0 – 15.0) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 2.0 (0.0 – 23.0) (P = NR) 

G5: 2.0 (0.0 – 15.0) (P = NR) 

G6: 16.0 (0.0 – 12.0) (P = NR) 

Diff between groups (P = NS)
C-413 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-414 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI Bulimia, median (range): 

NR 

EDI Bulimia, median (range): 

Post-tx: 

G1: 0.0 (0.0 – 12.0) (P = NR) 

G2: 0.0 (0.0 – 10.0) (P = NR) 

G3: 2.0 (0.0 – 12.0) (P = NR) 

3 Yr FU: 

G1: 0.0 (0.0 – 34.0) (P = NR) 

G2: 0.0 (0.0 – 14.0) (P = NR) 

G3: 0.0 (0.0 – 17.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.04) 

G3 better than G2 (G2 benefit at post-tx not 

maintained at FU) 

G4: 0.0 (0.0 – 34.0) (P = NR) 

G5: 0.0 (0.0 – 15.0) (P = NR) 

G6: 7.0 (0.0 – 15.0) (P = NR) 

Diff between groups (P < 0.05) 

G4 better than G6

Author, Yr: 

Carter et al., 2003 

(continued)

EDI Body dissatisfaction, median 

(range): 

NR 

EDI Body dissatisfaction, median (range): Post-tx:

G1: 5.0 (0.0 –23.0) (P = NR) 

G2: 10.0 (0.0 – 27.0) (P = NR) 

G3: 12.50 (0.0 – 27.0) (P = NR) 

3 Yr FU: 

G1: 8.0 (0.0 – 34.0) (P = NR) 

G2: 5.0 (0.0 – 27.0) (P = NR) 

G3: 7.0 (0.0 – 27.0) (P = NR) 

Diff over time (P = 0.004) 

G2 and G3 better vs. post-tx 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

G4: 7.0 (0.0 – 34.0) (P = NR) 

G5: 3.0 (0.0 – 25.0) (P = NR) 

G6: 15.0 (6.0 – 24.0) (P = NR) 

Diff between groups (P = NS) 
C-415 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-416 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, Yr: 

Carter et al., 2003 

(continued)

Eating-related dx 

BN Current (%): 

G4: 12 

G5: 7 

G6: 83 

Diff between groups (P < 0.05) 

G4 and G5 better than G6 

BN Last Yr (%): 

G4: 16 

G5: 27 

G6: 83 

Diff between groups (P < 0.05) 

G4 and G5 better than G6 

AN Current (%): 

G4: 1 

G5: 0 

G6: 0 

Diff between groups (P = NS) 

AN Last Yr (%): 

G4: 1 

G5: 13 

G6: 0 

Diff between groups (P = NS) 

EDNOS Current (%): 

G4: 15 

G5: 13 

G6: 17 

Diff between groups (P = NS) 

EDNOS Last Yr (%): 

G4: 20 

G5: 27 

G6: 17 

Diff between groups (P = NS) 

Any ED Current (%): 

G4: 28 

G5: 20 

G6: 100 

Diff between groups (P < 0.05) 

G4 and G5 better than G6 

Any ED Last Yr (%): 

G4: 35 

G5: 53 

G6: 100 

Diff between groups (P < 0.05) 

G4 and G5 better than G6 
C-417 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-418 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Chen et al., 2003 

Setting: 

Outpatient 

Sydney, Australia 

Enrollment period: 

NR 

To develop the Oxford 

University individual CBT 

(ICBT) manual into a 

group format (GCBT) 

and compare them on 

measures of binge 

eating, purging, dietary 

restraint, wt and shape 

attitudes, eating disorder 

attitudes, and general 

pathology at post-tx, and 

at 3- and 6-mo FU 

Groups 

G1: ICBT (N = 30)

G2: GCBT (N = 30)

Enrollment: 

Subjects recruited from 

University-affiliated hospital 

ED programs and general 

practitioners in the local 

area 

Referred: N = 153 

Presented for general psych 

assessment: N = 125 

Eligible: N = 94 

Presented for BN symptom 

assessment: and 

randomized: N = 71 

Enrolled: N = 60 

Dropouts: 

During tx: N = 16 

G1: 27% 

G2: 27% 

By 3 mo FU: N = 21 

By 6 mo FU: N = 23 

Age, yrs, mean (SD): 

25.80 (7.24) 

Sex: 

100% female 

Race/ethnicity: 

NR 

BN Duration, yrs, mean (SD): 

9.6 (7.26) 

BN Behaviors, N (%): 

Purging, 55 (92%) 

Vomiting, 55 (92%) 

Laxative abuse, 19 (32%) 

Diuretic abuse, 3 (5%) 

Overexercise, 27 (45%) 

> one form, 32 (53%) 

Treatment Hx, N (%): 

ED tx, 32 (53%) 

Psych tx, 28 (47%) 

Psychiatric Hx, N (%): 

Past depression, 39 (65%) 

Past self-harm, 16 (30%) 

Past substance abuse, 19 (32%) 

Current substance abuse, 9 (15%) 
C-419 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, 18 yrs or 

older, BN via DSM IV, 

BMI = 19 to 27 kg/m2 

Exclusion: 

Current BN tx, current 

suicide risk, medically 

unstable, other 

psychiatric comorbid 

dx, lived more than 1.5 

hr away from test site 

Pre-tx, post-tx, and FU assessments 

G1 (ICBT): 19, 50-minutes sessions 

based on Oxford semi-structured, 3 

stage CBT program (Fairburn et al., 

1993), over 4.5 mos, with optional 

self-help book (Fairburn, 1995) and 

information session with friends and 

family 

G2 (GCBT): 19, 90-minutes closedgroup sessions adapted from ICBT 

program with identical handouts, 

content, and optional material over 

4.5 mos; min 6 subjects per group 

Both txs conducted by same 

investigator; all sessions 

audiotaped. 

3- and 6-mo FU 

Randomized block 

design with 6 

consecutive subjects 

per unit randomized to 

either ICBT or GCBT 

using random digits 

(Pocock, 1983). 

A priori power 

calculation estimated 

30 subjects per group 

2 group x 4 timepoints repeated 

measures MANOVA 

with correction for 

multiple comparisons 

and post-hoc 

contrasts to assess 

change over time. 

Chi square test for 

categorical variables. 

Tx suitability ratings 

by patients and 

random, independent 

rater validations of 

16.6% of EDE and 

10% of therapy 

sessions 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

No 

Adverse events: 

Alcohol abuse (N = 2) 

AN (N = 1) 

Visual hallucinations (N = 1) 

Funding: 

Australian Research Council, 

Australian Postgraduate 

Award, Welcome Trust 

Principal Research FellowshiP 

Award 
C-420 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Objective Binge Episodes, past 28 

days, mean (SD): 

G1: 32.07 (23.85) 

G2: 28.17 (25.47) 

(P = NS)

Objective Binge Episodes, past 28 days, mean 

(SD): 

Post-tx: 

G1: 7.77 (12.88) (P = NR) 

G2: 10.57 (17.84) (P = NR) 

3 Mo FU: 

G1: 8.80 (14.22) (P = NR) 

G2: 7.33 10.62) (P = NR)

6 Mo FU: 

G1: 10.47 (14.24) (P = NR) 

G2: 9.60 (14.60) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Subjective, mean (SD): 

G1: 14.97 (41.31) 

G2: 10.57 (15.72) 

(P = NS)

Subjective, mean (SD): 

Post-tx: 

G1: 5.57 (15.49) (P = NR) 

G2: 9.83 (18.57) (P = NR) 

3 Mo FU: 

G1: 2.37 (4.94) (P = NR) 

G2: 9.00 (16.87) (P = NR) 

6 Mo FU: 

G1: 4.30 (11.17) (P = NR) 

G2: 8.79 (17.21) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Chen et al., 2003 

(continued) 

Objective and Subjective, mean (SD):

G1: 47.03 (45.87) 

G2: 38.73 (31.99) 

(P = NS)

Objective and Subjective, mean (SD): 

Post-tx: 

G1: 13.33 (19.24) (P = NR) 

G2: 20.40 (29.82) (P = NR) 

3 Mo FU: 

G1: 11.17 (14.34) (P = NR) 

G2: 16.33 (17.91) (P = NR) 

6 Mo FU: 

G1: 14.77 (16.64) (P = NR) 

G2: 20.03 (25.23) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-421 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

State Anxiety, mean (SD): 

G1: 50.8 (10.38) 

G2: 48.70 (11.22) 

(P = NS) 

State Anxiety, mean (SD): 

Post-tx: 

G1: 45.23 (11.60) (P = NR) 

G2: 43.87 (9.87) (P = NR) 

3 Mo FU: 

G1: 45.77 (11.21) (P = NR) 

G2: 45.70 (9.30) (P = NR) 

6 Mo FU: 

G1: 48.46 (10.67) (P = NR) 

G2: 42.43 (11.37) (P = NR) 

Diff over time (P = 0.02) 

Diff between group (P = NS) 

Diff between groups in 

change over time (P = 0.04)

G2 better than G1 

BMI, mean (SD): 

G1: 22.0 (2.1) 

G2: 22.4 (3.4) 

Diff between groups 

(P = NS)

BMI, mean (SD): 

Post-tx: 

G1: 22.2 (2.3) (P = NR) 

G2: 22.4 (3.3) (P = NR) 

3 Mo FU: 

G1: 22.0 (2.1) (P = NR) 

G2: 22.6 (3.0) (P = NR) 

6 Mo FU: 

G1: 22.3 (2.5) (P = NR) 

G2: 22.3 (2.9) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Trait Anxiety, mean (SD): 

G1: 55.33 (9.11) 

G2: 55.33 (8.15) 

(P = NS) 

Trait Anxiety, mean (SD): 

Post-tx: 

G1: 51.87 (9.09) (P = NR) 

G2: 50.97 (8.90) (P = NR) 

3 Mo FU: 

G1: 52.60 (8.50) (P = NR) 

G2: 52.33 (9.48) (P = NR) 

6 Mo FU: 

G1: 52.53 (8.24) (P = NR) 

G2: 49.93 (10.02) (P = NR) 

Diff over time (P = 0.03) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

 

BDI, mean (SD): 

G1: 22.00 (9.69) 

G2: 22.70 (10.57) 

(P = NS) 

BDI, mean (SD): 

Post-tx: 

G1: 15.37 (11.91) (P = NR) 

G2: 14.33 (10.36) (P = NR)

3 Mo FU: 

G1: 16.73 (11.93) (P = NR) 

G2: 14.17 (10.18) (P = NR) 

6 Mo FU: 

G1: 16.70 (12.74) (P = NR) 

G2: 13.37 (10.68) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

 
C-422 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Purging episodes, past 28 days: 

Vomiting, mean (SD): 

G1: 41.70 (48.79) 

G2: 31.20 (34.08) 

(P = NS)

Purging episodes, past 28 days: 

Vomiting, mean (SD): 

Post-tx: 

G1: 8.73 (16.39) (P = NR) 

G2: 18.83 (53.49) (P = NR) 

3 Mo FU: 

G1: 10.57 (16.89) (P = NR) 

G2: 10.77 (15.66) (P = NR) 

6 Mo FU: 

G1: 12.80 (17.86) (P = NR) 

G2: 11.20 (20.74) (P = NR) 

Diff over time (P < 0.001)

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Laxatives, mean (SD): 

G1: 2.10 (4.32) 

G2: 2.33 (5.16) 

(P = NS) 

Laxatives, mean (SD): 

Post-tx: 

G1: 0.06 (0.25) (P = NR) 

G2: 0.10 (0.40) (P = NR) 

3 Mo FU: 

G1: 0.93 (3.31) (P = NR) 

G2: 0.23 (1.10) (P = NR) 

6 Mo FU: 

G1: 1.23 (4.53) (P = NR) 

G2: 0.43 (2.19) (P = NR) 

Diff over time (P = 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Chen et al., 2003 

(continued) 

Overexercise, mean (SD): 

G1: 7.90 (10.98) 

G2: 8.07 (9.70) 

(P = NS)

Overexercise, mean (SD): 

Post-tx: 

G1: 2.53 (6.31) (P = NR) 

G2: 5.10 (8.97) (P = NR) 

3 Mo FU: 

G1: 2.37 (7.15) (P = NR) 

G2: 3.73 (7.87) (P = NR) 

6 Mo: 

G1: 2.47 (9.52) (P = NR) 

G2: 3.20 (7.17) (P = NR) 

Diff over time (P = 0.002) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-423 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL-90R (Global), mean 

(SD): 

G1: 1.28 (0.55) 

G2: 1.45 (0.63) 

(P = NS) 

SCL-90R (Global), mean 

(SD): 

Post-tx:

G1: 1.03 (0.67) (P = NR) 

G2: 1.08 (0.75) (P = NR) 

3 Mo FU: 

G1: 1.05 (0.68) (P = NR) 

G2: 1.12 (0.72) (P = NR) 

6 Mo FU: 

G1: 1.11 (0.71) (P = NR) 

G2: 1.01 (0.75) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

 
C-424 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-12 Restraint, mean (SD): 

G1: 3.97 (1.10) 

G2: 3.96 (0.88) 

(P = NS)

EDE-12 Restraint, mean (SD): 

Post-tx: 

G1: 2.36 (1.78) (P = NR) 

G2: 2.65 (1.59) (P = NR) 

3 Mo FU: 

G1: 2.37 (1.80) (P = NR) 

G2: 2.51 (1.62) (P = NR) 

6 Mo FU: 

G1: 2.68 (1.78) (P = NR) 

G2: 2.56 (1.66) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

EDE-12 Wt Concern, mean (SD): 

G1: 6.97 (3.65) 

G2: 7.60 (3.64) 

(P = NS)

EDE-12 Wt Concern, mean (SD): 

Post-tx: 

G1: 5.71 (4.38) (P = NR) 

G2: 6.13 (4.50) (P = NR) 

3 Mo FU: 

G1: 5.44 (4.50) (P = NR) 

G2: 6.18 (4.63) (P = NR) 

6 Mo FU: 

G1: 5.67 (4.49) (P = NR) 

G2: 6.02 (4.66) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Chen et al., 2003 

(continued) 

EDE-12 Shape Concern, mean (SD): 

G1: 6.78 (2.45) 

G2: 6.50 (2.65) 

(P = NS)

EDE-12 Shape Concern, mean (SD): 

Post –tx: 

G1: 5.08 (2.36) (P = NR) 

G2: 5.16 (1.93) (P = NR) 

3 Mo FU: 

G1: 4.50 (2.54) (P = NR) 

G2: 4.00 (1.97) (P = NR) 

6 Mo FU: 

G1: 4.86 (2.87) (P = NR) 

G2: 4.50 (1.97) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-425 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-426 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-12 total score, mean (SD): 

G1: 5.19 (1.36) 

G2: 5.23 (1.26) 

(P = NS)

EDE-12 Total score, mean (SD): 

Post-tx:

G1: 3.73 (2.05) (P = NR) 

G2: 3.97 (1.68) (P = NR) 

3 Mo FU: 

G1: 3.52 (2.17) (P = NR) 

G2: 3.87 (2.34) (P = NR) 

6 Mo FU: 

G1: 3.81 (2.21) (P = NR) 

G2: 3.74 (1.94) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Abstinence (Post): 

G1: 20% 

G2: 0% 

(P = 0.02) 

Abstinence (3 mo): 

G1: 16.7%% 

G2: 3.3% 

(P = NS) 

Abstinence (6 mo): 

G1: 13.3% 

G2: 10% 

(P = NS)

Author, yr: 

Chen et al., 2003 

(continued) 

EDE-12 Drive for Thinness, mean 

(SD): 

G1: 14.37 (4.06) 

G2: 14.93 (5.16) 

(P = NS)

EDE-12 Drive for Thinness, mean (SD): 

Post-tx: 

G1: 10.63 (5.58) (P = NR) 

G2: 11.20 (6.00) (P = NR) 

3 Mo FU: 

G1: 9.90 (6.13) (P = NR) 

G2: 10.70 (5.86) (P = NR) 

6 Mo FU: 

G1: 9.67 (6.77) (P = NR) 

G2: 9.53 (6.54) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-427 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-428 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-12 Bulimia, mean (SD): 

G1: 13.77 (4.11) 

G2: 12.87 (4.49) 

(P = NS)

EDE-12 Bulimia, mean (SD): 

Post-tx: 

G1: 8.07 (6.23) (P = NR) 

G2: 8.70 (6.45) (P = NR) 

3 Mo FU: 

G1: 8.33 (6.15) (P = NR) 

G2: 8.30 (6.60) (P = NR) 

6 Mo FU: 

G1: 6.26 (4.45) (P = NR) 

G2: 5.33 (4.73) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Chen et al., 2003 

(continued) 

EDE-12 Body Dissatisfaction, mean 

(SD): 

G1: 18.57 (7.75) 

G2: 16.57 (8.42) 

(P = NS)

EDE-12 Body Dissatisfaction, mean (SD): 

Post-tx: 

G1: 15.87 (8.25) (P = NR) 

G2: 14.70 (8.12) (P = NR) 

Diff over time (P = 0.001) 

3 Mo Fu: 

G1: 15.90 (8.89) (P = NR) 

G2: 14.23 (8.03) (P = NR) 

6 Mo FU: 

G1: 14.97 (8.99) (P = NR) 

G2: 12.43 (7.85) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-429 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-430 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Cooper and Steere, 

1995 

Setting: 

Outpatient, UK 

Enrollment period: 

18 mos, dates not 

provided 

Research objective: 

To compare CBT without 

exposure instructions versus 

with BT (EXRP) without 

cognitive restructuring to 

evaluate the validity of the 

CBT model of the 

maintenance of BN. 

Groups: 

G1: CBT (cog therapy only; 

N = 15) 

G2: BT (EXRP only; N = 16) 

Enrollment: 

• Randomized (N = 31) 

• Completed (N = 27) 

G1: 13 

G2: 14

Drop Outs: 

G1: N = 1 

G2: N = 1 

Withdrawn (due to severe 

depression): 

G1: N = 1 

G2: N = 1 

FU: 

G1: 12 

G2: 13 

1 in each group required tx 

for depression and was not 

assessed. Both responded 

poorly to tx. 

Age, yrs, mean (SD): 

23.8 (18-33) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Wt, % of matched 

population mean (range): 

98.9% (82.7-122.2%) 

Frequency of bulimic 

episodes during 4 wks 

before tx, mean (range): 

26.3 (6-72) 

Frequency of self-induced 

vomiting during 4 wks 

before tx, mean (range): 

58.8 (0-580) 

Onset of both bulimic 

episodes and purging, yrs, 

mean: 

19.6 

Duration of BN symptoms, 

mos, mean (range): 

56 (5-180) 

Duration of purging, mos, 

mean (range): 

55.5 (4-168) 
C-431 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN, however only 

patients who were 

‘bout purgers’ (Purged 

right after bingeing) 

were included. 

Exclusion: 

NR 

18 wks of tx with 19 tx sessions; 

individual sessions lasting 50 

minutes each. 

Phase 1: identical in each group (8 

sessions on a twice wkly basis; 

education, exploring the problem; 

instituting bx techniques to gain 

control of eating). 

Phase 2: G1: 8 wkly sessions 

followed Fairburn’s CBT (Problem 

solving, cog restructuring; without 

behavioral instruction or hw for 

reducing dietary restraint). G2: 8 

sessions (first 4 twice per wk for 

EXRP in session (eating and 

prevented vomiting; second 4 – wkly 

sessions and prevented bingeing 

rather than vomiting). Based on 

Rosen and Leitenberg (but modified 

to exclude cog factors). 

Phase 3: focused on maintenance 

as described by Fairburn (3 

fortnightly sessions). 

ANCOVA (controlling 

for pre tx diffs) but 

they did not report any 

significance levels for 

diffs pre-tx between 

the 2 groups and they 

did not state which 

variables they 

controlled for. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

N/A 

Adverse events: 

NR 

Funding: 

East Anglia Regional 

Health Authority 
C-432 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Cooper and Steere, 

1995 

(continued) 

Bulimic episodes/mo, mean (SD): 

G1: 21.9 (12.3) 

G2: 30.4 (19.4) 

(P = NR) 

Bulimic episodes/ mo, mean (SD): 

Post Treatment (after 18 wks): 

G1: 4.5 (7.6) (P = NR) 

G2: 7.4 (13.9) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 3.5 (6.3) (P = NR) 

G2: 16.5 (18.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Abstinence rates, N (%): 

G1: 6 (46%) 

G2: 7 (50%) 

(P = NS) 

Reduction in freq of bulimic episodes, %: 

G1: 78.0% 

G2: 78.7% 

(P = NS) 

Relapse Rate (Bingeing): 

G1: 0/6 who were abstinent 

G2: 5/7 who were abstinent 

Diff between groups (P < 0.04) 
C-433 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Present State 

Examination (PSE) 

Global mental state, 

mean (SD): 

G1: 17.2 (9.8) 

G2: 17.9 (6.6) 

(P = NR) 

PSE Global mental state, mean (SD): 

Post tx (after 18 wks): 

G1: 10.3 (7.7) (P = NR) 

G2: 9.3 (8.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NS) 

FU (12 mos): 

G1: 8.3 (8.5) (P = NR) 

G2: 12.4 (8.9) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NR) 

Wt, % matched 

population mean 

(SD): 

G1: 98.5 (11.5) 

G2: 99.3 (11.0) 

(P = NR) 

Wt, % of matched 

population mean (SD): 

Post-tx (after 18 wks): 

G1: 98.8 (8.8) (P = NR) 

G2: 99.2 (10.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

FU (12 mos): 

G1: 97.7 (10.4) (P = NR) 

G2: 99.5 (13.9) (P = NR) 

Diff over time (P = NR) 

(P = NR) 

Diff between groups in change 

over time (P = NR) 

MADRS Depression, 

mean (SD): 

G1: 21.5 (7.4) 

G2: 21.1 (7.7) 

(P = NR) 

MADRS Depression, mean (SD): 

Post tx (after 18 wks): 

G1: 14.0 (9.8) (P = NR) 

G2: 11.8 (11.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NR) 

FU (12 mos): 

G1: 8.8 (7.5) (P = NR) 

G2: 14.9 (10.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.03) 

G1 better than G2 

 

BDI, mean (SD): 

G1: 21.8 (8.3) 

G2: 17.9 (11.5) 

(P = NR) 

BDI, mean (SD): 

Post tx (after 18 wks): 

G1: 10.2 (9.4) (P = NR) 

G2: 10.4 (12.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NR) 

FU (12 mos): 

G1: 8.0 (9.4) (P = NR) 

G2: 13.0 (10.8) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.04) 

G1 better than G2 

 
C-434 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Self-induced vomiting/mo (SD): 

G1: 36.1 (37.8) 

G2: 79.9 (149.1) 

(P = NR) 

Self-induced vomiting/mo, mean (SD): 

Post Treatment (after 18 wks): 

G1: 4.5 (7.9) (P = NR) 

G2: 7.6 (13.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 4.3 (7.1) (P = NR) 

G2: 23.4 (25.8) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.007) 

G1 better than G2 

Abstinence rates, N (%): 

G1: 7 (54%) 

G2: 6 (43%) 

(P = NS) 

Reduction in freq of vomiting, %: 

G1: 82.8% 

G2: 91.1% 

(P = NS) 

Relapse rate (Purging): 

G1: 1/7 

G2: 5/6 

(P = NS) 

Author, yr: 

Cooper and Steere, 

1995 

(continued) 

EDE – Dietary restraint, mean (SD): 

G1: 3.4 (1.6) 

G2: 3.2 (1.3) 

(P = NR) 

EDE – Dietary restraint, mean (SD): 

Post Treatment (after 18 wks): 

G1: 1.2 (1.4) (P = NR) 

G2: 0.8 (1.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 1.0 (1.1) (P = NR) 

G2: 1.6 (1.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-435 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

STAI – State Anxiety, 

mean (SD): 

G1: 54.2 (8.4) 

G2: 43.1 (13.0) 

(P = NR) 

STAI – State Anxiety, mean (SD): 

Post tx (after 18 wks): 

G1: 38.8 (10.3) (P = NR) 

G2: 42.3 (15.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NS) 

FU (12 mos): 

G1: 41.8 (11.0) (P = NR) 

G2: 42.0 (12.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

 

STAI – Trait Anxiety, 

mean (SD): 

G1: 55.8 (11.0) 

G2: 52.0 (10.6) 

(P = NR) 

STAI – Trait Anxiety, mean (SD): 

Post tx (after 18 wks): 

G1: 44.8 (13.9) (P = NR) 

G2: 44.5 (14.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

FU (12 mos): 

G1: 44.3 (12.5) (P = NR) 

G2: 49.3 (13.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

 
C-436 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

SRQ Dietary restraint, mean (SD): 

G1: 13.6 (4.1) 

G2: 12.8 (4.5) 

(P = NR) 

SRQ Dietary restraint, mean (SD): 

Post Treatment (after 18 wks): 

G1: 11.2 (5.1) (P = NR) 

G2: 8.5 (5.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 11.2 (5.5) (P = NR) 

G2: 10.7 (4.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

EDE Shape concern, mean (SD): 

G1: 4.4 (1.2) 

G2: 4.3 (1.3) 

(P = NR) 

EDE Shape concern, mean (SD): 

Post Treatment (after 18 wks): 

G1: 2.7 (1.8) (P = NR) 

G2: 2.2 (1.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 2.6 (1.4) (P = NR) 

G2: 3.1 (1.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Cooper and Steere, 

1995 

(continued) 

EDE Wt concern, mean (SD): 

G1: 4.4 (1.3) 

G2: 3.8 (1.8) 

(P = NR) 

EDE Wt concern, mean (SD): 

Post Treatment (after 18 wks): 

G1: 2.6 (1.9) (P = NR)

G2: 1.6 (1.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 2.3 (1.3) (P = NR) 

G2: 2.4 (1.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-437 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-438 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Importance of shape and wt 

(geometric mean of 2 EDE items) 

(SD): 

G1: 3.4 (1.8) 

G2: 3.4 (2.3) 

(P = NR) 

Importance of shape and wt (geometric mean of 2 

EDE items) (SD): 

Post Treatment (after 18 wks): 

G1: 2.7 (1.8) (P = NR) 

G2: 1.7 (2.1) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 2.5 (1.2) (P = NR) 

G2: 2.4 (2.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

EAT, mean (SD): 

G1: 49.7 (16.9) 

G2: 44.3 (16.6) 

(P = NR) 

EAT, mean (SD): 

Post Treatment (after 18 wks): 

G1: 20.0 (14.2) (P = NR)

G2: 17.5 (15.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 18.8 (14.7) (P = NR) 

G2: 24.3 (17.1) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Cooper and Steere, 

1995 

(continued) 

BSQ Body shape dissatisfaction, 

mean (SD): 

G1: 124.5 (30.9) 

G2: 120.6 (36.4) 

(P = NR) 

BSQ Body shape dissatisfaction, mean (SD): 

Post Treatment (after 18 wks): 

G1: 84.3 (32.8) (P = NR) 

G2: 77.9 (36.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos: 

G1: 78.5 (26.3) (P = NR) 

G2: 89.3 (31.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-439 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-440 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Cooper and Steere, 

1995 

(continued) 

Desired wt, mean (SD): 

G1: 87.6 (6.3) 

G2: 87.1 (4.5) 

(P = NR) 

Desired wt, mean (SD): 

Post Treatment (after 18 wks): 

G1: 92.3 (6.9) (P = NR) 

G2: 91.7 (6.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (12 mos): 

G1: 91.1 (5.8) (P = NR) 

G2: 88.8 (8.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-441 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-442 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, year: 

Crosby, Mitchell et al., 

1993 

Setting: 

NR 

Enrollment period: 

NR 

Research objective: 

To reanalyze treatment 

response and relapse using 

survival analyses in a 12-wk 

RCT of group CBT for the tx 

of BN. 

Groups (N = 143): 

High Abstinence: HA 

High Intensity: HI 

Low Abstinence: LA 

Low Intensity: LI 

G1: HA/HI (N = 33) 

G2: HA/ LI (N = 41) 

G3: LA/HI (N = 35) 

G4: LA/LI (N = 34) 

Enrollment: 

• 143 enrolled and 

randomized 

Age, range: 

18 to 50 

Sex: 

100% female 

Race/ethnicity: 

NR 
C-443 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Aged 18 to 50; meeting 

DSM-IIIR criteria for BN, 

with additional criteria for 

frequency at 3/wk for 6 mos 

prior to evaluation 

Exclusion: 

Concomitant alcohol or drug 

abuse, bipolar disorder or 

schizophrenia 

12 wk study with 4 tx 

groups, differing on 2 

factors: early abstinence 

and tx intensity; 2 groups 

were “high abstinence”, with 

visits clustered early in tx, 2 

were “low abstinence”, 

where participants were 

instructed to improve at 

their own rate.; 2 groups 

were high intensity (45 

program hours), 2 were low 

intensity (22.5 hrs); factors 

were crossed to create 4 tx 

conditions. 

All participants selfmonitored daily eating 

behavior using the Eating 

Behaviors III. 

Time to tx response: 

performed separately for 4 

tx response definitions 

using survival analyses; 

drop-outs and completers 

who failed to meet tx 

response criteria were 

treated as censored 

observations. 

Time to relapse after initial 

response: analyzed in a 

sub-sample of participants 

using survival analyses; 

participants abstinent at tx 

end were treated as 

censored observations. 

In both analyses, 

relationships between 

groups and outcome 

variables were assessed by 

parametric accelerated 

failure time models, fitted 

using a log logistic 

distribution. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

NR 
C-444 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Initial Response: 

Total abstinence, no binging, vomiting, 

or laxative abuse per 2 wks (%): 

G1: 27 (82%) 

G2: 27 (66%) 

G3: 20 (57%)

G4: 8 (24%)

Overall: 82 (57%)

(P < 0.001) 

G1 sig higher overall 

G4 sig lower overall 

Maintained response, by last tx visit: 

Total abstinence (%): 

G1: 22 (67%) (P =NR) 

G2: 28 (68%) (P =NR) 

G3: 22 (63%) (P =NR) 

G4: 7 (21%) (P =NR) 

Overall: 79 (55%) (P =NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P

<0.0001) 

• 74 participants (90% initial; 93% maintained) 

met total criteria for both response times 

Author, year: 

Crosby, Mitchell et al., 

1993 

(continued) 

Near abstinence, 1 or fewer episodes per 

2 wks (%): 

G1: 28 (85%) 

G2: 34 (83%) 

G3: 24 (69%) 

G4: 16 (47%) 

Overall: 102 (71%) 

(P < 0.001) 

Near abstinence (%): 

G1: 25 (76%)(P =NR) 

G2: 30 (73%) (P =NR) 

G3: 23 (66%)(P =NR) 

G4: 9 (27%) (P =NR) 

Overall: 87 (61%) (P =NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 

0.0001) 

• 86 participants (84% initial; 99% maintained) 

met near criteria for both response times 
C-445 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-446 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, year: 

Crosby, Mitchell et al., 

1993 

(continued) 

Survival Analyses: 

Time to initial response, total abstinence: 

Diff between groups in change over time: χ2 = 46.9 

(P < 0.001) 

Diff between G1 and G2 (P = 0.005) 

G1 sig shorter than G2 

G2/G3 combined sig shorter than G4 

Diff between G2 and G3 (P = NS) 

Time to initial response, near abstinence: 

Diff between groups in change over time:χ2 = 34.7 

(P < 0.001) 

Diff between G1 and G2 (P = 0.064) 

G2/G3 combined sig shorter than G4; 

Diff between G2 and G3 (P = NS) 

Relapse after initial response, total abstinence: 

In first week, 48% G1 and 25% G3 relapsed; 

Diff between groups in change over time (P = NS) 

Relapse after initial response, near abstinence: 

Diff between groups (P <0.001) 

Diff between G4 and G1/G2/G3 combined (P < 

0.001) 

G4 sig higher than combined. 

G1 and G3 sig lower than others (P = NR) 

Diff between G1 and G3 (P = NS) 

Relapse after maintained, total abstinence: 

Diff between groups (P < 0001) 

Relapse after maintained, near abstinence: 

Diff between groups (P < 0001) 

Diff between G1 and G2/G3 combined in change 

over time (P = NS) 
C-447 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued)) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-448 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Davis et al., 1999 

Setting: 

Eating Disorder 

Outpatient Clinic of 

Toronto Hospital, 

Toronto, Canada 

Enrollment period: 

16 mos 

Research objective: 

To investigate the efficacy 

of stepped care involving 

brief group PE followed 

by CBT to treat BN.To 

study the co-variation 

between clinical outcome 

and nonspecific 

psychopathology. 

To determine predictors 

of best response to 

stepped care strategy. 

Groups: 

G1: PE only (N = 32) 

G2: PE + CBT (N = 39) 

Analysis presented on 56 

completers only 

G2R: CBT remitters (N = 16) 

G2N: CBT non-remitters (N = 21)

Enrollment: 

Referred by physician (71%) 

Recruited via newspaper ad 

(29%) 

Enrolled (N = 71) 

Completed initial 6 wk group PE 

and randomized (N = 58) 

G1: 19 

G2: 39 

Dropouts, pre-tx: 

G1: 13 

G2: 2 

Diff between groups in hx, 

demographics, bingeing, 

purging, and psychometric 

measures (P = NS) 

Dropouts, during tx: 

G1: 0 

G2: 2 

Age, yrs, mean (SD): 

27.1 (5.3) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 100% 

Duration of illness, yrs, 

mean (SD): 

7.6 (5.4) 

Education: 

College: 58% 

Employment: 

Full-time52% 

Marital status: 

Single: 78% 

Hx of past AN: 

34% 

Purge type: 

Vomit: 87% 

Laxatives: 34% 
C-449 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN by clinician or 

EDE, 85-125% of 

matched population 

mean wt, min 6-mo 

duration of illness 

Exclusion: 

Current psychological 

tx (therapy or meds); 

suicide risk; psychosis; 

medical instability; 

previous exposure to 

one of txs being 

studied 

Pre-tx Assessment:

EDE, BDI, BSI, RSE, 

semistructured interview, Binge 

Eating Adjective Checklist (BEAQ) 

Brief group PE (6, 90-minutes wkly 

sessions), manualized, focusing on 

self-care strategies (i.e., selfmonitoring, meal planning, 

cognitive restructuring, stimulus 

control, and problem-solving) as 

well as normalizing eating 

behavior. Initially, 5-8 BN study 

participants plus 6-16 non-BN clinic 

patients (EDNOS or AN) per group. 

Followed by interim assessments. 

Randomization (2:1) 

G1: 16 wks individual CBT (12 

sessions if < 4 binge/purge 

episodes in last 4 wks of mope; 20 

session if ≥ 4 episodes) 

G2: 16 wk no-tx 

Post-tx and FU assessments 

Post-assessment 

(as above) 

To test tx effects on 

psychopathology: 

ANCOVAs at post-tx 

and FU with pre-tx 

score as covariate 

(parametric data) or 

Mann-Whitney or 

Fischer’s exact test for 

non-parametric data. 

To examine 

covariation between 

remission in eating sx 

and psychopathology: 

univariate and 

multivariate ANOVA 

and paired t-tests. 

To predict outcome: 

discriminant function 

analysis between 

nonremitted and 

remitted PE + CBT. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

None reported 

Funding: 

Ontario Ministry of Health 
C-450 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge frequency, past 28 days, 

mean (SD): 

G1: 21.2 (12.8) 

G2: 24.2 (19.7) 

Binge frequency, past 28 days, mean (SD): 

Post-tx: 

G1: 11.5 (19.0) (P < 0.001) 

G2: 3.9 (7.4) (P < 0.001) 

Diff between groups (P < 0.03) 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G1: 8.4 (9.5), vs. post-tx (P = NS) 

G2: 3.6 (8.2), vs. post-tx (P = NS) 

Diff between groups (P < 0.02)

Diff between groups in change over time (P = NR) 

Purge frequency, past 28 days, 

mean (SD): 

G1: 30.1 (16.6) 

G2: 38.3 (43.1)

Purge frequency, past 28 days, mean (SD): 

Post-tx: 

G1: 16.7 (21.7) (P < 0.001) 

G2: 4.8 (9.0) (P < 0.001) 

Diff between groups (P < 0.002) 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G1: 12.3 (13.2), vs. post-tx (P = NS) 

G2: 4.8 (9.6), vs. post-tx (P = NS) 

Diff between groups (P < 0.012) 

Diff between groups in change over time (P = NR)

EDE-Global, mean (SD): 

G1: 3.5 (1.0) 

G2: 3.6 (1.1)

EDE Global, mean (SD): 

Post-tx: 

G1: 1.9 (1.1) (P < 0.001) 

G2: 2.1 (1.3) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G1: 2.2 (1.2), vs. post-tx (P = NS) 

G2: 2.0 (1.3), vs. post-tx (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Author, yr: 

Davis et al., 1999 

(continued) 

Binge remittance: 

Post-tx: 

G1: 26.3% 

G2: 51.4% 

Diff between groups (P = NS) 

16 wk FU: 

G1: 26.3% 

G2: 54.1% 

Diff between groups (P < 0.04)
C-451 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 21.3 (9.3) 

G2R: 18.9 (10.5) 

G2N: 22.1 (9.6) 

BDI, mean (SD): 

Post-tx: 

G1: 11.8 (7.3) (P < 0.05) 

G2R: 4.2 (4.5) (P < 0.05) 

G2N: 16.5 (12.1) (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G1 and G2N 

Diff between groups in change over time (P = NR)

16 wk FU: 

G1: 12.9 (7.2), vs. post-tx (P = NS) 

G2R: 7.1 (7.7), vs. post-tx (P = NS) 

G2N: 15.6 (12.4), vs. post-tx (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G2N 

Diff between groups in change over time (P = NR) 

 

Brief Symptom 

Inventory (Global), 

mean (SD): 

G1: 1.3 (0.6) 

G2R: 1.3 (0.8) 

G2N: 1.5 (0.7)

Brief Symptom Inventory (Global), mean (SD): 

Post-tx: 

G1: 1.0 (0.5) (P < 0.05) 

G2R: 0.4 (0.4) (P < 0.05) 

G2N: 1.2 (0.7) (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G1 and G2N 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G1: 1.0 (0.7), vs. post-tx (P = NS) 

G2R: 0.6 (0.6), vs. post-tx (P = NS) 

G2N: 1.2 (0.8), vs. post-tx (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G2N 

Diff between groups in change over time (P = NR)

 

Rosenberg Self-esteem 

(RSE), mean (SD): 

G1: 24.3 (5.4) 

G2R: 26.2 (4.8) 

G2N: 22.4 (4.3)

Rosenberg Self-esteem (RSE), mean (SD): 

Post-tx: 

G1: 26.5 (5.7) (P < 0.05) 

G2R: 34.6 (3.3) (P < 0.05) 

G2N: 24.1 (6.5) (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G1 and G2N 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G1: 26.9 (6.54), vs. post-tx (P = NS) 

G2R: 32.5 (4.8), vs. post-tx (P = NS) 

G2N: 24.6 (5.7), vs. post-tx (P = NS) 

Diff between groups (P < 0.05) 

G2R better than G2N 

Diff between groups in change over time (P = NR)

 
C-452 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Purge remittance: 

Post-tx: 

G1: 15.8% 

G2: 54.1% 

(P < 0.006) 

16 wk FU: 

G1: 21.1% 

G2: 51.4% 

(P < 0.03)

Full remittance: 

Post-tx: 

G1: 10.5% 

G2: 43.2% 

(P < 0.02) 

16 wk FU: 

G1: 15.8% 

G2: 37.8% 

(P = NS)

Binge frequency, past 28 days, 

mean (SD): 

G2R: 21.5 (16.5) 

G2N: 26.1 (22.0)

Binge frequency, past 28 days, mean (SD): 

Post-tx: 

G2R: 0.0 (NA) (P = NR) 

G2N: 6.8 (8.8) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G2R: 0.3 (1.3), vs. post-tx (P = NR) 

G2N: 6.2 (10.2), vs. post-tx (P = NR) 

Diff between groups (P < 0.05) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Davis et al., 1999 

(continued) 

Purge frequency, past 28 days, 

mean (SD): 

G2R: 26.1 (25.7) 

G2N: 42.1 (51.5)

Purge frequency, past 28 days, mean (SD): 

Post-tx: 

G2R: 0.0 (NA) (P = NR) 

G2N: 7.7 (10.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

16 wk FU: 

G2R: 0.6 (1.5) (P = NR) 

G2N: 7.3 (11.6) (P = NR) 

Diff between groups (P < 0.05) 

Diff between groups in change over time (P = NR) 
C-453 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Outcome, predictor (Wilks’s lambda), mean: 

RSE (0.805) 

G2R: 28.0 

G2N: 22.8 

Binge frequency 

(0.691) 

G2R: 11.1 

G2N: 18.6 

Binge Eating Adjective Checklist 

(0.583) 

G2R: 2.0 

G2N: 12.1 

Lower self-esteem, more frequent bingeing, and more 

dramatic shifts away from negative psychological and 

physical states during an episode of bingeing were 

sigly more characteristic of non-remitted than remitted, 

chi-square = 18.0 (P < 0.001)

 
C-454 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Davis et al., 1999 

(continued) 

EDE Global, mean (SD): 

G2R: 3.6 (1.1) 

G2N: 3.6 (1.1)

EDE Global, mean (SD): 

Post-tx: 

G2R: 1.3 (0.8) (P = NR) 

G2N: 2.8 (1.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

16 wk FU: 

G2R: 1.3 (0.9) (P = NR) 

G2N: 2.6 (1.3) (P = NR) 

Diff between groups (P < 0.05) 

Diff between groups in change over time (P = NR) 
C-455 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-456 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fairburn et al., 1991 

Companion articles: 

Fairburn, Jones et al., 

1993 

Fairburn, Peveler et al., 

1993 

Setting: 

Outpatient Clinic; 

Recruited from county 

of Oxfordshire, UK 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of CBT 

versus a simplified behavioral 

version of CBT in the tx of 75 

women with BN 

To assess the efficacy of CBT 

versus IPT in the tx of women 

with BN. 

Groups: 

G1: CBT (N = 25) 

G2: BT (N = 25) 

G3: IPT (N = 25) 

Enrollment: 

• 126 individuals referred 

from physicians for a 

study on tx of BN offered 

screening appts 

• 117 (85%) screened 

• 83 met study criteria 

• 3 excluded due to major 

psychiatric condition; 2 

excluded due to 

unavailability; 3 failed 

attendance to entry 

• 75 enrolled and 

randomized 

• 66 (88%) met full DSM 

III-R criteria for BN; 9 met 

all criteria save severity 

of attitudinal disturbance 

• 13 (17%) discontinued tx: 

4 from G1 (16%); 6 from 

G2 (24%); 3 from G3 

(12%); 2 others withdrew 

(1 from G2; 1 from G3) 

• 60 completed 

For entire sample (N = 75), 

unless otherwise indicated: 

Age, yrs, mean (95% CI): 

24.2 (22.8-25.6) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Vomiting frequency, 

days/mo, mean (CI) (N = 56): 

28.9 (23.2-34.7) 

Practiced by 72% of sample 

Laxative frequency, days/ 

mo, mean (CI) (N = 26): 

14.7 (8.9-20.4) 

Duration of BN, yrs, mean 

(CI): 

4.4 (3.4-5.3) 

Current BMI, kg/m2, mean 

(CI): 

22.2 (21.5-23.0) 

Current BMI classification, N 

(%): 

Underwt: 11 (18%) 

Normal wt: 42 (70%) 

Overwt: 4 (7%) 

Obese: 3 (5%) 

Highest BMI since 

menarche, kg/m2, mean (CI): 

25.3 (24.4-26.3) 

Lowest BMI since menarche, 

kg/m2, mean (CI): 

18.3 (17.6-18.9) 

EAT score, mean (CI): 

48.2 (44.3-52.0) 

SCL-90 Global Severity 

Index (GSI) score, mean (CI): 

1.4 (1.2-1.5) 

BDI, mean (CI): 

24.0 (21.4-26.6) 

Of entire sample, 56% 

practiced vomiting, 35% used 

laxatives; 12% used neither 
C-457 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

For prior 6 mos, met 

criteria for BN (DSM 

IIII-R); aged 17 yrs or 

older; BMI > 17 

Exclusion: 

Patients with 

concurrent AN 

Each tx group involved 19, 40-50 

minutes outpatient sessions over 18 

wks; for mo 1, sessions conducted 

2x/wk, then fortnightly for duration of 

study. 

CBT occurred in 3 stages: wks 1-4 

focused on behaviorally enhancing 

control over eating, including selfmonitoring; wks 5-12 cognitively 

focused; wks 13-18 maintenance of 

progress following end of tx. 

BT tx focused exclusively on the 

normalization of eating habits, 

including self-monitoring. 

IPT used manual developed by 

Klerman et al. (1984), diverging from 

protocol only in the first phase of tx--

focusing on the ED (rather than 

depression.) 

At baseline at end-of tx, eatingspecific issues, global fx, and 

depression were assessed using the 

EDE, EAT, SCL-90, and BDI. 

Two planned 

comparisons: CBT 

versus BT, and CBT 

versus IBT; Power 

analyses performed 

(assessing 20 persons 

per tx group); data 

inspected to assess 

whether 

transformation 

required for 

parametric testing; 

variables with skewed 

distribution were 

subject to log 

transformations; oneway ANOVA 

assessed pre-tx diffs; 

Tx effects assessed 

using 3 x 2, repeated 

measures ANOVA; 

diff effects between 

groups were assessed 

by ANCOVA with pretx values as the 

covariate; alpha was 

set at < 0.05, t-tests 

used for planned 

comparisons between 

groups. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

“Limited motivation to change” 

was the most common reason 

for attrition; 1 participant (G2) 

dropped out due to severe wt 

loss 

Funding: 

Welcome Trust, London, Eng; 

personal support for authors 

from lectureships/fellowships 
C-458 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Unless otherwise specified, N = 60 

*Geometric means (N = 43 and N = 19 for 

vomiting and laxative use, respectively).

Objective Bulimic Episodes, per 28 

days*, mean (95% CI): 

G1: 18.1 (12.2-26.5) 

G2: 14.9 (9.6-22.7) 

G3: 16.4 (12.1-22.2) 

(P = NS)

End-of-tx: 

Objective Bulimic Episodes, per 28 days*, 

mean (95% CI): 

G1: 0.6 (0.1-1.4) (P = NR) 

G2: 1.3 (0.3-3.4) (P = NR) 

G3: 1.8 (0.4-4.3) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

• Mean overall geometric frequency changed 

from 16.5 to 1.2 at end-of-tx: a 95% 

reduction 

• Similarly for subjective BE, no diff between 

groups (P = NS) or for both types combined 

(P = NS) 

Abstinence (no bulimic episodes), N (%): 

G1: 15/21 (71%) (P = NR) 

G2: 11/18 (62%) (P = NR) 

G3: 13/21 (62%) (P = NR) 

Diff between group (P = NS)

EDE-Dietary Restraint, mean (95% CI): 

G1: 3.7 (3.1-4.3) 

G2: 3.3 (2.6-4.0) 

G3: 3.3 (2.9-3.7) 

(P = NS)

EDE-Dietary Restraint, mean (95% CI): 

G1: 1.3 (0.7-1.9) (P = NR) 

G2: 2.3 (1.6-3.0) (P = NR) 

G3: 2.1 (1.5-2.7) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = 0.05) 

Diff between groups in change over time 

G1 better than G2 (P = 0.05) 

G1 better than G3 (P = 0.02) 

Self-induced vomiting, per 28 days, 

mean (95% CI): 

G1: 28.5 (18.1-44.6) 

G2: 18.5 (10.1-33.3) 

G3: 16.4 (9.9-26.6) 

(P = NS)

Self-induced vomiting, per 28 days, mean (95% 

CI): 

G1: 1.5 (0.5-3.1) (P = NR) 

G2: 0.9 (0-2.9) (P = NR) 

G3: 5.5 (1.6-14.9) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = 0.03) 

Diff between groups in change over time 

G1 vs. G2 (P = NS) 

G1 better than G3 (P = 0.03) 

Author, yr: 

Fairburn et al., 1991 

(continued) 

Laxative misuse, per 28 days, mean 

(95% CI): 

G1: 4.7 (1.4-12.6) 

G2: 13.1 (3.9-39.4) 

G3: 13.7 (6.4-28.2) 

(P = NS)

Laxative misuse, per 28 days, mean (95% CI) (N 

= 19): 

G1: 0.3 (0-1.6) (P = NR) 

G2: 1.4 (0-8.1) (P = NR) 

G3: 2.3 (0-15.5) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-459 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL-90 Global severity 

index (GSI), mean (95% 

CI): 

G1: 1.35 (1.04-1.65) 

G2: 1.26 (0.90-1.62) 

G3: 1.33 (1.08-1.59) 

(P = NS) 

End-of-tx: 

SCL-90 GSI, mean (95% CI): 

G1: 0.59 (0.33-0.85) (P = NR) 

G2: 0.76 (0.41-1.12) (P = NR) 

G3: 0.70 (0.46-0.94) (P = NR) 

Diff over time (P < 0.05) 

(P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI, kg/m2 mean (95% 

CI): 

G1: 22.4 (20.8-23.9) 

G2: 22.6 (21.0-24.2) 

G3: 22.2 (21.1-23.3) 

(P = NS) 

End-of-tx: 

BMI, kg/m2 mean (95% CI): 

G1: 23.3 (21.3-25.2) (P = NR)

G2: 23.0 (21.3-24.7) (P = NR)

G3: 22.2 (20.7-23.7) (P = NR)

Diff over time (P = 0.02) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

BDI, mean (95% CI): 

G1: 24.1 (20.1-28.1) 

G2: 22.3 (16.5-28.1) 

G3: 24.3 (18.6-30.0) 

(P = NS)

BDI, mean (95% CI): 

G1: 10.1 (5.3-15.0) (P = NR) 

G2: 13.6 (7.6-19.5) (P = NR) 

G3: 12.5 (7.6-17.4) (P = NR) 

Diff over time (P < 0.05) 

(P = NR) 

Diff between groups in change 

over time (P = NS)

 

 
C-460 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Unless otherwise specified, N = 60 

*Geometric means (N = 43 and N = 19 for 

vomiting and laxative use, respectively).

EDE-Attitudes to shape, mean (95% CI): 

G1: 4.1 (3.6-4.7) 

G2: 4.0 (3.4-4.7) 

G3: 3.6 (3.0-4.2) 

(P = NS)

End-of-tx: 

EDE-Attitudes to shape, mean (95% CI): 

G1: 2.1 (1.5-2.6) (P = NR) 

G2: 3.3 (2.5-4.0) (P = NR) 

G3: 2.6 (2.1-3.2) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = 0.01) 

Diff between groups in change over time 

G1 better than G2 (P = 0.003) 

G1 vs. G3 (P = NS) 

EDE-Attitudes to wt, mean (95% CI): 

G1: 4.3 (3.7-4.8) 

G2: 3.8 (3.2-4.5) 

G3: 3.7 (2.9-4.4) 

(P = NS)

EDE-Attitudes to wt, mean (95% CI): 

G1: 1.7 (1.1-2.2) (P = NR) 

G2: 2.9 (2.2-3.6) (P = NR) 

G3: 2.4 (1.9-2.9) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = 0.01) 

Diff between groups in change over time 

G1 better than G2 (P = 0.002) 

G1 better than G3 (P = 0.04) 

Author, yr: 

Fairburn et al., 1991 

(continued) 

EAT scores, mean (95% CI): 

G1: 45.4 (38.9-51.9) 

G2: 50.2 (43.7-56.7) 

G3: 46.1 (38.8-53.5) 

(P = NS)

EAT scores, mean (95% CI): 

G1: 15.5 (9.2-21.8) (P = NR) 

G2: 27.8 (19.4-36.3) (P = NR) 

G3: 29.0 (19.8-38.2) (P = NR) 

Diff over time (P < 0.05) 

Diff between groups (P = 0.02) 

Diff between groups in change over time 

G1 better than G2 (P = 0.05) 

G1 better than G3 (P = 0.01) 
C-461 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-462 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Fairburn, Jones et al., 

1993 

Companion articles: 

Fairburn et al., 1991 

Fairburn, Peveler et al., 

1993 

Setting: 

Outpatient Clinic; 

Recruited from county 

of Oxfordshire, UK 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of CBT 

versus IPT in the tx of women 

with BN at 4, 8, and 12-mo 

FU. 

Groups: 

G1: CBT (N = 20)

G3: IPT (N = 17) 

Enrollment: 

• During FU, 7/60 patients 

who completed tx were 

withdrawn (G1:1; G2: 3; 

G3: 3); 3 dropped out 

(G2: 2; G3: 1) 

• 25 (33%) of original 75 

participants either 

dropped out or were 

withdrawn; G1: 8 (32%); 

G2: 12 (48%); G3: 8 

(32%) 

• Diff between G1 and G2 

(P = 0.04); diff between 

G1 and G3 (P = 0.33) 

Age, yrs, mean (95% CI): 

24.2 (22.8-25.6) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-463 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

For prior 6 mos, met criteria 

for BN (DSM IIII-R); aged 

17 yrs or older; BMI > 17 

Exclusion: 

Patients with concurrent AN 

Assessments reported in 

Fairburn, Jones et al., 1991 

were further measured at 

4-, 8- and 12-mo FU. 

Proportion of participants 

who had ceased overeating 

and self-induced vomiting 

or laxative use were 

compared across tx; a 2 x 4 

ANCOVA was completed 

for each outcome variable 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

7 participants were 

withdrawn during FU due 

to coexisting severe 

depressive features (N = 

3), or BN sx too severe to 

withhold tx. 

Funding: 

Project grant from the 

Welcome Trust, London, 

Eng; personal support for 

authors from lectureships/ 

fellowships 
C-464 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

*Geometric means (N = 37 for objective BE; N = 

25 and N = 10 for vomiting and laxative misuse, 

respectively) 

Objective Bulimic Episodes, per 28 

days, mean (95% CI): 

G1: 18.5 (12.2-27.8) 

G3: 17.2 (12.5-23.5) 

(P = NS) 

End of tx: 

G1: 0.5 (0.02-1.1) (P = NR) 

G3: 1.5 (0.1-4.5) (P = NR) 

Objective Bulimic Episodes, per 28 days, mean 

(95% CI): 

4-mo FU: 

G1: 0.4 (-0.05-1.2) (P = NR) 

G3: 0.9 (-0.05-2.8) (P = NR) 

8-mo FU: 

G1: 0.4 (-.03-1.7) (P = NR) 

G3: 1.1 (0.1-3.2) (P = NR) 

12-mo FU: 

G1: 0.8 (.02-1.6) (P = NR) 

G3: 1.1 (0.01-3.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Mean overall geometric frequency was 0.9 at 12-

mo FU: a 95% reduction from baseline 

Similarly for subjective BE, no diff between groups 

(P = NS) or for both types combined (P = NS) 

EDE-Dietary Restraint, mean (95% CI): 

G1: 3.7 (3.1-4.3) 

G3: 3.2 (2.8-3.7) 

(P = NS) 

End of tx: 

G1: 1.3 (0.7-1.9) (P = NR) 

G3: 1.9 (1.2-2.6) (P = NR) 

EDE-Dietary Restraint, mean (95% CI): 

4-mo FU: 

G1: 1.3 (0.5-2.0) (P = NR) 

G3: 1.4 (0.8-2.1) (P = NR) 

8-mo FU: 

G1: 1.1 (0.5-1.8) (P = NR) 

G3: 1.8 (1.1-2.5) (P = NR) 

12-mo FU: 

G1: 1.3 (0.7-2.0) (P = NR) 

G3: 1.7 (1.0-2.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Fairburn, Jones et al., 

1993 

(continued) 

Self-induced vomiting, per 28 days, 

mean (95% CI): 

G1: 30.6 (19.5-48.2) 

G3: 18.1 (9.9-32.1) 

(P = 0.03) 

End of tx: 

G1: 1.3 (0.4-2.9) (P = NR) 

G3: 3.6 (0.5-12.8) (P = NR) 

Self-induced vomiting, per 28 days, mean (95% 

CI): 

4-mo FU: 

G1: 1.0 (0.02-2.9) (P = NR) 

G3: 3.4 (0.3-13.5) (P = NR) 

8-mo FU: 

G1: 1.2 (0.3-3.0) (P = NR) 

G3: 2.9 (0.2-11.3) (P = NR) 

12-mo FU: 

G1: 2.0 (0.6-4.5) (P = NR) 

G3: 2.4 (-0.04-11.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Mean overall geometric frequency was 2.14 at 12-

mo FU: a 90.9% reduction from baseline 
C-465 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL-90 GSI, mean (95% 

CI): 

G1: 1.38 (1.06-1.70) 

G3: 1.31 (0.99-1.63) 

End of tx: 

G1: 0.61 (0.34-0.88) 

G3: 0.60 (0.34-0.86) 

SCL-90 GSI, mean (95% CI): 

4-mo FU: 

G1: 0.52 (0.29-0.75) (P = NR) 

G3: 0.49 (0.22-0.76) (P = NR) 

8-mo FU: 

G1: 0.45 (0.22-0.68) (P = NR) 

G3: 0.45 (0.22-0.68) (P = NR) 

12-mo FU: 

G1: 0.46 (0.16-0.76) (P = NR) 

G3: 0.46 (0.21-0.69) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI, kg/m2 mean 

(95% CI): 

G1: 22.5 (20.8-24.1) 

(P = NR) 

G3: 22.5 (21.3-23.8) 

(P = NR) 

End of tx: 

G1: 23.4 (21.4-25.5) 

(P = NR) 

G3: 22.6 (21.0-24.2) 

(P = NR)

BMI, kg/m2 mean (95% CI): 

4-mo FU: 

G1: 23.3 (20.9-25.7) (P = NR) 

G3: 22.4 21.2-23.6) (P = NR) 

8-mo FU: 

G1: 23.1 (21.1-25.1) (P = NR) 

G3: 22.1 (20.6-23.5) (P = NR) 

12-mo FU: 

G1: 22.2 (20.9-23.5) (P = NR) 

G3: 21.6 (20.4-22.8) (P = NR) 

Diff over time (P < 0.0005) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BDI, mean (95% CI): 

G1: 24.1 (19.8-28.3) 

G3: 24.7 (17.8-31.6) 

End of tx: 

G1: 10.3 (5.1-15.4) 

G3: 11.7 (6.5-17.0)

BDI, mean (95% CI): 

4-mo FU: 

G1: 7.5 (3.1-11.9) (P = NR) 

G3: 8.8 (2.6-15.1) (P = NR) 

8-mo FU: 

G1: 6.0 (2.6-9.4) (P = NR) 

G3: 9.7 (3.5-15.9) (P = NR) 

12-mo FU: 

G1: 8.3 (2.3-14.2) (P = NR) 

G3: 7.7 (2.9-12.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

 

RSE, mean (95% CI): 

G1: 20.8 (19.0-22.5) 

G3: 21.3 (19.3-23.3) 

End of tx: 

G1: 27.1 (23.6-30.5) 

G3: 25.2 (22.8-27.7)

RSE, mean (95% CI): 

4-mo FU: 

G1: 27.4 (23.9-30.8) (P = NR) 

G3: 28.0 (24.3-31.7) (P = NR) 

8-mo FU: 

G1: 29.2 (26.2-32.2) (P = NR) 

G3: 28.0 (23.9-32.1) (P = NR) 

12-mo FU: 

G1: 28.9 (25.6-32.1) (P = NR) 

G3: 27.0 (22.6-31.4) (P = NR) 

Diff over time (P < 0.0005) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-466 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

*Geometric means (N = 37 for objective BE; N = 25 and N 

= 10 for vomiting and laxative misuse, respectively) 

Laxative misuse, per 28 days, 

mean (95% CI): 

G1: 4.6 (1.4-12.2) 

G3: 16.8 (5.3-49.1) 

(P = NS) 

Laxative misuse, per 28 days, mean (95% CI) (N = 19): 

End of tx: 

G1: 0.3 (-0.3-1.5) (P = NR) 

G3: 1.6 (-0.8-30.1) (P = NR) 

4-mo FU: 

G1: 0.3 (-0.1-1.8) (P = NR) 

G3: 1.5 (-0.8-32.1) (P = NR) 

8-mo FU: 

G1: 0.4 (-0.4-2.3) (P = NR) 

G3: 1.0 (-0.7-12.8) (P = NR) 

12-mo FU: 

G1: 0.9 (-0.4-4.3) (P = NR) 

G3: 0.8 (-0.7-7.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Sample too small to assess 

Author, yr: 

Fairburn, Jones et al., 

1993 

(continued) 

EDE-Attitudes to shape, mean 

(95% CI): 

G1: 4.2 (3.6-4.8) 

G3: 3.7 (3.0-4.4) 

(P = NS) 

EDE-Attitudes to shape, mean (95% CI): 

End of tx: 

G1: 2.1 (1.5-2.7) (P = NR) 

G3: 2.5 (1.9-3.1) (P = NR) 

4-mo FU: 

G1: 2.1 (1.5-2.6) (P = NR) 

G3: 2.1 (1.3-2.8) (P = NR) 

8-mo FU: 

G1: 1.9 (1.2-2.6) (P = NR) 

G3: 1.9 (1.3-2.6) (P = NR) 

12-mo FU: 

G1: 1.9 (1.3-2.4) (P = NR) 

G3: 1.7 (1.0-2.4) (P = NR) 

Diff over time (P = 0.007) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-467 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-468 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-Attitudes to wt, mean 

(95% CI): 

G1: 4.3 (3.7-4.9) 

G3: 3.8 (3.0-4.6) 

(P = NS) 

EDE-Attitudes to wt, mean (95% CI): 

End of tx: 

G1: 1.7 (1.1-2.3) (P = NR) 

G3: 2.3 (1.7-2.9) (P = NR)

4-mo FU: 

G1: 1.7 (1.1-2.4) (P = NR) 

G3: 2.0 (1.3-2.7) (P = NR) 

8-mo FU: 

G1: 1.8 (1.2-2.4) (P = NR) 

G3: 2.1 (1.4-2.7) (P = NR) 

12-mo FU: 

G1: 1.8 (1.2-2.4) (P = NR) 

G3: 1.8 (1.1-2.5) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EAT scores, mean (95% CI): 

G1: 45.7 (38.8-52.5) 

G3: 45.2 (36.5-53.9) 

(P = NS) 

EAT scores (N = 37), mean (95% CI): 

End of tx: 

G1: 15.4 (8.7-22.1) (P = NR) 

G3: 27.6 (17.0-38.2) (P = NR) 

4-mo FU: 

G1: 16.5 (9.2-23.8) (P = NR) 

G3: 18.7 (10.4-26.9) (P = NR) 

8-mo FU: 

G1: 14.5 (9.1-19.8) (P = NR) 

G3: 20.3 (11.3-29.3) (P = NR) 

12-mo FU: 

G1: 16.3 (7.9-24.7) (P = NR) 

G3: 20.4 (9.9-30.8) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Fairburn, Jones et al., 

1993 

(continued) 

Abstinence, ceasing to have episodes of uncontrolled 

overeating (both objective and subjective), and 

ceasing to take laxatives and vomit: 

12-mo FU:

G1: 36% (N = 9/25) 

G2: 20% (N = 5/20) 

G3: 44% (N = 11/25) 

Diff between groups (P < 0.05) 

G1 better than G2, odds ratio (CI): 2.49 (1.34-4.62) (P = 

0.05) 

G1 vs. G3 (P = NS)
C-469 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-470 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, year: 

Fairburn, Peveler et al., 

1993 

Companion articles: 

Fairburn et al., 1991 

Fairburn, Jones et al., 

1993 

Setting: 

Outpatient Clinic; 

Recruited from county 

of Oxfordshire, England 

Enrollment period: 

NR 

Research objective: 

To assess predictors of 12- 

month outcome in patients 

who received short-term 

psychological tx for BN; also 

to test the specific hypothesis 

that high attitudinal 

disturbance predicts poorer 

outcome in patients who 

initially respond to short-term 

tx. 

Groups: 

G1: CBT (N = 25) 

G2: BT (N = 25) 

G3: IPT (N = 25) 

Enrollment: 

• 126 individuals referred 

from physicians for a study 

on tx of BN offered 

screening appointments 

• 117 (85%) screened 

• 83 met study criteria 

• 3 excluded due to major 

psychiatric condition; 2 

excluded due to 

unavailability; 3 failed 

attendance to entry 

• 75 enrolled and 

randomized 

• 66 (88%) met full DSM IIIR criteria for BN; 9 met all 

criteria except severity of 

attitudinal disturbance 

• 60 (80%) completed tx: 

 G1: N = 21 (84%) 

 G2: N = 18 (72%) 

 G3: N = 21 (84%) 

• 50 (67%) completed FU 

• On the Personality 

Diagnostic Questionnaire, 

non-completers had higher 

score (56.6 ±15.6) 

compared to completers 

(46.1 ± 17.1) (P = 0.02) 

N = 75 unless otherwise 

indicated. 

Age, yrs, mean (95% CI): 

24.2 (22.8-25.6) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Vomiting frequency, 

days/mo, mean (CI) 

(N = 56): 

28.9 (23.2-34.7)

Laxative frequency, days/ 

mo, mean (CI) (N = 26): 

14.7 (8.9-20.4) 

Duration of BN, yrs, mean 

(CI): 

4.4 (3.4-5.3) 

Current BMI, kg/m2, mean 

(CI): 

22.2 (21.5-23.0) 

Highest BMI since 

menarche, kg/m2, mean 

(CI): 

25.3 (24.4-26.3) 

Lowest BMI since 

menarche, kg/m2, mean 

(CI): 

18.3 (17.6-18.9) 

EAT score, mean (CI): 

48.2 (44.3-52.0) 

SCL-90 GSI, mean (CI): 

1.4 (1.2-1.5) 

BDI, mean (CI): 

24.0 (21.4-26.6) 

Practiced vomiting: 

56% 

Used laxatives: 

35% 

Did neither: 

12% 
C-471 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

For prior 6 mos, met criteria 

for BN (DSM IIII-R); aged 

17 yrs or older; BMI > 17 

Exclusion: 

Patients with concurrent AN 

Each tx group involved 19, 

40-50 minutes outpatient 

sessions over 18 wks; For 

mo 1, sessions conducted 

2x/wk, then fortnightly for 

duration of study. 

CBT occurred in 3 stages: 

wks 1-4, focused on 

behaviorally enhancing 

control over eating, 

including self-monitoring; 

wks 5-12, cognitively 

focused; wks 13-18, 

maintenance of progress 

following end of tx. 

BT tx focused exclusively 

on the normalization of 

eating habits, including selfmonitoring. 

IPT used manual developed 

by Klerman et al. (1984), 

diverging from protocol only 

in the first phase of tx, 

focusing on ED (rather than 

depression.) 

At baseline at end-of tx, 

eating-specific issues, 

global fx, and depression 

were assessed using EDE, 

EAT, SCL-90, and BDI. 

Patients judged not to need 

immediate further tx entered 

into closed 1-yr FU. 

Based on prior research, 

pre-tx predictor variables 

selected for use in 

regression modeling. They 

included: ED duration, ED 

age of onset, hx of AN, 

objective binge frequency, 

dietary restraint severity, 

attitude disturbance (sum of 

EDE shape and wt 

concerns), ED 

psychopathology severity 

(sum of 5 EDE scales), 

SCL-90 GSI severity, selfesteem, personality 

disturbance. 

Linear regression to predict 

the continuous Outcome 

Index (overall severity of 

ED psychopathology); 

logistic regression to 

predict 2 categorical 

outcome indexes (1: 

decline in ED 

psychopathology within 1 

SD of mean of comparison 

sample, yes/no; 2: 

cessation of objective and 

subjective bingeing, 

vomiting, and laxative use, 

yes/no). 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NA 

Funding: 

Welcome Trust 
C-472 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, year: 

Fairburn, Peveler et 

al., 1993 

No sig group diffs in objective 

binge episodes, dietary restraint, 

vomiting frequency, laxative 

misuse. 

All analyses based on data from 50 patients who remained 

in the study to the end of FU. 

Relation between degree of pre-tx attitudinal 

disturbance and three indexes of outcome: 

Outcome 1: Global EDE, mean (SD): 1.40 (1.03) 

Degree of Attitudinal disturbance at pretreatment: 

Low 0 – 7 (N = 12): 1.55 (1.15) 

Moderate 8 – 10 (N = 20): 1.76 (1.10) 

Severe 11 – 12 (N = 18): 0.93 (0.70)

Diff between groups (P < 0.05) 

Moderate did worst, most severe did best. 

Outcome 2: Eating disorder psychopathology within 1 

SD of mean for same age women, N (%): 32 (64%): 

Degree of Attitudinal disturbance at pretreatment: 

Low (0 – 7) (N = 12): 8 (67%) 

Moderate (8 – 10) (N = 20): 9 (45%) 

Severe (11 – 12) (N = 18): 15 (83%) 

Diff between groups (P < 0.05) 

Intermediate did worst, most severe did best. 

Relative Risk (95% CI) for Outcome 2: 

Degree of Attitudinal disturbance: 

Moderate (8 – 10): 1.22 (0.22 – 6.82) 

Severe (11 – 12): 0.10 (0.01 – 1.11) 

Outcome 3: Met strict criteria for good behavioral 

outcome (ceased episodes of uncontrolled eating, 

vomiting, laxative use), N (%): 22 (44%): 

Degree of Attitudinal disturbance at pretreatment: 

Low (0 – 7) (N = 12): 5 (42%) 

Moderate (8 – 10) (N = 20): 5 (25%) 

Severe (11 – 12) (N = 18): 12 (67%) 

Diff between groups (P < 0.05) 

Intermediate did worst, most severe did best. 

RR (95% CI) for Outcome 3: 

Degree of Attitudinal disturbance: 

Moderate (8 – 10): 1.32 (0.25 – 7.17) 

Severe (11 – 12): 0.15 (0.02 – 1.25) 

Relapse at FU (no longer meeting Outcome 3), N (%): 

Degree of Attitudinal disturbance: 

Low (0 – 7): 1/11 (9%) 

Moderate (8 – 10): 2/7 (29%) 

Severe (11 – 12): 3/4 (75%) 

RR (95% CI) relapse after adjusting for tx type: 

Degree of attitudinal disturbance: 

Moderate (8 – 10): 3.4 (0.2 – 54.1) 

Severe (11 – 12): 45.2 (0.9 – 1,339.0) 
C-473 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

No sig group diffs global 

severity index or BDI. 

 
C-474 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Garner et al., 1993 

Setting: 

Outpatient 

Toronto, Canada 

Enrollment period: 

NR 

Research objective: 

To compare CBT and brief 

psychodynamic (“supportiveexpressive”) therapy, both 

delivered in an individual 

format, according to specific 

guidelines, and by 

experienced therapists. 

Groups: 

G1: CBT (N = 30) 

G2: Supportive-Expressive 

(N = 30) 

Enrollment: 

Referred to study and 

screened (N = 92) 

Met inclusion criteria and 

enrolled (N = 60) 

Stratified by: 

• Duration of illness ( < 3 

yrs, ≥ 3 yrs). 

• Current wt (86 – 110% 

and > 111% of MPMW) 

• Probably hx of AN (adult 

wt < 85% of MPMW) 

Completers (N: 50) 

G1: 25 

G2: 25 

In a few cases a patient who 

should have been assigned 

to 1 tx was assigned to the 

other because therapists in 

the assigned condition were 

unavailable to accept a 

referral at the time. Also, any 

patient who dropped out was 

replaced by the next suitable 

patient, who was assigned to 

the same tx cell, in order to 

obtain 25 patients who 

completed each tx. 

Age, mean (SD): 

G1: 23.7 (4.4) 

G2: 24.6 (4.0) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Height, in, mean (SD): 

G1: 65.6 (3.0) 

G2: 66.1 (2.5) 

(P = NS) 

Wt, lbs, mean (SD): 

G1: 126.4 (16.4) 

G2: 126.6 (13.1) 

(P = NS) 

Current wt, % of matched 

population mean (MPMW), 

mean (SD): 

G1: 95.3 (9.8) 

G2: 94.9 (7.9) 

(P = NS) 

Maximum wt, % MPMW, 

mean (SD): 

G1: 108.6 (9.9) 

G2: 111.8 (12.7) 

(P = NS) 

Min wt. % MPMW, mean 

(SD): 

G1: 84.3 (10.0) 

G2: 82.9 (8.7) 

(P = NS) 

Duration of illness, mo, 

mean (SD): 

G1: 71.8 (47.6) 

G2: 71.2 (40.2) 

(P = NS) 

Binge episodes, past 28 

days, mean (SD) (range): 

27.5 (25.1) (0-140) 

Vomiting episodes, past 28 

days, mean (SD) (range): 

42.2 (32.6) (8-154) 
C-475 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Russell criteria for BN 

and DSM III-R criteria 

with the exception that 

a min avg of 2 binges 

a wk involving “large” 

amounts of food was 

not required; min of 2 

episodes of vomiting a 

wk for the past mo, 

min duration of illness 

of 1 yr; present body 

wt of 85% to 120% 

MPMW; 18 to 35 yrs 

old 

Exclusion: 

Current tx for BN 

19, 45 to 60 minutes individual 

sessions delivered over 18 wks. 

Sessions occurred twice a wk during 

first mo, once a wk for the next 2 mo, 

and once every other wk for the final 

6 wks. 

G1: followed Fairburn’s (1985) CBT 

manual 

G2: Followed Luborsky’s (1984) 

manual, supplemented by 

psychodynamic writings on ED. 

Nondirective and emphasized 

listening to patient and helping 

identify problems and solutions. 

Repeated measures 

ANOVA. ANCOVA 

(Pre-tx scores as 

covariates). 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

NA 

Funding: 

Health and Welfare Canada 

project grant, NATO Grants for 

Collaborative Research, 

Research Associate Award, 

Research FellowshiP from the 

Ontario Mental Health 

Foundation 
C-476 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

 **For all outcome variables diff over time reported to be 

sig in text. 

Binge episodes, past 28 days, 

mean (SD): 

G1: 26.3 (30.2) 

G2: 31.1 (20.3) 

(P = NS)

Binge episodes, past 28 days, mean (SD): 

G1: 7.1 (14.1) 

G2: 9.6 (11.0) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Vomiting episodes, past 28 days, 

mean (SD): 

G1: 41.4 (38.7) 

G2: 44.1 (30.5) 

(P = NS)

Vomiting episodes, past 28 days, mean (SD): 

G1: 7.5 (13.5) (P = NR) 

G2: 16.7 (18.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Reduction in vomiting frequency, %: 

G1: 81.9 

G2: 62.1 

Diff between groups (P = NS) 

Improvement in vomiting frequency of at least 50%: 

G1: 92% 

G2: 68.0% 

Diff between groups (P = NR) 

Vomiting abstinence, past 28 days, N (%): 

G1: 9 (36.0%) 

G2: 3 (12.0%) 

Diff between groups (P = NR)

EAT Dieting, mean (SD): 

G1: 20.6 (8.6) 

G2: 19.7 (7.7) 

(P = NS)

EAT Dieting, mean (SD): 

G1: 6.8 (5.9) (P = NR) 

G2: 12.5 (9.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.008) 

G1 better than G2

EAT Bulimia and food 

preoccupation, mean (SD): 

G1: 11.2 (4.3) 

G2: 10.9 (4.0) 

(P = NS)

EAT Bulimia and food preoccupation, mean (SD): 

G1: 2.0 (3.7) (P = NR) 

G2: 4.9 (4.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.01) 

G1 better than G2

EAT Oral control, mean (SD): 

G1: 2.9 (2.9) 

G2: 2.8 (3.6) 

(P = NS)

EAT Oral control, mean (SD): 

G1: 1.6 (1.4) (P = NR) 

G2: 1.3 (1.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Garner et al., 1993 

(continued) 

EAT Total, mean (SD): 

G1: 34.7 (12.7) 

G2: 33.2 (11.6) 

(P = NS)

EAT Total, mean (SD): 

G1: 10.4 (9.1) (P = NR) 

G2: 18.7 (14.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.01) 

G1 better than G2 
C-477 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological Measures Biomarkers 

Baseline Outcome Baseline Outcome 

BDI, mean (SD): 

G1: 16.8 (9.9) 

G2: 18.7 (9.4) 

(P = NS) 

BDI, mean (SD): 

G1: 7.5 (10.6) (P = NR) 

G2: 13.4 (9.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.05) 

G1 better than G2 

Wt (% matched 

population mean 

wt), mean (SD): 

G1: 95.3 (9.8) 

G2: 94.9 (7.9) 

(P = NS) 

Wt gain, lb, mean: 

G1: 6.6 (100.4% MPMW, P = NR) 

G2: 3.0 (97.6% MPMW, P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

SCL-90-R, mean (SD): 

G1: 1.1 (0.7) 

G2: 1.3 (0.6) 

(P = NS) 

SCL-90-R, mean (SD): 

G1: 0.6 (0.7) (P = NR) 

G2: 1.0 (0.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.03) 

G1 better than G2 

RSE, mean (SD): 

G1: 25.0 (5.7) 

G2: 23.7 (5.3) 

(P = NS) 

RSE, mean (SD): 

G1: 29.4 (6.2) (P = NR) 

G2: 25.6 (5.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.03) 

G1 better than G2 

Millon Borderline 

subscale, mean (SD): 

G1: 73.4 (17.9) 

G2: 75.0 (13.3) 

(P = NS) 

Millon Borderline subscale, 

mean (SD): 

G1: 56.8 (17.4) (P = NR) 

G2: 73.7 (20.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.005) 

G1 better than G2 

Millon Dysthymia 

subscale, mean (SD): 

G1: 85.1 (17.4) 

G2: 89.2 (15.4) 

(P = NS) 

Millon Dysthymia subscale, 

mean (SD): 

G1: 65.6 (18.3) (P = NR) 

G2: 88.1 (16.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0001) 

G1 better than G2 

 
C-478 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Dietary restraint, mean (SD): 

G1: 3.7 (1.3) 

G2: 3.2 (1.5) 

(P = NS)

EDE Dietary restraint, mean (SD): 

G1: 1.5 (1.7) (P = NR) 

G2: 2.5 (1.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.009) 

G1 better than G2 

EDE Attitudes toward shape, mean 

(SD): G1: 3.3 (1.4) 

G2: 3.6 (1.0) 

(P = NS)

EDE Attitudes toward shape, mean (SD): 

G1: 2.0 (1.3) (P = NR) 

G2: 2.9 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G1 better than G2 

EDE Attitudes toward wt, mean 

(SD): 

G1: 2.4 (1.4) 

G2: 2.9 (1.1) 

(P = NS)

EDE Attitudes toward wt, mean (SD): 

G1: 1.6 (1.2) (P = NR) 

G2: 2.4 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE Bulimia: 

G1: NR 

G2: NR

EDE Bulimia: 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE Eating concerns: 

G1: NR 

G2: NR

EDE Eating concerns: 

G1: NR 

G2: NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.02) 

G1 better than G2 

EDI Drive for thinness: mean (SD) 

G1: 14.3 (4.4) 

G2: 14.1 (5.2) 

(P = NS) 

EDI Drive for thinness, mean (SD): 

G1: 5.9 (6.3) (P = NR) 

G2: 9.4 (6.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDI Bulimia, mean (SD): 

G1: 11.6 (4.9) 

G2: 10.2 (6.2) 

(P = NS)

EDI Bulimia, mean (SD): 

G1: 2.2 (3.9) (P = NR) 

G2: 4.8 (4.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.002) 

G1 better than G2

EDI Body dissatisfaction, mean 

(SD): 

G1: 15.5 (8.4) 

G2: 16.7 (8.0) 

(P = NS)

EDI Body dissatisfaction, mean (SD): 

G1: 11.7 (9.0) (P = NR) 

G2: 13.7 (7.5) (P = NR)

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Garner et al., 1993 

(continued) 

Treatment Satisfaction: 

Tx X Outcome Interaction (P = 0.02). G1 with good 

outcome were more satisfied with tx than G1 with poor 

outcomes or G2 with either good or poor outcomes. 

Good outcome = vomiting ≤ 4 episodes/mo)
C-479 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological Measures Biomarkers 

Baseline Outcome Baseline Outcome 

This page intentionally left blank. 
C-480 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Griffiths et al., 1994 

Setting: 

Teaching hospital, 

Sydney, Australia 

Outpatient 

Enrollment period: 

NR 

Research objective: 

Compare immediate post-tx 

effects of CBT, HBT and a 

wait list control group in 

treating BN. 

Groups: 

G1: Wait list control (N = 28) 

G2: CBT (N = 23) 

G3: Hypnobehavioral 

therapy (HBT) (N = 27) 

Enrollment: 

• Participants were 

recruited via media as 

well as referrals from the 

Eating Disorders Clinic 

within test site. 

• 130 participants 

presented with symptoms 

of BN 

• 85 completed the 

assessments and met 

criteria 

• 78 participants entered tx 

and were randomized to 

one of the 3 tx groups 

• 63 participants completed 

tx. 

Total Sample (N = 78)

Age, yrs, mean (SD): 

Total sample: 

25.91 (5.73) 

G1: 27.1 (1.24)

G2+G3: 24.4 (1.2)

(P < 0.05) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

21.89 (2.01) 

Height, cms, mean (SD): 

G1: NR 

G2: 165.60 (7.04) 

G3: 162.45 (5.35) 

(P < 0.05) 

Duration of bulimic 

symptoms, yrs, mean (SD):

Total: 6.19 (5.08) 

G1: NR 

G2: 5.40 (2.31) 

G3: 3.31 (2.99) 

(P < 0.05) 

Duration of objective 

bulimic episodes, yrs, 

mean (SD): 

Total: 4.54 (5.15) 

G1: NR 

G2: 3.42 (3.14) 

G3: 1.96 (3.04) 

(P < 0.05) 

Frequency (days/mo) of 

objective bulimic episodes, 

mean (SD): 

14.18 (7.78)

Frequency (days/mo) of 

self-induced 

vomiting,mean (SD): 

15.76 (10.40) 

Frequency (days/mo) of 

laxative abuse, mean (SD): 

4.69 (8.67) 

Hx of AN: 

25.6% 
C-481 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; age 17 to 50 

yrs; BMI 18 to 26; no 

more than 2 prior 

inpatient admissions 

for an ED; willing to 

participate in research 

and FU; willing to not 

seek additional tx 

during research study. 

Exclusion: 

Concurrent 

psychological or 

pharmacological tx; 

Coexisting major 

psychiatric disorder 

other than depressive 

or anxiety state or 

personality disorder; 

Physical dependence 

on drugs or alcohol; 

Suicide risk or poor 

physical health 

indicating need for 

hospitalization. 

Both forms of manualized tx were 

and conducted for 8 wks and 

included 7 individual, 50 to 60 minute 

long sessions (6 with therapist, 1 with 

dietitian). CBT manual based on 

Fairburn (1985); HBT manual based 

on Griffiths (1989). 

HBT: used hypnosis to reinforce what 

was taught within the CBT 

component. CBT: cognitive 

explanation of BN and used cognitive 

techniques. 

Waitlist: did not complete the full 

assessment at baseline. They were 

asked to keep a baseline eating diary 

for 1 wk after their intake interview 

and another 1-wk diary before 

attending their appointment 8 wks 

later. They were not contacted during 

the tx. 

T-tests and chi-square 

analyses done to 

examine baseline 

Diffs. MANOVA used 

to explore group Diffs. 

The variables of 

‘episodes of bingeing’ 

and ‘episodes of 

purging’ underwent 

log transformations. 

Post tx for G1 refers 

to the last wk of 

waiting for tx (wk 9). 

Score: 

Poor 

Intent to treat: 

Yes; however only completer 

results are presented in tables.

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NR 
C-482 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Griffiths et al., 1994 

(continued) 

 Serious psychological 

condition: 

20.5% 

Suicide attempts: 

24.4% 

Abused alcohol/drugs or 

both substances: 

21.8% 

Previous tx for AN, BN or 

obesity: 

28.2% 

Marital status: 

Single: 78.2% 

Married: 12.8% 

Separated: 2.6% 

Divorced: 5.1% 

Widowed: 1.3% 

Employment status: 

Employed: 64.1% 

Students: 14.1% 

Unemployed: 11.5% 

Food-related employment: 

6.5% 

Home duties: 3.8% 
C-483 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-484 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EAT-40, mean (SD): 

G1: 53 (16.06) 

G2: 46.63 (16.04) 

G3: 47.62 (19.91) 

(P = NR) 

EAT-40, mean (SD): 

G1: 45.73 (17.99) (P = NR) 

G2: 18.79 (11.65) (P = NR) 

G3: 25.91 (20.56) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS) 

EAT-26 – Dieting, mean (SD): 

G1: 21.41 (7.86) 

G2: 19.53 (9.62) 

G3: 20.67 (9.19) 

(P = NR)

EAT-26 – Dieting, mean (SD): 

G1: 18.96 (9.36) (P = NR) 

G2: 7.53 (6.48) (P = NR) 

G3: 11.19 (10.54) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

EAT-26 – Bulimia and Food 

Preoccupation, mean (SD): 

G1: 12.73 (3.72) 

G2: 11.53 (3.85) 

G3: 10.86 (4.77) 

(P = NR)

EAT-26 – Bulimia and Food Preoccupation, 

mean (SD): 

G1: 10.55 (5.18) (P = NR) 

G2: 1.95 (2.55) (P = NR) 

G3: 3.33 (3.93) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

EAT-26 – Oral Control, mean (SD): 

G1: 3.41 (1.27) 

G2: 2.16 (0.74) 

G3: 3.67 (1.97) 

G2 lower than G3 (P < 0.05)

EAT-26 – Oral Control, mean (SD): 

G1: 10.55 (5.18) (P = NR) 

G2: 1.95 (2.55) (P = NR) 

G3: 3.33 (3.93) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

Author, yr: 

Griffiths et al., 1994 

(continued) 

EDI-DT, mean (SD): 

G1: 15.46 (4.22) 

G2: 14.32 (5.39) 

G3: 14.95 (5.38) 

(P = NR)

EDI-DT, mean (SD): 

G1: 13.55 (5.33) (P = NR) 

G2: 7.58 (6.17) (P = NR) 

G3: 8.62 (7.07) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-485 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-486 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI-B, mean (SD): 

G1: 12.18 (4.24) 

G2: 11.58 (4.07) 

G3: 10.76 (4.97) 

(P = NR)

EDI-B, mean (SD): 

G1: 11.14 (5.14) (P = NR) 

G2: 3.32 (5.24) (P = NR) 

G3: 3.76 (4.63) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

EDI-BD, mean D (SD): 

G1: 18.32 (8.69) 

G2: 19.47 (7.94) 

G3: 18.09 (7.27) 

(P = NR)

EDI-BD, mean (SD): 

G1: 17.41 (8.17) (P = NR) 

G2: 14.21 (8.65) (P = NR) 

G3: 12.62 (7.95) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Number of days bingeing, mean (SD): 

G1: 4.77 (1.83) 

G2: 3.18 (1.49) 

G3: 3.95 (1.67) 

(P = NR)

Number of days bingeing, mean (SD): 

G1: 4.14 (2.21) (P = NR) 

G2: 1.25 (1.45) (P = NR) 

G3: 1.62 (2.09) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.01) 

G2 vs. G3 (P = NS)

Number of days purging, mean (SD): 

G1: 5.27 (2.00) 

G2: 3.38 (2.29) 

G3: 3.86 (2.46) 

(P = NR)

Number of days purging, mean (SD): 

G1: 4.95 (2.38) (P = NR) 

G2: 0.95 (1.23) (P = NR) 

G3: 1.67 (1.98) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

Episodes bingeing, mean (SD): 

G1: 9.82 (9.49) 

G2: 4.73 (2.79) 

G3: 6.38 (6.12) 

(P = NR)

Episodes bingeing, mean (SD): 

G1: 8.77 (11.05) (P = NR) 

G2: 1.50 (2.01) (P = NR) 

G3: 2.00 (2.62) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

Episodes purging, mean (SD): 

G1: 11.27 (9.87) 

G2: 6.48 (7.43) 

G3: 8.55 (9.94) 

(P = NR)

Episodes purging, mean (SD): 

G1: 11.27 (12.09) (P = NR) 

G2: 1.25 (1.77) (P = NR) 

G3: 2.19 (3.52) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time G2+G3 

better than G1 (P < 0.001) 

G2 vs. G3 (P = NS)

Author, yr: 

Griffiths et al., 1994 

(continued) 

Abstinence from bingeing: 

G1: 4.5% 

G2: 50% 

G3: 43% 

(P = NR)
C-487 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-488 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hsu et al., 2001 

Setting: 

Outpatient 

Boston, MA, USA 

Enrollment period: 

NR 

Research objective: 

To compare the 

efficacy of CT, NT, 

the combination 

(CNT), against a 

control support group

in the tx of BN. 

Groups: 

G1: Nutritional (NT) (N = 23) 

G2: Cognitive Therapy (CT) (N = 26) 

G3: Combined cognitive-nutritional 

(CNT) (N = 27) 

G4: Support (SG) (N = 24) 

Enrollment: 

100 randomized (stratified according 

to presence of concurrent major 

depression) 

Completion, N (%): 

Total sample: 73 (73%) 

G1: 14 (61%) 

G2: 22 (85%) 

G3: 24 (89%) 

G4: 13 (54%). 

G3 vs. G4 (P = 0.006) 

G2 vs. G4 (P = 0.02) 

G3 vs. G1 (P = 0.02) 

Wks in tx, mean (SD): 

G1: 10.91 (4.42) 

G2: 12.92 (2.91) 

G3: 12.78 (3.56) 

G4: 9.21 (5.61) 

G3 vs. G4 (P = 0.007) 

G2 vs. G4 (P = 0.01) 

G3 vs. G1 (P = 0.039) 

Age, yrs, mean (SD): 

Total sample: 24.5 (6.4) 

G1: 24.2 (5.6) 

G2: 23.3 (5.0) 

G3: 24.1 (5.3) 

G4: 26.5 (9.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of BN, yrs, 

mean (SD): 

Total sample: 5.7 (4.5)

G1: 5.0 (4.4) 

G2: 5.5 (3.2) 

G3: 5.9 (3.7) 

G4: 6.4 (6.3) 

(P = NS) 

Hx of AN, N (%): 

Total sample: 41 (41%) 

G1: 9 (39%) 

G2: 10 (38%) 

G3: 11 (4%1) 

G4: 11 (46%) 

(P = NS) 

Previous tx for BN, N 

(%): 

Total sample: 46 (46%) 

G1: 11 (48%) 

G2: 11 (42%) 

G3: 11 (41%) 

G4: 13 (54%) 

(P = NS) 

% ABW, mean (SD): 

Total sample: 112.2 (9.5) 

G1: 114.5 (9.4) 

G2: 112.5 (9.6) 

G3: 110.2 (8.7) 

G4: 111.9 (10.4) 

(P = NS) 
C-489 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, DSM III-R 

criteria for BN, within 

85 – 125% of IBW, 

between 17 – 45 yrs 

old, BE and vomiting 

at least 3 times per wk 

in previous 6 mo, 

absence of: alcohol or 

substance abuse in 

previous 12 mo, 

psychotic features, 

suicide attempt within 

last 6 mo, psychotropic 

meds. 

Exclusion: 

None 

Length: 14 wks (2 sessions for the 

first wk and then wkly) 

CNT: 16 2-hr sessions (1 hr of each) 

NT: 16 1-hr sessions aimed at 

helping patient to understand good 

nutrition, nutritional needs, 

relationship between nutrition and 

BE, meal planning, buying meals. 

CT: 16 1-hr sessions aimed at 

helping identify antecedents of 

bulimic episodes, 

thoughts/feelings/function/beliefs of 

episodes. Help develop alternative 

coping bx, cognitive restructuring, 

problem solving. 6 sessions of EXRP 

SG: 14, 90-minute sessions led by 2 

recovered patients and a mother of a 

recovered patient. Open support 

groups of 6-8 patients. 

Baseline 

characteristics:

ANOVA and chisquare 

Outcomes: chisquared contingency 

tests, Kruskal-Wallis 

non-parametric 

ANOVA, MannWhitney tests, 

ANCOVA followed by 

specific paired 

comparisons using 

least sig Diff. 

Completion rates 

and abstinence 

relative to type of tx:

Multiple linear and 

logistic regression 

with covariates 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NICHD 

General Clinical Research 

Center at New England 

Medical Center funded by the 

National Center for Research 

Resources of the NIH 
C-490 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge episodes/wk, mean (SD): 

Total sample: 10.9 (9.5)

G1: 12.3 (10.8) 

G2: 7.2 (4.3) 

G3: 12.1 (7.0) 

G4: 12.2 (13.4) 

(P = NS) 

Change in binge episodes/wk, mean (SD): 

G1: -8.39 (10.43) (P = NR) 

G2: -4.92 (4.97) (P = NR) 

G3: -9.41 (7.59) (P = NR) 

G4: -5.79 (11.44) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups in change over time (P = NS) 

Vomiting episodes/wk, mean (SD): 

Total sample: 12.2 (10.3) 

G1: 13.3 (11.2) 

G2: 7.7 (5.0) 

G3 13.4 (9.2) 

G4: 14.5 (13.6) 

(P = NS) 

Change in vomit episodes/wk, mean (SD): 

G1: -9.43 (11.42) (P = NR) 

G2: -5.73 (5.02) (P = NR) 

G3: -10.56 (8.42) (P = NR) 

G4: -4.58 (13.28) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups in change over time (P = NS) 

Meals eaten/wk, mean (SD): 

Total sample: 10.8 (6.7)

G1: 11.4 (6.8)

G2: 10.0 (7.1) 

G3: 10.9 (5.8) 

G4: 11.0 (7.3) 

(P = NS) 

Change in meals eaten/wk, mean (SD): 

G1: 4.87 (6.97) (P = NR) 

G2: 5.42 (6.50) (P = NR) 

G3: 7.07 (5.86) (P = NR) 

G4: 3.79 (7.83) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups in change over time (P = NS) 

Abstinence (no binge/purge in wk prior to post 

tx, N (%): 

G1: 4/23 (17%) 

G2: 9/26 (35%) 

G3: 14/27 (52%) 

G4: 5/24 (24%) 

G1 vs. G4 (P = NS) 

G2 vs. G4 (P = NS) 

G3 vs. G4 (P = 0.022) 

G3 vs. G1 (P = 0.011) 

EDI-Drive for Thinness: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in change over time (P = NR) 

G1 vs. G4 (P = NS) 

G2 vs. G4 (P = 0.011) 

G2 vs. G1 (P = NS) 

G3 vs. G4 (P < 0.001) 

G3 vs. G1 (P = 0.006) 

Author, yr: 

Hsu et al., 2001 

(continued) 

EDI-Bulimia: 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in change over time (P = NR) 

G1 vs. G4 (P = NS) 

G2 vs. G4 (P = NS) 

G2 vs. G1 (P = 0.029) 

G3 vs. G4 (P < 0.0045) 

G3 vs. G1 (P = 0.006) 
C-491 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS, mean (SD): 

Total sample: 17.64 (8.01) 

G1: 18.04 (7.54) 

G2: 14.92 (8.04) 

G3: 18.89 (8.28) 

G4: 18.79 (7.86) 

(P = NS) 

Change HDRS, mean (SD): 

G1: -5.96 (11.11) (P = NR) 

G2: -4.46 (7.98) (P = NR) 

G3: -8.33 (7.35) (P = NR) 

G4: -4.33 (8.08) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

 
C-492 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Laessle et al., 1991 

Setting: 

Munich, Germany; 

Sydney, Australia; 

outpatient 

Enrollment period: 

NR 

Research objective: 

To evaluate the efficacy 

of a nutritionalmanagement program 

which was aimed at 

modifying restrained 

eating vs. stress 

management in BN 

Groups: 

G1: Nutritional management (N = 27)

G2: Stress management (N = 28) 

Enrollment: 

Screened: N = 85 

Randomized: N = 55 

Drop out, N: 

G1: 5 

G2: 2 

(P = NS) 

Age, yrs, mean (SD): 

23.8 (3.8) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of Bulimic 

symptoms, yrs, mean 

(SD): 

7.5 (3.8) 

Bulimic episodes per wk, 

mean (SD): 

13.3 (10.8) 

Reported vomiting, N (%): 

50 (90.9) 

Reported laxative use, N 

(%): 

19 (34.5) 

Vomiting frequency, 

episodes per wk, mean 

(SD): 

14.8 (12.4) 

Current BMI, mean (SD): 

21.0 (1.8)

Max adult BMI, mean 

(SD): 

24.4 (4.2) 

Min adult BMI, mean (SD): 

G1: 18.2 (1.8) 

G2: 16.8 (2.1) 

(P < 0.01) 

Previously met criteria for 

AN, N (%): 

22 (40) 

Current substance abuse 

problems, N (%): 

7 (12.7) 

Previous psychiatric/ 

psychological tx, N: 

29 

AN = 7 

BN = 19 

Depression = 3 
C-493 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN, female age 18 to 

35 yrs, BMI between 

18 to 24, not more 

than 2 previous 

inpatient tx for 

psychiatric conditions, 

no co-existing major 

psychiatric disorder 

other than affective or 

anxiety, no indications 

for inpatient tx 

because of either a 

serious suicide risk or 

poor physical health. 

Exclusion: 

None 

Groups (co-led by 2 therapists) of 5-8 

participants in 15 two-hour sessions 

over a 3-mo period. The first 7 

sessions were the intensive phase 

within the first 3 wks. The remaining 8 

sessions were conducted on a wkly 

basis. Manuals were followed. 

G1: Discussed metabolic processes, 

energy requirements, body wt, 

biological and psychological effects of 

dieting; analysis of nutritional diaries 

and modification of inadequate 

patterns; advice on eating patterns, 

stimulus control, meal preparation 

was offered. 

G2: functional analysis of stressful 

situations relevant to BE; short term 

strategies to alter coping behavior in 

stressful situations, progressive 

muscle relaxation, problem solving, 

communication skills. No specific 

intervention to alter restrained eating, 

no individualized meal plan or 

homework. 

Repeated measures 

MANOVA with 1 

within factor (time) 

and 2 between factors 

(tx and center). 

Tested linear and 

quadratic trends over 

time. 

Tested separate 

models for the pre-tx 

to post-tx effects vs. 

the post-tx to 12 mo 

FU. 

Binge and vomiting 

behavior data were 

log-transformed. 

Fisher’s exact tests 

used to evaluate diffs 

in abstinence rates. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

1 patient hospitalized during 

FU 

Funding: 

NR 
C-494 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Laessle et al., 1991 

(continued) 

 Previous hospital 

admission, N: 

9 

AN = 6 

BN = 3 

Marital status, married or 

regular partner in 

heterosexual relationship, 

N (%): 

27 (49.1) 

Employment status, N (%): 

HS student: 6 (11.0) 

Tertiary student: 19 (34.5) 

Employed: 24 (42.6) 

Unemployed: 6 (11.0) 
C-495 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-496 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Baseline Outcomes 

Author, yr: 

Laessle et al., 1991 

(continued) 

Binge frequency, per wk, mean 

(SD): 

G1: 11.8 (10.6) 

G2: 14.0 (12.0) 

(P = NS) 

Binge frequency/wk, mean (SD): 

3 wks: 

G1: 4.0 (6.5) (P = NR) 

G2: 9.2 (13.0) (P = NR) 

Post-tx: 

G1: 3.5 (6.1) (P = NR) 

G2: 4.2 (7.2) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change over time (linear 

trend, P = NS) (quadratic trend, P < 0.05). 

After 3 wks, G1 better than G2 

6 mo: 

G1: 1.7 (3.4) (P = NR) 

G2: 3.0 (4.5) (P = NR) 

12 mo: 

G1: 1.0 (1.9) (P = NR) 

G2: 2.6 (4.8) (P = NR) 

Diff over time (P < 0.01) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Binge Abstinence rates, %: 

3 wks: 

G1: 29.6 

G2: 14.3 

(P = NS) 

Post-tx: 

G1: 40.7 

G2: 25.0 

(P = NS) 

6 mo: 

G1: 60 

G2: 25 

(P = 0.01) 

G1 better than G2 

12 mo: 

G1: 56 

G2: 25 

(P = 0.04) 

G1 better than G2 
C-497 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 19.5 (12.6) 

G2: 23.0 (9.5) 

(P = NS) 

BDI, mean (SD): 

3 wks: 

G1: 13.8 (11.8) (P = NR) 

G2: 12.2 (9.9) (P = NR) 

Post-tx: 

G1: 9.3 (9.2) (P = NR) 

G2: 11.8 (12.5) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NR)

Diff between group in change 

over time (P = NS) 

6 mo: 

G1: 8.3 (7.2) (P = NR) 

G2: 7.8 (9.5) (P = NR) 

12 mo: 

G1: 5.1 (8.0) (P = NR) 

G2: 8.3 (9.7) (P = NR) 

Diff between groups (P = NR)

Diff between group in change 

over time (P = NS) 

BMI, kg/m2

, mean (SD): 

G1: 21.2 (1.8) 

G2: 20.6 (1.9) 

(P = NS) 

BMI, kg/m2, mean (SD): 

3 wks: 

G1: 21.8 (1.7) (P = NR) 

G2: 20.7 (2.5) (P = NR) 

Post-tx: 

G1: 22.0 (1.9) (P = NR) 

G2: 20.7 (2.0) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

6 mo: 

G1:NR 

G2: NR 

12 mo: 

G1: NR 

G2: NR 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

STAI-State, mean (SD): 

G1: 49.6 (12.9) 

G2: 52.0 (13.2) 

(P = NS) 

STAI-State, mean (SD): 

3 wks: 

G1: 46.2 (14.4) (P = NR) 

G2: 45.8 (13.5) (P = NR) 

Post-tx: 

G1: 41.8 (13.8) (P = NR) 

G2: 43.4 (13.2) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

6 mo: 

G1: 13.5 (12.2) (P = NR) 

G2: 42.0 (14.5) (P = NR) 

12 mo: 

G1: 38.9 (12.8) (P = NR) 

G2: 44.2 (16.2) (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

 
C-498 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Baseline Outcomes 

Author, yr: 

Laessle et al., 1991 

(continued) 

Vomiting frequency, episodes per 

wk, mean (SD): 

G1: 11.3 (8.5) 

G2: 16.9 (13.9) 

(P = NS) 

Vomiting frequency/ wk, mean (SD): 

3 wks: 

G1: 4.5 (7.3) (P = NR) 

G2: 10.0 (13.6) (P = NR) 

Post-tx: 

G1: 3.7 (7.0) (P = NR) 

G2: 5.5 (8.8) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6 mo: 

G1: 2.2 (4.2) (P = NR) 

G2: 3.3 (4.5) (P = NR) 

12 mo: 

G1: 2.5 (5.2) (P = NR) 

G2: 3.1 (5.1) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Vomiting Abstinence rates (%): 

3 wks: 

G1: 40.7 

G2: 21.4 

(P = NS) 

Post-tx: 

G1: 48.1 

G2: 32.1 

(P = NS) 

6 mo: 

G1: 50 

G2: 29 

(P = NS) 

12 mo: 

G1: 56 

G2: 33 

(P = NS) 
C-499 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

STAI-Trait, mean (SD): 

G1: 55.2 (10.5) 

G2: 59.8 (7.4) 

(P = NS) 

STAI-Trait, mean (SD): 

3 wks: 

G1: 50.7 (13.2) (P = NR) 

G2: 52.2 (9.8) (P = NR) 

Post-tx: 

G1: 47.2 (12.3) (P = NR) 

G2: 45.4 (11.6) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.05) 

G2 better then G1 

6 mo: 

G1: 46.4 (11.9) (P = NR) 

G2: 44.5 (11.5) (P = NR) 

12 mo: 

G1: 44.6 (11.6) (P = NR) 

G2: 45.8 (12.8) (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

 
C-500 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Baseline Outcomes 

EAT, mean (SD): 

G1: 51.0 (19.1) 

G2: 51.4 (17.2) 

(P = NS) 

EAT, mean (SD): 

3 wks: 

G1: 29.9 (20.9) (P = NR) 

G2: 39.7 (15.4) (P = NR) 

Post-tx: 

G1: 27.3 (19.3) (P = NR) 

G2: 28.9 (21.6) (P = NR) 

Diff over time (linear trend (P < 0.0001) (quadratic 

trend, P < 0.05) 

Most improvements during the first three wks 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6 mo: 

G1: 24.9 (14.4) (P = NR) 

G2: 21.1 (14.9) (P = NR) 

12 mo: 

G1: 20.6 (18.0) (P = NR) 

G2: 19.2 (16.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Laessle et al., 1991 

(continued) 

Calories per day, mean (SD): 

G1: 1228 (493) 

G2: 1071 (588) 

(P = NS) 

Calories per day, mean (SD): 

3 wk: 

G1: 1821 (664) (P = NR) 

G2: 1299 (545) (P = NR) 

Post-tx: 

G1: 1697 (547) (P = NR) 

G2: 1584 (530) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups in change over time (quadratic 

trend, P < 0.05) 

G1 better than G2 after 3 wks 

6 mo: 

G1: 1621 (509) (P = NR) 

G2: 1623 (556) (P = NR) 

12 mo: 

G1: 1703 (589) (P = NR) 

G2: 1639 (649) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-501 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-502 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Baseline Outcomes 

EDI Drive for thinness, mean (SD):

G1: 13.8 (4.2) 

G2: 12.9 (5.3) 

(P = NS) 

EDI, Drive for thinness mean (SD): 

3 wks: 

G1: 8.6 (5.2) (P = NR) 

G2: 9.1 (3.9) (P = NR) 

Post-tx: 

G1: 7.4 (5.6) (P = NR) 

G2: 6.4 (4.7) (P = NR) 

Diff over time (linear trend, P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6 mo: 

G1: 7.1 (5.7) (P = NR) 

G2: 5.8 (4.9) (P = NR) 

12 mo: 

G1: 5.3 (4.6) (P = NR) 

G2: 6.2 (6.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Laessle et al., 1991 

(continued) 

EDI Bulimia, mean (SD): 

G1: 12.1 (4.6) 

G2: 12.2 (4.5) 

(P = NS) 

EDI Bulimia, mean (SD): 

3 wks: 

G1: 5.8 (4.7) (P = NR) 

G2: 7.6 (4.9) (P = NR) 

Post-tx: 

G1: 3.6 (4.9) (P = NR) 

G2: 4.7 (5.3) (P = NR) 

Diff over time (linear trend, P < 0.0001) (quadratic 

trend, P < 0.05) 

Most improvements during the first three wks 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6 mo: 

G1: 3.2 (4.1) (P = NR) 

G2: 5.1 (5.3) (P = NR) 

12 mo: 

G1: 3.0 (3.7) (P = NR) 

G2: 5.2 (5.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-503 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-504 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Baseline Outcomes 

Author, yr: 

Laessle et al., 1991 

(continued) 

EDI Body dissatisfaction, mean 

(SD): G1: 16.1 (6.9) 

G2: 15.1 (6.9) 

(P = NS) 

EDI Body dissatisfaction, mean (SD): 

3 wks: 

G1: 13.4 (7.0) (P = NR) 

G2: 11.3 (5.6) (P = NR) 

Post-tx: 

G1: 13.0 (7.3) (P = NR) 

G2: 10.5 (6.6) 

Diff over time (linear trend, P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6 mo: 

G1: 12.5 (8.6) (P = NR) 

G2: 10.6 (6.8) (P = NR) 

12 mo: 

G1: 12.3 (7.6) (P = NR) 

G2: 11.4 (6.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-505 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 

 
C-506 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Safer, Telch, and 

Agras, 2001 

Setting: 

Stanford, CA, USA 

Enrollment period: 

NR 

Research objective: 

To examine the effects of 

DBT adapted for the tx of 

binge/purge behaviors. 

Groups: 

G1: DBT (N = 16) 

G2: Wait list control (N = 15) 

Enrollment: 

• N = 31 

G1: N = 16 

G2: N = 15 

• Completed: N = 29 

G1 = 14 

G2: 14 

Age, yrs, mean (SD): 

34 (11) (range: 18-54) 

Sex: 

Female: G1: 100% 

Race/ethnicity: 

White: 87.1% 

BMI, kg/m2

, mean (SD): 

23.7 (5.6) kg/m2 

Employed: 

51.6% 

Full-time student: 

22.6% 

At least some college: 

77.4% 

Age at start of bulimic 

behavior, yrs, mean (SD): 

22.3 (7.0) 

Duration of bulimic 

behaviors, yrs, mean 

(SD): 

12.2 (8.6) 

Does not include 2 patients 

withdrawn from tx; No diff 

between groups on any 

baseline measures except 

the Negative Mood 

Regulation Scale score 

(P = 0.02) 
C-507 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

At least 1 binge/purge 

per wk over the 

previous 3 mos (25 

[80.6%] met full DSM 

criteria; 6 met modified 

criteria) 

Exclusion: 

BMI < 17.5; psychosis 

or severe depression 

with suicidal ideation; 

active drug/alcohol 

abuse; concurrent 

participation in 

psychotherapy or use 

of antidepressants/ 

mood stabilizers. 

20 sessions of wkly 50-minute 

individual psychotherapy 

specifically aimed at teaching 

emotional regulation skills to 

reduce rates of bingeing and 

purging. Tx manual was adapted 

for BN from Linehan’s skills training 

manual for txing BPD. 

Binge eating and 

purging: square root 

transformation and 

ANCOVA (baseline 

measures as 

covariates). 

Bonferroni 

corrections. 

Score: 

Good 

Intent to treat: 

Yes (for all participants with 

missing post tx data, but 

participants who were 

withdrawn for 

contraindications are not 

included in ITT). 

Blinding: 

N/A 

Adverse events: 

NR 

Funding: 

NIH 
C-508 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

After Bonferroni correction for multiple comparisons, 

diffs sig at P = 0.0045 

EDE – Binge Episodes, past 4 wks, 

median: 

G1: 27.0

G2: 22.0 

(P = NS) 

EDE – Binge Episodes, past 4 wks, median: 

G1: 1.5 (P = NR)

G2: 20.0 (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001)

EDE – Purge Episodes, past 4 wks, 

median: 

G1: 40.0 

G2: 28.0 

(P = NS) 

EDE – Purge Episodes, past 4 wks, median: 

G1: 1.0 (P = NR) (P = NR) 

G2: 28.0 (P = NR) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.002)

Author, yr: 

Safer, Telch, and 

Agras, 2001 

(continued) 

Emotional Eating Scale subscale: 

Anger/frustration, mean (SD): 

G1: 2.7 (0.8) 

G2: 2.7 (0.6) 

(P = NS) 

Mean Emotional Eating Scale subscale: 

Anger/frustration, mean (SD): 

G1: 1.8 (0.8) (P = NR) 

G2: 2.6 (0.9) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.006)

 Emotional Eating Scale subscale: 

Anxiety, mean (SD): 

G1: 2.1 (0.8) 

G2: 2.1 (0.9) 

(P = NS) 

Emotional Eating Scale subscale: 

Anxiety, mean (SD) 

G1: 1.3 (0.9) (P = NR) 

G2: 2.0 (0.8) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.006)

Emotional Eating Scale subscale: 

Depression, mean (SD): 

G1: 2.9 (0.7) 

G2: 2.7 (0.9) 

(P = NS) 

Emotional Eating Scale subscale: 

Depression, mean (SD): 

G1: 2.1 (1.0) (P = NR) 

G2: 2.6 (0.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.008)

Abstinence rates: 

G1: N = 4 (28.6%) 

G2: N = 0 (0%) 

Diff between groups (P < 0.05) 
C-509 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

After Bonferroni correction for 

multiple comparisons, diffs 

sig at P = 0.0045 

 NR 

Negative Mood Regulation 

Scale, mean (SD): 

G1: 81.3 (15.1) 

G2: 98.1 (16.8) 

(P = 0.02) 

Mean Negative Mood 

Regulation Scale, mean 

(SD): 

G1: 96.1 (24.0) (P = NR) 

G2: 97.7 (15.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.03) 

 

BDI, mean (SD): 

G1: 22.9 (8.9) 

G2: 19.2 (11.9) 

(P = NS) 

BDI, mean (SD): 

G1: 13.4 (11.6) (P = NR) 

G2: 17.4 (11.8) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.04) 

 

Positive and Negative 

Affect schedule subscale: 

Positive Affect, mean (SD): 

G1: 24.8 (8.3) 

G2: 26.1 (6.5) 

(P = NS) 

Positive and Negative 

Affect schedule subscale: 

Positive Affect, mean (SD): 

G1: 27.6 (8.2) (P = NR) 

G2: 28.3 (7.9) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

 

Negative Affect, mean 

(SD): 

G1: 31.5 (9.9) 

G2: 28.6 (6.9) 

(P = NS) 

Negative Affect, mean (SD): 

G1: 23.4 (8.4) (P = NR) 

G2: 30.0 (9.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P < 0.02) 

 
C-510 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Sundgot-Borgen, et al., 

2002 

Setting: 

Outpatient 

Oslo, Norway 

Enrollment period: 

NR 

Research objective: 

To examine the effect of 

CBT vs physical exercise 

and vs nutritional 

counseling as tx for BN 

Groups: 

G1: Exercise (N = 15) 

G2: CBT (N = 16) 

G3: Nutrition (N = 17) 

G4: Waitlist (N = 16) 

G5: Healthy Control (N = 13) 

Enrollment: 

77 ED patients recruited by letter 

from private practice, ED clinics 

• 10 ineligible 

• 3 declined 

• 64 randomized 

24 healthy participants recruited 

via college newspaper ads; 

8 excluded 

• ED symptoms (3) 

• menstrual irregularity (2) 

• vegetarian diet (2) 

• competitive running (1) 

Drop Outs 

G1: (3) 

G2: (2) 

G4: (1) 

Age, mean (SD): 

G1: 23 (2.3) 

G2: 22 (2.7) 

G3: 22 (2.9) 

G4: 23 (3.2) 

G5: 22 (4.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BN Duration, yrs, mean 

(SD): 

G1: 7 (3.7) 

G2: 5 (1.6) 

G3: 5 (2.3) 

G4: 6 (3.8) 

G5: NA 

(P = NS) 

Wkly Exercise, hrs, mean 

(SD): 

G1: 2.5 (3.8) 

G2: 2.1 (2.4) 

G3: 2.5 (2.2) 

G4: 3.1 (1.7) 

G5: 1.8 (1.3) 

(P = NS) 
C-511 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Patients: Age 18 to 29; 

meeting DSM IV 

criteria for BN 

Healthy controls: not 

meeting BN inclusion 

criteria; eumenorrhea; 

regular participation in 

wt. bearing exercise 

(1-2 hrs/wk); no use of 

meds; willingness to 

complete fitness test, 

dietary registration, 

med exam, and 4 

interviews 

Exclusion: 

Hx of AN or other 

psychiatric or somatic 

disorders; tx of EDs in 

previous 6 mos; 

current use of meds. 

16 wk outpatient tx for all groups 

Exercise: 2 hr introduction meeting, 

followed by 1-hr wkly session (45 

minute aerobic, 15 minutes cool 

down) with fitness instructor; 

participants advised to exercise 

independently 2/wk at least 35 

minutes 

CBT: wkly 2-hr group sessions, 

following modified Hsu et al. (1991) 

protocol (Martinsen et al., 1990). 

Nutrition Counseling: 2-hr group

sessions, 2/wk in the first 2 wks, wkly 

thereafter, and held by a RD; tx 

modified from Hsu et al. (1992) 

protocol to include food log 

discussions and wt monitoring biwkly. 

For G2 and G3, wt change >2kg was 

addressed by additional meal 

planning; participants were assigned 

90 m/wk of homework and food logs. 

BN sx (using EDI-II), physical activity, 

peak oxygen uptake, nutritional 

habits, and % body fat assessed at 

baseline, post-tx, 6- and 18-mos FU. 

Group diffs were 

assessed by ANOVA 

for repeated 

measures and by 

paired-sample t-tests 

and nonparametric 

tests. P values < 0.05 

were considered sig. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NR 

Adverse events: 

1 injury in G1 

Funding: 

NR 
C-512 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI Drive for Thinness, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

G2 vs G1 (P = NS) 

All other comparisons (P = NR) 

EDI Drive for Thinness, mean (SD): 

Post-Treatment: 

G1: NR 

G2: NR 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: 11.86 (4.33) (P = NR) 

G2: 7.15 (2.41) (P = NR) 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = 0.02) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

18-mo FU: 

G1: 13.43 (4.83) (P = NR) 

G2: 6.08 (4.65) (P = NR) 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = 0.000) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Sundgot-Borgen et 

al., 2002 

(continued) 

EDI Bulimia, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

(P = NR) 

EDI Bulimia, mean (SD): 

Post-Treatment: 

G1: NR 

G2: NR 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

6-mo FU 

G1: NR 

G2: 2.64 (1.6) (P = NR) 

G3: 5.00 (3.1) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = 0.02) 

G2 better than G3 

Diff between groups in change over time (P = NR) 

18-mo FU 

G1: NR 

G2: 2.14 (1.83) (P = NR) 

G3: 8.47 (2.15) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P < 0.000) 

G2 better than G3 

Diff between groups in change over time (P = NR) 
C-513 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 BMI, kg/m2, mean (SD):

G1: 21.0 (2.0) 

G2: 20.0 (1.9) 

G3: 21.0 (2.1) 

G4: 22.0 (2.5) 

G5: 21.0 (1.9) 

(P = NS) 

Post-tx: 

BMI, kg/m2, mean (SD): 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

G5: NR 

(P = NS) 

 % Body fat, mean (SD):

G1: 24.1 (8.3) 

G2: 23.4 (8.1) 

G3: 23.7 (8.9) 

G4: 21.6 (5.1) 

G5: 25.5 (7.0) 

(P = NS) 

% Body fat, mean (SD): 

G1: 21.5 (6.4) (P < 0.001) 

G2: NR 

G3: NR 

G4: NR 

G5: NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR)

 Fat mass, mean (SD): 

G1: 21.5 (6.4) 

G2: NR 

G3: NR 

G4: NR 

G5: NR 

(P = NS) 

18-mo FU: 

Fat mass, mean (SD): 

G1: 19.8 (4.89) 

Diff between groups (P = 0.034) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

 Peak O2 uptake, 

mL/kg/min, mean (SD):

G1: 43.5 (7.3) 

G2: 42.0 (6.0) 

G3: 44.1 (6.2) 

G4: 41.3 (12.2) 

G5: 43.1 (7.2) 

(P = NS) 

Peak O2 uptake, mL/kg/min, 

mean (SD): 

NR 
C-514 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Sundgot-Borgen et 

al., 2002 

(continued) 

EDI Body Dissatisfaction, mean 

(SD): 

NR 

(P = NR) 

EDI Body Dissatisfaction, mean (SD): 

Post-Treatment: 

G1: NR 

G2: 9.64 (4.86) (P = NR) 

G3: 14.24 (5.53) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P < 0.02) 

G2 better than G3 

Diff between groups in change over time (P = NS) 

6-mo FU 

G1: NR 

G2: 9.21 (3.02) (P = NR) 

G3: 14.00 (5.32) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P < 0.006) 

G2 better than G3 

Diff between groups in change over time (P = NS) 

18-mo FU: 

G1: NR 

G2: 10.71 (3.45) (P = NR) 

G3: 12.71 (5.58) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-515 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-516 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge Episodes/wk, mean (SD): 

G1: 7.3 (2.72) 

G2: 7.9 (2.95) 

G3: 7.7 (3.76) 

G4: 5.4 (2.63) 

(P = NS) 

Binge Episodes/wk, mean (SD): 

Post-Treatment: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

18-mo FU: 

G1: 1.7 (2.87) (P = 0.002) 

G2: 4.4 (3.37) (P = 0.009) 

G3: 6.8 (3.67) (P = NS) 

G4: 4.5 (2.33) (P = NS) 

Diff over time (P = NR) 

Diff between groups (P = 0.04) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Sundgot-Borgen et 

al., 2002 

(continued) 

Vomiting Episodes/wk, mean 

(SD): 

G1: 7.8 (3.39) 

G2: 8.6 (4.68) 

G3: 8.2 (4.34) 

G4: 5.6 (3.15) 

(P = NS) 

Vomiting Episodes/wk, mean (SD): 

Post-tx: 

G1: NR 

G2: NR 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: NR 

G2: 3.50 (2.93) (P = NR) 

G3: 7.06 (4.16) (P = NR) 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P < 0.01) 

G2 better than G3 

Diff between groups in change over time (P = NR) 

18-mo FU: 

G1: 2.4 (2.39) (P = 0.001) 

G2: 2.7 (1.94) (P = 0.003) 

G3: 7.2 (4.05) (P = NS) 

G4: 5.1 (2.47) (P = NS) 

Diff over time (P = NR) 

Diff between G2 and G3 (P < 0.001) 

G2 better than G3 

Diff between groups in change over time (P = NR) 
C-517 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-518 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Sundgot-Borgen et 

al., 2002 

(continued) 

Laxative Use, episodes/wk, mean 

(SD): 

NR 

(P = NR) 

Laxative Use, episodes/wk, mean (SD): 

Post-tx: 

G1: 0.85 (0.99) (P = NR) 

G2: 2.1 (1.7) (P = NR) 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P < 0.02) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: 0.00 (0.00) (P = NR) 

G2: 2.57 (2.10) (P = NR) 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = 0.000) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

18-mo FU: 

G1: 0.08 (0.28) (P = NR) 

G2: 3.10 (2.40) (P = NR) 

G3: NR 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P < 0.000) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

18-mo FU: 

62% G1 (N = 8) had recovered from BN, and one 

subject met EDNOS criteria 

36% G2 (N = 5) had recovered from BN, 2 met 

EDNOS criteria 

24% G3 (N = 4) met EDNOS criteria 
C-519 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-520 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Thackwray et al., 

1993 

Setting: 

Outpatient, USA 

Enrollment period: 

NR 

Research objective: 

Comparison of BT, CBT, 

and NSMT for BN 

Groups: 

G1: CBT (N = NR) 

G2: BT (N = NR) 

G3: NSMT (N = NR) 

Enrollment: 

• Respondents to ads 

were screened on the 

phone 

• 65 applicants were 

seen for a screening 

interview 

• 47 met criteria for BN 

and were eligible for the 

study 

• 47 were randomly 

assigned to one of 

three groups 

• 39 completed tx and the 

6-mo FU assessment 

Age, yrs, mean (SD): 

31.3 yrs (10.41) 

Sex: 

Female:100% 

Race/ethnicity: 

NR 

Duration of BN, yrs, mean 

(SD): 

6.7 (7.28) 

Employed full-time 

75% 

Full or part-time 

students: 

19% 

Homemakers: 

16% 

Mothers: 

56% 

Lives with spouse: 

62% 

Lives with parents: 

18% 

Lives with roommate: 

15% 

Lives alone: 

5% 
C-521 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female, BN criteria 

from DSM III-R. 

Exclusion: 

Prior dx or current 

involvement in tx for 

BN and medical 

conditions, such as 

pregnancy or severe 

renal or cardiac 

problems 

8 consecutive wkly 60-minutes 

individual sessions by one of two 

master’s level therapists. BT 

participants: a behavioral eating 

habit control program that was 

modified to focus on reducing 

binge eating and purging. 

Participants were given selfmonitoring forms to monitor daily 

caloric intake, binge eating and 

purging but not instructed to selfmonitor cognitions. CBT, 

abbreviated version of Fairburn’s 

(1985) manual used. Selfmonitoring included daily caloric 

intake, binge purge behavior and 

cognitions. Within therapy, 

dysfunctional beliefs and distorted 

cognitions were addressed and 

assertiveness, problem solving skill 

building and relaxation taught. 

Nonspecific self-monitoring group: 

provided with rationale on the value 

of insight development and 

resolution of intrapsychic conflicts 

through self-knowledge, given selfmonitoring forms and asked to 

numerically indicate total bingepurge episodes on a daily basis 

and estimate daily caloric intake. At 

all subsequent sessions, selfmonitoring forms collected and 

reviewed by the therapist and the 

therapist presented didactic 

information about early childhood 

experiences and participants 

discussed the material relative to 

themselves. The main diff between 

the BT, CBT and the NSMT group

was the emphasis on self-control of 

the participants via active 

participation in BT and CBT. 

ANOVAs to look at 

pre-tx diff among 

groups, expectancy 

ratings and therapist 

ratings. For the 

dependent variables 

of binge purge 

frequency, a 3 (time) x 

3 (group) ANOVA was 

done. A Chi-square 

analysis to examine 

percentage of 

abstinence between 

groups. MANOVA’s: 

to measure EDI. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NR 
C-522 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge-purge episodes/wk, mean 

(SD): 

G1: 5.4 (3.0) 

G2: 5.6 (4.0) 

G3: 5.6 (3.0) 

(P = NS) 

Binge-purge episodes/wk, mean (SD): 

Post-tx: 

G1: 0.6 (1.0) (P < 0.01) 

G2: 0.0 (0.0) (P < 0.01) 

G3: 1.0 (3.0) (P < 0.01) 

6-mo FU: 

G1: 0.4 (0.5) change from post-tx (P = NS) 

G2: 0.6 (0.5) change from post-tx (P = NS) 

G3: 2.7 (2.0) change from post-tx (P < 0.01) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDI drive for thinness, mean (SD): 

G1: 15.3 (5.0) 

G2: 13.1 (5.0) 

G3: 13.8 (5.0) 

(P = NS) 

EDI drive for thinness, mean (SD): 

Post-tx: 

G1: 10.1 (6.0) (P = NR) 

G2: 4.3 (4.0) (P = NR) 

G3: 11.7 (5.0) (P = NR) 

6-mo FU: 

G1: 8.3 (7.0) (P = NR) 

G2: 4.9 (4.0) (P = NR) 

G3: 10.9 (6.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G2 better than G1 and G3 at post-tx 

G2 better than G3 at FU 

Author, yr: 

Thackwray et al., 

1993 

(continued) 

EDI Bulimia, mean (SD): 

G1: 14.5 (5.0) 

G2: 12.3 (6.0) 

G3: 11.0 (5.0) 

(P = NS) 

EDI Bulimia, mean (SD): 

Post-tx: 

G1: 5.5 (6.0) (P = NR)

G2: 2.5 (2.0) (P = NR) 

G3: 8.8 (7.0) (P = NS) 

6-mo FU: 

G1: 2.9 (4.0) (P = NR) 

G2: 3.3 (3.0) (P = NR) 

G3: 7.8 (6.0) (P = NS) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.005) 

G2 better than G3 at post-tx 

G1 and G2 better than G3 at FU 
C-523 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 25.5 (7.0) 

G2: 22.8 (14.0) 

G3: 28.1 (10.0) 

(P = NS) 

BDI, mean (SD): 

Post-tx: 

G1: 10.8 (12.0) (P = NR) 

G2: 6.5 (9.0) (P = NR) 

G3: 16.1 (11.0) (P = NR) 

6-mo FU: 

G1: 7.2 (7.0) (P = NR) 

G2: 9.6 (8.0) (P = NR) 

G3: 19.3 (12.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.02) 

G1 better than G3 at 6-mo FU 

% IBW: 

Post-tx: 

G1: NR 

G2: NR 

G3: NR 

6-mo FU: 

G1: NR 

G2: NR 

G3: NR 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-524 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Thackwray et al., 

1993 

(continued) 

 Abstinence, %: 

Post-tx: 

G1: 92% 

G2: 100% 

G3: 69% 

Diff over time (P = NR) 

Diff between groups (P < 0.05) 

G1 and G2 better than G3 

Maintained Abstinence at 6-mo FU: 

G1: 69% 

G2: 38% 

G3: 15% 

Diff over time (P = NR) 

Diff between groups (P < 0.05) 

G1 better than G2 and G3 
C-525 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-526 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Treasure et al., 1999 

Setting: 

Eating Disorders Unit, 

Bethlem and Maudsley 

Hospital, UK 

Enrollment period: 

NR 

Research objective: 

Explore relationship between 

patient’s initial stage of 

change and symptom 

reduction, drop-out rate, and 

development of therapeutic 

alliance within context of CBT 

tx vs. MET tx. 

Groups: 

G1: MET followed by Group

CBT + MET followed by 

individual CBT (N = 48 + 39) 

G2: Individual CBT followed 

by Group CBT (N = 38) 

Enrollment: 

• 142 consecutive female 

attenders at unit 

assessed 

• 130 diagnosed with BN 

• 5 excluded because of 

complicating features 

• 12 were mixed cases AN 

(BP type) or EDNOS 

• 125 BN participants 

randomized 

Age, yrs, mean (SD): 

G1: 28.8 (7.8) 

G2: 28.5 (7.2) 

Sex: 

Female 100% 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 24.0 (6.5) 

G2: 26.3 (9.3) 

(P = NS) 

Duration of illness, yrs, 

mean (SD): 

G1: 10.8 (8.4) 

G2: 11.4 (6.4) 

Previous tx, %: 

G1: 62% 

G2: 62% 
C-527 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Dx of BN according to 

DSM IV 

Exclusion: 

Complicating features 

like diabetes mellitus; 

mixed cases of AN of 

binge purge subtype or 

EDNOS. 

All interventions were manual based. 

MET was based on the manual, 

“Clinician’s guide to getting better bit 

(e) by bit (e) (Schmidt and Treasure, 

1997) while patients followed the 

workbook for this guide. For CBT, 

therapists followed the first four 

chapters of “Bulimia Nervosa: A 

guide to recovery” (Cooper, 1993) 

and patients were given monitoring 

sheets, meal planning, activity lists 

and problem solving activities. 

Tx in 3 phases –initial 4-wk phase of 

individual tx followed by 8 wks of 

either group or individual care and 

the last phase of moly FUs. 

The three forms of tx: 

1) 4 wks of MET followed by 8 wks 

of group CBT 

2) 4 wks of individual CBT followed 

by group CBT for 8 wks 

3) 4 wks of MET followed by 8 wks 

of individual MET 

The two groups in which MET was 

first were combined to form G1. 

Continuous data 

analyzed using t-tests, 

ANOVA or stepwise 

regression analyses. 

Dichotomous data 

were cross-tabulated. 

Repeated measures 

ANOVA’s used to 

examine symptom 

diffs between wk 0 

and wk 4 with tx group

and pre-tx stage as 

between-group

factors. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

Participants blinded to stage of 

change that they fell into. 

Adverse events: 

NR 

Funding: 

NR 
C-528 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge frequency, mean (SD): 

G1: 5.0 (1.2) 

G2: 4.9 (1.1) 

(P = NS) 

Binge frequency, mean (SD): 

G1: NR 

G2: NR 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Vomiting frequency, mean (SD):

G1: 4.2 (1.9) 

G2: 4.4 (1.9) 

(P = NS)

Vomiting frequency, mean (SD): 

G1: NR 

G2: NR 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR)

Laxative use, mean (SD): 

G1: 2.3 (1.9) 

G2: 1.9 (1.7) 

(P = NS)

Laxative abuse, mean (SD): 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff over time (P < 0.005) 

Diff between groups in change over time (P = NR) 

Clinically sig improvement at 4 wks: 

Binge eating: 

G1: 53% 

G2: 68% 

Diff between groups (P = NS) 

Author, yr: 

Treasure et al., 1999 

(continued) 

Symptoms by initial stage at wk 

1: 

Binge frequency, mean (SD): 

Contemplation: 

G1: 4.7 (1.3) 

G2: 4.8 (1.2) 

(P = NR) 

Action: 

G1: 5.0 (1.4) 

G2: 5.6 (0.9) 

(P = NR)

Symptoms by initial stage: 

Binge frequency, mean (SD): 

Contemplation: 

G1: 3.8 (1.2) (P = NR) 

G2: 3.2 (1.3) (P = NR) 

Action: 

G1: 5.0 (1.4) (P = NR) 

G2: 5.6 (0.9) (P = NR) 

Diff between groups (P = NS) 

Diff between stages (P < 0.05) 

Diff between groups in change over time (P = NS) 

Diff between stages in change over time (P = NR)
C-529 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-530 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Vomiting frequency, mean (SD):

Contemplation: 

G1: 3.9 (1.8) 

G2: 4.6 (2.0) 

(P = NR) 

Action: 

G1: 3.5 (3.5) 

G2: 5.0 (2.2) 

(P = NR)

Clinically sig improvement at 4 wks: 

Vomiting: 

G1: 58% 

G2: 46% 

Diff between groups (P = NS) 

Vomiting frequency, mean (SD): 

Contemplation: 

G1: 2.8 (1.6) (P = NR) 

G2: 3.1 (1.5) (P = NR) 

Action: 

G1: 2.0 (1.4) (P = NR) 

G2: 3.6 (1.7) (P = NR) 

Diff between groups (P = NS) 

Diff between stages (P = NS) 

Diff between groups in change over time (P = NR) 

Diff between stages in change over time (P = NR)

Author, yr: 

Treasure et al., 1999 

(continued) 

Laxative abuse, mean (SD): 

Contemplation: 

G1: 2.3 (1.7) 

G2: 2.0 (1.8) 

(P = NR) 

Action: 

G1: 2.5 (2.1) 

G2: 1.6 (1.3) 

(P = NR)

Clinically sig improvement at 4 wks: 

Laxative use: 

G1: 27% 

G2: 13% 

Diff between groups (P = NS) 

Laxative abuse, mean (SD): 

Contemplation: 

G1: 1.4 (1.1) (P = NR) 

G2: 1.7 (1.7) (P = NR) 

Action: 

G1: 0.0 (0.0) (P = NR) 

G2: 0.0 (0.0) (P = NR) 

Diff between groups (P = NS) 

Diff between stages (P = NS) 

Diff between groups in change over time (P = NS) 

Diff between stages in change over time (P = NR)
C-531 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-532 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Ventura and Bauer, 

1999 

Setting: 

Private practice 

outpatient unit, Verona, 

Italy 

Enrollment period: 

February to July, 1996 

Research objective: 

To examine nutritional 

rehabilitation-enhanced CBT 

focused on psychobiological 

reorganization of eating 

behaviors as compared to 

traditional CBT tx focused on 

the prescription of regular 

eating patterns in individuals 

with BN. 

Groups: 

G1: PNR (N = 20) 

G2: TNR (N = 20)

Enrollment (N = 24):

Completed: 

• 6-mo tx (N = 20) 

• 9-mo FU 

G1 = 19 

G2 = 15 

• 12-mo FU 

G1 = 17 

G2 = 14 

Age, yrs, mean (SD): 

G1: 24.1 (6.0) 

G2: 24.0 (5.6) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BMI, kg/m2, mean (SD): 

G1: 21 (1.6) 

G2: 20.6 (1.5) 

Duration of illness, yrs, 

mean (SD): 

G1: 8.6 (4.9) 

G2: 6.5 (4.6)
C-533 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for BNpurging type 

Exclusion: 

Failure to complete 

food diary (more than 

5 days/mo or 2 wkends missing); 

requirement of 

hospitalization or 

refusal to participate 

After 4 wk assessment, 6 mo study 

duration; TNR was prescribed a 

regular eating pattern; PNR involved 

learning to control appetite and wt 

based on understanding 

psychobiological cues. 

In both groups, food diary used to 

record patterns of eating behavior, 

frequency of bingeing and/or 

vomiting; laxative misuse, excess 

exercise, carbohydrate and lipid 

intake; In G1, degree and duration of 

hunger, satiety, and differential 

satiety of macronutrients also 

recorded. 

In 1st mo, diaries were discussed 

1/wk, then bi-moly for the duration of 

the study. 

BMI, heart rate and blood pressure 

also taken at each visit. 

 

Between and within 

group diffs evaluated 

using a two-way 

ANOVA corrected for 

repeated measures. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NR 
C-534 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Data provided through graphic display 

only** 

Binge frequency (episodes/day), 

mean: 

G1: ** 

G2: ** 

(P = NS)

Binge frequency (episodes/day), mean: 

Post-tx: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

3-mo FU: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR)

Author, yr: 

Ventura and Bauer, 

1999 

(continued) 

Vomiting frequency (episodes/day), 

mean (SD): 

G1: **

G2: ** 

(P = NS)

Vomiting frequency (episodes/day), mean (SD): 

Post-tx: 

G1: ** (P = NR)

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

3-mo FU: 

G1: ** (P = NR)

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

6-mo FU: 

G1: ** (P = NR)

G2: ** (P = NR) 

Diff between groups (P = 0.001) 

Diff between groups in change over time (P = NR) 

Abstinence from purging at post-tx, N (%): 

G1: 18/20 (90%) 

G2: 2/20 (10%) 

(P = NR)
C-535 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-536 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Data provided through graphic display 

only** 

Carbohydrate Intake (servings/day), 

mean: 

G1: **

G2: ** 

(P = NS) 

Post-tx: 

Carbohydrate Intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001)

G1 higher than G2 

9-mo FU: 

Carbohydrate Intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

12-mo FU: 

Carbohydrate Intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Ventura and Bauer, 

1999 

(continued) 

Lipid intake (olive oil servings/day), 

mean: 

G1: ** 

G2: ** 

(P = NR) 

Post-tx: 

Lipid intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 higher than G2 

9-mo FU: 

Lipid intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 higher than G2 

12-mo FU: 

Lipid intake (servings/day), mean: 

G1: ** (P = NR) 

G2: ** (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 higher than G2 

No diffs reported between G1 and G2 regarding 

number of meals ingested 
C-537 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-538 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wilfley et al. 1993 

Setting: 

Outpatient; Stanford 

University School of 

Medicine, USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

group CBT and group IPT for 

binge eating in women with 

nonpurging BN. 

Groups: 

G1: group CBT (N = 18) 

G2: group IPT (N = 18) 

G3: waitlist control (N = 20) 

Enrollment: 

• 100 recruited via 

newspaper ads and 

screened 

• 56 met criteria and 

participated 

• 8 (22%) dropped out; 

attrition rates: G1: 33%, 

G2: 11% (P = NS) 

Age, yrs, mean (SD) 

(range): 

44.3 (8.3) (27-64) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 86% 

AA: 5% 

Hispanic: 5% 

Pacific Islander: 2% 

Indian: 2% 

Age of onset of bingeing, 

yrs, mean (SD) (range): 

20.4 (12.4) (3-44) 

Duration of binge eating, 

yrs, mean (SD) (range): 

23.7 (13.4) (2-53) 

BMI, kg/m2, mean (SD) 

(range): 

32.8 (5.2) (22.3-43.8) 

Civil Status: 

Never married: 10.7% 

Married: 58.9% 

Divorced: 28.6% 

Separated: 1.8% 

Education/Employment: 

College grad: 38% 

Some college: 50% 

HS grad or less: 12% 

Employed: 73% 
C-539 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; aged 18-65; 

met modified DSM IIIR criteria for BN, 

including full 

requirements for binge 

behavior without 

purging behavior 

Exclusion: 

Current of past hx of 

self-induced vomiting, 

laxative use or other 

purging behaviors; 

current use of 

antidepressants or 

appetite suppressants; 

concurrent tx for wt 

loss; concurrent DSM 

III-R dx or unipolar or 

bipolar affective 

disorder, psychosis, 

drug abuse, or 

alcoholism. 

Participants randomly assigned to 

group CBT, IPT or waitlist condition; 

G1 and G2 attended wkly 90 

minutes group sessions for 16 wks; 

groups consisted of 9 members and 

2 therapists, with 2 groups per tx 

condition. 

CBT tx used Telch et al. (1990) 

manual and focused on eliminating 

BE, not wt reduction; IPT tx used 

Fairburn et al. (1991) manual for BN 

and focused on interpersonal 

relationships. 

Waitlist had no contact with 

assessors during the 16 wk tx 

period. 

Including the 7-day calendar, binge 

eating recall method, the BDI, and 

Three Factor Eating Questionnaire, 

assessments were taken for all 

participants at baseline and 16 wk 

post-tx; participants in tx conditions 

were also assessed at 6 mo and 1yr 

FU 

At baseline and 16 wk 

post-tx, days of binge 

eating/wk, hunger, 

restraint, depression, 

interpersonal 

problems were 

assessed using 

repeated measures 

ANOVA. When sig 

interactions found, 

two-tailed Scheffe 

tests were used. 

When categorical 

measures compared, 

Chi-square test used. 

To assess change in 

binge behavior from 

baseline to 1 yr FU, 

paired t tests used. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

2 dropped out of tx due to 

illness 

Funding: 

NIMH 
C-540 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Days binged in past wk, mean (SD):

G1: 4.2 (1.5) 

G2: 4.7 (1.8) 

G3: 4.4 (1.8)

(P = NS) 

Intent to treat analysis 

Post-tx: 

Days binged in past wk, mean (SD): 

G1: 2.2 (2.4) (P = NR) 

G2: 1.4 (1.7) (P = NR) 

G3: 3.9 (1.7) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.0003)

G1 and G2 better than G3 (P = NR) 

G1 vs. G2 (P = NS) 

Reduction of bingeing: 

G1: 48% 

G2: 71% 

G3: 10% 

% Abstinent: 

G1: 28% 

G2: 44% 

G3: 0% 

TFEQ-Disinhibition, mean (SD): 

G1: 14.1 (1.8) 

G2: 14.2 (1.2) 

G3: 15.0 (0.94) 

(P = NR)

TFEQ-Disinhibition, mean (SD): 

G1: 13.1 (2.4) (P = NR) 

G2: 12.4 (2.8) (P = NR) 

G3: 14.9 (1.0) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G1 vs. G3 (P < 0.02) 

G1 better than G3 

G2 vs. G3 (P < 0.01) 

G2 better than G3 

G1 vs. G2 (P = NS)

Author, yr: 

Wilfley et al. 1993 

(continued) 

TFEQ-Hunger, mean (SD): 

G1: 10.2 (2.0) 

G2: 10.5 (2.8) 

G3: 9.9 (3.3) 

(P = NR) 

TFEQ-Hunger, mean (SD): 

G1: 9.2 (2.8) (P = NR) 

G2: 7.8 (4.8) (P = NR) 

G3: 9.2 (3.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-541 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 13.6 (8.1) 

G2: 13.0 (7.5) 

G3: 14.6 (7.5) 

(P = NR) 

BDI, mean (SD): 

G1: 12.3 (6.8) (P = NR) 

G2: 8.4 (6.7) (P = NR) 

G3: 14.2 (7.5) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

Wt, kg, mean (SD) 

(range): 

87.3 (14.2) (60-117.5) 

Change in wt, kg, mean: 

Post-tx: +2.0 kg

G1: NR 

G2: NR 

G3: NR 

Diff over time (P < 0.0007) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

RSE, mean (SD): 

G1: 3.1 (1.7) 

G2: 3.3 (1.5) 

G3: 2.8 (1.2) 

(P = NR)

RSE, mean (SD): 

G1: 2.8 (1.4) (P = NR) 

G2: 2.4 (1.3) (P = NR) 

G3: 3.0 (1.5) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS)

FU: 

G1: no change 

G2: - 3kg 

G3: NR 

Diff over time (P < 0.03) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)

Inventory of Interpersonal 

Problems, mean (SD): 

G1: 1.6 (0.5) 

G2: 1.7 (0.7) 

G3: 1.4 (0.5) 

(P = NR)

Inventory of Interpersonal 

Problems, mean (SD): 

G1: 1.4 (0.5) (P = NR) 

G2: 1.2 (0.6) (P = NR) 

G3: 1.2 (0.6) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS)

 
C-542 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ-Restraint, mean (SD): 

G1: 7.3 (3.8) 

G2: 7.3 (3.2) 

G3: 8.2 (3.4) 

(P = NR)

TFEQ-Restraint, mean (SD): 

G1: 9.3 (3.6) (P = NR) 

G2: 11.0 (5.6) (P = NR) 

G3: 8.6 (3.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.03) 

G2 vs. G3 (P = 0.02) 

G2 better than G3 

G1 vs. G2 (P = NS) 

FU: 

Change in binge frequency (days in past wk) 

from baseline, mean (SD): 

G1: -2.4 (P < 0.003) 

G2: -2.0 (P < 0.001) 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Binge frequency from 16wk post-tx to 1yr FU 

increased in both groups (P < 0.05) 

Author, yr: 

Wilfley et al. 1993 

(continued) 

Completers-only (G1: N = 10; G2: N = 13) 

Post-tx: 

Binge reduction, %: 

G1: 64% 

G2: 68% 

G3: 11% 

FU: 

Binge reduction, %: 

G1: 55% 

G2: 50% 

G3: NR 

Change in binge frequency (days in past wk), 

mean (SD): 

G1: -2.1 (P < 0.04) 

G2: -2.4 (P < 0.02) 

G3: NR 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Binge frequency from 16wk post-tx to 1yr FU 

increased in both groups (P < 0.005) 
C-543 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-544 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wolk and Devlin, 2001 

Companion article: 

Agras et al., 2000 

Setting: 

ED Unit, New York 

State Psychiatric 

Institute at Columbia 

Medical Center, NY, 

NY, USA 

Enrollment period: 

NR 

Research objective: 

To test the hypothesis that 

the stage of change is a 

useful predictor of dropout 

and related to tx outcome in 

individuals in brief 

psychotherapy for BN. 

Groups (N = 110): 

G1: CBT 

G2: IPT 

Sample from one site in 

Agras, Walsh et al. (2000) 

multicenter study 

Enrollment: 

• 129 screened 

• 110 randomized 

• 66 completed tx (G1 = 

32, G2 = 34; full BN 

remission = 14; 

subthreshold BN = 34; 

full BN = 18) 

 

Age, yrs, mean (SD): 

G1: 28.3 (7.0) 

G2: 27.9 (7.5) 

(P = NS) 

Sex: 

Female: NR 

Race/ethnicity N (%): 

White: 

G1: 87 (79) 

G2: 81 (74) 

(P = NR) 

Hispanic: 

G1: 11 (10) 

G2: 14 (13) 

(P = NR) 

African American: 

G1: 7 (6) 

G2: 7 (6) 

(P = NR) 

Asian: 

G1: 4 (4) 

G2: 7 (6) 

(P = NR) 

American Indian: 

G1: 1 (1) 

G2: 0 (0) 

(P = NR) 
C-545 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN, dx using SCID 

Exclusion: 

Severe physical or 

psychiatric condition 

that would interfere 

with tx; current AN; 

current 

psychotherapeutic tx 

of any type; all 

psychotropic meds; 

pregnancy; having 

received an adequate 

trial of CBT or IBT for 

BN prior to study 

19 sessions of CBT or IPT; CBT 

focused on shape, wt, and eating 

behaviors, IPT focused on noneating/wt-related personal issues; 

tx was conducted by doctoral level 

psychologist or psychiatrist. 

Prior to tx, Stage of Change scale 

used to predict outcome among 

randomized participants. 

Readiness to change assessed 

using an algorithm of the 

relationship between stages of 

change and tx response 

Associations between 

stages of change at 

baseline and 

categorical measures 

of outcome examined 

using chi-square tests.

Score: 

Good 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

9 withdrawn from tx, 8 of 

which received meds: 7 for 

severe depression, 1 for an 

acute onset of panic disorder 

Funding: 

NR 
C-546 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wolk and Devlin, 

2001 

(continued) 

Completer Analysis (N = 66): 

Stage of change as a predictor of outcome 

(remittance): 

Χ2 = 12.29 (P = 0.02), 0/10 “precontemplators” 

remitted at end of tx 

Stage of change as a predictor of 

improvement (undefined): 

G1: Χ2 = 3.09 (P = NS) 

G2: Χ2 = 12.11 (P = 0.02) 
C-547 

Evidence Table 7. Behavioral intervention trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-548 

Evidence Table 8. Self-help trials for bulimia nervosa 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Bailer et al., 2004 

Setting: 

Outpatient ED clinic, 

Department of General 

Psychiatry, University 

Hospital of Psychiatry, 

Vienna, Austria 

Enrollment period: 

NR 

Research objective: 

To evaluate the short and 

long-term efficacy of an 18 wk 

guided self-help program 

versus group CBT in the tx of 

patients with BN. 

Groups: 

G1: Self-help (N = 40) 

G2: CBT (N = 41) 

Enrollment: 

• 87 recruited via therapist 

or self-referral to ED 

clinic 

• 81 randomized (6 refused 

to participated for 

reasons NR) 

• G1: 30 (75%) completed 

tx; 25 (62.5%) completed 

1 yr FU 

• G2: 26 (63.4%) 

completed tx; 30 (73.1%), 

including 5 drop-outs, 

completed FU 

• Overall dropout rate: 

30.8%; Drop out rate 

between groups was not 

sig: G1: 25%; G2: 36.6%.

Age, yrs, mean (SD): 

G1: 23.3 (4.1) 

G2: 24.2 (4.9) 

(P = NS) 

Age at onset, yrs, mean 

(SD): 

G1: 17.3 (2.3) 

G2: 17.7 (3.2) 

(P = NS) 

Sex: 

Female: NR 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 21.7 (3.1) 

G2: 20.7 (2.4) 

(P = NS) 

Nonpurger, N (%): 

G1: 5 (12.5) 

G2: 4 (9.7) 

(P = NS) 

Meds, SSRIs, N (%): 

G1: 6 (15) 

G2: 14 (34.1) 

(P = 0.046) 

Lifetime AN, N (%): 

G1: 9 (22.5) 

G2: 17 (41.4) 

(P = NS) 

Lifetime major depression, 

N (%): 

G1: 12 (30) 

G2: 24 (58.5) 

(P = 0.009) 

Current major depression, 

N (%): 

G1: 2 (5) 

G2: 11 (26.8) 

(P = 0.008) 

Self-mutilation, N (%): 

G1: 15 (37.5) 

G2: 10 (24.3) 

(P = NS) 

Suicide attempts, N (%): 

G1: 2 (5) 

G2: 9 (21.9) 

(P = 0.026) 
C-549 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 17 and above; 

DSM IV criteria for BN 

Exclusion: 

Medically unstable or 

of severe suicide risk; 

unstable dosage of 

meds for BN over 3 

mos prior to study 

Upon enrollment, individuals 

randomized to G1 or G2; G1: selfhelp manual, self-paced over 18 

wks, and offered 18, 20 minutes 

wkly visits, as needed; G2: 18 wkly, 

90 minute sessions with 8-12 

participants using a CBT manual 

(based on Fairburn, 1985, and 

Agras, 1987) for BN; attendance at 

50% (9 sessions) defined tx 

completion. 

BN behavior self-monitored with EBIV; EDQ, EDI, BDI, ht, wt, and vital 

signs, assessed at baseline, mid-tx 

(10 wks), and tx-end (18wks), and 1 

yr FU. 

One-way ANCOVAs 

compared the two tx 

at all timepoints); 

when post-tx data 

missing, pre-tx values 

substituted; mixedeffects linear 

regression analyses 

performed to compare 

changes in outcome 

over time by tx 

condition, controlling 

for baseline values. 

Score: 

Fair 

Intent to treat: 

Yes, for primary analysis 

Blinding: 

No 

Adverse events: 

Except for 2 patients who 

moved, all other drop-outs 

either openly refused to 

participate (reasons: NR), or 

cancelled appts. 

Funding: 

Grant from the Osterreichische 

Nationalbank (Jubilaumsfonds 

Grant 6360) 
C-550 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Results from the primary, intent-to-treat 

analysis (N = 81), unless specified. 

Author, yr: Mid-tx, Post-tx, FU (N = 55) 

Bailer et al., 2004 

(continued) Binge Frequency, 4 wks, mean (SD): 

G1: 26.15 (21.51)

G2: 27.95 (29.66) 

(P = NR) 

Binge Frequency, 4 wks, mean (SD): 

Mid-tx: 

G1: 12.74 (12.90) 

G2: 14.10 (16.03) 

(P = NR) 

Post-tx: 

G1: 7.67 (9.06) (P = NR) 

G2: 16.31 (23.65) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1-yr FU: 

G1: 7.54 (13.15) (P = NR) 

G2: 13.11 (21.76) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Vomiting frequency (N = 64), 4 wks, 

mean (SD): 

G1: 21.2 (22.8) 

G2: 30.4 (32.8) 

(P = NR) 

Vomiting frequency, 4 wks, mean (SD): 

Mid-tx: 

G1: 9.78 (13.04) (P = NR) 

G2: 14.76 (18.59) (P = NR) 

Post-tx: 

G1: 6.00 (7.07) (P = NR) 

G2: 15.50 (23.99) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1-yr FU (N = 55): 

G1: 4.62 (13.15) (P = NR) 

G2: 11.89 (22.24) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.04) 

G1 better than G2 

Diff between groups in change over time (P = NS)
C-551 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 15.55 (9.98) 

G2: 17.75 (11.41) 

(P = NR) 

BDI, mean (SD): 

Mid-tx: 

G1: 9.61 (9.59) (P = NR) 

G2: 13.64 (11.29) (P = NR) 

Post-tx: 

G1: 8.27 (8.33) (P = NR) 

G2: 13.83 (11.48) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

1yr FU: 

G1: 7.61 (6.30) (P = NR) 

G2: 11.70 (12.99) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.05)

G1 better than G2 

Diff between groups in change 

over time (P = NS) 

BMI, mean (SD): 

G1: 21.68 (3.15) 

G2: 20.69 (2.44) 

(P = NR) 

BMI, mean (SD): 

Mid-tx: 

G1: 21.61 (2.25) (P = NR) 

G2: 20.94 (2.04) (P = NR) 

Post-tx: 

G1: 21.73 (2.28) (P = NR) 

G2: 20.74 (2.23) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

1yr FU: 

G1: 22.00 (2.25) (P = NR) 

G2: 20.45 (2.94) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.02) 

G2 better than G1 

Diff between groups in change 

over time (P = NS) 
C-552 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Laxative use, mean (SD): 

G1: 5.08 (14.86) 

G2: 4.03 (8.08) 

(P = NR) 

Laxative use, mean (SD): 

Mid-tx: 

G1: 0.19 (0.68) (P = NR) 

G2: 3.33 (7.47) (P = NR) 

Post-tx: 

G1: 0.33 (1.47) (P = NR) 

G2: 3.73 (8.75) (P = NR) 

Diff over time (P = 0.017) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1yr FU: 

G1: 0.08 (0.28) (P = NR) 

G2: 4.59 (10.15) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.025) 

G1 better than G2 

Diff between groups in change over time (P = NS) 

EDI-DT, mean (SD): 

G1: 14.0 (5.9) (P = NR) 

G2: 14.43 (5.16) (P = NR 

EDI-DT, mean (SD): 

Mid-tx: 

G1: 8.39 (6.73) (P = NR) 

G2: 10.00 (6.81) (P = NR) 

Post-tx: 

G1: 7.67 (6.53) (P = NR) 

G2: 10.87 (6.69) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1yr FU: 

G1: 6.59 (5.97) (P = NR) 

G2: 5.21 (5.64) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.009) 

G2 better than G1 

Author, yr: 

Bailer et al., 2004 

(continued) 

EDI-B, mean (SD): 

G1: 10.38 (5.29) 

G2: 10.25 (5.51) 

(P = NR) 

EDI-B, mean (SD): 

Mid-tx: 

G1: 4.32 (4.45) (P = NR) 

G2: 5.50 (4.86) (P = NR) 

Post-tx: 

G1: 3.10 (4.34) (P = NR) 

G2: 6.57 (5.32) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.01) 

G1 better than G2 

1yr FU (N = 55): 

G1: 3.32 (5.18) (P = NR) 

G2: 4.50 (5.06) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.018) 

G1 better than G2 

Diff between groups in change over time (P = NS) 
C-553 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-554 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDI-BD, mean (SD): 

G1: 15.55 (8.47) 

G2: 15.45 (7.60) 

(P = NR) 

EDI-BD, mean (SD): 

Mid-tx: 

G1: 10.96 (8.92) (P = NR) 

G2: 14.68 (9.34) (P = NR) 

Post-tx: 

G1: 9.97 (7.45) (P = NR) 

G2: 14.87 (8.07) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

1yr FU: 

G1: 10.18 (8.66) (P = NR) 

G2: 9.29 (9.42) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Meal Frequency, 4 wks, mean (SD): 

G1: 77.44 (43.57) 

G2: 59.49 (29.56) 

(P = NR) 

Meal Frequency, mean (SD): 

Mid-tx: 

G1: 80.65 (47.41) (P = NR) 

G2: 68.84 (33.53) (P = NR) 

Post-tx: 

G1: 72.76 (44.15) (P = NR) 

G2: 68.28 (26.13) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = 0.048) 

G1 greater than G2 

Diff between groups in change over time (P = NS) 

1yr FU: 

G1: 62.36 (29.85) (P = NR) 

G2: 52.37 (28.89) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

 “Recovered”, no binge or purge behavior for prior 

mo, N (%): 

Post-tx: 

G1: 3 (7.5) 

G2: 5 (12.2) 

1 yr FU: 

G1: 9 (22.5) 

G2: 6 (14.6) 

Author, yr: 

Bailer et al., 2004 

(continued) 

 “Remitted”, binge or purge episodes < 2x/wk in 

prior mo, N (%): 

Post-tx: 

G1: 16 (40) 

G2: 12 (29.3) 

1 yr FU: 

G1: 20 (50) 

G2: 15 (36.6) 
C-555 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-556 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Carter, Olmsted, et al., 

2003 

Setting: 

Individuals on a waiting 

list for tx at a hospitalbased specialty 

outpatient clinic, 

Toronto, Canada 

Enrollment period: 

NR 

Research objective: 

To examine the 

efficacy of a CBT 

self-help manual for 

tx of BN, and 

compare it to an 

“attention placebocontrol” condition 

(i.e., non-specific 

self-help manual) to 

control for 

nonspecific factors. A 

secondary aim was 

to identify predictors 

of outcome. 

Groups enrolled (N = 85): 

G1: CBT-based self-help (N = 28) 

G2: Non-specific self-help (N = 28) 

G3: Waitlist (N = 29) 

Enrollment: 

Potential subjects referred 

Phone screen: 245 

Invited for assessment interview: 123 

Completed assessment: 89 

Randomized 

(N = 85) 

Drop-outs, N (%): 

G1: 5 (17.9%) 

G2: 7 (25%) 

G3: 8 (27.6%) 

(P = NS) 

Completers, N: 

G1: 23 

G2: 21 

G3: 21 

Age, yrs, mean (SD), 

range: 

27 (8), 17-53 

Sex: 

Female, 100% 

Race/ethnicity, %: 

White: 83% 

Black: 25% 

Asian: 7% 

Other: 8% 

Marital status, %: 

Single: 71% 

Partnered: 22% 

Divorced: 6% 

Widowed: 1% 

BMI, kg/m2

, mean (SD), 

range: 

23.0 (5.0), 18-41 

BN Subtype: 

93% purging 

BN Onset, yrs, mean (SD), 

range: 

19 (6), 10-38 

BN Duration, yrs, mean 

(SD), range: 

7 (6), 0.5-33 

Objective Binge Episodes, 

past 4 wks, mean (SD, 

range: 

28 (23), 4-112 

Objective Purge Episodes, 

past 4 wks, mean (SD), 

range: 

41 (35), 0-112 
C-557 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

EDE criteria for BN, 

met modified DSM IV 

binge/purge frequency 

criteria (1x/wk), 

seeking specialized tx 

for first time 

Exclusion: 

Age < 17 yrs, 

pregnant, 

medical illness known 

to influence wt, 

current or prior 

specialist tx for ED, 

BMI < 18 kg/m2

Pre-tx assessment using subscales 

of EDE and EDI, wt, ht, BDI, BAI, 

RSE, Inventory of Interpersonal 

Problems, Dimensional 

Assessment of Personality 

Pathology 

Randomization and Instructions 

G1: 2-mo manualized CBT-based 

self-help program using 

‘Overcoming Binge Eating’ 

(Fairburn, 1995). 

G2: 2-mo manualized 

assertiveness skill-based self-help

program using ‘Self-Assertion for 

Women’ (Butler, 1992). 

G3: waitlist 

Post-assessment (as above) + 

compliance measure 

ITT: 2 (Pre-and post-) 

x 3 (CBT vs. nonspecific vs. waitlist) 

repeated measures 

ANOVA using pre-tx 

values carried forward 

for missing post-tx 

data. 

Paired t-test, 1-way 

ANOVA, and 

between-group t-test 

post-hoc 

comparisons. 

Chi Square tests to 

compared proportions 

of responders. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

No 

Adverse events: 

none 

Funding: 

Dean’s fund, Department of 

Medicine, University of 

Toronto 
C-558 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Objective binge frequency, past 4 wks, 

median: 

G1: 24.5 

G2: 18.5 

G3: 28.0 

(P = NR) 

Objective binge frequency, past 4 wks, median:

G1: 10 (P = 0.006) 

G2: 11.5 (P = 0.008) 

G3: 27.0 (P = NS) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Objective Purge frequency, past 4 

wks, median: 

G1: 26.0 

G2: 27.5 

G3: 46.5 

(P = NR) 

G1, G2 lower than G3 

Objective purge frequency, past 4 wks, 

median: 

G1: median = 22.5 (P = 0.04) 

G2: median = 16.5 (P = 0.005) 

G3: median = 32.0 (P = NS) 

Diff over time (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE Restraint, mean (SD): 

G1: 4.1 (1.3) 

G2: 3.7 (1.4) 

G3: 3.8 (1.7) 

(P = NR) 

EDE Restraint, mean (SD): 

G1: 3.9 (1.5) (P = NR) 

G2: 3.6 (1.6) (P = NR) 

G3: 3.7 (1.5) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

EDE Eating concern, mean (SD): 

G1: 4.5 (1.1) 

G2: 4.2 (1.3) 

G3: 4.1 (1.4) 

(P = NR) 

EDE Eating concern, mean (SD): 

G1: 4.3 (1.0) (P = NR) 

G2: 3.8 (1.2) (P = NR) 

G3: 3.8 (1.3) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

EDE Shape concern, mean (SD): 

G1: 5.2 (1.1) 

G2: 4.8 (1.3) 

G3: 4.7 (1.3) 

(P = NR) 

EDE Shape concern, mean (SD): 

G1: 5.0 (1.2) (P = NR) 

G2: 4.5 (1.3) (P = NR) 

G3: 4.6 (1.3) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Carter, Olmsted, et 

al., 2003 

(continued) 

EDE Wt concern, mean (SD): 

G1: 4.9 (1.2) 

G2: 4.3 (1.4) 

G3: 3.9 (1.6) 

(P = NR) 

EDE Wt concern, mean (SD): 

G1: 4.6 (1.2) (P = NR) 

G2: 4.0 (1.3) (P = NR) 

G3: 4.0 (1.4) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)
C-559 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 26.5 (11.4) 

G2: 24.4 (10.5) 

G3: 22.3 (10.0) 

(P = NR) 

BDI, mean (SD): 

G1: 26.9 (10.5) (P = NR) 

G2: 21.2 (11.1) (P = NR) 

G3: 20.9 (14.3) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR)

Decrease in Intense 

Exercise: 

G1 (P = 0.01) 

G2 (P = NS) 

G3 (P = NS) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.04) 

G1 better than G2, G3 

BAI, mean (SD): 

G1: 24.4 (12.0) 

G2: 23.4 (12.8) 

G3: 21.5 (9.6) 

(P = NR) 

BAI, mean (SD): 

G1: 25.4 (12.3) (P = NR) 

G2: 21.5 (12.8) (P = NR) 

G3: 19.6 (10.9) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR) 

Inventory of Interpersonal 

Problems, mean (SD): 

G1: 1.9 (0.6) 

G2: 1.9 (0.5) 

G3: 1.8 (0.6) 

(P = NR) 

Inventory of Interpersonal 

Problems, mean (SD): 

G1: 2.0 (0.7) (P = NR) 

G2: 1.6 (0.6) (P = NR) 

G3: 1.9 (0.6) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR) 

Knowledge of cognitivebehavioral psychoeducational content of tx 

manual, mean (SD): 

G1: 7.4 (2.7) 

G2: 8.3 (2.6) 

G3: 7.6 (2.9) 

(P = NR) 

Knowledge of cognitivebehavior psychoeducational content of tx 

manual, mean (SD): 

G1: 7.8 (2.7) (P = NR) 

G2: 8.0 (2.7) (P = NR) 

G3: 8.1 (2.6) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NR)

Knowledge of non-specific 

psychoeducational 

content of tx manual, 

mean (SD): 

G1: 5.7 (1.8) 

G2: 5.0 (1.7) 

G3: 4.7 (2.1) 

(P = NR)

Knowledge of non-specific 

psychoeducational content 

of tx manual, mean (SD): 

G1: 5.6 (2.2) (P = NR) 

G2: 6.6 (2.2) (P = 0.005) 

G3: 5.0 (2.3) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = 0.02) 

G2 better than G1, G3
C-560 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Carter, Olmsted, et 

al., 2003 

(continued) 

 
C-561 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Responders, decrease of at 

least 50% bingeing or purging, 

N (%): 

G1: 15 (53.6%) 

G2: 14 (50.0%) 

G3: 9 (31.0%) 

Diff between groups (P = NS) 

Compared to non-responders, 

responders had higher 

perfectionism (P = 0.03), higher 

compulsivity (P = 0.04), higher 

intimacy problems (P = 0.02), and 

lower CBT knowledge (P = 0.03)

Compliance, amount of manual 

read, %: 

G1: 78% 

G2: 59% 

(P = NS) 

Compliance, completed 

behavioral exercises, %: 

G1: 28.6% 

G2: 21.4% 

(P = NS) 

Predictors of compliance included 

lower baseline knowledge about 

ED (P = 0.02), higher intimacy 

problems (P = 0.02), and higher 

compulsivity (P = 0.02).
C-562 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Durand and King, 2003 

Setting: 

Three outpatient 

specialist clinics, 

London, UK 

Enrollment period: 

January 1995-June 

1997 

Research objective: 

To assess the efficacy 

of a general practicebased, self-help tx 

versus specialist 

outpatient tx for 

women with BN. 

Groups: 

G1: GP-supported self help (N = 34)

G2: Specialist tx (N = 34) 

Enrollment: 

209 referrals 

68 (32.5%) randomized 

Completed tx, N (%): 

G1: 34 (100%) 

G2: 26 (76%) 

Completed 6-mo FU, N (%): 

G1: 22 (64.7%) 

G2: 28 (82.4%) 

Completed 9-mo FU, N (%): 

G1: 26 (76.5%) 

G2: 28 (82.4%) 

Age, yrs, mean (SD): 

G1: 28.3 (6.5) 

G2: 24.5 (5.2) 

(P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 

G1: 29 (85%) 

G2: 30 (88%) 

(P = NR) 

Black: 

G1: 3 (9%) 

G2: 3 (9%) 

(P = NR) 

Other: 

G1: 1 (3%) 

G2: 1 (3%) 

(P = NR) 

Missing data: 

G1: 1 (3%) 

G2: 0 (0%) 

(P = NR) 

Duration of Eating 

Problem, yrs, mean (SD): 

G1: 7.7 (4.6) 

G2: 5.9 (3.9) 

(P = NR) 

Civil Status: 

Single: 

G1: 24 (71%) 

G2: 24 (71%) 

(P = NR) 

Married/cohabitating: 

G1: 5 (15%) 

G2: 9 (26%) 

(P = NR) 

Other: 

G1: 5 (15%) 

G2: 1 (3%) 

(P = NR) 
C-563 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

General practitioner 

referral; dx of BN 

(DSM IV); aged 18 or 

older; female; English 

speaking 

Exclusion: 

Requiring urgent clinic 

assessment; 

pregnancy; medical 

disorder such as 

diabetes; substance or 

alcohol misuse 

problems; suicidal 

intent 

Participants in self-help tx used 

manual “Bulimia Nervosa: a guide 

to recovery (Cooper, 1993), and 

advised to work through it with 

regular contact with GP, who also 

received copy of the manual and 

guidelines for administration. 

Participants in specialist tx seen 

by clinical tx team in one of three 

clinics on wkly or fortnightly basis 

for as long as deemed appropriate 

by specialist caregiver. 

Duration at clinician’s discretion. 

Repeated-measures 

MANOVA and 

MANCOVA conducted 

on BITE scores for 

two groups; Individual 

repeated measures 

analysis conducted to 

examine diff between 

BDI, EDE, and WLFL 

measures between 

groups. 

Power calculations 

conducted based on 

BITE. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

North Thames Regional 

Health Authority 
C-564 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BITE, mean (SD): 

G1: 34.1 (6.3) 

G2: 33.7 (5.9) 

(P = NR) 

BITE, mean (SD): 

6 mos: 

G1: 28.9 (11.3) (P = NR) 

G2: 28.2 (9.9) (P = NR) 

9 mos: 

G1: 26.2 (12.4) (P = NR) 

G2: 29.6 (11.4) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Objective bulimic episodes, past 28 

days, mean (SD): 

G1: 19.0 (15.2) 

G2: 20.4 (19.6) 

(P = NR)

Objective bulimic episodes, past 28 days, mean 

(SD): 

6 mos: 

G1: 16.4 (17.4) (P = NR) 

G2: 12.6 (14.2) (P = NR) 

9 mos: 

G1: 15.0 (17.4) (P = NR) 

G2: 14.9 (18.9) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Episodes of vomiting, past 28 days, 

mean (SD): 

G1: 35.1 (31.0) 

G2: 37.8 (33.9) 

(P = NR)

Episodes of vomiting, past 28 days, mean (SD): 

6 mos: 

G1: 25.0 (25.6) (P = NR) 

G2: 16.5 (18.7) (P = NR) 

9 mos: 

G1: 20.3 (27.0) (P = NR) 

G2: 20.5 (23.9) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Author, yr: 

Durand and King, 

2003 

(continued) 

EDE-Restraint, mean (SD): 

G1: 3.3 (1.0) 

G2: 3.3 (0.8) 

(P = NR)

EDE-Restraint, mean (SD): 

6 mos: 

G1: 2.8 (1.3) (P = NR) 

G2: 2.6 (1.4) (P = NR) 

9 mos: 

G1: 2.4 (1.4) (P = NR) 

G2: 2.8 (1.1) (P = NR) 

Diff over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)
C-565 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 27.7 (9.7) 

G2: 21.4 (10.7) 

(P = NR) 

BDI, mean (SD): 

6 mos: 

G1: 17.8 (11.7) (P = NR) 

G2: 18.1 (10.6) (P = NR) 

9 mos: 

G1: 16.2 (9.9) (P = NR) 

G2: 15.5 (10.8) (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NR) 

A direct relationship between BDI 

and BITE scores found (P = 0.001); 

as BDI scores decreased over time, 

so did BITE scores 

 

Patient-rated 

severity, mean (SD): 

G1: 7.6 (2.2) 

G2: 7.1 (2.6) 

(P = NR)

Patient-rated severity, mean (SD): 

6 mos: 

G1: 6.6 (3.2) (P = NR) 

G2: 6.1 (3.0) (P = NR) 

9 mos: 

G1: 5.8 (3.1) (P = NR) 

G2: 4.8 (2.8) (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P = NS)

 
C-566 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Eating Concern, mean (SD): 

G1: 2.4 (1.2) 

G2: 2.5 (1.0) 

(P = NR) 

EDE Eating Concern, mean (SD): 

6 mos: 

G1: 2.0 (1.3) (P = NR) 

G2: 2.1 (1.3) (P = NR) 

9 mos: 

G1: 1.8 (1.3) (P = NR) 

G2: 1.9 (1.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

EDE Wt concern, mean (SD): 

G1: 3.1 (1.3) 

G2: 3.4 (1.3) 

(P = NR)

EDE Wt concern, mean (SD): 

6 mos: 

G1: 2.6 (1.4) (P = NR) 

G2: 3.0 (1.2) (P = NR) 

9 mos: 

G1: 2.5 (1.5) (P = NR) 

G2: 2.9 (1.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

EDE Shape concern, mean (SD): 

G1: 3.4 (1.2) 

G2: 3.9 (1.1) 

(P = NR)

EDE Shape concern, mean (SD): 

6 mos: 

G1: 2.9 (1.3) (P = NR) 

G2: 3.3 (1.2) (P = NR) 

9 mos: 

G1: 2.9 (1.3) (P = NR) 

G2: 3.0 (1.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

Author, yr: 

Durand and King, 

2003 

(continued) 

EDE Global score, mean (SD): 

G1: 3.0 (1.0) 

G2: 3.3 (0.8) 

(P = NR)

EDE Global score, mean (SD): 

6 mos: 

G1: 2.6 (1.2) (P = NR) 

G2: 2.8 (1.0) (P = NR) 

9 mos: 

G1: 2.4 (1.2) (P = NR) 

G2: 2.6 (1.0) (P = NR) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-567 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-568 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Thiels et al., 1998 

Setting: 

Outpatient, Germany 

Enrollment period: 

NR 

Research objective: 

To evaluate the 

effectiveness of guided 

self-change for BN. 

Groups: 

G1: CBT (16 wkly 

sessions) 

G2: Guided Self-change 

(8 fortnightly guided 

sessions)

Enrollment: 

• Enrolled N = 62; 31 

each group

(alternating basis) 

• 13 (21%) dropped out 

during tx phase: 

G1: N = 4 (12.9%) 

G2: N = 9; (29.0%) 

• 14 (22.6%) of enrolled 

did not complete FU. 

No diffs in response to 

FU by condition. 

Age, yrs, mean (SD): 

G1: 28.7 (9.1)

G2: 27.5 (6.9) 

Diff between groups (P = NS) 

Sex: 

NR 

Race/ethnicity: 

NR 

Duration of BN, yrs, mean 

(SD): 

G1: 8.5 (9.2) 

G2: 6.1 (5.6) 

(P = NS) 

Age of Onset of BN, yrs, 

mean (SD): 

G1: 19.6 (4.7) 

G2: 20.3 (6.3) 

(P = NS) 

Previous BN tx, N (%): 

G1: 15 (48.4) 

G2: 12 (40.0) 

(P = NS) 

Previous AN tx, N (%): 

G1: 7 (22.6) 

G2: 3 (10.0) 

(P = NS) 

Previous tx for other 

psychiatric problems, N 

(%): 

G1: 2 (6.5) 

G2: 10 (33.3) 

(P = 0.02) 

Present co-morbidity, N: 

Affective Disorders: 

G1: 0 

G2: 2 

Substance-use Disorders: 

G1: 0 

G2: 0 

Anxiety/OC Disorders: 

G1: 4 

G2: 2 

Somatoform Disorders: 

G1: 2 

G2: 2 

AN: 

G1: 0 

G2: 0 

All (P = NS) 
C-569 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria BN 

or if prolonged dx of 

BN but recently 

improved and thus not 

currently meeting 

criteria. 

Exclusion: 

NR 

G1: 16 wkly CBT sessions. G2: 16 

wks but only 8 fortnightly tx 

sessions). First 4 sessions - chapters 

1-6 of CBT manual; remaining 

sessions: chose most relevant 

chapters to focus on. 

Both groups: 50 – 50 minutes 

sessions. 

ANCOVA: if additional 

tx influenced outcome; 

T-tests: diffs between 

tx and for 

demographics with 

most conservative F 

values (lower bound 

epsilon) and followed 

by approximate test 

for nonsign. 

Results: Yatescorrected chi-square 

test: categorical data; 

confidence interval 

analysis: abstinence 

rates. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

British council (academic 

research collaboration project 

269), the German academic 

exchange service, and 

Bielefeld university of applied 

sciences 
C-570 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Values presented for the Completer 

sample (N = 48) first, followed by the 

Randomized sample (N = 62) (when 

available) 

Both txs led to improvements on all measures 

through FU (text) 

EDE Overeating, mean (SD): 

G1: 2.95 (0.82) 

G2: 3.02 (1.10) 

(P = NR) 

EDE Overeating, mean (SD): 

G1: 2.99 (0.85) 

G2: 3.00 (1.01) 

(P = NS) 

EDE Overeating: 

Mid-tx: 

G1: 2.18 (1.07) (P = NR) 

G2: 2.44 (1.22) (P = NR) 

Post-tx: 

G1: 1.53 (1.55) (P = NR) 

G2: 2.27 (1.21) (P = NR) 

FU: 

G1: 1.07 (1.61) (P = NR) 

G2: 1.17 (1.23) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDE Vomiting: 

G1: 3.79 (1.71) 

G2: 3.65 (1.65) 

(P = NR) 

EDE Vomiting: 

G1: 3.76 (1.76) 

G2: 3.23 (1.86) 

(P = NS) 

EDE Vomiting: 

Mid-tx: 

G1: 2.83 (1.93) (P = NR) 

G2: 2.83 (1.81) (P = NR) 

Post-tx: 

G1: 2.06 (2.30) (P = NR) 

G2: 2.57 (1.84) (P = NR) 

FU: 

G1: 1.38 (2.00) (P = NR) 

G2: 1.59 (1.82) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Thiels et al., 1998 

(continued) 

EDE Shape Concern, mean (SD): 

G1: 2.98 (1.47) 

G2: 3.30 (1.82) 

(P = NR) 

EDE Shape Concern, mean (SD): 

Mid-tx: 

G1: 2.94 (1.30) (P = NR) 

G2: 2.78 (1.55) (P = NR) 

Post-tx: 

G1: 2.37 (1.34) (P = NR) 

G2: 2.50 (1.53) (P = NR) 

FU: 

G1: 2.32 (1.68) (P = NR) 

G2: 1.68 (1.43) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)
C-571 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

 BMI, kg/m2

, mean (SD): 

Total sample: 21.95 (3.56)

G1: 21.31 (3.11) 

G2: 22.57 (3.89) 

(P = NS) 

BMI at FU, kg/m2, mean 

(SD): 

Total sample: 21.93 (3.11) 

G1: NR

G2: NR

Diff between groups in 

change over time (P = 0.02)

BDI, mean (SD): 

G1: 21.0 (8.3) 

G2: 19.5 (8.4) 

(P = NR) 

BDI, mean (SD): 

G1: 22.4 (9.9) 

G2: 19.5 (8.6) 

(P = NS) 

BDI, mean (SD): 

Mid-tx: 

G1: 12.0 (8.7) (P = NR) 

G2: 17.0 (10.2) (P = NR) 

Post-tx: 

G1: 9.9 (8.8) (P = NR) 

G2: 14.8 (11.4) (P = NR) 

FU: 

G1: 11.4 (10.5) (P = NR) 

G2: 10.2 (9.9) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 

Self-Concept (self-esteem) 

Questionnaire, mean (SD): 

G1: 95.9 (19.9) 

G2: 104.3 (22.7) 

(P = NR) 

Self-Concept (self-esteem) 

Questionnaire, mean (SD): 

G1: 96.3 (26.9) 

G2: 103.8 (24.1) 

(P = NS) 

Self-Concept (self-esteem) 

Questionnaire, mean (SD):

Mid-tx: 

G1: 111.6 (18.3) (P = NR) 

G2: 112.0 (30.6) (P = NR) 

Post-tx: 

G1: 119.4 (22.9) (P = NR) 

G2: 118.6 (29.2) (P = NR) 

FU: 

G1: 121.6 (31.3) (P = NR) 

G2: 139.3 (33.5) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS)

Diff between groups in 

change over time (P = NS) 
C-572 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Wt Concern, mean (SD): 

G1: 3.53 (1.40) 

G2: 3.20 (1.42)

(P = NR) 

EDE Wt Concern, mean (SD): 

Mid-tx: 

G1: 2.83 (1.39) (P = NR) 

G2: 3.05 (1.75) (P = NR) 

Post-tx: 

G1: 2.21 (1.63) (P = NR) 

G2: 2.42 (1.95) (P = NR) 

FU: 

G1: 1.92 (1.57) (P = NR) 

G2: 1.83 (1.57) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDE Dietary restraint, mean (SD): 

G1: 3.79 (1.71) 

G2: 3.65 (1.65)

(P = NR) 

EDE Dietary restraint, mean (SD): 

Mid-tx: 

G1: 2.42 (1.37) (P = NR) 

G2: 2.63 (1.44) (P = NR) 

Post-tx: 

G1: 1.83 (1.45) (P = NR) 

G2: 2.34 (1.46) (P = NR) 

FU: 

G1: 1.56 (1.80) (P = NR) 

G2: 1.46 (1.57) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Thiels et al., 1998 

(continued) 

EDE Severity, mean (SD): 

G1: 4.17 (0.65) 

G2: 4.05 (0.58)

(P = NR) 

EDE Severity, mean (SD): 

Mid-tx: 

G1: 3.04 (1.02) (P = NR) 

G2: 3.41 (1.10) (P = NR) 

Post-tx: 

G1: 2.43 (1.44) (P = NR) 

G2: 3.18 (1.22) (P = NR) 

FU: 

G1: 2.26 (1.36) (P = NR) 

G2: 2.32 (1.49) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-573 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-574 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BITE score, mean (SD): 

G1: 30.1 (5.0) 

G2: 33.8 (9.4) 

(P = NR) 

BITE score, mean (SD): 

G1: 32.0 (5.6) 

G2: 34.1 (8.5) 

(P = NS) 

BITE score, mean (SD): 

Mid-tx: 

G1: 23.8 (9.4) (P = NR) 

G2: 28.1 (11.0) (P = NR) 

Post-tx: 

G1: 17.0 (13.1) (P = NR) 

G2: 27.0 (12.3) (P = NR) 

FU: 

G1: 15.4 (14.2) (P = NR) 

G2: 18.2 (12.5) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = 0.05) 

G2 better than G1 

Diff between groups in change over time (P = NS) 

Author, yr: 

Thiels et al., 1998 

(continued) 

Eating Disorders Awareness Test, 

mean (SD): 

G1: 21.5 (6.9) 

G2: 22.5 (7.8) 

(P = NR) 

Eating Disorders Awareness Test, 

mean (SD): 

G1: 22.8 (7.6) 

G2: 23.1 (7.9) 

(P = NS) 

Eating Disorders Awareness Test, mean (SD): 

Mid-tx: 

G1: 26.3 (6.7) (P = NR) 

G2: 33.0 (9.7) (P = NR) 

Post-tx: 

G1: 29.6 (8.3) (P = NR) 

G2: 34.3 (10.3) (P = NR) 

FU: 

G1: 32.5 (8.0) (P = NR) 

G2: 35.5 (9.4) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-575 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-576 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Thiels et al., 1998 

(continued) 

Abstinence rates, N (%) (95% CI): 

Stopped binge eating in previous wk: 

Mid-tx (N = 31): 

G1: 10 (32.3%) (16.7 – 51.4) 

G2: 6 (19.4%) (7.5 – 48.0) 

Post-tx (N = 31): 

G1: 19 (61.3%) (42.2 – 78.1) (P = NR) 

G2: 5 (16.1%) (5.5 – 33.7) (P = NR) 

FU (G1, N = 24; G2 N = 23): 

G1: 17 (70.8%) (48.9 – 87.4) (P = NR) 

G2: 16 (69.6%) (47.1 – 86.8) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Stopped vomiting in previous wk: 

Mid-tx (N = 31): 

G1: 9 (29.0%) (14.2 – 48.0) 

G2: 9 (29.0%) (14.2 – 48.0) 

Post-tx (N = 31): 

G1: 17 (54.8%) (36.0 – 72.7) (P = NR) 

G2: 8 (25.8%) (11.9 – 44.6) (P = NR) 

FU (G1, N = 24; G2, N = 23): 

G1: 17 (70.8%) (48.9 – 87.4) (P = NR) 

G2: 14 (60.9%) (38.5 – 80.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Stopped binge eating and vomiting combined: 

Mid-tx (N = 31): 

G1: 8 (25.8%) (11.9 – 44.6) 

G2: 5 (16.1%) (5.5 – 33.7) 

Post tx (N = 31): 

G1: 17 (54.8%) (36.0 – 72.7) (P = NR) 

G2: 4 (12.9%) (3.6 – 29.8) (P = NR) 

FU (G1, N = 24; G2, N = 23): 

G1: 17 (70.8%) (48.9 – 87.4) (P = NR) 

G2: 14 (60.9%) (38.5 – 80.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-577 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-578 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Treasure et al., 1996 

Companion article: 

Turnbull et al., 1997 

Setting: 

Tertiary referral center 

in UK 

Enrollment period: 

NR 

Research objective: 

Examine if sequential 

program (self-help manual for 

8 wks followed by 8 sessions 

of CBT for patients who 

remained symptomatic) is 

different from standard CBT 

(16 wks administered 

consecutively or following an 

8-wk waiting period). 

Groups: 

G1: Self-help manual/sequential 

tx (N = 55) 

G2: standard CBT (N = 55)* 

Enrollment: 

• 125 consecutive referrals 

with a dx of BN or atypical 

BN were screened 

• 7 were excluded; 8 declined 

• 110 patients randomized 

• From G1, 41 attended 

assessment at 8 wks, 46 at 

16 wks and 30 at 18 mos 

• In G2, subgroup 1 

(immediate tx) consisted of 

27 individuals and subgroup

2 (delayed tx) had 28 

individuals. 

• Of the 55 in G2, 40 were 

reassessed at 16 wks (end 

of tx) and 34 at 18 mos. 

• 86 completed tx 

• 18 mos after tx (14-26 mos), 

all patients were contacted 

and sent a questionnaire. 64 

responded. FU took place in 

person or by phone. 

* Half of the individuals in the 

CBT group (delayed tx) served 

as waiting list control 

participants in another study – 

Treasure et al., 1994). 

Age, yrs, mean (SD): 

G1: 25.6 (5.5) 

G2: 25.9 (6.3) 

(P = NS) 

Age at onset, yrs, mean 

(SD): 

G1: 17.5 (4.8) 

G2: 17.0 (4.4) 

(P = NS) 

Illness Duration, yrs, 

mean (SD): 

G1: 8.0 (5.0) 

G2: 9.1 (6.5) 

(P = NS) 

Sex: 

NR 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 23.7 (5.4) 

G2: 24.4 (6.4) 

(P = NS) 

Total symptom score: 

G1: 6 

G2: 6 

(P = NS) 

Hx of AN: 

G1: 29% 

G2: 28% 

(P = NS) 

Previous tx: 

G1: 44% 

G2: 55% 

(P = NS) 

Current depression: 

G1: 23% 

G2: 35% 

(P = NS) 

Current amenorrhea: 

G1: 12% 

G2: 10% 

(P = NS) 

Social class 

(Professional class): 

G1: 53% 

G2: 56% 

(P = NS) 
C-579 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

ICD-10 dx of BN or 

atypical BN 

Exclusion: 

Individuals were 

excluded for severe 

comorbidity (diabetes, 

high risk of suicide or 

alcohol dependence) 

or pregnancy. 

G1 was allocated the manual, asked 

to work at their own pace and were 

told that the manual contained all the 

information needed for them to 

overcome their BN. They were asked 

to keep a therapeutic diary (this was 

used as part of the assessment at 8 

wks). After 8 wks, patients who 

remained symptomatic were offered 

up to 8 sessions of CBT. Those who 

no longer met criteria for BN or 

atypical BN were invited to come for 

FU at 16 wks. 

G2 was subdivided into two grps. Half 

of them were offered immediate CBT 

for 16 wks and the other half were 

offered tx after a waiting period of 8 

wks after which they received 16 wks 

of CBT (this group was a waiting list 

control in Treasure, 1994). The two 

subgroups were combined at the end 

of their txs for comparisons with G1. 

Patients were considered fully 

recovered if they were not bingeing, 

vomiting or using any other wt control 

behaviors or if information was not 

available, their BITE symptom score 

was < or equal to 11 and their BITE 

severity score was 0. 

T tests were used to 

test for group diffs at 

baseline. Chi-square 

analyses were done 

for categorical data. 

Wilcoxon tests were 

used to assess within 

group changes for 

bulimic symptom 

scores, which were 

not normally 

distributed. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

Mental Health Foundation 

and Medical Research 

Council 
C-580 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Treasure et al., 1996 

(continued) 

Bulimia rating scale symptom score, 

median: 

G1: 6 

G2: 6 

(P = NR) 

End of tx: 

Bulimia rating scale symptom score, median: 

G1: 2 (P = 0.00) 

G2: 2 (P = 0.00) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Total remission rate/”fully recovered” (no 

bingeing, vomiting or using any other wt 

control mechanism): 

G1: 30% 

G2: 30% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

18 mo FU: 

Bulimia rating scale symptom score, median: 

G1: 1.5 (P = NS) 

G2: 1 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Total remission rate/”fully recovered”: 

G1: 40% 

G2: 41% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Additional tx sought: 

G1: 38% 

G2: 17% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-581 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-582 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Turnbull et al., 1997 

Companion article: 

Treasure et al., 1996 

Setting: 

Tertiary referral center 

in UK 

Enrollment period: 

NR 

Research objective: 

Examined pre tx predictors of 

outcome for two tx’s for BN. 

Outcome (i.e., severity of 

eating disorder 

psychopathology) was 

defined as a sum of binge 

frequency, vomiting, abuse of 

laxatives or diuretics, and 

intense exercising. 

Groups: 

G1: Self-help

manual/sequential tx (N = 55) 

G2: standard CBT (N = 55) 

Enrollment: 

• 125 consecutive referrals 

with a dx of BN or atypical 

BN were screened 

• 7 were excluded; 8 

declined 

• 110 patients randomized 

• From G1, 41 attended 

assessment at 8 wks, 46 at 

16 wks and 30 at 18 mos 

• In G2, subgroup 1 

(immediate tx) consisted of 

27 individuals and 

subgroup 2 (delayed tx) 

had 28 individuals. 

• Of the 55 in G2, 40 were 

reassessed at 16 wks (end 

of tx) and 34 at 18 mos. 

• 86 completed tx 

• 18 mos after tx (14-26 

mos), all patients were 

contacted and sent a 

questionnaire. 64 

responded. FU took place 

in person or by phone. 

Age, yrs, mean (SD): 

G1: 25.6 (5.5) 

G2: 25.9 (6.3) 

(P = NS) 

Age at onset, yrs, mean 

(SD): 

G1: 17.5 (4.8) 

G2: 17.0 (4.4) 

(P = NS) 

Sex: 

NR 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 23.7 (5.4) 

G2: 24.4 (6.4) 

(P = NS) 

Total symptom score: 

G1: 6 

G2: 6 

(P = NS) 

Hx of AN: 

G1: 29% 

G2: 28% 

(P = NS) 

Previous tx: 

G1: 44% 

G2: 55% 

(P = NS) 

Current depression: 

G1: 23% 

G2: 35% 

(P = NS) 

Current amenorrhea: 

G1: 12% 

G2: 10% 

(P = NS) 

Social class 

(Professional class): 

G1: 53% 

G2: 56% 

(P = NS) 
C-583 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

ICD-10 dx of BN or 

atypical BN 

Exclusion: 

Individuals were 

excluded for severe 

comorbidity (diabetes, 

high risk of suicide or 

alcohol dependence) 

or pregnancy. 

G1 was allocated the manual, asked 

to work at their own pace and were 

told that the manual contained all the 

information needed for them to 

overcome their BN. They were asked 

to keep a therapeutic diary (this was 

used as part of the assessment at 8 

wks). After 8 wks, patients who 

remained symptomatic were offered 

up to 8 sessions of CBT. Those who 

no longer met criteria for BN or 

atypical BN were invited to come for 

FU at 16 wks. 

G2 was subdivided into two grps. Half 

of them were offered immediate CBT 

for 16 wks and the other half were 

offered tx after a waiting period of 8 

wks after which they received 16 wks 

of CBT (this group was a waiting list 

control in Treasure, 1994). The two 

subgroups were combined at the end 

of their txs for comparisons with G1. 

Patients were considered fully 

recovered if they were not bingeing, 

vomiting or using any other wt control 

behaviors or if information was not 

available, their BITE symptom score 

was < or equal to 11 and their BITE 

severity score was 0. 

Stepwise linear 

regressions to predict 

outcome at end of tx 

and at 18 mo FU. As 

there was no diff 

between the two 

groups, some of the 

data was pooled to 

look at predictors. 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

Mental Health Foundation and 

Medical Research Council 
C-584 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Turnbull et al., 1997 

(continued) 

Global Symptoms (sum of binge frequency, 

vomiting, laxative and/or diuretic abuse, 

intense exercising): 

End of tx: 

Duration of illness as predictor: 

G1: NR (P = NS) 

G2: NR (P < 0.02) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Binge frequency as predictor: 

G1: NR (P < 0.05) 

G2: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

18 mo FU: 

Duration of illness as predictor: 

G1: NR (P = NS) 

G2: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Binge frequency as predictor: 

G1: NR (P < 0.05) 

G2: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-585 

Evidence Table 8. Self-help trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-586 

Evidence Table 9. Other trials for bulimia nervosa 

Study Description Objective Design 

Patient 

Characteristics 

Author, yr: 

Braun et al., 1999 

Setting: 

Outpatient, New York, 

USA 

Enrollment period: 

NR 

Research objective: 

During a 3-wk winter tx 

period, to assess the 

efficacy of winter bright light 

therapy versus dim red light 

(Placebo) therapy on binge 

and purge frequency and 

depressive sx in women 

with BN. 

Groups: 

G1: Active light (N = 16) 

G2: Dim light/Placebo (N = 18) 

Enrollment: 

• Recruited via therapist or 

newspaper ads 

• Subjects matched for age, 

degree of seasonality 

(measured by Seasonal 

Patterns Assessment 

Questionnaire), and 

concurrent depression 

(DSM IV) 

• Total screened = N 

• 34 enrolled 

Age, yrs, mean (SD): 

G1: 30.50 (7.3) 

G2: 30.50 (8.6) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Current Major 

Depression: 

G1: 25% (N = 4) 

G2: 22.2% (N = 4) 

Lifetime Major 

Depression: 

G1: 75% (12) 

G2: 72.2% (13) 

No patients met criteria 

for major depression 

with a seasonal pattern. 
C-587 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM IV criteria for 

BN; age 18 to 50; 

premenopausal 

Exclusion: 

Current drug or alcohol 

abuse or dependence, 

bipolar disorder, 

schizophrenia, 

ophthalmologic 

disease, serious 

medical conditions, or 

current wt less that 

90% IBW 

(Metropolitan Table); 

current anorexia; 

involvement in 

psychotherapy 

regimen or taking 

psychiatric meds for 

less than 3 mos prior 

to study; change in 

therapeutic tx or meds 

immediately preceding 

or during study 

Parallel-design, 8 wk study, taking 

place during winter mos (NovDec; Jan-March); 3 wk baseline 

data collection followed by 3 wk tx 

period, and 2 wks FU; all subjects 

received Apollo light boxes to 

deliver either 10,000 lux white 

light (G1) or 50 lux red light (G2) 

arriving at the retina; all used 

lights 1⁄2 hr/day at home between 

6 and 9pm while watching 

television; daily phone contact 

with about compliance with 

participants, who avoided outdoor 

light before 8am or used 

sunglasses. 

For 8 wks, all completed daily 

food diaries, including B/P

behaviors, urge to binge, meals 

and snacks, carbohydrate 

cravings, menstrual ad sleep logs, 

and BDIs. 

At baseline, tx-end, and 2-wk FU, 

wt, BDI, HAM-D, Seasonal 

Patterns Assessment 

Questionnaire (SPAQ) and YBCEDS were assessed. 

MANOVA across time 

points was used to 

assess light tx by time 

interaction; Pearson r 

correlations between 

the change in various 

outcome measures 

were computed in 

groups; ANOVA was 

used to assess diff 

between group s in 

change over time. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

Double 

Adverse events: 

No subjects withdrew due to 

side effects; 5 were removed 

from G1 due to med change, 

vacation in sun, 

noncompliance, and failure to 

meet binge frequency at 

baseline; 5 G2 were removed 

due to failure to meet BN 

criteria. 

Funding: 

NIMH and fund established by 

the NY Community Trust by 

Dewitt-Wallace 
C-588 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge Frequency, wkly, mean (SD): 

G1: 6.7 (3.1) 

G2: 4.9 (2.9) 

(P = NS) 

Binge Frequency, wkly, mean (SD): 

Post-tx: 

G1: 4.3 (3.9) (P = NR) 

G2: 3.9 (3.3) (P = NR) 

2 wk FU: 

G1: 4.1 (4.5) (P = NR) 

G2: 3.6 (3.3) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.017)

G1 better than G2 in change from baseline to post-tx

Purge Frequency, wkly, mean (SD): 

G1: 7.7 (4.8) 

G2: 6.3 (5.9) 

(P = NS) 

Purge Frequency, wkly, mean (SD): 

Post-tx: 

G1: 5.2 (4.5) (P = NR) 

G2: 4.3 (4.0) (P = NR) 

2 wk FU: 

G1: 4.5 (6.2) (P = NR) 

G2: 4.2 (4.2) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Meal Frequency, wkly, mean (SD): 

G1: 14.5 (5.0) 

G2: 16.3 (3.8) 

(P = NS) 

Meal Frequency, wkly, mean (SD): 

Post-tx: 

G1: 16.4 (4.0) (P = NR) 

G2: 16.8 (3.4) (P = NR) 

2 wk FU: 

G1: 17.4 (3.5) (P = NR) 

G2: 16.5 (3.7) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Braun et al., 1999 

(continued) 

YBC-EDS, total, mean (SD):

G1: 15.1 (4.5) 

G2: 16.4 (5.1) 

(P = NS) 

YBC-EDS, total, mean (SD): 

G1: 11.4 (6.0) (P = NR) 

G2: 13.4 (5.9) (P = NR) 

2 wk FU: 

G1: 10.4 (7.4) (P = NR) 

G2: 11.8 (7.4) (P = NR) 

Diff over time (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-589 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 16.9 (9.4) 

G2: 13.1 (9.1) 

(P = NS) 

BDI, mean (SD): 

Post-tx: 

G1: 13.0 (7.5) (P = NR) 

G2: 10.8 (9.1) (P = NR) 

2 wk FU: 

G1: 11.9 (8.7) (P = NR) 

G2: 10.5 (8.7) (P = NR) 

Diff over time (P = 0.003) 

Diff between groups (P = NS) 

Diff between groups in 

change over time (P = NS)

 

HAM-D, mean (SD): 

G1: 7.9 (6.7) 

G2: 9.7 (7.6) 

(P = NS) 

HAM-D, mean (SD): 

Post-tx: 

G1: 3.7 (3.7) (P = NR) 

G2: 5.5 (4.1) (P = NR) 

2 wk FU: 

G1: 4.4 (4.4) (P = NR) 

G2: 4.7 (6.4) (P = NR) 

Diff over time (P = 0.005) 

Diff between groups (P = NS) 

Diff between groups in 

change over time (P = NS) 

 

HAM-D-SAD items, mean 

(SD): 

G1: 5.7 (3.6) 

G2: 5.5 (4.1) 

(P = NS) 

HAM-D-SAD, mean (SD): 

Post-tx: 

G1: 2.3 (2.3) (P = NR) 

G2: 2.4 (2.2) (P = NR) 

2 wk FU: 

G1: 5.6 (4.5) (P = NR) 

G2: 4.0 (5.5) (P = NR) 

Diff over time (P = 0.014) 

Diff between groups (P = NS) 

Diff between groups in 

change over time (P = NS) 

 
C-590 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Braun et al., 1999 

(continued) 

Seasonal Patterns Assessment 

Questionnaire (SPAQ): 

G1: 43.8% (16) met full criteria for SAD, 

18.8% (3) met sub-threshold criteria 

G2: 44.4% (18) met SAD criteria, 16.7% (3) 

met sub-threshold. 

SPAQ GSS, mean (SD): 

G1: 11.1 (5.2) 

G2: 11.0 (5.3) 

(P = NS) 

SPAQ Sleep, mean (SD): 

G1: 1.5 (1.2) 

G2: 1.3 (1.1) 

(P = NS) 

SPAQ -Wt, mean (SD): 

G1: 1.8 (1.1) 

G2: 1.3 (1.1) 

(P = NS) 

SPAQ Appetite, mean (SD): 

G1: 1.7 (1.0) 

G2: 1.6 (1.2) 

(P = NS) 

SPAQ Energy, mean (SD): 

G1: 2.2 (1.1) 

G2: 2.3 (1.2) 

(P = NS) 

From baseline to Tx-end, SPAQ global 

scores were not correlated with change in 

binge frequency. 

Seasonal Patterns Assessment 

Questionnaire (SPAQ): 

G1: NR 

G2: NR 

(P = NR) 

Correlation between change in HAM-D-SAD 

scores and change in carbohydrate craving 

G1: (r = 0.66) (P = 0.38) 

G2: (r = -.41) (P = 0.24) 

Correlation between change in HAM-D-SAD 

scores and change in binge frequency 

G1: (r = 0.44) (P = 0.20) 

G2: (r = -.75) (P = 0.012) 
C-591 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-592 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Esplen et al., 1998 

Setting: 

Outpatient; Toronto, 

Canada 

Enrollment period: 

20 mos 

Research objective: 

To test the efficacy of a 

guided image therapy to 

enhance self-comfort in 

individuals with BN vs. a 

control tx of eating behavior 

journaling therapies 

Groups enrolled: 

G1: guided imagery (N = 28) 

G2: control (N = 30) 

Enrollment: 

Potential subjects referred by 

consultation service (N = 51) 

or in response to 

advertisements (N = 7) 

Informed consent 

Pre-tx psychometric 

assessment 

Randomization 

6 wks of tx 

Post-tx psychometric 

assessment 

Drop-outs: 

G1: N = 4 

G2: N = 4 

Completers reported: 

G1: N = 24 

G2: N = 28 

Age, yrs, mean (SD): 

G1: 27.2 (6.3) 

G2: 26.1 (5.8) 

(P = NS) 

Sex: 

96.5% female 

Race/ethnicity: 

NR 

BMI, kg/m2

, mean (SD): 

G1: 21.0 (1.0) 

G2: 21.3 (1.3) 

(P = NS) 

Duration of BN, mos, mean 

(SD): 

G1: 83.0 (55.5) 

G2: 86.0 (63.9) 

(P = NS) 

Previous AN, N (%): 

Completers: 12 (24%) 

Drop-outs: 6 (75%) 

(P = NR) 
C-593 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM III-R criteria for 

BN 

CBW > 85% of avg for 

sex, age, and height 

< 15 yr illness duration 

no current psych tx 

no risk factors for 

inpatient tx 

Exclusion: 

Current psych tx or 

Indications for 

inpatient tx 

Pre-tx assessment 

Randomization 

G1: 6 wkly sessions of manual-based 

guided imagery exercises on 

relaxation and self-exploration; takehome tape provided; journaling 

G2: 6 wkly sessions of manual-based 

explorations of eating pattern 

journals; comments on observed 

patterns but no guidelines 

Post-assessment 

2 (group) x 2 (time) 

repeated measures 

ANOVA; regression 

analysis of psych 

variables on eating 

behaviors; 

correlations between 

psych variables; Chi 

Square for abstinence 

rates. 

Active dose = 4 wks of 

therapy, so 

“completer” was ≥ 4 

session attendance 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

Not reported 

Funding: 

Ontario Mental Health 

Foundation 
C-594 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Esplen et al., 1998 

(continued) 

Binge frequency/wk, mean (SD): 

G1: 5.6 (3.5) 

G2: 4.9 (2.6) 

(P = NS) 

Binge Frequency/wk, mean (SD): 

G1: 1.7 (1.7) (P = NR) 

G2: 5.2 (2.6) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = 0.05) 

Diff between groups in change over time 

(P < 0.001) 

G1 better than G2 

% Reduction in Binge Freq: 

G1: 73.6% (23.9) 

G2: - 9.0% (43.4) 

(P = NR)

 Purge frequency/wk, mean (SD): 

G1: 6.3 (5.8) 

G2: 5.0 (4.6) 

(P = NS)

Purge Frequency/wk, mean (SD): 

G1: 1.7 (1.7) (P = NR) 

G2: 4.8 (4.6) (P = NR) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P < 0.001) 

G1 better than G2 

% Reduction in Purge Freq: 

G1: 72.5% (26.1) 

G2: - 6.2% (32.5) 

(P = NR)

 Abstinence/Remission: 

G1: NR 

G2: NR

Abstinence, N: 

G1: 6/24 

G2: 0/26 

(P < 0.001)
C-595 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Eating Disorder Inventory: 

Drive for thinness (DT), mean (SD): 

G1: 14.8 (4.5) 

G2: 14.1 (5.5) 

(P = NR) 

Eating Disorder Inventory: 

Drive for thinness (DT), mean (SD): 

G1: 10.1 (6.4) (P = NR) 

G2: 15.5 (5.4) (P = NR) 

Diff over time (P = 0.015) 

Diff between groups (P = NS) 

Diff between groups in change over time 

(P < 0.001) 

G1 better than G2 

% Making Sig DT improvement: 

G1: 50.0 

G2: 3.8 

Diff between groups (P < 0.0002)

Bulimia (B), mean (SD): 

G1: 9.4 (5.0) 

G2: 11.5 (5.5) 

(P = NR)

Bulimia (B), mean (SD): 

G1: 4.7 (5.1) (P = NR) 

G2: 11.9 (5.7) (P = NR) 

Diff over time (P = 0.002) 

Diff between groups (P = 0.001) 

Diff between groups in change over time 

(P < 0.001) 

G1 better than G2 

% Making Sig B improvement: 

G1: 37.5 

G2: 3.8 

Diff between groups (P < 0.004)

Body Dissatisfaction (BD), mean (SD): 

G1: 16.1 (8.8) 

G2: 18.9 (7.9) 

(P = NR)

Body Dissatisfaction (BD), mean (SD) 

G1: 12.5 (8.7) (P = NR) 

G2: 18.7 (7.7) (P = NR) 

Diff over time (P = 0.028) 

Diff between groups (P = 0.05) 

Diff between groups in change over time 

(P < 0.043) 

G1 better than G2

% Making Sig BD improvement: 

G1: 33.3 

G2: 7.7 

Diff between groups (P = NS)

Author, yr: 

Esplen, et al., 1998 

(continued) 

% Making Clinically Sig Improvement on 

Eating Attitudes Test: 

G1: 58% 

G2: < 10% 

Diff between groups (P < 0.05) 

Diff between groups in change over time 

Total score (P < 0.001) 

Bulimia subscale (P < 0.001) 

Dieting subscale (P < 0.001) 

G1 better than G2
C-596 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Mitchell et al., 2004 

Companion articles: 

Agras, et al., 2000 and 

Halmi et al., 2002 

Setting: 

Outpatient, Cornell 

University, Rutgers 

University and 

University of 

Minnesota, USA 

Enrollment period: 

NR 

Research objective: 

Comparing two outpatient 

relapse prevention 

strategies for individuals 

with BN who have become 

abstinent from bingeing and 

purging after CBT tx. 

Groups: 

G1: Crisis prevention (N = 30) 

G2: FU (N = 27) 

Enrollment: 

• In the original study, 194 

participants were screened 

by phone, interviewed and 

recruited to receive CBT. 

• 6 participants withdrew and 

48 dropped out during the 

CBT tx. 

• After 140 individuals 

completed CBT, between 

wks 16 and 17, patients 

were reassessed relative 

to their remission status. 

• 57 individuals achieved 

abstinence (defined as 

abstinence from bingeing 

and purging in the last 28 

days) and were 

randomized to FU only or 

crisis intervention. 

• In this study, participants 

were reassessed at 17, 43 

and 70 wks after tx. 

• 48 individuals completed 

the 17-wk FU assessment 

after end of tx, 41 

completed the 

assessments at 43 wks 

and 34 completed the 70 

wk FU. 

Age, mean (SD): 

G1: 28.8 (8.6) 

G2: 29.8 (9.4) 

Sex: 

NR 

Race/ethnicity: 

NR 

Hx of anorexia: 

G1: 7% 

G2: 22% 

Hx of depression: 

G1: 53% 

G2: 48% 

Personality disorder: 

G1: 27% 

G2: 33% 

Hx of substance abuse: 

G1: 10% 

G2: 22% 

Duration of bingeing (SD): 

G1: 10.6 (8.1) 

G2: 12.1 (8.9) 

(P = NS) 

Duration of purging (SD): 

G1: 10.27 (7.4) 

G2: 12.0 (9.0) 

(P = NS) 

Pre-CBT objective binges: 

G1: 18 

G2: 19 

(P = NS) 

Pre-CBT purges: 

G1: 27 

G2: 28 

(P = NS) 
C-597 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

From the participants in the 

original study, individuals 

were included in this study if 

they had remained 

abstinent from bingeing and 

purging in the 28 days prior 

to the beginning of this tx 

protocol. 

Exclusion: 

Individuals from the original 

study who were bingeing or 

purging at the end of CBT 

tx. 

Within the crisis intervention 

model, participants could 

request additional tx if they 

became symptomatic or 

feared they would relapse 

within the first 17 wks. 

Emphasis was placed on 

calling early if problems 

developed with the intent 

that participants would be 

seen quickly for an 

additional two or three 

sessions as necessary to 

reestablish the goals of 

therapy and to assist in 

relapse prevention work. 

Participants were allowed 

up to 8 sessions during the 

period of FU. Those in the 

FU group were contacted 

for FU assessments only 

and were not offered further 

tx. 

Cox regression used to test 

diffs between 2 tx groups in 

length of time until 

resumption of bingeing 

and/or purging. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

NA 

Adverse events: 

37% of the participants 

resumed bingeing or 

purging by the end of the 

17-wk FU period. An 

additional 16% of the 

participants resumed 

bulimic behavior within the 

yr after the FU tx. Of the 

individuals who resumed 

bulimic behavior, only 4 

met criteria for BN 

according to DSM III-R. 

Funding: 

McKnight Foundation and 

Minnesota Obesity Center 
C-598 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Mitchell et al., 2004 

(continued) 

Length of time until resumption of bingeing and 

purging 

G1: Data reported in figure only 

G2: Data reported in figure only 

Diff between groups (P = NR) 

Diffs between groups in time to resumption (P = NS) 
C-599 

Evidence Table 9. Other trials for bulimia nervosa (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

NR NR NR NR 
C-600 

Evidence Table 10. Medication trials for binge eating disorder 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Appolinario et al., 

2003 

Setting: 

Two sites; outpatient; 

locations: Obesity and 

Eating Disorders 

Group, Institute of 

Psychiatry, Federal 

University of Rio de 

Janeiro/Institute of 

Diabetes and 

Endocrinology of Rio 

de Janeiro, Rio de 

Janeiro, Brazil and 

the Eating Disorders 

Program from the 

Federal University of 

Sao Paulo, Sao 

Paulo, Brazil 

Enrollment period: 

October 1, 2000 

through July 31, 2001 

Research objective: 

To assess the efficacy and 

safety of sibutramine 

hydrochloride (a serotonin 

and norepinephrine 

reuptake inhibitor) in 

reducing the frequency of 

binge eating and its effect 

on wt loss, binge eating risk, 

and self-reported 

depression over the course 

of 12 wks. 

Groups: 

G1: sibutramine 

hydrochloride (N = 30) 

G2: placebo (N = 30) 

Enrollment: 

• 750 screened by 

telephone and recruited 

through media ads 

• 233 further in-person 

evaluation by staff 

members 

• 79 enrolled (19 

excluded from the 

double blind phase for 

presenting with only 2 

binge days during the 

wk after the placebo 

run-in phase) 

• 60 randomized 

• 48 completers (G1: 23; 

G2: 25) (P = NS) 

Age yrs, mean (SD): 

G1: 35.2 (9.0) 

G2: 36.6 (10.2) 

(P = NS) 

Sex: 

% Female 

G1: 87% 

G2: 90% 

(P = NS) 

Race/ethnicity: 

White: 

G1: 73% 

G2: 87% 

(P = NS) 

Hx of major depression, 

N (%): 

G1: 11 (37) 

G2: 9 (30) 

(P = NS) 
C-601 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion Criteria 

Treatment Statistical Methods Quality 

Inclusion: 

Ages 18-60; BMI:30-45; DSM 

IV criteria for BED and BES 

score ≥ moderate range (i.e., > 

17). 

Exclusion: 

Pregnant, lactating or not 

using medically-accepted form 

of contraception; current or 

past dx of BN; psychosis; 

mania; organic dementia; 

alcohol or other drug abuse; 

suicide risk; diabetes mellitus; 

supine diastolic arterial 

pressure > 110 mm Hg; 

unstable medical illness or 

clinically sig abnormal 

laboratory results; current or 

previous use of sibutramine or 

other investigational drugs; 

concurrent use of 

antidepressants, 

antipsychotics, lithium 

carbonate, cyproheptadine 

hydrochloride, bromocriptine 

mesylate, ergotamine tartrate 

and related drugs, atropine, 

thyroid hormones, systemic 

steroids (except menopause 

hormone therapy), antiobesity 

agents, drugs that interfere 

with the GI tract movements 

such as antidiarrhea and 

antinausea drugs, 

anticoagulants, digitalis, antiParkinson drugs that interfere 

with amine activity; any form of 

psychotherapy within 3 mos of 

study entry; hx of obesity 

surgery; smoking cessation 

within past 3 mos or intent to 

quit during study period. 

After completing entry 

screening procedures, 

participants (N = 79) 

underwent 2-wk, single-blind 

placebo run-in phase prior to 

randomization. Subjects 

who reported binge eating 

episodes on at least 2 days 

w/in the last wk and who 

scored > 17 on the BES 

were randomized to 12-wks 

of either 15 mg of 

sibutramine hydrochloride 

(N = 30) or placebo (N = 

30). Subjects’ binge eating 

frequency, binge eating risk, 

self-reported depression, 

and wt were assessed at 

baseline and at 2, 4, 8, and 

12 wks. 

Two-tailed, unpaired t 

tests or X2

 tests for 

between group diff in 

baseline variables; 

repeated random 

regression analyses 

(including time trend 

analyses) to assess 

between group changes 

in primary and 

secondary variables at 

baseline, 2, 4, 8, and 12 

wks; logistic regression 

to test between group

diff in response (i.e., 

50% reduction in binge 

frequency) and 

remission (i.e., cessation 

of binge eating) rates. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events, N: 

Dry mouth: 

G1: 22 

G2: 3 

(P < 0.01) 

Headache: 

G1: 6 

G2: 14 

(P < 0.01) 

Constipation: 

G1: 7 

G2: 0 

(P < 0.001) 

All other adverse events 

(i.e., nausea, insomnia, 

sudoresis, lumbar pain, 

depressive mood, flu 

syndrome, malaise, 

others) (P = NS). 

Funding: 

Abbott Laboratories, Sao 

Paulo, Brazil 
C-602 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge days per wk, mean (SD): 

G1: 4.1 (1.8) 

G2: 3.9 (1.8) 

(P = NS) 

Binge days per wk, mean (SD): 

Completion 

G1 and G2: Data presented in graph 

(P = NR) 

Diff between groups in change over time (P = 

0.03): 

G1 better than G2 

Wk 2: 

G1: 1.7 (1.9) 

G2: 3.3 (2.2) 

Within group change from baseline (P = NR) 

(P = NR) 

Diff between groups in change over time (P = 

0.002) 

G1 better than G2 

Wk 4: 

G1: 1.7 (1.6) 

G2: 3.0 (2.1) 

Within group change from baseline (P = NR) 

(P = NR) 

Diff between groups in change over time (P = NR) 

Wk 8: 

G1: 1.8 (2.2) 

G2: 2.5 (2.1) 

Within group change from baseline (P = NR) 

(P = NR) 

Diff between groups in change over time (P = NR) 

Wk 12: 

G1: 1.4 (2.0) 

G2: 2.3 (2.2) 

Within group change from baseline (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 

0.04) 

G1 better than G2 

Author, yr: 

Appolinario et al., 

2003 

(continued) 

BES, mean (SD): 

G1: 29.2 (7.2) 

G2: 29.1 (5.9) 

(P = NS) 

BES, mean (SD): 

Completion 

G1 and G2: Data not presented 

(P = NR) 

Diff between groups in change over time (P < 

0.001) 

G1 better than G2 

Wk 2: 

G1: 26.8 (9.3) 

G2: 27.6 (6.5) 

Within group change from baseline (P = NR) 

(P = NR) 

Diff between groups in change over time (P = NR) 
C-603 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Wt, kg, mean (SD): 

G1: 102.8 (13.2) 

G2: 98.7 (12.9) 

(P = NS) 

Wt, kg, mean (SD): 

Completion 

G1 and G2: Data presented in 

graph 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P < 0.001) G1 better 

than G2 

Wk 2: 

G1: 98.7 (11.0) 

G2: 99.2 (13.4) 

Within group change from 

baseline (P = NR) 

(P = NR) 

Diff between groups in change 

over time (P = NR) 

Wk 4: 

G1: 96.9 (10.8) 

G2: 99.7 (12.5) 

Within group change from 

baseline (P = NR) 

(P = NR) 

Diff between groups in change 

over time (P = 0.02) G1 better 

than G2 

Wk 8: 

G1: 96.0 (11.4) 

G2: 99.9 (13.3) 

Within group change from 

baseline (P = NR) 

(P = NR) 

Diff between groups in change 

over time (P = NR) 

Wk 12: 

G1: 95.4 (12.3) 

G2: 100.1 (13.6) 

Within group change from 

baseline (P = NR) 

(P = NR) 

Diff between groups in change 

over time (P = NR) 
C-604 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Wk 4: 

G1: 23.6 (11.4) 

G2: 26.1 (8.8) 

Within group change from baseline (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.04) 

G1 better than G2 

Wk 8: 

G1: 21.0 (12.6) 

G2: 26.4 (9.5) 

Within group change from baseline (P = NR) 

(P = NR) 

Diff between groups in change over time (P = NR) 

Wk 12: 

G1: 19.7 (12.4) 

G2: 24.4 (8.9) 

Within group change from baseline (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 

0.005) G1 better than G2 

Author, yr: 

Appolinario et al., 

2003 

(continued) 

Response, N (%) of completers: 

G1: 18 (78%) 

G2: 13 (52%) 

(P = NR) 

Diff between groups in change over the 12-wk study 

(P = 0.005) 

G1 better than G2 
C-605 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 17.3 (9.7) 

G2: 18.6 (9.1) 

(P = NS)

BDI, mean (SD): 

Completion 

G1 and G2: Data presented in 

graph 

Diff between groups (P = NS) 

Diff between groups in change over 

time (P < 0.001) 

G1 better than G2 

Wk 2: 

G1: 14.6 (7.9) 

G2: 19.4 (11.2) 

Within group change from baseline 

(P = NR) 

(P = NR) 

Diff between groups in change over 

time (P = NR) 

Wk 4: 

G1: 13.1 (8.6) 

G2: 18.4 (10.4) 

Within group change from baseline 

(P = NR) 

(P = NR) 

Diff between groups in change over 

time (P = NR) 

Wk 8: 

G1: 12.9 (8.5) 

G2: 18.3 (10.8) 

Within group change from baseline 

(P = NR) 

(P = NR) 

Diff between groups in change over 

time (P = NR) 

Wk 12: 

G1: 9.9 (7.6) 

G2: 17.9 (10.6) 

Within group change from baseline 

(P = NR) 

Diff between groups (P = 0.002) 

G1 better than G2 

Diff between groups in change over 

time (P = NR)

 
C-606 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Arnold et al., 2002 

Setting: 

Outpatient; single 

center; USA 

Enrollment period: 

February 1998 to June 

2000 

Research objective: 

To assess the efficacy and 

safety of fluoxetine in the tx 

of BED 

Groups: 

G1: fluoxetine (N = 30) 

G2: placebo (N = 30) 

Enrollment: 

• 60 enrolled 

• 30 assigned to each tx 

group 

• 24 (40%) withdrew over 

study course (G1: 57%; G2:

23%) 

Diff between groups (P = 0.02) 

Of the 24, 10 withdrew, postbaseline 

Age, mean (SD): 

G1: 41.9 (9.7) 

G2: 40.8 (9.0) 

(P = NS) 

Sex: 

Female 

G1: 93% 

G2: 93% 

(P = NS) 

Race/ethnicity: 

White: 

G1: 90% 

G2: 87% 

(P = NS) 

AA: 

G1: 10% 

G2: 13% 

(P = NS) 

Duration of BED yrs, mean 

(SD): 

G1: 19.9 (12.5) 

G2: 16.7 (9.5) 

(P = NS) 

Current major depressive 

disorder: 

G1: 27% 

G2: 23% 

(P = NS) 

Lifetime (current or past) 

major depressive disorder 

(%): 

G1: 67% 

G2: 63% 

(P = NS) 
C-607 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED, and ≥ 3 BE 

episodes wkly for at 

least 6 mos; age 18-

60; wt > 85% IBW. 

Exclusion: 

Pregnant or lactating; 

concurrent AN; 

concurrent or recent 

(within 1 yr) substance 

abuse or dependence; 

lifetime hx of 

psychosis, mania, 

hypomania, or 

dementia; hx of any 

psychiatric disorder 

that could interfere 

with diagnostic 

assessment, tx, or 

compliance; suicide 

risk; received 

psychotherapy or 

behavioral therapy 

within 3 mos of entry; 

clinically unstable 

medical illness; hx of 

seizures, lab 

abnormalities; MAOIs 

within 4 wks, or 

psychotropic meds 

within 2 wks of entry; 

received 

investigational meds or 

depot neuroleptics 

within 3 mos of entry; 

previously treated with 

fluoxetine; 

experienced < 3 

binges in wk before 

randomization. 

After 1 wk of single-blind placebo 

admin, subjects randomized to 

fluoxetine or placebo for 6 wks. 

Dosage began with 20mg/day for 3 

days; As tolerated, dose increased 

to 40 mg/day for 3 days, then 60 

mg/day. After 2 wks, dose could 

increase to 80 mg/day. At endpoint, 

mean dose (SD) for G1: 71.3 

(11.4); G2: 67.3 (11.5). 

Subjects seen wkly, and assessed 

for number of binges since prior 

visit, CGI-S, meds dose and 

compliance (capsule count), 

adverse events, non-study med 

use, vital signs and wt. 

HAM-D administered at baseline, 

wks 2, 4, and 6. 

PreTx comparisons 

between groups using 

Fisher exact test, and 

2-sample t tests for 

continuous variables. 

2 mixed-model 

repeated-measures 

analyses were made 

for each outcome 

(except response 

category): a timetrend analyses 

assessing rate of 

change between 

groups, and an 

endpoint analysis, 

assessing change 

between groups from 

baseline to wk 6. 

Response categories 

analyzed using the 

exact trend test; 2 

analyses: for tx 

completers only, and 

for all subjects. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Most common, reported by 

G1 (N): 

Sedation (5), dry mouth (11), 

headache (9), nausea (7), 

insomnia (7), diarrhea (6), 

fatigue (6), increased urinary 

frequency (4), sexual 

dysfunction (4). 

Across groups, hand and foot 

swelling, palpitations, and 

apathy were also reported; no 

sig diff between groups. 

Funding: 

Investigator-initiated grant, Eli 

Lily and Company 
C-608 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges/wk, mean (SD): 

G1: 6.0 (2.5) 

G2: 6.1 (4.8) 

(P = NS) 

Binges/wk, mean (SE): 

8-wks: 

G1: 1.8 (2.9) 

G2: 2.7 (3.8) 

Diff between groups (P = NS) 

Diff between groups in log rate of change (P = 0.033) 

G1 better than G2 

Percentage decrease in frequency of binges: N (%) 

Intent to treat sample: G1 = 29; G2 = 21 

None ( < 50%): G1: 7 (24); G2: 9 (43) 

Moderate (50%-74% decrease): G1: 8 (28); G2: 4 (19) 

Marked (75%-99% decrease): G1: 1 (3); G2: 3 (14) 

Remission (100%): G1: 13 (45) (P = NR) G2: 5 (24) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Percentage decrease in frequency of binges: N (%) 

Completers sample: G1 = 23; G2 = 12 

None ( < 50%): G1: 4 (17); G2: 4 (33) 

Moderate (50%-74% decrease): G1: 5 (22); G2: 2 (17) 

Marked (75%-99% decrease): G1: 1 (4); G2: 3 (25) 

Remission (100%): G1: 13 (57); G2: 2 (25) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Arnold et al., 2002 

(continued) 

Abstinence rate, N (%): 

G1: NR 

G2: NR 

Abstinence rate N (%): 

G1: 13 (45) (P = NR) 

G2: 5 (24) (P = NR) 

(P = NR) 
C-609 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI-S, mean (SD): 

G1: 4.2 (0.4) 

G2: 4.3 (0.6) 

(P = NS) 

6 wks: 

CGI-S, mean (SE): 

G1: 2.2 (1.4)

G2: 3.3 (1.4)

Diff between groups (P = NR) 

Diff between groups in change over 

time (time trend analysis, P = 0.032; 

endpoint analysis, P = 0.012) 

G1better than G2 

Baseline: 

Wt, kg (SD): 

G1: 110.4 (24.1) 

G2: 103.5 (19.0) 

(P = NS) 

6 wks: 

Wt, kg (SE): 

G1: 112.5 (25.0) 

G2: 110.3 (18.2) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (time trend analysis, P = 0.001; 

endpoint analysis, P = 0.0001) 

G1 better than G2 

HAM-D, mean (SD): 

G1: 4.8 (4.3) 

G2: 4.2 (2.9) 

(P = NS) 

HAM-D score (SE): 

G1: 2.6 (3.0) 

G2: 5.5 (4.1) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (time trend analysis, P = NS; 

endpoint analysis, P = 0.003) 

G1 better than G2 

BMI, kg/m2 (SD): 

G1: 39.6 (7.0) 

G2: 36.7 (6.8) 

(P = NS) 

BMI, kg/m2 (SE): 

G1: 40.0 (7.2) 

G2: 39.5 (6.3) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (time trend analysis, P = 0.0001; 

endpoint analysis, P = 0.0001) 

G1 better than G2 

Interaction effects: 

No evidence for differential effects in 

subjects with and without current 

major depressive disorder. 

 
C-610 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hudson et al., 1998 

Setting: 

Outpatient, Harvard 

Medical 

School/McLean 

Hospital, University of 

Cincinnati and 

University of 

Minnesota, USA 

Enrollment period: 

February to 

September 1993 

Research objective: 

To assess the efficacy of 

the SSRI fluvoxamine in 

treating patients with BED in 

a three-center randomized 

placebo-controlled trial. 

Groups: 

G1: Fluvoxamine (N = 42) 

G2: Placebo (N = 43) 

Enrollment: 

• 115 patients entered 

study 

• 85 randomly assigned 

(Boston = 26; Cincinnati 

= 30; Minnesota = 29) 

• 10 participants withdrew 

before end of 4 wks 

• Another 8 participants 

withdrew between wks 

4 and 9 

• 67 patients completed 9 

wks of tx (a sigly 

greater proportion of 

patients treated with 

fluvoxamine 

discontinued tx 

because of an adverse 

medical event or for any 

reason) 

Age, yrs, mean (SD): 

G1: 41.2 (9.9) 

G2: 43.0 (9.5) 

(P = NS) 

Sex: 

Female: 

G1: 93% 

G2: 88% 

(P = NS) 

Race/ethnicity: 

Caucasian: 

G1: 98% 

G2: 95% 

(P = NS) 

Hx of major depression: 

G1: 48% 

G2: 28% 

(P = NS) 
C-611 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met draft criteria for BED 

from the DSM IV, had to have 

reported a hx of at least 3 

BEs per wk for at least 6 

mos. Binge defined using 

DSM IV criteria and the 

number of calories consumed 

had to be at least 1500 kcal., 

had to be aged 18-60, had to 

wt > 85% of the midpoint of 

IDW for height. 

Exclusion: 

Pregnant, lactating, displayed 

concurrent AN, concurrent or 

recent (last 1 yr) major 

depression or obsessive 

compulsive disorder or 

lifetime substance abuse, 

psychosis, mania, or organic 

dementia, posed a sig suicide 

risk and received 

psychotherapy or behavior 

therapy within 3 mos prior to 

entry into study, hx of 

psychosurgery or seizures, 

hx of any psychiatric disorder 

that could interfere with 

diagnostic assessment, tx or 

compliance, clinically 

unstable medical illness, 

clinically sig abnormal lab 

results, received monoamine 

oxidase inhibitors, tricyclics, 

neuroleptics, lithium or 

fluoxetine in the four wks 

before randomization, had 

received investigational meds 

or depot neuroleptics within 3 

mos before randomization 

and had previously received 

fluvoxamine. 

One wk lead-in period. During 

lead-in, patients took one capsule 

each evening. After that, 

participants randomly assigned to 

therapy with fluvoxamine or 

placebo. Participants seen wkly 

for a total of nine wks. Dose was 

50 mg every evening for a min of 

three days in the initial part of tx. 

After day 4, dose could be 

adjusted on an individual basis (50 

mg -300 mg) until end of tx. 

Adjustments to the number of 

capsules taken per day were 

made at discretion of investigator 

and meds was increased until a 

patient was asymptomatic or 

intolerant of higher doses. Binges 

measured by patient diaries 

including number of capsules of 

meds taken. Meds compliance 

also monitored by counting 

capsules at wkly visits. The diff 

between fluvoxamine and placebo 

groups in number of capsules 

consumed per day was diff for 

patients who completed 4 and 9 

wks of tx (P < 0.008 and P < 0.007 

respectively) 

Fisher’s exact test 

for categorical 

variables and a t test 

for continuous 

variables used to 

compare baseline 

characteristics. 

Outcomes analyzed 

using repeated 

measures random 

regression analysis. 

Analyses also done 

to ensure that 

groups did not differ 

in tx response by 

center (Boston, 

Cincinnati and 

Minneapolis). 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double

Adverse events: 

A sig greater percentage of 

patients receiving fluvoxamine 

experienced insomnia, nausea 

and abnormal dreams when 

compared with patients 

receiving placebo. The 

commonly reported adverse 

events included insomnia, 

headache, nausea, asthenia, 

depression, dizziness, 

somnolence, abnormal 

dreams, dry mouth, 

nervousness, and decreased 

libido. 

Funding: 

The Upjohn Co. and Solvay 

Pharmaceuticals 
C-612 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Hudson et al., 1998 

(continued) 

NR Binge frequency: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.006) 

G1 sig greater rate of reduction than G2 

Remission (ITT): 

G1: 38% (P = NR) 

G2: 26% (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Remission (9 wk completers): 

G1: 45% (P = NR) 

G2: 24% (P = NR) 

Diff between groups (P = 0.04) 

Diff between groups in change over time (P = NR) 

Remission (> 4 wk completers): 

G1: 44% (P = NR) 

G2: 24% (P = NR) 

Diff between groups (P = 0.04) 

Diff between groups in change over time (P = NR) 
C-613 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS, mean (SD): 

G1: 4.4 (3.6) 

G2: 4.1 (3.7) 

(P = NS) 

HDRS, mean (SD): 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI, kg/m2, mean (SD): 

G1: 34.2 (6.0) 

G2: 36.8 (8.2) 

(P = NS) 

BMI: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.04) 

G1 sig greater rate of 

reduction than G2 

 CGI severity scale: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.002) 

G1 sig greater rate of reduction 

than G2. 

CGI Improvement scale: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.02) 

G1 sig greater rate of increase 

than G2 

 
C-614 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Laederach-Hoffman 

et al., 1999 

Setting: 

Counseling center for 

wt problems – 

Medical Outpatient 

Clinic of the University 

of Berne, Switzerland 

Enrollment period: 

NR 

Research objective: 

1) To determine if a 

combination of imipramine 

and diet counseling with 

psych support is more 

effective in treating obese 

binge eaters than placebo 

and diet counseling with 

psych support. 

2) If wt loss achieved during 

the 8 wks of drug therapy is 

maintained for subsequent 6 

mos, with diet counseling 

and psyc support continuing 

during this time. 

Groups: 

G1: imipramine (25 mg 

T.I.D.) (N = 15) 

G2: placebo (N = 16) 

Enrollment: 

• 500 med records 

screened 

• 100 records fit criteria 

• 31 agreed to participate 

and randomized 

• 29 completed 

Age, yrs, mean (SD): 

G1: 40.7 (10.9) 

G2: 35.7 (10.3) 

(P = NS) 

Sex: 

Female: 27/31

Race/ethnicity: 

NR 

Systolic BP, mean (SD): 

G1: 132.3 (18.0) 

G2: 131.4 (13.5) 

(P = NS) 

Diastolic BP, mean (SD): 

G1: 87.0 (9.4) 

G2: 87.5 (9.1) 

(P = NS) 
C-615 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

BED per DSM IV, 

overwt or obese 

defined as BMI > 27.5 

kg/m2

, age: 20-60. 

Exclusion: 

Endocrine disorder, 

diabetes mellitus, 

pregnancy, arterial 

hypertension, renal 

diseases, pulmonary 

diseases (chronic 

obstructive lung 

disease, bronchial 

asthma, etc), use of 

psychoactive meds or 

appetite suppressants, 

contraindications for 

drugs with 

anticholinergic side 

effects, psychiatric 

disorders including 

cyclothymia, 

schizophrenia, major 

depression, 

personality disorders, 

concomitant 

psychotherapy, and 

other eating disorders 

including BN (fulfilling 

all DSM IV criteria) 

and AN 

8 wks of imipramine (25 mg 3X/day 

TID) or placebo. 

Diet counseling – 30 minutes of 

individual diet counseling by a 

dietitian biwkly. 

Psych Support – behavioral 

oriented: 

1) individual 15-35 minutes 

sessions biwkly 

2) group therapy for 1.5 hours (N = 

10-14) moly guided by an assistant 

dietitian. Diet counseling and psych 

support continued for 6 mos. 

Repeated measures 

ANOVA using 

Bonferroni/Dunn 

corrections. Fisher 

PLSD t test (Post-hoc) 

where appropriate. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

Double 

Adverse events: 

2 patients dropped out due to 

side effects. One G2 patient 

complained of hunger, 

sweating, palpitations, 

arrhythmia, and general 

malaise. One G1 had skin 

eruptions and an aversion to 

tablet intake. After 8 wks, no 

diff in total number of adverse 

side effects using the patient 

termination report score. 

However, anticholinergic 

effects (constipation, dry 

mouth, blurred vision) were 

more often reported in 

imipramine group (7 vs 3 

times, P < 0.05). 

Funding: 

NR 
C-616 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: Estimate is change from baseline, mean (SD) 

Laederach-Hoffman et 

al., 1999 

(continued) 

BE, mean (SD): 

G1: 7.1 (4.1) 

G2: 7.1 (4.1) 

(P = NS) 

BE, mean 

8 wks: 

G1: -4.5 (4.2) (P < 0.001) 

G2: -1.7 (2.9) (P = NS) 

(P = NR) 

Diff between groups in change over time (P < 0.02) 

G1 better than G2 

32 wks: 

G1: -3.2 (2.9) 

G2: 0.0 (1.4) 

(P = NR) 

Diff between groups in change over time (P = 0.0001)

G1 better than G2 
C-617 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Estimate is change over time (SD) Estimate is change over time (SD)

SDS (SD): 

G1: 35.3 (6.3) 

G2: 35.0 (5.8) 

(P = NS) 

SDS: 

G1: 28.9 (5.8) 

(P = NS) 

G2: 30.8 (7.3) 

(P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Body Weight Index 

kg/m2

, mean (SD): 

G1: 36.1 (6.3) 

G2: 43.2 (9.4) 

(P < 0.02) 

Body Weight Index: 

G1: NR 

G2: NR 

 Body Wt, kg, mean 

(SD): 

G1: 96.0 (14.2) 

G2: 114.8 (29.5) 

(P < 0.05)

Wt change, kg, mean: 

8 wks: 

G1: -2.1 (1.7) (P = NR) 

G2: 0.2 (3.3) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P < 0.05) 

G1 better than G2 

32 wks: 

G1: -5.0 (2.8) (P < 0.01) 

G2: + 2.1 (6.8) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.0002) 

G1 better than G2 

HAM-D, mean (SD): 

G1: 22.6 (9.8) 

G2: 21.3 (12.0) 

(P = NS) 

HAM-D, mean (SD): 

8 wks: 

G1: -9.6 (7.1) (P < 0.001) 

G2: -3.5 (8.9) (P = NR) 

Diff between groups (P = 0.02) 

G1 better than G2 

32 wks: 

G1: -6.8 (5.0) (P < 0.01) 

G2: 0.0 (4.9) (P < 0.01) 

(P = NR) 

Diff between groups in change 

over time (P < 0.0001) 

G1 better than G2 

Waist HiP Ratio 

(SD): 

G1: 0.96 (0.07) 

G2: 1.01 (0.07) 

(P = NS) 
C-618 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

McElroy, Arnold et al., 

2003 

Setting: 

Outpatient, University 

of Cincinnati Medical 

Center, USA 

Enrollment period: 

Sept., 1998 through 

June, 2000 

Research objective: 

To assess the efficacy of 

topiramate in the tx of BED 

associated with obesity. 

Groups: 

G1: Topiramate (N = 30) 

G2: Placebo (N = 31) 

Enrollment: 

• 98 individuals were 

screened 

• 61 participants met 

criteria and agreed to 

participate 

• 35 participants 

completed 14 wks of tx 

Age, yrs, mean (SD): 

G1: 40.9 (8.2) 

G2: 40.7 (9.1) 

(P = NS) 

Sex: 

NR 

Race/ethnicity: 

NR 
C-619 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Aged 18-60, DSM IV 

TR criteria for BED; 

obese (BMI > 30 

kg/m2) and score > 15 

on YBOCS-BE. 

Exclusion: 

1) substance use 

disorder (DSM IV TR) 

within the last 6 mos, 

2) unstable bipolar 

disorder (DSM IV TR) 

within the past 3 mos, 

3) clinically sig 

suicidality, 4) any 

current or past 

psychiatric disorder 

that could interfere 

with diagnostic 

assessment, tx or 

adherence, 5) clinically 

unstable medical 

illness, 6) hx of 

nephrolithiasis or 

seizures, 7) clinically 

sig abnormal 

laboratory results, 8) 

need for tx with any 

meds that might 

adversely interact with 

or obscure the action 

of topiramate, 9) tx 

with psychoactive 

meds within two wks of 

random assignment, 

10) tx with an 

experimental drug or 

an experimental 

device within 30 days 

of random assignment, 

or 11) previous tx with 

topiramate. 

2-5 wk screening period, followed 

by 14-wk tx period (topiramate 

flexible-dose 25 mg- 600mg/d; 

median 212mg/d) and 2-wk taper 

and discontinuation period. 

Patients evaluated at least twice 

during screening period and after 

wks 1, 2, 4, 6, 8, 10 and 14 during 

tx. They were seen at the end of 

wks 15 and 16 during 

discontinuation. For primary 

efficacy measure, patients given 

take-home diaries at each visit and 

asked to record binges and meds 

(once begun). Study meds 

provided in pre-packaged bottles 

that were identical for placebo and 

meds. 

Baseline 

characteristics 

compared using 

Fisher’s exact test and 

t test. For primary 

analyses, used 

repeated measures 

random regression 

analyses. Also, 

nonparametric 

Wilcoxon rank sum 

test used to compare 

change from baseline 

for each group. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

9 individuals withdrew 

because of adverse events 

(G1 = 6; G2 = 3) 

G1: headache, paresthesias 

and amenorrhea. 

G2: leg cramps, sedation and 

testicular soreness. Adverse 

events among individuals who 

continued in the study were 

reported to be “mild” or 

“moderate” and “resolved with 

time or dose reduction”. 

Funding: 

Ortho McNeill Pharmaceutical 
C-620 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge frequency per wk: 

G1: 5.3 (2.8) 

G2: 6.3 (2.8) 

(P = NS) 

Reduction in binge frequency per wk: 

G1: 94% 

G2: 46% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.02) 

Diff between groups in rate of change (P < 0.0004) 

G1 greater reduction than G2 

Binge day frequency per wk: 

G1: 4.3 (1.8) 

G2: 4.8 (1.8) 

(P = NS) 

Reduction in binge day frequency per wk: 

G1: 93% 

G2: 46% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.02) 

Diff between groups in rate of change (P < 0.0001) 

G1 greater reduction than G2 

Author, yr: 

McElroy, Arnold et al., 

2003 

(continued) 

YBOCS-BE total, mean (SD): 

G1: 21.5 (3.9) 

G2: 21.6 (4.6) 

(P = NS) 

YBOCS-BE total, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

Diff between groups in rate of change (P < 0.004) 

G1 greater improvement than G2 

 YBOCS-BE Obsessions, mean (SD): 

G1: 10.5 (2.1) 

G2: 10.7 (2.4) 

(P = NS) 

YBOCS-BE Obsessions, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

Diff between groups in rate of change (P < 0.04) 

G1 greater improvement than G2 

 YBOCS-BE Compulsions, mean 

(SD): 

G1: 11.0 (2.1) 

G2: 10.7 (2.4) 

(P = NS) 

YBOCS-BE Compulsions, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

Diff between groups in rate of change (P < 0.0008) 

G1 greater improvement than G2 
C-621 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI severity, mean 

(SD): 

G1: 4.7 (0.9) 

G2: 4.9 (0.8) 

(P = NS) 

CGI severity, mean (SD): 

G1: NR 

G2: NR 

Diff between groups (P = 0.01) 

Diff between groups in rate of 

change (P < 0.02) 

G1 greater improvement than G2

BMI kg/m2

, mean (SD): 

G1: 44.2 (7.1) 

G2: 42.0 (6.7) 

BMI: 

G1: NR 

G2: NR 

(P = NR) 

Diff between groups in rate 

of change (P < 0.003) 

G1 greater improvement 

than G2 

HDRS, mean (SD): 

G1: 5.9 (5.1) 

G2: 5.8 (4.8) 

(P = NS) 

HDRS, mean (SD): 

G1: NR 

G2: NR 

(P = NR) 

Diff between groups in rate of 

change (P = NS) 

Wt kgs, mean (SD): 

G1: 120.4 (18.8) 

G2: 123.4 (24.4) 

Wt loss, kg, mean: 

G1: 5.9 

G2: 1.2 

(P = NR) 

Diff between groups in rate 

of change (P < 0.005) 

G1 greater improvement 

than G2 
C-622 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

McElroy et al., 2000 

Setting: 

Outpatient; single 

center; USA 

Enrollment period: 

NR 

Research objective: 

Placebo-controlled trial to 

assess the efficacy of the 

SSRI sertraline in the tx of 

BED. 

Groups: 

G1: Sertraline (N = 18) 

G2: Placebo (N = 16) 

Enrollment: 

• 34 randomized and 

enrolled 

• 26 (13 in each group) 

completed 6 wks tx 

Age, mean (SD): 

G1: 43.1 (9.9) 

G2: 41.0 (12.2) 

(P = NS) 

Sex: 

G1: Female: 89% 

G2: Female: 100% 

(P = NS) 

Race/ethnicity: 

NR 

Current major depressive 

disorder: 

G1: 17% 

G2: 19% 

(P = NS) 

Lifetime major 

depressive disorder: 

G1: 61% 

G2: 44% 

(P = NS) 
C-623 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED and had 

experienced ≥ 3 BE/wk 

for at least prior 6 mos; 

BE defined by DSM IV 

criteria plus required 

size at least 1500 kcal 

18-60 yrs 

wt > 85% of IBW. 

Exclusion: 

Current AN dx; 

substance use 

disorder within past 6 

mos; hx of psychosis 

or mania; risk of 

suicide; use of 

psychotropics within 2 

wks of randomization; 

previous use of 

sertraline; < 3 binges 

in the wk prior to 

randomization. 

1 wk of single-blind placebo 

administration followed by 

randomization to sertraline or 

placebo group for 6 wks. Tx dose 

began at 1 capsule of 50mg/day for 

at least 3 days; after, adjusted as 

tolerated to between 1 to 4 

capsules daily. Mean end of study 

dose in G1: 187 mg (SD = 30). 

Subjects monitored binges using 

diaries. Wkly clinical interviews 

assessed binges since last visit, 

CGI ratings, meds dose, and wt. At 

wks 0, 2, 4, 6, HDRS was 

administered. 

Except for response 

category, repeated 

measures random 

regression analyses 

used to assess 

outcomes, using txby-time as the effect 

measure. 

Binge frequency was 

analyzed using 

logarithmic 

transformation to 

stabilize variance. 

Response category 

diff compared by 

exact trend test for 

two-by-k-ordered 

tables. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Single-blind placebo 

administration; double-blind 

randomization and tx 

Adverse events: 

No subjects withdrew due to 

adverse events 

Participants experiencing 

insomnia: 

G1: 7 (39%) 

G2: 1 (6%) 

(P = 0.04) 

Funding: 

In part by Pfizer, Inc. 
C-624 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

McElroy et al., 2000 

(continued) 

Binges/wk, mean (SD): 

G1: 7.6 (4.8) 

G2: 7.2 (5.8) 

(P = NS) 

Binges/wk, mean (SD): 

G1: 1.13 (1.56) (P = NR) 

G2: 3.85 (3.81) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.008) 

G1 better than G2 

Frequency of binges: 

Percentage decrease measured by categorical change 

in response: 

Remission or cessation of binges: G1:7; G2: 2 

Marked = 75%-99% decrease: G1: 2; G2:3 

Moderate = 50%-74% decrease: G1: 3; G2: 4 

None = < 50% decrease: G1: 0; G2: 4 

Diff between groups in change over time (P = NS) 
C-625 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS (SD): 

G1: 6.4 (3.9) 

G2: 7.5 (8.4) 

(P = NS) 

HDRS: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

(SE): 1.33 (1.00) 

(P = NS) 

BMI, kg/m2, mean (SD):

G1: 36.4 (7.4) 

G2: 35.8 (7.5) 

(P = NS) 

BMI, kg/m2: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (SE): -0.596 (0.189) 

(P = 0.002) 

G1 better than G2 

 CGI score: 

Severity 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) diff 

between groups in change over time 

(SE): -1.007 (0.183) 

(P < 0.001) 

G1 better than G2 

CGI score: 

Improvement: 

G1: NR (P = NR) 

G2: NR (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time 

(SE): 0.929 (0.230) (P < 0.001) 

G1 better than G2 

 
C-626 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

McElroy, Hudson et 

al., 2003 

Setting: 

Single center; 

outpatient; USA 

Enrollment period: 

August 2000 through 

July 2001 

Research objective: 

Placebo-controlled, 

randomized trial to assess 

the safety and efficacy of 

citalopram (Celexa), an 

SSRI, in BED 

Groups: 

G1: Citalopram (N = 19) 

G2: Placebo (N = 19) 

Enrollment: 

• 50 screened who were 

recruited through 

advertisements (12 of 

these did not meet 

criteria and were not 

enrolled) 

• 38 enrolled (19 

assigned to each 

group) 

• 31 after 4 wks 

Age, yrs, mean (SD): 

G1: 42.0 (9.0) 

G2: 39.2 (12.0) 

(P = NS) 

Sex: 

Female: 95% 

(P = NS) 

Race/Ethnicity: 

White: 

G1: 79% 

G2: 95% 

(P = NS) 

Current major depressive 

disorder: 

G1: 21% 

G2: 42% 

(P = NS) 

Lifetime major 

depressive disorder: 

G1: 63% 

G2: 74% 

(P = NS) 
C-627 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM IV criteria for 

BED and had also 

experienced ≥ 3 bingeeating episodes wkly for 

at least the prior 6 mos; 

18 to 60 yrs; wt > 85% of 

IBW. 

Exclusion: 

Pregnant or lactating; 

concurrent AN or BN; 

concurrent or recent 

(within 1 yr of study 

entry) substance abuse 

or dependence: lifetime 

hx of psychosis, mania 

or hypomania, or 

dementia: hx of any 

psychiatric disorder that 

could interfere with 

diagnostic assessment, 

tx, or compliance: posed 

a sig suicide risk; 

received psychotherapy 

or behavioral therapy 

within 3 mos of entry into 

study; clinically unstable 

medical illness; hx of 

seizures; clinically sig 

laboratory abnormalities; 

received monoamine 

oxidase inhibitors within 

4 wks of randomization; 

received other 

psychotropic meds within 

2 wks of randomization; 

received investigational 

meds or depot 

neuroleptics within 3 

mos of randomization; 

previously treated with 

citalopram; experienced 

< 3 binges in the wk 

before randomization 

(i.e., were considered 

placebo responders). 

1 wk of single-blind placebo 

administration, followed by 

random assignment to citalopram 

or placebo for 6 wks. 

Randomized tx began with 20 

mg/day for first 7 days; increased 

as tolerated to 40 mg/day for 7 

days, and then 60 mg/day for 

remainder of study. Meds could 

be reduced to min of 1 capsule 

(20 mg) daily if intolerable side 

effects at any time during tx 

period. End of study dose in G1 

and G2 60 mg for 17 subjects 

and 40 mg for 2 subjects in each 

group. 

Subjects monitored binges and 

meds through diaries. Binge 

defined using DSM IV criteria, 

assessed via wkly clinical 

interview and subjects’ diaries. 

Diaries recorded binges, duration 

of binges, food consumed during 

binges. 

Repeated-measures 

random regression 

analyses, sometimes 

referred to as mixedmodel repeatedmeasures analyses. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

Sweating (P = 0.008), fatigue 

(P = 0.046), dry mouth, 

headache, diarrhea, nausea, 

sedation, insomnia, sexual 

dysfunction (P = NS) 

Funding: 

In part by Forest Laboratories 
C-628 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges/wk, mean (SD): 

G1: 5.2 (3.6) 

G2: 5.7 (2.6) 

(P = NS) 

Binges/wk, mean (SD): 

G1: 1.7 (3.1) 

G2: 3.4 (3.0) 

Change over time from baseline to wk 6: -0.375 (0.222) (P = NS) 

Rate of change: -0.311 (0.086) (P = 0.003) 

G1 better than G2

Binge days/wk 

frequency, mean (SD): 

G1: 4.0 (1.7) 

G2: 4.0 (1.5) 

(P = NS) 

Binge days/wk, mean (SD): 

G1: 1.2 (2.0) 

G2: 2.8 (2.2) 

Change over time from baseline to wk 6: -0.488 (0.199) (P = 0.016)

G1 better than G2 

Rate of change: -0.324 (0.076) (P = < 0.001)

Frequency of binges: 

Percentage decrease measured by categorical change. diff 

between remission (cessation of binges):

• marked (75%-99% decrease)

• moderate (50%-74% decrease)

• none ( < 50% decrease) 

(P = NS) 

YBOCS-BE score 

Total, mean (SD): 

G1: 19.4 (4.2) 

G2: 18.5 (3.1) 

(P = NS)

YBOCS-BE score 

Total: 

G1: 7.6 (7.2) 

G2: 13.2 (5.9) 

Change over time from baseline to wk 6:-5.73 (2.33) (P = 0.007) 

G1 better than G2 

Rate of change: -3.73 (1.37) (P = 0.007) 

G1 better than G2

YBOCS-BE score 

Obsessions, mean 

(SD): 

G1: 9.3 (2.2) 

G2: 9.3 (1.8) 

(P = NS)

YBOCS-BE Score 

Obsessions: 

G1: 4.3 (3.6) 

G2: 6.8 (2.6) 

Change over time from baseline to wk 6: -2.48 (1.22) (P = 0.04) 

G1 better than G2 

Rate of change: -1.44 (0.72) (P = 0.05) 

G1 better than G2

Author, yr: 

McElroy, Hudson et 

al., 2003 

(continued) 

YBOCS-BE score 

Compulsions, mean 

(SD): 

G1: 10.1 (2.2) 

G2: 9.2 (1.7) 

(P = NS)

YBOCS-BE Score 

Compulsions: 

G1: 3.4 (3.9) 

G2: 6.4 (3.6) 

Rate of change: -2.26 (0.72) (P = 0.002) 

G1 better than G2 

Change over time from baseline to wk 6: -2.88 (1.27) (P = 0.02) 

G1 better than G2 
C-629 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

CGI-S, mean (SD): 

G1: 4.5 (0.7) 

G2: 5.0 (0.7) 

(P = 0.03) 

CGI-S, mean (SD): 

G1: 2.4 (1.4) 

G2: 3.6 (1.7) 

Change over time from baseline 

to wk 6: 

(P = NS) 

Rate of change: -0.475 (0.217) 

(P = 0.028) 

G1 better than G2 

BMI, kg/m2

, mean (SD): 

G1: 41.4 (6.9) 

G2: 34.2 (7.4) 

(P = 0.003) 

BMI, kg/m2

, mean (SD): 

G1: 40.9 (7.0) 

G2: 35.7 (7.5) 

Change over time from baseline 

to wk 6: -0.818 (0.254) 

(P = 0.001) 

Rate of change: -0.525 (0.145) 

(P < 0.001) 

G1 greater than G2

HAM-D, mean 

(SD): 

G1: 3.1 (3.2) 

G2: 2.7 (3.7) 

 (P = NS) 

HAM-D, mean (SD): 

G1: 1.4 (2.3) 

G2: 1.9 (3.1) 

Change from baseline to wk 6 

(P = NS) 

Rate of change: -1.05 (0.54) 

(P = 0.05) 

G1 better than G2 

Wt, kg, mean (SD): 

G1: 116.8 (21.0) 

G2: 94.6 (23.2) 

(P = 0.004) 

Wt, kg, mean (SD): 

G1: 114.1 (22.4) 

G2: 99.8 (24.7) 

Change over time from baseline 

to wk 6:-2.49 (0.66) (P < 0.001)

G1 better than G2 

Rate of change: -1.43 (0.40) 

(P < 0.001) 

G1 better than G2

Interaction effects: 

No differential effects in subjects 

with and without current major 

depressive disorder or by 

varying BMI at baseline
C-630 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Pearlstein et al., 2003 

Setting: 

Outpatient program; 

single center; USA 

Enrollment period: 

NR 

Research objective: 

To replicate the findings of 

previous double-blind RCT 

of fluvoxamine on BED. This 

trial was 12 wks rather than 

9 and used EDE to classify 

BE; to assess tx effects on 

associated ED 

psychopathology as 

measured by EDE. 

Groups: 

G1: Fluvoxamine (N = 9) 

G2: Placebo (N = 11) 

Enrollment: 

• 25 recruited via ads and 

referral 

• 25 screened 

• 20 completed 

Age, yrs, mean: 

41.0 

Sex: 

Female: 17 

Male: 3 

Race/ethnicity: 

Caucasian: 90% 

Marital status: 

Currently married: 70% 

Employment status: 

Currently employed: 90% 

Avg BMI (kg/m2

): 

41.16 
C-631 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV research 

criteria for BED based 

on EDE 

Exclusion: 

NR 

Prior to tx, all subjects completed 

two intake assessment sessions, 1 

wk apart. At the first, BED dx was 

confirmed using EDE, and subjects 

instructed on completing food logs; 

At the second, the SCID, HAM-D, 

and CGI were administered, and 

SCL-90 and BDI were completed. 

After 1 wk of single-blind placebo, 

subjects randomized to flexible dose 

tx or placebo; tx was titrated up to 

150 mg b.i.d. Avg dose for tx was 

239 mg/day, 264 mg/day for 

placebo. 

Tx lasted 12 wks; first 6 wks, 

subjects met wkly with research 

nurse and psychiatrist, and biwkly 

for final 6 wks. Visits included 

collecting food logs, vital signs, 

noting adverse events, distributing 

materials on healthy eating, 

distributing study meds, determining 

dosage by response and tolerability. 

At wk 12, subjects received EDE 

and HAM-D by blinded- interview, 

and completed self-report 

questionnaires. Post-study, subjects 

offered continued tx. 

Independent samples 

t-tests to measure 

between-group

change. 

Repeated measures 

ANOVAs to determine 

effect of tx on 

outcome variables 

after trial end. 

Score: 

Good 

Intent to treat: 

NR 

Blinding: 

Double 

Adverse events, N: 

In study completers: 

Sedation: 

G1: 8 

G2: 3 

Nausea: 

G1: 4 

G2: 1 

Dry mouth: 

G1: 4 

G2: 3 

Decreased libido: 

G1: 3 

G2: 0 

Funding: 

Solvay Pharmaceuticals 
C-632 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Number of days with binges, 

past 28 days, mean (SD): 

G1: 14.67 (55.68) 

G2: 20.00 (6.21) 

(P = NS) 

Binge frequency: 

G1: NR 

G2: NR 

(P = NS) 

Number of days with binges, 

past 28 days, mean (SD): 

G1: 3.11 (4.20) 

G2: 7.31 (9.31) 

Diff between groups (P = NR) 

Change over time for both groups (P < 0.001) 

Diff between groups in change over time (P = NS) 

EDE Restraint, mean (SD): 

G1: 2.04 (1.24) 

G2: 1.60 (1.08) 

(P = NS) 

EDE Restraint, mean (SD): 

G1: 0.91 (0.78) 

G2: 1.45 (0.98) 

Diff between groups (P = NR) 

Change over time for both groups (P = NS) 

Diff between groups in change over time (P = NS) 

EDE Eating Concern, mean (SD): 

G1: 1.10 (0.96) 

G2: 1.82 (1.02) 

(P = NS) 

EDE Eating Concern, mean (SD): 

G1: 0.31 (0.39) 

G2: 0.44 (0.55) 

Diff between groups (P = NR) 

Change over time for both groups (P < 0.001) 

Diff between groups in change over time (P = NS) 

EDE Shape Concern, mean (SD): 

G1: 3.38 (0.74) 

G2: 3.56 (0.43) 

(P = NS)

EDE Shape Concern, mean (SD): 

G1: 2.24 (0.85) 

G2: 2.50 (1.15) 

Diff between groups (P = NR) 

Change over time for both groups (P < 0.001) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Pearlstein et al., 2003 

(continued) 

EDE Wt Concern, mean (SD): 

G1: 3.73 (0.49) 

G2: 3.32 (0.94) 

(P = NS)

EDE Wt Concern, mean (SD): 

G1: 2.40 (1.22) 

G2: 2.36 (1.07) 

Diff between groups (P = NR) 

Change over time for both groups (P < 0.001) 

Diff between groups in change over time (P = NS) 
C-633 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, means per item (SD): 

G1: 0.44 (0.22) 

G2: 0.68 (0.57) 

(P = NS) 

BDI, means (SD): 

G1: 0.32 (0.30) 

G2: 0.37 (0.26) 

Diff between groups (P = NR)

Change over time for both 

groups (P < 0.01) 

Diff between groups in 

change over time (P = NS) 

Wt, lbs, mean (SD): 

G1: 243 (85) 

G2: 258 (96) 

(P = NS) 

Wt, lbs, mean (SD): 

G1: 242 (82) 

G2: 262 (99) 

Diff between groups (P = NR) 

Change over time for both 

groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

HAM-D, mean (SD): 

G1: 10.78 (9.22) 

G2: 14.27 (12.40) 

(P = NS) 

HAM-D, mean (SD): 

G1: 9.38 (9.71) 

G2: 7.38 (9.71) 

Diff between groups (P = NR)

Change over time for both 

groups (P = NS) 

Diff between groups in 

change over time (P = NS) 

 

SCL-90, mean (SD): 

G1: 0.62 (0.33) 

G2: 0.85 (0.55) 

(P = NS) 

SCL-90, mean (SD): 

G1: 0.30 (0.29) 

G2: 0.40 (0.29) 

Diff between groups (P = NR)

Change over time for both 

groups (P < 0.001) 

Diff between groups in 

change over time (P = NS) 

 
C-634 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Stunkard et al., 1996 

Setting: 

Outpatient, Wt and 

Eating Disorders 

Program, University of 

Pennsylvania, 

Philadelphia, PA, USA 

Enrollment period: 

NR 

Research objective: 

RCT investigating use of dfenfluramine for tx of BED 

Groups: 

G1: d-fenfluramine (N = 14) 

G2: placebo (N = 14) 

Enrollment: 

• 1450 screened using 

two-stage procedure 

(structured telephone 

interview followed by 

face-to-face interview) 

• 50 met criteria 

• All received placebo for 4 

wks 

• After 4 wks, only 28 

continued to meet criteria

• 14 randomly assigned to 

each of the two groups 

• 2 from each group

dropped out in the first 

two wks of tx 

Age, mean (SD): 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Binges per wk in the first 

wk, mean (SD): 

G1: 2.2 (1.3) 

G2: 2.3 (2.0) 

BMI, kg/m2, mean (SD): 

(N = 22) 

36.7 (5.8) 
C-635 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met criteria for BED 

established by Spitzer 

et al. (1992) and used 

in DSM IV; female. 

Exclusion: 

None 

Placebo for 4 wks. Only patients 

who continued to meet criteria 

(binges on at least 2 days per wk) 

were randomized. Patients in the 

meds group received 15 mg of dfenfluramine once a day for the first 

wk, twice a day for the next 6 wks 

and once a day for the eighth wk. 

Sig of the diff in the 

two groups tested by 

student’s t test. 

Multiple linear 

regression analyses 

used to test for sig grp

diff while controlling 

for baseline 

depression and wt. 

Slopes reported for 

change in binge days; 

eating inventory, 

eating habits 

checklist; but no 

values at FU intervals 

reported. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

Double 

Adverse events: 

Reported for patients in both 

groups. Headache and 

diarrhea more common in 

meds than placebo grp. For 

one patient in drug grp, 

moderately severe rash 

reported which went away 3 

mos after discontinuation of 

drug. 

Funding: 

Servier Amerique and NIMH 
C-636 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges per wk, mean (SD): 

G1: 2.2 (1.3) 

G2: 2.3 (2.0) 

(P = NS) 

Binges per wk, mean (SD): 

Post tx: 

G1: 0.6 (1.0) (P = 0.0001) 

G2: 2.3 (2.9) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.02) 

G1 better than G2 

Diff between groups in change over time (controlling 

for baseline wt and depression scores) (P = 0.01) 

1 mo FU: 

G1: 1.3 

G2: 1.1 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

4 mo FU: 

G1: 1.8 

G2: 1.3 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Binge days per wk, mean (SD): 

G1: 2.45 (1.00) 

G2: 2.39 (1.32) 

(P = NS) 

Change binge days per wk, mean (SD): 

G1: -0.24 (0.13) 

G2: -0.15 (0.16) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Gormally Eating Habits Checklist, 

mean (SD): 

G1: 27.83 (10.60): 

G2: 22.25 (8.67) 

(P = NS) 

Change Gormally Eating Habits Checklist, mean 

(SD): 

G1: -0.65 (1.04) 

G2: -0.08 (0.73) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Eating Inventory – Restraint, mean 

(SD): 

G1: 9.63 (5.91) 

G2: 9.16 (3.76) 

(P = NS) 

Change Eating Inventory – Restraint, mean (SD): 

G1: 0.23 (0.52) 

G2: 0.14 (0.37) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Eating Inventory-Disinhibition, 

mean (SD): 

G1: 12.80 (3.24) 

G2: 12.17 (3.09) 

(P = NS) 

Change Eating Inventory-Disinhibition, mean (SD):

G1: -0.18 (0.54) 

G2: -0.03 (0.23) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Eating Inventory – Hunger score, 

mean (SD): 

G1: 9.51 (4.17) 

G2: 8.56 (3.05) 

(P = NS) 

Change Eating Inventory – Hunger score, mean 

(SD): 

G1: -0.15 (0.46) 

G2: 0.02 (0.19) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Stunkard et al., 1996 

(continued) 

 Abstinence % (completers): 

G1: 80% 

G2: 33% 

Diff between groups (P = NR) 
C-637 

Evidence Table 10. Medication trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 15.31 (8.18) 

G2: 9.76 (9.75) 

(P = NS) 

Change BDI, mean (SD): 

G1: -0.21 (0.50) 

G2: -0.04 (0.46) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Wt lbs, mean (SD): 

G1: 238.30 (50.20) 

G2: 210.0 (33.80) 

(P = NS) 

Change wt lbs, mean (SD): 

G1: -0.02 (0.93) 

G2: 0.06 (0.70) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-638 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 1994 

Setting: 

Outpatient, Stanford 

University, CA, USA 

Enrollment period: 

NR 

Research objective: 

To compare the effects of wt 

loss tx, CBT, and desipramine 

on binge eating and wt in a 3 

group additive design in 

overwt participants with BED. 

Groups: 

G1: wt loss therapy for 9 

mos (N = 37) 

G2: CBT for 3 mos followed 

by wt loss therapy for 6 mos 

(CBT/WL) (N = 36) 

G3: CBT for 3 mos followed 

by both wt loss therapy and 

desipramine for 6 mos 

(CBT/WL-D) (N = 36) 

Enrollment: 

Randomized: 109 

Drop out, N (%): 

G1: 10 (27%) 

G2: 6 (17%) 

G3: 8 (23%) 

(P = NS) 

End of tx: N = 88 

3 mo FU: 

Drop out, N: 

G1: 6 

G2: 5 

G3: 3

Age yrs, mean (SD) 

(range): 

45.0 (10) (22 – 65) 

(P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

BMI, mean (SD): 

38.6 (6.6) 

Age of onset of BE yrs, 

mean (SD): 

19 (10.7) 

(P = NR) 

Age of onset of overwt yrs, 

mean (SD): 

15.5 (10.2) 

(P = NR) 

Education: 

College grad: 55% 

Some college: 38% 
C-639 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED 

Exclusion: 

Current involvement in 

a wt loss program, 

currently taking 

antidepressant meds 

or any meds that might 

influence wt, sufficient 

suicidality that may 

make outpt tx with 

desipramine 

dangerous, 

drug/alcohol abuse, hx 

of purging within the 

prior 12 mo, BMI < 27. 

G1: Wt loss-30 90-minutes group

sessions wkly for the first 24 wks 

and then bi-wkly. Based on 

modified LEARN program (without 

BE materials). Focus on gradual 

lifestyle changes. 

G2: CBT based on manual by 

Telch et al., for BED for 12 wkly 

sessions. Followed by 18 sessions 

of the wt loss therapy as described 

above. 

G3: Following completion of CBT, 

received desipramine and wt loss 

therapy. Seen in small groups 

immediately before or after wt loss 

groups (wkly for first 4 wks, bi-wkly 

for 4 wks, and then at 4-wk 

intervals). Groups conducted by 

psychiatrist who explained meds. 

Began on 25 mg and dose 

increased depending on side 

effects and therapeutic effects to a 

max dose of 300 mg. Discontinued 

over a 2-wk period following post-tx 

assessment. Mean dose 285 mg 

with a mean blood level of 212 

ng/mL. 

Assessments: baseline, wk 12, 

24, 36 (Post-tx), 3-mo FU 

Repeated measures 

ANOVA followed by 

ANCOVAs (controlling 

for baseline 

characteristics) at 

each time point. 

Pairwise comparisons 

to determine diff 

between groups. 

At wk 12, analysis of 

G2 and G3 are 

combined. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

24% discontinued desipramine 

before the post tx assessment 

because of side effects. 

Funding: 

NIH 
C-640 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Agras et al., 1994 

(continued) 

Binges/wk, mean (SD): 

G1: 4.5 (1.6) 

G2: 4.4 (1.4) 

G3: 5.1 (1.4) 

(P = NS) 

Binges/wk, mean (SD): 

12 wks: 

G1: 2.5 (1.9) 

G2: 1.5 (1.4) 

G3: 1.8 (1.3) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.01) 

G2 + G3 better than G1 

24 wks: 

G1: 1.2 (1.2) 

G2: 1.1 (1.1) 

G3: 1.6 (1.8) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

36 wks (Post-tx): 

G1: 1.5 (0.2) 

G2: 1.2 (1.3) 

G3: 0.9 (0.9) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

3 mo FU: 

G1: 2.0 

G2: 1.7 

G3: 1.5 

Diff between groups (P = NR) 
C-641 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 12.9 (6.5) 

G2: 13.5 (7.8) 

G3: 13.7 (8.1) 

(P = NS) 

BDI, mean (SD): 

12 wks: 

G1: 11.6 (8.0) 

G2: 12.7 (9.2) 

G3: 10.8 (8.9) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

24 wks: 

G1: 11.2 (8.5) 

G2: 8.5 (6.5)

G3: 8.6 (8.2) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

36 wks: 

G1: 11.3 (10.3) 

G2: 8.9 (7.6) 

G3: 7.8 (7.8) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Wt, kg, mean (SD): 

G1: 102.9 (15.8) 

G2: 102.1 (15.7) 

G3: 111.9 (17.4) 

(P = NS) 

Wt, kg, mean (SD): 

12 wks: 

G1: 100.9 (16.8) (P = NR) 

G2: 102.7 (16.5) (P = NR) 

G3: 112.7 (18.5) (P = NR) 

Diff between groups (P = NR) 

Diff between groups (G2 + G3) vs 

G1 in change over time (P < 0.002)

G1 better than G2, G3 

24 wks: 

G1: 100.4 (17.3) 

G2: 100.7 (16.7) 

G3: 107.0 (20.1) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

36 wks: 

G1: 99.2 (16.9) 

G2: 100.5 (17.6) 

G3: 105.9 (20.5) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

3 mo FU 

Wt change from baseline, kg, 

mean: 

G1: -4.15 

G2: 0 

G3: -4.8 

Diff between groups (P = NS) 

Diff between groups (G2 vs G3) in 

change over time (P < 0.05) 

G3 better than G2 

G1 vs G2 (P = NS) 

G1 vs G3 (P = NS) 
C-642 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ-Disinhibition, mean (SD): 

G1: 13.7 (1.8) 

G2: 14.0 (1.1) 

G3: 14.6 (1.2) 

Diff between G1 vs G3 (P < 0.03) 

G3 higher disinhibition 

Diff between G1 vs G2 (P = NS) 

Diff between G2 vs G3 (P = NS) 

TFEQ - Disinhibition, mean (SD): 

12 wks: 

G1: 12.7 (2.6) 

G2: 12.7 (1.8) 

G3: 12.2 (2.3) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

24 wks: 

G1: 11.7 (3.0) 

G2: 10.8 (2.7) 

G3: 9.7 (3.5) 

Diff between groups (P = NR) 

Diff between groups (G1 vs G3) in change over time 

(P < 0.008) 

G3 less disinhibited vs G1 

Diff between G1 vs G2 in change over time (P = NS) 

Diff between G2 vs G3 in change over time (P = NS) 

36 wks (Post-tx): 

G1: 11.6 (2.6) 

G2: 10.8 (3.1) 

G3: 10.2 (4.2) 

(P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Agras et al., 1994 

(continued) 

TFEQ-Hunger, mean (SD): 

G1: 10.3 (2.9) 

G2: 9.1 (2.9) 

G3: 10.6 (2.6) 

Diff between groups (P = NS) 

TFEQ - Hunger, mean (SD): 

12 wks: 

G1: 9.4 (3.2) 

G2: 7.8 (3.1) 

G3: 8.3 (2.4) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

24 wks: 

G1: 8.5 (3.2) 

G2: 6.2 (2.9) 

G3: 5.8 (3.1) 

Diff between groups (P = NR) 

Diff groups in change over time 

G3 less hunger than G1 (P < 0.0004) 

G2 less hunger than G1(P < 0.03) 

G2 vs G3 (P = NS) 

36 wks (Post-tx): 

G1: 8.4 (3.2) 

G2: 6.4 (3.2) 

G3: 7.2 (2.8) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-643 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-644 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ Restraint, mean (SD): 

G1: 8.7 (4.5) 

G2: 6.6 (2.8) 

G3: 8.2 (3.6) 

Diff between G1 vs G2 (P < 0.05), 

G1 higher restraint 

Diff between G2 vs G3 (P < 0.05) 

G3 higher restraint 

Diff between G1 vs G3 (P = NS) 

TFEQ Restraint mean (SD): 

12 wks: 

G1: 11.2 (5.1) 

G2: 8.5 (3.5) 

G3: 10.4 (0.5) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

24 wks: 

G1: 12.5 (5.1) 

G2: 10.8 (0.4) 

G3: 14.6 (3.3 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

36 wks (Post-tx): 

G1: 12.0 (5.1) 

G2: 10.9 (4.5) 

G3: 13.4 (3.4) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Agras et al., 1994 

(continued) 

 Remission of BE, %: 

36 wks (Post-tx): 

G1: 19% 

G2: 37% 

G3: 41% 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

3 mo FU: 

G1: 14% 

G2: 28% 

G3: 32% 

Diff between groups (P = NR) 
C-645 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-646 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Grilo, Masheb, and 

Salant, 2005 

Setting: 

Outpatient, Yale 

University Medical 

School, USA 

Enrollment period: 

NR 

Research objective: 

To determine whether 

adding Orlistat (a lipase 

inhibitor used for txing 

obesity) to CBT 

facilitates wt loss in 

obese individuals with 

BED 

Groups: 

G1: Orlistat plus CBT (N = 25) 

G2: Placebo plus CBT (N = 25) 

Enrollment: 

Telephone Screened: 174 

Evaluated: 61 

Randomized: 50 

Drop outs: 

G1: 6 

G2: 5 

Completed Trial, N (%): 

Total: 39 (78) 

G1: 19 (76%) 

G2: 20 (80%) 

(P = NS) 

Age, mean (SD): 

Range (35-58) 

G1: 45.2 (7.4) 

G2: 47.0 (7.0) 

(P = NS) 

Age of onset, yrs, mean 

(SD): 

G1: 23.5 (12.2) 

G2: 27.2 (14.0) 

(P = NS) 

Sex, Female: N (%): 

G1: 21 (84%) 

G2: 23 (92%) 

(P = NS) 

Race/ethnicity, N (%): 

Caucasian: 

G1: 22 (88%) 

G2: 22 (88%) 

African American: 

G1: 1 (4%) 

G2: 2 (8%) 

Hispanic: 

G1: 2 (8%) 

G2: 1 (4%) 

Race/ethnicity (P = NS) 

Attended or completed 

college, N (%): 

G1: 20 (80%) 

G2: 21 (84%) 

(P = NS) 

DSM IV Dx, Lifetime, N 

(%): 

Any Axis 1: 

G1: 13 (52%) 

G2: 17 (68%) 

(P = NS) 

Major depressive 

disorder: 

G1: 9 (36%) 

G2: 12 (48%) 

(P = NS) 

Dysthymic disorder: 

G1: 1 (4%) 

G2: 4 (16%) 

(P = NS) 
C-647 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED; age: 35-60; BMI 

≥ 30. 

Exclusion: 

Concurrent tx for 

eating, wt, or 

psychiatric illness; 

medical conditions that 

influence wt or eating 

(e.g., diabetes or 

thyroid problems, as 

determined by 

laboratory testing); 

severe current 

psychiatric conditions 

requiring diff txs 

(psychosis, bipolar 

disorder); pregnancy 

or lactation. 

CBT: Individually administered CBT 

using guided self-help and 

Overcoming Binge Eating (Fairburn 

1995). 6 brief individual meetings 

(15 – 20 minute sessions) during 12 

wk period. 

Meds: Orlistat (120 mg 3 times per 

day) or placebo for12 wks. Patients 

given a once-daily fat soluble 

multivitamin to be taken 2 hrs prior 

to study med at dinner. Clinical mgt 

of meds included brief individual 

meetings (10 – 15 m) held wkly 

during the first 4 wks and then moly. 

Diet: Instructed to eat 3 meals and 

2-3 snacks per day; aim for modest 

balanced calorie diet with goals of 

1200 kcal for women and 1500 kcal 

for men, limit fat to less than 30% of 

intake, and follow Food Guide 

Pyramid for balanced food choices 

and portion sizes. 

Assessments at end of 12 wks of tx 

and at 2 mo FU. Encouraged to 

continue to use CBT teachings 

during FU but to not take orlistat or 

begin new tx. 

ANCOVA Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

General side effects were 

“slightly higher” in G1. 

Particularly, gastrointestinal 

events were higher for G1. 

Drop out due to side effects: 

G1: N = 2 

G2: N = 0 

(P = NR) 

Funding: 

American Heart Association; 

Donaghue Medical Research 

Foundation 
C-648 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Grilo, Masheb, and 

Salant; 2005 

(continued) 

 Anxiety Disorders: 

G1: 6 (24%) 

G2: 6 (24%) 

(P = NS) 

Substance use disorders: 

G1: 4 (16%) 

G2: 1 (4%) 

(P = NS) 
C-649 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-650 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Remission rates (No OBEs for past 28 days 

based on EDE), N (%): 

Post Tx: 

G1: 16 (64%) 

G2: 9 (36%) 

Diff between groups (P = 0.05) 

G1 better G2 

Diff between groups in change over time (P = NR) 

FU: 

G1: 13 (52%); (P = NR) 

G2: 13 (52%); (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

EDE Binge episodes (OBE)/ mo: 

G1: 16.4 (8.0) 

G2: 13.5 (6.6) 

(P = NS) 

Binge Eating, OBEs/Mo, mean (SD): 

Post Treatment: 

G1: 3.2 (5.5) (P = NR) 

G2: 3.6 (5.2) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 3.4 (6.5) (P = NR) 

G2: 2.8 (5.3) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

EDE, dietary restraint, mean (SD): 

G1: 2.0 (1.4) 

G2: 2.1 (1.4) 

(P = NS) 

EDE, dietary restraint, mean (SD): 

Post Treatment: 

G1: 2.1 (2.3) (P = NR) 

G2: 2.0 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 2.1 (1.3) (P = NR) 

G2: 2.3 (1.3) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Grilo, Masheb, and 

Salant, 2005 

(continued) 

EDE, eating concern, mean (SD): 

G1: 2.6 (1.3) 

G2: 2.7 (1.1) 

(P = NS) 

EDE, eating concern, mean (SD): 

Post Treatment: 

G1: 0.9 (1.0) (P = NR) 

G2: 1.0 (1.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 1.1 (1.3) (P = NR) 

G2: 1.2 (1.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-651 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 17.1 (8.9) 

G2: 20.6 (9.6) 

(P = NS) 

BDI, mean (SD): 

Post tx: 

G1: 10.1 (7.7) (P = NR) 

G2: 14.7 (9.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

FU: 

G1: 9.9 (8.6) (P = NR) 

G2: 14.6 (10.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

BMI, kg/m2, mean 

(SD): 

36.0 (4.7) 

G1: 36.2 (4.7) 

G2: 36.8 (5.1) 

(P = NS) 

Wt Loss (kg), mean (SD): 

Post-tx: 

G1: -3.5 (3.5) (P = NR)

G2: -1.6 (2.4) (P = NR)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.02) 

G1 better than G2 

FU: 

G1: 3.4 (5.0) (P = NR)

G2: 1.3 (3.1) (P = NR)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Percentage Wt Loss, mean 

(SD): 

Post-tx: 

G1: -3.3% (3.3); (P = NR) 

G2: -1.6% (2.4); (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = 0.04) 

G1 better G2 

FU: 

G1: 3.4 (5.0) (P = NR)

G2: 1.3 (3.1) (P = NR)

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

G1: 3.3 (5.0) (P = NR) 

G2: 1.3 (3.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Achieved ≥ 5% Wt loss, N 

(%): 

Post-tx: 

G1: 9 (36%) (P = NR)

G2: 2 (8%) (P = NR) 

Diff between groups (P = 0.02) 

G1 better than G2 

Diff between groups in change 

over time (P = NR) 

FU: 

G1: 8 (32%); (P = NR)

G2: 2 (8%); (P = NR) 

Diff between groups (P = 0.03) 

G1 better than G2 

Diff between groups in change 

over time (P = NR) 
C-652 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE, wt concern, mean (SD): 

G1: 3.9 (0.8) 

G2: 3.7 (0.7) 

(P = NS) 

EDE, wt concern, mean (SD): 

Post Treatment: 

G1: 2.8 (1.1) (P = NR) 

G2: 3.0 (0.7) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 2.8 (1.3) (P = NR) 

G2: 2.7 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EDE, shape concern, mean (SD): 

G1: 4.3 (0.8) 

G2: 4.4 (0.8) 

(P = NS) 

EDE, shape concern, mean (SD): 

Post Treatment: 

G1: 2.8 (1.4) (P = NR) 

G2: 3.3 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 2.9 (1.6) (P = NR) 

G2: 3.0 (1.4) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Grilo, Masheb, and 

Salant, 2005 

(continued) 

EDE interview global score, mean 

(SD): 

G1: 3.2 (0.9) 

G2: 3.2 (0.7) 

(P = NS) 

EDE interview global score, mean (SD): 

Post Treatment: 

G1: 2.1 (1.0) (P = NR) 

G2: 2.4 (0.7) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

G1: 2.2 (1.1) (P = NR) 

G2: 2.3 (1.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-653 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-654 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Grilo, Masheb and 

Wilson, 2005 

Setting: 

Outpatient,Yale 

University; New 

Haven, CT, USA 

Enrollment period: 

NR 

Research objective: 

To test the efficacy of 

CBT and fluoxetine alone 

and in combination for 

BED. 

Groups: 

G1: Placebo (N = 27) 

G2: fluoxetine (N = 27) 

G3: CBT + placebo (N = 28) 

G4: CBT + fluoxetine (N = 26) 

Enrollment: 

Telephone Screened: 410 

Personal Interview: 200 

Met criteria and were 

randomized: 108 

Completed, N (%): 

G1: 23 (85%) 

G2: 21 (78%) 

G3: 22 (79%) 

G4: 20 (77%) 

(P = NS) 

Age, mean (SD): 

Range (21-59) 

G1: 43.6 (8.5) 

G2: 44.3 (9.5) 

G3: 43.6 (8.5) 

G4: 44.7 (8.1) 

(P = NS) 

Sex: 

Female, N (%): 

G1: 23 (85.2) 

G2: 19 (70.4) 

G3: 22 (78.6) 

G4: 20 (76.9) 

(P = NS) 

Race/ethnicity, N (%): 

Caucasian: 

G1: 20 (74.1) 

G2: 27 (100) 

G3: 26 (92.9) 

G4: 23 (88.5) 

African-American: 

G1: 5 (18.5) 

G2: 0 (0) 

G3: 2 (7.1) 

G4: 2 (7.7) 

Hispanic-American: 

G1: 2 (7.4) 

G2: 0 (0) 

G3: 0 (0) 

G4: 1 (3.8) 

(P = NS) 

Education, N (%): 

Attended/Finished 

College: 

Total Sample: 95 (87%) 

College: 

G1: 13 (48.1) 

G2: 14 (51.9) 

G3: 14 (50.0) 

G4: 11 (42.3) 

Some College: 

G1: 12 (44.4) 

G2: 11 (40.7) 

G3: 9 (32.1) 

G4: 11 (42.3) 
C-655 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED; Age: 18-60; 

100%-200% of ideal wt 

for hgt. 

Exclusion: 

Any concurrent tx for 

eating, wt, or 

psychiatric problems; 

medical conditions 

(diabetes, thyroid 

problems, 

hypoglycemia) that 

influence wt/eating; 

severe psychiatric 

conditions requiring 

diff txs (psychosis, 

bipolar disorder); and 

pregnancy or lactation. 

Pharmacological Treatment:

Fluoxetine (60 mg/day) started 

immediately and without taper at 

end of tx. Clinical management 

involved brief individual meetings 

(10 – 15 min) held wkly during first 

4 wks and bi-wkly thereafter. 

Meetings focused solely on 

medical regimen. 

CBT: wkly individual 60-minutes 

sessions for 16 wks and followed 

Fairburn’s manual for BN. 

Patients self monitored overeating 

behaviors including binge eating.

Tx: 16 wks 

Logistic regression 

analyses compared 

remission rates based 

on self-monitoring 

across the tx while 

controlling for the 

frequency of OBEs for 

the mo prior to 

beginning tx as 

determined at 

baseline. 

ANCOVA and 

repeated measures 

ANOVAs used for 

secondary analyses. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

Double 

Adverse events: 

NR 

Funding: 

National Institutes 

of Healthy. Eli Lily 

and Co provided 

fluoxetine and 

matching Placebo 

Pills 
C-656 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Grilo, Masheb, and 

Wilson, 2005 

(continued) 

 HS: 

G1: 2 (7.4) 

G2: 2 (7.4) 

G3: 5 (17.9) 

G4: 4 (15.4) 

(P = NS) 

DSM IV Co-morbidity 

Lifetime, N (%): 

Any Axis I Disorder: 

G1: 17 (63.0) 

G2: 20 (74.1) 

G3: 21 (75.0) 

G4: 21 (80.8) 

(P = NS) 

Major Depressive 

Disorder: 

G1: 12 (44.4) 

G2: 11 (40.7) 

G3: 17 (60.7) 

G4: 14 (50.0) 

(P = NS) 

Anxiety Disorders: 

G1: 10 (37.0) 

G2: 9 (33.3) 

G3: 13 (46.4) 

G4: 8 (30.8) 

(P = NS) 

Alcohol use disorders: 

G1: 7 (25.9) 

G2: 4 (14.8) 

G3: 6 (21.4) 

G4: 9 (34.6) 

(P = NS) 

Drug use disorders: 

G1: 5 (18.5) 

G2: 4 (14.8) 

G3: 6 (21.4) 

G4: 4 (15.4) 

(P = NS) 

Any Axis II personality 

disorder: 

G1: 12 (44.4) 

G2: 7 (25.9) 

G3: 7 (25.0) 

G4: 8 (30.8) 

(P = NS) 

Age Onset BED, mean 

(SD): 

G1: 23.8 (19.0) 

G2: 24.5 (11.9) 

G3: 25.9 (18.1) 

G4: 22.4 (13.0) 

(P = NS) 
C-657 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

This page intentionally left blank. 
C-658 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Binge days (OBE)/mo, mean (SD): 

G1: 13.5 (7.4) 

G2: 16.5 (7.6) 

G3: 17.4 (7.5) 

G4: 16.5 (7.2) 

(P = NS) 

EDE Binge episodes (OBE)/mo, mean 

(SD): 

G1: 16.3 (11.9) 

G2: 20.0 (11.6) 

G3: 22.8 (14.7) 

G4: 22.7 (13.7) 

(P = NS) 

Binge episodes/mo (EDE-Q), mean (SD): 

G1: 7.2 (9.2) (P = NR) 

G2: 10.3 (11.1) (P = NR) 

G3: 1.8 (3.9) (P = NR) 

G4: 4.7 (6.9) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.002) 

G3 better than G1 

G3 vs G2 (P = 0.000) 

G3 better than G2 

G4 vs G1 (P = 0.02) 

G4 better than G1 

G4 vs G2 (P = 0.001) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Grilo, Masheb, and 

Wilson, 2005 

(continued) 

EDE Q Binge episodes/mo, mean (SD): 

G1: 13.2 (9.3) 

G2: 17.9 (12.2) 

G3: 16.6 (8.9) 

G4: 15.2 (7.7) 

(P = NS) 

Binge episodes/mo (daily self-monitoring), 

mean (SD): 

G1: 7.4 (10.2) (P = NR) 

G2: 11.0 (11.2) (P = NR) 

G3: 2.6 (5.8) (P = NR) 

G4: 4.2 (6.9) (P = NR) 

(P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.004) 

G3 better than G1 

G3 vs G2 (P = 0.04) 

G3 better than G2 

G4 vs G1 (P = 0.05) 

G4 better than G1 

G4 vs G2 (P = 0.001) 

G4 better than G2 

Diff between groups in change over time (P = NR) 
C-659 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 18.7 (9.7) 

G2: 16.9 (8.4) 

G3: 16.5 (8.4) 

G4: 20.2 (12.1) 

(P = NS) 

BDI, mean (SD): 

G1: 11.7 (10.3) (P = NR) 

G2: 11.8 (9.8)) (P = NR) 

G3: 6.5 (6.8) (P = NR) 

G4: 9.2 (7.3) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.04) 

G3 better than G1 

G3 vs G2 (P = 0.01) 

G3 better than G2 

G4 vs G1 (P = NS) 

G4 vs G2 (P = 0.04) 

G4 better than G2 

Diff between groups in 

change over time (P = NR) 

BMI, kg/m2, mean (SD): 

G1: 35.7 (7.2) 

G2: 38.9 (9.5) 

G3: 35.0 (6.2) 

G4: 35.7 (8.3) 

(P = NS) 

BMI, kg/m2, mean (SD): 

G1: 35.7 (7.5) (P = NR) 

G2: 38.1 (9.6) (P = NR) 

G3: 34.2 (5.8) (P = NR) 

G4: 34.9 (7.9) (P = NR) 

Diff between groups 

(P = NR) 

Diff between groups in 

change over time 

(P = NS) 
C-660 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-Q Dietary Restraint, mean (SD): 

G1: 2.2 (1.5) 

G2: 2.4 (1.7) 

G3: 2.6 (1.5) 

G4: 2.5 (1.4) 

(P = NS) 

EDE-Q Dietary Restraint, mean (SD): 

G1: 1.8 (1.5) (P = NR) 

G2: 2.4 (1.6) (P = NR) 

G3: 1.4 (1.0) (P = NR) 

G4: 1.6 (1.4) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = NS) 

G3 vs G2 (P = 0.002) 

G3 better than G2 

G4 vs G1 (P = NS) 

G4 vs G2 (P = 0.01) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

EDE-Q Eating Concern, mean (SD): 

G1: 3.4 (1.4) 

G2: 4.0 (1.2) 

G3: 3.6 (1.2) 

G4: 3.9 (1.2) 

(P = NS) 

EDE-Q Eating Concern, mean (SD): 

G1: 2.1 (1.5) (P = NR) 

G2: 2.8 (1.8) (P = NR) 

G3: 1.3 (0.7) (P = NR) 

G4: 1.5 (1.3) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.01) 

G3 better than G1 

G3 vs G2 (P = 0.01) 

G3 better than G2 

G4 vs G1 (P = 0.007) 

G4 better than G1 

G4 vs G2 (P = 0.008) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Grilo, Masheb and 

Wilson, 2005 

(continued) 

Wt Concern (EDE-Q), mean (SD): G1: 

3.9 (1.5) 

G2: 4.1 (0.9) 

G3: 4.0 (0.8) 

G4: 4.3 (0.9) 

(P = NS) 

Wt Concern (EDE-Q), mean (SD): 

G1: 3.0 (1.5) (P = NR) 

G2: 3.3 (1.3) (P = NR) 

G3: 2.6 (1.0) (P = NR) 

G4: 2.4 (1.5) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = NS) 

G3 vs G2 (P = 0.04) 

G3 better than G2 

G4 vs G1 (P = 0.01) 

G4 better than g1 

G4 vs G2 (P = 0.001) 

G4 better than G2 

Diff between groups in change over time (P = NR) 
C-661 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-662 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-Q Shape Concern, mean (SD): 

G1: 4.5 (1.4) 

G2: 5.0 (0.8) 

G3: 5.0 (0.8) 

G4: 5.1 (0.7) 

(P = NS) 

EDE-Q Shape Concern, mean (SD): 

G1: 3.6 (1.8) (P = NR) 

G2: 3.9 (1.7) (P = NR) 

G3: 3.2 (1.4) (P = NR) 

G4: 3.1 (1.8) (P = NR) 

Diff between groups:

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.02) 

G3 better than G1 

G3 vs G2 (P = 0.04) 

G3 better than G2 

G4 vs G1 (P = 0.003) 

G4 better than G1 

G4 vs G2 (P = 0.007) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

EDE-Q Global Score, mean (SD): 

G1: 3.5 (1.5) 

G2: 3.9 (1.2) 

G3: 3.8 (1.1) 

G4: 4.0 (1.1) 

(P = NS) 

EDE-Q Global Score, mean (SD): 

G1: 2.6 (1.6) (P = NR) 

G2: 3.1 (1.6) (P = NR) 

G3: 2.1 (1.0) (P = NR) 

G4: 2.2 (1.5) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.007) 

G3 better than G1 

G3 vs G2 (P = 0.004) 

G3 better than G2 

G4 vs G1 (P = 0.002) 

G4 better than G1 

G4 vs G2 (P = 0.001) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Grilo, Masheb and 

Wilson, 2005 

(continued) 

TFEQ Hunger, mean (SD): 

G1: 9.6 (3.9) 

G2: 10.0 (3.3) 

G3: 9.7 (3.2) 

G4: 10.0 (3.1) 

(P = NS) 

TFEQ Hunger, mean (SD): 

G1: 8.4 (4.3) (P = NR) 

G2: 8.9 (4.6) (P = NR) 

G3: 6.7 (3.3) (P = NR) 

G4: 5.7 (4.0) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = NS) 

G3 vs G2 (P = NS) 

G4 vs G1 (P = 0.008) 

G4 better than G1 

G4 vs G2 (P = 0.004) 

G4 better than G2 

Diff between groups in change over time (P = NR) 
C-663 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-664 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ Cognitive Restraint, mean (SD): 

G1: 8.1 (3.63) 

G2: 8.6 (4.0)

G3: 7.8 (3.7)

G4: 8.7 (4.5)

P = NS))

TFEQ Cognitive Restraint, mean (SD): 

G1: 9.9 (5.0) (P = NR) 

G2: 9.9 (4.7) (P = NR) 

G3: 10.1 (3.1) (P = NR) 

G4: 10.0 (4.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

TFEQ Disinhibition, mean (SD): 

G1: 13.9 (1.9) 

G2: 14.0 (1.3) 

G3: 14.2 (1.6) 

G4: 14.0 (1.7) 

(P = NS) 

TFEQ Disinhibition, mean (SD): 

G1: 12.1 (4.3) (P = NR) 

G2: 12.2 (3.6) (P = NR) 

G3: 9.3 (3.8) (P = NR) 

G4: 8.3 (4.8) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = 0.001) 

G3 better than G1 

G3 vs G2 (P = 0.002) 

G3 better than G2 

G4 vs G1 (P = 0.000) 

G4 better than G1 

G4 vs G2 (P = 0.001) 

G4 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Grilo, Masheb and 

Wilson, 2005 

(continued) 

BSQ, Body Dissatisfaction, mean (SD) 

G1: 135.4 (35.2) 

G2: 136.3 (26.0) 

G3: 133.5 (24.3) 

G4: 139.1 (28.8) 

(P = NS) 

BSQ, Body Dissatisfaction, mean (SD): 

G1: 123.6 (41.0) (P = NR) 

G2: 117.5 (41.5) (P = NR) 

G3: 100.9 (23.5) (P = NR) 

G4: 106.0 (40.2) (P = NR) 

Diff between groups: 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G3 vs G1 (P = NS) 

G3 vs G2 (P = 0.03) 

G3 better than G2 

G4 vs G1 (P = 0.05) 

G4 better than G1 

G4 vs G2 (P = NS) 

Diff between groups in change over time (P = NR) 
C-665 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-666 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Grilo, Masheb and 

Wilson, 2005 

(continued) 

Remission rates (Per EDE), %: 

G1: 26% 

G2: 22% 

G3: 61% 

G4: 50% 

Diff between groups (P = 0.007) 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G4 vs G1 (P = 0.05) G4 better than G1 

G4 vs G2 (P = 0.03) G4 better than G2 

G3 vs G1 (P = 0.008) G3 better than G1 

G3 vs G2 (P = 0.004) G3 better than G2 

Remission rates (Per EDE-Q): 

G1: Data in figure 

G2: Data in figure 

G3: Data in figure 

G4: Data in figure 

Diff between groups (P = 0.003) 

G1 vs G2 (P = NS) 

G3 vs G4 (P = NS) 

G4 vs G1 (P = 0.02) G4 better than G1 

G4 vs G2 (P = 0.003) G4 better than G2 

G3 vs G1 (P = 0.03) G3 better than G1 

G3 vs G2 (P = 0.005) G3 better than G2 
C-667 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-668 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Ricca et al., 2001 

Setting: 

Outpatient clinic for 

ED of the University 

of Florence and the 

Casa di Cura (villa dei 

pini), Florence, Italy 

Enrollment period: 

January 1 – July 31, 

1998 

Research objective: 

Compare the efficacy 

and tolerability of 

fluoxetine, 

fluvoxamine, and CBT, 

individually and 

combined with each 

other, after 6 mos of 

acute tx and one yr FU 

among patients with 

BED. 

Groups: 

G1: CBT (N = 20) 

G2: CBT + Fluoxetine (N = 22) 

G3: CBT + Fluvoxamine (N = 23) 

G4: Fluoxetine (N = 21) 

G5: Fluvoxamine (N = 22) 

Enrollment: 

• 118 referred 

• 7 did not meet criteria, 3 

refused 

• 108 were randomized. 

Drop out, N (%): 

G1: 3 

G2: 6 (27.2) 

G3: 5 (21.7) 

G4: 5 (23.8) 

G5: 6 (27.2) 

(P = NS) 

Subjects allocated to tx by day of 

the wk of appointment. Drug tx is 

open label 

Age, yrs, mean (SD): 

25.9 (6.8) 

G1: 26.3 (6.7) 

G2: 25.2 (6.3) 

G3: 25.1 (6.9) 

G4: 25.1 (6.1) 

G5: 26.1 (5.9) 

(P = NS) 

Sex, N: 

Female: 64; Male: 44 

G1: F: 13; M: 7 

G2: F: 13; M: 9 

G3: F: 13; M: 10 

G4: F: 12; M: 9 

G5: F:13; M:9 

(P = NS) 

Race/ethnicity: 

NR 

BMI, mean (SD): 

G1: 32.0 (6.0) 

G2: 31.7 (5.6) 

G3: 32.5 (6.1) 

G4: 32.1 (3.8) 

G5: 32.7 (4.1) 

(P = NS) 

Duration of BED, yrs, 

mean (SD): 

G1: 6.4 (6.0) 

G2: 4.9 (5.1) 

G3: 4.8 (4.4) 

G4: 5.1 (4.7) 

G5: 5.3 (4.8) 

(P = NS) 

Age of Onset, mean (SD): 

G1: 19.9 (2.3) 

G2: 24.4 (3.2) 

G3: 20.5 (3.6) 

G4: 21.2 (3.1) 

G5: 22.1 (3.6) 

(P = NS) 

Comorbidity per SCID for 

DSM III-R, N (%): 

Total people with comorbid 

dx: 15 

Major depression: 7 (6.4) 

Dysthymia: 6 (5.5) 

Adaptation disorder with 

depressed mood: 4 (3.6) 

OCD: 2 (1.8) 

Panic Disorder: 2 (1.8) 
C-669 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

BED dx per DSM IV; 

age: 18-45; absence of 

diabetes mellitus, 

thyroid disorders, or 

any other disease 

interfering with eating 

behavior; absence of 

any contraindication to 

tx; absence of 

pregnancy or lactation. 

Exclusion: 

See above 

G1: 22 individual sessions of 50 

min each for 24 wks. 

G2: 20 mg/day for first wk; 40 

mg/day for second wk; 60 mg/day 

for following 20 wks in a single 

dose. CBT as in G1 

G3: 100 mg/day for the first wk; 

100 mg bid for the second wk; 100 

mg tid for the next 20 wks. CBT as 

in G1 

G4: 20 mg/day for first wk; 40 

mg/day for second wk; 60 mg/day 

for following 20 wks in a single 

dose. Visits: once per mo. Therapy 

interrupted if serious adverse 

events. 

G5: 100 mg/day for the first wk; 

100 mg bid for the second wk; 100 

mg tid for the next 20 wks. Visits: 

once per mo. Therapy interrupted if 

serious adverse events. 

After the 24th wk, therapy ended. 

Drugs progressively decreased up

to discontinuation over a period of 

1 mo. No further tx or FU for 1 yr. 

Chi Square, ANOVA, 

Wilcoxin, MannWhitney U. No 

adjustment for 

multiple comparisons 

Data collected at end 

of tx (6 mos) and 1 yr 

FU 

Score: 

Poor 

Intent to treat: 

Yes 

Blinding: 

No 

Adverse events: 

G2: 6 (27.2%) (nausea: 4, 

insomnia: 3; anorgasmia: 1; 

vomiting; reduction in drug 

dose: 2 

G3: 6 (nausea: 5, 

hypersomnia: 2; diarrhea: 1; 

required reduction in drug 

dose: 3 

G4: 7 (nausea: 4; headache: 

3; vomiting: 2; insomnia: 1);

required reduction in drug 

dose: 4 

G5: 7 (nausea: 5; 

hypersomnia: 3; headache: 2; 

vomiting: 2); required a 

reduction in drug dose: 3 

Funding: 

NR 
C-670 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE total score, median: 

G1: 3.8 

G2: 3.8 

G3: 4.0 

G4: 3.4 

G5: 3.8 

(P = NR) 

EDE total score, median: 

Post-tx: 

G1: 3.4 (P < 0.01) 

G2: 2.7 (P < 0.01) 

G3: 2.7 (P < 0.01) 

G4: 3.8 (P = NS)

G5: 3.8; (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G3 better than G1 or G2 

1 yr FU: 

G1: 3.3 (P = NS) 

G2: 2.7 (P = NS)

G3: 2.6 (P = NS) 

G4: 3.9 (P = NS)

G5: 3.8 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Ricca, et al., 2001 

(continued) 

EDE Restraint, median: 

G1: 3.8

G2: 2.6 

G3: 3.3 

G4: 3.8 

G5: 3.5 

(P = NR)

EDE Restraint, median: 

Post-tx: 

G1: 2.9 (P < 0.01) 

G2: 2.7 (P = NS)

G3: 2.1 (P < 0.01) 

G4: 3.9 (P = NS)

G5: 3.4 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.01) 

G3 better than G1 or G2 

1 yr FU: 

G1: 2.8 (P = NS) 

G2: 2.7 (P = NS) 

G3: 2.1 (P = NS) 

G4: 3.9 (P = NS)

G5: 3.4 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)
C-671 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, median: 

G1: 22

G2: 16.5 

G3: 22 

G4: 20 

G5: 21 

(P = NR) 

BDI, median: 

Post tx: 

G1: 14 (P < 0.01) 

G2: 10.5 (P < 0.01)

G3: 10 (P < 0.01)

G4: 15 (P < 0.01) 

G5: 14 (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

1 yr FU: 

G1: 14 (P = NS) 

G2: 10.5 (P = NS)

G3: 10 (P = NS) 

G4: 16 (P = NS)

G5: 14 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

BMI: 

Post-tx: 

G1 - G5: Data presented in 

figure only 

G1: change (P < 0.01) 

G2: change (P < 0.01) 

G3: change (P < 0.01) 

G4: change (P = NS) 

G5: change (P = NS) 

Diff between groups (P = NR) 

Diff between G1, G2, G3 in 

change over time (P = NS) 

1 yr FU: 

G1 - G5: Data presented in 

figure only 

G1: change (P < 0.01) 

G2: change (P < 0.01) 

G3: change (P < 0.01) 

G4: change (P = NS) 

G5: change (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

STAI-State, median: 

G1: 46

G2: 47.5 

G3: 52 

G4: 46.2 

G5: 48.2 

(P = NR) 

STAI-State, median: 

Post tx: 

G1: 37 (P < 0.01)

G2: 45 (P = NS) 

G3: 32 (P < 0.01)

G4: 44.8 (P = NS)

G5: 34.1 (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.01) 

G3 better than G1 

1 yr FU: 

G1: 40 (P = NS) 

G2: 48 (P = NS)

G3: 32 (P = NS) 

G4: 50.5 (P < 0.01)

G5: 36.1 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 
C-672 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Eating concern, median: 

G1: 3.6

G2: 3.6 

G3: 4.4 

G4: 4.0 

G5: 3.8 

(P = NR)

EDE Eating concern, median: 

Post-tx: 

G1: 3.3 (P < 0.01) 

G2: 2.8 (P < 0.01) 

G3: 2.8 (P < 0.01) 

G4: 3.9 (P = NS)

G5: 3.7 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.01) 

G2 and G3 better than G1 

1 yr FU: 

G1: 3.3 (P = NS) 

G2: 2.8 (P = NS)

G3: 2.1 (P = NS) 

G4: 4.0 (P = NS)

G5: 3.7 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

Author, yr: 

Ricca, et al., 2001 

(continued) 

EDE Wt Concern, median: 

G1: 4.4

G2: 4.3 

G3: 4.2 

G4: 4.2 

G5: 4.3 

(P = NR)

EDE Wt Concern, median: 

Post-tx: 

G1: 3.7 (P < 0.01) 

G2: 2.9 (P < 0.01) 

G3: 3.2 (P < 0.01) 

G4: 4.1 (P = NS)

G5: 4.3 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

1 yr FU: 

G1: 3.6 (P = NS) 

G2: 2.9 (P = NS)

G3: 3.0 (P = NS) 

G4: 4.0 (P = NS)

G5: 4.2 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)
C-673 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

STAI-Trait, median: 

G1: 48

G2: 48 

G3: 52 

G4: 47.5 

G5: 49.6 

(P = NR) 

STAI-Trait, median: 

Post tx: 

G1: 44.5 (P < 0.01)

G2: 46 (P = NS) 

G3: 36 (P < 0.01)

G4: 46.8 (P = NS)

G5: 35 (P < 0.01) 

Diff between groups (P = NR) 

Diff between groups in change 

over time 

G3 better than G1(P < 0.01) 

G5 better than G1 (P < 0.01) 

1 yr FU: 

G1: 44 (P = NS) 

G2: 48 (P = NS)

G3: 36 (P = NS) 

G4: 47.1 (P = NS)

G5: 34.9 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 
C-674 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Shape Concern, median: 

G1: 3.3

G2: 3.2 

G3: 3.7 

G4: 3.6 

G5: 3.5 

(P = NR)

EDE Shape Concern, median: 

Post-tx: 

G1: 3.2 (P < 0.01)

G2: 2.8 (P < 0.01) 

G3: 2.9 (P < 0.01)

G4: 3.7 (P = NS)

G5: 3.6 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

1 yr FU: 

G1: 3.1 (P = NS) 

G2: 2.2 (P = NS)

G3: 3.1 (P = NS) 

G4: 3.8 (P = NS)

G5: 3.6 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

Author, yr: 

Ricca, et al., 2001 

(continued) 

Binge eating episodes /mo, mean 

(SD): 

G1: 18 (2.3) 

G2: 17 (3.1) 

G3: 18 (3.5) 

G4: 20 (4.3) 

G5: 20 (5.8) 

(P = NR)

Binge eating episodes /mo, mean (SD): 

Post-tx: 

G1: 8 (3.9) (P < 0.001) 

G2: 6 (4.6) (P < 0.001) 

G3: 8 (3.2) (P < 0.001)

G4: 19 (3.5) (P = NS) 

G5: 18 (2.4) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

1 yr FU: 

G1: 8 (5.1) (P = NS) 

G2: 7 (3.4) (P = NS) 

G3: 8 (2.4) (P = NS) 

G4: 21 (3.1) (P = NS) 

G5: 18 (1.7) (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-675 

Evidence Table 11. Medication plus behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-676 

Evidence Table 12. Behavioral intervention trials for binge eating disorder 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Agras et al., 1995 

Setting: 

Single center; 

outpatient: location: 

Stanford University 

School of Medicine 

Behavioral Medicine 

Program, Stanford, 

CA, USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of a 

12-wk CBT program for the 

tx of BED. Another primary 

goal is to evaluate whether 

the addition of 12 wks of IPT 

would improve primary BED 

outcomes among tx nonresponders. 

Groups: 

G1: CBT (N = 39) 

G2: Assessment only 

waitlist control (N = 11) 

Enrollment: 

• 262 potential subjects 

either referred to study 

or recruited via ads 

were phone screened 

• 89 invited for in-person 

diagnostic interview 

• 64 eligible for 

enrollment (14 did not 

complete baseline 

assessment) 

• 50 enrolled and 

randomized 

• 42 completers at 24 

wks (G1: N = 31; G2: N 

= 11) (P = NR) 

Age, mean (SD): 

Range: 24-65 

Total sample: 

47.6 (10.1) 

G1: NR 

G2: NR 

(P = NS) 

Sex: 

Female N (%): 

43 (86%) 

Race/ethnicity: 

NR 

Age of overwt onset, yrs, 

mean (SD): 

18.9 (12.8) 

Mean age of binge eating 

onset, yrs, mean (SD): 

21.1 (12.0) 

BMI, kg/m2

, mean (SD): 

Total sample: 37.1 (7.3) 

G1: NR 

G2: NR 

(P = NR) 
C-677 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met proposed criteria 

for BED (Walsh, 1992) 

Exclusion: 

Current involvement in 

a wt loss program; 

currently taking antidepressant meds or 

any med that could 

impact wt; current drug 

or alcohol abuse; 

current major 

psychiatric illness such 

as psychosis; hx of 

purging within the last 

6 mos; BMI < 27 (i.e., 

not requiring tx for 

overwt) 

Following clinical interview 

assessments, subjects randomized 

at a ratio of 4:1 to either a 12-wk 

CBT program or waitlist control. 

CBT: 12 90 minutes sessions wkly, 

based on manual developed by 

Telch, plus walking and nutritional 

ed. Subjects who met 3 criteria for 

successful response to CBT 

(stabilization or wt loss for at least 

the last 4 wks of tx; initiating a min 

aerobic exercise program such as 

walking for 30 m, 3 times per wk; 

and abstinence from binge eating for 

at least the last 2 wks of tx) were 

assigned to a 12-wk behavioral wt 

loss program. Those who did not 

meet the criteria for successful 

response after 12 wks of CBT were 

assigned to an additional 12 wks of 

IPT. IPT: group format, 90 minutes 

each using Wilfley (1993) design. 

Repeated measure 

MANOVAs to assess 

between group diffs 

on primary and 

secondary outcome 

variables; signal 

detection methods to 

explore predictors of 

tx response. 

Score: 

Poor 

Intent to treat: 

For some analyses as a 

comparison. Authors reported 

that comparing ITT vs. nonITT analyses revealed no 

Diffs, so non-ITT results 

reported. 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NIH 
C-678 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge days/wk, mean (SD): 

G1: 4.4 (1.8) 

G2: 3.7 (1.2) 

(P = NS) 

G1A: 4.2 (1.9) 

G1B: 4.5 (1.7) 

(P = NS) 

Binge days/wk, mean (SD): 

Wk 12 (end of tx) 

G1: 0.7 (1.0) (P = NR) 

G2: 3.4 (2.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Wk 24: 

G1: 1.0 (1.4) (P = NR) 

G2: 2.9 (2.0) (P = NR) 

Diff between groups (P = 0.0001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

BES, mean (SD): 

G1: 29.4 (6.7) 

G2: 25.2 (7.9) 

(P > 0.01) 

BES, mean (SD) 

Wk 12 (end of tx): 

G1: 18.1 (8.0) (P = NR) 

G2: 23.8 (6.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Wk 24: 

G1: 17.7 (7.1) (P = NS) 

G2: 24.9 (10.4) (P = NS) 

Diff between groups (P = 0.0001) 

G1 better than G2 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 1995 

(continued) 

TFEQ, mean (SD): 

Disinhibition: 

G1: 14.1 (1.6) 

G2: 13.6 (1.6) 

(P = NS) 

TFEQ, Disinhibition, mean (SD): 

Wk 12 (end of tx) 

G1: 12.1 (2.6) (P = NR) 

G2: 13.6 (1.7) (P = NR) 

Diff between groups (NR) 

Diff between groups in change over time (P = NR) 

Wk 24: 

G1: 10.9 (2.9) (P = NR) 

G2: 13.5 (1.1) (P = NR) 

Diff between groups (P = 0.004) 

G1 lower than G2 

Diff between groups in change over time (P = NR) 
C-679 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 14.6 (9.7) 

G2: 11.2 (6.8) 

(P = NS) 

BDI, mean (SD): 

Wk 12 (end of tx) 

G1: 11.5 (8.7) (P = NR) 

G2: 11.9 (6.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wk 24: 

G1: 10.5 (8.2) (P = NR) 

G2: 11.0 (8.3) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wt, kg, mean (SD): 

G1: 108 (26.7) 

G2: 106.1 (20.3) 

(P = NS) 

Wt, kg, mean (SD): 

Wk 12 (end of tx): 

G1: 109.4 (27.3) (P = NR) 

G2: 109.8 (23.1) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

Wk 24: 

G1: 107.4 (28) (P = NR) 

G2: 110.2 (22.8) (P = NR) 

Diff between groups (P = 0.02) 

G1 less than G2 

Diff between groups in change 

from wk 12 (P = NR) 

SCL-90, global, mean 

(SD): 

G1: 0.9 (0.7) 

G2: 0.8 (0.5) 

(P = NS) 

SCL-90, global, mean (SD): 

Wk 12 (end of tx) 

G1: 0.8 (0.5) (P = NR) 

G2: 0.8 (0.6) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

from baseline (P = NR) 

Wk 24: 

SCL-90, global mean (SD): 

G1: 0.6 (0.4) (P = NR) 

G2: 0.7 (0.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

 
C-680 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Hunger: 

G1: 10.1 (2.7) 

G2: 9.9 (3.5) 

(P = NS) 

Wk 12 (end of tx) 

Hunger: 

G1: 8.5 (2.6) (P = NR) 

G2: 10.0 (3.2) (P = NR) 

Diff between groups (NR) 

Diff between groups in change over time (P = NR) 

Wk 24: 

Hunger: 

G1: 7.5 (2.9) (P = NR) 

G2: 9.0 (3.7) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Restraint: 

G1: 7.0 (3.6) 

G2: 7.1 (3.8) 

(P = NS) 

Wk 12 (end of tx) 

Restraint: 

G1: 9.4 (3.3) (P = NR) 

G2: 7.8 (4.4) (P = NR) 

Diff between groups (NR) 

Diff between groups in change over time (P = NR) 

Wk 24: 

Restraint: 

G1: 10.5 (4.3) (P = NR) 

G2: 8.2 (4.8) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Agras et al., 1995 

(continued) 

Abstinence for at least 2 wks by wk 12 (%): 

G1: 55% 

G2: 9% 

Diff between groups (P < 0.008) 

G1 greater than G2 
C-681 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-682 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Eldredge et al., 1997 

Setting: 

Outpatient; Northern 

California, USA 

Enrollment period: 

NR 

Research objective: 

To assess the efficacy of 

CBT vs waitlist control in 

treating BED in obese 

individuals (additional 

analyses concerning 

extended tx for nonresponders not reported 

since patients not 

randomized). 

Groups: 

G1: CBT (N = 36) 

G2: Wl control (N = 10) 

Enrollment: 

• 75 scheduled for dx 

interview after meeting 

requirements of 

preliminary telephone 

screening 

• 10 subjects on waitlist for 

previous study reinterviewed 

• 46 enrolled 

• 37 remained at 24 wks 

Age, yrs, mean (SD): 

Total: 45.2 (9.8) 

G1: NR 

G2: NR 

(P = NS) 

Age of onset of overwt, 

yrs, mean (SD): 

Total: 15.8 (11.7) 

G1: NR 

G2: NR 

(P = NS) 

Age of onset of bingeeating, yrs, mean (SD): 

Total: 22.0 (13.7) 

G1: NR 

G2: NR 

(P = NS) 

Sex (N): 

Female: 44 

Male: 2 

Race/ethnicity: 

NR 

Wt, kg,mean (SD): 

Total: 106.8 (28.2) 

G1: NR 

G2: NR 

(P = NS) 
C-683 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV proposed 

criteria for BED; obese 

(BMI ≥ 27) 

Exclusion: 

Concurrent additional 

tx which might 

interfere with this study 

(i.e., wt loss program, 

anti-depressant meds, 

any meds that could 

influence wt); current 

drug or alcohol abuse; 

hx of purging within 

the last 6 mos; current 

major medical or 

psychiatric condition 

that could affect tx 

(i.e., pregnancy, 

psychosis, or severe 

suicidality). 

Randomly assigned according to 3.5 

to 1 ratio to 12-wks of group CBT or 

waitlist control. G1: randomly 

assigned to one of three identical tx 

groups. Subjects who met clinical 

criteria of success (i.e., abstinence 

of binge-eating for at least the last 2 

wks of tx, initiation of a min aerobic 

exercise program, and wt 

stabilization or wt loss for at least 

the last 4 wks of tx) by wk-12 were 

then provided with 12-wks of 

behavioral wt loss tx. Those who did 

not meet clinical criteria of success 

by the end of wk-12 received add 

12-wks of CBT. 

ANOVAs and 

repeated measures 

ANOVAs to assess 

between group diff for 

primary and 

secondary variables of 

interest 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

No 

Adverse events: 

NR 

Funding: 

NIH 
C-684 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BES mean: 

G1: 27.97 

G2: 29.38 

(P = NS) 

BES mean: 

G1: 17.07 (P = NR) 

G2: 20.88 (P = NR) 

Change over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

TFEQ restraint, mean: 

Restraint: 

G1: 8.52 

G2: 6.88 

(P = NS)

TFEQ scales mean: 

Restraint: 

G1: 11.26 (P = NR) 

G2: 9.38 (P = NR) 

Change over time (P < 0.0002) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

TFEQ Disinhibition mean: 

G1: 13.90 (NR) 

G2: 13.63 (NR) 

(P = NS)

TFEQ Disinhibition: 

G1: 10.94 (P = NR) 

G2: 12.63 (P = NR) 

Change over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

TFEQ Hunger mean: 

G1: 8.94 

G2: 9.5 

(P = NS)

TFEQ Hunger: 

G1: 6.65 (P = NR) 

G2: 9.63 (P = NR) 

Change over Time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

% decrease in # of binge eating days by 12-

wks, mean: 

G1: 68.2 

G2: 19.8 

Diff between groups (P = 0.046) 

G1 better than G2

Author, yr: 

Eldredge et al., 1997 

(continued) 

Treatment-responders by 12-wks: 

50% of the treated sample (N = 18)
C-685 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean: 

G1: 13.67 (NR) 

G2: 14.38 (NR) 

(P = NS) 

BDI, mean: 

G1: 9.17 (P = NR) 

G2: 7.88 (P = NR) 

Change over time (P = 0.002) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

BMI, kg/m2 mean: 

G1: 37.05 (NR) 

G2: 43.35 (NR) 

Diff between groups (P = NS) 

BMI, kg/m2

 mean 

G1: 36.29 (P = NR) 

G2: 44.73 (P = NR) 

Diff between groups 

(P = 0.03) 

G1 better than G2 

Diff between groups in 

change over time (P = NS)

GSI, mean: 

G1: 0.63 (NR) 

G2: 0.75 (NR) 

(P = NS)

GSI, mean at 12-wks: 

G1: 0.52 (P = NR) 

G2: 0.47 (P = NR) 

Change over time (P = 0.06) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-686 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Gorin et al., 2003 

Setting: 

Outpatient Wt Control 

and Diabetes 

Research Center, 

Providence, RI, USA 

Enrollment period: 

NR 

Research objective: 

To evaluate effects of 

spouse involvement in 

group CBT for BED and 

replicate previous literature 

on effectiveness of CBT for 

BED.

Groups: 

G1: Standard CBT (N = 32) 

G2: CBT-SI (N = 31) 

G3: Waitlist control group

(CG) (N = 31) 

Enrollment: 

• 896 women responded 

to an advertisement 

• 399 completed brief 

telephone screening 

• 109 invited to complete 

baseline assessment 

• 15 ineligible and 

excluded 

• 94 blocked by binge 

eating frequency and 

randomly assigned to 

one of three conditions

Age, yrs, mean (SD): 

45.20 yrs (10.03) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 86%
C-687 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women, aged 18-65, 

meeting DSM IV 

criteria for BED, 

having BMI > = 25 and 

having a spouse or 

cohabiting partner who 

is willing to participate 

in study. 

Exclusion: 

Engaged in binge 

purging behaviors > 

once a mo, met DSM 

IV criteria for AN, BN 

or EDNOS, receiving 

concurrent tx for wt 

loss, taking appetite 

suppressants and/or 

pregnant. 

G1: 90-minute group meetings (with 

6 – 11 participants per group) held 

once a wk for 12 wks. 8 advanced 

clinical psychology grad students 

served as co-leaders. Protocol 

based on a BED therapist manual 

created by Telch and Agras (1992). 

G2: standard CBT manual modified 

but tx goals the same; however, in 

CBT-SI goals included having both 

partners understand BED, perceive 

coping resources as available, 

agree about course of action and 

feel confident about ability to deal 

with BED. All partners required to 

attend all group meetings. In each 

session participants start by 

discussing eating problems and 

progress with their partners. 

Partners encouraged to participate 

in discussions. In add to regular 

homework, husbands set behavioral 

goals to assist wives in decreasing 

frequency of BE. 

G3: completed assessments at T1 

and T2 and then entered tx. FU 

assessments at 6 mos. 

For certain analyses 

data from standard 

CBT and CBT SI were 

combined (and called 

active CBT) to 

compare with control 

group. To ensure 

adequate power, the 

study’s apriori 

hypotheses were 

examined using 

planned orthogonal 

contrasts. For each 

set of planned 

orthogonal contrasts, 

group diffs were 

tested with mixed 

model ANOVA’s. 

Group diff on 

dichotomous variables 

assessed with chisquare tests. Two sets 

of comparisons were 

performed: active CBT 

(G1 + G2) versus 

waitlist (G3) and 

standard CBT (G1) 

versus CBT-SI (G2). 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

Dissertation grant from Society 

for Science of Clinical 

Psychology and funding from 

Applied Behavioral Medicine 

Research Institute. 
C-688 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Days binged (7-day recall) (SD): 

G1: 3.81 (1.66) 

G2: 3.41 (2.09) 

G3: 3.77 (1.82) 

(P = NS) 

Post-tx: 

Days binged (7-day recall) (SD): 

G1: 1.81 (1.97) (P = NR) 

G2: 1.18 (1.76) (P = NR) 

G3: 2.95 (1.84) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.04) 

G1 and G2 better than G3 

Diff between G1 and G2 (P = NR) 

Diff between G1 and G2 in change over time (P = NS) 

FU: 

Days binged (7-day recall) (SD): 

G1: 1.05 (1.43) (P = NR) 

G2: 0.67 (0.86) (P = NR) 

G3: Data not provided 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Gorin et al., 2003 

(continued) 

Objective Binge episodes (SD): 

G1: 7.61 (5.66) 

G2: 9.55 (6.09) 

G3: 8.47 (5.21) 

(P = NS) 

Objective Binge episodes (SD): 

G1: 2.44 (2.83) (P = NR) 

G2: 3.32 (4.35) (P = NR) 

G3: 5.87 (4.64) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Post tx: Standard CBT (G1) versus CBT-SI (G2) 

(*Means as above) 

Objective Binge episodes: 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU: 

Objective Binge episodes (SD): 

G1: 1.63 (2.09) (P = NR) 

G2: 3.50 (4.64) (P = NR) 

G3: Data not provided 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-689 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI (SD): 

G1: 18.71 (8.89) 

G2: 20.41 (9.96) 

G3: 17.41 (9.93) 

(P = NS) 

BDI (SD): 

G1: 14.76 (9.32) (P = NR) 

G2: 11.82 (9.42) (P = NR) 

G3: 16.77 (9.54) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P < 0.05) 

G1 and G2 better than G3 

Post tx: Standard CBT (G1) 

versus CBT-SI (G2) (*Means as 

above) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

FU (no data reported for waitlist

grp): 

G1: 12.89 (8.05) (P = NR) 

G2: 12.24 (9.23) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

Body Mass Index, mean 

(SD): 

G1: 38.72 (8.78) 

G2: 40.51 (8.29) 

G3: 39.37 (7.53) 

(P = NS) 

Body Mass Index, mean (SD): 

G1: 38.65 (8.51) (P = NR) 

G2: 40.37 (8.33) (P = NR) 

G3: 39.73 (7.79) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P < 0.05) 

G1 and G2 better than G3 

Post tx: Standard CBT (G1) 

versus CBT-SI (G2) (*Means as 

above) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 

FU (no data reported for waitlist 

grp): 

G1: 37.83 (8.84) (P = NR) 

G2: 39.74 (8.67) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over 

time (P = NS) 
C-690 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge abstinence (SD): 

G1+G2 (37%) (P = NR) 

G3 (9%) (P = NR) 

Diff between groups (P < 0.05) Active CBT higher 

percentage of abstinent participants. 

Diff between groups in change over time (P = NR) 

Post tx: Standard CBT (G1) versus CBT-SI (G2) 

(*Means as above): 

G1 (29%) (P = NR) 

G2 (46%) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

FU (no data reported for waitlist grp) 

FU: 

Binge abstinence (SD): 

G1 (47%) (P = NR) 

G2 (52%) (P = NR) 

G3: Data not provided 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Gorin et al., 2003 

(continued) 

TFEQ Restraint, mean (SD): 

G1: 9.24 (4.01) 

G2: 6.41 (2.91) 

G3: 7.32 (3.96) 

(P = NS) 

TFEQ Restraint, mean (SD): 

G1: 9.52 (4.30) (P = NR) 

G2: 8.41 (3.32) (P = NR) 

G3: 7.30 (4.73) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Post tx: Standard CBT (G1) versus CBT-SI (G2) 

(*Means as above) 

G1: diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

FU: 

G1: 12.11 (3.00) (P = NR) 

G2: 8.24 (3.00) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-691 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-692 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ Disinhibition, mean (SD): 

G1: 12.48 (1.89) 

G2: 13.14 (2.23) 

G3: 13.45 (1.26) 

(P = NS) 

TFEQ Disinhibition, mean (SD): 

G1: 10.86 (3.81) (P = NR) 

G2: 11.55 (3.05) (P = NR) 

G3: 13.23 (2.31) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G1 and G2 better than G3 

Post tx: Standard CBT (G1) versus CBT-SI (G2) 

(*Means as above): 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU (no data reported for waitlist grp): 

G1: 9.74 (3.87) (P = NR) 

G2: 11.00 (3.39) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Gorin et al., 2003 

(continued) 

TFEQ Hunger (SD): 

G1: 8.81 (3.64) 

G2: 10.77 (3.21) 

G3: 9.82 (2.68) 

(P = NS) 

TFEQ Hunger (SD): 

G1: 7.14 (3.88) (P = NR) 

G2: 9.23 (3.18) (P = NR) 

G3: 9.86 (3.47) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.05) 

G1 and G2 better than G3 

Post tx: Standard CBT (G1) versus CBT-SI (G2) 

(*Means as above) 

TFEQ Hunger: 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FU (no data reported for waitlist grp): 

TFEQ-hunger (SD): 

G1: 5.68 (3.62) (P = NR) 

G2: 8.71 (3.74) (P = NR) 

G3: Data not provided 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-693 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 

 
C-694 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Hilbert and TuschenCaffier, 2004 

Setting: 

Outpatient; 

Psychotherapeutic unit 

at University of 

Marburg, Germany. 

Enrollment period: 

NR 

Research objective: 

Compare CBT with CBT-E 

and CBT along with CBT-C 

Groups: 

G1: CBT-E (N = 14) 

G2: CBT-C (N = 14) 

Enrollment: 

• Recruited through ads for 

free group therapy. 

• 130 responded to ads 

and were screened for 

eligibility 

• 77 eligible and invited for 

initial contact. 

• 66 attended meeting 

• 34 remained interested 

• 2 excluded because of 

diagnostic status and 4 

did not return for later 

appointments. 

• Randomization after 

preparation for therapy. 

Age, yrs, mean (SD): 

G1: 42.1 (12.1) 

G2: 38.6 (8.5) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age of first binge, yrs, 

mean (SD): 

G1: 21.7 (14.7) 

G2: 18.7 (10.4) 

(P = NS) 

Duration of BED, yrs, mean 

(SD): 

G1: 13.5 (10.7) 

G2: 17.7 (13.2) 

(P = NS) 

Education: 

University degree: 

G1: 14.3% 

G2: 7.1% 

HS degree: 

G1: 35.7% 

G2: 50.0% 

Secondary school degree: 

G1: 50.0% 

G2: 42.9% 

(P = NS) 

Full syndrome BED: 

G1: 71.4% 

G2: 71.4% 

Subthreshold BED: 

G1: 28.6% 

G2: 28.6% 

(P = NS) 
C-695 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV criteria for 

BED except for 

frequency criterion 

(frequency of 1 day 

per wk over last 6 mos 

allowed) 

Exclusion: 

Pregnancy, presence 

of psychotic 

symptoms; substance 

dependence; 

suicidality; use of 

psychoactive meds or 

meds affecting body 

wt. 

19 wkly sessions within 5 mos and 

self-management phase of 3 

sessions. Sessions 2 hrs long and 

groups had 4 – 5 members. 

Therapy based on manualized tx 

for CBT for BN with emphasis on 

body image disturbance. All group

sessions conducted by a PhD level 

clinical psychologist. Nutritionist 

and physical therapist also 

provided services. In initial part of 

tx, focus was on causes and 

factors maintaining binge eating for 

the individual and included 

interventions aimed at increasing 

motivation for change. 

For CBT-C condition: participants 

trained and given homework on 

cognitive restructuring of neg body 

related cognitions. For exposure 

condition, multiple body exposure 

sessions, including in vivo mirror 

exposure to one’s whole body. 

Within both conditions, info and 

group discussions on body image, 

body wt, social aspects of obesity 

and exercise were conducted. 

Multivariate 

generalized linear 

models for repeated 

measures used. 

Univariate FU tests 

done for sig 

multivariate results. 

Nonparametric tests 

analyzed changes 

over time for tx diffs at 

each time point. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

N/A 

Adverse events: 

NR 

Funding: 

Deutshce 

Forschungsgemeinschaft DFG
C-696 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binges per wk in the past mo, mean 

(SD): 

G1: 2.9 (1.8) 

G2: 3.4 (1.9) 

(P = NS) 

Binges per wk in past mo, mean (SD): 

Post-tx: 

G1: 0.6 (0.7) 

G2: 1.0 (1.9) 

4 mo FU, mean (SD): 

G1: 1.2 (2.0) 

G2: 0.5 (1.0) 

Change over time (P = 0.045) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Binge episodes, %: 

G1: 16.7% 

G2: 16.7% 

(P = NS)

Binge episodes: 

Post-tx 

G1: 0% 

G2: 0% 

4 mo FU, mean (SD): 

G1: 0% 

G2: 16.6% 

Change over timeNR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Video confrontation, neg automatic 

thoughts on one’s body, mean (SD): 

G1: 13.3 (5.9)

G2: 17.4 (10.8) 

(P = NS) 

Video confrontation, neg automatic thoughts 

on one’s body, mean (SD): 

Post-tx: 

G1: 9.7 (7.7) 

G2: 13.7 (11.7) 

4 mo FU, mean (SD): 

G1: 8.8 (8.3) 

G2: 12.8 (7.0) 

Change over time (P < 0.05) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Hilbert and TuschenCaffier, 2004 

(continued) 

Test meal, mean (SD): 

G1: 5.0 (3.3) 

G2: 4.5 (3.2) 

(P = NS)

Test meal, neg automatic thoughts on eating, 

mean (SD): 

Post-tx: 

G1: 2.1 (1.5) 

G2: 6.7 (5.1) 

4 mo FU, mean (SD): 

G1: 2.8 (2.7) 

G2: 3.0 (2.3) 

Change over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-697 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 19.0 (8.6) 

G2: 16.0 (7.7) 

(P = NS) 

BDI, mean (SD): 

Post-tx 

G1: 12.8 (8.8) 

G2: 12.7 (9.0) 

4 mo FU, mean (SD): 

G1: 13.9 (8.7) 

G2: 12.3 (6.9) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI kg/m2, mean (SD): 

G1: 34.0 (10.2) 

G2: 36.4 (10.4) 

(P = NS) 

BMI, kg/m2, mean (SD): 

Post-tx: 

G1: 33.1 (10.4) 

G2: 37.2 (10.3) 

4 mo FU, mean (SD): 

G1: 33.6 (11.0) 

G2: 36.4 (11.0) 

Change over time (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 
C-698 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-Wt concern, mean (SD): 

G1: 3.2 (0.8) 

G2: 3.8 (1.1) 

(P = NS) 

EDE-Wt concern, mean (SD): 

Post-tx: 

G1: 2.3 (1.9) 

G2: 2.3 (1.5) 

4 mo FU, mean (SD): 

G1: 2.5 (1.7) 

G2: 2.2 (1.5) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

EDE- shape concern, mean (SD): 

G1: 3.7 (0.7) 

G2: 3.7 (1.2) 

(P = NS) 

EDE- shape concern, mean (SD): 

Post-tx: 

G1: 2.6 (1.6) 

G2: 2.3 (1.5) 

4 mo FU, mean (SD): 

G1: 2.8 (1.7) 

G2: 2.1 (1.3) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Body Satisfaction Questionnaire, 

mean (SD): 

G1: 120.7 (22.6) 

G2: 133.9 (20.0) 

(P = NS) 

Body Satisfaction Questionnaire, mean (SD): 

Post-tx: 

G1: 94.3 (37.8) 

G2: 104.8 (29.2) 

4 mo FU, mean (SD): 

G1: 92.2 (35.8) 

G2: 97.4 (31.9) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Hilbert and TuschenCaffier, 2004 

(continued) 

EDE-Restraint, mean (SD): 

Post-tx: 

G1: 0.9 (1.2) 

G2: 0.9 (1.2) 

4 mo FU, mean (SD): 

G1: 1.0 (1.2) 

G2: 1.1 (1.3) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-699 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-700 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE-eating concern, mean (SD): 

G1: 0.7 (0.8) 

G2: 1.1 (1.0) 

(P = NS) 

EDE-eating concern, mean (SD): 

Post-tx: 

G1: 0.2 (0.3) 

G2: 0.4 (0.6) 

4 mo FU, mean (SD): 

G1: 0.2 (0.3) 

G2: 0.4 (0.6) 

Change over time (P < 0.001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Hilbert and TuschenCaffier, 2004 

(continued) 

Recovered (abstinent for last 28 days): 

Post-tx: 

G1: 33.3% 

G2: 75% 

Diff between groups (P = NS) 

4 mo FU: 

G1: 50.0% 

G2: 66.7% 

Diff between groups (P = NS)
C-701 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-702 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Pendleton et al., 2002 

Setting: 

NR 

Enrollment period: 

NR 

Research objective: 

To evaluate the effects of 

adding exercise and 

maintenance to CBT for 

BED in obese women. 

Groups: 

G1: CBT with exercise and 

maintenance (N = 28) 

G2: CBT with exercise, 

without maintenance (N = 27) 

G3: CBT without exercise and 

with maintenance (N = 27) 

G4: CBT without exercise or 

maintenance (N = 28) 

Enrollment: 

• 114 enrolled 

• 26 did not return after 

baseline assessment: 

G1: N = 4 

G2: N = 7 

G3: N = 4 

G4: N = 11 

• 84 completed 6 mos 

Completion rate: 

1 in each group did not 

complete all assessments. 

G1: 24 

G2: 20 

G3: 23 

G4: 17 

Age, yrs, mean (SD): 

45 (8.3) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 76% 

Black: 13% Black 

Mexican Am: 8% 

Other: 3% 

(P = NS) 
C-703 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Female; age: 25-60; > 

30 lbs overwt; profile 

for BE as per QEWPR; hx of sedentary 

lifestyle and occ. Also - 

$200 deposit and 

physician clearance to 

participate. 

Exclusion: 

No hx of 

cardiovascular 

disease, diabetes, 

metabolic disorder, GI 

disorder/surgery; 

nonsmoker; not 

pregnant/lactating; not 

receiving tx for psych 

problems or major 

depression; no hx of 

drug abuse 

CBT: wkly 90-minutes group

sessions for 4 mos based on CBT tx 

for BED (based on Telch et al., 

1990) facilitated by experienced 

RDs. 

Exercise: info and instructions on 

incorporating and maintaining 

exercise in routine; provided 

membership to a center and 

encouraged to gradually increase 

aerobic exercise; expectations were 

at least 45 minutes per session, 3 x 

per wk (attendance was recorded). 

Maintenance: 12 biwkly meetings 

over 6 mos (mos 4-10; exercisers 

continued to meet and exercise, 

CBT only continued with sessions 

only). FU at 16 mos. 

ANOVA and chisquare for comparison 

of completers and 

noncompleters. 

Kruskal-Wallace 

ANOVA by ranks to 

analyze binge days. 

Repeated Msrs 

ANOVA for BMI. 

Bivariate correlations 

for exploratory 

analyses. 

Score: 

Poor 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

NR 

Funding: 

NIDDK 
C-704 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Pendleton et al., 2002 

(continued) 

Binge days, mean (SD): 

G1: 4.2 (2.3) 

G2: 4.6 (2.1) 

G3: 4.6 (1.9) 

G4: 4.8 (2.0) 

(P = NS) 

Binge Days, mean (SD): 

4 mos: 

G1: 0.6 (1.1) (P = NR) 

G2: 1.0 (1.3) (P = NR) 

G3: 2.4 (2.2) (P = NR) 

G4: 1.9 (2.0) (P = NR) 

Diff between groups (P = 0.004) 

Diff between G1 vs G4 (P = 0.039) 

G1 better than G4 

Diff between groups in change over time 

Exercisers (G1 + G2) > non-exercisers (G3 + G 4) (P = 0.001) 

Maintenance (G1 + G3) vs no maintenance (G2 + G4) (P = NS)

10 mos: 

G1: 0.5 (0.8) 

G2: 1.0 (1.3) 

G3: 1.3 (1.6) 

G4: 2.0 (1.6) 

Change over time (P = NR) 

Diff between groups (P = 0.018). diff between G1 vs G4: 

(P = 0.002) 

G1 better than G4 

Diff between groups in change over time 

Exercisers (G1 + G2) > non-exercisers (G3 + G 4) (P = 0.012) 

Maintenance (G1 + G3) vs no maintenance (G2 + G4) (P = NS).

16 mos: 

G1: 1.0 (1.7) (P = NR) 

G2: 0.8 (1.4) (P = NR) 

G3: 1.8 (2.2) (P = NR) 

G4: 2.5 (1.8) (P = NR) 

Change over time (P = NR) 

Diff between groups (P = 0.006) 

Diff between G1 vs G4 (P = 0.007); G1 better than G4 

Diff between groups in change over time 

Exercisers (G1 + G2) > non-exercisers (G3 + G 4) (P = 0.002) 

Maintenance (G1 + G3) vs no maintenance (G2 + G4) (P = NS)
C-705 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD): 

G1: 15.7 (9.7) 

G2: 18.1 (10.7) 

G3: 19.0 (10.5) 

G4: 18.0 (7.2) 

BDI, mean (SD): 

4 mos: 

G1: 6.4 (5.5) (P = NR) 

G2: 7.3 (7.8) (P = NR) 

G3: 9.7 (6.2) (P = NR) 

G4: 11.8 (9.6) (P = NR) 

Diff between groups NR 

G1 + G2 change over time (P = 0.007) 

10 mos: 

G1: 5.2 (5.1) (P = NR) 

G2: 11.0 (1.07) (P = NR) 

G3: 9.1 (8.1) (P = NR) 

G4: 8.7 (5.6) (P = NR) 

Diff between G1 vs G2: 

(P = 0.025) 

Diff between groups in change over 

time (P = NR) 

16 mos: 

G1: 5.1 (5.9) (P = NR) 

G2: 8.2 (8.6) (P = NR) 

G3: 8.0 (7.7) (P = NR) 

G4: 10.4 (8.2) (P = NR) 

Diff between G1 + G3 vs G2 + G4 

(P = NS) 

Diff between groups in change over 

time (P = NR) 

Wt: 

97.2 (17.8) kg 

BMI, kg/m2

, mean: 

36.2 (6.5) kg/m2 

(P = NS) 

Change in BMI (SD): 

4 mos: 

G1: -1.04 (2.1) (P = NR) 

G2: -0.46 (1.3) (P = NR) 

G3: -0.11 (1.2) (P = NR) 

G4: 0.77 (1.3) (P = NR) 

10 mos: 

G1: -2.53 (4.0) (P = NR) 

G2: -0.12 (16) (P = NR) 

G3: -83 (2.4) (P = NR) 

G4: 0.54 (2.0) (P = NR) 

16 mos: 

G1: -2.26 (3.9) (P = NR) 

G2: -0.75 (2.4) (P = NR) 

G3: -0.24 (3.0) (P = NR) 

G4: 1.33 (2.0) (P = NR) 

Change over entire period: G1 + 

G2 vs G3 + G4 (P = 0.004) 

G1 + G2 better than G3 + G4 

G1 + G3 vs G2 + G4 (P = 0.006). 

G1 + G3 better than G2 + G4. 

G1 vs G4 (P = 0.001) 

G1 better than G4 
C-706 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Pendleton et al., 2002 

(continued) 

 Abstinence (no binge days): 

4 mos: 

G1: 67% 

G2: 50% 

G3: 22% 

G4: 41% 

(P = NR) 

10: 

G1: 63% 

G2: 45% 

G3: 43% 

G4: 23% 

(P = NR)

16 mos: 

G1: 58% 

G2: 65% 

G3: 39% 

G4: 18% 

Diff between groups (P = NR) 
C-707 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-708 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Riva et al., 2003 

Setting: 

Inpatient; Eating 

Disorders Unit, Istituto 

Auxologico Italiano, 

Verbania, Italy 

Enrollment period: 

NR 

Research objective: 

To compare psychological 

and eating-related 

outcomes of ECT, CBT, NG, 

and waitlist control in 

patients with BED at 6 mo 

FU. 

Groups (N = 36): 

G1: ECT (N = NR) 

G2: CBT (N = NR) 

G3: NG (N = NR) 

G4: waitlist (N = NR) 

Enrollment: 

• 120 consecutive 

patients screened 

• 36 met criteria, and 

consented 

Age, mean (SD): 

33.07 (8.08) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Wt, kg, mean (SD): 

105.44 (17.73) 

Ht, cm, mean (SD): 

1.62 (0.06) 

BMI, kg/m2, mean (SD): 

39.80 (6.10) 
C-709 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Women aged 18 to 50; 

met DSM IV criteria for 

BED at least 6 mos; 

written and informed 

consent to participate 

Exclusion: 

Concurrent: severe 

psychiatric 

disturbance, 

involvement in other tx 

including meds, 

medical condition not 

related to BED 

Inpatient, lasting 6 wks; 

Assessments administered at 

baseline, post-tx, and 6 mo FU. 

NG: 5 wkly groups held by 

dieticians, low-calorie diet and 

physical training; ECT: NG plus 15 

additional, sessions over 6 wks (5 

wkly group, 10 bi-wkly VREDIM). 

CBT:NG plus 15 CBT sessions (5 

wkly group, 10 bi-wkly individual. 

Power analysis 

revealed low/medium 

power due to small 

sample and high SD. 

Accordingly, repeated 

and independent 

measures were 

assessed using 

marginal homogeneity 

test, an exact 

measure, nonparametric algorithm 

reliable with small, 

sparse or tied data. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

Commission of the European 

Communities (CEC); 

specifically, the IST program 

through the VEPSY Updated 

research project. 
C-710 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Riva, Bacchetta et al., 

2003 

(continued) 

NR 6 mo FU: 

Bulimia scores, EDI: 

G1: 9.33 

G2: 14.56 

G3: 18.11 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P < 0.05) 

G1 better than G2 and G3 

Diff between groups in change over time (P = NR) 

Resisting Temptations scores, DIET: 

G1: 19.11 

G2: 12.00 

G3: 10.89 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P < 0.05) 

G1 better than G2 and G3 

Diff between groups in change over time (P = NR) 

Body Satisfaction Scale, Total scores: 

G1: 8.5 

G2: 17.3 

G3: 16.2 

G4: NR 

Diff over time (P = NR) 

Diff between groups (P = < 0.05) 

G1 better than G2 and G3 

Diff between groups in change over time (P = NR) 

Abstinence, bingeing: 

G1: 77% 

G2: 56% 

G3: 22% 

G4: NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-711 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

State Anxiety scores, 

STAI X2: 

G1: 49.44 

G2: NR 

G3: 49.77 

G4: NR 

(P = NS) 

BDI scores: 

G1: 22.23 

G2: 20.55 

G3: NR 

G4: NR 

(P = NS) 

Post–tx: 

State Anxiety scores, 

STAI X2: 

G1: 36.77 (P = NS) 

G2: NR (P = NS) 

G3: 38.77 (P = 0.013) 

G4: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

BDI scores: 

G1: 8.11 (P = 0.008) 

G2: 12.11 (P = 0.05) 

G3: NR (P = NS) 

G4: NR (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NR) 

Wt, kg (SD): 

G1: 103.7 (17.2) 

G2: 109.3 (10.5) 

G3: 103.8 (21.3) 

G4: NR 

(P = NS) 

Post-tx: 

Wt, kg (SD): 

G1: 97.2 (15.6) (P = NR) 

G2: 102.1 (9.14) (P = NR) 

G3: 103.8 (21.3) (P = NR) 

G4: NR 

Diff over time (P = NR) 

reported as sig in text 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 

6 mo FU: 

G1: NR 

G2: NR 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NR) 
C-712 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Telch, Agras and 

Linehan, 2001 

Setting: 

Outpatient; Stanford 

University, USA 

Enrollment period: 

NR 

Research objective: 

Assess the efficacy of DBT 

tx compared to a waitlist 

control in women with BED. 

Groups: 

G1: DBT (N = 22) 

G2: Waitlist (N = 22) 

Enrollment: 

• 465 screened by 

telephone 

• 88 scheduled for 

clinical screening; 77 

attended 

• 44 enrolled and 

randomized 

• G1: 18 completed 

through 6-mo FU; G2:

14 accepted waitlist 

tx, and 10 completed. 

Age, mean (SD): 

50 (9.1) 

Age of drop-outs, mean 

(SD): 

Drop-outs: 41.0 (10.5) 

Non-drop-outs: 50. (9.2) 

(P < 0.04) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 94% 

Marital Status: 

Married: 47% 

Divorced: 35% 

Never married: 18% 

Educational Status: 

Completed college: 70% 

Completed HS: 100% 

Lifetime psychopathology: 

Major depression: 38% 

Anxiety disorders: 35% 

Psychotic disorders: 3% 

Bulimia nervosa: 6% 

Substance abuse or 

dependence: 27% 

Current psychopathology: 

Major depression: 9% 

Anxiety disorder: 18% 

Personality disorder: 27% 

Age of onset, binge eating, 

yrs, mean (SD): 

20.9 (11.7) 

Duration of binge eating, 

yrs, mean (SD): 

29.2 (11.7) 

BMI, kg/m2, mean (SD): 

36.4 (6.6) 
C-713 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Age 18 to 65; met full 

DSM IV diagnostic 

research criteria for 

BED 

Exclusion: 

Current involvement in 

psychotherapy, wt loss 

tx, or use of 

psychotropic meds; 

current substance 

abuse or dependence; 

current suicidality or 

psychosis; pregnancy 

Over 20 wks, tx was delivered at 

wkly, group 2hr sessions to teach 

DBT skills; tx manual was adapted 

from Linehan’s DBT for borderline 

personality disorder 

For all participants, assessments, 

and ht and wt measures were 

taken at baseline, post-tx (20 wks), 

3-, and 6-mo FU. 

T-test or chi-square 

analyses were 

completed to compare 

baseline measures, as 

well as dropouts 

versus tx completers; 

tx outcomes were 

assessed using a oneway ANCOVA with 

baseline measures as 

covariates. 

Analyses were 

restricted to those 

who completed tx. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

No 

Adverse events: 

During FU period, 3 women in 

G1 were treated with either 

psychotherapy or meds for a 

major depressive episode, and 

1 enrolled in a very-low-calorie 

diet program. 

Funding: 

NIMH 
C-714 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Note: Means are reported; square root 

transformations were used in 

analyses. 

Binge days, per 28 days, median 

(SD): 

G1: 10.5 (9.0) 

G2: 14.0 (5.0) 

(P = NS) 

Binge days, per 28 days, median (SD): 

G1: 0 (0) (P = NR) 

G2: 8.5 (10.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 better than G2 

Binge episodes, per 28 days, 

median (SD): 

G1: 11.5 (10.8) 

G2: 14.5 (7.5) 

(P = NS) 

Binge episodes, per 28 days, median (SD): 

G1: 0 (0) (P = NR) 

G2: 10.0 (14.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 better than G2 

EDE, Wt Concerns, median (SD): 

G1: 3.4 (1.1) 

G2: 3.6 (0.6) 

(P = NS) 

EDE, Wt Concerns, median (SD): 

G1: 2.2 (0.9) (P = NR) 

G2: 3.1 (1.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.02) 

G1 better than G2 

EDE, Shape Concerns (SD): 

G1: 3.7 (0.7) 

G2: 4.0 (0.8) 

(P = NS) 

EDE, Shape Concerns (SD): 

G1: 2.3 (0.9) (P = NR) 

G2: 3.1 (1.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.03) 

G1 better than G2 

EDE, Eating Concerns, median 

(SD): 

G1: 1.6 (1.1) 

G2: 1.8 (1.0) 

(P = NS) 

EDE, Eating Concerns, median (SD): 

G1: 0.4 (0.4) (P = NR) 

G2: 1.4 (0.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 better than G2 

EDE, Restraint, median (SD): 

G1: 1.6 (1.0) 

G2: 1.9 (1.1) 

(P = NS) 

EDE, Restraint, median (SD): 

G1: 1.4 (1.0) (P = NR) 

G2: 1.8 (1.3) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

Author, yr: 

Telch, Agras and 

Linehan, 2001 

(continued) 

BES, median (SD): 

G1: 28.8 (6.1) 

G2: 31.8 (6.0) 

(P = NS) 

BES, median (SD): 

G1: 15.7 (9.4) (P = NR) 

G2: 28.2 (8.3) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001) 

G1 better than G2
C-715 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, median (SD): 

G1: 12.8 (7.4) 

G2: 13.8 (9.1) 

(P = NS) 

BDI, median (SD): 

G1: 9.9 (10.0) (P = NR) 

G2: 12.8 (8.3) (P = NR) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

Wt, lbs, median (SD): 

G1: 214.7 (49.8) 

G2: 223.4 (37.1) 

(P = NS) 

Wt, lbs, median (SD): 

G1: 209.2 (49.8) (P = NR) 

G2: 223.8 (37.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

RSE, median (SD): 

G1: 26.0 (6.8) 

G2: 28.9 (5.0) 

RSE, median (SD): 

G1: 29.4 (6.1) 

G2: 29.2 (4.5) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = NS) 

 
C-716 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EES, Anxiety, median (SD): 

G1: 2.3 (0.9) 

G2: 2.7 (0.6) 

(P = NS) 

EES, Anxiety, median (SD): 

G1: 1.5 (0.9) (P = NR) 

G2: 2.4 (1.0) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Telch, Agras and 

Linehan, 2001 

(continued) 

EES, Depression, median (SD): 

G1: 3.0 (0.7) 

G2: 3.3 (0.7) 

(P = NS) 

EES, Depression, median (SD): 

G1: 2.4 (1.0) (P = NR) 

G2: 3.0 (0.8) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)
C-717 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-718 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wilfley et al., 2002 

Setting: 

Outpatient; Eating 

disorder clinics at 

Yale U and at San 

Diego State U, USA 

Enrollment period: 

NR 

Research objective: 

Compare effects of group

CBT and group IPT on 

overwt individuals with BED. 

Groups: 

G1: CBT (N = 81) 

G2: IPT (N = 81) 

Enrollment: 

• 974 individuals 

expressed interest 

• 320 met criteria based 

on phone screens 

• 195 met criteria after 

being interviewed 

• 162 interested, eligible 

and randomized 

• Participants randomly 

assigned to two groups 

of 9 participants each 

within 9 cohorts 

• 146 completed tx and 

some assessments 

• 133 completed all three 

FU CBT (N = 65); IPT 

(N = 68) 

Age, mean (SD): 

G1: 45.6 (9.6) 

G2: 44.9 (9.6) 

(P = NS) 

Sex: 

Female: 

G1: 82.7% 

G2: 82.7% 

(P = NS) 

Race/ethnicity: 

White: 

G1: 93.9% 

G2: 91.4% 

(P = NS) 

AA: 

G1: 3.7% 

G2: 3.7% 

(P = NS) 

Hisp: 

G1: 1.2% 

G2: 4.9% 

(P = NS) 

Native American: 

G1: 1.2% 

G2: 0% 

(P = NS) 

Age at onset of disorder, 

yrs, mean (SD): 

G1: 24.1 (13.5) 

G2: 25.7 (12.9) 

(P = NS) 

DSM III-R current Mood 

dx: 

G1: 25.9% 

G2: 18.5% 

(P = NS) 

DSM III-R current anxiety 

dx: 

G1: 12.3% 

G2: 13.6% 

(P = NS) 

DSM III-R current 

substance use dx: 

G1: 6.2% 

G2: 1.2% 

(P = NS) 
C-719 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV research criteria for 

BED: avg of ≥2 days of 

binge eating per wk for at 

least 6 mos, marked 

distress regarding binge 

eating, at least 3 of 5 

associated behavioral 

features (e.g., eating when 

not physically hungry), no 

regular use of inappropriate 

compensatory behavior, 

age: 18 – 65, BMI: 27 – 48 

kg/m2.

Exclusion: 

Pregnant or planning to 

become pregnant, taking wt 

affecting or psychotropic 

meds, psychiatric conditions 

warranting immediate tx 

(e.g., psychotic symptoms, 

substance dependence or 

suicidality) and currently 

enrolled in psychotherapy or 

wt loss program. 

Both: 20 90-minutes wkly 

group sessions and 3 

individual sessions. Wkly 

personalized written 

feedback detailing progress. 

Both groups manual-based 

and led by two therapists. 

G1: 3 phases focusing on 

behavioral strategies, 

cognitive skills and relapse 

prevention. G2: focused on 

problem resolution within 4 

social domains: Grief, 

interpersonal role disputes, 

role transitions and 

interpersonal deficits. 

GEE approach. Used to 

test hypotheses about tx 

effects, time course and tx 

x time interactions with 

linear, quadratic and cubic 

components of time as the 

within-subjects factors and 

tx and interactions between 

time components and tx as 

between-subjects factors. 

Primary analyses included 

post tx and FU time points 

for three primary outcomes: 

recovered (no objective 

binge episodes in the last 

mo), improved (fewer than 

4 days of objective binge 

episodes in the last mo) 

and being at or below a 

comparative level of eating 

disorder attitudes and 

behaviors. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

NIMH 
C-720 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Wilfley et al., 2002 

(continued) 

 Any current Axis I DSM III-R dx: 

G1: 37.0% 

G2: 29.6% 

(P = NS) 

Any current Axis II DSM III-R 

dx: 

G1: 37.0% 

G2: 38.3% 

(P = NS) 
C-721 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 
C-722 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wilfley et al., 2002 

(continued) 

Binge days, mean (SD): 

G1: 17.3 (6.9) 

G2: 16.3 (7.2) 

(P = NS) 

Binge days, mean (SD): 

Post tx 

G1: 0.6 (1.6) (P < 0.001) 

G2: 0.9 (2.0) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

4 mos post tx vs. post-tx: 

G1: 2.0 (4.6) (GEE quadratic: P < 0.001, GEE cubic: P = 0.002) 

G2: 1.5 (3.9) (GEE quadratic: P < 0.001, GEE cubic: P = 0.002) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

8 mos post tx vs. post-tx: 

G1: 2.1 (5.0) (GEE quadratic P < 0.001) 

GEE cubic (P = 0.002) 

G2: 1.9 (4.5) (GEE quadratic (P < 0.001) 

GEE cubic (P = 0.002) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

12 mos post tx vs. post-tx: 

G1: 1.7 (4.3) (P = NR) 

G2: 1.2 (2.6) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-723 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

Total GSI, mean (SD): 

G1: 43.3 (7.8) 

G2: 42.0 (8.9) 

(P = NS) 

Total GSI, mean (SD): 

Post tx: 

G1: 32.8 (8.8) (P < 0.001) 

G2: 32.3 (8.5) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

4 mos post tx: 

G1: 33.0 (8.4) 

G2: 33.2 (10.9) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

8 mos post tx 

G1: 31.9 (9.7) 

G2: 32.7 (10.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

12 mos post tx: 

G1: 32.0 (8.9) 

G2: 30.7 (10.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

BMI, mean (SD): 

G1: 37.4 (5.3) 

G2: 37.4 (5.1) 

(P = NS) 

BMI, mean (SD): 

Post tx 

G1: 37.5 (5.3) (P = NS) 

G2: 37.2 (5.2) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

4 mos post tx vs. post-tx: 

G1: 37.4 (5.3) 

G2: 36.6 (5.3) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

8 mos post tx vs. post-tx: 

G1: 37.5 (5.1) 

G2: 36.4 (5.5) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

12 mos post tx vs. post-tx: 

G1: 37.2 (5.1) 

G2: 36.3 (5.4) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Linear main effect of time since 

FU (P = 0.008) 
C-724 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Restraint, mean (SD): 

G1: 1.8 (1.2) 

G2: 2.1 (1.3) 

(P = NS) 

EDE Restraint, mean (SD): 

Post tx 

G1: 0.9 (0.9) (P = 0.001) 

G2: 1.5 (1.1) (P = 0.001) 

Diff between groups (P = 0.001) 

Diff between groups in change over time (P < 0.001) 

G2 better than G1 

4 mos post tx: 

G1: 0.9 (0.9) (P = 0.001) 

G2: 1.3 (1.2) (P = 0.001) 

Diff between groups (P = 0.04) 

Diff between groups in change over time (P = 0.04); 

G1 better than G2 

8 mos post tx: 

G1: 0.8 (0.8) (P = 0.001) 

G2: 1.2 (1.2) (P = 0.001) 

Diff between groups (P = 0.08) 

Diff between groups in change over time (P = 0.04) 

12 mos post tx: 

G1: 1.0 (1.1) 

G2: 1.3 (1.3) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = 0.04) 

Author, yr: 

Wilfley et al., 2002 

(continued) 

EDE Shape Concern, mean (SD): 

G1: 3.8 (1.0) 

G2: 3.8 (0.9) 

(P = NS) 

EDE Shape Concern, mean (SD): 

Post tx 

G1: 2.3 (1.4) (P < 0.001) 

G2: 2.4 (1.1) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

4 mos post tx: 

G1: 2.3 (1.2) (P = NS) 

G2: 2.4 (1.2); (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

8 mos post tx: 

G1: 2.3 (1.3) (P = NS) 

G2: 2.2 (1.2) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mos post tx: 

G1: 2.2 (1.3) (P = NS) 

G2: 2.2 (1.3) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-725 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

SCL Depression, mean 

(SD): 

G1: 44.3 (8.3) 

G2: 42.4 (9.6) 

(P = NS) 

SCL Depression, mean (SD): 

Post tx: 

G1: 34.8 (7.9) (P < 0.001) 

G2: 33.6 (8.6) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

4 mos post tx: 

G1: 34.2 (8.3) 

G2: 34.6 (10.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

8 mos post tx: 

G1: 33.3 (8.6) 

G2: 34.4 (10.7) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

12 mos post tx: 

G1: 33.1 (8.2) 

G2: 32.2 (10.3) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

 
C-726 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

EDE Wt Concern, mean (SD): 

G1: 3.3 (1.1) 

G2: 3.2 (1.1) 

(P = NS) 

EDE Wt Concern, mean (SD): 

Post tx 

G1: 2.0 (1.2) (P < 0.001) 

G2: 2.1 (1.2) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

4 mos post tx: 

G1: 2.0 (1.1) (P = NS) 

G2: 2.2 (1.3) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

8 mos post tx: 

G1: 2.1 (1.2) (P = NS) 

G2: 1.9 (1.1) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mos post tx: 

G1: 1.9 (1.3) (P = NS) 

G2: 1.9 (1.3) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Wilfley et al., 2002 

(continued) 

EDE Eating Concern, mean (SD): 

G1: 2.4 (1.2) 

G2: 2.3 (1.5) 

(P = NS) 

EDE Eating Concern, mean (SD): 

Post tx 

G1: 0.6 (0.8) (P < 0.001) 

G2: 0.7 (0.8) (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

4 mos post tx: 

G1: 0.6 (0.8) (P = NS) 

G2: 0.8 (1.0) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

8 mos post tx: 

G1: 0.6 (0.7) (P = NS) 

G2: 0.7 (0.9) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mos post tx: 

G1: 0.6 (0.8) (P = NS) 

G2: 0.6 (0.9) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-727 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-728 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Wilfley et al., 2002 

(continued) 

 Abstinence from binge-eating: 

Post tx 

G1: (82%) (P = NR) 

G2: (74%) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mos post tx: 

G1: (72%) (P = NR) 

G2: (70%) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-729 

Evidence Table 12. Behavioral intervention trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-730 

Evidence Table 13. Self-help trials for binge eating disorder 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Carter and Fairburn, 

1998 

Setting: 

Single center; 

outpatient; Dept. of 

Psychiatry, University 

of Oxford, UK 

Enrollment period: 

NR 

Research objective: 

To assess effectiveness 

of two self-help

programs for treating 

BED symptoms in 

comparison to a waitlist 

control. In addition to 

evaluating changes in 

eating- and wt-related 

outcomes, authors 

investigated potential 

group diffs in overall 

psychiatric symptom 

reporting and in 

knowledge of the 

educational content of 

the self-help materials. 

Groups: 

G1: guided self-help (N = unclear)

G2: pure self-help (N = unclear) 

G3: waitlist control (N = unclear) 

Enrollment: 

• 234 potential subjects 

responded to media 

advertisements and received 

an initial phone screen 

• 91 were invited for an inperson assessment interview 

• 72 were enrolled and 

randomized into the two selfhelp tx conditions 

• 65 remained after 12 wks (G1 

= 8 and G3 = 1; P = NR) 

* Group numbers inconsistent in 

text and figures: text indicates 72 

randomized; tables and figures 

refer to total N = 93. 

Age, yrs mean (SD) 

(range): 

Total Sample: 

39.7 (10.0) (21-59) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 97% 

Age of onset, yrs, mean 

(SD): 

23.6 (11.1) 

(P = NS) 

Medically obese (BMI>30): 

60% 

(P = NS) 

Marital Status: 

Married or cohabitating: 63%

Divorced: 12% 

Widowed: 3% 

Single: 22% 

Employed: 

67% 
C-731 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

DSM IV and EDE 

criteria for BED 

including wkly 

objective BE over the 

last 3 mos without 

compensatory 

behaviors; aged: 18-65 

Exclusion: 

Pregnancy; medical 

disorder or tx known to 

impact eating or wt; 

BN or AN; previous tx 

for binge-eating; 

current psychiatric tx 

12 wks of a guided self-help or a 

pure cognitive-behavioral self-help

program for binge-eating; In the 

pure self-help condition, subjects 

sent a copy of Overcoming Binge 

Eating and asked to follow program 

as best as possible on their own; In 

the guided self-help, subjects 

received 6-8 25-minute sessions 

with trained facilitator who provided 

assistance in adhering to the 

program outlined in Overcoming 

Binge Eating; Outcome variables 

assessed after 12 wks of tx in all 3 

groups, and at 3-mo, and 6-mo FU 

for the two tx groups only. 

Primary analyses 

included repeated 

measures ANOVAs 

and post-hoc 

comparisons to test 

between group diffs 

over course of the 

study; Chi-square 

tests used to test 

between group diffs in 

remission/abstinence 

rates. 

Score: 

Good 

Intent to treat: 

Yes 

Blinding: 

NA 

Adverse events: 

NR 

Funding: 

Wellcome Prize Studentship

and Wellcome Principal 

Fellowship 
C-732 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge eating/28 days, mean (SD): 

G1: 17.8 (10.6) 

G2: 19.7 (12.9) 

G3: 21.6 (12.5) 

(P = NS) 

Binge eating/28 days, mean (SD): 

12 wks (end of tx) 

G1: 4.3 (7.8) (P = 0.01) 

G2: 9.3 (11.7) (P = 0.01) 

G3: 13.5 (10.3) (P = NS) 

Diff between groups 

G1 vs G3 (P = 0.001) 

G1 better than G3 

G2 vs G3 (P < 0.05) G2 better than G3 

G1 vs. G2 (P = NS) 

Diff between groups in change over time (P = NR) 

3-mos: 

G1: 3.6 (3.5) (P = NS) 

G2: 5.0 (4.3) (P = NS) 

G3: NA 

(P = NR) 

G1 better than G2 

Diff between groups in change over time (P = NS) 

6-mos: 

G1: 3.7 (4.2) (P = NR) 

G2: 4.7 (4.0) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

G1 better than G2 

Diff between groups in change over time (P = NS) 

Author, yr: 

Carter and Fairburn, 

1998 

(continued) 

Abstinence/cessation rates: 

12 wks (end of tx) 

G1: 50% 

G2: 43% 

G3: 8% 

Diff between groups 

G1 vs G3 (P = 0.001) 

G1 better than G3 

G2 vs G3 (P = 0.008) 

G2 better than G3 

3-mos: 

G1: 41% 

G2: 37% 

G3: NA 

Diff between groups (P = NS) 

6-mos: 

G1: 50% 

G2: 40% 

G3: NA 

Diff between groups (P = NS) 
C-733 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

GSI, mean (SD): 

G1: 0.9 (0.6) 

G2: 1.3 (0.8) 

G3: 1.2 (0.8) 

(P = NS) 

GSI, mean (SD): 

12 wks (end of tx): 

G1: 0.7 (0.6) (P = 0.01) 

G2: 0.8 (0.6) (P = 0.01) 

G3: 1.2 (0.7) (P = NS) 

Diff between groups 

G1 vs G3 (P = 0.003) 

G1 better than G2 

G2 vs G3 (P = 0.04) 

G1 better than G3 

G1 vs G2 (P = NS) 

Diff between groups in change 

over time (P = NS) 

3-mos: 

G1: 1.6 (1.4) (P = NR) 

G2: 1.7 (1.5) (P = NR) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

6-mos: 

G1: 1.5 (1.4) (P = NR) 

G2: 1.8 (1.5) (P = NR) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Wt, kg, mean (SD): 

Total sample: 85.8 (19.7) 

G1: NR 

G2: NR 

Wt, kg, mean (SD): 

G1: NR 

G2: NR 

 BMI kg/m2, mean (SD): 

G1: 32.2 (6.4) 

G2: 30.6 (6.6) 

G3: 31.5 (6.6) 

(P = NS) 

BMI kg/m2

, mean (SD): 

12 wks (end of tx): 

G1: 31.7 (6.1) (P = NR) 

G2: 30.7 (6.6) (P = NR) 

G3: 31.9 (7.4) (P = NR) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

3-mos: 

G1: 30.8 (5.9) (P = NR) 

G2: 29.4 (5.6) (P = NR) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

6-mos: 

G1: 31.6 (6.2) (P = NR) 

G2: 30.4 (6.5) (P = NR) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-734 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Carter and Fairburn, 

1998 

(continued) 

Global EDE, mean (SD): 

G1: 3.6 (0.8) 

G2: 3.7 (0.8) 

G3: 3.6 (1.0) 

(P = NS) 

Global EDE, mean (SD): 

12 wks (end of tx) 

G1: 2.1 (1.2) (P = 0.01) 

G2: 2.7 (1.3) (P = 0.01) 

G3: 3.5 (0.8) (P = NR) 

Diff between groups 

G1 vs G3 (P = 0.001) 

G1 better than G3 

G2 vs G3 (P = 0.03) 

G2 better than G3 

G1 vs. G2 (P = NS) 

Diff between groups in change over time (P = NR) 

3-mos: 

G1: 2.1 (1.3) (P = NS) 

G2: 2.6 (1.5) (P = NS) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

6-mos: 

G1: 2.4 (1.3) (P = NS) 

G2: 2.6 (1.5) (P = NS) 

G3: NA 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

 Restraint, mean (SD): 

G1: 2.5 (1.4) 

G2: 2.4 (1.5) 

G3: 2.4 (1.4) 

(P = NS) 

Restraint, mean (SD): 

12 wks (end of tx) 

G1: 1.2 (1.3) (P = 0.01) 

G2: 2.1 (1.4) (P = NS) 

G3: 2.6 (1.4) (P = NS) 

Diff between groups 

G1 vs G3 (P = 0.002) 

G1 better than G3 

G1 vs. G2 (P = 0.006) 

G1 better than G2 

G2 vs G3 (P = NS) 

Diff between groups in change over time (P = NR) 

G1 > G2, G3 

3-mos: 

G1: 1.0 (1.0) (P = NS) 

G2: 1.9 (1.6) (P = NS) 

G3: NA 

Diff between groups 

G1 vs G2 (P = 0.01) 

G1 better than G2 

6-mos: 

G1: 1.3 (1.2) (P = NR) 

G2: 2.0 (1.6) (P = NR) 

G3: NA 

Diff between groups 

G1 vs G2 (P = NS) 
C-735 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-736 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Eating Concern, mean (SD): 

G1: 3.4 (1.2) 

G2: 3.5 (1.0) 

G3: 3.6 (1.3) 

(P = NS) 

Eating Concern, mean (SD): 

12 wks (end of tx) 

G1: 1.4 (1.3) (P = NR) 

G2: 2.0 (1.6) (P = NR) 

G3: 3.7 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

3-mos: 

G1: 1.6 (1.5) (P = NR) 

G2: 2.2 (1.7) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

6-mos: 

G1: 1.8 (1.5) (P = NR) 

G2: 2.2 (1.6) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Carter and Fairburn, 

1998 

(continued) 

Shape Concern, mean (SD): 

G1: 4.8 (1.0) 

G2: 4.9 (0.8) 

G3: 4.8 (1.3) 

(P = NS) 

Shape Concern, mean (SD): 

12 wks (end of tx) 

G1: 3.3 (1.5) (P = NR) 

G2: 3.7 (1.6) (P = NR) 

G3: 4.6 (0.9) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

3-mos: 

G1: 3.3 (1.6) (P = NR) 

G2: 3.6 (1.8) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

6-mos: 

G1: 3.6 (1.6) (P = NR) 

G2: 3.7 (1.7) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 
C-737 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-738 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Carter and Fairburn, 

1998 

(continued) 

Wt Concern, mean (SD): 

G1: 3.8 (1.0) 

G2: 4.0 (1.1) 

G3: 3.6 (1.3) 

(P = NS)

Wt Concern, mean (SD): 

12 wks (end of tx) 

G1: 2.5 (1.6) (P = NR) 

G2: 3.1 (1.4) (P = NR) 

G3: 3.7 (1.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

3-mos: 

G1: 2.6 (1.5) (P = NR) 

G2: 2.8 (1.7) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)

6-mos: 

G1: 2.8 (1.5) (P = NR) 

G2: 2.7 (1.7) (P = NR) 

G3: NA 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR)
C-739 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-740 

Evidence Table 13. Self-help trials for binge eating disorder (continued)

Study Description Objective Design 

Patient 

Characteristics 

Author, yr: 

Peterson et al., 2001 

Setting: 

Eating disorders 

research clinic, 

University of 

Minnesota, 

Minneapolis, USA 

Outpatient 

Enrollment period: 

NR 

Research objective: 

To compare the short 

and long-term 

outcomes of three 

models of delivery of 

group CBT for 

patients with BED. 

Groups: 

G1: Therapist led (TL) (N = 16)

G2: Partial self-help (PSH) (N = 19) 

G3: Structured self-help (SSH) (N = 16) 

Enrollment: 

• screened by phone for eligibility 

• Potential participants attended 

orientation session and completed 

self-report questionnaires 

• Participants scheduled for 

assessment session for structured 

interviews 

• Participants assigned to one of four 

conditions with group size ranging 

from 4 to 10 (avg = 6) 

• Total of ten groups conducted at 

different time points 

• Of 51 participants, 44 completed 8 

wks of tx. 

Age, mean (SD): 

Total sample: 42.9 

yrs (10.1) 

G1: NR 

G2: NR 

G3: NR 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 96% 

African American: 2% 

Native American: 2% 

G1: NR 

G2: NR 

G3: NR 

(P = NS) 
C-741 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met criteria for BED as 

listed in appendix for 

disorders warranting 

further investigation in 

the DSM IV using the 

SCID-patient version. 

Exclusion: 

Taking any current 

psychoactive meds or 

involved in 

psychotherapy; 

substance abuse or 

dependence within 6 

mos prior to enrollment 

in study, medical 

instability and acute 

risk of self-injury; met 

criteria for full or 

subthreshold BN, i.e., 

individuals who 

engaged in any 

compensatory 

behaviors in last six 

mos, including selfinduced vomiting, 

abuse of diuretics or 

laxatives, fasting or 

excessive exercise 

For all participants, active tx 8 

wks. Tx modified from manualbased CB intervention for BN. 

All participants given detailed 

manual that included 

psychoeducational materials 

and homework assignments. 

Included 14 one-hour sessions 

held twice wkly in the first 6 

wks and wkly for final two wks. 

Each session included: 

psychoeducational info for the 

first 30 minutes and a 

discussion focusing on review 

of homework assignment for 

the second 30 min. 

Groups not conducted 

simultaneously. G1:

psychologist provided 

psychoeducational info and led 

group discussion and 

homework review. In G2:

participants viewed videotape 

of psychologist delivering 

psychoeducational info 

followed by psychologist 

joining group and leading 

discussion in second 30 min. 

In G3: participants watched 

videotape and led their own 

discussion and review of 

homework, were given 

detailed list of discussion 

topics and group members 

facilitated discussion on 

rotating basis. The videotapes 

viewed by G2 and G3 were 

filed during the TL condition 

psychoeducational 

component. 

ANOVA and chisquare analyses used 

to compare groups on 

baseline demographic 

variables. A mixed 

effects model used to 

evaluate group, time 

and group x time 

interaction for the 

primary and 

secondary outcome 

variables. Chi-square 

analyses used to 

evaluate outcome 

based on SCID dx at 

post and FU 

assessments as well 

as on abstinence 

rates. 

Score: 

Fair 

Intent to treat: 

No 

Blinding: 

NA 

Adverse events: 

None reported 

Funding: 

McKnight Foundation; Minnesota 

Obesity Center; NIH; 

Neuropsychiatric Research 

Institute 
C-742 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

Objective Binge Episodes – based 

on Eating Behavior – IV (SD): 

G1: 3.4 (1.7) 

G2: 5.5 (6.7) 

G3: 2.9 (2.2) 

(P = NR) 

Objective binge episodes, mean (SD): 

Post tx: 

G1: 0.6 (1.4) (P = NR) 

G2: 0.7 (1.5) (P = NR) 

G3: 0.7 (2.2) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

G1: 0.8 (1.1) (P = NR) 

G2: 1.1 (2.5) (P = NR) 

G3: 0.9 (1.6) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 0.7 (0.9) (P = NR) 

G2: 0.4 (0.7) (P = NR) 

G3: 1.7 (3.9) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 0.5 (0.8) (P = NR) 

G2: 1.1 (2.7) (P = NR) 

G3: 1.0 (2.0) (P = NR) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-743 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI, mean (SD) 

G1: 15.5 (9.9) 

G2: 11.1 (9.1) 

G3: 13.5 (9.5) 

(P = NR) 

BDI, mean (SD) 

Post tx: 

G1: 10.5 (9.9) 

G2: 5.6 (3.6) 

G3: 9.0 (8.1) 

Diff over time: (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

One mo FU: 

G1: 6.6 (7.2) 

G2: 5.7 (4.6) 

G3: 6.4 (7.3) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Six mo FU: 

G1: 6.4 (7.0) 

G2: 6.3 (5.6) 

G3: 6.9 (6.0) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

12 mos FU: 

G1: 7.8 (8.1) 

G2: 3.9 (3.7) 

G3: 6.6 (7.4) 

Diff over time (P = 0.001) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

BMI kg/m2

, mean (SD): 

Total sample: 34.1 

(7.04) 

G1: 32.6 (8.2) 

G2: 35.8 (6.0) 

G3: 33.6 (7.0) 

(P = NR) 

BMI, kg/m2

, mean (SD) 

Post tx: 

G1: 32.5 (8.9) 

G2: 36.2 (5.5) 

G3: 32.4 (7.2) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

One mo FU: 

G1: 31.5 (9.0) 

G2: 35.8 (5.7) 

G3: 33.3 (7.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

Six mo FU: 

G1: 30.2 (7.7) 

G2: 36.2 (6.5) 

G3: 32.0 (8.6) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 

12 mo FU: 

G1: 31.2 (7.9) 

G2: 35.8 (7.0) 

G3: 32.8 (7.4) 

Diff between groups (P = NS) 

Diff between groups in change 

over time (P = NS) 
C-744 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Total binge episodes, mean (SD): 

G1: 8.3 (3.1) 

G2: 9.2 (6.7) 

G3: 6.6 (2.2) 

(P = NR) 

Total binge episodes, mean (SD): 

Post tx: 

G1: 2.8 (3.2) 

G2: 2.0 (3.4) 

G3: 2.4 (6.6) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

G1: 4.4 (4.0) 

G2: 3.7 (5.5) 

G3: 1.2 (1.6) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 3.7 (3.9) 

G2: 3.2 (3.0) 

G3: 3.0 (3.6) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 3.5 (3.4) 

G2: 3.1 (4.8) 

G3: 3.3 (3.6) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Peterson et al., 2001 

(continued) 

Body Shape Questionnaire (BSQ) 

(SD) 

G1: 140.6 (40.0) 

G2: 141.1 (28.0) 

G3: 127.7 (25.5) 

Body Shape Questionnaire (BSQ), mean (SD) 

G1: 108.4 (45.3) 

G2: 113.7 (26.9) 

G3: 110.2 (23.8) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

G1: 92.2 (28.7) 

G2: 112.9 (27.5) 

G3: 103.5 (28.6) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 94.0 (30.5) 

G2: 113.9 (23.0) 

G3: 103.7 (23.2) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 91.1 (36.4) 

G2: 109.9 (33.0) 

G3: 105.2 (24.1) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-745 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS, mean (SD) 

G1: 13.3 (7.3) 

G2: 8.8 (6.9) 

G3: 7.7 (5.9) 

(P = NR) 

HDRS, mean (SD) 

Post tx: 

G1: 10.5 (7.3) 

G2: 4.8 (3.3) 

G3: 8.0 (6.4) 

Diff over time (baseline to post tx) (P = 0.03) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

One mo FU: 

G1: 7.6 (3.7) 

G2: 6.3 (4.9) 

G3: 7.0 (7.0) 

Diff over time (baseline to 1 mo) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

Six mo FU: 

G1: 6.5 (4.4) 

G2: 7.7 (7.9) 

G3: 5.5 (4.6) 

Diff over time (baseline to 6 mos) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

12 mos FU: 

G1: 9.9 (8.6) 

G2: 3.8 (3.9) 

G3: 6.2 (4.7) 

Diff over time (baseline to 12 mos) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS)

 
C-746 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

Hours binged, mean (SD): 

G1: 9.0 (6.6) 

G2: 13.5 (13.4) 

G3: 10.0 (5.4) 

(P = NR) 

Hours binged, mean (SD): 

Post tx: 

G1: 2.6 (3.2) 

G2: 2.1 (3.4) 

G3: 3.2 (8.9) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

Hours Binged (SD): 

G1: 3.0 (2.4) 

G2: 3.8 (5.8) 

G3: 2.5 (3.8) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

Hours binged (SD): 

G1: 2.3 (2.3) 

G2: 3.0 (2.5) 

G3: 3.6 (5.0) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

Hours binged (SD) 

G1: 2.4 (1.8) 

G2: 2.8 (4.6) 

G3: 4.5 (5.2) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-747 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-748 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

Percent abstinent from objective 

binge for last wk: 

G1: 0% 

G2: 0% 

G3: 0% 

(P = NR) 

Percent abstinent from Objective Binge for last wk: 

Post tx: 

G1: 78.6% 

G2: 75.0% 

G3: 90.0% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

One mo FU: 

G1: 54.5% 

G2: 69.2% 

G3: 63.6% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Six mo FU: 

G1: 55.6% 

G2: 70.0% 

G3: 75.0% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 66.7% 

G2: 84.6% 

G3: 75.0% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-749 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-750 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

TFEQ Restraint, mean (SD): 

G1: 8.9 (4.8) 

G2: 8.4 (4.2) 

G3: 8.4 (4.4) 

(P = NR) 

TFEQ Restraint, mean (SD): 

Post tx: 

G1: 8.4 (3.5) 

G2: 10.2 (4.3) 

G3: 8.4 (3.9) 

Diff over time (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

G1: 9.2 (3.7) 

G2: 10.2 (4.1) 

G3: 9.3 (4.0) 

Diff over time (baseline to 1 mo) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 9.1 (4.6) 

G2: 10.1 (3.8) 

G3: 9.7 (5.1) 

Diff over time (baseline to 6 mos) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 8.2 (3.2) 

G2: 10.8 (5.0) 

G3: 10.2 (5.6) 

Diff over time (baseline to 1 mo) (P = NS) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-751 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-752 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

TFEQ Disinhibition (SD): 

G1: 13.6 (2.0) 

G2: 13.7 (2.3) 

G3: 13.9 (1.7) 

(P = NR) 

TFEQ Disinhibition (SD): 

Post tx: 

G1: 10.9 (2.7) 

G2: 11.2 (2.4) 

G3: 10.9 (3.9) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU: 

G1: 9.7 (3.1) 

G2: 12.3 (2.2) 

G3: 10.8 (3.5) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 9.8 (2.6) 

G2: 12.4 (2.2) 

G3: 10.7 (3.4) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 11.1 (2.6) 

G2: 10.0 (3.2) 

G3: 11.2 (3.6) 

Diff over time (P < 0.001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 
C-753 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-754 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

TFEQ Hunger, mean (SD): 

G1: 10.9 (3.2) 

G2: 8.7 (3.7) 

G3: 9.7 (3.8) 

(P = NR) 

TFEQ Hunger, mean (SD): 

Post tx: 

G1: 7.3 (3.3) 

G2: 6.9 (2.5) 

G3: 7.7 (4.7) 

Diff over time (P < 0.0001) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

One mo FU:) 

G1: 6.8 (3.7) 

G2: 8.3 (3.2) 

G3: 7.3 (5.1) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Six mo FU: 

G1: 7.4 (3.5) 

G2: 9.8 (3.3) 

G3: 7.1 (5.0) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

12 mo FU: 

G1: 8.4 (3.7) 

G2: 8.4 (4.0) 

G3: 7.2 (5.2) 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Peterson et al., 2001 

(continued) 

 Abstinent from objective binge episodes: 

Post tx: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

One mo FU: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Six mo FU: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

12 mo FU: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-755 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-756 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Author, yr: 

Peterson et al., 2001 

(continued) 

 Abstinent from total binge episodes: 

Post tx: 

Data: NR 

Diff between groups (P = 0.05) 

G3 > G1 and G2 

Diff between groups in change over time (P = NR) 

One mo: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

Six mo FU: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 

12 mo FU: 

Data: NR 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-757 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-758 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Peterson et al., 1998 

Setting: 

Single center; 

outpatient; University 

of Minnesota, 

Minneapolis, MN, 

USA 

Enrollment period: 

NR 

Research objective: 

Compare the efficacy 

of a therapist-led 

versus self-guided 

group CBT 

interventions for BED 

Groups: 

G1: Therapist-led (N = 16) 

G2: Partial self-help (N = 19) 

G3: Structured self-help (N = 15) 

G4: Waitlist control (N = 11) 

Enrollment: 

• 238 screened who were 

recruited through newspaper 

ads 

• 61 randomized (50 total to the 

active conditions) 

• 42 participants from the active 

conditions (G1, G2, and G3) 

remained at 8 wks, no sig diff in 

rate of retention 

Age, yrs, mean (SD): 

Total sample: 42.4 (10.2) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 96.5% 

(P = NS) 

Education: 

College-educated: 

51.7% 

(P = NS) 

Marital status: 

Married: 46.4% 

Divorced: 30.4% 

Never married: 19.6% 

Other: 3.6% other 

(P = NS) 
C-759 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Met DSM IV criteria for 

BED 

Exclusion: 

Receiving current 

psychotropic meds or 

psychotherapy; 

substance abuse or 

dependence within the 

past 6 mos; assessed 

to be medically 

unstable or at risk of 

self-injury; engaged in 

compensatory 

behaviors (e.g., selfinduced vomiting, 

laxative or diuretic 

abuse, excessive 

exercising or fasting) 

within the last six mos 

Tx: manualized 8 wk-14 session CBT 

protocol adapted for BED. Subjects 

randomized in groups to waitlist, 

therapist-led, partial self-help, or 

structured self-help conditions. All 

groups met twice wkly for first six wks 

then wkly for final 2 wks. All 1 hr. 

sessions divided into two 30 minute 

parts: 1) reviewing psychoed material 

related to improving BED symptoms 

and 2) discussion and review of 

homework. In partial and structured 

self-help conditions, group members 

first watched videotape of therapist 

who was leading the therapist led 

group. In partial self-help condition, 

therapist led discussion for second 

part of the group while in structured 

self-help condition, group member on 

a rotating basis was responsible for 

leading discussion component for 

each session. 

Regression analysis 

using a mixed effects 

linear regression 

model to est mean 

changes over time in 

the primary outcome 

variables of interest 

for the active tx 

conditions only; 

ANCOVAs for 

comparing between 

group diffs on 

secondary outcomes 

while controlling for 

baseline assessment; 

survival analysis for 

comparing retention 

rates of randomized 

subjects. 

Score: 

Fair 

Intent to treat: 

Yes 

Blinding: 

Single 

Adverse events: 

NR 

Funding: 

McKnight Foundation grant; 

Minnesota Obesity Center 
C-760 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Objective binge-eating episodes/wk, 

mean (SD): 

G1: 3.4 (1.7) 

G2: 5.5 (6.5) 

G3: 3.1 (2.1) 

G4: 3.5 (4.9) 

(P = NS) 

Mean objective binge-eating episodes/wk (SD): 

G1: 0.7 (1.3) 

G2: 1.3 (3.4) 

G3: 0.4 (1.1) 

G4: 4.7 (4.7) 

Change over time (P < 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P < 0.001)

G1, G2, G3 better than G4 

Abstinence rate: 

G1: 68.8% 

G2: 68.4% 

G3: 86.7% 

G4: 12.5% 

Diff between groups G1 vs G2 vs G3 (P = NS) 

Diff between G1 + G2 + G3 vs G4 (P = 0.004) 

Diff between groups in change over time (P = NR) 

Total binge-eating episodes/wk, 

mean (SD): 

G1: 7.7 (3.8) 

G2: 8.2 (5.9) 

G3: 6.8 (2.4) 

G4: 5.7 (6.0) 

(P = 0.008) 

G1, G2 > G3 

Mean total binge-eating episodes/wk (SD): 

G1: 3.3 (3.6) 

G2: 2.7 (4.3) 

G3: 1.8 (2.9) 

G4: 6.6 (4.5) 

Change over time (P < 0.0001) 

Diff between groups (P =NR) 

Diff between groups in change over time (P = 0.002) 

G1, G2, G3 better than G4 

Abstinence rates for total binges: 

G1: 18.8% 

G2: 36.8% 

G3: 53.3% 

G4: 0% 

Diff between groups G4 vs G1, G2, G3 (P = 0.04): 

G4 worse than G1, G2, and G3 

Diff between G1, G2, and G3 (P = NS) 

Author, yr: 

Peterson et al., 1998 

(continued) 

Hours spent binge-eating/wk, mean 

(SD): 

G1: 9.0 (6.7) 

G2: 13.4 (13.0) 

G3: 9.8 (5.5) 

G4: 8.3 (7.6) 

(P = NS) 

Mean hours spent binge-eating/wk (SD): 

G1: 4.2 (6.9) 

G2: 3.2 (5.9) 

G3: 2.3 (3.3) 

G4: 9.6 (6.5) 

Change over time (P < 0.0001) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.005) 

G1, G2, G3 better than G4 

Abstinence rate for hours spent bingeing: 

Data: NR

Diff between groups G4 vs G1, G2, G3 (P = 0.04) 

G4 worse than G1, G2, and G3 

Diff between G1, G2, and G3 (P = NS) 
C-761 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

HDRS (SD): 

Data NR 

HDRS: 

Data NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS) 

BMI, kg/m2

: 

Data NR 

BMI, kg/m2: 

Data NR 

Diff between groups (P = NR) 

Diff between groups in change 

over time (P = NS)
C-762 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BES: 

NR 

BES: 

Data NR 

Diff between groups (P = NR 

Diff between groups in change over time (P = 0.024)

G4 < (G1 = G2 = G3) 

TFEQ: 

NR 

TFEQ Restraint: 

Data NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

TFEQ Disinhibition: 

Data NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.003)

G4 < (G1 = G2 = G3) 

TFEQ Hunger: 

Data NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.010)

G4 < (G1 = G2 = G3) 

Author, yr: 

Peterson et al., 1998 

(continued) 

BSQ: 

NR 

BSQ: 

NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-763 

Evidence Table 13. Self-help trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-764 

Evidence Table 14. Other trials for binge eating disorder 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Levine, Marcus, and 

Moulton, 1996 

Setting: 

NR 

Enrollment period: 

NR 

Research objective: 

To examine the effects of an 

exercise intervention in the 

tx of obese women with 

BED. 

Groups: 

G1: Active tx (N = 44) 

G2: Delayed control (N = 33) 

Enrollment: 

• 77 recruited, randomized, 

and completed post-tx 

assessments 

Age, yrs, mean (SD): 

G1: 36.3 (6.8) 

G2: 37.0 (6.1) 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian 

G1: 88.6% 

G2: 78.8% 

(P = NS) 

Education: 

Attended college: 

G1: 84.1% 

G2: 75.8% 

(P = NS) 

Married: 

G1: 56.8% 

G2: 60.6% 

(P = NS) 
C-765 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

NR 

Exclusion: 

NR 

Participants randomized to one of 

two identical 24-wk tx programs or 

to a delayed tx control; active tx 

included exercise and calorie goal 

components. 

As preliminary analyses found no 

diff between identical active tx 

groups, they were combined for 

analyses. 

Assessments were conducted at 

baseline and post-tx; physical 

activity and binge eating status was 

assessed using the PEI and EDE 

respectively. 

Repeated measures 

ANOVAs used to 

assess diff between 

groups over time. 

Data reporting diff 

between groups 

based on exercise 

and abstinence, not 

reported in evidence 

table. 

Score: 

Poor 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

NR 

Funding: 

NR 
C-766 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

Binge days/28 days, mean (SD): 

G1: 21.8 (11.8) 

G2: 20.7 (11.9) 

(P = NS) 

NR 

Exercise, days/wk, mean (SD): 

G1: 0.61 (1.4) 

G2: 0.62 (1.3) 

(P = NR) 

Exercise, days/wk, mean (SD): 

G1: 2.4 (2.4) (P = NR) 

G2: NR 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.003)

G1 better than G2 

Calorie expenditure, kcal/wk, mean 

(SD): 

G1: 680.6 (823.0) 

G2: 610.9 (481.1) 

(P = NR) 

Calorie expenditure, kcal/wk, mean (SD): 

G1: 1103.2 (1111.1) (P = NR) 

G2: 610.9 (481.1) (P = NR) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NR) 

Author, yr: 

Levine, Marcus, and 

Moulton, 1994 

(continued) 

At post-tx, 82.4% tx group achieved abstinence. 
C-767 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

BDI score, mean (SD): 

G1: 18.3 (7.8) 

G2: 20.2 (7.8) 

(P = NS) 

NR BMI, kg/m2, mean (SD): 

G1: 35.7 (4.6) 

G2: 38.2 (6.0) 

(P = 0.05) 

NR 
C-768 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Study Description Objective Design Patient Characteristics 

Author, yr: 

Riva et al., 2002 

Setting: 

Inpatient, wt-control tx 

program, Eating 

Disorders Unit of the 

Istituto Auxologico 

Italiano, Verbania 

Italy 

Enrollment period: 

NR 

Research objective: 

To preliminarily test the 

efficacy of VR-based tx of 

body image attitudes and 

related constructs in women 

with BED. 

Groups (N = 20): 

G1: VR (N = NR) 

G2: psycho-nutritional 

control (N = NR) 

Enrollment: 

• 20 patients from ED 

program randomized, 

enrolled, and completed 

Age, yrs, mean (SD): 

G1: 30.50 (6.72) 

G2: 30.10 (6.95) 

(P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 
C-769 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Inclusion/Exclusion 

Criteria Treatment Statistical Methods Quality 

Inclusion: 

Aged 18 to 45; met 

DSM IV research 

criteria for BED for a 

min of 6 mos 

Exclusion: 

Taking antidepressant 

or any meds that might 

influence wt; hx of 

drug or alcohol abuse; 

current major 

psychiatric condition 

such as psychosis; hx 

of purging within 

previous 6 mos; BMI < 

30 

For G1 and G2, tx lasted 

approximately 6.5 wks; G1

received 7 sessions of Virtual 

Reality for Eating Disorders 

Modification (VREDIM) tx plus a 

low calorie diet (1200 cal/day) and 

physical training (30 minutes 

walking 2 times/wk); G2 received 

low cal diet, physical training, and 

psycho-nutritional, CBT-based 

group therapy, 3 times/wk. 

Assessments given at baseline and 

post-tx. 

Power analysis 

revealed low/medium 

power due to small 

sample and high SD. 

Accordingly, repeated 

and independent 

measures assessed 

using exact measures, 

non-parametric 

algorithms reliable 

with small, sparse or 

tied data. Specifically, 

the marginal 

homogeneity test was 

used. 

Score: 

Fair 

Intent to treat: 

NR 

Blinding: 

NR 

Adverse events: 

No participants experienced 

stimulation sickness, often 

associated with VR. 

Funding: 

Commission of the European 

Communities (CEC) and the 

IST Programme (Project 

VESPY) 
C-770 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

BIAQ, total score, mean: 

G1: 33.20 

G2: 31.00 

(P = NR) 

BIAQ, total score, mean: 

G1: 32.40 (P = NS) 

G2: 29.50 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

BIAQ, Eating Restraint score, mean:

G1: 3.00 

G2: 4.40 

(P = NR) 

BIAQ, Eating Restraint, mean: 

G1: 5.20 (P = NS) 

G2: 5.00 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

CDRS, Real Body score, mean: 

G1: 7.80 

G2: 8.40 

(P = NR) 

CDRS, Real Body score, mean: 

G1: 8.10 (P = NS) 

G2: 8.00 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

CDRS, Ideal Body score, mean: 

G1: 4.40 

G2: 4.40 

(P = NR) 

CDRS Ideal Body score, mean: 

G1: 5.10 (P = 0.035) 

G2: 4.80 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

CDRS, Body Satisfaction Index, 

mean: 

G1: 1.87 

G2: 2.55 

(P = NR) 

CDRS, Body Satisfaction Index, mean: 

G1: 1.66 (P = NS) 

G2: 2.29 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

BSS, total score, mean: 

G1: 51.30 

G2: 57.20 

(P = NR) 

BSS, total score, mean: 

G1: 47.60 (P = NS) 

G2: 53.70 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Riva et al., 2002 

(continued) 

WELSQ, total score, mean: 

G1: 107.60 

G2: 129.10 

(P = NR) 

WELSQ, total score, mean: 

G1: 146.80 (P = 0.050) 

G2: 130.30 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.005)

G1 better than G2 
C-771 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

STAI-State, total score, 

mean: 

G1: 47.80

G2: 39.20 

(P = NR) 

STAI-State, total score, 

mean: 

G1: 38.80 (P = 0.023) 

G2: 37.70 (P = NS) 

Diff between groups (P = NR)

Diff between groups in 

change over time (P = 0.035)

G1 better than G2 

Wt., kg, mean (SD): 

G1: 120.06 (28.34) 

G2: 109.82 (21.48) 

(P = NR) 

NR 

BMI, kg/m2, mean (SD): 

G1: 44.07 (10.10) 

G2: 42.35 (8.55) 

(P = NR) 

NR 
C-772 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

FRS Real Body score, mean: 

G1: 6.90 

G2: 6.80 

(P = NR) 

FRS Real Body score, mean: 

G1: 6.80 (P = NS) 

G2: 6.60 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FRS Ideal Body score, mean: 

G1: 3.80 

G2: 3.80 

(P = NR) 

FRS Ideal Body score, mean: 

G1: 3.90 (P = NS)

G2: 3.80 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

FRS Body Satisfaction Index, mean: 

G1: 1.87 

G2: 2.35 

(P = NR)

FRS Body Satisfaction Index, mean: 

G1: 1.82 (P = NS) 

G2: 2.28 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS)

DIET total score, mean: 

G1: 48.80 

G2: 46.87 

(P = NR) 

DIET total score, mean: 

G1: 39.03 (P = NS) 

G2: 45.90 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

DIET Positive Social score, mean: 

G1: 54.00 

G2: 47.57 

(P = NR) 

DIET Positive Social score, mean: 

G1: 34.57 (P = 0.06) 

G2: 45.06 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

DIET Overeating score, mean: 

G1: 53.33 

G2: 44.67 

(P = NR)

DIET Overeating score, mean: 

G1: 31.50 (P = 0.30) 

G2: 44.00 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = 0.05) 

G1 better than G2 

Author, yr: 

Riva et al., 2002 

(continued) 

DIET Negative Emotions score, mean:

G1: 47.40 

G2: 44.60 

(P = NR) 

DIET Negative Emotions score, mean: 

G1: 37.60 (P = NS) 

G2: 47.20 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 
C-773 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-774 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Eating Related Measures 

Study Description Baseline Outcomes 

DIET Resisting Temptations score, 

mean: 

G1: 40.00 

G2: 38.75 

(P = NR)

DIET Resisting Temptations score, mean: 

G1: 43.75 (P = NS) 

G2: 37.75 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over (P = NS) 

DIET Exercise score, mean: 

G1: 46.00

G2: 57.00 

(P = NR)

DIET Exercise score, mean: 

G1: 36.25 (P = NS) 

G2: 53.25 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

DIET Food Choice score, mean: 

G1: 40.50 

G2: 40.75 

(P = NR)

DIET Food Choice score, mean: 

G1: 43.00 (P = NS) 

G2: 41.75 (P = NS) 

Diff between groups (P = NR) 

Diff between groups in change over time (P = NS) 

Author, yr: 

Riva et al., 2002 

(continued) 

 Abstinence (No binge-eating in last 2 wks), 

mean: 

G1: 100% 

G2: 100% 

Diff between groups (P = NS) 

Diff between groups in change over time (P = NR) 
C-775 

Evidence Table 14. Other trials for binge eating disorder (continued) 

Psychological/Psychiatric Measures Biomarkers 

Baseline Outcomes Baseline Outcomes 

This page intentionally left blank. 
C-776 

Evidence Table 15. Anorexia nervosa outcomes 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Ben-Tovim et 

al., 2001 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Adelaide, 

South Australia 

Yrs followed: 

5 

To identify 

predictors of 

outcome and 

to assess 

effects of 

available txs 

for AN or BN 

Inclusion: 

15 yrs old and older; living in 

Adelaide, South Australia; 

either making first contact with 

secondary or tertiary services 

for tx of ED or were 

recontacting such services 

after a tx break of at least 6 

mos. 

Exclusion: 

None 

Recruitment: 

Agreement to participate was 

obtained from all identifiable 

specialist service providers in 

Adelaide, apart from one 

psychiatrist in individual 

practice. 

Sample Size: 

Fulfilled criteria: N = 235 

Agreed to participate: N = 220 

Baseline sample: 

AN: N = 95 

BN: N = 88 

Reasons for loss to FU: 

Anorexia: 3 deaths, of which, 

2 related to ED 

BN: 2 lost, reason NR 

Analysis Sample Size at FU: 

AN: N = 92 

BN: N = 86 

Mean Age (SD) 

AN: 22.5 (6.9) 

BN: 23.8 (6.4) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Wt, kg, Mean (SD): 

AN: 44.8 (6.5) 

BN: 62.6 (10.8) 

Height, m, Mean (SD): 

AN: 1.65 (0.07) 

BN: 1.65 (0.06) 

BMI, Mean (SD): 

AN: 16.5 (1.9) 

BN: 23.1 (3.9) 

Duration of ED, yrs: 

AN: 7.4 (7.0) 

BN: 6.4 (4.7) 

AN subtype at initial 

assessment: 

Abstainers: 59% 

Binge-purgers: 41% 

Score: 

Good 

Method of dx: 

Dx made by 

treating clinician 

and confirmed by 

Flinders Symptom 

Score (FSS) 

interview. Dx was 

according to DSM 

III-R 

Funding: 

Australian National 

Health and Medical 

Research Council, 

Flinders 2000, and 

the Centre for 

Applied Research 

in Mental Health 
C-777 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Evaluation in person or by telephone annually. 

Statistical Methods 

Dependent variable: Total scores from M-R-H 

scales at 5 yrs 

Multiple Regression 

M-R-H Subscales: 

Subscale A: Dietary and eating patterns, body 

concern, and body wt 

Subscale B: Menstrual pattern 

Subscale C: Mental State 

Subscale D: Psychosexual state 

Subscale E: Work and Family Relations 

Descriptive Results 

AN: 

Dx at 5 yrs: 

AN: 20 (21%) 

BN: 5 (5%) 

EDNOS: 9 (9%) 

No ED: 56 (59%) 

Unknown: 2 (2%) 

Died: 3 (3%) 

M-R-H Outcomes: 

Good (mean score: 8 – 12): 32 (34%) 

Intermediate (score 4 - < 8): 51 (54%) 

Poor (score 0 - < 4) 12 (13%) 

BN 

Dx at 5 yrs: 

AN: 1 (1%) 

BN: 7 (8%) 

EDNOS: 11 (13%) 

No ED: 65 (74%) 

Unknown: 4 (5%) 

Died: 0 

M-R-H Outcomes: 

Good: 67 (76%) 

Intermediate (score 4 - < 8): 17 (19%) 

Poor (score 0 - < 4) 2 (2%) 

Unknown: 2 (2%) 

Multivariate Results 

Predictors of higher M-R-H total mean score at 5 yrs: 

AN: 

Model 1 

Age (P = 0.48) 

M-R-H subscale A at baseline (P = 0.02) pos assoc. 

M-R-H subscale B at baseline (P = 0.11) 

M-R-H subscale C at baseline (P = 0.13) 

M-R-H subscale D at baseline (P = 0.23) 

M-R-H subscale E at baseline (P = 0.17) 

Duration of Illness (yrs) (P = 0.18) 

BMI at baseline (P = 0.08) pos assoc 

Goodness of fit model (P < 0.0001), R2

 = 0.0.33 

Model 2 

Disability adjustment scale, subscale 2 at baseline (P = 0.0006) 

neg assoc 

Flinders Medical Centre Symptom Score at baseline (P = 0.03) neg 

assoc 

Body Attitudes Questionnaire Subscales: Attractiveness at 6 mo: 

(P = 0.008) pos assoc 

Change in salience of wt and shape over first 6 mos (P = 0.024) 

pos assoc 

Goodness of fit model (P < 0.0001), R2

 = 0.25 
C-778 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Ben-Tovim et 

al., 2001 

(continued) 

 
C-779 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Evaluation in person or by telephone annually. 

Statistical Methods 

Dependent variable: Total scores from M-R-H 

scales at 5 yrs 

Multiple Regression 

M-R-H Subscales: 

Subscale A: Dietary and eating patterns, body 

concern, and body wt 

Subscale B: Menstrual pattern 

Subscale C: Mental State 

Subscale D: Psychosexual state 

Subscale E: Work and Family Relations 

Descriptive Results 

BN: 

Model 1 

Age (P = 0.47) 

M-R-H subscale A at baseline (P = 0.01) neg assoc 

M-R-H subscale B at baseline (P = 0.50) 

M-R-H subscale C at baseline (P = 0.16) 

M-R-H subscale D at baseline (P = 0.28) 

M-R-H subscale E at baseline (P = 0.28) 

Duration of Illness (yrs) (P = 0.11) 

BMI at baseline (P = 0.27) 

Goodness of fit model (P < 0.056); R2

 = 0.085 

Model 2 

Disability adjustment scale, subscale 2 at recruitment (P = 0.009) 

neg assoc 

Body Attitudes Questionnaire Subscales: 

Feeling fat at recruitment (P = 0.02) neg assoc 

Attractiveness at 6 mo (P = 0.001) pos assoc 

Change in Zung Depression over first 6 mos (P = 0.0003) pos 

assoc 

Goodness of fit model (P < 0.0001), R2

 = 0.31 
C-780 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Birmingham et 

al, 2005 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Vancouver, 

British 

Columbia, 

Canada 

FU duration, 

years, Mean 

(SD): 

7.3 (4.9) for 

AN pts 

8.7 (5.2) for all 

patients 

SMR Inclusion: 

DSM-III dx of an ED 

Exclusion: 

None stated 

Recruitment: 

Referrals to adult tertiary care 

ED program in Vancouver, BC 

from 1981-2000 evaluated and 

given dx of ED using DSM 

criteria. 

Sample Size: 

(N = 954) 

AN (N = 326) 

BN (N = 474) 

Loss to FU: 

None reported 

Age at tx start, mean 

(SD):

Total: 26.1 (8.6) 

AN: 24.7 (9.6) 

Sex: 

Total, N (%): 

Females: 927 (97.2%) 

Males: 27 (2.8%) 

AN, N (%): 

Females: 312 (95.7%) 

Males: 14 (4.3%) 

Race/ethnicity: 

NR 

Age at death, mean 

(SD): 

36.3 (10.7) 

Time to death, 

years, mean (SD): 

6.2 (4.8) 

Score: 

Fair 

Method of 

diagnosis: 

DSM III criteria for 

ED during clinical 

assessment 

(In discussion, 

authors state they 

use DSM III, DSM IIIR, and DSM V 

criteria, but not 

mentioned in 

methods.) 

Funding: 

NR 
C-781 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Vital status assessed by searching Vital 

Statistics Agency of the BC Ministry of 

Health. For each death record, ICD-10 

code recorded. 

Expected number of deaths obtained by 

applying age gender and year specific 

mortalities of general BC pop to cumulative 

person-yrs of the study cohort. 

Statistical Method: 

SMR 

AN Results: 

17 pts died 

• suicide (n=7) 

• pneumonia (n=2) 

• hypoglycemia (n=2) 

• liver disease (n=2) 

• cancer (n=2) 

• alcohol poisoning (n=1) 

• subdural hemorrhage (n=1) 

SMR for AN = 10.5 (95% CI = 5.5-15.5) 

BN Results: 

7 pts died 

Cause of death NR 

SMR for BN = 2.0 (95% CI = 0.5-3.5) 
C-782 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description Research objective 

Eligibility Criteria 

Recruitment and 

Sample Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Bulik, Sullivan et 

al., 2000 

Companion 

article: 

Sullivan, Bulik et 

al., 1998 

Design: 

Case series 

Comparison 

Group: 

Yes 

Location: 

Christchurch, 

New Zealand 

Yrs followed: 

12 yrs from tx 

referral 

To explore what 

distinguished women 

who were fully 

recovered from 

women who 

recovered partially or 

who developed a 

chronic illness. 

To examine diff 

between women who 

recovered fully and 

community controls to 

identify residual diff 

despite remission of 

the ED. 

To examine 

distinguishing 

characteristics of 

women who 

continued to suffer 

from an ED on avg 15 

yrs after initial dx 

Inclusion: 

Cases: Newly dx via 

DSM III-R criteria for 

definite or “probable” 

AN, all determined meet 

lifetime DSM III-R 

criteria for AN; age 23-

45 

Comparisons: Age 

matched to AN cases; 

age 23-45 

Exclusion: 

Cases: None 

Comparisons: 

subthreshold AN 

symptoms 

Recruitment: 

Cases: Newly dx via 

DSM III-R criteria during 

inpatient, outpatient or 

assessment from 1981-

1984 among those who 

received ED services at 

Princess Margaret 

Hospital, Christchurch, 

New Zealand, for 

definite or “probable” AN 

Comparisons: 

randomly selected 

names obtained from 

1993 Christchurch 

electoral record 

Both: letter to invite 

participation; FU phone 

call; personal interview 

Initial Sample Size: 

Records reviewed: 239 

Potential AN: 89 

Potential Controls: 111 

Reasons for loss to 

FU: 

Death: 1 due to suicide 

while being treated for 

AN, 3 could not be 

located, 8 did not give 

consent, and 7 did not 

meet criteria for AN 

Mean Age: 

Values NR: 

Diff between groups 

G4 older than G1, G2, 

G3 (P = NR) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Lowest past BMI, 

mean (SD): 

G1: 14.8 (1.2) 

G2: 14.8 (2.0) 

G3: 14.3 (1.4) 

G4: NR 

(P = NS) 

Highest past BMI, 

mean (SD): 

G1: 23.1 (3.4) 

G2: 23.1 (2.9) 

G3: 21.7 (2.4) 

G4: 27.3 (6.7) 

(P < 0.001) 

G4 higher than other 

groups 

Age at first diet, 

mean (SD): 

G1: 14.5 (2.7) 

G2: 16.6 (4.4) 

G3: 14.7 (3.3) 

G4: 21.5 (6.6) 

(P < 0.001) 

G4 older than other 

groups 

Age of onset of AN, 

mean (SD): 

G1: 16.4 (2.6) 

G2: 17.4 (5.1) 

G3: 16.4 (3.5) 

(P = NS) 

Lifetime BN 

G1: 100% 

G2: 24% 

G3: 80% 

G4: 4% 

(P < 0.001) 

Score: 

Good 

Method of dx: 

Criteria for DSM 

III or DSM IIIR 

determined 

through review 

of hospital 

records. 

Funding: 

Canterbury 

Medical 

Research 

Foundation 
C-783 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Cases: Hospital record of AN patients reviewed by 2 

trained abstractors 

Interview using Diagnostic Interview for Genetic Studies 

and rated on the GAFS. Completed the EDI, TFEQ, 

Parental Bonding Instrument and the Temperament and 

Character Inventory 

Statistical Analysis: 

Chi-Square, ANOVA, ANCOVA to compare the 3 

recovery groups and controls. Age was included as a 

covariate in all analyses. Critical P adopted to control for 

multiple comparisons (P < 0.01) 

Descriptive Results 

Diff between groups (controlling for age): 

Current BMI, mean (SD): 

G1: 20.6 (2.1) 

G2: 20.4 (1.4) 

G3: 18.5 (2.6) 

G4: 25.6 (6.5) 

(P < 0.0001) 

G4 higher than all other groups 

Desired BMI, mean (SD): 

G1: 20.1 (1.8) 

G2: 20.2 (1.3) 

G3: 17.9 (2.5) 

G4: 22.6 (2.6) 

(P < 0.001) 

G4 higher than other groups; G3 lower than G1 and G2 

GAF Scale, mean (SD): 

G1: 75.5 (11.2) 

G2: 72.0 (15.1) 

G3: 52.5 (12.2) 

G4: 80.3 (10.0) 

(P < 0.001) 

G3 lower functioning than other groups; G2 lower 

functioning than G4 

TFEQ, Cognitive Restraint, mean (SD): 

G1: 9.9 (5.9) 

G2: 11.4 (5.3) 

G3: 15.2 (5.3) 

G4: 6.5 (4.8) 

(P < 0.001) 

G3 higher restraint than other groups; G4 lower restraint 

than G1 and G2 

TFEQ, Disinhibition, mean (SD): 

(P = NS) 

TFEQ, Hunger, mean (SD): 

(P = NS) 

EDI, Drive for Thinness, mean (SD): 

G1: 4.5 (5.1) 

G2: 4.7 (4.9) 

G3: 11.8 (8.0) 

G4: 3.1 (1.2) 

Diff between groups (P < 0.0001) 

G3 worse than other groups 

EDI, Bulimia, mean (SD): 

G1: 1.3 (1.9) 

G2: 0.5 (1.0) 

G3: 4.0 (4.4) 

G4: 1.0 (1.6) 

(P < 0.0001) 

G3 worse than all other groups 
C-784 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description Research objective 

Eligibility Criteria 

Recruitment and 

Sample Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Bulik, Sullivan et 

al., 2000 

Companion 

article: 

Sullivan, Bulik et 

al., 1998 

(continued) 

Analysis sample: 

Cases = 70 

Comparisons = 98 

G1: Cases fully 

recovered (no current 

ED dx; > 85% IBW, no 

current bingeing and 

purging): N = 21 

G2: Cases partially 

recovered (no current 

ED dx but reported 

current bingeing or 

purging or maintained a 

wt < 85% IBW): 

N = 34 

G3: Cases chronically ill 

(met criteria for ED at 

time of interview): 

N = 15 

G4: Comparisons: 

N = 98 

 
C-785 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

EDI, Body Dissatisfaction, mean (SD): 

G1: 8.4 (8.2) 

G2: 9.0 (8.3) 

G3: 15.6 (9.8) 

G4: 11.5 (9.3) 

Diff between groups (P = NS) 

EDI, Perfectionism, mean (SD): 

G1: 7.3 (4.5) 

G2: 5.6 (4.9) 

G3: 8.2 (4.4) 

G4: 3.4 (3.3) 

Diff between groups (P < 0.0001) 

G4 had less perfectionism than all other groups 

G1 had less perfectionism than G3 

TCI, Harm Avoidance, mean (SD): 

G1: 16.9 (6.8) 

G2: 20.1 (6.9) 

G3: 24.8 (9.6) 

G4: 17.6 (7.8) 

Diff between groups (P < 0.007) 

G3 had higher harm avoidance than G1 or G4 

TCI, Reward Dependence, mean (SD): 

G1: 17.3 (3.9) 

G2: 16.6 (3.4) 

G3: 14.8 (3.9) 

G4: 17.5 (3.4) 

Diff between groups (P = NS) 

TCI, Self-Directedness, mean (SD): 

G1: 33.8 (8.1) 

G2: 28.7 (8.6) 

G3: 24.5 (9.1) 

G4: 33.7 (7.2) 

Diff between groups (P < 0.001) 

G1 did better than G2 or G3 

G4 did better than G2 or G3 

PBI, Maternal Care, mean (SD): 

G1: 22.2 (10.2) 

G2: 23.8 (9.1) 

G3: 15.8 (11.2) 

G4: .26.0 (7.9) 

Diff between groups (P < 0.002) 

G3 lower score than G1, G2, G4 

PBI, Maternal Protection, mean (SD): 

G1: 18.1 (8.8) 

G2: 15.1 (9.3) 

G3: 14.2 (8.4) 

G4: 13.2 (7.5) 

Diff between groups (P = NS) 
C-786 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description Research objective 

Eligibility Criteria 

Recruitment and 

Sample Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Bulik, Sullivan et 

al., 2000 

Companion 

article: 

Sullivan, Bulik et 

al., 1998 

(continued) 

 
C-787 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

PBI, Maternal Protection, mean (SD): 

G1: 18.1 (8.8) 

G2: 15.1 (9.3) 

G3: 14.2 (8.4) 

G4: 13.2 (7.5) 

Diff between groups (P = NS) 

PBI, Paternal Care, mean (SD): 

G1: 19.9 (8.5) 

G2: 22.8 (10.0) 

G3: 13.0 (13.1) 

G4: 23.2 (9.2) 

Diff between groups (P < 0.004) 

G3 lower score than G1 or G4 

PBI, Paternal Protection, mean (SD): 

G1: 15.2 (8.0) 

G2: 11.8 (5.7) 

G3: 17.4 (10.6) 

G4: 12.5 (7.5) 

Diff between groups (P = NS) 
C-788 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Crisp et al., 

1992 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

England and 

Scotland 

Yrs followed: 

G1: 21.8 (5.1) 

G2: 22.1 (4.9) 

20 yr FU to 

determine the 

long-term 

mortality of AN 

in two cohorts 

Inclusion: 

Both Crisps criteria and DSM 

III-R criteria for AN. 

Exclusion: 

NR 

Recruitment: 

G1: Received tx at St 

George’s Hospital in London 

between May 1968-December 

1973 

G2: Registered on the 

Aberdeen Psychiatric Case 

Register in Aberdeen, 

Scotland between January 

1965 and December 1973. 

Contact through telephone, 

physician, letter, friends and 

family, Social Services and 

Death Registry. 

Sample Size: 

G1: N = 105 

G2: N = 63 

Reasons for loss to FU: 

G1: Died = 4 (2 from 

complications of AN, 1 from 

suicide, and 1 other; 

Untraced = 4 

G2: Died = 8 (3 complications 

of AN, 4 suicides, 1 other); 

Untraced: 2 

Mean Age at FU (yrs): 

G1: 38.8 (6.7) 

G2: 40.9 (7.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mean age at onset of illness 

(yrs): 

G1: 16.8 (3.8) 

G2: 19.1 (5.3) 

Diff between groups (P < 0.01) 

Duration of illness (yrs): 

G1: 3.7 (4.1) 

G2: 2.0 (2.4) 

Diff between groups (P < 0.01) 

Score: 

Fair 

Method of 

dx: 

NR 

Funding: 

NIMH 
C-789 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Treatment Intervention: 

G1: Intensive individual and family 

therapy coupled with nutritional tx.

G2: Medical ward, outpt, inpatient 

(consisted of various tx’s including: 

refeeding, nursing, meds, ECT, and/or 

modified insulin) 

Study Methods: 

Record review 

Statistical Methods: 

SMR, % 

Descriptive Findings: 

Mortality 

Death in 0 – 12 yrs, N (%): 

G1: 2 (2%) 

G2: 3 (5%) 

Death in 12 – 24 yrs, N (%): 

G1: 2 (2%) 

G2: 5 (8%) 

SMR: 

G1: 1.36 times more likely to die than women of the same age in England 

and Wales during 1973 – 1989 

G2: 4.71 times more likely to die than women of the same age in Scotland 

in 1973 – 1979. 

Diff between groups (P = NS) 

Causes of Death: 

Anorexia, N: 

G1: 2 (2%) 

G2: 3 (5%) 

Suicide, N: 

G1: 1 (1%) 

G2: 4 (6%) 

Other, N: 

G1: 1 (1%) cancer 

G2: 1 (2%) cancer 
C-790 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr:

Dancyger et 

al., 1997 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Minnesota and 

Iowa 

Yrs followed: 

10 

To assess the 

relationships 

among MMPI 

clinical scales 

over a 10-yr 

period in a 

sample of AN 

patients 

Inclusion: 

Initial inclusion criteria involved 

modified Feighner et al. 1972, 

and subsequently covered 

DSM III-R and DSM IV for AN. 

Exclusion: 

NR 

Recruitment: 

All participants at intake were 

part of a larger collaborative 

study and were admitted into a 

35-day hospital inpatient tx for 

AN, 40 from U of Iowa and 36 

from U of Minnesota 

Sample Size: 

Initial Sample: 

N = 76 

Reasons for loss to FU: 

Excluded because of 

incomplete data: N = 7 

Died: N = 5 

Refused participation: N = 9 

Did not complete MMPI: N = 3 

Analysis sample 

N = 52 

Mean Age at 

Admission for sample 

of N = 76, yrs (SD): 

19.29 (4.97) 

Mean age of FU 

sample: 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of dx: 

Independent 

Clinician Dx 

At intake: use of 

Feighner et al., 

1972, DSM III-R 

and DSM IV 

criteria. Outcome 

classification was 

determined at FU 

using the M-R 

scale. 

Funding: 

NR 
C-791 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Participants administered the MMPI at 

admission, at discharge and at 10-yr 

FU. During FU interview, participants’ 

outcome assessed via M-R score using 

last 6-mos prior to the FU as window for 

evaluation of clinical status. 

Outcome categories: 

Poor: < 85% of IBW with amenorrhea or 

frequent bingeing and purging (i.e., met 

criteria for BN, AN, or both) 

Intermediate: intermittently at < 85% 

IBW, had some disturbed menses or 

some bingeing and purging behavior 

(i.e., subthreshold AN, BN, or EDNOS) 

Good: > 85% IBW, normal menses but 

binged and purged < once/mo 

Recovered: above the 85% IBW cutoff, 

had no menstrual disturbances, 

reported no bingeing or purging 

behavior, and free from any other eating 

or body image disturbance 

Raw MMPI scale scores were Kcorrected and converted to T-scores 

(mean = 50, SD = 10). Clinical elevation 

is defined as a T-score of 70 or higher 

Statistical Analyses 

Repeated measures MANOVAs used to 

detect diff between outcome status 

groups’ MMPI scale scores at the three 

assessment time points. MANOVA’s 

were followed by pairwise comparisons 

with alpha level corrected using 

Bonferroni procedure 

Correlational analyses performed to 

assess relationships between MMPI 

scale scores at the three time points 

Individual configural analyses of MMPI 

conducted to determine MMPI 

configurations at the three assessment 

points 

Backward elimination stepwise multiple 

regression models with MMPI scales as 

predictors of outcome status at FU were 

conducted 

Descriptive Findings 

Outcome status at 10-yr FU: 

Recovered: N = 16 

Good: N = 7 

Intermediate: N = 11 

Poor: N = 18 

Mean changes in MMPI scale scores from Admission to Discharge to 

FU 

Lying (P = NS) 

Frequency (P = NS) 

Defensiveness (P = NS) 

Hypochondriasis (1) (P < 0.05) Admission > Discharge and FU 

Depression (2) (P < 0.05) Admission > Discharge and FU 

Hysteria (3) (P < 0.05) Discharge < Admission and FU 

Psychopathic Deviate (4) (P = NS) 

Masculinity-Femininity (5) (P = NS) 

Paranoia (6) (P = NS) 

Psychasthenia (7) (P < 0.05) (Admission > Discharge and FU) 

Schizophrenia (8) (P = NS) 

Hypomania (9) (P = NS) 

Social Introversion (10) (P = NS) 

Configural Analysis of MMPI at FU 

Impulsive/characterological: 9 

Normal/Depressive: 32/3 

Other: 8 

Percentage of Subjects with each Single Peak MMPI Score at FU 

Depression (2): 14% 

Hysteria (3): 18% 

Psychopathic Deviate (4): 17% 

Paranoia (6): 13% 

Psychasthenia (7): 12% 

Hypomania (9): 7% 

Social Introversion (10): 8% 

Percentage of Outcome Groups with at least one MMPI Clinical 

Elevation at FU 

Poor: 67% 

Intermediate: 45% 

Good: 14% 

Recovered: 12% 

Correlations Between MMPI Scale Scores at Discharge and FU 

Hypochondriasis: r = 0.32 (P = NS) 

Depression: r = 0.56 (P < 0.003) 

Hysteria: r = 0.37 (P < 0.05) 

Psychopathic Deviate: r = 0.39 (P < 0.05) 

Masculinity/Femininity: r = 0.17 (P = NS)

Paranoia: r = 0.41 (P < 0.05) 

Psychasthenia: r = 0.52 (P < 0.003) 

Schizophrenia: r = 0.37 (P < 0.05) 

Hypomania: r = 0.31 (P = NS) 

Social Introversion: r = 0.68 (P < 0.003) 
C-792 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr:

Dancyger et 

al., 1997 

(continued) 

 
C-793 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Diff in MMPI Scale Scores at FU By Outcome Groups (Recovered 

versus Poor) 

Lying (P = NS) 

Frequency (P = NS) 

Defensiveness (P = NS) 

Hypochondriasis: (P < 0.05) (Recovered < Poor) 

Depression: (P < 0.05) (Recovered < Poor) 

Hysteria: (P < 0.05) (Recovered < Poor) 

Psychopathic Deviate: (P < 0.05) (Recovered < Poor) 

Masculinity-Femininity (P = NS) 

Paranoia (P = NS) 

Psychasthenia: (P < 0.05) (Recovered < Poor) 

Schizophrenia: (P < 0.05) (Recovered < Poor) 

Hypomania (P = NS) 

Social Introversion (P = NS) 

Change in Overall MMPI score admission to FU 

(P < 0.001) Recovered greater decline than poor 

Multivariate Result 

Predictors of outcome at 10 yr FU using backward-elimination 

stepwise multiple regression. (Predicted 25% of the variance) 

Hypochondriasis (scale 1):higher scores associated with poorer outcome 

Paranoia (scale 6): higher scores associated with poorer outcome. 

Psychopathic deviate: higher scores associated with poorer outcome 
C-794 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics Quality 

Authors, yr: 

Deter and 

Herzog, 1994 

Companion 

article: 

Herzog, 

Schellberg, 

and Deter, 

1997 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Germany 

Yrs followed: 

Mean: 11.8 yrs 

(Range: 9-19) 

To determine if long 

term outcomes of 

AN patients are 

associated with 

higher recovery (> 

50%) and mortality 

rates (>5%) and 

lower rates of 

chronicity and poor 

outcome; whether 

inclusion of 

psychiatric and 

medical comorbidity 

and social 

adaptation 

influence results 

compared with 

mere evaluation of 

the physical status 

using M-R criteria 

and which 

predictors remain 

sig over time 

Inclusion: 

Fulfilled dx criteria for AN 

according to Feighner et al., 

and on retrospective analysis, 

the DSM III-R criteria. 

Exclusion: 

Somatic diseases at first 

presentation which did not 

have any direct etiologic 

relation to AN; Male 

Recruitment: 

All AN patients admitted and 

treated consecutively between 

1/71 and 10/80 at University 

Medical Clinic of Heidelberg. 

Sample Size: 

Initial Sample 

N = 84 

Restricting AN: N = 29 (35%) 

Mild purging: N = 19 (23%) 

Severe purging: N = 36 (43%) 

Reasons for loss to FU: 

Death: N = 9. Of these, 

suicide: N = 2 

Analysis sample: 

N = 75 

Mean Age 

32.5 (6.1) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of dx: 

Feighner et al., and 

on retrospective 

analysis DSM III-R 

Funding: 

German Ministry 

for Research and 

Technology 
C-795 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Descriptive Results 

Wt, kg, mean (SD): 

At first presentation: 36.3 (6.2) 

FU: 53.1 (9.5) 

Diff over time (P < 0.0001) 

Wt, %ABW, 37: 

At first presentation: 65.2 (9.9) 

FU: 88.4 (14.8) 

Diff over time (P < 0.0001) 

BMI 

At first presentation: 13.3 (2.0) 

FU: 19.6 (3.3) 

Diff over time (P < 0.0001) 

Amenorrhea, %: 

At first presentation: 100% 

FU: 14.9% 

Diff over time (P < 0.0001) 

ED Morbidity at FU: 

BN: 10/74 (14%) 

Mild bulimic symptoms: 12 (16%) 

Laxative abuse without binge eating: 8% 

ANSS Avg Outcome Score, mean (SD) 

At first presentation: 20.1 (3.9) 

FU: 8.7 (5.3) 

Diff over time (P < 0.0001) 

ANSS Pathological findings (%), mean (SD) 

At first presentation: 67.2 (12.3) 

FU: 29.6 (17.4) 

Diff over time (P < 0.0001) 

ANSS Somatic symptoms, mean (SD) 

At first presentation: 61.7 (15.9) 

FU: 23.5 (18.6) 

Diff over time (P < 0.0001) 

M-R Scale, Avg Outcome Score, mean (SD) 

At first presentation: 2.4 (1.4) 

FU: 8.6 (2.8) 

Diff over time (P < 0.0001) 

Study Methods: 

Interview using ANSS, physical examination and 

medical record review 

Statistical Methods 

ANOVA, MANOVA 

T test or Student-Newman-Keuls 

Spearman correlations and factor analyses 

Step-wise multiple regression 

Comparisons: ANOVA and Student-NewmanKeul’s 

Outcome categories 

Permanent recovery: rated as good according to MR scale and remained so 

Relapse: rated as good according to M-R scale but 

afterwards assessed as intermediate or poor 

Persistent ED: not defined 

M-R Scale, Menstrual function, mean (SD) 

At first presentation: 0.5 (0.3) 

FU: 10.1 (3.9) 

Diff over time (P < 0.0001) 

 M-R Scale, Mental state, mean (SD) 

At first presentation: 4.0 (0.8) 

FU: 8.1 (2.5) 

Diff over time (P < 0.0001) 
C-796 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Deter and 

Herzog, 1994 

(continued) 

 
C-797 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

M-R Global Outcome at FU (modified by Eckert, 1990): 

Good: 53.6% 

Intermediate: 25.0% 

Poor:10.7% 

Deceased: 10.7% 

Psychiatric Morbidity, DSM III-R at FU: 

Phobic Disorders: 12.2% 

Substance Abuse: 13.5% 

Major Depression: 8.1% 

Personality Disorders: 17.6% 

Chronic Psychosis: 5.4% 

OCD: 8.1% 

Psychiatric morbidity: 32.4% 

Somatic Morbidity at FU: 32% 

Healthy according to M-R scale criteria: 

2 yr FU: 5% 

4 yr FU: 23% 

6 yr FU: 37% 

9 yr FU: 43% 

11 yr FU: 52% 

AN dx: 

2 yr FU: 67% 

4 yr FU: 40% 

6 yr FU: 23% 

9 yr FU: 17% 

Diff between recovered patients (N = 36) 

Persistent eating disorders/dead (N = 31) 

Relapsing patients (N = 17) 

Age at onset of illness, yrs, mean: 

Permanent recovery: 16.8 

Persistent: 18.8 

Relapsing: 18.1 

Diff between groups (P = NR) 

Age at first presentation, yrs, mean: 

Permanent recovery: 19.3 

Persistent: 23.3 

Relapsing: 18.9 

Diff between groups (P = 0.007) 

Permanent recovery younger than Persistent 

Persistent older than Relapsing 

Duration of illness prior to first presentation, yrs, mean: 

Permanent recovery: 2.4 

Persistent: 4.5 

Relapsing: 0.8 

Diff between groups (P = 0.005) 

Persistent longer duration than Relapsing 

Somatic symptoms (%): 

Permanent recovery: 57.2 

Persistent: 67.5 

Relapsing: 62.6 

Diff between groups (P = 0.03) 

Recovery less symptoms than Persistent 
C-798 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Deter and 

Herzog, 1994 

(continued) 

 
C-799 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Laxatives at first presentation (rating 0 – 4): 

Permanent recovery: 1.1 

Persistent: 2.1 

Relapsing: 1.6 

Diff between groups (P = 0.04) 

Recovery did better than Persistent 

Vomiting at first presentation (rating 0 – 4): 

Permanent recovery: 1.6 

Persistent: 2.1 

Relapsing: 0.5 

Diff between groups (P = 0.03) 

Persistent higher rating than Relapsing 
C-800 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Deter et al., 

2005 

Design: 

Prospective 

and 

retrospective 

Comparison 

Group: 

No 

Location: 

Heidelberg, 

Germany 

Yrs followed: 

11.8 (2.4) 

Range: 9-19 

In a long-term 

FU of AN 

patients, 

develop

simple, 

clinically 

interpretable 

data that can 

be helpful in 

clinical 

decisionmaking 

Inclusion: 

• Met criteria for AN 

according to Feighner et 

al.; DSM III-R 

Exclusion: 

• Male; additional somatic 

diseases not related to AN 

Recruitment: 

• All AN inpatients who were 

treated consecutively from 

1/1/1971 and 10/31/1980 

at the Department of 

General Clinical and 

Psychosomatic Medicine, 

University of Heidelberg 

Medical School. 

Sample Size: 

Initial sample: 

N = 84 

Reasons for loss to FU: 

Death: 9 due to ED 

(electrolyte disturbances) and 

secondary consequences of 

chronic AN such as infections 

or renal failure; 2 due to 

suicide. 

• Not available for 

examination: N = 5 

Analysis sample size: 

N = 70 

Mean Age at Intake, 

mean (SD): 

20.7 (4.1) 

Avg length of illness 

before inclusion: 

2.7 (3.9) 

Mean relative ABW at 

first admission: 

65.2% (9.9) 

BMI (SD): 

13.3 (2.0) 

Sex: 

Female; 100% 

Race/ethnicity: 

NR 

Social Class: 

Lower: 45.2% 

Middle: 48.8% 

Upper: 6.0% 

Score: 

Fair 

Method of dx: 

Feighner criteria 

and DSM III-R in 

retrospective 

analysis. Method of 

dx NR 

Funding: 

NR 
C-801 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Predictor variables, including medical 

data, collected at inpatient admission, 

interviews and diagnostics with 

physicians, psychotherapists. 

Annual collections of MR outcome 

categories by general practitioner or 

information provided by health insurance 

agencies. 

FU assessments made an avg of 3.6 yrs 

and again 11.8 yrs after first admission. 

Isolated predictors known from the 

literature over longer time periods and 

carried out a separate investigation of 

predictors of the Heidelberg-Mannheim 

study over a mean period of 12 yrs (range 

9-19yrs). 

Calculated separate hierarchic regression 

analyses on the bases of the course of the 

M-R categories for four individually 

recorded areas: anamnestic, 

psychological, somatic and social data 

sets. 

Outcomes 

Global score: Sum of 6 predictor 

variables (age of onset, purging, albumin, 

GOT, ANSS psychic findings, ANSS social 

findings)

Statistical methods: 

Univariate analysis to predict M-R 

outcome categories at 4, 8, and 12 yrs; 

and the Deter-Herzog criteria after 12 yrs 

(U test calculated for quantitative 

predictors and the Chi-square for 

dichotomized variables). 

Multivariate testing to obtain most sig 

predictors. 

Survival analyses to assess “survival rate.” 

Similarity or diff between strata checked 

by the log-rank test. 

Descriptive Results 

Univariate Analysis: 

Factors associated with good somatic M-R outcome at 4 yrs (P 

values NR): 

Early onset of disease 

No strong vomiting or laxative abuse 

No vomiting 

Positive M-R eating habits and psychological status scales at baseline 

Positive ANSS social status score 

No sexual partner 

No amenorrhea 

Factors associated with good somatic M-R outcome at 8 yrs (P 

values NR): 

Younger age overall 

Early onset of disease 

Lower strong vomiting or laxative abuse 

Low M-R values for eating habits and social activities at baseline 

Low ANSS values for low occupational integration, body image 

disturbance, self-destructive tendencies, pathological findings 

Higher social activities 

Potassium and albumin levels 

Factors associated with good somatic M-R outcome at12 yrs (P 

values NR): 

Positive ANSS psychic and social scale scores 

Younger age overall 

Earlier onset of disease 

Good M-R ratings of psycho-sexual integration, personal contacts, 

eating habits, abundance of family, social activities 

Low ANSS values for low occupational integration, low understanding of 

family of origin, % pathological findings 

Potassium level 

Albumin level 

Low addictive tendencies 

Predictor of favorable psychosocial and somatic Deter-Herzog 

course at 12 yrs (some P values NR): 

Good social integration (P = 0.05) 

No severe psychic symptoms (P = 0.04) 

Earlier onset of disease 

Lower strong vomiting or laxative abuse 

Low M-R values for eating habits at baseline 

Potassium level 

Glucose level 

Albumin level 

Multivariate Analysis: 

Predictors of Deter-Herzog criteria at 12 yrs: 

Serum albumin level (P = 0.01) 

ANSS social integration score (P = 0.03) 
C-802 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Deter et al., 

2005 

(continued) 

 
C-803 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

 Survival Analysis: 

Predictors of Persistence (“survival) of AN symptoms at 12 yrs (N = 81): 

Age of onset and purging (P = 0.001) 

• Poor outcome (high AN symptoms) = disease onset > 18 yrs 

• Moderate outcome = onset < 18 yrs + purging 

• Good outcome = onset < 18 yrs, no purging 

Albumin and glutamic-oxalo acetic transaminase (GOT) levels (P = 0.013) 

• Poor outcome = low albumin level 

• Moderate outcome = normal albumin, high GOT 

• Good outcome = normal albumin and GOT 

Global prognosis score (P = 0.019) 

• Poor outcome = high global score 

• Good outcome = low global score
C-804 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Eckert et al., 

1995 

Design: 

Case series 

Comparison 

Group: 

No

Location: 

USA 

Yrs followed: 

10 

Mean: 

9.6 (0.8) 

(range: 8.5 – 

10.5)

To describe 

the clinical 

course and 

outcome of the 

core symptoms 

of AN who 

participated 10 

yrs previously 

in a 

collaborative 

hospital tx 

study. 

Inclusion: 

Feighner’s and DSM III-R 

criteria for AN. 

Exclusion: 

NR 

Recruitment: 

76 of the 105 patients who 

participated in a 35 day 

hospital tx study which 

compared the efficacy of a 

behavior therapy program with 

a cyproheptadine regimen. 76 

is the total enrollment of all 

patients from 2 of the three 

collaborative referral hospitals 

participating in the tx study. 

Sample Size: 

N = 76 

Mean Age (SD) 

(range): 

20.0 (5.2) (12 – 36) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: 100% 

Marital Status: 

Single: 62 (82%) 

Married/Divorced: 14 

(18%) 

Duration of illness, 

yrs, mean (SD) 

(range): 

3.0 (3.2) (0.3 – 19) 

Avg wt below normal, 

%, mean (SD) (range): 

31.1 (8.8) (9.8 – 47.4) 

Binge-eating: 

36 (47%) 

Vomiting: 

29 (38%) 

Laxative abuse: 

31 (41%) 

Previous 

hospitalizations for 

AN: 

37 (49%) 

Previous outpt 

therapy for AN: 

36 (47%) 

Age at FU, Median 

(range): 

28 (21 – 47) 

Score: 

Fair 

Method of dx: 

Structured Clinical 

Interview: 

Diagnostic Interview 

Schedule 

Funding: 

NIMH 
C-805 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Where possible, subjects and their 

parents were interviewed personally by 

two well-trained research assistants 

either in their homes or at the hospital. 

Outcomes (based upon clinical status 

for the 1 yr interval preceding FU): 

Recovered: Wt within 15 % of ideal wt, 

cyclical menses, and no sig disturbance 

in eating or wt control behavior or body 

image disturbance. 

Good: Wt within 15% of IBW, cyclical 

menses, and the presence of sig eating 

or wt control behavior (e.g., binge eating, 

vomiting, laxative diuretic abuse, diet pill 

use, undue dieting) or sig body image 

disturbance. 

Intermediate: Wt only intermittently 

within 15% of IBW and/or presence of 

menstrual disturbances. 

Poor: Wt has remained below 15% of 

IBW and menstruation has been absent 

or virtually absent. 

Statistical Methods 

Frequencies and chi-squares 

Descriptive Results: 

Deaths: 

5 (crude mortality rate: 6.6%) 

All complications of AN (no suicides) all showed early signs of poor 

outcome (very low wt at hospitalization and time of death, older age of 

onset, disturbance in wt control behavior. 

Expected mortality rate: 

0.39 

Ratio of observed to expected deaths: 

12:82 

Diff (P < 0.05); study population had a sigly increased mortality. 

Various sociodemographic characteristics: 

Compared to expected age-sex scales from the US, the study population 

had: more subjects living alone, not in a conjugal relationship, lived more 

often with non-relatives, had never been married, and were more often 

childless or had fewer children (P < 0.001) and more induced abortions 

(P < 0.01). 

Menses: 

First onset or return of menses during FU: 60 (85%); 49 (69%) 

spontaneously and 11 (16%) with meds. 

Of spontaneous remissions: 

Within first yr: 35% 

Within 5 yrs: 85% 

Within last 5 yrs of study: 15% 

Mean % of IBW when regained menses spontaneously: 92.0% (11.4) 

(range: 70.9 – 138.3%); Wt was achieved and maintained at 12.4 (14.0) 

(range: 1 – 72) mos before menses returned. 

Regularity of menstrual pattern in last 6 mos preceding FU, N (%): 

Regular: 34 (48%) 

Somewhat irregular (variation 4 – 10 days): 6 (18%) 

Very irregular (variation > 10 days): 6 (8%) 

Skipped or rare menses: 7 (19%) 

Never menstruated: 11 (15%) 

Wt at FU: 

Below normal wt (BMI < 17.5 and < 85% below avg wt): 16 (22.5%) 

Normal wt (BMI: 17.5 – 23.5 and between 85 – 115% of avg wt): 52 

(73.2%) 

Mild obesity (BMI 23.6 – 26.5 and between 116 – 125% of avg wt): 2 

(2.8%) 

Severe obesity (BMI > 26.5 and > 125% of avg wt): 1 (1.4%) 

Relapse (first wt loss below normal at any time after the index 

hospitalization): 

n = 34 during the first 8 yrs of FU 

Probability of relapse: 

0.37; 24 (37%) of all 66 subjects who attained normal wt during FU 

relapsed before they had been normal wt for 1 yr. If they maintained their 

wt for at least 1 yr, their chance of continuing to remain in normal wt 

improved considerably. 
C-806 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Eckert et al., 

1995 

(continued) 

 
C-807 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Correlates of wt at FU per Anorectic Outcome Scale (Lower wt was 

associated with): 

Greater food faddiness (P < 0.01) 

Greater laxative abuse (P < 0.01) 

Other wt loss behavior (P < 0.01) 

Greater body image disturbance (P < 0.01) 

Greater fear of becoming fat (P < 0.05) 

Greater disturbed sexual adjustment (P < 0.01) 

Worse psychological adjustment (P < 0.01) 

Disturbed menses (P < 0.01) 

Bingeing (P = NS) 

Vomiting (P = NS) 

Sense of ineffectivenss (P = NS) 

Dependency (P = NS) 

Social and educational/vocational adjustment (P = NS) 

Distribution among the categories of outcome by symptoms, N 

Recovered: 18 

Good: 20 

Intermediate: 24 

Poor: 9 

Mean BMI: 

Total: 18.5 

Recovered: 20.2 

Good: 20.3 

Intermediate: 18.0 

Poor: 13.7 

Diff between groups (P = NR) 

Educational/vocational: 

Recovered: 0.11 

Good: 0.60 

Intermediate: 0.25 

Poor: 1.0 

Diff between groups (P < 0.001) 

Pairwise group comparisons (P = NR) 

Comorbid psychiatric dx: 

Any Lifetime dx: 

Diff between recovered vs 3 other groups (P = NS) 

Current psychiatric dx: 

Diff between recovered versus all other groups: 

Major affective disorder (P < 0.01) 

Anxiety disorders (P < 0.05) 

Phobias (P < 0.05) 

Recovered less comorbidity. 

Diff between good and intermediate (P = NS) 

ED dx and outcome category at 10 yr FU: 

No dx: 

Total: 18 (23.7%) 

Recovered: 18 

Good: 0 

Intermediate: 0 

Poor: 0 

Diff between groups (P = NR) 
C-808 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Eckert et al., 

1995 

(continued) 

 
C-809 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

EDNOS: 

Total: 27 (35.5%) 

Recovered: 0 

Good: 10 

Intermediate: 17 

Poor: 0 

Diff between groups (P = NR) 

BN: 

Total: 17 (22.4%) 

Recovered: 0 

Good: 10 

Intermediate: 7 

Poor: 0 

Diff between groups (P = NR) 

AN: 

Total: 7 (9.2%) 

Recovered: 0 

Good: 0 

Intermediate: 0 

Poor: 7 

Diff between groups (P = NR) 

AN/BN 

Total: 2 (2.6%) 

Recovered: 0 

Good: 0 

Intermediate: 0 

Poor: 2 

Diff between groups (P = NR) 

Treatment during FU: 

Rehospitalized for tx of AN during FU: 23 (32%) 

# hospitalization, mean (SD) (range): 2.7 (2.3) (1 – 8) 

Rehospitalized for psychiatric problems other than AN: 11 (16%) 

# hospitalizations, mean (SD) (range): 3.3 (3.1) (1- 10) 

Outpatient tx: 

54 (76%) 

Mos of tx, mean (SD) (range): 

23.5 (26.4) (1 – 111) 
C-810 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Eddy, Keel, 

Dorer et al., 

2002

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA 

Years 

followed: 

8-12 (minimum 

7 yrs, median 

8 yrs FU) 

To compare 

patients 

with 

restricting 

AN and 

binge/purge 

AN on 

measures 

of 

impulsivity, 

course and 

long-term 

(8-12 yrs) 

outcome 

Inclusion: 

DSM III-R criteria for AN and/or 

BN. Reclassified to DSM IV 

criteria for subtype. Female, 

age 12 or older, residence 

within 200 miles of study site 

Exclusion: 

Evidence of organic brain 

syndrome or terminal illness 

and lack of fluency in English 

Recruitment: 

Patients who sought tx at one of 

participating facilities and met 

DSM III-R criteria for AN, 

restricting type, AN, binge/purge 

type, or BN recruited 

Sample Size: 

N = 246 subjects (136 AN) 

N = 51 AN restricting type 

(ANR) 

• N = 24 ANR “pure” 

• N = 27 ANR “not pure 

N = 85 AN binge/purge (ANBP) 

N = 110 BN 

Loss to FU Reasons: 

9 (3.7%) died (all AN: N = 2; AN 

Pure: N = 2; AN Not Pure: N = 5 

ANBP). 

Cause of death NR 

Attrition rate: 7%. 

Mean Age at Intake, 

yrs: 

ANR Pure: 20.8 

ANR Not Pure: 23.8 

ANBP: 22.7 

Sex: 

Female: 100% 

Race/ethnicity: 

Not reported 

Score: 

Fair 

Method of diagnosis: 

Independent Clinician 

Diagnosis 

Funding: 

Not reported 
C-811 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Schedule for Affective Disorders and 

Schizophrenia - Lifetime Version to 

diagnose Axis I disorders, Structured 

Interview for DSM III Personality 

Disorders to diagnose Axis II disorders. 

FU interviews were conducted using the 

Eating Disorders Longitudinal Interview 

FU Evaluation modified to include a 

section on eating disorders derived from 

the Diagnostic Interview Schedule. 6 

point Psychiatric Status Rating scale 

was used to determine ED outcome. 

Outcome Categories: 

ANR Pure: No lifetime history of 

binging or purging at intake or during 

first 3 mos. of study 

ANR Not Pure: History of binging and 

purging behavior at intake, infrequent 

binge/purge behavior at intake (i.e. at 

least once weekly), or binge/purge 

behavior during first 3 mos. of study 

ANBP: full criteria for AN and regularly 

(at least once weekly) engaged in 

binge/purge behaviors (defined as 

vomiting, diuretic use, laxative use) 

Full recovery: absence of 

symptomatology or the presence of 

minimal symptomatology for at least 8 

consecutive weeks. 

Relapse: return of full criteria 

symptomatology for at least 1 week 

following a period of full recovery. 

Overall functioning and 

symptomatology: based on monthly 

100-point Global Assessment of 

Severity scale ratings.

Statistical Analyses 

For ordered variables, two-way 

comparisons using Wicoxon rank sum 

test and three way comparisons using 

Kendall’s tau. For dichotomous 

outcomes, two-way comparisons using 

chi-square or Fisher exact test and 

three way comparisons using exact 

logistic models containing linear and 

quadratic contrasts. 

Exact logistic regression and ordinary 

regression models used to control for 

duration of illness. 

Descriptive Findings 

At intake: 

Duration of illness, years: 

ANR Pure: 3.4 

ANR Not Pure: 3.4 

ANBP: 6.5 

Diff between groups (P = 0.002) 

Percent IBW: 

ANR Pure: 75% 

ANR Not Pure: 75% 

ANBP: 82% 

Diff between groups (P <0.001) 

History of MDD, %: 

ANR Pure: 71% 

ANR Not Pure: 59% 

ANBP: 71% 

Diff between groups (P = NS) 

History of Hospitalization: 

ANR Pure: 54% 

ANR Not Pure: 70% 

ANBP: 40% 

Diff between groups (P = NS) 

Personality Disorder, %: 

ANR Pure: 22% 

ANR Not Pure: 55% 

ANBP: 38% 

Diff between groups (P = NS) 

Global Assessment of Severity Scale: 

ANR Pure: 53.5 

ANR Not Pure: 42.5 

ANBP: 50.0 

Diff between groups (P = NS) 

History of Alcohol Abuse: 

ANR Pure: 4% 

ANR Not Pure: 11% 

ANBP: 19% 

Diff between groups (P =NS) 

History of Drug Abuse: 

ANR Pure: 0% 

ANR Not Pure: 13% 

ANBP: 16% 

Diff between groups (P = 0.04) 

History of Kleptomania: 

ANR Pure: 0% 

ANR Not Pure: 7% 

ANBP: 13% 

Diff between groups (P = NS) 

History of Suicidality: 

ANR Pure: 4% 

ANR Not Pure: 29% 

ANBP: 27% 

Diff between groups (P = .04) 
C-812 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Eddy, Keel, 

Dorer et al., 

2002

(continued) 

 
C-813 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Cox models used to compare survival 

across diagnostic groups and control for 

duration of illness. 

Borderline Personality Disorder: 

ANR Pure: 0% 

ANR Not Pure: 10% 

ANBP: 9% 

Diff between groups (P = NS) 

Association between binge-purge behaviors in AN and course and 

outcome variables: 

Full recovery: 

ANR Pure: 45.6% 

ANR Not Pure: 21.5% 

ANBP: 38.6% 

Diff between groups (P = NS) 

Partial Recovery: 

ANR Pure: 87.5% 

ANR Not Pure: 85.9% 

ANBP: 87.1% 

Diff between groups (P = NS) 

Relapse: 

ANR Pure: 31.4% 

ANR Not Pure: 46.7% 

ANBP: 67.8% 

Diff between groups (P = NS) 

Deaths: 

ANR Pure: 8.3% 

ANR Not Pure: 7.4% 

ANBP: 5.9% 

Diff between groups (P = NS) 

Global Assessment of Severity Scale: 

ANR Pure: 59 

ANR Not Pure: 52 

ANBP: 55 

Diff between groups (P = NS) 

Category Crossovers by 8 yrs FU (median): 

ANRs: 

N = 28 of the ANR’s became ANBP

N = 10 of ANR Pure became ANBP 

N = 18 of ANR Not Pure became ANBP 

N = 4 of ANR Pures who became ANBP had onset of binging and purging 

N = 3 of ANR Pures who became ANBP had onset binging only 

N = 3 of ANR Pures who became ANBP had onset purging only 

N = 14 of ANR group did not develop ANBP 

N = 4 of those who remained ANR were fully recovered 

N = 4 of those who remained ANR were partially recovered 

N = 6 of those who remained ANR continued to meet full criteria for ANR 

For those who crossed over from ANR to ANBP, the majority (ANR, 

51.5%; ANR Pure, 37.8%; ANR Not Pure, 65%) occurred during the first 

five years of FU or by a median of 8.4 yrs of illness 
C-814 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 1999 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

Germany 

Yrs followed: 

2 yr FU: 2.5 (0.9) 

6 yr FU: 6.2 (.9) 

To examine 

issues 

regarding 

course and 

long-term 

outcome of 

AN. 

Inclusion: 

Females 

DSM IV for AN 

Admitted to inpatient ED tx 

Exclusion: 

None stated 

Recruitment: 

Females who where dx’ed 

with AN and admitted to ED 

inpatient program (Klinik 

Roseneck) in Upper 

Bavaria Germany from 

1985-1988. 

Sample Size: 

Initial Sample: 

(N = 103) 

Loss to FU: 

Death (N = 6) 

Traffic accident during 

exercise = 1 

Cardiac and renal 

failure = 2 

Hypocalcemia = 2 

Cardiac failure and 

cachexia = 1 

Not reached (N = 1) 

Refused to participate (N = 

1) 

Analysis Sample: 

2 yr FU (N = 98) 

6 yr FU (N = 95) 

Mean Age at tx start (SD) 

24.9 (6.7) yrs 

Sex: 

Female 100% 

Race/ethnicity: 

NR 

Mean BMI (kg/cm2

) at tx start 

(SD) 

14.3 (1.7) 

Duration of AN symptoms 

before tx start (SD) 

6.3 (4.8) yrs 

Age onset (SD) 

18.5 (6.4) yrs 

Discharge status 

Normal: 85 

Premature: 1 

By team: 3 

By mutual agreement: 13 

Improvement at discharge: 

Sig: 16 (15.8%) 

Marked: 44 (43.6%) 

Slight: 30 (29.7%) 

Unchanged: 9 (8.9%) 

Slightly worse: 1 

Marked worse: 1 

Duration of tx (days) (SD): 

118.6 (49) 

Education: 

< 9 yrs: 1.9% 

> 9 yrs: 68.9% 

13+ yrs: 26.2% 

University degree: 2.9% 

Score: 

Good 

Method of dx: 

Specially 

trained 

psychologists or 

physician using 

DSM IV criteria 

for AN based 

on interview 

and/or 

questionnaire 

data. 

Funding: 

WilhelmSanderStiftung, Munich 

Germany; 

Bundesministeri

um fur Bildung, 

Forschung und 

Technologie in 

Germany
C-815 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Patients assessed at admission to inpatient, 

discharge from inpatient, 2 yrs, 6 yrs FU. 

For FU, patients sent questionnaire packet to 

complete. After packet returned, interview 

conducted by specially trained psychologists 

and physicians. Those not able to do long 

interview were given shorter version. Long 

interview were face to face or by phone, short 

by phone only.

Results: 

Descriptives 

Mean BMI (kg/cm2) (SD) 

Tx start - 14.3 (1.7) 

Discharge from tx – 15.5 (1.7) 

2 yr FU – 17.1 (3.4) 

6 yr FU – 17.9 (2.8) 

Statistical Method: 

Repeated measures MANOVAs 

Pairwise t tests 

Longitudinal comparisons used sets complete 

for all time points. 

ED diagnostic outcome (DSM IV): 

2 yr FU: 

AN: 36.6% 

BN: 9.9% 

BED: 0 

EDNOS: 3.0% 

None: 45.5% 

6 yr FU: 

AN: 26.8% 

BN: 9.9% (16.8% cumulative) 

BED: 0 

EDNOS: 2.0% 

None: 55.4% 

Outcomes 

SIAB-P, supplemented by PSR 

Global outcomes: aggregate of 10 outcome 

categories 

• Good – outcome of 1 or 0 

• Intermediate – outcome of 2 

• Poor – outcome of 3-4 

M-R general outcome 

• Good – within normal range and normal 

menstruation 

• Intermediate – wt not consistently in normal 

range or menstrual irreg. 

• Poor – wt below normal, menstruation 

absent or nearly absent 

PSR ED Symptoms Ratings: 

2 yr FU: 

Marked: 30.4% 

Partial Remission: 30.4% 

Residual: 23.9% 

Usual self: 15.3% 

6 yr FU: 

Marked: 30.4% 

Partial Remission: 25.0% 

Residual: 21.4% 

Usual self: 23.2% 

 Global outcomes 

Good: 34.7% 

Intermediate: 38.6% 

Poor: 20.8% 

Dead: 5.9% 
C-816 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

1999 

(continued) 

 
C-817 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Menstruation: 

2 yr FU: 

Normal Menses: 21 (22.8%) 

Irreg menses: 9 (9.8%) 

Amenorrhea: 48 (52.2%) 

No period other reasons: 2 (2.2%) 

OCP or hormones: 12 (13.0%) 

6 yr FU: 

Normal Menses: 34 (37%) 

Irreg menses: 12 (13.0%) 

Amenorrhea: 22 (23.9%) 

No period other reasons: 7 (7.6%) 

OCP or hormones: 17 (18.5) 

 M-R outcomes: 

2 yr 

Good: 13 (12.9%) 

Intermediate: 20 (19.8%) 

Poor: 63 (62.3%) 

6 yr 

Good: 25 (26.9%) 

Intermediate: 23 (24.7%) 

Poor: 39 (41.9%) 

Diff in course of disease AN-R and AN-BP (P = NS) 

 Comorbidity rates ar 6 yr FU (N = 75):

Borderline Personality Disorder: 12% 

Substance abuse (excl. lax): 20% 

Mood disorders: 53% 

Anxiety disorders: 32% 
C-818 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

1999 

(continued) 

 
C-819 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Change over time in EDI (N = 59) 

Total 

Beginning of therapy vs 2 yr FU (P < 0.05) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Worsened 

Drive for Thinness 

Beginning of therapy vs 2 yr FU (P < 0.01) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.01) Worsened 

Bulimia 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P = NS) 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.001) Worsened 

Body dissatisfaction 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P = NS) 

End of therapy vs 2 yr FU (P = NS) 

End of therapy vs 6 yr FU (P = NS) 

Ineffectiveness 

Beginning of therapy vs 2 yr FU (P < 0.05) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Worsened 

Perfectionism 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P = NS) 

End of therapy vs 2 yr FU (P = NS) 

End of therapy vs 6 yr FU (P = NS) 
C-820 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

1999 

(continued) 

 
C-821 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Change over time in SIAB (N = 52) 

Total scale 

Beginning of therapy vs 2 yr FU (P < 0.001) Improved 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P = NS) 

2 yr FU vs 6 yr FU (P < 0.001) Improved 

Body image and ideal of thinness 

Beginning of therapy vs 2 yr FU (P < 0.001) Improved 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P = NS) 

End of therapy vs 6 yr FU (P = NS) 

2 yr FU vs 6 yr FU (P = NS) 

Depression 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P < 0.01) Improved 

2 yr FU vs 6 yr FU (P < 0.001) Improved 

Anxieties and obsessions 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Improved 

2 yr FU vs 6 yr FU (P < 0.001) Improved 
C-822 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

1999 

(continued) 

 
C-823 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Change over time SCL-90 (N = 53) 

Global Severity Index 

Beginning of therapy vs 2 yr FU (P < 0.01) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P = NS) 

Positive Symptom Total 

Beginning of therapy vs 2 yr FU (P < 0.01) Improved 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P < 0.05) Worsened 

End of therapy vs 6 yr FU (P = NS) 

Positive Symptom Distress Index 

Beginning of therapy vs 2 yr FU (P < 0.01) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Worsened 

Somatization 

Beginning of therapy vs 2 yr FU (P < 0.05) Improved 

Beginning of therapy vs 6 yr FU (P < 0.05) Improved 

End of therapy vs 2 yr FU (P = NS) 

End of therapy vs 6 yr FU (P = NS)

Obsessive-compulsive disorder 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P = NS) 

Interpersonal Sensitivity 

Beginning of therapy vs 2 yr FU (P < 0.05) Improved 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.001) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Worsened 

Depression 

Beginning of therapy vs 2 yr FU (P < 0.01) Improved 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 2 yr FU (P < 0.01) Worsened 

End of therapy vs 6 yr FU (P < 0.05) Worsened

Anxiety 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P = NS) 

End of therapy vs 2 yr FU (P = NS) 

End of therapy vs 6 yr FU (P = NS) 

Anger-hostility 

Beginning of therapy vs 2 yr FU (P = NS) 

Beginning of therapy vs 6 yr FU (P < 0.01) Improved 

End of therapy vs 2 yr FU (P < 0.05) Worsened 

End of therapy vs 6 yr FU (P = NS) 

BDI (N = 62) 

Beginning of therapy vs 6 yr FU (P < 0.001) Improved 

End of therapy vs 6 yr FU (P < 0.05) Worsened
C-824 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

1999 

(continued) 

 
C-825 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Prognostic factors based on PSR 

2 yr FU 

Early onset AN (P < 0.05) Worse 

Low BMI at end of tx (P < 0.01) Worse 

6 yr FU 

Binge in mo before tx (P < 0.05) Worse 

Other mental dx prior to tx (P < 0.05) Worse 

Low body wt at end of tx (P < 0.05) Worse
C-826 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

Design: 

Case series 

Comparison 

Group: 

No

Location: 

Massachusetts, 

USA 

Yrs followed: 

Mean: 8.6 

To determine 

predictors of 

serious 

suicide 

attempts in 

women with 

AN and BN. 

Inclusion: 

Female, English speaking, 

meet full criteria for AN and/or 

BN, at least 12 yrs of age, 

reside within 200 miles of the 

study site. 

Exclusion: 

Organic brain syndrome or 

terminal illness. 

Recruitment: 

554 consecutive women who 

sought tx for eating disorder at 

Massachusetts General 

Hospital or other Boston area 

clinics between October 1987 

and June 1990. 

Sample Size 

Initial Sample: 

Met dx criteria: N = 268 

Agreed to participate: N = 229 

Additional participants 

identified: N = 21 

Reasons for loss to FU: 

Drop out prior to first FU: N = 4 

Analysis Sample 

N = 246 

AN-Restricting: 51 

AN-Binge Purge: 85 

BN: 110 

Mean Age: 

24.8 (range: 13 – 45) 

at entry to the study. 

Sex: 

Female:100% 

Race/ethnicity: 

Non-Caucasian: 4% 

Mean duration of 

illness: 

6.7 yrs 

(range: 3 mos – 21 yrs) 

Score: 

Good 

Method of dx: 

LIFE-EAT-II and the 

PSR scale 

Funding: 

NIMH, Rubenstein 

Foundation, and 

Harvard Eating 

Disorders Care 
C-827 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU interviews conducted every 6 – 12 

mos in person when possible. 

Statistical Methods 

Non-parametric tests to examine diff on 

self-report measures administered at 

intake between subjects who made 

suicide attempts and those who did not. 

Kaplan-Meier survival analyses to 

determine time to first suicide attempt, 

and time-varying proportional hazards 

(Cox) regression models used to 

determine influence of baseline and 

course variables on time to first suicide 

attempt. 

Multiple regression to predict time to 

first suicide attempt. 

Descriptive Results 

Baseline, Reported hx of suicide attempts prior to study entry: 

AN: 30.1% 

BN: 22.7% 

Rates of suicide attempts: 

AN: 30 (22.1%) 

BN: 12 (10.9%) 

Death from suicide: N = 4 (none had a previous suicide attempt). 

Diff between baseline self report measures for suicide attempters and 

non-attempters, mean (SD): 

AN 

EDI, drive for thinness (P = NS) 

EDI, Bulimia (P = NS) 

EDI, body dissatisfaction (P = NS) 

EDI, ineffectiveness: 

• attempters: 15.2 (8.6) 

• non-attempters: 11.4 (7.8) 

• (P = 0.04); Attempters did worse 

EDI, perfectionism (P = NS) 

EDI, interpersonal distrust (P = NS) 

EDI, interoceptive awareness (P = NS) 

EDI, maturity fears (P = NS) 

BDI: 

attempters: 27.6 (12.1) 

non-attempters: 22.7 (11.3) 

(P = 0.05). Attempters had greater depression. 

Symptom distress (P = NS) 

Global severity index (P = NS) 

Positive symptom total (P = NS) 

BN 

EDI, drive for thinness (P = NS) 

EDI, Bulimia (P = NS) 

EDI, body dissatisfaction (P = NS) 

EDI, ineffectiveness: 

• attempters: 14.6 (7.1) 

• non-attempters: 8.4 (6.1) 

• (P = 0.007); Attempters did worse 

EDI, perfectionism (P = NS) 

EDI, interpersonal distrust: 

• attempters: 7.1 (4.0) 

• non-attempters: 4.5 (3.4) 

• (P = 0.04). Attempters did worse. 

EDI, interoceptive awareness 

• attempters: 17.7 (7.6) 

• non-attempters: 10.9 (5.9) 

• (P = 0.003). Attempters did worse 

EDI, maturity fears: 

• attempters: 7.6 (7.3) 

• non-attempters: 3.7 (4.3) 

• (P = 0.03). Attempters did worse. 
C-828 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

(continued) 

 
C-829 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

BDI: 

attempters: 27.0 (11.7) 

non-attempters: 19.6 (9.5) 

(P = 0.03). Attempters had greater depression. 

Symptom distress: 

• attempters: 2.2 (0.46) 

• non-attempters: 1.9 (1.4) 

• (P = 0.006). Attempters did worse 

Global severity index: 

• attempters: 1.6 (0.49) 

• non-attempters: 1.0 (0.54) 

• (P = 0.002). Attempters did worse. 

Positive symptom total: 

• attempters: 64.0 (11.7) 

• non-attempters: 47.7 (18.0) 

• (P = 0.003). Attempters did worse. 

Multivariate Results 

Predictors of time to first suicide attempt during course of studyhypothesis testing results: 

AN 

Hx of suicide attempt at intake (P < 0.009) 

Eating disorder symptomatology (P = NS) 

Severity of drug use (P < 0.01) 

Alcohol use (P = NS) 

BN 

Laxative use (P < 0.05) 

Hx of drug use disorder prior to start of the study (P < 0.01) 

AN 

Hx of suicide attempt at intake: HM = 1.09, 95% CI (1.31 – 6.71) (P = 

0.009); Shorter time to first attempt 

Drug use: HM = 0.92, 95% CI (1.40 – 4.52) (P = 0.01); Greater use 

shorter time 

Individual therapy: HM = 3.54, 95% CI (1.20 – 10.42) (P = 0.013); Yes, 

shorter time 

Neuroleptic meds: HM = 5.03, 95% CI (1.50 – 16.86) (P = 0.02); Yes, 

shorter time 

Age of onset: HM = 1.06, 95% CI (1.00 – 1.12) (P = 0.05); Older age, 

shorter time 

Group therapy: HM = 2.35, 95% CI (1.00 – 5.53) (P = 0.06) 

Severity of depression: HM = 1.21, 95% CI (0.99 – 1.50) (P = NS) 

Alcohol use: HM = 1.54, 95% CI (0.99 – 1.04) (P = NS) 
C-830 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

(continued) 

 
C-831 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

BN 

Group therapy: HM = 11.32, 95% CI (2.33 – 55.02) (P = 0.002) 

Yes, shorter time 

Age of onset: HM = 0.82, 95% CI (0.70 – 0.97) (P = 0.008) 

Younger age, shorter time 

Hx of drug use disorder: HM = 8.94, 95% CI (1.87 – 42.77) (P = 0.009) 

Greater hx, shorter time 

Individual therapy: HM = 10.39, 95% CI (1.03– 105.12) (P = 0.020) 

Yes, shorter time 

Paranoid personality disorder at intake: HM = 66.5, 95% CI (3.60 – 

129.84) (P = 0.020) 

Yes, shorter time 

Severity of laxative use: HM = 1.21, 95% CI (1.50 – 46.30) (P = 0.022) 

More, shorter time 

Psychiatric hospitalization: HM = 10.75, 95% CI (1.16 – 99.86) (P = NS) 
C-832 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Gillberg, 

Råstam, and 

Gillberg, 1995 

Companion 

article: 

Gillberg, 

Råstam, 

Gillberg, 1994 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteburg, 

Sweden 

Yrs followed: 

6.7 from onset 

of AN (6.3-7.0) 

Cases: 4.9 

from first exam 

Comparisons: 

4.6 from first 

exam 

To analyze 

stability of 

personality 

disorders over 

a 6-yr period 

after reported 

AN onset 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, 

sex, school 

Exclusion: 

Cases: None 

Comparisons: None 

Recruitment: 

Cases: From total 

population of Göteburg, 

Sweden, born in 1970 and 

developing AN before age 

18; pooled with second 

population screening 

sample reported by school 

and hospital health care 

workers during FU. Some 

clinically referred and some 

screened through school 

nurses and doctors, 

pediatricians, and child 

psychiatrists 

Comparisons: Same 

schools as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Age, mean (95% CI): 

Cases: 21.0 (20.5-21.4) 

Comparisons: 20.8 (20.3-21.3) 

Sex: 

Women in AN sample: N = 48 

Race/ethnicity: 

NR 

Age of AN onset, mean 

(range): 

14.3 (13.9-14.7) 

Score: 

Good 

Method of dx: 

Structured 

interview using 

the SCID-I 

Funding: 

Swedish 

Medical 

Research 

Council, 

Swedish Social 

Research 

Council, Swen 

Jerring 

Foundation, 

Fulbright 

Commission, 

Wilhelm and 

Martina 

Lundgren 

Foundation, 

Sennerdahl 

Foundation 
C-833 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Psychiatric interview, blinded to original 

disease status. Performed the SCID-II, 

Dewey Social Awareness Test, 

examined individual 

neurodevelpmentally/ neuro-logically, 

and administered the Wechsler Adult 

Intelligence Sale-Revised. 

Statistical Methods: 

Chi-square comparisons 

Descriptive Results 

AN Recovery (self report): 47% 

Comparison of Personality Disorders between AN and control group at 

age 21 (mean of 6 yrs after onset) 

Cluster A 

All categories (P = NS) 

Cluster B 

All categories (P = NS) 

Cluster C 

Avoidant: Cases (14%) Comparison (2%) (P < 0.07) 

Dependent (P = NS) 

Obsessive-compulsive: Cases (29.5%) Comparison (6%) (P < 0.001) 

Passive-aggressive (P = NS) 

Any cluster C: Cases (37%) Comparison (10%) (P < 0.001) 

Other 

Self-defeating (P = NS) 

Any SCID personality disorder: Cases (41%) Comparison (18%) (P < 

0.02) 

2 or more SCID personality disorders: Cases (23.5%) Comparison (2%) 

(P < 0.01) 

Comparison of Autism Spectrum Disorders and Empathy Disorders 

Asperger’s syndrome: Cases (12%) Comparison (0%) (P < 0.05) 

Any autistic like condition: Cases (20%) Comparison (0%) (P < 0.001) 

Empathy disorder: Cases (29.5%) Comparison (4%) (P < 0.002) 

OCD/OCPD/Asperger syndrome/autistic-like condition at both 16 and 21: 

Cases (N = 23) Comparison (N = 2) (P < 0.01) 

Concurrence of Axis II and Axis I Disorders 

No axis II/ASD-no axis I: Cases (25.5%) Comparison (70%) (P < 0.0001) 

No axis II/ASD-at least 1 axis I (P = NS) 

At least 1 axis II/ASD-at least 1 axis I: Cases (31%) Comparison (12%) (P 

< 0.01) 

At least 1 axis II/ASD-no axis I (P = NS) 
C-834 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Gillberg, 

Råstam, 

Gillberg 1994 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteburg, 

Sweden 

Yrs followed: 

6.7 from onset 

of AN (6.3-7.0) 

Cases: 4.9 

from first exam 

Comparisons: 

4.6 from first 

exam 

To analyze 

whether in the 

intermediateterm, outcome 

is worse in AN 

than 

comparisons; 

to evaluate the 

contribution of 

empathy deficit 

associated 

with AN to 

outcomes; to 

compare AN 

outcome in this 

sample to 

those of 

previous 

studies using 

the M-R scales 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, sex, 

school 

Exclusion: 

Cases: None 

Comparisons: None 

Recruitment: 

Cases: From total pop of 

Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: Same schools 

as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Age of AN onset: 

14.3 yrs 

Range: 13.9-14.7 

Mean Age at First 

Exam: 

Cases: 16.1 (95% CI: 

15.7-16.5) 

Comparisons: 16.0 

(95% CI: 15.5-16.5) 

Mean Age at FU: 

Cases: 21 (95% CI: 

20.5-21.4) 

Comparisons: 20.8 

(95% CI: 20.3-21.3) 

Sex (both groups), N: 

Females: 96 

Males:6 

Race/ethnicity: 

NR 

Min BMI kg/m2, mean: 

Cases: 14.9 (2.6) 

Comparisons: NR 

BMI at first exam, 

kg/m2, mean: 

Cases: 18.3 (2.9) 

Comparisons: NR 

BMI at FU, kg/m2, 

mean: 

Cases: 21.2 (3.5) 

Comparisons: NR 

Score: 

Good 

Method of dx: 

Structured interview 

using the SCID-I 

Funding: 

NR 
C-835 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

At time of dx, all participants, then 

children and adolescents, and their 

mothers were interviewed by a 

psychiatrist. At FU, both groups were 

screened by another 

psychiatrist/psychologist blind to the 

original group status, via SCID-II for 

personality disorder dx, clinician-based 

capacity for empathy, Dewey social 

awareness test, neurological testing, 

WAIS-R, wt, and ht (self-report). All 

individuals also examined by 

psychiatrist to administered the first 

interview, using SCID-I for Axis I 

disorders, the M-R AN outcome scales 

and a rating of empathic skills. At end of 

interview, DSM III-R dx made 

independently by both clinicians; 

empathy dx was made conjointly by 

both. 

Outcome measures 

Recovered/not-recovered for individuals 

dx in teenage yrs (interview data from 

M-R scale), 

Avgd scale scores according to MorganRussell interview 

Good, intermediate and poor outcome: 

good = nrml body wt (100 +- 15%avg 

body wt.), 

Intermediate = normal or near normal wt 

and/or menstrual abnormalities, poor = 

low wt and absent or scanty 

menstruation. (BMI or % wt details 

regarding these definitions were NR). 

Statistical Methods: 

Chi square tests for matched pairs were 

used. 

Descriptive Results 

Recovery status AN group, Morgan Russell self-progress rating: 

Recovered: 47%

Not-recovered: 53% 

Not recovered but improved: 39% 

Not recovered but static: 12% 

Not recovered and worse: 2% 

Some type of ED in AN group: 44% 

Avg total M-R Scores: 

Cases: very poor: 39% (avg score of 8.5 or less) 

Good-Intermediate and Poor Outcome for AN group: 

Good: 41% 

Intermediate: 35% 

Poor: 24%

Dietary Restriction and concern about body wt, M-R scale: 

Dietary Restriction 

None: Cases: 47%, Comparisons: 88% 

Less than 1⁄2 timeCases: 18%, Comparisons: 12% 

About 1⁄2 timeCases: 6%, Comparisons: 0 

More than 1⁄2 timeCases: 4% Comparisons: 0 

All the timeCases: 26% Comparisons: 0 

Diff between groups (P < 0.001) 

Worry about body wt or appearance 

None: Cases:16% Comparisons: 57% 

Less than 1⁄2 timeCases: 35% Comparisons: 31% 

About 1⁄2 timeCases: 2% Comparisons: 8% 

More than 1⁄2 timeCases: 10% Comparisons: 0 

All the timeCases:37% Comparisons: 4% 

Diff between groups (P < 0.001) 

Body wt during last 6 mos: 

Near avg all timeCases: 53% Comparisons:96% 

Usually near avg, but occasionally deviant: Cases: 16% Comparisons: 4% 

Always deviated: Cases: 18% Comparisons: 0 

Always much deviated: Cases: 14% Comparisons: 0 

Diff between groups (P < 0.001) 

Menstruation: 

Cases: halted menstruation never returned: 8%, Regular or cyclical 

menarche: 50% 

Comparisons: Regular or cyclical menarche: 90% 

Diff between groups (P < 0.001) 

AN group tx type (specifically for ED) and outcome status: 

Poorest outcome: 5 had no tx, 10 had only psychiatric tx (2, outpatient 

only; 9, family therapy, 1, individual psychotherapy). 

Best outcomes, 3 no tx, 3 pediatrician support and zinc supplements, 2 

met with psychiatrist ( < 8 times), 7 received therapy (>8 times) 

Diff between groups (P = NS) 
C-836 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Gillberg, 

Råstam, and 

Gillberg 1994 

Companion 

article: 

Gillberg, 

Råstam, and 

Gillberg 1995 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteburg, 

Sweden 

Yrs followed: 

6.7 from onset 

of AN (6.3-7.0) 

Cases: 4.9 

from first exam 

Comparisons: 

4.6 from first 

exam 

To analyze the 

associated 

physical and 

neurodevelopmental 

problems over 

5 yrs in 

individuals with 

AN, and 

matched 

comparisons. 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, sex, 

school 

Exclusion: 

Cases: None 

Comparisons: None 

Recruitment: 

Cases: From total pop of 

Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: Same schools 

as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Age of AN onset: 

14.3 yrs 

Range: 13.9-14.7 

Mean Age at First 

Exam: 

Cases: 16.1 95% CI 

(15.7-16.5) 

Comparisons: 16.0 

95% CI (15.5-16.5) 

Mean Age at FU: 

Cases: 21 

95% CI (20.5-21.4) 

Comparisons: 20.8 

95% CI (20.3-21.3) 

Sex (both groups), N: 

Females: 96 

Males:6 

Race/ethnicity: 

NR 

Score: 

Good 

Method of dx: 

Structured interview 

using the SCID-I 

Funding: 

NR 
C-837 

 Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

At time of dx, all participants, then 

children and adolescents, and their 

mothers were interviewed by a 

psychiatrist. At FU, another 

psychiatrist/psychologist blind to the 

original group status, screened both 

groups: via SCID-II for personality 

disorder dx, clinician-based capacity for 

empathy, Dewey social awareness test, 

neurological testing, WAIS-R, wt, and ht 

(self-report). All individuals also 

examined by psychiatrist who 

administered first interview, using SCID-I 

for Axis I disorders, M-R AN outcome 

scales, and a rating of empathic skills. At 

end of interview, DSM III-R dx made 

independently by both clinicians; 

empathy dx was made conjointly by both. 

Neurodevelopmental exam included 

growth charts of wt and ht development 

from age 7 through time of 1st exam; wt 

and ht immediately before onset of AN 

were compared to FU data 

Outcome measures 

At 16 yrs: Extreme underwt = BMI≤17; 

Extreme overwt = BMI ≥25. 

At 21 yrs: Extreme underwt = lowest wt 

≤45kg; Extreme overwt = heaviest ≥80kg. 

Extreme shortness was dx in individuals 

who were shorter than the shortest 

individual in the comparison group. 

Statistical Methods: 

Wilcoxon test for matched pairs were 

used. 

Descriptive Results 

Wt at first screen, kg (SD): 

Cases: 49.4 (8.8), 95% CI (47.0-51.8) 

Comparisons: 56.2 (6.6), 95% CI (54.4-58.0) 

Diff between groups (P < 0.01) 

Wt at FU, kg (SD): 

Cases: 58.9 (6.6), 95% CI (54.4-58.0) 

Comparisons: 58.2 (7.9), 95% CI (58.2-62.6) 

Diff between groups (P = NR) 

Ht at first screen, cm (SD): 

Cases: 164.3 (5.8), 95% CI (162.7-165.9) 

Comparisons: 166.7 (6.9), 95% CI (164.8-168.8) 

Diff between groups (P = NS) 

Ht at FU, cm (SD): 

Cases: 166.2 (6.4), 95% CI (164.4-168.8) 

Comparisons: 169.1 (6.8), 95% CI (167.2-171.0) 

Diff between groups (P < 0.05) 

BMI at first screen, kg/m2 (SD): 

Cases: 18.3 (2.9) 95% CI (17.5-19.1) 

Comparisons: 20.2 (1.9) (95% CI (19.7-20.8) 

Diff between groups (P = NS) 

BMI at FU, kg/m2 (SD): 

Cases: 21.2 (3.5) 95% CI (20.2-22.2) 

Comparisons: 21.2 (2.3) 95% CI (20.5-21.8) 

Diff between groups (P = NS) 

Extremely Underwt at first screen: 

G1: 15 

G2: 1 

Diff between groups (P < 0.001) 

Extremely Underwt at FU: 

G1: 4 

G2: 0 

Diff between groups (P < 0.05) 

Extremely Overwt at first screen: 

G1: 1 

G2: 0 

Diff between groups (P = NR) 

Extremely Overwt at FU: 

G1: 3 

G2: 0 

Diff between groups (P < 0.05) 

Extremely Short at first screen: 

G1: 0 

G2: 0 

Diff between groups (P = NS) 
C-838 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Gillberg, 

Råstam, 

Gillberg 1994 

(continued) 

 
C-839 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

At time of dx, all participants, then children 

and adolescents, and their mothers were 

interviewed by a psychiatrist. At FU, 

another psychiatrist/psychologist blind to 

the original group status, screened both 

groups: via SCID-II for personality disorder 

dx, clinician-based capacity for empathy, 

Dewey social awareness test, neurological 

testing, WAIS-R, wt, and ht (self-report). All 

individuals also examined by psychiatrist 

who administered first interview, using 

SCID-I for Axis I disorders, M-R AN 

outcome scales, and a rating of empathic 

skills. At end of interview, DSM III-R dx 

made independently by both clinicians; 

empathy dx was made conjointly by both. 

Neurodevelopmental exam included growth 

charts of wt and ht development from age 7 

through time of 1st exam; wt and ht 

immediately before onset of AN were 

compared to FU data 

Outcome measures 

At 16 yrs: Extreme underwt = BMI≤17; 

Extreme overwt = BMI ≥25. 

At 21 yrs: Extreme underwt = lowest wt 

≤45kg; Extreme overwt = heaviest ≥80kg. 

Extreme shortness was dx in individuals 

who were shorter than the shortest 

individual in the comparison group. 

Statistical Methods: 

Wilcoxon test for matched pairs were used. 

Extremely Short at FU: 

G1: 6 

G2: 0 

Diff between groups (P < 0.05) 

Physical Disorders: 

Diff between groups at baseline or FU (P = NS) 

Neurodevelopmental: 

Fine and gross motor skills, tremor, mirror movements, handedness (P 

= NS) 

Dysdiadochokinesis, at both time patients: 

G1: 10 

G2: 1 

Diff between groups (P < 0.01) 

In terms of outcome, 20 AN individuals had “poor outcome” based on 

the Morgan Russell scale. Of those, 8 were dysdiadochokinesis group

(P = NS). 
C-840 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Gowers et al., 

2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Britian 

Yrs followed: 

G1: 2 

G2: 3 to 7 

To clarify the 

relationship

between a 

range of 

presenting 

features, tx 

received, and 

medium to 

long-term 

outcome in 

AN. 

Inclusion: 

DSM III-R criteria for AN 

Exclusion: 

NR 

Recruitment: 

75 consecutive cases of 

adolescent-onset AN were 

drawn from a series attending 

a regional adolescent service. 

Of these, G1: 35 had 

participated in a prospective 

study of family values in AN 

and G2: 40 were immediately 

preceding cases presenting to 

the department 

Sample Size: 

Initial sample: 

N = 75 

Reasons for loss to FU: 

Insufficient information: N = 1 

Deceased: N = 2 

Analysis sample: 

N = 73 

Full outcome (including ht and 

wt) available for 56 

Mean Age 

15.2 

G1: 14.10 

G2: 15.6 

Sex: 

Males: N = 4 (all from 

G1) 

Females: N = 71 

Race/ethnicity: 

NR 

Length of Illness 

(mos): 

13.0 

G1: 14.1 

G2: 12.0 

Wt, as % of expected 

wt: 

76.5 

G1: 78.2 

G2: 75.1 

M-R Global 

Assessment Score: 

4.61 

G1: 5.05 

G2: 4.24 

Subtype, Restricting, 

N: 44 

G1: 21 

G2: 23 

Purging: 

N: 31 

G1: 14 

G2: 17 

Score: 

Poor 

Method of dx: 

G1: K-SADS 

diagnostic 

interview 

G2: clinical 

assessment 

Funding: NR 

Funding: 

NR 
C-841 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Interviews in-person or by telephone. Some 

interviews with relatives or physician 

informants. Calculation of M-R Global 

Assessment Score 

Outcome categories 

Good: wt maintained > 85% expected body 

wt, menstruation resumed and social 

functioning satisfactory; M-R Global 

Assessment Score ≥ 9

Intermediate: substantial improvement in 

ED obtained with wt maintained > 85% of 

expected wt, but either menstruation not 

resumed or sig concern about eating and 

wt or was another psychosocial difficulty; 

M-R Global Assessment Score 6 – 9 

Poor: still suffering ED and wt maintained < 

85%; M-R Global Assessment Score < 6: 

15 (20.0%) 

Statistical Analyses 

Data were examined for diffs between the 

two series on key presentation variables 

using ANOVA and chi square. 

Stepwise multiple regression to determine 

the relationship between covarying 

predictor variables with M-R Global 

Assessment Score at FU. 

Descriptive Outcomes 

M-R Global Assessment Score Outcomes: 

Good:45.3% 

Intermediate:30.7% 

Poor: 20.0% 

Inadequate Information: 4.0% 

Descriptive variables by outcomes: 

Age at onset, mean, yrs, mos: 

Good: 14, 3 

Intermediate: 13, 10 

Poor: 13, 11 

Diff between groups (P = NS) 

Length of illness, mean, mos: 

Good: 11.1 

Intermediate: 14.5 

Poor: 15.3 

Diff between groups (P = NS) 

Wt as % of mean matched population wt: 

Good: 81.3 

Intermediate: 73.3 

Poor: 70.7 

Diff between groups (P = 0.001) 

Higher wt associated with better outcome 

Presenting M-R Global Assessment Scale: 

Good: 5.3 

Intermediate: 4.15 

Poor: 3.68 

Diff between groups (P = 0.001) 

Higher MRGAS associated with better outcome 

Never an inpatient: 

Good: 31 

Intermediate: 13 

Poor: 7 

Diff between groups (P = 0.001) 

Never inpatient associated with better outcome 

Multivariate Results 

Predictors of M-R Global Assessment Scale score in step-wise 

regression 

Inpatient admission (P = 0.0006) 

Presenting MRGAS (P = 0.001) 
C-842 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Halmi, Eckert 

et al., 1991

Companion 

article: 

Schork et al., 

1994 

Design: 

Case series 

Comparison 

Group: 

Yes 

Location: 

USA (Iowa 

City, IA; 

Minneapolis, 

MN; White 

Plains, NY 

Years 

followed: 

10 

To determine 

the prevalence 

of lifetime and 

current 

psychiatric 

diagnoses in 

AN patients 

compared to 

comparisons. 

Inclusion: All patients met 

modified Feighner diagnostic 

criteria for AN. Other details in 

Halmi et al., 1979. 

Comparisons matched patients 

on age, sex, and 

socioeconomic class. 

Exclusion: 

Hx of eating disorder or body 

weight above normal range for 

comparisons; See Halmi et al., 

1979, for more details. 

Recruitment: 

Cases had previously 

participated in a 35-day 

hospital tx study comparing 

behavior therapy 

vs.medication 

(cyproheptadine). 

Comparisons recruited via 

advertisements in local 

newspapers and on local 

college campuses. 

Sample Size (N): 

Completed tx: 76 

Completed FU: 

Patients: 62 

Comparisons: 62 

Patients’ mothers: 57 

Patients’ fathers: 49 

Comparisons mothers: 57 

Comparisons fathers: 49 

Reasons for Loss to FU: 

9 refused to participate, 5 

deceased (causes unknown). 

Mean Age, yrs 

(SD): 

Pre-tx: 20 (5.2) 

10 yr FU: 29 (5.2) 

Sex: 

Female 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of diagnosis: 

Prospective 

assessment using 

Feighner criteria; 

retrospective DSM-III-R. 

Funding: 

NR 
C-843 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

For General Psychiatric diagnoses: Diagnostic 

Interview Schedule (Version III) used to interview 

patients, comparisons, and parents of both patients 

groups. Results were computer-scored, yielding a 

positive or negative score on every diagnosis for 

each subject. Any dx within the past year was 

considered ‘current’. A positive dx of a drug or 

alcohol disorder was made for “abuse without 

dependence”, “dependence without abuse”, abuse, 

and dependence. Obsessive-compulsive behaviors 

concerning food, weight, or body image were 

excluded as positive evidence of criteria for 

obsessive-compulsive behaviors. The Research 

Diagnostic Criteria-Family History (RDC-FH) method 

was used to obtain psychiatric dx of first-degree 

relatives from mothers of patients and comparisons. 

For ED dx at FU: A structured ED history was 

created from detailed information about binge 

frequency, laxative and diuretic abuse, typical 

anorectic attitudes, menstrual function, and weight 

changes. 

Pearson’s Chi-square test was used to compare 

differences in the prevalence of psychiatric disorders 

between patients and comparisons. 

Descriptive Findings: 

Eating Disorder Dx at 10-yr FU: 

AN =2, BN = 2, normal weight bulimia (NWB) = 14, ED-NOS 

= 24, no ED = 17. 

Lifetime DSM-III-R Dx in Patients by Dx at 10 yr FU and in 

Matched Comparisons, N: 

Any Affective Disorder: 

Patients: 52; Comparisons: 14 

Diff between groups (P = NR) 

Major depression: 

Patients: 42; Comparisons: 13 

Diff between groups (P < 0.01) 

Mania: 

Patients: 2; Comparisons: 1 

Diff between groups (P = NS) 

Dysthymia: 

Patients: 20; Comparisons: 2 

Diff between groups (P < 0.01) 

Bipolar: 

Patients: 2; Comparisons: 0 

Diff between groups (P = NS) 

Atypical Bipolar: 

Patients: 6; Comparisons: 0 

Diff between groups (P < 0.01) 

Anxiety Disorders: 

Patients: 40; Comparisons: 13 

Diff between groups (P = NS) 

Obsessive-compulsive: 

Patients: 16; Comparisons: 4 

Diff between groups (P < 0.01) 

Agoraphobia: 

Patients: 9; Comparisons: 2 

Diff between groups (P < 0.05) 

Simple phobia: 

Patients: 8; Comparisons: 9 

Diff between groups (P = NS) 

Social phobia: 

Patients: 21; Comparisons: 2 

Diff between groups (P < 0.01) 

Panic: 

Patients: 5; Comparisons: 0 

Diff between groups (P = NS) 

Schizophrenia: 

Patients: 4; Comparisons: 0 

Diff between groups (P = NS)

Alcohol abuse: 

Patients: 5; Comparisons: 9 

Diff between groups (P = NS) 

Cannabis abuse: 

Patients: 8; Comparisons: 15 

Diff between groups (P = NS) 

Amphetamine abuse: 

Patients: 1; Comparisons: 5 

Diff between groups (P = NS) 
C-844 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Halmi, Eckert 

et al., 1991

(continued) 

 
C-845 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Barbiturates: 

Patients: 0; Comparisons: 2 

Diff between groups (P = NS) 

Opioids: 

Patients: 0; Comparisons: 1 

Diff between groups (P = NS) 

Hallucinogens: 

Patients: 0; Comparisons: 1 

Diff between groups (P = NS) 

Antisocial personality: 

Patients: 0; Comparisons: 2 

Diff between groups (P = NS) 

Tobacco: 

Patients: 9; Comparisons: 11 

Diff between groups (P = NS) 

Psychosexual dysfunction: 

Patients: 28; Comparisons: 16 

Diff between groups (P < 0.05) 

Homosexual: 

Patients: 0; Comparisons: 1 

Diff between groups (P = NS) 

Comorbid DSM-II Dx at 10 yr FU, N (%): 

No Dx: 

Patients: 29 (46.8); Comparisons: 40 (64.5) 

Diff between groups (P < 0.05) 

Major depression: 

Patients: 18 (29.0); Comparisons: 4 (6.4) 

Diff between groups (P < 0.01) 

Obsessive-compulsive: 

Patients: 7 (11.3); Comparisons: 1 (1.6) 

Diff between groups (P < 0.05) 

Phobia: 

Patients: 15 (24.2); Comparisons: 8 (12.9) 

Diff between groups (P = NS) 

Mania: 

Patients: 1 (1.6); Comparisons: 1 (1.6) 

Diff between groups (P = NS) 

Dysthymia: 

Patients: 15 (24.2); Comparisons: NR 

Bipolar: 

Patients: 2 (3.2); Comparisons: 0 (0) 

Diff between groups (P = NS) 

Panic disorder: 

Patients: 3 (4.8); Comparisons: 1 (1.6) 

Diff between groups (P = NS) 

Alcohol abuse: 

Patients: 2 (3.2) Comparisons: 4 (6.4) 

Diff between groups (P = NS) 

Schizophrenia: 

Patients: 2 (3.2); Comparisons: 0 (0) 

Diff between groups (P = NS) 

Tobacco: 

Patients: 9 (14.5); Comparisons: 8 (12.9) 

Diff between groups (P = NS) 
C-846 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Halmi, Eckert 

et al., 1991

(continued) 

 
C-847 

Evidence Table 15. Anorexia Nervosa Outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Substance abuse: 

Patients: 0 (0); Comparisons: 2 (3.2) 

Diff between groups (P = NS) 

Antisocial personality disorder: 

Patients: 0 (0); Comparisons: 2 (3.2) 

Diff between groups (P = NS) 

Gambling: 

Patients: 0 (0); Comparisons: 1 (1.6) 

Diff between groups (P = NS) 

Homosexuality: 

Patients: 0 (0); Comparisons: 1 (1.6) 

Diff between groups (P = NS) 

Affective disorders: 

No-ED group better than normal weight bulimics (P = 0.003). 

Dysthymia: 

No-ED group better than normal weight bulimics (P = 0.02). 
C-848 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Halvorsen, 

Anderson, and 

Heyerdahl, 

2004 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Drammen, 

Norway 

Yrs followed: 

8.8 (3.4) 

(3.5-14.5) 

To investigate 

the 

intermediate to 

long-term 

outcome of 

adolescent 

onset AN in a 

group referred 

to child and 

adolescent 

psychiatric 

services. 

Inclusion: 

Females 

DSM IV for AN 

Referred by a physician and 

accept for tx at Buskerud 

Hospital 

Exclusion: 

None stated 

Recruitment: 

Females who where dx’ed with 

AN and admitted to Child and 

Adol Psychiatry program at 

Buskerud Hospital from 1986-

1998. These former patients 

contacted to participate in FU 

study. 

Sample size: 

Initial sample: 

(N = 55) 

Reasons for loss to FU: 

Refusal to participate (N = 4) 

Analysis sample: 

(N = 51) 

Interviewed (N = 47) 

Patients complete 

questionnaire: 

(N = 2) 

Parents complete 

questionnaire (N = 2) 

Mean Age at tx start 

(SD) 14.9 (1.7) yrs 

Range: 9.2-17.8 

Sex: 

Female 100% 

Race/ethnicity: 

NR 

Mean BMI (kg/cm2

) at 

tx start (SD) 

15.1 (1.5) 

Mean wt loss at tx 

start (SD) 

23.2% (8.2) 

Mean wt loss at tx 

start corrected for 

increase in ht. (SD) 

24.4% (7.7) 

Duration of sx before 

tx start (SD) 

11.2 (6.7) mos 

Age onset (SD) 

14.0 (1.7) yrs 

Range: 8.2-16.8 

Lowest BMI during tx 

(kg/cm2

) (SD) 

14.8 (1.6) 

Onset prior to 

menarche: 

24% 

Vomit before or during 

tx: 

28% 

SES background 

Upper: 16 (31%) 

Middle: 22 (43%) 

Lower: 13 (25%) 

Age at FU 

23.8 (3.4) yrs 

Patients in family tx 

51 (100%) 

Patients in ind. 

psychotx. 

17 (33%) 

Pt hospitalized in 

pediatric ward: 

61% 

Score: 

Fair 

Method of dx: 

DSM IV criteria for 

AN, BN, EDNOS 

from EDE info and 

body wt. 3 

experienced 

specialists 

conducted 

interviews. 

Where no 

interview, 

questionnaire and 

telephone interview 

with patient or 

parent 

Funding: 

Norwegian 

Research Council, 

the Norwegian 

Foundation for 

Health and 

Rehabilitation, the 

Regional Centre for 

Child and Adol 

Psychiatry, 

Regions East and 

South, and 

Buskerud Hospital. 
C-849 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Demographic and tx data obtained 

retrospectively from med. records. 

3 experienced specialist conducted semistructured interviews and patients completed 

questionnaire packets. Patients not 

interviewed were interviewed by telephone 

and completed questionnaires. Parents were 

interviewed when patients unavailable. 

Interviews: 

• Eating Disorder Examination 

• Mini International Neuropsychiatric 

Interview 

• Yale-Brown Obsessive Compulsive Scale 

• Global Assessment of Functioning 

Questionnaires 

• Eating Disorder Inventory (EDI) 

• Overall Life Satisfaction 

Statistical Methods: 

ANOVA and t-tests 

Wilcoxon (Mann-Whitney) 

Tukey HSD 

Chi-Square 

Pearson’s correlations 

Outcomes 

Recovered = no DSM IV dx for AN, BN, 

EDNOS based on EDE and wt. Where EDE 

not administered, dx based on telephone and 

questionnaires. 

M-R general outcome 

• Good – within 15% of ABW and normal 

menstruation 

• Intermediate – wt below 15% of ABW or 

menstrual irregular 

• Poor – wt below 15% ABW, menstruation 

absent or nearly absent, or BN 

Descriptive Results: 

Outcomes: 

No ED at FU: 42 (82%) 

AN: 1 (2%) 

BN: 1 (2%) 

EDNOS: 7 (14%) 

Deaths: 0 

M-R Scale 

Good: N = 40 (80%) 

Intermediate: N = 8 (16%) 

Poor: N = 2 (4%) 

Psychiatric dx at FU: 

No dx including no ED N = 28 (55%) 

No dx excluding ED: N = 31 (61%) 

Depression: N = 11 (22%) 

Anxiety (not OCD): N = 13 (27%) 

OCD: N = 1 (2%) 

Post-traumatic stress disorder: N = 5 (10%) 

Tourettes: N = 1 (2%) 

Diff in psychiatric dx between patients with and without ED at 

FU: 

No DSM dx (excluding ED) (P = NS) 

Two or more dx: No ED at FU: 13%, ED at FU: 56% (P = 0.004) 

Depression: No ED at FU: 13%, ED at FU: 67% (P < 0.001) 

Anxiety disorder (except OCD): No ED at FU: 20%, ED at FU: 56% 

(P = 0.047) 

OCD (P = NS) 

Post-traumatic stress disorder (P = NS) 

Dissociative disorder (P = NS) 

Psychosis (P = NS) 

Tourettes (P = NS) 

GAF-S >80: Very good functioning: No ED at FU: 48%, ED at FU: 0 

(P = 0.008) 

GAF-F >80: Very good functioning: No ED at FU: 65%, ED at FU: 0 

(P = 0.001 

GAF-S Mod to severe problems: No ED at FU: 8%, ED at FU: 67% 

(P < 0.001) 

GAF-F Mod to severe problems (P = NS) 

Hx of suicide ideation (P = NS) 

Hx of suicide attempts (P = NS) 
C-850 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Hebebrand et 

al., 1997 

Design: 

Case series 

Comparison 

Group: 

No 

Setting: 

Marburg, 

Germany 

Yrs followed: 

Mean (SD): 

9.5 (5.3) 

Range: 0-33.6 

yrs 

To investigate 

whether AN 

patients with a 

low BMI at 

referral have 

low BMI at 

long-term FU 

Inclusion: 

DSM III-R AN, female 

Exclusion: 

24 males, 7 females with 

additional somatic diseases at 

referral, 7 females pretreated 

whose BMI at referral were > 

17.5 kg/m2

Recruitment: 

Composite of 5 study cohorts 

with a total of 341 

consecutively ascertained 

inpatients with AN. 

Initial sample size: 

N = 341 

Reasons for loss to FU: 

Excludes: N = 37 (see above) 

Deaths: N = 12 (10 due to 

emaciation after a mean of 4.2 

(4.0) yrs (range: 0-13) 

and 2 due to suicide) 

Other: N = 19 (Reasons NR)

Analysis sample size: 

N = 272 

Mean Age at referral: 

16.7 (4.5) 

Range: 

10-42 

Mean Age at FU: 

26.2 (6.9) 

Range: 

15-58 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of ED before 

referral, yrs, mean 

(SD) (range): 

BMI < 13 at referral: 

2.2 (3.3) (0 – 19) 

BMI ≥ 13 at referral: 

1.3 (1.73) (0 – 16) 

Diff between groups 

(P < 0.05) 

Score: 

Fair 

Method of dx: 

DSM III-R 

Funding: 

Deutsche 

Forschungsgemeins

chaft 
C-851 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Record review 

Statistical Methods 

Corrected for multiple U tests

Post hoc U; chi-square 

Fisher’s exact test 

Logistic regression 

Descriptive Results 

Correlation between BMI at referral and FU: r = 0.33 (P < 0.00001) 

BMI at FU, mean (SD) (range): 

BMI < 13 at referral 

18 (3.4) (9.5 – 25.3) 

BMI at FU, mean (SD) (range): 

BMI ≥ 13 at referral: 

20.0 (2.6) (13.4 – 27.1) 

Diff between groups at endpoint (P < 0.05) 

Mortality rate patients with BMI < 13 at referral: 11% (11/100 patients) 

Mortality rate patients ≥ 13 BMI at referral: 0.6% (1/172 patients) 

Diff between groups (P = 0.0001) 

Multivariate Results 

Predicting Lower BMI at FU: 

≤17.5 or > 17.5 (ICD-10 criteria for dx of AN) 

BMI at referral (P = 0.00002) Lower at referral predicts lower BMI at FU 

Age at referral (P = 0.03) Older at referral predicts lower BMI at FU 

Age at FU (P = 0.007) Younger at FU predicts lower BMI at FU 

Age at onset (P = NS) 
C-852 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Herzog, 

Schellberg, 

and Deter, 

1997 

Companion 

article: 

Deter and 

Herzog, 1994 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

Heidelberg, 

Germany 

Yrs followed: 

11.7 (2.43) 

Examine the 

time course 

structure of 

likelihood of 

first recovery 

periods for AN 

patients. 

Identify patient 

characteristics 

that influence 

the occurrence 

and timing of 

first recovery. 

Inclusion: 

Feighner criteria for AN and, 

later, DSM III-R criteria. 

Exclusion: 

None 

Recruitment: 

Patients who received 

inpatient tx at Dept. of General 

Clinical and Psychosomatic 

Medicine, U of Heidelberg 

Medical School between 1971-

1980 

Sample Size: 

Original Sample: 

(N = 88) (Feighner criteria) 

(N = 84) 4 excluded who did 

not meet DSM III-R criteria. 

Reasons for loss to FU: 

Death: 9 (7 due to AN 

complications, 2 suicides) 

Unavailable for examination 

(no explanation given): 5 

Incomplete data: 1 

Analysis sample size: 

(N = 69)

Mean Age at tx intake 

(SD): 

20.7 (4.1) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Avg. length of illness 

prior to study 

inclusion (SD): 

2.7 (3.9) yrs 

% ABW at study 

inclusion (SD) 

65.2 (9.9) 

Mean BMI at study 

inclusion (kg/m2

) (SD) 

13.3 (2.0) 

SES at study 

inclusion: 

Lower: 45.2% 

Middle: 48.0% 

Upper: 6.0% 

Score: 

Fair 

Method of dx: 

Feighner et al. 

(1972) criteria, 

confirmed using 

DSM III-R criteria, 6 

patients diagnosed 

AN retrospectively. 

Funding: 

German Ministry of 

Technology and 

Research 
C-853 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Treatment 

All patients had received 3 mo inpatient 

including individual psychotherapy with 

behavioral elements, psychodynamic 

elements, group psychotherapy, and 

counseling by a social worker. 

Study Methods: 

Predictor variables, collected at 

admission for inpatient tx include:

Social class, duration of illness, wt, 

purging, vomiting, laxative abuse, 

glucose, calcium, phosphate, albumin, 

creatinine, alkaline phosphatase, and the 

AN Symptom Score (Deter, 1992)

including psychological, social and 

physical subscores. 

FU assessments by physician or 

psychotherapist.

M-R outcome criteria obtained annually 

from general practitioner. Records of add 

hospitalizations, if reported by general 

physician or insurance carrier, were 

requested. 

Statistical Methods: 

Discrete-time Survival Analysis 

Outcomes 

M-R outcome criteria: 

Good: wt normal, menstruation regular 

Intermediate (wt < 85% ABW or 

amenorrhea 

Poor: wt < 85% ABW and amenorrhea 

Outcome assessment made based on 

lowest known wt and most unfavorable 

menstruation status of that yr. 

“First recovery” is first rating of ”Good” 

outcome. 

Descriptive Results: 

Recovery: 

Greater chance of recovery in first 6 yrs than in later period 

Recovery sooner than 6 yrs after first tx: 50% of patients 

Avg. patient in sample had first recovery by 5.8 yrs. 

Throughout 12 yrs, likelihood of recovery remained below 0.2. 

Avg duration to first recovery: 

Low serum ceatinine at baseline (.7 mg/dl): 3.3 yrs. 

Medium serum creatinine at baseline (1.1 mg/dl):6.1 yrs. 

High serum creatinine at baseline (1.5 mg/dl): > 11 yrs. 

Multivariate Results: 

Sig predictors of change over time in the likelihood of first 

recovery: 

Serum creatinine levels at baseline (P < 0.008) lower is better 

Purging behavior (P < 0.0049) less is better 

Purging and social ANSS interaction: (P < 0.04); less purging and fewer 

social disturbances is better 

Non purging patients with high or low social ANSS scores and purging 

patients with low social ANSS scores all had median survival time of 3.9 

-5.2. Purging patients with high social ANSS had different course with 

only 33% having a first recovery by 11 yrs. 
C-854 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, Yr: 

Herzog et al., 

1999 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA, 

USA 

Yrs followed: 

Median = 7.5; 

interviews 

conducted 

every 6 mos 

for 11 yrs 

To assess 

factors 

associated 

with recovery 

and relapse in 

AN and BN 

Inclusion: 

DSM III-R for AN and BN at tx 

intake (participants reclassified 

according to DSM IV criteria 

during the study); anorexic and 

bulimic episodes not separated 

by a period of remission of at 

least 8 wks duration. 

Exclusion: 

None 

Recruitment: 

Women who sought tx in 

eating disorder programs in 

Boston, MA between 1987 and 

1990. An additional 21 women 

with AN recruited in 1991. 

Sample size 

Initial sample size: 

ANR: 51 

ANBP: 85 

BN: 110 

Reasons for loss to FU: 

Drop outs: 17 

Died (dx group and reasons 

NR): 7 

Analysis sample size: 

NR 

Mean age at tx intake 

(SD): 

ANR: 23.9 (8.5) 

ANBP: 24.5 (5.9) 

BN: 25.5 (6.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at ED onset (SD): 

ANR: 17.5 (6.1) 

ANBP: 16.9 (4.7) 

BN: 19.4 (5.8) 

Proportion ABW: 

ANR: 0.73 (0.09) 

ANBP: 0.82 (0.10) 

BN: 1.03 (0.15) 

Lifetime hx major 

depression: 

ANR: 64.7% 

ANBP: 71.3% 

BN: 60.7% 

Lifetime hx Axis I: 

ANR: 62.7% 

ANBP: 78.1% 

BN: 74.1% 

Lifetime hx Axis II: 

ANR: 25.5% 

ANBP: 37.9% 

BN: 23.2% 

Lifetime hx substance 

use disorder: 

ANR: 5.9% 

ANBP: 16.1% 

BN: 12.3% 

Duration intake 

episode: 

ANR: 6.4 (6.7) 

ANBP: 7.6 (5.4) 

BN: 6.1 (6.3) 

Score: 

Good 

Method of dx: 

Modified version of 

Schedule for 

Affective Disorders 

and Schizophrenia 

– Lifetime version 

Funding: 

NIMH, Rubenstein 

Foundation, 

Harvard Eating 

Disorders Center 
C-855 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

FU interviews generally conducted by 

telephone by trained interviewers. 

Instruments included: Eating Disorders 

Longitudinal Interval FU Evaluation 

(LIFE-EAT-II)-semi-structured 

Statistical Methods: 

Survival analysis, proportional hazards 

(Cox) regression 

Outcome Categories: 

Full recovery (absence of symptoms or 

presence of only residual symptoms for 

at least 8 consecutive wks) at some 

point over 90 mos 

Partial recovery (reduction of symptoms 

to < full recovery for ≥ 8 consecutive 

wks 

AN Findings 

Descriptive Results 

Full recovery: 

33.7% 

At 2 yrs: ANR: 8%; ANBP: 13% 

At 7 yrs: ANR: 34%; ANBP: 32% 

Partial recovery: 

83.7% 

At 2 yrs: ANR: 61%; ANBP: 67% 

At 7 yrs: ANR: 83%; ANBP: 82% 

Median time to partial recovery (wks): 

ANR: 78; ANBP: 53 

Diff ANR and ANBP (P = NS) 

Relapse after full recovery: 

40% 

No remission through yr 7: 

ANR: 17% 

ANBP: 18% 

Multivariate Results 

Sig predictors of time to full recovery (adjusted): 

Percent of ABW at intake: HM = 250.1, 95% CI (6.90-9.066) heavier is 

better 

Duration of intake episode: HM = 0.89, 95% CI (0.81-0.96), shorter is better 

Sig predictors of time to partial recovery (adjusted): 

Duration of intake episode: HM = 0.63, 95% CI (0.45-0.87) Shorter is better 

Percent ABW at intake: HM = 18.89, 95% CI (0.32-1.105) Higher is better 

Hx of hospitalization: HM = 29.60, 95% CI (1.11-791.21) Fewer 

hospitalizations is better 

Hx of major depression: HM = 1.64, 95% CI (1.07-2.51) Not having major 

depression is better 

Duration of intake episode x proportion ABW: HM = 1.65, 95% CI (1.10-

2.47); ABW values >93% and shorter intake episode is better than ABW < 

93% and longer duration of intake episode 

Percent ABW x hx of hospitalization: HM = 0.007, 95% CI (0.0001-0.44); 

ABW values ≤ 69% and having hx of hospitalization is better than ABW > 

69% and no hx of hospiatlization 

BN Findings 

Descriptive Results 

Full recovery: 

73.8% 

At 2 yrs: BN: 53% 

At 7 yrs: BN 73% 
C-856 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, Yr: 

Herzog et al., 

1999 

(continued) 

 
C-857 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Partial recovery: 

99.0% 

At 2 yrs: BN: 88% 

At 7 yrs: BN: 98% 

Median time to partial recovery (wks): BN: 14 

Relapse after full recovery: 

35.3% 

Multivariate Results 

Sig predictors of time to full recovery: none identified 

Sig predictors of time to partial recovery: none identified 
C-858 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Herzog et al., 

1997 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

Germany 

Yrs followed: 

11.9 

Range: 9-18 

Examine 

relationship

between 

laboratory 

findings and 

AN disease 

outcomes 

Inclusion: 

Feighner criteria for AN and, 

later, DSM III-R criteria. 

Exclusion: 

None 

Recruitment: 

Patients who received 

inpatient tx at U of Heidelberg 

Medical School between 1971-

1980 

Sample Size: 

Original Sample: 

(N = 84) met Feighner and 

DSM III-R criteria for AN. 

Reasons for loss to FU: 

Missing lab data: 9 

Refused to participate: 9 

Analysis sample size: 

(N = 66) 

Mean Age at tx intake 

(SD): 

20.7 (6.0) 

Range: 15-36 

Mean Age at FU (SD): 

32.2 yrs 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

% ABW at study 

inclusion (SD) 

65.2 (9.9) 

Score: 

Poor 

Method of dx: 

Feighner et al. 

(1972) criteria, 

confirmed using 

DSM III-R criteria, 

method of making 

determination not 

reported 

Medical 

comorbidity was 

ICD-9 criteria 

Funding: 

German Ministry of 

Technology and 

Research 
C-859 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Treatment 

All patients had received 3 mo inpatient 

including individual psychotherapy with 

behavioral elements, psychodynamic 

elements, group psychotherapy, and 

counseling by a social worker. 

Study Methods: 

FU exam on patients who received 

inpatient tx. Baseline is records at first 

admission. 

FU assessments by physician or 

psychotherapist at U. of Heidelberg Med 

Clinic. 

FU included 1) past and present 

histories, lab exam, physical exam, and 

bone mineral density 2)standardized and 

open interviews re course of illness 3) 

discharge letters of all inpatient tx btween 

tx and FU. 

M-R outcome criteria obtained annually 

from general practitioner. Records of add 

hospitalizations, if reported by general 

physician. 

Statistical Methods: 

Wilcoxon signed rank test 

Students t-test 

Discriminant Analysis of T0 data 

Multiple linear regression analysis 

Outcomes 

M-R outcome criteria: 

Good: wt normal, menstruation regular 

Intermediate (wt < 85% ABW or 

amenorrhea 

Poor: wt < 85% ABW and amenorrhea 

Chronicity score: sum of outcome 

categories of every yr. 

Underwt score: index of underwt x time. 

Descriptive Results: 

M-R outcome at FU: 

Good: 47% 

Intermediate: 27% 

Poor: 14% 

Death:12% 

Mean ABW: 

Baseline: 65% 

FU: 87% 

Mean BMI: 

Baseline: 13.7; FU: 19.3 

BN (DSM III-R) at FU: 16%

Diff in baseline lab findings by M-R scale outcomes 

(good/intermediate vs poor/deceased): 

Albumin (P = 0.004) Poor/deceased lower 

Uric acid (P = 0.02) Poor/deceased higher 

Potassium (P = 0.03) Poor/deceased lower 

Creatinine (P = 0.04) Poor/deceased higher 

Diff in having at least 1 comorbidity by M-R scale outcome 

categories (good/intermediate vs poor/deceased) 

Poor/deceased: 67% 

Good/intermediate: 27% 

Age matched German females: 8% 

Mortality (N = 8): 

SMR: 9.6 

Mean age of death: 29 yrs 

Mean duration of AN: 9 yrs (range 1-14) with death avg 4.2 (0-13) yrs 

after first presentation. 

All met DSM III-R of AN at death, Severe purging (N = 7). BMI < 11: N = 

5. Suicide: N = 1. 

Lab predictors of death and chronicity 

Low serum albumin at baseline: OR = 4.7, 95% CI (1.1 – 20.2) 

Discriminant Analyses btwn surviving and deceased patients showed 

baseline albumin (P < 0.0001) and wt (P = 0.011) discriminated best, 

correctly classifying 88% of deceased and 86% of surviving patients. 

Adding age onset, duration at first presentation, freq. vomit and lax, 

social class, social or psych of ANSS did not improve model. 

Multivariate Analysis 

Baseline predictors of chronicity in step-wise model: 

Creatinine (P < 0.0001) 

Albumin (P = 0.024) 

Glucose levels (P = 0.04) 
C-860 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Herzog et al., 

1996 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA 

Yrs followed: 

4 

To assess the 

rates of 

recovery for 

restrictor and 

bulimic 

anorexics to 

determine 

whether 

bulimic 

behavior sig 

affects the 

course of AN. 

To assess 

possible 

subtypes of BN 

based on the 

presence or 

absence of a 

hx of AN. 

Inclusion: 

DSM III-R criteria for BN 

and or AN 

Exclusion: 

NR

Recruitment: 

Participants who sought 

evaluation for an eating 

disorder at the 

Massachusetts General 

Hospital Eating Disorders 

Unit and at other Bostonarea eating disorders 

programs between 10/87 

and 6/90.

Sample Size: 

Initial sample: 

Telephone Screen: N = 554 

Met criteria: N = 268 

Participated: N = 229 

Drop out: N = 4 

Analysis Sample: 

N = 225 

ANR (AN and no regular 

bingeing or purging): N = 

39 

ANBP (AN and regularly 

engage in bingeing or 

purging): N = 37 

BNPAN (BN now and hx of 

AN): N = 28 

BNSAN (BN now, underwt 

at intake and do not meet 

full criteria for AN): N = 36 

BN (BN with no prior hx of 

AN): N = 89 

Age, mean (SD) (range), yrs 

24.5 (6.7) 

ANR: 21 (18 – 27) 

ANBP: 22 (19 – 25) 

BNSAN: 25 (21 – 29) 

BNPAN: 23 (20 – 27) 

BN: 24 (20 – 30) 

Diff between groups (P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset of first 

disorder, mean (range), yrs 

ANR: 17 (15 – 20) 

ANBP: 17 (15– 19) 

BNSAN: 17 (14 – 19) 

BNPAN: 16 (15 – 18) 

BN: 18 (16 – 20) 

Diff between groups (P = NS) 

% attempted suicide: 

ANR: 18 

ANBP: 33 

BNSAN: 53 

BNPAN: 19 

BN: 28 

Diff between groups BNSAN 

had higher rates of suicide 

attempts versus BN and 

BNPAN (P < 0.001) 

Score: 

Good 

Method of dx: 

Semi-structured 

interview 

(Schedule for 

Affective 

Disorders and 

SchizophreniaLifetime Version 

modified to 

include 

diagnostic 

criteria for DSM 

III-R eating 

disorders derived 

from the 

Diagnostic 

Interview 

Schedule). 

Eating Disorders 

Longitudinal FU 

Evaluation. 

Funding: 

NIMH, 

Rubenstein 

Foundation, Eli 

Lilly and Co, The 

Boston Obesity, 

Nutrition 

Research Center 
C-861 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU interviews conducted every 3 mos. 

Anniversary (12, 24, 36 mo) FUs conducted in 

person whenever possible. 

Full recovery: asymptomatic (Psychiatric Status 

Rating PSR < 3) for at least 8 consecutive wks. 

Partial recovery: maintaining for at least 8 

consecutive wks a PSR level of 3 or 4. Do not 

meet full criteria for AN or BN but still experience 

sig symptomatology. 

Analytic Strategy 

Fisher’s Exact Test and Wilcoxon Rank Sum Test 

Kaplan-Meier survival method for probability of 

recovery. 

Cox proportional hazards models to identify 

prognostic factors 

Descriptive Results 

% at least partially recovered: 

BN: 91% 

Trend (P < 0.01) 

% fully recovered: 

BN: 62% 

Trend (P < 0.01) 

Multivariate Results 

BN Predictors of recovery; Adjusted for duration of the 

current episode (N = 150): 

Duration of current episode (P = NS) 

Age at onset of eating disorder (P = NS) 

Age at onset of first eating disorder (P = NS) 

Current disorders involving a lack of impulse control (P = NS) 

Wt < 90% of ideal (P = NS) 

Bingeing frequency (P = NS) 

Purging frequency (P = NS) 

Current depression (P = NS) 

Personality disorder (P = NS) 

Any current Axis I disorder (P = NS) 

AN Predictors of recovery: Adjusted for duration of the 

current episode (N = 75): 

Duration of current episode: RR = 0.50, 95% CI (0.27 – 0.94) 

Age at onset of eating disorder (P = NS) 

Age at onset of first eating disorder (P = NS) 

Current disorders involving a lack of impulse control (P = NS) 

Bulimic behaviors (P = NS) 

Current depression (P = NS) 

Any current Axis I disorder (P = NS) 
C-862 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Herzog et al., 

2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA, 

USA 

Yrs followed: 

11 

To assess 

rates and 

causes of 

death for a 

cohort of 

women with 

AN or BN and 

provide 

descriptive 

information on 

their ED and 

comorbid 

dx. 

Inclusion: 

Initially, meeting DSM III-R 

criteria for AN, AN/BN, or BN; 

Subsequently, using DSM IV 

definitions, met criteria for ANR, ANBP, or BN. 

Exclusion: 

None 

Recruitment: 

Between October 1987 and 

June 1990, tx seekers at 

Massachusetts General 

Hospital. 556 recruited. 

Sample Size: 

Using DSM IV criteria, 

participants classified as 

AN-R (N = 51), 

ANBP (N = 85), and 

BN (N = 110) status 

Reasons for loss to FU: 

NR 

Mean Age 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mean duration of 

illness: 

7.2 yrs 

Score: 

Fair 

Method of dx: 

SADS-L modified 

to include 

diagnostic criteria 

for DSM III-R as 

well as psychiatric 

hx, later updated to 

DSM IV criteria 

Funding: 

NIMH ROI Grant, 

sponsor: 

Rubenstein 

Foundation and 

Harvard Eating 

Disorders Center. 
C-863 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Data on mortality collected as part of a 

longitudinal study of AN and BN. Other 

data sources included death certificates, 

autopsy reports, relative interviews, and 

a National Death Index search. 

The Eating Disorders Longitudinal FU 

Evaluation (LIFE-EAT II) was 

administered to subjects at 6-mo 

intervals. General information regarding 

subjects’ functioning in the mos prior to 

death was obtained by interviewing a 

family member. 

Descriptive findings: 

AN 

At 11th yr FU: # of AN deaths: 7 (Crude mortality rate = 5.1%, 7 / 136) 3 

subjects committed suicide. 

SMR indicates a sigly raised mortality rate for death at 9.6 times the 

expected rate (P = 0.001), 95% CI (3.86 -19.8) and for suicide at 

58.1times the expected rate (P = 0.001), 95% CI (11.7 -169.7). 

Characteristics of deceased participants: 

• At intake, 5 met ANBP dx: 2 met full AN and BN criteria; 2 met 

full AN criteria with BN sx; 1 met full BN criteria with AN sx. 

• Ages: 24-46 yrs. 

• Yrs ill at death: 9-28 

• 2 met ANR criteria at intake, but later exhibited BN sx 

• At time of death, of the 5 ANBP participants, 2 were classified 

as ANBP, 2 met AN-partial recovery criteria, 1 met AN-full 

recovery criteria. 

• All had a hx of comorbid Axis I disorders: most common dx was 

alcoholism. Other comorbid disorders included bipolar disorder 

major depressive disorder and drug abuse. 

• All participated in multiple types of tx: both individual 

psychotherapy and pharmacotherapy 

• Hospitalized at least once: N = 6 

• Participated in group therapy: N = 6 

• Nutritional counseling: N = 5 

• Participated in family therapy: N = 4 

• All 3 subjects who committed suicide had reported suicidal 

ideation and 2 subjects had made at least one prior suicide 

attempt. 

BN 

At 11th yr FU, # of BN deaths: 0 
C-864 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Isager et al., 

1985 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Copenhagen, 

Denmark 

Mean Yrs 

followed: 

12.5 (range = 

4-22) 

To assess the 

time to death 

and time to 

first relapse in 

a group of 

consecutively 

treated AN 

patients 

between 1960-

1976 utilizing 

survival 

analytic 

procedures 

Inclusion: 

Dx of AN by the following 

criteria: 

Wt loss via reduced food 

intake, vomiting or excessive 

activity; Amenorrhea (if 

reproductive age); Distorted 

body image; clinical picture not 

explained by other somatic or 

psychiatric illness 

Exclusion: 

Inpatient < 1 wk or < 2 

outpatient visits; Other somatic 

dx (e.g., ulcer, psychosis) 

Recruitment: 

Patients who made first 

contact with a university 

hospital in Copenhagen for AN 

tx between 1960-1976. 

Review of all hospital records 

with a dx of AN from three 

departments at Rigshospital, 

University of Copenhagen, 

Child Psychiatry, Psychiatry, 

and Internal Medicine. 

Sample Size: 

151 (142 living: 114 contacted 

via direct semistructured 

interview; information about 

the remaining patients was 

obtained via hospital records 

and from official Danish 

registers) 

Loss to FU Reasons: 

Death: N = 9 (N = 6 from 

suicide; N = 2 from AN 

complications; N = 1 who was 

severely underwt with probable 

suicide) 

Mean Age, yrs 

(range): 

At primary contact: 

19.0 (8-43) 

At onset of AN: 

16.6 (7-41) 

Sex: 

Female: 93% 

Race/ethnicity: 

NR 

Mean Duration of 

Illness, yrs (range): 

2.4 (0.1-15) 

Previous 

Hospitalizations for 

AN (%): 

65% 

Females, onset of AN 

before Menarche: 

18% 

Mean Wt at primary 

contact, kgs (range): 

36.8 (19-60) 

% ABW at primary 

contact (range): 

68% (40-102)

Bulimia: 

28% 

Vomiting: 

41% 

Duration of primary 

contact, mos (range): 

12 (0.3-76) 

Score: 

Fair 

Method of dx: 

Review of records 

by authors to meet 

the diagnostic 

inclusion criteria 

Funding: 

The Danish Medical 

Council; The 

GangstedRasmussen Fonde 

af; the Enkefru C. 

Hermansens 

Mindelegat and the 

Petra Slettens Fond 
C-865 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU data obtained by direct semistructured interview 

of 80% of the original cohort (N = 114). Hospital 

records, the National Registry of Patients, the 

Central Persons Registry, and the Registry of 

Causes of Death used to assess patient relapse and 

mortality. 

Statistical Methods 

Survival probability curves for time to first relapse 

and time to death were calculated. 

Outcome measure 

Relapse: lost 15% or more of wt gained during 

course of tx within a yr’s time (i.e., wt = 50 kg or 

less). 

Descriptive Findings 

Deceased Patients 

Total Sample (N = 9): 6% 

Previous Hospitalization (N = 6): 30% (30 per 1000 per yr) 

Nonhospitalized (N = 3): 2% (2 per 1000 per yr) 

Diff between groups (P < 0.001) 

Remission Rate by End of Primary Contact (N = 120): 

80% 

Relapse Rates During FU (N = 120): 

First yr: N = 17 (14% hazard rate) 

Second yr: N = 4 (4% hazard rate) 

Third-Tenth yr: N = 1-3 per yr (hazard rate NR) 

Total FU period: 3% avg annual hazard rate 

Duration of therapeutic contact < 1 yr (N = 75): 4% per yr 

hazard rate 

Duration of therapeutic contact > or = 1 yr (N = 45): 2% per yr 

hazard rate 

Diff between groups based on therapeutic contact (P < 0.05) 
C-866 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Ivarsson et al., 

2000 

Companion 

article: 

Nilsson et al., 

1999 

Råstam, 

Gillberg and 

Gillberg, 1995 

Wentz et al., 

2001 

Wentz et al., 

2000 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteberg, 

Sweden 

Yrs followed: 

10 (1985-

1996) 

To assess and 

compare the 

prevalence 

and course of 

depressive 

disorders in a 

sample of 

adolescents 

with and 

without AN at 

baseline over a 

10-yr period. 

Inclusion: 

Cases: 

DSM III-R or DSM IV criteria 

for AN 

Born 1970 or later 

AN onset < 18 yrs old 

Comparisons: 

No eating disorder dx, 

matched to cases on age, sex, 

school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total population 

of Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: 

Same schools as AN group 

selected by the school nurse 

Sample Size: 

AN: N = 51 

Comparisons: N = 51 

Reasons for loss to FU: 

No attrition reported 

Mean Age at 

Baseline, yrs (SD): 

AN: 16.1 (NR) 

Comparisons: 

16.0 (NR) 

Age at 5-yr FU: 

21 

Age at 10-yr FU: 

24 

Mean Age of Onset of 

AN, yrs (SD): 

14.3 (NR) 

Sex: 

Female: 94% 

Race/ethnicity: 

NR 

Score: 

Good 

Method of dx: 

At baseline 

evaluation, clinical 

dx made via a 

psychiatric interview 

based on DSM III-R 

criteria 

Current and Lifetime 

prevalence of eating 

disorder, depressive 

disorder, and other 

Axis I dx made 

using SCID-P, DSM 

III-R version via 

record review of 

initial interviews at 

baseline and via 

clinical interview at 

FU 

Funding: 

None reported 
C-867 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

All participants initially underwent a 

thorough psychiatric interview at 

baseline, a standardized clinical interview 

at age 21 and again at age 24 to assess 

current and lifetime hx of eating disorders 

and depressive disorders. Family hx of 

depressive disorders in first degree 

relatives also obtained. Dx made in 

person-N = 102 for first FU, N = 99 for 

second FU; by phone for second FU, N = 

3 

Participants who did not meet diagnostic 

criteria for an eating disorder were 

categorized as “no ED”. The same 

categorization strategy was used to 

classify those who did not meet 

diagnostic criteria for a depressive 

disorder (i.e., major depression, 

dysthymia, or bipolar disorder). 

The timeframes for assessing FU 

outcomes are: 

“outcome 2” = assessment of current and 

lifetime hx of ED or Depressive Disorder 

between baseline and age 21 

“outcome 3” = assessment of current and 

lifetime hx of ED or Depressive Disorder 

between age 21 and age 24 

Statistical Analyses 

Chi-square tests, Fisher’s exact test, and 

McNemar tests to evaluate and compare 

linear associations between dichotomous 

variables. 

Backward stepwise multivariate logistic 

regression to assess risk of depressive 

disorder over time, controlling for 

diagnostic group status. 

Descriptive Findings 

Lifetime Prevalence of Depressive Disorder: 

AN: 84% 

Comparisons: 18% 

(P < 0.001) 

Rate of Depressive Disorder prior to AN: 

AN: 2% 

Comparisons: 4% 

(P = NS) 

Rate of Depressive Disorder by FU Period: 

Outcome 2: AN: 57% 

Outcome 3: NR 

Stability of Depressive Disorder between FU Periods: 

Baseline-Outcome 2 (P = NS) 

Outcome 2-Outcome 3 (P < 0.05) 

Number of Periods of Lifetime Dx of Depressive Disorder (N): 

0: AN (8) Comparisons (42) 

1: AN (18) Comparisons (6) 

2: AN (18) Comparisons (3) 

3: AN (7) Comparisons (0) 

(P < 0.0001) AN > Comparisons 

Types of Depressive Disorder in AN and Comparisons (N): 

None: AN (8), Comparisons (42) 

Dysthymia: AN (9) Comparisons (2) 

MDD: AN (28) Comparisons (6) 

Double Depression: AN (3) Comparisons (0) 

Bipolar Disorder: AN (3) Comparisons (1) 

(P < 0.0001) AN > Comparisons 

Rates of Depressive Disorder by ED status at Outcome 3, N (%): 

No ED /No Depressive Disorder (77): 84.6% 

No ED/Depressive Disorder (14): 15.4% 

ED/No Depressive Disorder (3): 27.2% 

ED/Depressive Disorder (8): 72.8% 

(P < 0.0001) Lower rates of Depressive Disorder in resolved ED 

Rates of Familial Depressive Disorder by Participant Depressive 

Disorder Status: 

(P = NR) 

Multivariate Results 

Predictors of Depressive Disorder at Outcome 2: 

Diagnostic Group (P < 0.00001), OR = 7.7, 95% CI (3.0 to 19.6) 

Depressive Disorder at Baseline (I = NS) 

Family Hx of Depressive Disorder (P = NS) 

Predictors of Depressive Disorder at Outcome 3: 

Diagnostic Group (P < 0.05), OR = 4.03, 95% CI (1.15 to 14.19) 

Depressive Disorder at Outcome 2 (P < 0.05), OR = 3.17 (1.05 to 9.58) 

Family Hx of Depressive Disorder (P = NS) 
C-868 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Keel et al., 

2003 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, Mass 

Yrs followed: 

Mean: 8.6 

Median: 9 

To determine 

mortality ratios 

and predictors 

of fatal 

outcome in 

women dx with 

AN or BN. 

Inclusion: 

(1) DSM III-R dx of AN or BN 

retrospectively (2) female (3) 

min age of 12 yrs (4) residence 

within 200 miles of Boston (5) 

English speaking, and (6) no 

evidence of organic brain 

syndrome or terminal illness. 

Exclusion: 

None 

Recruitment: 

294 women recruited for 

participation in a prospective 

longitudinal study between 

January 1, 1987, and 

December 31, 1991. Virtually 

all seeking outpatient tx for 

their Ed at the Massachusetts 

General Hospital Eating 

Disorders Unit or other Boston 

area eating disorder programs 

(37% received inpatient). 

Sample Size: 

N = 294 met study criteria 

N = 250 agreed to participate 

N = 246 randomized and 

participated (4 dropped out 

after intake interview) 

Retrospectively application of 

DSM IV criteria: 

Met AN criteria: N = 136 

Met BN criteria: N = 110 

Mean Age 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of dx: 

Structured 

diagnostic 

interview 

Funding: 

NIMH; Eli Lily and 

Co.; Rubenstein 

Foundation; 

Harvard Eating 

Disorders Center 
C-869 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

During FU interviews, the Longitudinal 

Interval FU Evaluation adapted for EDs 

used to assess ED and comorbid 

psychiatric disorders. Course of disorder 

coded on a wk-by-wk basis using PSR. 

Social adjustment evaluated on a 5-

point scale. GAF used to evaluate 

overall level of symptom severity from 

all disorders and psychosocial function. 

Social adjustment, GAF scores, and tx 

rated on a wk-by-wk basis throughout 

FU. Interviews conducted, in person 

when possible, every 6 to 12 mos. 

FU telephone calls conducted to 

determine vital status for all longitudinal 

study participants as of October 

2000. 

Statistical Methods 

Crude mortality rates and SMRs 

calculated. Expected number of deaths 

derived from US decennial life tables for 

1989-1991. Expected number of 

suicides derived from 1995 Annual 

Report: Vital Statistics of 

Massachusetts.

Cox regression models used to 

determine predictors of fatal outcome. 

Multivariate regression model used to 

predict death. 

Descriptive 

Number of Deaths: 

11 (4.5%) 

AN: 10 

ANR: 5 

ANBP: 5 

Diff by subtype (P = NS) 

BN: 1 

Crude mortality: 

AN: 7.4% 

BN: 0.9% 

SMR 

AN: 11.6; 95% CI (5.5-21.3) 

BN: 1.3; 95% CI (0.0-7.2) 

Mortality rates elevated in AN but not BN 

Cause of death 

ANBP: Pneumonia 

ANR (N = 3) Suicide 

ANBP: Cardiac dysrythmia 

ANBP: Alcohol poisoning 

ANBP: Diabetes mellitus 

BN: Mitral valve prolapse 

ANR: Amyotrophic lateral sclerosis 

ANBP: Suicide 

ANR: Heart and liver failure

SMR associated with suicide for AN: 56.9, 95% CI (15.3-145.7), sig higher 

Multivariate Results 

Sig predictors of death among AN patients (controlling for age and 

duration of illness before intake): 

Greater severity of alcohol use disorders (P < 0.001) 

Greater severity of substance use disorders (P = 0.03) 

Worse social adjustment (P = 0.02) 

Worse GAF scores at FU (P = 0.01) 

Using the Bonferroni-corrected P = 0.0016, only severity of alcohol use 

disorder remained sig. 

Predictors of time to death among AN patients 

Duration of illness at tx intake: HM = 1.48, 95% CI (1.11-1.99) (P = 0.001) 

Affective disorder hospitalization at intake: HM = 0.0001, 95% CI (0.00-

0.27) (P = 0.001) 

Suicidality associated with mental illness other than ED and substance 

abuse: HM = 23.92, 95% CI (0.81-705.52) (P = 0.05) 

Severity of alcohol use over course of illness: HM = 5.55, 95% CI (1.68-

18.29) (P = 0.001)
C-870 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Lee et al., 

2005 

Companion 

article: 

Lee, Chan, 

and Hsu, 2003 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Hong Kong 

Yrs followed: 

9 

To examine 

the 

relationship

between 

control and 

the 

intermediate 

term outcome 

of Chinese 

patients with 

AN. 

Inclusion: 

DSM III-R criteria for AN 

including: Typical (N = 63) and 

Atypical (N = 25; all criteria 

except “fat phobia”) 

Exclusion: 

NR 

Recruitment: 

Individuals contacted from 

January 2000-June 2001with 

onset of illness at least 4 yrs 

before study who had been 

seen at psychiatric and eating 

disorders clinics of a 

university-affiliated general 

hospital between May 1984 – 

June 2000. 

Sample Size: 

Initial sample size: 

N = 88 

Reasons for loss to FU: 

Deaths: N = 3 (Suicide: N = 2; 

Emaciation: N = 1); Mortality 

rate 3.4%; SMR: 10.5 

Refused to participate: N = 2 

Alive but could not be traced:

N = 3

Analysis sample size: 

N = 80 

Of these, 74 completed selfrated scales including: 

Typical (N = 56) and Atypical 

(N = 18; all criteria except “fat 

phobia”), also categorized as 

Restrictive (N = 51); Bulimic (N 

= 23) 

Mean age at onset of 

illness: 

18.1 (3.9) 

Mean age at clinical 

presentation: 

20.4 (5.4) 

Mean age at time of 

study: 

27.0 (6.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

Chinese: 100% 

BMI, before illness, 

mean: 

19.6 (2.4) 

BMI, mean, at clinical 

presentation: 

14.6 (1.9) 

Score: 

Fair 

Method of dx: 

SCID, M-R Outcome 

Assessment 

Schedule 

Funding: 

Research Grant 

Council, Hong Kong 
C-871 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Interviewer assessed M-R Outcomes, 

SCI 

Statistical Analyses: 

Simple t-tests, ANOVA, post-hoc 

Bonferroni t-test 

Outcomes (based on avg score from 

M-R Outcome Assessment 

Schedule): 

Good (>8) 

Intermediate (>4 and ≤8) 

Poor: 0-4 

Descriptive Results 

M-R Outcome: 

Good: 62.2% 

Intermediate: 32.9% 

Poor: 5.3% 

M-R Outcome categories in relation to SCI profile scale categories: 

Overall general sense of control (scale 1): 

Good: 4.28 (0.70) 

Intermediate: 3.73 (0.89) 

Poor: 2.86 (0.97) 

Diff between groups (P = 0.001) 

Good group higher sense of control than other groups 

Positive sense of control (scale 2): 

Good: 4.04 (0.74) 

Intermediate: 3.69 (0.93) 

Poor: 2.95 (1.41) 

Diff between groups (P = 0.026) 

Good group higher pos sense of control than poor group 

Negative sense of control (scale 3): 

Good: 3.19 (0.99) 

Intermediate: 4.17 (1.07) 

Poor: 5.35 (0.53) 

Diff between groups (P = 0.001) 

Good group lower neg sense of control than other groups 

Specific sense of control (scale 4): 

Good: 4.65 (0.72) 

Intermediate: 4.03 (0.73) 

Poor: 3.18 (0.81) 

Diff between groups (P = 0.001) 

Good group higher sense of control than other groups 

Positive assertive mode of control (scale 5): 

Diff between groups (P = NS) 

Positive yielding mode of control (scale 6): 

Diff between groups (P = NS) 

Negative assertive mode of control (scale 7): 

Good: 2.04 (0.38) 

Intermediate: 2.39 (0.46) 

Poor: 2.23 (0.72) 

Diff between groups (P = 0.007) 

Good group lower neg assertives than other group 

Good group less neg assertive than intermediate group

Negative yielding mode of control (scale 8): 

Good: 2.10 (0.63) 

Intermediate: 2.43 (0.52) 

Poor: 2.95 (0.81) 

Diff between groups (P = 0.009) 

Good group less neg yielding than poor group 
C-872 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Lee et al., 

2005 

Companion 

article: 

Lee, Chan, 

and Hsu, 2003 

(continued) 

 
C-873 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Desire for control (scale 9): 

Good: 4.19 (0.80) 

Intermediate: 4.86 (1.07) 

Poor: 4.66 (1.37) 

Diff between groups (P = 0.016) 

Intermediate group higher desire for control than poor group 

Diff between typical and atypical patients on control: 

Typical lower sense of control in the domain of body (P = 0.033) 

Typical lower sense of control in the domain of mind (P = 0.036) 

Typical stronger desire for control (P = 0.014) 
C-874 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, Yrs: 

Lee, Chan, 

and Hsu, 2003 

Companion 

article: 

Lee et al., 

2005 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Hong Kong 

Yrs followed 

(SD): 

Avg 9 (5.2) 

after onset of 

illness 

To determine 

intermediateterm outcomes 

for AN among 

Chinese 

patients in 

Hong Kong. 

Inclusion: 

DSM III-R criteria for AN 

including: Typical (N = 63) and 

Atypical (N = 25; all criteria 

except “fat phobia”) 

Exclusion: 

NR 

Recruitment: 

Onset of illness at least 4 yrs 

before study who had been 

seen at psychiatric and eating 

disorders clinics of a 

university-affiliated general 

hospital between May 1984 – 

June 2000. 

Sample Size: 

Initial sample size: 

N = 88 

Reasons for loss to FU: 

Deaths: N = 3 (Suicide: N = 2; 

Emaciation: N = 1); Mortality 

rate 3.4%; SMR: 10.5 

Refused to participate: N = 2 

Alive but could not be traced: 

N = 3 

Analysis sample size: 

N = 80 

Of these, 74 completed selfrated scales 

Mean age (SD): 

26.9 (6.7) 

Range: 16.2 – 47.7 

Mean onset age (SD) 

18.1 (3.8) 

Range: 11.2 – 28.0 

Age at clinical 

presentation (SD): 

20.4 (5.3) 

Range: 12.3 – 38.0 

Premorbid BMI: 

19.6 (2.4) 

Typical: 

20.1 (2.3) 

Atypical: 

18.5 (2.2) 

(P = 0.004) 

BMI at clinical 

presentation: 

14.4 (2.0) 

Typical: 

14.8 (1.9) 

Atypical: 

13.2 (1.6) (P < 0.001) 

Current BMI: 

18.5 (2.8) 

Sex: 

Female: 100% 

Race/ethnicity: 

Chinese: 100% 

AN Subtypes: 

Restrictive: 67.0% 

Bulimic: 33.0% 

Hospitalized: 

72% 

Social Class (as 

defined by U.K. 

Registrar General’s 

classification of 

paternal occupation): 

I: 5.7% 

II: 9.1% 

III: 27.3% 

IV: 47.7% 

V: 10.2% 

Score: 

Fair 

Method of dx: 

SCID, M-R Outcome 

Assessment 

Schedule 

Funding: 

Research Grant 

Council, Hong Kong 
C-875 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Interviewer assessed M-R Outcome 

Assessment Schedule, Hamilton Depression 

Rating Scale, and Structured Clinical 

Interview. Self-rated evaluations included 

EDI, EAT, EDE, 36-Item Short-Form Health 

Survey, SCL-90, Beck Depression Inventory, 

Rosenberg Self-Esteem Scale 

Statistical Methods 

Chi-Square, t-tests, ANOVA, correlation 

coefficients to compare diff in outcome. 

Outcomes (based on avg score from M-R 

Outcome Assessment Schedule): 

Good (>8) 

Intermediate (>4 and ≤8) 

Poor: 0-4 

Descriptive Results 

Median duration for recovery (BMI ≥ 17.5):

3.7 yrs, 95% CI (3.2 – 4.2) 

3 consecutive menstrual cycles: 

5.0 yrs, 95% CI (3.9 – 6.1) 

MR-Scale Outcomes 

(N = 74) 

Good: 

Total: 61.8% 

Typical: 52.6% 

Atypical: 89.47% 

Intermediate: 

Total: 32.9% 

Typical: 42.11% 

Atypical: 5.26% 

Poor: 

Total: 5.3% 

Typical: 5.26% 

Atypical: 5.26% 

Diff between typical and atypical (P = 0.006); Atypical did better 

ED Dx Outcomes: 

No ED: N = 34 

AN: N = 11 

BN: N = 15 

EDNOS: N = 14 

ED Dx Outcomes: 

No ED: 

Typical: 40.68% 

Atypical: 57.14% 

BN: 

Typical: 25.42% 

Atypical: 4.76% 

EDNOS: 

Typical: 15.25% 

Atypical: 28.57% 

AN, restricting: 

Typical: 4 (6.78%) 

Atypical: 9.52% 

AN, bulimic: 

Typical: 11.86% 

Atypical: 0.00% 

Diff between groups (P = 0.06) 

EAT-26, mean (SD): 

Typical: 28.75 (16.94) 

Atypical: 14.00 (8.90) 

Diff between groups (P = 0.001) 

Atypical better 
C-876 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, Yrs: 

Lee, Chan, 

and Hsu, 2003 

(continued) 

Never married: 

80% 

Fully employed: 

62.5%
C-877 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 EDE-Q, mean (SD): 

Typical: 2.56 (1.53) 

Atypical: 1.02 (0.80) 

Diff between groups (P = 0.001) 

Atypical better 

EDI Drive for thinness, mean (SD): 

Typical: 7.48 (7.00) 

Atypical: 1.61 (3.96) 

Diff between groups (P = 0.001) 

Atypical better 

EDI Bulimia, mean, SD: 

Typical: 4.20 (5.70) 

Atypical: 1.78 (3.06) 

Diff between groups (P = 0.03) 

Atypical better
C-878 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, yr: 

Löwe et al., 

2001 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Germany 

Yrs followed: 

Mean (SD) = 

21.3 (2.9) 

Examine 

clinical course, 

predictors and 

outcome of 

patients 21 yrs 

after first 

inpatient tx for 

AN. 

Inclusion: 

Feighner diagnostic criteria for 

AN (at initial assessment) and 

DSM IV criteria 

(retrospectively) 

Exclusion: 

No severe somatic disorders 

Recruitment: 

Patients who received 

inpatient tx between 1971-

1980 at U Medical Hospital in 

Heidelberg, Germany 

Sample Size: 

Initial sample: 

84 participants evaluated at 

3.6 and 11.7 yr FU 

Reasons for loss to FU: 

Deceased N = 14 (12 directly 

due to AN), could not contact 

or refused, N = 7. 

Analysis sample: N = 63 

Mean Age at FU (SD): 

42.0 (6.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mean BMI at FU (SD): 

20.2 (3.1) 

Marital Status: 

Never married: 17.5% 

Divorced/separated/wi

dowed: 11.1% 

Married/living with 

partner: 71.4% 

Living arrangements: 

Alone: 20.6% 

With partner: 60.3% 

With family members: 

19.1% 

Has children: 

68.3% 

Able to work: 

71.4% 

Score: 

Fair 

Method of dx: 

Feighner’s 

diagnostic criteria 

for AN (on initial 

assessment) and 

Psychiatric Status 

Rating Scale for AN 

(at FU) 

Funding: 

German Ministry of 

Technology and 

Research and 

Medical faculty of 

University of 

Heidelberg 
C-879 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Psychiatric interview, physical 

examination, and standardized 

psychological questionnaires 

Outcome groups defined corresponding 

to Psychiatric Status Rating Scale for 

AN (PSR): 

Good (full recovery): 1 

Intermediate (Partially recovered): 2,3,4 

Poor (including mortality): 5,6 

Statistical Methods 

Subjects-yrs method (to calculate 

mortality), ANOVA, Fischer’s exact 

tests, paired t-tests, ordered logistic 

regressions. 

Descriptive Findings 

Percentage of Individuals with outcome according to PSR scale: 

Good: 50.6% 

Intermediate: 20.8% 

Poor: 26% 

Mean BMI by PSR scale outcome groups (SD): 

Good: 21.6 (2.3) 

Intermediate: 19.7 (2.1) 

Poor: 15.3 (2.7) 

Diff between groups (P < 0.001) 

GAF scores by PSR scale outcome groups (SD): 

Good: 73.7% (12.2) 

Intermediate: 66.6% (14.5) 

Poor: 39.4% (15.2) 

Diff between groups (P < 0.001) 

Psychosocial outcomes by PSR scale outcome groups: 

Marital status (P = NS) 

Living arrangement (P < 0.001) worse outcome more likely to live alone 

Percentage who have children (P = 0.03) Poor outcome less likely 

Percentage able to work (P < 0.001) worse outcome less able to work 

Mood disorders by PSR scale outcome groups: 

Good: 7.7% 

Intermediate: 31.3% 

Poor: 37.5% 

Diff between groups (P = 0.02) 

Anxiety disorders by PSR scale outcome groups: 

Good 10.3% 

Intermediate:18.8% 

Poor: 37.5% 

Diff between groups (P = NS) 

Substance related disorders by PSR outcome groups: 

Good: 5.1% 

Intermediate: 6.3% 

Poor: 50.0% 

Diff between groups (P < 0.001) 

Regression predicting PSR scale outcome at T3 FU (21 yrs from 

inpatient admission) based on variable values from T2 (12 yrs from 

inpatient admission) (each analyzed separately): 

BMI: 

OR = 0.68, 95% CI (0.55 - 0.84) (P < 0.001); higher is better 

Severity of psychological symptoms: 

OR = 1.30, 95% CI (1.16-1.47) (P < 0.001); less severe is better 

Severity of social problems: 

OR = 1.25, 95% CI (1.10-1.42) (P < 0.001); less severe is better 

EDI-Ineffectiveness: 

OR = 1.20, 95% CI (1.07-1.35) (P = 0.003); lower is better 

EDI-Perfectionism: 

OR = 1.18, 95% CI (1.01-1.37) (P = 0.042); lower is better 
C-880 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, yr: 

Löwe et al., 

2001 

(continued) 

 
C-881 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 EDI-Interpersonal distrust: 

OR = 1.21, 95% CI (1.03-1.44) (P = 0.023) 

Lower is better 

EDI-Interoceptive awareness: 

OR = 1.16, 95% CI (1.02-1.31) (P = 0.021) 

Lower is better 

Haemoglobin (mmol/l): 

OR = 0.46, 95% CI (0.23-0.91) (P = 0.025) 

Higher is better 

Alkaline Phosphatase: 

OR = 1.02, 95% CI (1.01-1.04) (P = 0.013) 

Lower is better 
C-882 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

MøllerMadsen, 

Nystrup, and 

Nielsen, 1996 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Denmark 

Mean Yrs 

followed: 

7.8 

Range: < 1-17 

To assess 

the 

mortality 

rates of 

AN 

patients 

living in 

Denmark 

who were 

admitted 

for 

inpatient tx 

between 

1970 and 

1987 

Inclusion: 

All former AN inpatients whose 

data was recorded in the Danish 

Central Register on Psychiatric 

Admission between 1/1/70 and 

12/31/86 with an ICD-8 AN primary 

or secondary dx 

Exclusion: 

None 

Recruitment: 

See inclusion criteria above 

Sample Size: 

N = 853 probands identified 

through Danish Central Register on 

Psychiatric Admission during 

specified time period. 

Reasons for loss to FU: 

Death: N = 50 (N = 13 from AN 

complications; N = 11 from natural 

causes; N = 18 from suicide; N = 2 

from accidents; N = 1 from 

unknown causes; N = 3 could not 

be determined in time for the 

analysis) 

Mean Age, yrs (SD): 

At First Psychiatric 

Admission: 

AN as primary dx 

(women): 21.3 (7.5) 

AN as secondary dx 

(women): 

27.4 (12.1) 

(P < 0.001) 

AN as primary dx 

(male): NR 

AN as secondary dx 

(male): NR 

(P = NS) 

At Death: 

Female (N = 45): 36 

(range = 18.1-64.7) 

Male (N = 5): 24.5 

(range = 14.2-48.1) 

(P = NR) 

Sex: 

Female:93% 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of dx: 

Verification of ICD-8 

AN primary or 

secondary dx from 

Danish Central 

Register on 

Psychiatric 

Admission; How the 

dx was ascertained 

was not reported 

Funding: 

Fru C. Hermansens 

Mindelegat, 

Snedkermester J. 

Wichmann og fru 

else Wichmann’s 

Fond; Dansk 

Psykiatrisk 

Forskningsfond af 

1967; Foundation 

for Research into 

Mental Disorders 
C-883 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Mortality status of the sample assessed through linking 

data obtained from Danish Central Register on 

Psychiatric Admission between 1970 and 1987 to 

information in the Danish Central Persons Registry and 

the Register on Causes of Death at the Danish National 

Health Board. Mortality status was assessed on 

11/15/87. 

Also reviewed from Register on Causes of Death, a list of 

individuals who had ICD-8 ED dx on their death 

certificate to evaluate the accuracy of utilizing the Danish 

Central Register on Psychiatric Admission for quantifying 

the number of persons with AN. 

SMR standardized against age, sex, and period in the 

population from which patients were drawn.

Statistical Methods 

SMRs were calculated for male and female probands 

separately, for age at first psychiatric admission (females 

only), for period of first psychiatric admission within the 

first five yrs (females only), and for length of FU (females 

only). Chi-square tests used to test for diff between 

observed and expected mortality for each of the above 

categories. 

Descriptive Findings 

Patient mortality: 

60% due to AN or suicide 

SMR By Gender 

Female (N = 45 died): 9.2, 95% CI (6.7-12.3) (P < 0.001) 

diff from expected 

Male (N = 5 died): 8.2, 95% CI (2.7-19.1) (P < 0.001) diff 

from expected 

Diff between groups (P = NS) 

SMR By Length of FU in yrs (Females only; N = 790) 

< 1 (N = 14 died): 30.5, 95% CI (16.7-51.2) (P < 0.001) 

diff from expected 

1-4 (N = 14 died): 8.6, 95% CI (4.7-14.5) (P < 0.001) diff 

from expected 

5-9 (N = 10 died): 5.9, 95% CI (2.8-10.9) (P < 0.001) diff 

from expected 

10-14 (N = 6 died): 5.7, 95% CI (2.1-12.4) (P < 0.001) diff 

from expected 

> or = 15 (N = 1 died): 10.5, 95% CI (0.27-58.5) (P = NS) 

SMR By Age at First Psychiatric Admission (Females 

only; N = 790) 

< 15 (N = 0 died): NA 

15-19 (N = 6 died): 6.6, 95% CI (2.4-14.4) (P < 0.001) diff 

from expected 

20-24 (N = 13 died): 17.5, 95% CI (9.3-29.9) (P < 0.001) 

diff from expected 

25-29 (N = 10 died): 17.0, 95% CI (8.1-31.3) (P < 0.001) 

diff from expected 

30-34 (N = 4 died): 7.7, 95% CI (2.1-19.7) (P < 0.005) diff 

from expected 

> or = 35 (N = 12 died): 6.6, 95% CI (3.4-11.5) 

(P < 0.001) diff from expected 

SMR By Period of First Psychiatric Admission 

(Females only; N = 658-cases admitted) 

1970-1974 (N = 6 died): 11.0, 95% CI (4.03-23.9) (P < 

0.001) diff from expected 

1975-1979 (N = 8 died): 11.3, 95% CI (4.9-22.3) (P < 

0.001) diff from expected 

1980-1984 (N = 12 died): 18.8, 95% CI (9.7-32.8) (P < 

0.001) diff from expected 

1970-1984 (N = 26 died): 13.8, 95% CI (8.9-20.2) (P < 

0.001) diff from expected 

Diff between periods (P = NS) No change in pattern over 

time 
C-884 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Morgan, 

Purgold, and 

Welbourne, 

1983 

Design: 

Case series 

Comparison 

Group: 

None 

Location: 

Bristol, UK 

Mean Yrs 

followed: 

5.8 

Range (4-8.5) 

To assess 

both longterm 

outcomes 

and sig 

predictors 

of outcome 

in a group

of former 

AN patients 

treated in a 

specialized, 

communitybased 

outpatient 

program 

Inclusion: 

Met diagnostic criteria specified by 

Russell (1970): endorsement of wt 

loss behaviors such as food 

avoidance, self-induced vomiting, 

purging, excessive exercise; 

presence of an endocrine disorder 

(i.e., amenorrhea, impotence, loss 

of libido); marked fear of becoming 

fat and a distorted judgment of 

body size; non-specific depressive, 

phobic, obsessional or hysterical 

symptoms may accompany other 

features 

Exclusion: 

NR 

Recruitment: 

Participants were a series of 

consecutive referrals to the Bristol 

Royal Infirmary AN clinic between 

1973 and 1978. Approximately half 

had received inpatient tx. 

Sample Size: 

N = 78 

Reasons for loss to FU: 

Death: N = 1 

Insufficient FU info obtained: N = 4 

Age at Presentation (%): 

< 18: 35% 

18-30: 62% 

>30: 4% 

Mean Age at onset of 

Food Difficulties, yrs 

(SD): 

17.2 (3.3) 

Sex: 

Female: N = 73 

Race/ethnicity: 

NR 

Social Class at 

Presentation (%): 

I: 6% 

II: 49% 

III: 33% 

IV: 8% 

V: 0% 

Marital Status at 

Presentation (%): 

Single: 87% 

Married/Divorced: 13% 

Duration of Food 

Difficulties, yrs (%): 

< 1: 38% 

1-2: 17% 

2-3: 15% 

3-7: 15% 

>7: 15% 

Median: 1.6 

Previous psych tx for 

AN (%): 

12% 

Lowest Mean ABW 

(Matched Normals (SD): 

67.8 (8.2) 

Binge-eating at 

presentation: 

37% 

Vomiting at 

presentation: 

35% 

Score: 

Fair 

Method of dx: 

Russell (1970) 

criteria for AN 

via clinical 

interview at 

presentation 

and at FU 

Funding: 

South Western 

Regional Health 

Authority 

Research 

Committee 
C-885 

Evidence Table 15. Anorexia nervosa outcomes (continued)

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

During the FU period, outcome information 

gathered directly from patient via interview (69%), 

directly from interviews with relative of the patient 

(8%), through a questionnaire sent to the patient 

(9%), or from other informants either directly or 

indirectly (14%). 

M-R scales used to quantify clinical outcome status 

at FU utilizing last 6-mos prior to FU interview as 

timeframe for assessment. This yielded both an avg 

outcome score (i.e.,, composite rating based on 12-

pt scales for nutritional status, mental status, sexual 

adjustment, menstrual functioning, and SES, with 

high scores more indicative of good prognosis) and 

the general outcome category (i.e., based on body 

wt and menstrual functioning: Good = maintained 

ABW w/in 15% of avg norms and regular menstrual 

cycles; Intermediate = intermittent maintenance of 

ABW w/in 15% of avg norms and/or there is 

continued menstrual dysfunction; Poor = ABW 

never reached w/in 15% of avg norms and menses 

have been absent or sporadic. 

Statistical Analyses 

Percentages, frequencies, means, ranges, and 

medians 

Chi-square analyses to assess predictors of clinical 

outcome status at FU. 

Descriptive Findings 

Binge-eating at FU: 

27% 

Vomiting at FU: 

9% 

General Outcome Status Category: 

Good: 58% 

Intermediate: 19% 

Poor: 19% 

Deceased: 1% 

Unknown: 3% 

Predictors of poorer general M-R outcome category: 

Greater duration of food difficulties (P < 0.05) 

Greater duration of amenorrhea (P = 0.029) 

Family hostility towards patient (P = NS) 

Disturbed relationship between patient and family (P = 0.02) 

Personality difficulties (P = NS) 

Age of onset (P = NS) 

Degree of wt loss (P = NS) 

Vomiting (P = NS) 

Binge-eating (P = NS) 

Father’s social class (P = NS) 

Neurotic/behavioral disorder at school (P = NS) 

Previous psychological tx (P = NS) 

Mental illness in nuclear family (P = NS) 

Sibling rivalry (P = NS) 

Anomalous family situation (P = NS) 

Predictors of poorer avg M-R outcome scores: 

Greater duration of food difficulties (P < 0.01) 

Duration of amenorrhea (P < 0.0042) 

Family hostility towards patient (P < 0.05) 

Disturbed relationship between patient and family (P = 0.018) 

Personality difficulties (P = 0.05) 

Vomiting (P = NS) 

Binge-eating (P = NS) 

Father’s social class (P = NS) 

Neurotic/behavioral disorder at school (P = NS) 

Previous psychological tx (P = NS) 

Mental illness in nuclear family (P = NS) 

Sibling rivalry (P = NS) 

Anomalous family situation (P = NS) 
C-886 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Nilsson et al., 

1999 

Companion 

article: 

Ivarsson et al., 

2000 

Råstam, 

Gillberg and 

Gillberg, 1995 

Wentz et al., 

2001 

Wentz et al., 

2000 

Design: 

Prospective 

cohort 

Comparison 

Group: Yes 

Location: 

Göteberg, 

Sweden 

Yrs followed: 

10 (1985-

1996) 

To assess and 

compare the 

prevalence of 

personality 

disorders, 

obsessivecompulsive 

disorder and 

autism 

spectrum 

disorders in a 

group of 

adolescents 

with and 

without AN at 

baseline over a 

10-yr period 

Inclusion: 

Cases: 

DSM III-R or DSM IV 

criteria for AN 

Born 1970 

AN onset < 18 yrs old 

Comparisons: no eating 

disorder dx, matched to 

cases on age, sex, school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total 

population of Göteburg, 

Sweden, born in 1970 and 

developing AN before age 

18; pooled with second 

population screening 

sample reported by school 

and hospital health care 

workers during FU. Some 

clinically referred and some 

screened through school 

nurses and doctors, 

pediatricians, and child 

psychiatrists 

Comparisons: 

Same schools as AN group 

selected by the school 

nurse 

Sample Size: 

Initial sample: 

AN: N = 51 

Control: N = 51 

Reasons for loss to FU: 

Did not complete outcome 

assessment: N = 1 (AN 

group) 

Analysis Sample: 

AN: 50 

Control: 51 

FU 1 = 6 yrs from AN onset 

FU 2 = 10 yrs from AN 

onset 

Mean Age at Baseline, 

yrs (range): 

AN: 16.1 (15.7-16.5) 

Comparisons: 16.0 

(15.5-16.5) 

(P = NS) 

Mean Age at AN Onset, 

yrs (range): 

14.3 (13.9-14.7) 

Mean Age at FU 1, yrs: 

AN: 21.0 

Comparisons: 20.8 

(P = NS) 

Mean Age at FU 2, yrs: 

AN: 24.5 

Comparisons: 24.2 

(P = NS) 

Mean Time of AN 

Onset to FU 1, yrs 

(range): 

6.7 (6.3-7.0) 

Mean Time of AN Onset 

to FU 2, yrs (range): 

10.2 (9.7-10.6) 

Mean Time Between 

Baseline and FU 1, yrs 

(range): 

AN: 4.9 (4.7-5.2) 

Comparisons: 4.6 (4.3-

4.9) 

(P = NS) 

Mean Time Between 

Baseline and FU 2, yrs 

(range): 

AN: 8.4 (8.1-8.8) 

Comparisons: 8.1 (7.7-

8.4) 

(P = NS) 

Mean Time Between 

FU 1 and FU 2, yrs: 

AN: 3.5 

Comparisons: 3.4 

(P = NS) 

Sex: 

Female: 94% 

Race/ethnicity: 

NR 

Score: 

Good 

Method of dx: 

Psychiatric interview at 

baseline consistent with 

DSM III-R 

Structured, 

standardized clinical 

interviews (SCID-II, 

DSM III-R version) to 

assess for personality 

disorder prevalence; 

Pervasive 

developmental disorder 

prevalence according to 

DSM III-R criteria also 

obtained via clinical 

interview 

Structured standardized 

clinical interviews 

(SCID-I, DSM III-R 

version) to assess 

prevalence of Axis I 

psychiatric disorders 

Semi-structured 

interview (Schedule for 

the Assessment of 

Conduct Disorder, 

Hyperactivity, Anxiety 

Disorder, Mood 

Disorder, and 

Psychoactive 

Substance Abuse—

CHAMPS) to evaluate 

prevalence of ADHD 

Structured, 

standardized clinical 

interview (SCID-II for 

DSM III-R) for PD dx, 

for Axis I dx (SCID-I for 

DSM III-R), for 

Asperger’s disorder 

(Asperger Syndrome 

Diagnostic Interview), 

for impulsivity 

symptoms (CHAMPS), 

and the Y-BOCS for 

OCD at FU 2 

Funding: 

NR 
C-887 

Evidence Table 15. Anorexia nervosa outcomes (continued)

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

The prevalence of PD’s, 

PDD’s/Aspergers, impulsivity symptoms, 

obsessive compulsive symptoms and 

Axis I dx assessed at baseline and at 6- 

and 10-yr FU via standardized clinical 

interview methods. Participants also 

administered the M-R outcome scales, 

an alexithymia questionnaire (i.e., TAS20) and underwent a battery of 

neuropsychological tests at the final FU. 

Clinicians rated participants for difficulties 

with reciprocal interactions at the 10-yr 

FU (e.g., mimicry, gestures, eye contact 

in communication, mental status). 

Although standard interviews for DSM IIIR were used to assess PD prevalence, 

PD’s in this sample were also coded 

separately according to the DSM IV 

criteria at final FU. 

Statistical Analyses 

Chi-square tests for matched and 

unmatched pairs for categorical, 

diagnostic status. 

Two-sample t-tests performed for 

continuous variables (Y-BOCS and TAS20) 

10-yr FU findings 

Descriptive Results 

Rates of Eating Disorders in AN group: 27% 

Prevalence of Tx for AN: 75% 

Mean Wt, kg (95% CI): 

AN: 62.3 (58.5-66.1) 

Comparisons: 63.7 (60.8-66.5) 

(P = NS) 

Mean BMI, kg/m2

 (95% CI): 

AN: 22.2 (21.0-23.4) 

Comparisons: 22.2 (21.2-23.2) 

(P = NS) 

Prevalence of OCD (N): 

AN: 8 

Comparisons: 1 

(P < 0.05) AN > Comparisons 

Mean TAS-20: 

AN: 42.2, 95% CI (38.7-45.9) 

Comparisons: 38.6, 95% CI (36.0-41.1) 

(P = NS) 

Prevalence of Impulsivity (N): 

AN: 13 

Comparisons: 9 

(P = NS) 

Personality Disorder Prevalence: 

Any Cluster A (P = NS) 

Any Cluster B (P = NS) 

Any Cluster C (P < 0.05) AN > Comparisons, particularly for OCPD 

Any PD (P < 0.05) AN > Comparisons 

Prevalence of Autism Spectrum Disorder (N): 

AN: 9 

Comparisons: 1 

(P < 0.02) AN > Comparisons 

Clinical Severity Outcome of AN sample using M-R Scale by 

subgroup status (consistent comorbid dx across all three time 

points): 

AN with OCPD/ASD: 7.3 (1.3) 

AN without OCPD/ASD: 9.8 (2.1) 

(P < 0.01) Comorbid group worse than non-comorbid group 

Mean TAS-20 Scores for AN sample by Subgroup status (consistent 

comorbid dx across all three time points): 

AN with OCPD/ASD: 54.5 (14.4) 

AN without OCPD/ASD: 39.9 (11.0) 

(P = 0.002) Higher alexithymia in comorbid AN group 
C-888 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Patton, 1988 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

United 

Kingdom 

Yrs followed, 

mean (SD): 

AN: 7.6 (3.0) 

BN: 5.7 (2.1) 

Range: 4-15 

Calculate a 

standardized 

mortality rate 

for eating 

disorders in a 

large 

population 

Inclusion: 

Eating disorder dx 

AN (Russell, 1970): 

Loss of 25% of BW 

Amenorrhea 

Fear of putting on wt 

BN (Russell, 1979): 

Uncontrollable urge to 

overeat (binge) 

Self-induced vomiting or 

laxative abuse (Purge) 

Feat of becoming fat 

Exclusion: 

NR 

Recruitment: 

Reviewed records of all eating 

disordered patients assessed 

in the eating disorders unit of 

the Academic Department of 

Psychiatry at Royal Free 

Hospital, 1971-81. 

Sample Size: 

Initial: 

N = 481 

Reasons for loss to FU: 

Lost to FU: N = 21 

Deaths: N = 14 

• AN: N = 11 

• Suicide: N = 6 

• Low wt: N = 5 

• BN: N = 3 

• Car accident: N = 2 

• Low wt: N = 1 

Analysis sample: 

Located / Analyzed: N = 460 

• AN: 332 (72.1%) 

• BN: 96 (20.9%) 

• Other: 32 (7.0%) 

Mean Age (yrs): 

AN: 22.4 

BN: 23.5 

Mean Wt (kg): 

AN: 41 

BN: 58.9 

Sex: 

Female: 95.9% 

Male: 4.1% 

Race/ethnicity: 

NR 

Mean Age of Onset 

(yrs): 

AN: 18.9 

BN: 18.6 

Mean Duration of 

Illness (yrs): 

AN: 3.5 

BN: 4.9 

2nd Dx at Assessment: 

Depression, N = 52 

AN: N = 26 

BN: N = 26 

Score: 

Fair 

Method of dx: 

Russell diagnostic 

criteria for AN and 

BN applied 

retrospectively to 

case note 

description of 

presentation 

Funding: 

Grant from the 

Wellcome 

Foundation 
C-889 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study methods 

Attempted to locate by: 

Contact with referring physician 

Last known address 

National Health Service Central Registry 

Located 95.6% 

FU conducted, 1985-86 

Sex specific death rates derived from 

1981 death rates for England and 

Whales 

Analysis methods 

Observed mortality rate (study 

population) 

Expected mortality rate (general 

population) 

Standardized mortality ratio (SMR) = 

observed / expected 

Stepwise linear discriminant function 

analysis: to examine the relationship of 

crude mortality to the prognostic 

variables 

Descriptive Results 

Mortality rate 

Crude mortality rate (%): 

AN: 3.1 

BN: 3.3 

Expected mortality rate: 

AN: 1.83 

BN: 0.32 

Standardized mortality rate 

AN: 6.01 (P < 0.01) Higher than expected 

BN: 9.38 (P = NS) 

AN mortality rate (by length of FU): 

Actual mortality 

Overall: 11 

After 4 yrs: 6 

After 8 yrs: 1 

Expected mortality rate 

 Overall: 1.83 

 After 4 yrs: 1.04 

 After 8 yrs: 0.37 

Standardized mortality rate 

 Overall: 6.01 (P < 0.01) Higher than expected 

 After 4 yrs: 5.76 (P < 0.05) Higher than expected 

 After 8 yrs: 2.70 (P = NS) 

Predictors of mortality in individuals with AN 

wt < 35 kg at presentation: 

 Crude (%): 8.1 (N = 5) 

 Expected: 0.33 

 Standardized: 15.15 (P < 0.05) Higher than expected 

More than one inpatient admission: 

 Crude (%): NR 

 Expected: NR 

 Standardized: NR (P < 0.01) Higher than expected 

age < 20 yrs at presentation: 

 Crude (%): 2.8 (N = 4) 

 Expected: 0.41 

 Standardized: 9.76 (P = NS)

age 20-29 yrs at presentation: 

 Crude (%): 2.9 (N = 4) 

 Expected: 0.56 

 Standardized: 7.09 (P = NS)

age ≤ 30 yrs at presentation: 

 Crude (%): 6.0 (N = 3) 

 Expected: 0.86 

 Standardized: 3.49 (P = NS)
C-890 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Pinter et al., 

2004 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Kortenberg, 

Belgium 

Yrs followed: 

1 

To identify a 

sensitive BMI 

cutoff at 

admission in 

order to predict 

low BMI at 1-yr 

FU in a sample 

of AN patients 

who had gone 

through an 

inpatient tx 

program. 

Inclusion: 

Met DSM IV criteria for AN; 

were able to obtain FU data 

Exclusion: 

Co-morbid somatic problems 

Recruitment: 

252 consecutive patients 

admitted into inpatient Eating 

Disorders Unit of the U Centre 

Sint-Jozef in Kortenberg, 

Belgium for AN between 1994 

and 2001. 232 patients met 

inclusion criteria. 

Sample Size: 

Initial Sample 

252 admitted 

Reasons for loss to FU: 

Not reported 

Analysis Sample 

232 had 1-yr FU data 

Mean Age at 

Admission, yrs (SD): 

21.7 (6.68) 

Range: 12-40 

Mean BMI at 

Admission, kg/m2 

(

SD): 

14.5 (1.62) 

Mean BMI at 6-mo FU, 

kg/m2

 (SD): 

18.7 (1.22) 

Mean BMI at 1-yr FU, 

kg/m2

 (SD): 

18.2 (1.8) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Score: 

Poor 

Method of dx: 

Not reported 

Funding: 

NR 
C-891 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

All included participants underwent 

intensive, multi-dimensional inpatient tx 

program for AN. This first phase of tx 

typically lasted 5-6 mos. Following this, 

patients were then followed in an 

aftercare program that consisted of 

attending outpatient group meeting every 

two wks for an additional 6 mos. Wt 

assessments conducted at end of 

inpatient tx (i.e., approximately 6 mos) 

and at the termination of the outpatient 

FU (i.e., at 1-yr). 

Patients’ BMI and clinical severity 

assessed using Maudsley Body Mass 

Index Chart. 

Statistical Analyses 

Pearson’s product moment correlations 

to evaluate linear associations between 

BMI values at intake and at 1-yr FU. 

Mann-Whitney U tests performed to 

identify sig BMI cut points inclusive of the 

range of 12-16 kg/m2

 to separate those 

with high versus low BMIs at 1-yr FU 

based on baseline or admission BMI. 

Descriptive Findings 

Changes in BMI from 6-m to 1-yr (% of sample): 

Unchanged: 12.5% 

Increase: 45.2% 

Decrease: 42.2% 

BMI and Clinical Status Severity Category at 1-yr FU (N): 

< 12 (life threatening AN): 0 

12-13.5 (Critical AN): 4 

13.5-15 (Severe AN): 6 

15-17.5 (AN): 62 

17.5-20 (Underwt): 131 

20-25 (Normal wt): 29 

Correlations Between BMI at Admission and 1-yr FU: 

r = 0.24 

Admission BMI Cut-offs Predicting 1-yr FU BMI: 

< / = or > 12 (P = NS) 

< / = or > 13 (P = NS) 

< / = or > 14 (P < 0.01) 

< / = or > 15 (P < 0.001) 

< / = or > 16 (P < 0.001) 
C-892 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Råstam, 

Gillberg, and 

Gillberg; 1995 

Companion 

article: 

Ivarsson et al., 

2000 

Nilsson et al., 

1999 

Wentz et al., 

2001 

Wentz et al., 

2000 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteburg, 

Sweden 

Yrs followed: 

From onset to 

FU 

Cases: 6.7 

from onset 

From first 

exam to FU: 

Cases: 4.9, 

Comparisons: 

4.6 

To analyze the 

associated 

physical and 

neurodevelop

mental 

problems in 

individuals with 

AN over 6 yrs 

after disease 

onset, and a 

matched 

comparison 

group. 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, sex, 

school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total population 

of Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: Same schools 

as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Age of AN onset 

(yrs): 

14.3 

Range:13.9-14.7 

Mean Age at First 

Exam: 

G1: 16.0 (95% CI: 

15.5-16.5) 

G2: 16.0 (95% CI: 

15.5-16.5) 

Mean Age at FU: 

G1: 21 (95% CI: 20.5-

21.4) 

G2: 20.8 (95% CI: 

20.3-21.3) 

Sex (both groups), N: 

Females: 96 

Males: 6 

Race/ethnicity: 

NR 

Score: 

Good 

Method of dx: 

Structured interview 

using the SCID-I 

Funding: 

Swedish Medical 

Research Council, 

Swedish Social 

Research Council, 

Swen Jerring 

Foundation, 

Fulbright 

Commission, 

Wilhelm and Martina 

Lundgren 

Foundation 
C-893 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

At time of dx, all participants and their 

mothers were interviewed by a 

psychiatrist. At FU, were screened by 

another psychiatrist/psychologist blind to 

the original group status. Both groups 

screened: via SCID-II for personality 

disorder dx, clinician-based capacity for 

empathy, Dewey social awareness test, 

neurological testing, WAIS-R, wt, and ht 

(self-report). All individuals examined by 

psychiatrist who administered first 

interview, using SCID-I for Axis I 

disorders, M-R AN outcome scales, and 

rating of empathic skills. At end of 

interview, DSM III-R dx made 

independently by both clinicians; empathy 

dx was made conjointly by both. 

Neurodevelopmental exam included 

growth charts of wt and ht development 

from age 7 through time of 1st exam; wt 

and ht immediately before onset of AN 

compared to FU data. 

AN Outcomes classifications (1) 

recovered/not-recovered (2) avg M-R 

scale scores (3) good, intermediate and 

poor outcome: good = nrml body wt (100 

+- 15% avg body wt.), intermediate = 

normal or near normal wt and/or menstrual 

abnormalities, poor = low wt and absent or 

scanty menstruation. (BMI or % wt details 

regarding these definitions were NR). 

Statistical Methods: 

Chi-square tests for matched pairs were 

used. 

Descriptive Results 

Axis I Dx: 

ED at FU in AN group: 

AN: 6% 

BN: 22% 

EDNOS: 14% 

None: 59% 

EAT Scores at FU, mean: 

Cases: 19.2, 95% CI (13.1-25.1) 

Comparisons: 5.3, 95% CI (4.2-6.4) 

Diff between groups (P < 0.001) 

Comparison Axis I disorders between AN and control group at age 

21 (mean of 6 yrs after onset) 

Affective Disorders 

Unipolar major depression (P = NS) 

Any affective disorders (P = NS) 

Anxiety Disorders 

Agoraphobia (P = NS) 

Social phobia (P = NS) 

Panic disorder (P = NS) 

Generalized anxiety disorder (P = NS) 

Any anxiety disorder except OCD (P = NS) 

OCD: 

Cases: N = 10 

Comparisons: N = 3 (P < 0.05) 

Psychotic Disorders 

Schizoaffective disorder (P = NS) 

Psychosis NOS (P = NS) 

Schizophrenic disorder (P = NS) 

Any psychotic disorder (P = NS) 

Somatoform Disorders: 

Somatization disorder (P = NS) 

Hypochondria (P = NS) 

Body dysmorphic disorder (P = NS) 

Any somatization disorder (P = NS) 

Tic Disorders: 

Tourette’s disorder (P = NS) 

Impulse control Disorders: 

Trichotillomania (P = NS) 

Any tic disorder (P = NS) 

Simple Phobias: 

(P = NS) 

Comparisons of any Axis I Dx in AN and control groups over time: 

All but 1 Case, and 39% of Comparison group met criteria for at least 

one Axis 1 disorder in their lifetime. (P < 0.001) 
C-894 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Råstam, 

Gillberg, and 

Wentz 2003 

Design: 

Prospective 

cohort 

Comparison 

Group: 

Yes 

Location: 

Göteburg, 

Sweden 

Yrs followed: 

10 

To analyze 

overall 

outcome, and 

associated 

physical and 

mental health 

problems at 10 

yr FU among 

teenage-onset 

AN population 

and matched 

controls. 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, 

sex, school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total 

population of Göteburg, 

Sweden, born in 1970 and 

developing AN before age 

18; pooled with second 

population screening 

sample reported by school 

and hospital health care 

workers during FU. Some 

clinically referred and 

some screened through 

school nurses and 

doctors, pediatricians, and 

child psychiatrists. 48 

screened via personal 

interview, 3 via phone 

Comparisons: 

Same schools as AN 

group; 51 screened in 

person 

Sample Size: 

Cases: 51 

Comparisons: 51 

Age of AN onset: 

14.3 yrs 

Range: 13.9-14.7 

Restrictors: 13.3 yrs; 95% CI 

(12.1-14.6) 

Bingers/purgers: 14.6; 95% 

CI (14.2-15.0) 

(P < 0.05) 

Mean Age at First Exam: 

Cases: 16.0 

(95% CI: 15.5-16.5) 

Comparisons: 16.0 

(95% CI: 15.5-16.5) 

Mean Age at FU: 

Cases: 24.5 (95% CI: 24.0-

25.0) 

Comparisons: 24.2 (95% CI: 

23.7-24.7) 

Sex, N: 

Females: 96 

Males:6 

Race/ethnicity: 

NR 

Full-time employment/ 

study: 

Cases: 65%, 

Comparisons: 88% (P < 0.01) 

Mean duration of AN, yrs: 

Cases: 3.3, 95% CI (2.7-3.8) 

Total duration of EDs, yrs: 

Cases: 6.3 

95% CI (5.4-7.2) 

Score: 

Good 

Method of dx: 

Structured 

interview using 

the SCID-I 

Funding: 

Swedish Medical 

Research Council, 

Göteburg Medical 

Society, Wilhelm 

and Martina 

Lundgrem 

Foundation, 

SoderstromKonigska Nursing 

Home 

Foundation, and 

state grants under 

LUA agreement. 
C-895 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Treatment received by Cases: 

Lifetime tx for ED: 29 (57%) 

Conjoint family therapy: 19 

Individuals with ASD and/ or OCPD: 6/8 

No tx: 12 

Tx for individuals with persisiting ED: 

11/14 

Tx for recovered AN: 18/37 

Study Methods: 

Each individual seen by 3 psychiatrists, 

1 blind to the original dx group status. 

Measurements: SCID-I and SCID-II for 

DSM IV; Y-BOCS; ASDI (Asperger 

Syndrome Diagnostic Interview); 

Modified M-R Scales; GAF scale. 

Full recovery with respect to ED 

symtomatology; Psychiatric tx; 

Neuropsychiatric exam; physical exam, 

Self report: EAT, BDI. 

Statistical Methods: 

Chi-square tests for matched pairs were 

used. 

AN Outcomes classification: 

Full recovery: free of symptoms of AN or BN for not less than 8 

consecutive wks including sustained absence of wt deviation, 

compensatory behaviors, deviant attitudes regarding wt and shape 

including wt phobia. Also relaxed attitude towards eating in general for not 

< 6 mos. 

Modified M-R Outcome categories: 

Good: normal body wt (100 +- 15%avg body wt.) + normal menstruation 

Intermediate: normal or near normal wt or normal menstrual but not both, 

Poor: under wt and absent or scanty menstruation. (BMI or % wt details 

regarding these definitions were NR). 

Descriptive Results at 10 yr FU 

ABW (kg): 

Cases: 62.3,95% CI (58.5-66.1) 

Comparisons: 63.7, 95% CI (60.8-66.5) 

(P = NS) 

Mean BMI: 

Cases: 22.2, 95% CI (21.0-23.4) 

Comparisons: 22.2, 95% CI (20.5-21.8) 

(P = NS) 

ED in AN group: 

AN 3 (6%) 

BN 2 (4%) 

EDNOS 9 (18%) 

Any ED 14 (27%) 

Absence of any ED symptoms for at least 6 mos: 

Cases: 20 (39%) 

Comparisons: 46 (90%) 

Diff between groups (P < 0.0001) Cases less likely than Comparisons 

Diff in current Axis I Psychiatric Dx: 

Any affective disorder, current (P = NS) 

Current Axis I, excluding ED (P = NS) 

Panic disorder, social phobia, simple phobia, general anxiety disorder, 

any anxiety disorder (P = NS) 

Current OCD: Cases: N = 8; Comparisons: N = 1; (P = 0.05) 

Psychotic disorders (P = NS) 

Impulse control disorders (P = NS) 

Somatoform dx (P = NS) 

Tic disorders (P = NS) 

Diff in lifetime Axis I Psychiatric Dx: 

Major Depression and Dysthymic disorders (P = NS) 

Any affective disorder: Cases: N = 49; Comparisons: N = 12 (P < 0.0001) 

Panic disorder, social phobia, simple phobia, general anxiety disorder, 

any anxiety disorder excluding OCD (P = NS) 

OCD: Cases: 18; Comparisons: 5 (P = 0.01) 

Any anxiety disorder, including OCD: Cases: 29, Comparisons:16 

(P = 0.02) 

Psychotic disorders (P = NS) 

Impulse control disorders (P = NS) 

Somatoform dx (P = NS) 

Tic disorders (P = NS) 

Any Axis I, including ED: Cases: 51, Comparisons: 26; (P = 0.0001) 

Any Axis I, excluding ED: Cases: 51, Comparisons: 26; (P = 0.0001) 
C-896 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Råstam, 

Gillberg, and 

Wentz 2003 

(continued) 

 
C-897 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Diff in Axis II disorders: 

Cluster A 

All categories currently (P = NS) 

All cluster A ever (P = NS) 

Cluster B 

All categories currently (P = NS) 

All categories ever (P = NS) 

Cluster C 

Avoidant: Cases currently (P = NS) 

Dependent currently (P = NS) 

Obsessive-compulsive currently (P = NS) 

Passive-aggressive currently (P = NS) 

Any cluster C currently: Cases: 11, Comparisons: 4; (P < 0.05) 

Any cluster C ever: Cases: 32, Comparisons: 11; (P < 0.01) 

Autistic disorder, Asperger syndrome, Autistic-like condition, OCPD 

currently (P = NS) 

OCPD ever: Cases: 28, Comparisons: 7; (P < 0.001) 

ASD currently: Cases: 9; Comparisons:1; (P < 0.02) 

ASD ever: Cases: 12, Comparisons: 1; (P < 0.01) 

Any OCPD/ASD currently: Cases 14, Comparisons: 6 (P < 0.05) 

Any OCPD/ASD ever: Cases: 32, Comparisons: 8; (P < 0.001) 

Any OCPD/ASD at baseline, 1st and 2nd FU: Cases: 8, Comparisons: 0; 

(P < 0.02) 

Other personality disorders 

Self-defeating (P = NS) 

Any SCID personality disorder (P = NS) 

Mean age of OCD onset (P = NS) 

Overall Outcome Measures: 

Diff in avg M-R Scale Outcomes: 

Cases: Good: 49%; Intermediate: 41%; Poor: 10% 

Cases: 9.4, 95% CI (8.8-10.0), Comparisons: 11.2, 95% CI (10.8-11.5) 

(P < 0.0001) 

Diff in modified M-R Scale Outcomes: 

Cases: 

Good: 43% 

Intermediate: 29% 

Poor: 27% 

Diff in dietary Restriction: 

Cases: 47% 

Comparisons: 16% (P < 0.01) 

Diff in worry about wt and appearance: 

Cases: 69% 

Comparisons: 27% (P < 0.001) 

Diff in normal menstruation: 

Cases: 65% 

Comparisons: 85% (P < 0.05) 

AN group very poor overall outcome (M-R score < 8.5) (N): 

Cases at 6 yr FU: 20 

Cases at 10 yr FU: 16 

Correlation between avg FU scores at 6 and 10 yrs: r = 0.72 (P < 0.0001) 
C-898 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Råstam, 

Gillberg, and 

Wentz 2003 

(continued) 

 
C-899 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Diff GAF scale, mean scores: 

Case: 65.3, 95% CI (61.0-69.7) 

Comparisons: 84.8, 95% CI (81.7-87.9) 

(P < 0.0001) 

AN group outcomes in relation to psychiatric disorders and PDs:

M-R Score: 

Cases OCPD/ASD at baseline, 1st and 2nd FU: 7.3 

All other cases: 9.8 (P < 0.01) 

Median GAF score: 

Cases with Axis 1: 60 

All other cases: 75 (P < 0.01) 

Mean GAF score: 

Cases with OCD: 50 

All other cases: 70 (P < 0.02) 

Diff neurodevelopmental and other physical problems: 

Fine and gross motor skills, tremor, mirror movements, handedness 

(P = NS) 

Dysdiadochokinesis: 

Cases: 11 

Comparisons: 2 (P < 0.02) 

GI problems: 

Cases: 47% 

Comparisons: 27% (P < 0.05; P < 0.055 adj) 
C-900 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Saccomani et 

al., 1998 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Genoa, Italy 

Yrs followed: 

Mean 9.6 yrs, 

Range 4 to 19 

yrs 

To assess 

outcomes and 

comorbid 

mood and 

personality 

disorders in 

patients dx 

with AN during 

childhood or 

adolescence. 

Inclusion: 

AN dx at admission based on 

Feighner’s, DSM III, or DSM 

III-R criteria. Dx reclassified at 

FU using DSM IV 

Exclusion: 

None 

Recruitment: 

Record survey of patients 

admitted to Gaslini Dept of 

Neurology and Psychiatry 

between 1976-1990. 

Sample Size: 

Initial sample: 

Identified through records: 

N = 87 

Reasons for loss to FU: 

2 not found, 4 refused 

Analysis sample: 

Agreed to participate at FU: 

N = 81 

Mean Age: 

NR 

Mean Age of Onset, 

yrs, mean (range): 

14.5 (9 to 21) 

% Wt Loss, mean 

(SD): 

28.3 (6.3) 

BMI kg/m2

, mean 

(SD): 

13.9 (1.8) 

Sex: 

Female, N = 72 

Males, N = 9 

Amenorrhea: 

100% of females 

Menses resumed: 

87% 

Race/ethnicity: 

NR 

Score: 

Poor 

Method of dx: 

Initial inclusion dx: 

Feighner’s, DSM III, 

or DSM III-R criteria 

by chart review 

No info provided 

about qualifications 

of reviewers or 

method. 

Dx reclassified at 

FU using DSM IV. 

No info provided 

about diagnosticians 

or method. 

Funding: 

None reported 
C-901 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Records survey of all patients admitted 

between 1976-1990 meeting criteria for 

AN by Feighner’s, DSM III, DSM III-R 

criteria. 

At FU, patients sent a questionnaire 

designed by investigators to evaluate AN 

clinical features, social adjustment, 

familial and sexual relations, mental 

state, and psychiatric disorders in the 

previous 6 mos; and the Middlesex 

Hospital Questionnaire (MHQ). 

Information used to determine Jeammet 

scale (modified M-R Scale). 

Corraborative data gathered from semistructured interview of family or 

boyfriends. 

Of 81 patients contacted, all completed 

both questionnaires, 28 had face-to-face 

semi-structured interview, 39 agreed only 

to phone interview, and 2 patients had 

info provided by psychotherapist. 

Statistical Method: 

Kruskal-Wallis analysis of variance for 

continuous data 

Fisher tests for categorical data 

Outcomes: 

Jeammet (modified M-R Outcome Scale): 

Good – 8 of 10 items score a 1 or 2 (on 4 

patient. scale) 

Intermediate – 4 to 7 items score 1 or 2 

(on 4 patient. scale) 

Poor - < 3 items score 1 or 2 (on 4 

patient. scale) 

Descriptive Results: 

AN Outcome:

Good: 43 (53%) 

Intermediate: 27 (33%) 

Poor: 11 (14%) 

Binge eating by outcome group

Poor: 45% 

Intermediate: 28% 

Good: 14% 

(P = 0.034) 

Medical emergencies by outcome group 

Poor: 55% 

Intermediate: 21% 

Good: 4% 

(P = 0.0003) 

Length/type of tx by outcome group: 

Outpatient tx 

Good: 49% 

Intermediate: 26% 

Poor: 0% 

Medium-term hospitalization 

Good: 32% 

Intermediate: 11% 

Poor: 36% 

Long-term hospitalization 

Good: 0% 

Intermediate: 37% 

Poor: 36% 

Co-morbid psych dx by outcome group: 

Personality disorders 

Good: 0% 

Intermediate: 41% 

Poor: 73% 

(P < 0.001) 

Mood disorders 

Good: 14% 

Intermediate: 63% 

Poor: 73% 

(P = 0.002) 

Other diff by outcome group: 

For eating behavior, wt, menstruation, body image, occupation, social 

contact, familial relationships, sexual relations, insight, mental state 

(P = 0.001). Good better than Poor 

For social, familial and sexual relationships, insight, and mental state 

(P = 0.001). Good better than Intermediate 

For wt and sexual relationships (P = 0.001). Intermediate better than 

Poor 
C-902 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Schork et al., 

1994 

Companion 

articles: 

Halmi, Eckert 

et al., 1991 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

USA (Iowa 

City, IA; 

Minneapolis, 

MN; White 

Plains, NY 

Years 

followed: 

10 

To compare 

general 

psychopatholo

gy, eating 

disorder dx 

status, and 

clinical 

outcome in 

women 10 yrs 

after their 

hospital tx for 

AN. 

Inclusion: Modified Feighner 

dx criteria for AN. Other details 

in Halmi et al., 1979 and Halmi 

et al., 1991. 

Exclusion: 

See Halmi et al., 1979, for 

details. 

Recruitment: 

Patients who completed 35-

day hospital tx study for AN. 

Sample Size (N): 

Completed tx: 76 

Completed FU: 59 

Reasons for Loss to FU: 

3 did not complete the MMPI, 

9 refused to participate, 5 

deceased (causes unknown). 

Mean Age, Yrs 

(SD): 

NR 

Sex: 

Female 

Race/ethnicity: 

NR 

Score: 

Poor 

Method of diagnosis: 

Prospective 

assessment using 

Feighner criteria; 

retrospective DSM-III-R. 

Funding: 

NR 
C-903 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

ED clinical status at FU: DSM III-R ED diagnostic 

categories, plus two versions of the Categories of 

General Outcome classification scheme 

1) M-R scale: 

Recovered: within 15% of IBW, normal menses, no 

sig disturbance in eating or body image 

Good: within 15% IBW, normal menses, but with 

presence of binge-eating, self-induced vomiting, 

laxative abuse, or other clearly abnormal eating 

behavior 

Intermediate: weight only intermittently within 15% 

IBW, or some menstrual disturbance, or both 

Poor: weight always more than 15% below IBW 

during the year prior to assessment 

2) Modified Ratnasuriya et al. (1991) scheme: 

Good: weight within 15% of IBW, normal menses 

Intermediate: weight only intermittently within 15% 

IBW, or some menstrual disturbance, or both 

Poor: weight always more than 15% below IBW 

during the year before assessment and absent or 

sporadic menses, or the occurrence of either 

overeating or vomiting weekly or more, regardless of 

weight or menstrual status 

Minnesota Multiphasic Personality Inventory used to 

assess general psychopathology at FU. 

Statistical Approach 

Chi-square tests to assess diff across groups 

MANOVA to assess outcome group differences in 

MMPI followed by univariate ANOVAs and TukeyKramer pairwise post-hoc comparisons for separate 

clinical scales. 

Descriptive Findings: 

M-R outcome at 10-yr FU by current ED Dx, N: 

Recovered: 16 (No ED: 16; EDNOS: 0; BN: 0; AN: 0; AN+BN: 

0) 

Good: 15 (No ED: 0; EDNOS: 8; BN: 7; AN: 0; AN+BN: 0) 

Intermediate: 21 (No ED: 0; EDNOS: 14; BN: 7; AN: 0; 

AN+BN: 0) 

Poor: 7 (No ED: 0; EDNOS: 0; BN: 0; AN: 5; AN+BN: 2) 

Ratnasuriya outcome at 10-yr FU by current ED Dx, N: 

Good: 24 (No ED: 16; EDNOS: 8; BN: 0; AN: 0; AN+BN: 0) 

Intermediate: 13 (No ED: 0; EDNOS: 13; BN: 0; AN: 0; 

AN+BN: 0) 

Poor: 22 (No ED: 0; EDNOS: 1; BN: 14; AN: 5; AN+BN: 2) 

Multivariate Results: 

MMPI Scales by M-R Outcome: 

Recovered had sig lower score vs. poor outcome group: 

hypochondriasis (P = 0.004), depression (P = 0.017), 

psychasthenia (P = 0.005), and schizophrenia (P = 0.027). 

Recovered sig lower score vs. intermediate outcome group: 

psychasthenia (P = 0.04) and schizophrenia (P = 0.019). 

MMPI Scales by Ratnasuriya Outcome: 

Good outcome group better than poor outcome: 

hypochondriasis (P = 0.001), depression (P < 0.001), hysteria 

(P = 0.001), psychopathic deviate (P = 0.007), paranoia (P = 

0.012), psychasthenia (P < 0.001), and schizophrenia (P = 

0.002). 

Intermediate Outcome group better than Poor Outcome 

group: on depression (P = 0.036), psychopathic deviate (P = 

0.049), and schizophrenia (P = 0.042). 

MMPI Scales by ED Dx at FU: 

No-ED group better than AN group: hypochondriasis (P = 

0.008), depression (P = 0.006), psychasthenia (P = 0.001), 

and schizophrenia (P = 0.012). 

No-ED group better than BN group: hysteria (P = 0.05) and 

psychasthenia (P = 0.01). 

Number of Clinically Elevated MMPI Scales by Current ED 

Dx at FU (N): 

No ED: none (14); 1 (2); 2 (0); ≥ 3 (0) 

ED-NOS: none (13); 1 (4); 2 (1); ≥ 3 (4) 

Severe ED (AN, BN, AN+BN): none (7); 1 (1); 2 (5); ≥ 3 (8) 

Patients with no ED more likely to have no clinically elevated 

scales vs. “severe ED” outcome groups (AN, BN, or AN+BN) 

(P = 0.001). 
C-904 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics 

Quality 

Adverse Events 

Authors, year: 

Schork et al., 

1994 

(continued) 

 
C-905 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Number of MMPI Scales in Clinical Range by M-R 

Outcome (N): 

Recovered: none (14); 1 (2); 2 (0); ≥ 3 (0) 

Good: none (10); 1 (0); 2 (2); ≥ 3 (3) 

Intermediate: none (9); 1 (4); 2 (2); ≥ 3 (6) 

Poor: none (1); 1 (1); 2 (1); ≥ 3 (4) 

Recovered + Good Outcome groups less likely to have 

clinically elevated scales vs. Intermediate + Poor Outcome 

groups (P = 0.003). 

Number of MMPI Scales in Clinical Range by Ratnasuriya 

Outcome (N): 

Good: none (21); 1 (2); 2 (0); ≥ 3 (1) 

Intermediate: none (6); 1 (4); 2 (0); ≥ 3 (3) 

Poor: none (8); 1 (1); 2 (4); ≥ 3 (9) 

Good Outcome groups more likely to have no clinically 

elevated scales vs. Poor Outcome groups (P < 0.001). 
C-906 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Strober et al., 

1996 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

10 

To examine 

the predictive 

power of binge 

eating 

behavior in 

predicting firstonset 

substance use 

disorder in AN 

patients. 

Inclusion: 

Met DSM III-R criteria for AN 

at intake; 12-17 yrs 11 mos at 

intake 

Exclusion: 

See original study (Strober and 

Yager, 1984) for more specific 

details 

Recruitment: 

Consecutive inpatient 

admissions to UCLA 

Neuropsychiatric Institute, Los 

Angeles, CA, USA, for the tx of 

AN between 1980 and 1985. 

Sample Size: 

Original sample: 

N = 97 

Reasons for loss to FU: 

Subjects dropped out of tx w/in 

10 days of admission and 

refused participation in FU. 

Analysis sample: 

N = 95 

Binge-eaters at intake (N = 18) 

Restrictors at intake (N = 77) 

Binge-eaters at intake and FU: 

including 23 who developed 

binge eating during FU 

(N = 41) 

Restrictors at both intake and 

FU, no binge eating (N = 54) 

Binge eaters at FU only 

(N = 23) 

Mean Age at Intake: 

15.1

Sex: 

Female: 94% 

Race/ethnicity: 

White: 93% 

Family structure: 

2-parent: 79% 

SES: 

Middle-upper class: 

91%

BMI at Intake (SD): 

14.1 (1.9) 

Score: 

Good 

Method of dx: 

Method of ED dx 

NR, Structured 

clinical interviews 

using the SADS, 

Kiddie-SADS, and 

LIFE 

Funding: 

NR 
C-907 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Intervention: 

Inpatient tx 

Study Methods 

Semi-structured interview, information 

from knowledgeable informants, M-R 

scale completed, LIFE completed, 

interview every 6 mos for 5 yrs and 

annually for 5 yrs. 

Statistical Methods 

Fisher’s exact test for comparisons of 

dichotomous variables; Survival analyses 

to compare groups’ time to onset of SUD 

and effects of covariates on time-toresponse were assessed via stepwise Cox 

regression analyses. 

Descriptive Results 

SUD Incidence During 10-yr FU: 

Substance abuse: N = 11 

Substance dependence: N = 7 

Mean Onset of SUD from Intake: 

Total sample: 199 wks (range: 48-401) 

Binge eaters at intake: 163 wks 

Restrictors at intake: 235 wks 

Cumulative Probability and Relative Risk of SUD During 10-yr FU: 

Binge eaters at intake: 0.50 (SE = 0.12) 

Restrictors at intake: 0.12 (SE = 0.04) 

Diff between groups’ survival distributions: RR = 5.80 (P = 0.0001) 

Binge eaters faster rate of developing SUD than restrictors 

Binge eaters at intake or FU: 0.34 (SE = 0.07) 

Restrictors at both intake and FU: 0.07 (SE = 0.04) 

Diff between groups’ survival distributions: RR = 5.53 (P = 0.0007) 

Binge eaters faster rate of developing SUD than restrictors 

Diff between groups (P = NS) 

Binge eaters at intake: 0.50 (SE = 0.12) 

Binge eaters at FU only: 0.22 (SE = 0.09) 

Diff between groups’ survival distributions: RR = 2.89 (P = 0.05) Binge 

eaters at intake faster rate of developing SUD than binge eaters at FU 

only 

Restrictors at both intake and FU: 0.07 (SE = 0.04) 

Binge eaters at FU only: 0.22 (SE = 0.09) 

Diff between groups’ survival distributions (P = 0.06) 

Binge eaters at intake: 0.50 (SE = 0.12) 

Restrictors at both intake and FU: 0.07 (SE = 0.04) 

Diff between groups’ survival distributions: RR = 9.20 (P = 0.0001) 

Binge eaters faster rate of developing SUD than restrictors 

Incidence of SUD in First Degree Relatives (%): 

Binge eaters at intake: 55.6 

Restrictors at intake: 14.3 

Binge eaters at intake or FU: 31.7 

Restrictors at both intake and FU: 14.8 

Binge eaters at FU only: 13.0 

Binge-eating status in relation to SUD in first degree relatives: 

Binge eaters at intake v. Restrictors at intake: OR = 7.5, 95% CI (2.4-

23.2) worse in binge eaters 

Binge eaters at intake v. Restrictors at both intake and FU: OR = 7.2, 

95% CI (2.2-23.8) worse in binge eaters 

Binge eaters at intake or FU v. Restrictors at both intake and FU: OR = 

2.7, 95% CI (1.0-7.2) worse in binge eaters 

Binge eaters at intake v. Binge eaters at FU only: OR = 8.3, 95% CI 

(1.8-38.4) worse in early binge-eating 

Restrictors at both intake and FU v. Binge eaters at FU only (P = NS) 
C-908 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Strober et al., 

1996 

(continued) 

 
C-909 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Multivariate Results 

SUD Onset 

Binge-eating at Intake (P = 0.001) 

Family Hx of SUD (P = NS) 

BMI at Intake (P = NS) 

Highest-Lowest BMI (P = NS) 

Parental Separation/Divorce (P = NS) 

Current/Lifetime Hx of Depression or Anxiety at Intake (P = NS) 

New Onset of Depression or Anxiety at FU (P = NS) 
C-910 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Strober, Freeman 

and Morrell, 1997 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

10 to 15 yrs from 

time of index 

admission 

To assess 

the longterm 

course of 

recovery 

and 

relapse 

and 

predictors 

of outcome 

in AN. 

Inclusion: 

DSM III criteria for AN 

Exclusion: 

NR 

Recruitment: 

All consecutive admissions to 

ED inpatient tx program for AN 

at UCLA Neuropsychiatric 

Institute between 1/1/80 and 

12/31/85. 

Sample Size: 

Initial Sample: 

N = 95 

Loss to FU: 

2 patients left hospital within 

10 days of admission and 

refused further participation. 

Analysis Sample: 

N = 93 

Age Range At Time of 

Intake 

12 to 17 yrs, 11 mos 

Age range at FU: 

22 – nearly 33 yrs 

Sex: 

Female: N = 85 

(89.5%) 

Race/ethnicity: 

White: N = 88 (92.6%) 

BMI, mean (SD): 

14.1 (1.9); 69% of avg 

expected body wt 

Duration of illness, 

mos, mean (range): 

29 mos (8 – 88 mos) 

Hx of binge eating: 

N = 18 (18.9%) 

Restrictor at intake: 

N = 77 (81.1%) 

Hx of self-induced 

vomiting: 

11 (61.1%) of intake 

binge eaters; 17 

(22.1%) of intake 

restrictors 

Prior 

Hospitalizations: 

Psych tx for AN 

(24.2%) 

Med tx for wt loss 

complications (35.8%) 

Prior psych care 

(82.1%) 

Score: 

Fair 

Method of dx: 

Examinations 

conducted by two 

senior faculty 

members. 

Funding: 

NR 
C-911 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Participants had all received inpatient tx. 

Interviews were scheduled at 6-mo 

intervals from the point of discharge 

throughout the first 5 yrs, and annually 

thereafter until completion of FU. 

Outcome definitions 

Full recovery: free of all symptoms of 

AN or BN for at least 8 consecutive wks. 

Partial recovery: wt within 15% of avg 

and normal cyclical menstruation is 

sustained for at least 8 consecutive wks. 

Intermediate outcome: wt within 15% 

of avg not maintained with consistency, 

and/or there is menstrual irregularity 

Poor: wt < 85% of avg and menstruation 

iabsent, or nearly always so, or if patient 

exhibits BN. 

Post-discharge relapse: drop in body 

wt to < 85 of avg, occurring prior to point 

at which patient meets criteria for partial 

recovery. 

Post-recovery relapse: when patient 

had prospectively observed 

exacerbation of illness following either 

partial recovery or full recovery. For 

those following full recovery, new illness 

further categorized as subsyndromal if 

patient had reappearance of 

psychological symptoms but remained 

at least 85% of avg body wt, and 

syndromal if wt fell below this criterion. 

Statistical Methods 

Chi Square, t tests, life tables, KaplanMeier extension of survival analysis. 

Pairwise comparisons of survival curves 

for particular subgroups of interest: log 

rank test and Breslow (GehenWilcoxon) test 

Individual predictor variables: univariate 

and multivariate Cox proportional 

hazards regression models 

Isolate sig of individual predictors: 

stepwise multiple logistic regression 

Descriptive Results 

Partial recovery: 82/95 (86.3%) 

Full recovery: 72/95 (75.8%) 

Current dx of chronically ill (did not achieve full/partial recovery) (N = 13): 

BN (9/13; 9.5%); AN, restricting (3/13; 3.2%); AN, binge eating (1/13; 

1.1%) 

Median time to partial recovery: 57.4 mos 

Median time to full recovery: 79.1 mos 

Cumulative Probability of Recovery Through FU by interval start 

time, mos: 

0 mos: Partial = 2%, Full = 0% 

12: Partial = 10%, Full = 0% 

24: Partial = 21%, Full = 1% 

36: Partial = 33%, Full = 9% 

48: Partial = 55%, Full: 18% 

60: Partial = 70%, Full = 37% 

72: Partial = 74%, Full = 59% 

84: Partial = 75%, Full = 63% 

96: Partial = 80%, Full = 67% 

108: Partial = 84%, Full = 73% 

120: Partial = 87%, Full = 73% 

132-180 mos: Partial = 87%, Full = 77% 

Diff in psychosocial adjustment by partial recovery or better or not: 

Good work status, yr 5: 

Partial recovered: 71% 

Not partial recovered: 26% 

OR = 7.3, 95% CI (2.9 – 18.3) (P < 0.0001) 

Good work status, yr 10: 

Partial recovered:80% 

Not partial recovered:25% 

OR = 11.8, 95% CI (3.4 – 41.6) (P < 0.0001) 

Good social relating, yr 5: 

Partial recovered:73% 

Not partial recovered:54% 

OR = 2.3, 95% CI (0.9 – 5.6) (P = NS) 

Good social relating, yr 10: 

Partial Recovered: 85% 

Not partial recovered:38% 

OR = 9.3 95% CI (2.8 – 30.4) (P < 0.0002) 

Higher life satisfaction, yr 5: 

Partial Recovered: 41% 

Not partial recovered:15% 

OR = 3.8, 95% CI (1.4 – 10.6) (P < 0.012) 

Higher life satisfaction, yr 10: 

Partial Recovered: 68% 

Not partial recovered: 6% 

OR = 32.4, 95% CI (4.1 – 259.2) (P < 0.0001) 
C-912 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Strober, Freeman 

and Morrell, 1997 

(continued) 

 
C-913 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Diff in psychosocial adjustment by full recovery or not: 

Good work status, yr 5: 

Recovered: 87% 

Not recovered:67% 

OR = 3.2, 95% CI (1.1 – 9.2) (P = 0.029) 

Good work status, yr 10: 

Recovered:96% 

Not recovered: 62% 

OR = 13.8, 95% CI (3.4 – 55.8) (P < 0.0001) 

Good social relating, yr 5: 

Recovered: 91% 

Not recovered: 65% 

OR = 5.6, 95% CI (1.7 – 18.2) (P = 0.003) 

Good social relating, yr 10: 

Recovered: 90% 

Not recovered: 73% 

OR = 3.3, 95% CI (1.0 – 10.5) (P = 0.053) 

Higher life satisfaction, yr 5: 

Recovered: 89% 

Not recovered: 69% 

OR = 11.9, 95% CI (4.0 – 35.3) (P < 0.0001) 

Higher life satisfaction, yr 10: 

Recovered: 87% 

Not recovered: 54% 

OR = 5.7, 95% CI (2.0 – 16.2) (P = 0.002) 

Onset of binge eating during FU among those who were restrictors 

at baseline. N = 23/77 (29%) 

Time to onset of binge eating: median (range): 24 mos (3 – 59 mos); 95% 

CI (16.2 – 31.8). 

Binge eating commenced when patient within 85% of avg body expected 

wt: 19/23 (82.6%) 

Fulfilled BN criteria: 16/23 (65.2%) 

Post discharge relapse: N = 28 (29.5%) 

Survival time, mos (mean): 

Entire sample: 129.3, 95% CI (114.4 – 144.2) 

In patients who relapsed: 15.0, 95% CI (10.2 – 19.9); median: 11.0, 95% 

CI (5.8 – 16.2) 

Mean time to post-discharge relapse, mos: 

Chronically ill group: 10.8, 95% CI (4.9 – 16.6); median: 7.0, 95% CI (5.6 

– 8.4) 

Patients who eventually recovered: 19.9, 95% CI (12.3 – 27.5); median: 

13.0, 95% CI (4.2 – 21.8) 

Post-Recovery Relapse: 

Following partial recovery: N = 8 (9.8%) by 13 mos from time of partial 

recovery 

Syndromal relapses following full recovery: N = 0 

Subsyndromal relapses following full recovery: N = 5 (7.1%) by 19 mos 
C-914 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Strober, Freeman 

and Morrell, 1997 

(continued) 

 
C-915 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Multivariate Results 

Predictors of Chronic Outcome (Intermediate or Poor): 

Extreme, compulsive drive to exercise: OR = 4.3, 95% CI (1.2 – 15.3) 

(P = 0.023) 

Hx of poor social relating preceding onset of illness: OR = 3.5, 

95% CI (1.2 – 12.8) (P = 0.044) 

Early age of onset (P = NS) 

Predictors of longer time to full recovery 

Hostile attitudes toward family: HR = 0.67, 95% CI (0.5 – 0.9) (P = 0.046) 

Extreme compulsivity in daily routines: HR = 0.59, 95% CI (0.4 = 0.9) 

(P = 0.035) 

Early age of onset (P = NS) 

Predictors of binge eating during FU among those who were 

restrictors at baseline: 

Hostile attitudes toward family: OR = 6.7, 95% CI (2.2 – 20.2) 

(P = 0.0007) 

Lack of parential-expressed empathy/affection toward patient: OR = 3.1, 

95% CI (1.1 – 8.6) (P = 0.028) 

Predictors of earlier time to relapse (adj for duration of 

hospitalization): 

Final outcome status (chronic versus partial or full recovery): HR = 2.5, 

95% CI (1.1 – 5.5) (P = 0.027) 

Compulsive drive to exercise at time of discharge: HR = 2.2, 

95% CI (1.1 – 4.9) (P = NR) 
C-916 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics 

Quality 

Adverse Events 

Authors, yr: 

Sullivan, Bulik 

et al., 1998 

Design: 

Case Series 

Comparison 

Group: 

Yes 

Location: 

Christchurch, 

New Zealand 

Yrs followed: 

12 

To ascertain 

the 

intermediate to 

long-term 

outcomes for 

women who 

had been 

referred for tx 

for AN an avg 

of 12 yrs 

earlier – using 

clear 

diagnostic defs 

and a 

structured 

method. To 

compare 

outcomes to a 

community 

sample. 

Inclusion: 

Cases: Newly dx via DSM III-R 

criteria for definite or 

“probable” AN, all determined 

to meet lifetime DSM III-R 

criteria for AN; age 23-45 

Comparisons: Age matched 

to AN cases; age 23-45 

Exclusion: 

Cases: None 

Comparisons: subthreshold 

AN symptoms 

Recruitment: 

Cases: Newly dx via DSM III-R 

criteria during inpatient, 

outpatient or assessment from 

1981-1984 among those who 

received ED services at 

Princess Margaret Hospital, 

Christchurch, New Zealand, for 

definite or “probable” AN 

Comparisons: randomly 

selected names obtained from 

electoral record 

Both: letter to invite 

participation; FU phone call; 

personal interview 

Sample Size: 

Initial Sample 

Records reviewed: 239 

Potential AN: 89 

Potential comparisons: 111 

Reasons for loss to FU: 

Death: 1 due to suicide while 

being treated for AN, 3 could 

not be located, 8 did not give 

consent, and 7 did not meet 

criteria for AN 

Analysis sample: 

Cases = 70 

Comparison = 98 

Mean Age (yrs) 

At interview: 

Cases: 32.4 (7.8) 

Comparison: 35.5 (6.2) 

(P < 0.01)

Cases: 

AN onset: 16.9 yrs 

(4.1) 

Age at first tx: 20.9 

(8.0) 

Interval between 

onset and interview 

(yrs): 

15.4 (7.0) 

Sex: 

Female: 100% 

Race/ethnicity: 

European 

Cases: 98.6% 

Comparison: 96.0% 

(P = NS) 

Never married: 

Cases: 45.7% 

Comparison: 16.3% 

(P < 0.01) 

Managerial or 

professional occ: 

Cases: 21.4% 

Comparison: 25.5% 

Morbidity: 

Lifetime AN 

Cases: 100%: 

Comparison: 0% 

Current full 

syndrome AN 

Cases: 10% 

Comparison: 0% 

Current 

subtrhreshold AN: 

Cases: 5.7% 

Comparisons: 0% 

Lifetime BN 

Cases: 54.3% 

Comparison: 2% 

Current BN 

Cases: 11.4% 

Comparison: 0% 

Score: 

Good 

Method of dx: 

Criteria for DSM III 

or DSM IIIR 

determined through 

review of hospital 

records. 

Funding: 

Cantebury Medical 

Research 

Foundation 

New Zealand Health 

Research Council 
C-917 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Study Methods 

Cases: Hospital record of AN patients 

reviewed by 2 trained abstractors 

ED attitudes measured via EDI and 

TFEQ 

Psychiatric disorders defined according 

to DSM III-R criteria 

Current assessment of social and 

occupational functioning using GAFS 

Statistical Methods 

Chi-square, ANOVA, ANCOVA 

Outcome: diff between AN and 

Comparison groups. 

All analyses adjust for age.

Descriptive Findings 

Diff in percentage of groups with dx at 12 yr FU: 

Lifetime Mood Disorders 

Major depression: Cases: 51.4%; Comparisons: 35.7% (P ≤ 0.05) 

Bipolar I disorder (P = NS) 

Bipolar II disorder (P = NS) 

Any mood disorder: Cases: 60.0%; Comparisons: 41.8% (P ≤ 0.05) 

Lifetime Drug Use Disorders 

Alcohol dependence: Cases: 27.1%; Comparisons: 10.2% (P ≤ 0.05) 

Cannabis dependence (P = NS) 

Other drug dependence (P = NS) 

Any drug dependence: Cases: 30.0%; Comparisons: 12.2% (P ≤ 0.05) 

Lifetime Anxiety Disorders 

OCD: Cases: 15.9%; Comparisons: 2.0% (P ≤ 0.01) 

Panic Disorder (P < 0.05) Cases worse 

Social Phobia (P = NS) 

Separation Anxiety Disorder: Cases: 17.1%; Comparisons: 2.0% (P ≤ 0.01) 

Overanxious Disorder: Cases: 37.1%; Comparisons: 3.1% (P ≤ 0.001 

Any Anxiety Disorder: Cases: 60%; Comparisons: 32.7% (P ≤ 0.001) 

Multivariate Results 

BMI at interview (kg/m2), Mean (SD) 

Cases: 20.1 (2.1); Comparison: 25.6 (6.4) 

Diff between groups at endpoint controlling for age (P ≤ 0.001) 

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.001) 

Ideal BMI, Mean (SD) 

Cases: 19.6 (2.0); Comparison: 22.6 (2.6) 

Diff between groups at endpoint controlling for age (P ≤ 0.001) 

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.001)

EDI Subscale Scores: 

Drive for Thinness, Mean (SD) 

Cases: 6.2 (6.4); Comparison: 3.1 (4.2) 

Diff between groups at endpoint controlling for age (P ≤ 0.01)

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.05)

Bulimia, Mean (SD) 

Cases: 1.5 (2.7); Comparison: 1.0 (1.6) 

Diff between groups at endpoint controlling for age (P = NS) 

Diff between groups at endpoint controlling for age and current AN 

(P = NS)

Body Dissatisfaction, Mean (SD) 

Cases: 10.3 (8.9); Comparison: 11.5 (9.3) 

Diff between groups at endpoint controlling for age (P = NS) 

Diff between groups at endpoint controlling for age and current AN (P = NS)
C-918 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics 

Quality 

Adverse Events 

Authors, yr: 

Sullivan, Bulik 

et al., 1998 

(continued) 

 
C-919 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Perfectionism, Mean (SD) 

Cases: 6.7 (4.7); Comparison: 3.4 (3.3) 

Diff between groups at endpoint controlling for age (P ≤ 0.001) 

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.001)

Three Factor Eating Questionnaire Scale Score: 

Cognitive Restraint, Mean (SD) 

Cases: 11.7 (5.7); Comparison: 5.5 (4.8) 

Diff between groups at endpoint controlling for age (P ≤ 0.001)

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.001) 

Disinhibition, Mean (SD) 

Cases: 5.7 (4.1); Comparison: 5.9 (4.0) 

Diff between groups at endpoint controlling for age (P = NS)

Diff between groups at endpoint controlling for age and current AN 

(P = NS) 

Hunger, Mean (SD) 

Cases: 3.8 (2.4); Comparison: 4.8 (3.0) 

Diff between groups at endpoint controlling for age (P ≤ 0.01)

Diff between groups at endpoint controlling for age and current AN 

(P ≤ 0.05)

Global Assessment of Functioning Score 

Diff between groups adjusting for case/control status, age, current ED, 

mood, anxiety or dependence disorder (P = 0.002) 

Worse in AN group 
C-920 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Tanaka et al., 

2001 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Osaka, Japan 

Yrs followed: 

8.3 (SD 3.8) 

Range 4.0-

17.7 

To investigate: 

the 

intermediateterm outcomes 

of AN patients 

who had 

inpatient tx at 

least 4 yrs 

prior, and 

prognostic 

factors 

associated 

with later FU 

outcomes. 

Inclusion: 

Women 

Retrospectively fit DSM IV for 

AN, inpatient tx min. of 4 yrs 

prior to study. 

Exclusion: 

BN 

Recruitment: 

Completing inpatient tx at 

Osaka City University Hospital 

between January 1982 and 

December 1999, a min. of 4 

yrs prior to study were 

contacted by telephone. 

Received face-to-face or 

telephone semi-structured 

interviews or just FU 

questionnaires if not available 

for interviews. Information re: 

deceased patients obtained 

from patient’s parents. 

Sample size: 

Initial sample: 

Patients treated (N = 185) 

Met DSM IV for AN and 4 yrs 

had passed (N = 69) 

Reasons for loss to FU: 

Deceased (N = 7) 

Emaciation (N = 3) 

Suicide (N = 2) 

Murdered (N = 1) 

Burn to death (N = 1) 

Refused (N = 1) 

Analysis sample: 

N = 61 (not including 7 

deceased patients) 

Mean Age (SD): 

22.7 (6.0) yrs 

Range: 13.7-37.4 yrs 

Sex: 

Female 100% 

Age onset (SD): 

18.8 (4.3) yrs 

Duration illness (SD): 

4.1 (4.3) yrs 

#Admissions (SD): 

1.1 (1.5) 

Education (SD): 

12.3 (2.8) yrs 

BMI (SD) (kg/m2

): 

14.0 (2.1) 

Premorbid BMI (SD) 

(kg/m2): 

20.5 (2.8) 

Max BMI (SD) (kg/m2

): 

21.9 (4.0) 

Min BMI (SD) (kg/m2

): 

12.9 (2.4) 

AN-R: 44.3% 

AN-BP: 55.7% 

Suicide attempts: 

39.3% 

Alcohol abuse: 

8.2% 

At FU: 

Duration of illness 

after onset (SD): 

12.4 (5.3) yrs 

BMI (SD) (kg/m2

): 

18.2 (3.4)

BMI 

< 17.5: 31% 

Score: 

Fair 

Method of dx: 

Retrospective using 

DSM IV 

Funding:

NR 
C-921 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Retrospectively identified 61 patients 

with DSM IV crit. for AN who had 

inpatient tx at least 4 yrs prior. 

Contacted by telephone for face-to-face 

or telephone semi-structured interview 

and assessment. Those not 

participating in interview were given only 

assessments packets. Data confirmed 

by interviewing spouse or parent. 

Information on deceased patients 

provided by parent. 

Japanese version of EDI, EAT 

administered 

Statistical Method: 

One way ANOVA 

Chi Square 

Kruskal-Wallis 

Outcomes 

M-R Outcome Assessment Schedule for 

prior 6 mos: Avg composite outcome 

from ratings on 12 patient scale of avg 

of 5 subscales (eating difficulties, 

menstrual state, mental state, 

psychosexual state, socioeconomic 

state). 

General outcome based on wt and 

menstrual function for prior 6 mos: 

Good: Wt within 15% ABW and regular 

menses 

Intermediate: Wt within 15% ABW, but 

not sustained and/or menstrual 

disturbances. 

Poor: Wt less than within 15% ABW and 

menses absent or near absent OR 

bingeing and or purging wkly 

Descriptive Results: 

FU menstruation status: 

Regular menses = 63.0% 

Amenorrhea = 22.2% 

M-R Outcomes: 

Good: 31 (51%) 

Intermediate: 8 (13%) 

Poor: 15 (25%) 

Deceased: 7 (11%) 

Predictors of general outcome categories: 

Good vs Poor: 

Younger at referral (P = 0.01) 

Younger at admission (P = 0.01) 

Higher BMI at FU (P < 0.001) 

Higher min BMI (P = 0.005) 

Good vs. Intermediate: 

Higher BMI at FU (P < 0.001) 

Good vs. Deceased: 

Fewer number of admissions (P = 0.001) 

Intermediate vs. Deceased: 

Fewer number of admissions (P = 0.001) 

Poor vs. Deceased: 

Fewer number of admissions (P = 0.001) 

Predictors at FU of M-R outcome categories: 

Good vs. Poor: 

Higher food intake (P < 0.001) 

Higher body wt (P < 0.001) 

Better menstrual state (P < 0.001) 

Better mental state (P < 0.001) 

Better attitude towards sexual matters (P = 0.002) 

Greater overt sexual behavior (P < 0.001) 

Better relationship with family (P < 0.001) 

Greater emancipation from family (P < 0.001) 

Greater social contacts outside family (P = 0.03) 

Greater social activities outside family (P < 0.001) 

Good vs. Intermediate: 

Higher food intake (P < 0.001) 

Higher body wt (P < 0.001) 

Better menstrual state (P < 0.001) 

Greater emancipation from family (P < 0.001)
C-922 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Tolstrup et al., 

1985 

Design: 

Case series 

through record 

review and FU 

Comparison 

Group: 

No 

Location: 

Copenhagen, 

Denmark 

Yrs followed: 

Mean = 12.5 

Range (4-22) 

Report the 

long-term 

outcome of AN 

using an 

intensive and 

comprehensive 

evaluation at 

FU in a large 

enough 

sample for 

statistical 

validity after an 

adequate 

observation 

period. 

Comparing 

outcome 

across three 

hospital points 

of contact. 

Inclusion: 

Dx of AN by the following 

criteria: 

Wt loss via reduced food 

intake, vomiting or excessive 

activity; Amenorrhea (if 

reproductive age); Distorted 

body image; clinical picture not 

explained by other somatic or 

psychiatric illness 

Exclusion: 

Inpatient < 1 wk or < 2 

outpatient visits; Other somatic 

dx (e.g., ulcer, psychosis) 

Recruitment: 

Review of all hospital records 

with a dx of AN from three 

departments at Rigshospital, 

University of Copenhagen, 

Child Psychiatry, Psychiatry, 

and Internal Medicine, 1960-

1976. 

Sample Size: 

Initial sample: 

Records reviewed: 192 

Records selected: 151 

Child Psychiatry: 64 

Psychiatry: 51 

Internal Medicine: 36 

Reasons for loss to FU: 

Deaths: N = 9 

Analysis sample: 

N = 142 surviving at FU 

Interviewed: 114 

Questionnaire: 19 

Hospital records: 6 

Central Registry only: 3 

Mean Age at baseline 

(yrs): 

Total: 19 

Child Psychiatry: 15.2 

Psychiatry: 24.2 

Internal Med: 21.7 

Sex: 

Female: 140 

Male: 11 

Race/ethnicity: 

NR 

Mean % Underwt (at 

baseline): 

Total: 32 

Child Psychiatry: 29 

Psychiatry: 34 

Internal Med: 34 

Mean duration of 

Illness at baseline 

(yrs): 

Total: 2.4 

Child Psychiatry: 1.4 

Psychiatry: 3.2 

Internal Med: 2.1 

Mean Duration of 

Treatment (mos): 

Total: 12 

Child Psychiatry: 17 

Psychiatry: 13 

Internal Med: 2.5 

Previous 

hospitalization 

(before primary 

contact): 

Total: 64% 

Child Psychiatry: 69% 

Psychiatry: 65% 

Internal Med: 56% 

Mean age at FU, yrs 

(range): 

31 (16-63) 

Mean wt at FU: 

84% of reference

Score: 

Poor 

Method of dx: 

Review of records 

by authors to meet 

the diagnostic 

inclusion criteria 

Funding: 

the Danish Medical 

Research Council, 

the GangstedRasmussen Fonde, 

the Enketru C. 

Hermansens 

Mindelegat, the 

Petra Slettens Fond 
C-923 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods

FU record review conducted 1981-82 

Surviving subjects contacted and invited 

to participate in semi-structured 

interview lasting approx 120 min (87 

were audiotaped; 12 were videotaped) 

The interview included: 

• Determination of socioeconomic 

status (SES) 

• Global clinical evaluation 

General somatic outcome: 

Good: wt ≥ 86% ABW, normal 

menstruation (if female) 

Intermediate: Wt 71 – 85% ABW 

Poor: wt ≤70 % ABW; Psychiatric dx 

Subjects who were also parents were 

invited to participate in supplementary 

interview on parental functioning 

For those subjects who could not be 

interviewed in person, interview was 

mailed as a questionnaire when 

possible. 

In some cases, hospital records or 

government records were only 

information available 

Outcomes: 

Global clinical evaluation: Interviewer’s 

evaluation 

General somatic outcome, 

modification of M-R criteria: 

Good: wt 86-114% of ABW, 

menstruation normal 

Intermediate: wt 71%-85% of ABW, and 

menstruation mostly absent or sporadic 

Poor: wt 70% of ABW or less, 

menstruation mostly absent or sporadic 

Subjects deceased: 9 

Cause of death: suicide 6; malnutrition 2; unclear: 1 

Mean age at death: 27.1 yr 

Department of primary contact for the deceased: Child Psychiatry: 1; 

Psychiatry: 5; Internal Medicine: 3 

Global Clinical Evaluation: 

Well-functioning: 49 (43%) 

Moderately impaired: 44 (39%) 

Poorly functioning: 21 (18%) 

General somatic outcome, N (%) 

Good: 60 (40) 

Intermediate: 44 (29) 

Poor: 29 (19) 

Dead: 9 (5) 

Diff between departments (P = NS) 

Diff between departments over time (P = NS) 

Psychiatric dx, N (%) 

No mental disorder: 61 (47) 

AN: 37 (25) (includes 8 with BN variants) 

Neurosis: 15 (11) 

Psychotic depression: 9 (6) 

Schizophrenia: 3 (2) 

Borderline psychosis: 4 (3) 

Character disorder: 2 (1) 

Diff between departments (P = NS) 

Diff between departments over time (P = NS) 
C-924 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Wentz et al., 

2001 

Companion 

article: 

Gillberg, 

Råstam and 

Gillberg, 1995 

Ivarsson et al., 

2000 

Nilsson et al., 

1999 

Wentz et al., 

2000 

Companion 

article: 

Wentz et al., 

2001 

Design: 

Prospective 

cohort 

Comparison 

Group: Yes 

Location: 

Göteberg, 

Sweden 

Yrs followed: 

10 (1985-

1996) 

Compare the 

rate of 

psychiatric 

disorders in an 

AN group with 

a community 

matched 

sample, 10 yrs 

after reported 

AN onset 

Examine 

whether long 

term outcome 

is worse in AN 

group and 

related to 

specific 

personality 

and/or 

psychiatric 

disorders. 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, sex, 

school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total population 

of Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: 

Same schools as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Mean Age (yrs): 

Cases: 24.5 

95% CI (24.0-25.0) 

Comparisons: 24.2 

95% CI (23.7-24.7) 

Age at onset: 

14.3 

Range: 13.9-14.7 

Sex: 

Cases: 

Female: 48 

Male: 3 

Comparison: 

Female: 48 

Male: 3 

Race/ethnicity: 

NR 

Full-time employment 

Cases: 65% 

Comparison: 88% 

(P < 0.01) 

Cases with at least 8 

sessions of some 

form of tx: 

N = 29 

AN duration: 

Cases: 3.3yrs; 

95% CI (2.7-3.8) 

ED duration Cases: 

6.3yrs; 

95% CI (5.4-7.2) 

BN symptoms: 

Cases: 75% 

Score: 

Good 

Method of dx: 

AN evaluation by 

school nurse and 

psychiatrist by 

structured interview 

using SCID; 

personality disorder 

and/or autism via 

blind evaluation of 

case hx by 

psychiatrist 

Funding: 

Swedish Medical 

Research Council, 

Göteborg Medical 

Society, Wilhelm 

and Martina 

Lundgren 

Foundation, 

Göteborg 

Freemasons, 

SöderströmKönigska Nursing 

Home Foundation, 

and grants from the 

state under the LUA 

agreement 
C-925 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Assessment evaluation by a psychiatrist 

for Axis 1 dx; by another blinded 

psychiatrist for Axis 2 and ASD dx via 

SCID-1 and 2 structured interview (3 by 

telephone). Eating behavior evaluated 

using EAT. Outcomes based on M-R 

Scales, GAF 

Statistical Methods 

Chi-square test for matched and 

unmatched pairs for psych dx 

Two-sample t-test for BMI, anthropometric 

data 

McNemar test for for MR subscales 

Wilcoxon (Mann-Whitney) rank sum test 

for median GAF scores 

Spearman rank order correlation 

coefficient for correlations between the MR and GAF scores 

Outcome Definitions 

Full recovery from ED: no disturbed 

eating attitude or behavior in respect to 

food and shape for at least 6 mos before 

assessment 

Descriptive Results 

Current body wt 

AN: 62.3 kg, 95% CI (58.5-66.1) 

Comparisons: 63.7 kg, 95% CI (60.8 – 66.5) 

Diff between groups (P = NS)

Current BMI 

AN: 22.2 kg/m2, 95% CI (21.0-23.4) 

Comparisons:22.2 kg/m2 95% CI (21.2-23.2) 

Diff between groups (P = NS) 

Free from ED Symptoms/Full Recovery from ED: 

AN: 39% 

Comparisons: 90% 

Diff between groups (P < 0.001) 

Diff between groups in current psychiatric disorders 

Major depression unipolar (P = NS) 

Major depression bipolar I (P = NS) 

Major depression bipolar II (P = NS) 

Dysthymic disorder (P = NS) 

Any effective disorder (P = NS) 

Panic disorder (P = NS) 

Social phobia (P = NS) 

Simple phobia (P = NS) 

OCD, AN: 8; Comparisons: 1 (P < 0.05) 

General anxiety disorder (P = NS) 

Any anxiety disorder (P = NS) 

Psychotic disorder (P = NS) 

Substance abuse (P = NS) 

Any axis I disorder (inc ED) AN: 27; Comparisons: 14 (P < 0.05) 

Any axis I disorder (exc ED) (P = NS) 

Diff between groups in lifetime psychiatric disorders 

Major depression unipolar (P = NS) 

Major depression bipolar I (P = NS) 

Major depression bipolar II (P = NS) 

Dysthymic disorder (P = NS) 

Any effective disorder: AN: 49; Comparisons: 12 (P < 0.0001) 

Panic disorder (P = NS) 

Social phobia (P = NS) 

Simple phobia (P = NS) 

OCD: AN: 18; Comparisons: 5 (P < 0.01) 

General anxiety disorder (P = NS) 

Any anxiety disorder: AN: 29; Comparisons: 16 (P < 0.02) 

Psychotic disorder (P = NS) 

Substance abuse (P = NS) 

Any axis I disorder (inc ED) AN: 51; Comparisons: 26 (P < 0.0001) 

Any axis I disorder (exc ED): AN: 51; Comparisons: 26 (P < 0.0001) 

Current Eating Disorders 

AN: AN 6%; Comparisons: 0% 

BN: AN 4%; Comparisons: 0% 

EDNOS: AN:18%; Comparisons: 0% 
C-926 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Wentz et al., 

2001 

(continued) 

 
C-927 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Avg M-R Scale Score 

AN: 9.4, 95% CI (8.8-10.0) 

Comparisons: 11.2, 95% CI (10.8-11.5) 

Diff between groups (P < 0.0001)

Dietary restriction 

AN: 47%; Comparison: 16% 

Diff between groups (P < 0.01)

Worry about body wt and appearance 

AN: 69%; Comparisons: 27% 

Diff between groups (P < 0.001) 

Normal menstruation 

AN: 65%; Comparisons: 85% 

Diff between groups (P < 0.05) 

Mean GAF Score 

AN: 65.3, 95% CI (61.0-69.7) 

Comparisons: 84.8, 95% CI (81.7-87.9) 

Diff between groups (P < 0.0001) 
C-928 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics 

Quality 

Adverse Events 

Authors, yr: 

Wentz et al., 

2000 

Companion 

article: 

Ivarsson et al., 

2000 

Nilsson et al., 

1999 

Råstam, 

Gillberg and 

Gillberg, 1995 

Wentz et al., 

2001 

Design: 

Prospective 

cohort 

Comparison 

Group: Yes 

Location: 

Göteberg, 

Sweden 

Yrs followed: 

10 (1985-

1996) 

To examine 

prospectively 

the long-term 

medical 

complications 

in a 

communitybased study of 

AN 

Inclusion: 

Cases: 

DSM III-R for AN 

Born 1970 

AN onset < 18 yrs old 

Comparison: 

Matched to cases on age, sex, 

school 

Exclusion: 

Cases: 

None 

Comparisons: 

None 

Recruitment: 

Cases: From total population 

of Göteburg, Sweden, born in 

1970 and developing AN 

before age 18; pooled with 

second population screening 

sample reported by school and 

hospital health care workers 

during FU. Some clinically 

referred and some screened 

through school nurses and 

doctors, pediatricians, and 

child psychiatrists 

Comparisons: 

Same schools as AN group 

Sample Size: 

Cases: 51 

Comparisons: 51 

Mean age at first 

examination: 

Cases: 16.1, 

95% CI (15.7-16.5) 

Comparisons: 16.0, 

95% CI (15.5-16.6) 

Mean Age at FU 

Case: 24.5, 95% CI 

(24.0 -25.0) 

Comparisons: 24.2, 

95% CI (23.7-24.7) 

Sex: 

Cases: 

Females: 48 

Males: 3 

Race/ethnicity: 

NR 

Score: 

Good 

Method of dx: 

Independent 

clinician, used 

SCID at FU 

Funding: 

Medical Research 

Council grant, 

Wilhelm and 

Martina Lundgren 

Foundation, 

Göteborg Medical 

Society, Göteborg 

Freemasons, 

SöderströmKönigska 

Nursing Home 

Foundation, and 

grants from the 

State 
C-929 

Evidence Table 15. Anorexia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

The two groups were examined by a 

psychiatrist blind to diagnostic group

status, who performed all 

neurodevelopmental and neurological 

examinations. Physical examinations 

were also conducted on all participants, 

and gross motor skills, tremor, and 

diadochokinesis (DDK) were measured 

using a battery of tests. 

Poor outcome was defined by M-R 

classification, based on low wt and 

absent or scanty menstruation. 

Ratnasuriya et al. (1991) Modified 

outcome criteria was used, including 

persisting eating disorder in the poor 

outcome definition. 

Statistical methods: 

Neurodevelopmental tests and the 

frequencies of physical disorders were 

analysed with the χ2 tests. 

Descriptive Results: 

Mean (SD) wt, height, and BMI of AN and Comparisons groups at 16, 

21, and 24 yrs (10 yr FU): 

Wt, kg: 

Cases: 

16 yrs: 49.4 (8.8) diff between cases and comparisons (P < 0.01) 

21 yrs: 58.9 (11.8) 

24yrs: 62.3 (12.7) 

Comparisons: 

16 yrs: 56.2 (6.6) 

21 yrs: 60.4 (7.9) 

24yrs: 63.7 (10.0) 

BMI, kg/m2: 

Cases: 

16 yrs: 18.3 (2.9)b

21 yrs: 21.2 (3.5) 

24yrs: 22.2 (4.1) 

Comparisons: 

16 yrs: 20.2 (1.9) 

21 yrs: 21.2 (2.3) 

24yrs: 22.2 (3.4) 

Diff between groups in psychiatric disorders at FU 

Overall 

Cases: 53% 

Comparisons 27% (P<= 0.05) 

Anxiety disorders 

Cases: 35% 

Comparisons 22% (P = NS) 

OCD: 

Cases: 16% 

Comparisons 2% (P < 0.05) 

Depressive disorder, lifetime dx 

Cases: 96% 

Comparisons: 24% (P < 0.0001) 

Current depressive disorder: 

Cases: 10% 

Comparisons 4% (P = NS) 

Diff between groups in physical complaints/disorders: 

Gastrointestinal problems 

Cases: 47% 

Comparisons: 27% (N = 14) (P = 0.05) 

Hirsuitism: more prevalent in cases (P = 0.05) 

Diff between groups in neurodevelopmental findings: 

Fine and gross motor skills, coordination, tremor, mirror movements, or 

handedness (P = NS) 

Dysdiadochokinesis 

Cases: N = 11 

Comparisons: N = 2 (P < 0.01) 
C-930 

Evidence Table 16. Bulimia nervosa outcomes 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Ben-Tovim et 

al., 2001 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Adelaide, 

South Australia 

Yrs followed: 

5 

To identify 

predictors of 

outcome and 

to assess 

effects of 

available txs 

for AN or BN 

Inclusion: 

15 yrs old and older; living in 

Adelaide, South Australia; 

either making first contact with 

secondary or tertiary services 

for tx of ED or were 

recontacting such services 

after a tx break of at least 6 

mos. 

Exclusion: 

None 

Recruitment: 

Agreement to participate was 

obtained from all identifiable 

specialist service providers in 

Adelaide, apart from one 

psychiatrist in individual 

practice. 

Sample Size: 

Fulfilled criteria: N = 235 

Agreed to participate: N = 220 

Baseline sample: 

AN: N = 95 

BN: N = 88 

Reasons for loss to FU: 

Anorexia: 3 deaths, of which, 

2 related to ED 

BN: 2 lost, reason NR 

Analysis Sample Size at FU: 

AN: N = 92 

BN: N = 86 

Mean Age (SD): 

AN: 22.5 (6.9) 

BN: 23.8 (6.4) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Wt, kg, Mean (SD): 

AN: 44.8 (6.5) 

BN: 62.6 (10.8) 

Height, m, Mean (SD): 

AN: 1.65 (0.07) 

BN: 1.65 (0.06) 

BMI, Mean (SD): 

AN: 16.5 (1.9) 

BN: 23.1 (3.9) 

Duration of ED, yrs: 

AN: 7.4 (7.0) 

BN: 6.4 (4.7) 

AN subtype at initial 

assessment: 

Abstainers: 59% 

Binge-purgers: 41% 

Score: 

Fair 

Method of dx: 

Dx made by treating 

clinician and 

confirmed by 

Flinders Symptom 

Score (FSS) 

interview. Dx was 

according to DSM 

III-R 

Funding: 

Australian National 

Health and Medical 

Research Council, 

Flinders 2000, and 

the Centre for 

Applied Research in 

Mental Health 
C-931 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Evaluation in person or by telephone annually. 

Statistical Methods 

Dependent variable: Total scores from M-R-H 

scales at 5 yrs 

Multiple Regression 

M-R-H Subscales: 

Subscale A: Dietary and eating patterns, body 

concern, and body wt 

Subscale B: Menstrual pattern 

Subscale C: Mental State 

Subscale D: Psychosexual state 

Subscale E: Work and Family Relations 

Descriptive Results 

AN: 

Dx at 5 yrs: 

AN: 20 (21%) 

BN: 5 (5%) 

EDNOS: 9 (9%) 

No ED: 56 (59%) 

Unknown: 2 (2%) 

Died: 3 (3%) 

M-R-H Outcomes: 

Good (mean score: 8 – 12): 32 (34%) 

Intermediate (score 4 - < 8): 51 (54%) 

Poor (score 0 - < 4) 12 (13%) 

BN 

Dx at 5 yrs: 

AN: 1 (1%) 

BN: 7 (8%) 

EDNOS: 11 (13%) 

No ED: 65 (74%) 

Unknown: 4 (5%) 

Died: 0 

M-R-H Outcomes: 

Good: 67 (76%) 

Intermediate (score 4 - < 8): 17 (19%) 

Poor (score 0 - < 4) 2 (2%) 

Unknown: 2 (2%) 

Multivariate Results 

Predictors of higher M-R-H total mean score at 5 yrs: 

AN: 

Model 1 

Age (P = 0.48) 

M-R-H subscale A at baseline (P = 0.02) pos assoc. 

M-R-H subscale B at baseline (P = 0.11) 

M-R-H subscale C at baseline (P = 0.13) 

M-R-H subscale D at baseline (P = 0.23) 

M-R-H subscale E at baseline (P = 0.17) 

Duration of Illness (yrs) (P = 0.18) 

BMI at baseline (P = 0.08) pos assoc 

Goodness of fit model (P < 0.0001), R2 = 0.0.33 

Model 2 

Disability adjustment scale, subscale 2 at baseline (P = 0.0006) 

neg assoc 

Flinders Medical Centre Symptom Score at baseline (P = 0.03) 

neg assoc 

Body Attitudes Questionnaire Subscales: Attractiveness at 6 mo 

(P = 0.008) pos assoc 

Change in salience of wt and shape over first 6 mos (P = 0.024) 

pos assoc 

Goodness of fit model (P < 0.0001), R2 = 0.25 
C-932 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Ben-Tovim et 

al., 2001 

(continued) 

 
C-933 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Evaluation in person or by telephone annually. 

Statistical Methods 

Dependent variable: Total scores from M-R-H 

scales at 5 yrs 

Multiple Regression 

M-R-H Subscales: 

Subscale A: Dietary and eating patterns, body 

concern, and body wt 

Subscale B: Menstrual pattern 

Subscale C: Mental State 

Subscale D: Psychosexual state 

Subscale E: Work and Family Relations 

Descriptive Results 

BN: 

Model 1 

Age (P = 0.47) 

M-R-H subscale A at baseline: (P = 0.01) neg assoc 

M-R-H subscale B at baseline (P = NS) 

M-R-H subscale C at baseline (P = NS) 

M-R-H subscale D at baseline (P = NS) 

M-R-H subscale E at baseline (P = NS) 

Duration of Illness (yrs) (P = NS) 

BMI at baseline (P = NS) 

Goodness of fit model (P < 0.056); R2

 = 0.085 

Model 2 

Disability adjustment scale, subscale 2 at recruitment (P = 0.009) 

neg assoc 

Body Attitudes Questionnaire Subscales: 

Feeling fat at recruitment (P = 0.02) neg assoc 

Attractiveness at 6 mo (P = 0.001) pos assoc 

Change in Zung Depression over first 6 mos (P = 0.0003) pos 

assoc 

Goodness of fit model (P < 0.0001), R2

 = 0.31 
C-934 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fairburn et al., 

1995 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Oxford, 

England 

Mean Yrs 

followed (SD): 

5.8 (2.0) 

To assess and 

compare the 

long-term 

outcomes of 

patients with 

BN and identify 

predictors of 

outcomes. 

Inclusion: 

Female, over 17 yrs of age, 

BN according to Russell 

criteria, wt > 79% of matched 

mean wt (Fairburn et al., 1986) 

For prior 6 mos, met criteria for 

BN (DSM IIII-R); aged 17 yrs 

or older; BMI > 17 (Fairburn et 

al., 1991) 

Exclusion: 

Co-existing major psychiatric 

disorder other than depressive, 

anxiety, or obsessional state, 

current physical dependence 

on alcohol or drugs, need for 

hospitalization, on-going tx 

from another source, not 

available through 1 yr FU 

(Fairburn et al., 1986) 

Concurrent AN (Fairburn et al., 

1991) 

Recruitment: 

Tx referrals from general 

practitioners and psychiatrists 

within community (Oxfordshire, 

England) 

Recruited for first trial 1982-

1984: N = 24 

Recruited for second trial 

1985-1988: N = 75 

Sample Size: 

Initial sample: 

Total = 99 

Trial 1: N = 20 

Trial 2: N = 69 

CBT: N = 35 

FIT: N = 32 

BT: N = 22 

Reasons for loss to FU: 

Untraceable: N = 2 

Declined participation: N = 3 

Did not respond: N = 3 

Refused face-to-face or phone 

interview: N = 1 

Died: N = 1 

Analysis sample: 

N = 89 (those who participated 

in either a face-to-face or 

phone FU interview) 

Mean number of binge 

days per 28 days at 

baseline (SD): 

24.8 (18.5) 

Mean number of selfinduced vomiting 

episodes per 28 days 

at baseline (SD): 

31.9 (38.8) 

Mean number of 

laxative misuse 

episodes per 28 days 

at baseline (SD): 

4.3 (10.0) 

Body wt at baseline, 

kg (SD): 

60.6 (10.1) 

BMI at baseline, kg/m2

(SD): 

22.0 (3.1) 

Mean Age at FU, yrs 

(SD): 

29.6 (5.5) 

Mean duration of ED at 

Baseline, yrs (SD): 

6.7 (5.1) 

Marital Status at FU 

(%):

Single: 30% 

Married/living as 

married: 69% 

Divorced: 1% 

Employment Status at 

FU (%): 

Paid: 71% 

Students: 9% 

At home: 15% 

Unemployed or 

disabled: 5% 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mean age at study 

recruitment: 

Trial 1: 22.5 (3.8) 

Trial 2: 24.3 (6.0) 

Score: 

Fair 

Method of dx: 

EDE with an 

experienced 

clinician based on 

DSM IV criteria for 

eating disorders 

Sections from the 

SCID (DSM III-R 

version) were used 

to assess for 

mood, anxiety, and 

psychoactive 

substance use 

disorders 

Funding: 

United Kingdom 

Medical Research 

Council; Wellcome 

Trust 
C-935 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Treatment: 

Analysis combines samples drawn from 2 

similar RCTs that compared 

effectiveness of various psychotherapy 

techniques for the tx of BN 

symptomatology (i.e., CBT, BT, FIT = 

focal interpersonal therapy). 

Study 1: Short term psychological tx 

(CBT) administered in 19 sessions over 

18 wks 

Study 2: Either CBT, BT or FIT 

Study Methods 

FU participants did not have to complete 

tx. At FU, participants administered EDE, 

portions of SCID, Brief Symptom 

Inventory (for general psychiatric 

symptoms), and Adult Personality 

Functioning Assessment interview (for 

dimensions of social functioning). Each 

participant’s physical hth and medical hx 

also queried at time of the FU interview. 

Statistical Analyses 

Both parametric and nonparametric tests 

used to evaluate sig diffs in variables of 

interest. Forward stepwise regression 

analyses performed to test for sig 

predictors of outcome. A 3x4 repeated 

measures ANOVA conducted to identify 

any sig tx effects on outcome. Log-odds 

models of tx were computed. 

Descriptive Findings 

Eating Disorder Diagnostic Status at FU (%): 

AN: 3% 

BN: 19% 

EDNOS: 24% 

Psychiatric Status at FU: 

Major depressive disorder: N = 8 

Anxiety: N = 16 

Substance use: N = 3 

AN/BN (60%) versus non-AN/BN (19%) (P < 0.001) Higher rates of 

general psychiatric disorders in the ED group 

Remission Status (no DSM ED) at 12-mo and 6-yr FU (%): 

Had ED at end of tx and remission at 12 mos: 24% 

Had ED at end of tx and remission at 6 yr: 41% 

No ED end of tx and 12 mo FU: 82% 

No ED end of tx and 6 yr FU: 71% 

Proportion with AN or BN at FU by original tx received: 

CBT: 20% 

FIT: 27% 

BT: 22% 

(P = NS) 

Change in Eating-related Measures from recruitment to FU: 

Mean binge episodes/28 days: (P < 0.0001) reduction 

Mean vomiting episodes/28 days (P < 0.0001) reduction 

Mean laxative misuse episodes/28 days (P < 0.0001) reduction 

Dietary restraint (P < 0.0001) reduction 

Overeating (P < 0.0001) reduction 

Eating concern (P < 0.0001) reduction 

Shape concern (P < 0.0001) reduction 

Wt concern (P < 0.0001) reduction 

Global EDE (P < 0.0001) reduction 

Psychiatric symptom (P < 0.0001) reduction 

Change in Body-related Measures from Baseline to FU: 

Body wt: (P = 0.018) increase 1.57 (6.14) kg 

BMI (P = NS) 

Remission Rates at FU based on original tx received: 

CBT: OR = 3.43, 95% CI (1.77-6.63) 

FIT: OR = 2.58, 95% CI (1.32 to 5.02) 

BT: comparison 

(P < 0.001) 

Abstinence rates for key behavioral features of BN at FU by original 

tx received: 

CBT: 50% 

FIT: 52% 

BT: 18% 

Diff between groups (P = 0.044) at end point 

No sig overall effect of tx on proportion of abstinent subjects and no diff 

effect of tx over time. 
C-936 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fairburn et al., 

1995 

(continued) 

 
C-937 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

 Mean reductions in Global EDE from baseline to FU by original tx 

condition (SD): 

CBT: 2.22 (1.00) 

FIT: 1.51 (1.00) 

BT: 1.36 (1.32) 

Change over time (P = 0.04) 

Mean Eating Disorder symptom level at FU by original tx received 

(SD): 

CBT: 1.27 (1.12) 

FIT: 1.50 (1.20) 

BT: 2.08 (1.27) 

Diff between CBT and FIT (P = 0.049) CBT had fewer symptoms 

Diff between CBT and BT (P = 0.015) CBT had fewer symptoms 

Multivariate Results 

Predictors of Current AN or BN Outcome Status (adjusted for type 

of tx received and duration of FU): 

Paternal obesity: OR = 5.73, 95% CI (1.56 -21.1) (P = 0.007) 

Premorbid obesity: OR = 4.31, 95% CI (1.35 -13.7) (P = 0.01) 

Predictors of Change in Global EDE score Outcome: 

Paternal obesity (P = 0.007) More severe is worse 

Premorbid obesity: 

(P = 0.005) More severe is worse 
C-938 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Fairburn et al., 

2000 

Companion 

article: 

Fairburn et al., 

2003 

Stice and 

Fairburn, 2003 

Design: 

Prospective 

cohort 

Comparison 

Group: 

No 

Location: 

Oxford, 

England 

Yrs followed: 

5 yrs 

To assess the 

natural course 

of primary and 

secondary 

symptoms in 

two 

communitybased cohorts 

of BN and BED 

participants 

over a 5-yr 

span of time. 

Inclusion: 

Met DSM IV diagnostic criteria 

for BN; Age 16 to 35 

Exclusion: 

None 

Recruitment: 

Participants were originally 

recruited to take part in casecontrol studies investigating 

risk factors for BN. Potential 

participants were initially 

identified from among women 

registered with family practices 

within Oxfordshire, England. 

Initial Sample Size: 

At Recruitment: 

BN: N = 102 

Reasons for loss to FU: 

BN: N = 1 untraceable; N = 2 

nonresponders; N = 7 declined 

Analysis sample size: 

At 5-yr FU: 

BN: N = 92 (90%): 87 inperson interviews, 5 phone 

interviews 

Data on BED sample not 

reported due to small sample 

size ( < 50) 

Mean Age at Baseline, 

yrs (SD): 

23.9 (5.0) 

Marital status at 

Baseline (%): 

Single: 59% 

Married/cohabitating: 36% 

Separated/divorced: 5% 

Social Class at Baseline 

(%): 

1-2: 46% 

3 (non-manual): 8% 

3 (manual): 36% 

4-5: 9% 

other: 2% 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Hx of AN (%): 

15% 

Current Treatment for 

ED (%): 

10% 

Past Treatment for ED 

(%): 

16% 

Mean Age at Onset of 

ED, yrs (SD): 

15.7 (4.3) 

Score: 

Good 

Method of dx: 

EDE interview 

Funding: 

Wellcome Trust 

program grant; 

Henry J. Kaiser 

Family 

Foundation and 

the Center’s 

Foundations’ 

Fund for 

Research in 

Psychiatry 
C-939 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Participants were contacted at 15-mo intervals over the course 

of a 5-yr period. They were administered a series of self-report 

questionnaires including the BSI, the Robson self-esteem 

questionnaire, and the Social Adjustment Scale. Eating 

disorder primary (i.e., objective bulimic episodes, self-induced 

vomiting, laxative misuse) and secondary (i.e., restraint, wt 

concern, eating concern, shape concern) symptoms were 

assessed through clinical interview with the EDE at each time 

point. 

Statistical Analyses 

Descriptive statistics for reporting means, standard deviations, 

and percentages of variables at different time points. 

Paired t-tests and Wilcoxon matched pairs or McNemar tests 

to assess sig changes from recruitment to 5-yr FU. 

Descriptive Findings 

% BN at each FU Time Point (N = 74): 

15-mos: 31% 

30-mos: 20% 

45-mos: 19% 

60-mos: 15% 

%BED at each FU Time Point: 

15-mos: 4% 

30-mos: 8% 

45-mos: 5% 

60-mos: 7% 

%AN at each FU Time Point: 

15-mos: 3% 

30-mos: 3% 

45-mos: 4% 

60-mos: 1% 

%EDNOS at each FU Time Point: 

15-mos: 32% 

30-mos: 40% 

45-mos: 35% 

60-mos: 32% 

% Any DSM IV ED at each FU Time Point: 

15-mos: 66% 

30-mos: 64% 

45-mos: 58% 

60-mos: 49% 

% Remission (No DSM IV ED Dx): 

15-mos: 34% 

30-mos: 20% 

45-mos: 28% 

60-mos: 35% 

% Relapse (Any DSM IV ED Dx): 

30-mos: 32% 

45-mos: 33% 

60-mos: 26% 

Psychoactive Drug Use at 5-yr FU (%): 

3% 

BMI Status at 5-yr FU (%): 

< 20.0: 12% 

20-24.9: 53% 

25.0-29.9: 15% 

> or = 30: 20% 

Exposure to Treatment (%): 

During FU: 28% 

By end of FU: 40% 
C-940 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fairburn et al., 

2000 

(continued) 

 
C-941 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Outcomes at 5 yr FU: 

Mean Objective Bulimic Episodes (Bingeeating) w/in last 3 mos (SD): 

15.3 (29.4) 

Reduction from baseline (P < 0.001) 

Mean Self-induced Vomiting Episodes w/in last 

3 mos (SD): 

15.5 (42.9) 

Reduction from baseline (P < 0.001) 

Mean Laxative Misuse w/in last 3 mos (SD): 

3.4 (14.8) 

Reduction from baseline (P < 0.001) 

Mean EDE Restraint (SD): 

1.82 (1.59) 

Reduction from baseline (P < 0.001) 

Mean EDE Shape Concern (SD): 

2.55 (1.49) 

Reduction from baseline (P < 0.001) 

Mean EDE Wt Concern (SD): 

2.35 (1.50) 

Reduction from baseline (P < 0.001) 

Mean EDE Eating Concern (SD): 

0.84 (1.13) 

Reduction from baseline (P < 0.001) 

Mean BSI (SD): 

0.90 (0.77) 

Reduction from baseline (P < 0.01) 

Alcohol Misuse (%): 

26% 

Increase from baseline (P < 0.05) 

Mean Self-esteem (SD): 

42.3 (9.7) 

Change from baseline (P = NS) 

Mean Social Adjustment (SD): 

1.40 (0.28) 

Change from baseline (P = NS) 

Mean Wt, kg (SD): 

69.8 (19.2) 

Increase from baseline (P < 0.01) 

Mean BMI (SD): 

25.5 (6.4) 

Increase from baseline (P < 0.05) 
C-942 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fairburn et al., 

2003 

Companion 

article: 

Fairburn et al., 

2000 

Stice and 

Fairburn, 2003 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

England 

Yrs followed: 

5 

To identify 

predictors of 

persistence of 

BN and to test 

hypotheses 

derived from 

cognitive 

behavior 

theory of 

persistence. 

Inclusion: 

Women 

DSM IV for BN 

Exclusion: 

None 

Recruitment: 

Patients in family practices in 

Oxfordshire, England. 

Screened with self-report 

version of the EDE. 

Sample Size: 

Sample size: N = 102 

No loss to FU 

Mean Age at 

recruitment (SD): 

23.7 (4.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Social class: 

I or II (high): 47% 

III (middle): 45% 

IV or V (low): 9% 

Age of full BN onset: 

19.0 (4.0) 

No prior tx for ED: 

82% 

No current tx for ED: 

89% 

Some tx for ED 

during 5 yr FU: 

24% 

Score: 

Good 

Method of dx: 

Interview using EDE 

Funding: 

Wellcome Trust 

program grant, 

NIMH 
C-943 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Interviewer administered EDE, Brief 

Symptom Inventory 

Statistical Methods: 

ANOVA or chi-square comparing 

remitted and persistent outcome groups 

Multiple regression used for change 

over time analyses. 

Binge eating outcome classifications: 

Persistent: at least 2 episodes of 

behavior at 1 or both of last 2 

assessments 

Remitted: not engaged in any relevant 

behavior (over past 3 mos) at 2 

consecutive assessments and all 

subsequent assessments 

Not classified 

Analyses compares binge eating 

outcomes separately based on: 1) binge 

eating behaviors and 2) compensatory 

behaviors 

Descriptive Findings 

Binge eating outcome classification based on binge eating behavior 

(N): 

Remitted: 39 (38%) 

Persistent: 45 (44%) 

Not classified: 18 (18%) (P = NR) 

Binge eating outcome classification based on compensatory 

behavior (N): 

Remitted: 39 (38%) 

Persistent: 49 (48%) 

Not classified: 14 (14%) (P = NR) 

Relationship between remitted vs. persistent binge eating outcome 

(based on binge eating behaviors) and baseline variables: 

Age at onset (P = NS)

Duration of disturbed eating: Persistent: 9.8; Remitted: 6.9 (P < 0.01) 

Binge eating frequency (P = NS) 

Compensatory behavior frequency (P = NS) 

Global EDE Score (P = NS) 

Overevaluation of shape and wt: Persistent: 3.2; Remitted: 2.6 (P < 0.05)

Dietary restraint (P = NS) 

General psychiatric symptoms (P = NS)

Self-esteem (P = NS) 

Social adjustment: Persistent: 1.5; Remitted: 1.3; (P < 0.05) 

BMI (P = NS) 

Proportion with hx of AN: (P = NS) 

Proportion with hx of childhood obesity: RR = 1.9, 95% CI (1.1-3.5) (P < 

0.05)

Proportion classified as persistent based on compensatory behavior: 

RR = 2.6, 95% CI (1.6-4.2) (P < 0.0001)

Relationship between remitted vs persistent binge eating outcome 

(based on compensatory behavior) and baseline variables: 

Age at onset (P = NS)

Duration of disturbed eating (P = NS)

Binge eating frequency (P = NS) 

Compensatory behavior frequency (P = NS) 

Global EDE Score (P = NS) 

Overevaluation of shape and wt (P = NS)

Dietary restraint (P = NS) 

General psychiatric symptoms (P = NS)

Self-esteem (P = NS)

Social adjustment (P = NS) 

BMI (P = NS) 

Proportion with hx of AN: (P = NS)

Proportion with hx of childhood obesity (P = NS)

Proportion classified as having persistent course based on binge eating 

behavior: RR = 3.0, 95% CI (1.6-5.4) (P < 0.0001)
C-944 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fairburn et al., 

2003 

(continued) 

 
C-945 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Multivariate Findings 

Change over time: 

Change in frequency of binge eating: 

• Related to initial overall evaluation of shape and wt (P < 0.07)

• Initial level of overevaluation of shape and wt nonsig when effects of 

change in dietary restraint sig controlled in model.

Change in level of restraint: 

• Pos related to initial level of overevaluation of shape and wt (P < 0.01)
C-946 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

2004 

Design: 

Case series 

Comparison 

Group: 

Yes 

Location: 

Upper Bavaria, 

Germany 

Yrs followed: 

12 

To describe 

the longer-term 

course and 

outcome of BN 

and to identify 

risk factors for 

an unfavorable 

course. 

Inclusion: 

Cases: 

BN-Purging type per DSM IV 

(Patients reassessed in later 

yrs per DSM IV and were 

included if met diagnostic 

criteria at time of hospital 

admission) 

Comparisons: 

Females, aged 18-30, never 

suffered from eating disorder 

Exclusion: 

None reported 

Recruitment: 

Cases: Of 635 consecutively 

admitted patients with eating 

disorders between 9/85 – 6/88, 

196 met inclusion criteria. 

Comparisons: general 

population 

Sample Size: 

Cases: 

Began tx: N = 196 

Completed 2 yr FU: 194/196 

(99%) 

Completed 6 yr FU: 185/194 

alive (95.4%) 

Completed 12 yr FU: 163/192 

alive (84.9%) 

Comparisons: N = 202 

Reasons for Loss to FU 

Unable to reach: N = 3 

Refused participation: N = 26 

Age at admission, 

mean (SD): 

25.6 (6.7) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Length of inpatient 

tx, days, mean (SD): 

95.5 (42.6) 

Score: 

Fair 

Method of dx: 

Structured Interview 

for AN and Bulimic 

Syndromes (SIABEX) 

Funding: 

Wilhelm SanderStiftung, Munich, 

Germany; German 

Bundesministerium 

fur Bildung 

Forschung und 

Technologie (BMBF) 
C-947 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Patients were assessed at the beginning 

of inpatient tx, at the end of tx, at 2, 6, and 

12 yr FU. 

Each FU consisted of two steps: all 

patients completed a questionnaire and 

were then contacted for an interview 

Analytic Strategy 

MANOVA with repeated measures based 

on five time points. Post hoc Scheffe 

range tests when appropriate. 

Logistic regression with all predictors 

entered in step one. 

Standardized mortality ratio computed on 

the basis of expected deaths between 

1/87 and 9/99 in the West German female 

population controlled by age groups. 

Descriptive Results 

Body image, ideal of slimness, and bulimic behavior decreased in 

severity at 12 yr FU when compared with any previous time –point 

(P < 0.001). Values NR 

BMI: 

End of tx: 21.1 (4.5) 

12 yr FU: 22.1 (5.3) 

Diff over time (P = NR) 

Obesity (BMI > 30), N (%): 

2 yr FU: 12/192 (6.3%) 

6 yr FU: 11/182 (6.0%) 

12 yr FU: 14/163 (8.6%) 

Diff over time (P = NR) 

BMI < 17.5, N (%): 

2 yr FU: 12/192 (6.3%) 

6 yr FU: 12/182 (6.6%) 

12 yr FU: 8/163 (4.9%) 

Diff over time (P = NR) 

EDI, drive for thinness: 

Baseline: 12.5 (5.5) 

End of tx: 6.8 (5.5) 

2 yr FU: 7.5 (6.0) 

6 yr FU: 5.1 (5.7) 

12 yr FU: 3.3 (4.2) 

Diff over time (P < 0.001) 

EDI, bulimia: 

Baseline: 12.5 (4.7) 

End of tx: 3.3 (4.3) 

2 yr FU: 6.1 (5.8) 

6 yr FU: 4.0 (5.1) 

12 yr FU: 2.4 (4.0) 

Diff over time (P < 0.001) 

EDI, body dissatisfaction: 

Baseline: 16.7 (8.5) 

End of tx: 10.4 (9.2) 

2 yr FU: 12.2 (9.1) 

6 yr FU: 10.2 (8.4) 

12 yr FU: 8.9 (8.2) 

Diff over time (P < 0.001) 

EDI, perfectionism: 

Baseline: 6.8 (4.8) 

End of tx: 5.4 (3.7) 

2 yr FU: 5.7 (3.9) 

6 yr FU: 5.2 (3.7) 

12 yr FU: 4.7 (3.3) 

Diff over time (P < 0.001) 
C-948 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

2004 

(continued) 

 
C-949 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Diagnostic Outcome at 2 yrs (N = 162), N (%): 

Recovered and no ED dx: 86 (53.1%) 

AN-restricting: 1 (0.6%) 

AN-binge/purge type: 2 (1.2%) 

BN-purging type: 48 (29.6%) 

BN-nonpurging type: 7 (4.3%) 

BED: 0 

EDNOS: 12 (7.4%) 

Deceased: 0 

Diagnostic Outcome at 6 yrs (N = 162), N (%): 

Recovered and no ED dx: 108 (66.7%) 

AN-restricting: 2 (1.2%) 

AN-binge/purge type: 5 (3.1%) 

BN-purging type: 34 (21.0%) 

BN-nonpurging type: 1 (0.6%) 

BED: 2 (1.2%) 

EDNOS: 2 (1.2%) 

Deceased: 2 (1.2%) 

Diagnostic Outcome at 12 yrs (N = 162), N (%): 

Recovered and no ED dx: 107 (66.0%) 

AN-restricting: 1 (0.6%) 

AN-binge/purge type: 2 (1.2%) 

BN-purging type: 16 (9.9%) 

BN-nonpurging type: 1 (0.6%) 

BED: 3 (1.9%) 

EDNOS: 22 (13.6%) 

Deceased: 4 (2.5%) 

Standard Mortality Ratio: 

2.36, 95% CI (0.05 – 4.67) 

Bingeing at 12 yr FU: 

At least twice per wk: 22.1% 

Less than twice per wk: 18.4% 

Not binged in the preceding three mos: 59.5% 

Vomiting at 12 yr FU: 

At least twice per wk: 20.8% 

Less than twice per wk: 11.3% 

Not at all: 67.9% 

SIAB-EX Score at 12 yr FU: 

Total scale: 

BN recovered (N = 114): 0.5 (0.3) 

BN all (N = 158): 0.6 (0.4) 

Healthy Comparisons (N = 202): 0.3 (0.2) 

Diff between BN recovered and healthy comparisons (P < 0.001) 

BN recovered greater than comparisons 

Diff between BN all and healthy comparisons (P < 0.01) 

BN all greater than comparisons 

Amenorrhea: 

Beginning of tx: 18.1% 

12 yr FU: 1.6% 
C-950 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter and 

Quadflieg, 

2004 

(continued) 

 
C-951 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Psychiatric Co-morbidity at 12 yr FU: 

Lifetime 79.7%; current 1 mo: 41.1% 

Mood disorders: Lifetime 69.0%; current 1 mo: 16.5% 

Major depression: Lifetime 58.2%; current 1 mo: 10.8% 

Dysthymic: Lifetime 14.6%; current 1 mo: 5.1% 

Anxiety: Lifetime 36.1%; current 1 mo: 22.2% 

Substance use: Lifetime 36.1%; current 1 mo: 14.6% 

Borderline Personality Disorder: 9.5% 

Additional Treatment 

Inpatient tx days, mean (SD): 

2 yr FU: 15.1 (37) 

2 – 6 yr FU: 9.5 (29) 

6 – 12 yr FU: 6.4 (14) 

Patients who received at least one inpatient tx during 12 yrs: 

140/158 (88.6%) 

Admissions per yr to any type of institution, N: 

2 yr FU: 31.5 

2 – 6 yr FU: 22 

6 – 12 yr FU: 18.5 

Multivariate Results 

Predictors of any ED at FU: 

Lifetime psychiatric comorbidity predicted poor outcome: 

2 yr: OR: 2.53, 95% CI (1.06 – 6.06) (P < 0.05) 

6 yr: OR: 2.81, 95% CI (1.02 – 7.71) (P < 0.05) 

12 yr: OR: 2.52, 95% CI (0.93 – 6.80) (P = NS) 

With PSR as outcome criterion: 

2 yr: OR: 3.55, 95% CI (1.34 – 9.41) (P < 0.05) 

6 yr: OR: 2.40, 95% CI (0.88 – 6.58) (P = NS) 

12 yr: OR: 3.71, 95% CI (1.16 – 11.91) (P < 0.05) 

Positive hx of AN predicted poor outcome: 

2 yr (P = NS) (values NR) 

6 yr: OR: 2.05, 95% CI (0.94 – 4.45) (P = NS) 

12 yr (P = NS) (Values NR) 

With PSR as outcome criterion: 

2.38, 95% CI (1.03 – 5.50) (P < 0.05) 

Childhood obesity 

2 yr: OR: 2.86, 95% CI (1.02 – 8.06) (P < 0.05) 

Other yrs (P = NS) 

Higher age at onset of ED 

12 yr: OR: 1.01, 95% CI (1.01 – 1.16) (P < 0.05) 

Other yrs (P = NS) 

Longer duration of ED: 

All yrs (P = NS) 

Higher frequency of binges: 

All yrs: (P = NS) 

Having undergone tx for ED prior to index tx: 

All years (P = NS) 
C-952 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, year: 

Fichter and 

Quadflieg, 1997 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

Upper Bavaria, 

Germany 

Yrs followed: 

6.2 (0.9) from 

end of tx

To assess the 2 

and 6 yr course 

and outcome of 

BN among a 

group of women 

with BN-purging 

type. 

Inclusion: 

Females 

DSM-IV for BN-purging type 

Admitted to inpatient ED tx 

Exclusion: 

None stated 

Recruitment: 

Females who where dx’ed with 

BN and admitted to ED inpt 

program at Klinik Roseneck in 

Upper Bavaria Germany from 

1985-1988. 

Sample Size: 

Initial (N = 196) 

Finished tx (N=166) 

2 yr FU (N = 184) 

6 yr FU (N=185) 

Loss to FU at 6 yr: 

Death (N=2) 

(pneumonia = 1 

pneumonia & heart problems = 1)

Not reached (N=6) 

Refused to participate (N=3) 

Mean Age at inpt 

admission (SD): 

25.6 (6.7) yrs 

Sex: 

Female 100% 

Race/ethnicity: 

NR 

Duration of sx before 

tx start (SD): 

8.1 (4.9) yrs 

Age of onset (SD): 

17.6 (4.8) yrs 

Inpatient days (SD): 

95.5 (43) 

Discharge Status: 

Normal: 166 

Premature: 10 

By team: 1 

By mutual agreement: 

18 

Improvement at 

discharge: 

Sig improvement: 47 

(24.1%) 

Marked improvement: 

77 (39.5%) 

Slight improvement: 60 

(30.8%) 

Unchanged: 9 (4.6%) 

Slightly worse: 1 (0.5%) 

Marked worse: 1 (0.5%) 

Education: 

< 9 yrs: 1% 

≥ 9 yrs: 69% 

≥ 13 yrs: 25% 

University degree: 

5% 

Score: 

Fair 

Method of diagnosis: 

Specially trained 

psychologists or 

physician used. 

DSM-IV criteria for BN 

based on interview 

and/or SIAB data. 

Funding: 

Wilhelm-SanderStiftung
C-953 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Study Methods: 

Patients assessed at admission to inpt, 

discharge from inpt, 2 yrs, 6 yrs. 

For FU, pts sent questionnaire packet 

to complete. After packet returned, 

interview conducted by specially 

trained psychologists and physicians. 

Those not able to do long interview, 

given shorter version. Long interview 

were face to face or by phone, short by 

phone only. 

Questionnaires: 

SIAB, EDI, AN Inventory for SelfRating, BN version of PSR, SCL-90, 

Complaint List, BDI, Munich Diagnostic 

Checklist for DSM-III-R 

Assessments: 

2.0 (0.7) yrs and 6.2 (0.9) yrs 

Statistical Method: 

Repeated measures MANOVAs 

Pairwise t tests 

Longitudinal comparisons used sets 

complete for all time points. 

Outcomes 

SIAB, supplemented by PSR 

Global outcomes: aggregate of 10 

outcome categories including 

overconcern with eating and wt, binge 

attacks, counterregulatory measures, 

body wt, depression, obsessions, 

anxiety, substance abuse, sexual 

problems, problems in social behavior 

Good – outcome of 1 or 0 

Intermediate – outcome of 2 

Poor – outcome of 3-4 

PSR 

Good – outcome of 1 or 2 

Intermediate – outcome of 3-4 

Poor – outcome of 5-6 

Results: 

Descriptive 

Binge 2 times per wk (self-report): 

Tx start: 100% 

Discharge: 46% 

2 yr and 6 yr FU: 42% 

Vomiting (≥ 2 times per wk): 

Tx start: 88.1% 

Discharge: 49.7% 

2 yr FU: 42.7% 

6 yr FU: 33.6% 

Mean BMI (SD): 

Tx start : 21.5 (5.0) 

Discharge from tx : 21.1 (4.4) 

2 yr FU: 21.5 (4.3) 

6 yr FU: 21.8 (4.6) 

Wt outcome: 

Good: (19<BMI<30): 73.9% 

Intermediate: (BMI 30-40, or 17.5-19): 17.0% 

Poor: (BMI< 17.5, BMI > 40): 9.1% 

Dx outcome (DSM-IV): 

At 2 yr FU: 

BN:35.8% 

AN: 1.6% 

BED: 0% 

EDNOS: 8.0% 

No ED dx: 54.5% 

At 6 yr FU: 

BN: 21.4% 

AN: 3.7% 

BED: 1.1% 

EDNOS: 1.6% 

No ED dx: 71.1%: 

PSR ED sx ratings (N):

At 2 yr FU: 

Marked sx: 29 

Partial remission: 25 

Residual sx: 25 

Usual self: 20 

At 6 yr FU: 

Marked sx: 25 

Partial remission: 26 

Residual sx: 45 

Usual self:37 

Global outcome at 6 yr FU:

Good: 59.9% 

Intermediate: 29.4% 

Poor: 9.6% 

Deceased: 1.1% 
C-954 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, year: 

Fichter and 

Quadflieg, 1997 

(continued) 

 
C-955 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Study Methods: 

Patients assessed at admission to inpt, 

discharge from inpt, 2 yrs, 6 yrs. 

For FU, pts sent questionnaire packet 

to complete. After packet returned, 

interview conducted by specially 

trained psychologists and physicians. 

Those not able to do long interview, 

given shorter version. Long interview 

were face to face or by phone, short by 

phone only. 

Questionnaires: 

SIAB, EDI, AN Inventory for SelfRating, BN version of PSR, SCL-90, 

Complaint List, BDI, Munich Diagnostic 

Checklist for DSM-III-R 

Assessments: 

2.0 (0.7) yrs and 6.2 (0.9) yrs 

Statistical Method: 

Repeated measures MANOVAs 

Pairwise t tests 

Longitudinal comparisons used sets 

complete for all time points. 

Outcomes 

SIAB, supplemented by PSR 

Global outcomes: aggregate of 10 

outcome categories including 

overconcern with eating and wt, binge 

attacks, counterregulatory measures, 

body wt, depression, obsessions, 

anxiety, substance abuse, sexual 

problems, problems in social behavior 

Good – outcome of 1 or 0 

Intermediate – outcome of 2 

Poor – outcome of 3-4 

PSR 

Good – outcome of 1 or 2 

Intermediate – outcome of 3-4 

Poor – outcome of 5-6 

Change over time EDI 

Total 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P < 0.0001) Improved 

Drive for Thinness 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Disharge vs 2 yr FU: (P = NS) 

Discharge vs 6 yr FU: (P < 0.05) Worsened 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Bulimia: 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P < 0.05) Worsened 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Body dissatisfaction 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P = NS) 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Ineffectiveness 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Perfectionism 

Beginning of tx vs 2 yr FU: (P < 0.01) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P = NS) 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P = NS) 

Change over time AN SIAB 

Total 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Body image and ideal of slimness 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P = NS) 

Discharge vs 6 yr FU: (P < 0.05) Improved 

2 yr FU vs 6 yr FU: (P < 0.01) Improved 
C-956 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, year: 

Fichter and 

Quadflieg, 1997 

(continued) 

 
C-957 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Depression 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Anxieties and obsessions 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Bulimic behavior 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Laxative abuse 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Improved 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P = NS) 

Psychiatric comorbidities at 2 yr FU (N=184) and 6 yr FU (N=165) 

Borderline Personality Disorder 

2 yr FU: 5.4% 

6 yr FU: 3.6% 

Lifetime: 8.9% 

Substance abuse (excluding laxatives) 

2 yr FU: 23.9% 

6 yr FU: 21.2% 

Lifetime: 41.6% 

Mood disorders 

2 yr FU: 29.9% 

6 yr FU: 45.5% 

Lifetime: 55.3% 

Anxiety disorders 

2 yr FU: 13.0% 

6 yr FU: 31.5% 

Lifetime: 34.2%

SCL-90: general psychopathology (N=118) 

Global severity index 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P = NS) 
C-958 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, year: 

Fichter and 

Quadflieg, 1997 

(continued) 

 
C-959 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Positive symptom total (PST) 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: Improved 

Positive Symptom Distress Index (PSDI) 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P = NS) 

Somatization 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P = NS) 

Obsessive-compulsive symptoms 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P < 0.001) Improved 

Depression 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.001) Worsened 

Discharge vs 6 yr FU: (P = NS) 

2 yr FU vs 6 yr FU: (P < 0.01) Improved 

Anxiety 

Beginning of tx vs 2 yr FU: (P < 0.001) Improved 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 2 yr FU: (P < 0.01) Worsened 

Discharge vs 6 yr FU: (P < 0.001) Improved 

2 yr FU vs 6 yr FU: (P < 0.01) Improved 

BDI 

Beginning of tx vs 6 yr FU: (P < 0.001) Improved 

Discharge vs 6 yr FU: (P = NS) 
C-960 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

Design: 

Case series 

Comparison 

Group: 

No

Location: 

Massachusetts, 

USA 

Yrs followed: 

Mean: 8.6 

To determine 

predictors of 

serious 

suicide 

attempts in 

women with 

AN and BN. 

Inclusion: 

Female, English speaking, 

meet full criteria for AN and/or 

BN, at least 12 yrs of age, 

reside within 200 miles of the 

study site. 

Exclusion: 

Organic brain syndrome or 

terminal illness. 

Recruitment: 

554 consecutive women who 

sought tx for eating disorder at 

Massachusetts General 

Hospital or other Boston area 

clinics between October 1987 

and June 1990. 

Sample Size 

Initial Sample: 

Met dx criteria: N = 268 

Agreed to participate: N = 229 

Additional participants 

identified: N = 21 

Reasons for loss to FU: 

Drop out prior to first FU: N = 4 

Analysis Sample 

N = 246 

AN-Restricting: 51 

AN-Binge Purge: 85 

BN: 110 

Mean Age: 

24.8 (range: 13 to 45) 

at entry to the study. 

Sex: 

Female:100% 

Race/ethnicity: 

Non-Caucasian: 4% 

Mean duration of 

illness: 

6.7 yrs (range: 3 mos – 

21 yrs) 

Score: 

Good 

Method of dx: 

LIFE-EAT-II and the 

PSR scale 

Funding: 

NIMH, Rubenstein 

Foundation, and 

Harvard Eating 

Disorders Care 
C-961 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU interviews conducted every 6 – 12 

mos in person when possible. 

Statistical Methods 

Non-parametric tests to examine diff on 

self-report measures administered at 

intake between subjects who made 

suicide attempts and those who did not. 

Kaplan-Meier survival analyses to 

determine time to first suicide attempt, 

and time-varying proportional hazards 

(Cox) regression models used to 

determine influence of baseline and 

course variables on time to first suicide 

attempt. 

Multiple regression to predict time to 

first suicide attempt. 

Descriptive Results 

Baseline, Reported hx of suicide attempts prior to study entry: 

AN: 30.1% 

BN: 22.7% 

Rates of suicide attempts: 

AN: 30 (22.1%) 

BN: 12 (10.9%) 

Death from suicide: N = 4 (none had a previous suicide attempt) 

Diff between baseline self report measures for suicide attempters and 

non-attempters, mean (SD): 

AN 

EDI, drive for thinness (P = NS) 

EDI, Bulimia (P = NS) 

EDI, body dissatisfaction (P = NS) 

EDI, ineffectiveness: 

• attempters: 15.2 (8.6) 

• non-attempters: 11.4 (7.8) 

• (P = 0.04); Attempters did worse 

EDI, perfectionism (P = NS) 

EDI, interpersonal distrust (P = NS) 

EDI, interoceptive awareness (P = NS) 

EDI, maturity fears (P = NS) 

BDI: 

attempters: 27.6 (12.1) 

non-attempters: 22.7 (11.3) 

(P = 0.05). Attempters had greater depression. 

Symptom distress (P = NS) 

Global severity index (P = NS) 

Positive symptom total (P = NS) 

BN 

EDI, drive for thinness (P = NS) 

EDI, Bulimia (P = NS) 

EDI, body dissatisfaction (P = NS) 

EDI, ineffectiveness: 

• attempters: 14.6 (7.1) 

• non-attempters: 8.4 (6.1) 

• (P = 0.007); Attempters did worse 

EDI, perfectionism (P = NS) 

EDI, interpersonal distrust: 

• attempters: 7.1 (4.0) 

• non-attempters: 4.5 (3.4) 

• (P = 0.04). Attempters did worse. 

EDI, interoceptive awareness 

• attempters: 17.7 (7.6) 

• non-attempters: 10.9 (5.9) 

• (P = 0.003). Attempters did worse 

EDI, maturity fears: 

• attempters: 7.6 (7.3) 

• non-attempters: 3.7 (4.3) 

• (P = 0.03). Attempters did worse. 
C-962 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

(continued) 

 
C-963 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

BDI: 

attempters: 27.0 (11.7) 

non-attempters: 19.6 (9.5) 

(P = 0.03) 

Attempters had greater depression. 

Symptom distress: 

• attempters: 2.2 (0.46) 

• non-attempters: 1.9 (1.4) 

• (P = 0.006). Attempters did worse 

Global severity index: 

• attempters: 1.6 (0.49) 

• non-attempters: 1.0 (0.54) 

• (P = 0.002). Attempters did worse. 

Positive symptom total: 

• attempters: 64.0 (11.7) 

• non-attempters: 47.7 (18.0) 

• (P = 0.003). Attempters did worse. 

Multivariate Results 

Predictors of time to first suicide attempt during course of studyhypothesis testing results: 

AN 

Hx of suicide attempt at intake (P < 0.009) 

Eating disorder symptomatology (P = NS) 

Severity of drug use (P < 0.01) 

Alcohol use (P = NS) 

BN 

Laxative use (P < 0.05) 

Hx of drug use disorder prior to start of the study (P < 0.01) 

AN 

Hx of suicide attempt at intake: HM = 1.09, 95% CI (1.31 – 6.71) 

(P = 0.009); Shorter time to first attempt 

Drug use: HM = 0.92, 95% CI (1.40 – 4.52) (P = 0.010); Greater use 

shorter time 

Individual therapy: HM = 3.54, 95% CI (1.20 – 10.42) (P = 0.013); Yes, 

shorter time 

Neuroleptic meds: HM = 5.03, 95% CI (1.50 – 16.86) (P = 0.02); Yes, 

shorter time 

Age of onset: HM = 1.06, 95% CI (1.00 – 1.12) (P = 0.05); Older age, 

shorter time 

Group therapy: HM = 2.35, 95% CI (1.00 – 5.53) (P = 0.06) 

Severity of depression: HM = 1.21, 95% CI (0.99 – 1.50) (P = 0.06) 

Alcohol use: HM = 1.54, 95% CI (0.99 – 1.04) (P = 0.08) 
C-964 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Franko et al., 

2004 

(continued) 

 
C-965 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

BN 

Group therapy: HM = 11.32, 95% CI (2.33 – 55.02) (P = 0.002); Yes, 

shorter time 

Age of onset: HM = 0.82, 95% CI (0.70 – 0.97) (P = 0.008); Younger age, 

shorter time 

Hx of drug use disorder: HM = 8.94, 95% CI (1.87 – 42.77) (P = 0.009); 

Greater hx, shorter time 

Individual therapy: HM = 10.39, 95% CI (1.03– 105.12) (P = 0.020); Yes, 

shorter time 

Paranoid personality disorder at intake: HM = 66.5, 95% CI (3.60 – 

129.84) (P = 0.020); Yes, shorter time 

Severity of laxative use: HM = 1.21, 95% CI (1.50 – 46.30) (P = 0.022); 

More, shorter time 

Psychiatric hospitalization: HM = 10.75, 95% CI (1.16 – 99.86) (P = NS) 
C-966 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Gendall et al., 

2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

New Zealand 

Yrs followed: 

1 

To determine 

the clinical and 

nutritional 

variables 

associate with 

menstrual 

disturbance in 

women 

presenting for 

tx for BN at 1 

yr FU. 

Inclusion: 

Women, age 17-45, DSM IV 

criteria for BN, purging type 

Exclusion: 

AN, BMI < 17 or >30 kg/m2

 

Current use of psychoactive 

meds, hysterectomy or using 

oral contraceptives 

Recruitment: 

Women participating in 

outpatient tx trial recruited 

through media ads 

general practitioner and mental 

health worker referrals 

Sample Size: 

N = 82 

Loss to FU: 

None 

Mean Age, yrs (SD) 

26.2 (6.2) 

Sex: 

Female 100% 

Race/ethnicity: 

NR 

Mean BMI (kg/cm2

) 

(SD) 

23.0 (2.7) 

Age Menarche (SD) 

13.0 (1.5) 

PreTx Irregular 

Menses: 

45.1% 

Hx of Amenorrhea 

46.3% 

Wt. Min (kg) (SD) 

51.9 (6.9) 

Wt. Max (kg) (SD) 

69.5 (10.8) 

Wt Max-min (kg) (SD) 

17.6 (8.4) 

BN duration (mos) 

(SD) 

65.5 (64.7) 

# Binges 

prior 2 wks (SD) 

10.2 (10.6) 

# Purges prior 2 wks 

(SD) 

11.7 (12.1) 

Hx of AN 

20.7% 

Recency AN (mos) 

(SD) 

18.5 (7.9) 

PreTreatment Maj. 

Dep: 

22.0% 

PreTx smoker: 

25.6% 

PreTx substance 

abuse: 

23.2% 

Score: 

Good 

Method of dx: 

Clinician 

administered SCID 

for DSM III-R, 

Global Assessment 

of Functioning, 

Structured clinical 

interview for core 

BN symptoms in 

past fortnight 

Funding: 

NR 
C-967 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Intervention: 

Outpatient tx testing use of exposure with 

response prevention to cognitive behavioural 

therapy for BN 

Study Methods: 

Assessed PreTx and at 1 yr Post-Tx. 

At pre-Tx and 1 yr FU clinician administered 

SCID-III-R, Global Assessment of Functioning 

Scale, structured clinical interview of core BN 

sx., Hamilton Depression Rating Scale 

(HDRS) adjusted for wt. and appetite items. 

Body wt and height measures. 

Statistical Method: 

Log transformation of non-normal distributions 

ANOVA 

Chi-Square 

Logistic regression analyses 

Outcomes 

Irregular menstruators: Absent or irregular 

menstrual cycles within past 3 mos. 

Descriptive Results: 

Women with vs. without regular menses – 1 yr FU 

Women with irregular menses – 30.5% 

Irregular menses at 1 yr FU associated with following baseline 

measures: 

Low past min. body wt. (P = 0.05) 

Greater max.-min. wt diff (P = 0.001) 

Current smoking (P = 0.03) 

At FU, dx of major depression in past 6 mos: 

Regular menstruators: 18.5% 

Irregular menstuators: 44% 

(P = 0.03) 

Irregular at PreTx became regular at FU: 56.8% 

Multivariate Results 

Sig predictors of irregular menses at 1 yr FU: 

Greater max.-min. wt diff (P = 0.003) 

Current smoking (P = 0.01) 
C-968 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Herzog et al., 

2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA, 

USA 

Yrs followed: 

11 

To assess 

rates and 

causes of 

death for a 

cohort of 

women with 

AN or BN and 

provide 

descriptive 

information on 

their ED and 

comorbid 

dx. 

Inclusion: 

Initially, meeting DSM III-R 

criteria for AN, AN/BN, or BN; 

Subsequently, using DSM IV 

definitions, met criteria for ANR, ANBP, or BN. 

Exclusion: 

None 

Recruitment: 

Between October 1987 and 

June 1990, tx seekers at 

Massachusetts General 

Hospital. 556 recruited. 

Sample Size: 

Using DSM IV criteria, 

participants classified as 

AN-R (N = 51), 

ANBP (N = 85), and 

BN (N = 110) status 

Reasons for loss to FU: 

NR 

Mean Age 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Mean duration of 

illness: 

7.2 yrs 

Score: 

Fair 

Method of dx: 

SADS-L modified to 

include diagnostic 

criteria for DSM III-R 

as well as 

psychiatric hx, later 

updated to DSM IV 

criteria 

Funding: 

NIMH ROI Grant, 

sponsor: Rubenstein 

Foundation and 

Harvard Eating 

Disorders Center. 
C-969 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Data on mortality collected as part of a 

longitudinal study of AN and BN. Other 

data sources included death certificates, 

autopsy reports, relative interviews, and 

a National Death Index search. 

The Eating Disorders Longitudinal FU 

Evaluation (LIFE-EAT II) was 

administered to subjects at 6-mo 

intervals. General information regarding 

subjects’ functioning in the mos prior to 

death was obtained by interviewing a 

family member. 

Descriptive findings: 

AN 

At 11th yr FU: # of AN deaths: 7 (Crude mortality rate = 5.1%, 7 / 136) 3 

subjects committed suicide. 

SMR indicates a sigly raised mortality rate for death at 9.6 times the 

expected rate (P = 0.001), 95% CI (3.86 -19.8) and for suicide at 

58.1times the expected rate (P = 0.001), 95% CI (11.7 -169.7). 

Characteristics of deceased participants: 

• At intake, 5 met ANBP dx: 2 met full AN and BN criteria; 2 met full AN 

criteria with BN sx; 1 met full BN criteria with AN sx. 

• Ages: 24-46 yrs. 

• Yrs ill at death: 9-28 

• 2 met ANR criteria at intake, but later exhibited BN sx 

• At time of death, of the 5 ANBP participants, 2 were classified as 

ANBP, 2 met AN-partial recovery criteria, 1 met AN-full recovery 

criteria. 

• All had a hx of comorbid Axis I disorders: most common dx was 

alcoholism. Other comorbid disorders included bipolar disorder major 

depressive disorder and drug abuse. 

• All participated in multiple types of tx: both individual psychotherapy 

and pharmacotherapy 

• Hospitalized at least once: N = 6 

• Participated in group therapy: N = 6 

• Nutritional counseling: N = 5 

• Participated in family therapy: N = 4 

• All 3 subjects who committed suicide had reported suicidal ideation 

and 2 subjects had made at least one prior suicide attempt. 

BN 

At 11th yr FU, # of BN deaths: 0 
C-970 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, Yr: 

Herzog et al., 

1999 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA, 

USA 

Yrs followed: 

Median = 7.5; 

interviews 

conducted 

every 6 mos 

for 11 yrs 

To assess 

factors 

associated 

with recovery 

and relapse in 

AN and BN 

Inclusion: 

DSM III-R for AN and BN at tx 

intake (Participants reclassified 

according to DSM IV criteria 

during the study); anorexic and 

bulimic episodes not separated 

by a period of remission of at 

least 8 wks duration. 

Exclusion: 

None 

Recruitment: 

Women who sought tx in 

eating disorder programs in 

Boston, MA between 1987 and 

1990. An additional 21 women 

with AN recruited in 1991. 

Sample size 

Initial sample size: 

ANR: 51 

ANBP: 85 

BN: 110 

Reasons for loss to FU: 

Dropouts: 17 

Died (dx group and reasons 

NR): 7 

Analysis sample size: 

NR 

Mean age at tx intake 

(SD): 

ANR: 23.9 (8.5) 

ANBP: 24.5 (5.9) 

BN: 25.5 (6.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at ED onset (SD): 

ANR: 17.5 (6.1) 

ANBP: 16.9 (4.7) 

BN: 19.4 (5.8) 

Proportion ABW: 

ANR: 0.73 (0.09) 

ANBP: 0.82 (0.10) 

BN: 1.03 (0.15) 

Lifetime hx major 

depression: 

ANR: 64.7% 

ANBP: 71.3% 

BN: 60.7% 

Lifetime hx Axis I: 

ANR: 62.7% 

ANBP: 78.1% 

BN: 74.1% 

Lifetime hx Axis II: 

ANR: 25.5% 

ANBP: 37.9% 

BN: 23.2% 

Lifetime hx substance 

use disorder: 

ANR: 5.9% 

ANBP: 16.1% 

BN: 12.3% 

Duration intake 

episode: 

ANR: 6.4 (6.7) 

ANBP: 7.6 (5.4) 

BN: 6.1 (6.3) 

Score: 

Good 

Method of dx: 

Modified version of 

Schedule for 

Affective Disorders 

and Schizophrenia 

– Lifetime version 

Funding: 

NIMH, Rubenstein 

Foundation, 

Harvard Eating 

Disorders Center 
C-971 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

FU interviews generally conducted by 

telephone by trained interviewers. 

Instruments included: Eating Disorders 

Longitudinal Interval FU Evaluation 

(LIFE-EAT-II)-semi-structured. 

Statistical Methods: 

Survival analysis, proportional hazards 

(Cox) regression 

Outcome Categories: 

Full recovery (absence of symptoms or 

presence of only residual symptoms for 

at least 8 consecutive wks) at some 

point over 90 mos 

Partial recovery (reduction of symptoms 

to < full recovery for ≥ 8 consecutive 

wks 

AN Findings 

Descriptive Results 

Full recovery: 

33.7% 

At 2 yrs: ANR: 8%; ANBP: 13% 

At 7 yrs: ANR: 34%; ANBP: 32% 

Partial recovery: 

83.7% 

At 2 yrs: ANR: 61%; ANBP: 67% 

At 7 yrs: ANR: 83%; ANBP: 82% 

Median time to partial recovery (wks): 

ANR: 78; ANBP: 53 

Diff ANR and ANBP (P = NS) 

Relapse after full recovery: 

40% 

No remission through yr 7: 

ANR: 17% 

ANBP: 18% 

Multivariate Results 

Sig predictors of time to full recovery (adjusted): 

Percent of ABW at intake: HM = 250.1, 95% CI (6.90-9.066) heavier is 

better 

Duration of intake episode: HM = 0.89, 95% CI (0.81-0.96), shorter is better 

Sig predictors of time to partial recovery (adjusted): 

Duration of intake episode: HM = 0.63, 95% CI (0.45-0.87) Shorter is better 

Percent ABW at intake: HM = 18.89, 95% CI (0.32-1.105) Higher is better 

Hx of hospitalization: HM = 29.60, 95% CI (1.11-791.21) Fewer 

hospitalizations is better 

Hx of major depression: HM = 1.64, 95% CI (1.07-2.51) Not having major 

depression is better 

Duration of intake episode x proportion ABW: HM = 1.65, 95% CI (1.10-

2.47); ABW values >93% and shorter intake episode is better than ABW < 

93% and longer duration of intake episode 

Percent ABW x hx of hospitalization: HM = 0.007, 95% CI (0.0001-0.44); 

ABW values ≤ 69% and having hx of hospitalization is better than ABW > 

69% and no hx of hospiatlization 

BN Findings 

Descriptive Results 

Full recovery: 

73.8% 

At 2 yrs: BN: 53% 

At 7 yrs: BN 73% 
C-972 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, Yr: 

Herzog et al., 

1999 

(continued) 

 
C-973 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Partial recovery: 

99.0% 

At 2 yrs: BN: 88% 

At 7 yrs: BN: 98% 

Median time to partial recovery (wks): BN: 14 

Relapse after full recovery: 

35.3% 

Multivariate Results 

Sig predictors of time to full recovery: none identified 

Sig predictors of time to partial recovery: none identified 
C-974 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Herzog et al., 

1996 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, MA 

Yrs followed: 

4 

To assess the 

rates of 

recovery for 

restrictor and 

bulimic 

anorexics to 

determine 

whether 

bulimic 

behavior sig 

affects the 

course of AN. 

To assess 

possible 

subtypes of BN 

based on the 

presence or 

absence of a 

hx of AN. 

Inclusion: 

DSM III-R criteria for BN and 

or AN 

Exclusion: 

NR

Recruitment: 

Participants who sought 

evaluation for an eating 

disorder at the Massachusetts 

General Hospital Eating 

Disorders Unit and at other 

Boston-area eating disorders 

programs between 10/87 and 

6/90.

Sample Size: 

Initial sample: 

Telephone Screen: N = 554 

Met criteria: N = 268 

Participated: N = 229 

Dropout: N = 4 

Analysis Sample: 

N = 225 

ANR (AN and no regular 

bingeing or purging): N = 39 

ANBP (AN and regularly 

engage in bingeing or 

purging): N = 37 

BNPAN (BN now and hx of 

AN): N = 28 

BNSAN (BN now, underwt at 

intake and do not meet full 

criteria for AN): N = 36 

BN (BN with no prior hx of 

AN): N = 89 

Age, mean (SD) 

(range), yrs 

24.5 (6.7) 

ANR: 21 (18 – 27) 

ANBP: 22 (19 – 25) 

BNSAN: 25 (21 – 29) 

BNPAN: 23 (20 – 27) 

BN: 24 (20 – 30) 

Diff between groups 

(P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Age at onset of first 

disorder, mean 

(range), yrs 

ANR: 17 (15 – 20) 

ANBP: 17 (15– 19) 

BNSAN: 17 (14 – 19) 

BNPAN: 16 (15 – 18) 

BN: 18 (16 – 20) 

Diff between groups 

(P = NS) 

% attempted suicide: 

ANR: 18 

ANBP: 33 

BNSAN: 53 

BNPAN: 19 

BN: 28 

Diff between groups 

BNSAN had higher 

rates of suicide 

attempts versus BN 

and BNPAN 

(P < 0.001). 

Score: 

Good 

Method of dx: 

Semi-structured 

interview (Schedule 

for Affective 

Disorders and 

SchizophreniaLifetime Version 

modified to include 

diagnostic criteria 

for DSM III-R eating 

disorders derived 

from the Diagnostic 

Interview Schedule). 

Eating Disorders 

Longitudinal FU 

Evaluation. 

Funding: 

NIMH, Rubenstein 

Foundation, Eli Lilly 

and Co, The Boston 

Obesity, Nutrition 

Research Center 
C-975 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU interviews conducted every 3 mos. Anniversary (12, 

24, 36 mo) FUs conducted in person whenever possible. 

Full recovery: asymptomatic (Psychiatric Status Rating 

PSR < 3) for at least 8 consecutive wks. 

Partial recovery: maintaining for at least 8 consecutive 

wks a PSR level of 3 or 4. Do not meet full criteria for AN 

or BN but still experience sig symptomatology. 

Analytic Strategy 

Fisher’s Exact Test and Wilcoxon Rank Sum Test 

Kaplan-Meier survival method for probability of recovery. 

Cox proportional hazards models to identify prognostic 

factors 

Descriptive Results 

% at least partially recovered: 

BN: 91% 

Trend (P < 0.01) 

% fully recovered: 

BN: 62% 

Trend (P < 0.01) 

Multivariate Results 

BN Predictors of recovery; Adjusted for duration of 

the current episode (N = 150): 

Duration of current episode (P = NS) 

Age at onset of eating disorder (P = NS) 

Age at onset of first eating disorder (P = NS) 

Current disorders involving a lack of impulse control 

(P = NS) 

Wt < 90% of ideal (P = NS) 

Bingeing frequency (P = NS) 

Purging frequency (P = NS) 

Current depression (P = NS) 

Personality disorder (P = NS) 

Any current Axis I disorder (P = NS) 

AN Predictors of recovery: Adjusted for duration of 

the current episode (N = 75): 

Duration of current episode: RR = 0.50, 

95% CI (0.27 – 0.94) 

Age at onset of eating disorder (P = NS) 

Age at onset of first eating disorder (P = NS) 

Current disorders involving a lack of impulse control: 

(P = NS) 

Bulimic behaviors (P = NS) 

Current depression (P = NS) 

Any current Axis I disorder (P = NS) 
C-976 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Author, yr 

Herzog et al., 

1993 

Design: 

Prospective 

cohort 

Comparison 

Group: 

No 

Setting: 

Boston, MA, 

USA 

Yrs followed: 

1 yr (with some 

having 2 yr 

FU) 

To asses the 

course and 

outcome of BN 

at 1 yr in a 

large cohort of 

women with 

ED. 

Inclusion: 

DSM III-R dx of AN and/or BN; 

Female; age ≥ 12; residence 

within 200 mi of Boston; 

English speaking; no evidence 

of organic brain syndrome or 

terminal illness. 

Exclusion: 

None 

Recruitment: 

Patients who sought tx 

between 10/1987 and 6/1990 

at the Massachusetts General 

Hospital Eating Disorders Unit 

and other Boston area eating 

disorder programs. Tx not 

controlled at study intake. 

554 telephone screened 

268 (48%) met criteria for 

AN/BN 

229 (85%) agreed to 

participate 

Sample Size 

Initial sample: 

AN: N = 41 

BN: N = 98 

Analysis sample size: 

Final N for 1 yr FU = 225 

AN = 41 

BN = 96 

AN/BN = 88 

Completed 18 mo: 79% 

Completed 24 mos: 45% 

Only BN results presented in 

ET due to sample size and 

disease definition restrictions. 

Mean Age At Intake, 

mean (SD): 

22.8 (7.4) 

Age when first met 

criteria, mean (SD): 

18.8 (4.0) 

Duration of episode, 

mos, mean (SD): 

57.7 (62) 

IBW at intake, %, mean 

(SD): 

104% (15%) 

Comorbid Axis I dx, %: 

61% 

In tx at 12-mo FU, %: 

79% 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Intake duration, mean 

(SD): 

79 (73) mos range: 3 

mos - > 10 yrs.

Score: 

Good 

Method of dx: 

Schedule for 

Affective Disorders 

and Schizophrenia 

– Lifetime Version 

(SADS-L), modified 

to include dx 

criteria for DSM IIIR eating disorders. 

Funding: 

NIMH 
C-977 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Methods and Statistical Analysis Main Outcomes and Results 

Study Methods 

Inperson FU interviews conducted every 3 mo 

after intake into the study. 

Axis II: Structured Interview for DSM III 

Personality Disorders (SIDP). 

FU: Eating Disorders Longitudinal Interval FU 

Evaluations (LIFE Eat II) 

For all disorders, Psychiatric Status Ratings 

(PSR) completed each FU point. Full 

recovery: at least 8 consecutive wks at a PSR 

level of 1 or 2; partial recovery: at least 8 

consec wks at PSR level 3 or 4 or less than 8 

consec wks at a PSR of 1 or 2. 

Statistical Methods 

Kaplan-Meier survival method for cumulative 

probability of recovery. 

Log rank to compare times to recovery across 

three dx. 

Cox regression to determine if intake 

psychopathology or eating disorder 

characteristics predicted time to recovery. 

Descriptive Results 

Rate of recovery at 1 yr FU: 

First shift to subclinical (loss of full criteria without considering 

duration), N (%): 83 (86%) 

Partial recovery, N (%): 68 (71%) 

Full recovery, N (%): 53 (56%) 

Predictors of partial recovery 

IBW: 

Hazard multiplier: 1.07 

95% CI (0.97 – 1.18) 

Percent IBW did not predict time to recovery. 
C-978 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Jäger et al., 

2004 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Hanover, 

Germany 

Yrs followed: 

8.1 (0.6) 

To investigate 

the long-term 

social 

adjustment of 

women with 

BN after tx and 

the course of 

sx and related 

dimensions 

over time. 

Inclusion: 

Women 

DSM III-R for BN 

Exclusion: 

Acute drug abuse 

Acute psychosis 

Recruitment: 

Continuation of Hanover BN 

study with add FU 8 yrs after 

start of tx. Initially 92 women 

offered systemic outpatient or 

analytic inpatient tx at 

Department of 

Psychosomatics and 

Psychotherapy, Hanover 

Medical School. 

Sample Size: 

Initial sample: 

Patients in tx sample (N = 83) 

Reasons for loss to FU: 

Refused (N = 3) 

Analysis sample: 

Participated through FU 

(N = 80) 

At FU: 

Mean Age (SD): 

31.7 (4.1) yrs 

Sex: 

Female 100% 

Score: 

Fair 

Method of dx: 

DSM III-R, method not 

reported 

Funding: 

Robert-BoschFoundation, Stuttgart, 

Germany for 5 yrs and 

Lilly-Pharma, Germany 

for final assessment 
C-979 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Patients were followed up 8 yrs after tx 

completion. FU patients were interviewed 

by telephone and completed a mailed 

questionnaire. 

Telephone interview covering 

symptomatology and general health. 

Mailed questionnaire including: 

Depression scale 

An inventory of bodily complaints 

Freiburg Personality Inventory 

Eating Attitude Inventory 

Eating Disorders Inventory 

Bulimia Severity Score 

Collateral info obtained by family and 

friends (no method reported) 

Statistical Method: 

Chi2

 and binomial tests 

Repeated measure ANOVA 

Huynh-Feld-Epsilon correction 

Friedman ANOVA or Cochran Q test 

0.9% of missing values substituted by 

mean of adjacent measures 

Outcomes 

Interview screen of ED symptoms and 

general health 

Depression scale 

An inventory of bodily complaints 

Freiburg Personality Inventory 

Eating Attitude Inventory 

Eating Disorders Inventory 

Bulimia Severity Score 

Calculated total score of intake 

restrictions 

Descriptive Results: 

Social adaptation: BN study sample vs general population 

Married: 29.9% vs 61.4% (P < 0.001) 

Living with partner: 56.4% vs 73.4% (P < 0.001) 

Proportion of hospitalized patients/yr due to all reasons: 21.9% vs 10.7% 

(P < 0.001) 

No diff between BN and general pop. on employment, receive unemploy. 

benefits, welfare as main income source. 

Mental Health outcomes: 

Comorbid clinical neurotic or psychosomatic dx in addition to BN reduced 

from 35 at intake to 8 at FU. 

Personality disorders reduced from 13 at intake to 3 at FU. 

Eating related outcomes 

Number binges per wk:62.5% 

Still DSM III-R for BN: 28.9% 

EDNOS (bulimic): 8.8% 

EDNOS (anorexic): 1.3% 

No DSM III-R ED dx: 61.2% 

Change over time (Discharge through 8 yr FU) 

Binges decreased over time to FU in both tx groups (P < 0.001) 

Severity index decreased over time to FU in both tx groups (P < 0.001) 

Analytic inpatients better improvement over time (P < 0.007) 

Number normal meals per wk increased over time to FU (P < 0.001) 

Number restrictions of intake decreased over time to FU (P < 0.001) 

Analytic inpatients fewer restrictions (P = 0.048) 

EAT-Bulimia decreased over time to FU (P < 0.001) 

Analytic inpatients having greater decrease (P = 0.005) 

EAT-Dieting decreased over time to FU (P < 0.001) 

EDI-Ineffectiveness decreased over time to FU (P < 0.001) 

Depressiveness decreased over time to FU (P < 0.001) 

Analytic inpatients having greater decrease (P = 0.036) 
C-980 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Johnson, Tobin, 

and Dennis, 

1990 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

University of 

Chicago, IL, USA

Yrs followed: 

1 

To compare 

bulimics with 

and without 

Borderline 

Personality 

Disorder at 1 

yr FU after 

initiation of tx. 

Inclusion: 

DSM III-R criteria for BN 

Exclusion: 

NR 

Recruitment: 

Patients who sought tx at 

University of Chicago 

Medical Center 

Sample Size: 

N = 55 

BPD: N = 21 

NBPD: 

N = 19 

Mean Age: 

25 (5.1); Mode: 15 yrs; diff between 

groups (P = NS) 

Sex: 

Female: 100% 

Race/ethnicity: 

Mode: Caucasian 

Age of onset of bingeing: 

16.7 

Diff between groups (P = NS) 

Duration of binge eating behavior, 

mean yrs: 

6.8 

Diff between groups (P = NS) 

Age of onset of vomiting: 

19.1 

Diff between groups (P = NS) 

Duration of vomiting, mean yrs: 

5.6 

Diff between groups (P = NS) 

Number of dieting attempts during 

last yr, mean: 

20 

Diff between groups (P = NS) 

Controlled dieting behavior: 

Diff between groups (P < 0.05) 

NBPD engaged in more controlled 

dieting 

Current wt, mean (lbs): 

127 

Diff between groups (P = NS) 

Previous low wt, mean (lbs): 

113 

Diff between groups (P = NS) 

Previous high wt, mean (lbs): 

146 

Diff between groups (P = NS) 

Frequency of binges per wk: 

10 

Diff between groups (P = NS) 

Binge days per wk: 

5 

Diff between groups (P = NS) 

Frequency of purging per wk: 

13 

Diff between groups (P = NS) 

Score: 

Poor 

Method of dx: 

Diagnostic 

Survey of Eating 

Disorders, 

revised; 

Borderline 

Syndrome Index 

(BSI): Borderline 

group: ≥ 23; 

Nonborderline 

group: ≤ 12 

Funding: 

Barr and 

Dunagan 

Foundation 
C-981 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

FU assessments were conducted by mail 

1 yr after entry into tx. 

Tx intervention: Combination of CBT and 

psychodynamic; frequency: 1 – 2X per 

wk (depending on patient) for some 

portion of the yr. 

Analytic Strategy 

Chi-square comparisons 

Outcomes: 

Remission: no episodes of binge eating 

or purging during two wks prior to FU 

Sigly improved: Reduced frequency of 

binge/purge by 50% from initial 

assessment to 1 yr FU. 

Family Hx of psychiatric illness: 

Borderline: 76% 

Nonborderline: 32% 

Diff between groups (P < 0.01) 

Family hx of affective disorder: 

Borderline:48% 

Nonborderline: 32% 

Diff between groups (P = NS) 

Family hx of alcoholism: 

Borderline:48% 

Nonborderline:16% 

(P = NR) 

Continued to meet DSM III-R criteria for BN: 

Borderline: 62% 

Nonborderline: 21% 

Diff between groups (P < 0.05); Borderline did worse. 

Complete remission: 

Borderline: 10% 

Nonborderline: 47% 

Sigly improved: 

Borderline: 48% 

Nonborderline: 42% 

Unimproved: 

Borderline: 24% 

Nonborderline: 5% 

Increase in symptoms: 

Borderline: 19% 

Nonborderline: 5% 

BDI, mean: 

Borderline: 18 

Nonborderline: 4 

(P = NR) 

GSI/SCL-90: 

Borderline: 1.24 

Nonborderline: 0.34 

(P = NR) 

In tx at end of 1 yr, N: 

Borderline: 14 

Nonborderline: 7 

Diff between groups (P < 0.05) 

Mean number of tx sessions: 

Borderline: 67 

Nonborderline: 35 

Diff between groups (P < 0.05) 
C-982 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Johnson, 

Tobin, and 

Dennis, 1990 

(continued) 

Purge days per wk: 

5 

Diff between groups (P = NS)

BDI: 

Borderline: 27 

Nonborderline: 9 

Diff between groups (P < 0.001) 

Borderline more depressed 

Global Severity Index of SCL90: 

Borderline: 1.93 

Nonborderline: 0.69 

Diff between groups (P < 0.001) 

Borderline greater severity 

Drive for thinness: 

Diff between groups (P < 0.01) 

Borderline worse 

Distorted body image: 

Diff between groups (P < 0.01) 

Borderline worse 
C-983 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

This page intentionally left blank. 
C-984 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Keel et al., 

2003 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Boston, Mass 

Yrs followed: 

Mean: 8.6 

Median: 9 

To determine 

mortality ratios 

and predictors 

of fatal 

outcome in 

women dx with 

AN or BN. 

Inclusion: 

(1) DSM III-R dx of AN or BN 

retrospectively (2) female (3) 

min age of 12 yrs (4) residence 

within 200 miles of Boston (5) 

English speaking, and (6) no 

evidence of organic brain 

syndrome or terminal illness. 

Exclusion: 

None 

Recruitment: 

294 women recruited for 

participation in a prospective 

longitudinal study between 

January 1, 1987, and 

December 31, 1991. Virtually 

all seeking outpatient tx for 

their Ed at the Massachusetts 

General Hospital Eating 

Disorders Unit or other Boston 

area eating disorder programs 

(37% received inpatient). 

Sample Size: 

N = 294 met study criteria 

N = 250 agreed to participate 

N = 246 randomized and 

participated (4 dropped out 

after intake interview) 

Retrospectively application of 

DSM IV criteria: 

Met AN criteria: N = 136 

Met BN criteria: N = 110 

Mean Age 

NR 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Score: 

Fair 

Method of dx: 

Structured 

diagnostic 

interview 

Funding: 

NIMH; Eli Lily and 

Co.; Rubenstein 

Foundation; 

Harvard Eating 

Disorders Center 
C-985 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

During FU interviews, the Longitudinal 

Interval FU Evaluation adapted for EDs 

used to assess ED and comorbid 

psychiatric disorders. Course of disorder 

coded on a wk-by-wk basis using PSR. 

Social adjustment evaluated on a 5-

point scale. GAF used to evaluate 

overall level of symptom severity from 

all disorders and psychosocial function. 

Social adjustment, GAF scores, and tx 

rated on a wk-by-wk basis throughout 

FU. Interviews conducted, in person 

when possible, every 6 to 12 mos. 

FU telephone calls conducted to 

determine vital status for all longitudinal 

study participants as of October 

2000. 

Statistical Methods 

Crude mortality rates and SMRs 

calculated. Expected number of deaths 

derived from US decennial life tables for 

1989-1991. Expected number of 

suicides derived from 1995 Annual 

Report: VitalStatistics of Massachusetts.

Cox regression models used to 

determine predictors of fatal outcome. 

Multivariate regression model used to 

predict death. 

Descriptive 

Number of Deaths: 

11 (4.5%) 

AN:10 

ANR: 5 

ANBP: 5 

Diff by subtype (P = NS) 

BN: 1 

Crude mortality: 

AN: 7.4% 

BN: 0.9% 

SMR 

AN: 11.6; 95% CI (5.5-21.3) 

BN: 1.3; 95% CI (0.0-7.2) 

Mortality rates elevated in AN but not BN 

Cause of death 

ANBP: Pneumonia 

ANR (N = 3) Suicide 

ANBP: Cardiac dysrythmia 

ANBP: Alcohol poisoning 

ANBP: Diabetes mellitus 

BN: Mitral valve prolapse 

ANR: Amyotrophic lateral sclerosis 

ANBP: Suicide 

ANR: Heart and liver failure

SMR associated with suicide for AN: 56.9, 95% CI (15.3-145.7), sig higher 

Multivariate Results 

Sig predictors of death among AN patients (controlling for age and 

duration of illness before intake): 

Greater severity of alcohol use disorders (P < 0.001) 

Greater severity of substance use disorders (P = 0.03) 

Worse social adjustment (P = 0.02) 

Worse GAF scores at FU (P = 0.01) 

Using the Bonferroni-corrected P = 0.0016, only severity of alcohol use 

disorder remained sig. 

Predictors of time to death among AN patients 

Duration of illness at tx intake: HM = 1.48, 95% CI (1.11-1.99) (P = 0.001) 

Affective disorder hospitalization at intake: HM = 0.0001, 

95% CI (0.00-0.27) (P = 0.001) 

Suicidality associated with mental illness other than ED and substance 

abuse: HM = 23.92, 95% CI (0.81-705.52) (P = 0.05) 

Severity of alcohol use over course of illness: HM = 5.55, 

95% CI (1.68-18.29) (P = 0.001)
C-986 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Keel et al., 

2001 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed 

(SD): 

10 (0.7) 

To determine 

the 

independence 

of the 

association 

between body 

dissatisfaction 

and 

depression 

from bulimic 

symptoms 

among women 

who had BN at 

the time of the 

baseline 

assessment. 

Inclusion: 

Met DSM III criteria for BN, 

with the add criterion of binge 

eating coupled with purging 

episodes occurring at least 3 

times per wk for at least 6 mos 

prior to study participation. 

Additional inclusion and 

exclusion criteria reported in 

the original study (Mitchell et 

al., 1990). 

Exclusion: 

One woman removed from 

analyses because baseline 

and FU assessments indicated 

she had never met full DSM IV 

criteria for BN because her 

binge eating episodes 

were not objectively large. 

Recruitment: 

Women with BN who 

completed participation in a 

controlled tx outcome study at 

the U of Minnesota’s ED 

Research offices, Minneapolis, 

MN between 1985 and 1987 

(Mitchell et al., 1990) were 

mailed an invitation to 

participate in FU study. 

Sample Size: 

Original sample 

Recruited: N = 125 

Reasons for loss to FU: 

Located: N = 115 (92%) 

Exclusion due to not meeting 

DSM IV criteria: N = 1 

Reasons NR: N = 13 

Analysis sample: 

N = 101 

Mean Age (SD): 

34.3 (5.2) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian: N = 100, 

99% 

Non-Caucasian N = 1, 

1% 

Education: 

Not completed HS: 1% 

4-yr college: 42% 

Graduate school: 15% 

Occupational level:

Administrative: 37% 

Clerical/sales: 29% 

with approximately 10% 

Manual position: 11% 

Professional position: 

10% 

Score: 

Fair 

Method of dx: 

NR 

Funding: 

McKnight Center 

Grant; NIH Obesity 

Grant 
C-987 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Participants were mailed consent forms 

and questionnaires to complete at home, 

and asked to complete an interview 

either over the telephone or in person. 

Face-to-face interviews were conducted 

either at the University of Minnesota’s 

Eating Disorders research office or within 

subjects’ homes. 

Participants were administered the 

HDRS (depression), EDI (ED symptoms), 

SCID-I, and BDQ (body dissatisfaction) 

at baseline and FU. 

Analytic Strategy: 

Multiple regression analyses utilized to 

test the independence and strength of 

concurrent and prospective associations 

of body dissatisfaction, depression, and 

BN symptoms. 

Multivariate Findings: 

Regression of body dissatisfaction on bulimic symptoms and 

depression: 

Baseline concurrent body dissatisfaction (N = 101) (R2 = 0.21) 

Bulimic symptoms β (SE B), β: 0.59 (0.15), 0.36 (P < 0.001) 

Depression, β (SE B), β: 0.22 (0.11), 0.19 (P < 0.05) 

FU concurrent body dissatisfaction (N = 97) (R2 = 0.32) 

Bulimic symptoms, β (SE β), β: −7.32 (1.73), -0.37 (P < 0.001) 

Depression, β (SE β), β: 1.92 (0.49), 0.35 (P < 0.001) 

Prospective (N = 97) (R2 = 0.19) 

Bulimic symptoms, β (SE β), β −1.22 (0.76), -0.17 (P = NS) 

Depression, β (SE β), β 1.26 (0.54),0.24 (P < 0.5) 

Baseline body dissatisfaction, β (SE β), β: 1.54 (0.47), 0.35 (P < 0.01) 

Regression analyses for depression and body dissatisfaction 

Baseline concurrent (N = 101) (R@ = 0.09), β = 0.33 (P < 0.01) 

Depression on Body Dissatisfaction, β (SE β): 0.27 (0.08) 

Body dissatisfaction on Depression, β (SE β): 0.35 (0.11) 

FU concurrent (N = 97) (R2 = 0.19) β = −0.44 (P < 0.001)

Depression on Body Dissatisfaction, β (SE β): 0.08 (0.02) 

Body dissatisfaction on Depression, β SE β: 2.45 (0.51) 

Prospective – baseline to FU (N = 97) 

Depression on Body Dissatisfaction (controlling for baseline depression, 

R2, = 0.08 β (SE β) β: 0.08, 0.01 (0.08), 0.01 (P = NS) 

Body dissatisfaction on Depression (controlling for baseline body 

dissatisfaction), R2 = 0.016, β (SE β) β: 1.04 (0.52), 0.20 (P < 0.05) 
C-988 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other 

Characteristics Quality 

Authors, yr: 

Keel, Mitchell, 

Davis et al., 

2000 

Companion 

article: 

Keel et al., 

1999 

Keel, Mitchell, 

Miller et al., 

2000 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

Mean: 11.5 

(1.9) 

To compare 

definitions of 

ED outcome 

found in the 

BN literature 

and to 

determine the 

impact of 

definitions on 

the description 

and prediction 

of outcome. 

Inclusion: 

Met the DSM III criteria for BN and 

the additional criterion of binge 

eating coupled with vomiting or 

laxative abuse at least 3 times each 

wk for 6 mos preceding 

presentation 

Exclusion: 

None 

Recruitment: 

Participation in two previous studies 

on BN (Mitchell, Pyle et al., 1988, 

and Mitchell, Pyle et al., 1990) who 

were initially evaluated at the 

University of Minnesota’s Eating 

Disorders Clinic between 1981-

1987.Subjects from 2 previous 

studies recontacted via letter from 

one of investigators. 

Final participation rate = 80.5% 

No diff in participation rates 

between the 2 studies 

Sample Size: 

Original (N = 222) 

Reasons for loss to FU: 

Not located (confirmed not 

deceased) (N = 22) 

Deceased (N = 1) 

Severely disabled and blind (N = 1) 

Refused (N = 21) 

Did not meet DSM IV criteria for BN 

based on initial assessment and 

SCID-I/P at FU (N = 4) 

Final sample (N = 173) 

Analysis sample size: 

N = 173 

Mean Age 

35.3 (5.1) yrs 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 99%, N = 171 

Not White: 1%, N = 2 

Mean duration of 

FU, yrs (SD): 

11.5 (1.9) 

Education: 

HS: 99% 

College: 30% 

Graduate school:15% 

Ever married: 

75% 

Still in 1st marriage: 

50% 

Vocation: 

Manual labor: < 10% 

Clerical/sales: 26.6% 

Administration: 33.5% 

Professional: < 10% 

Score: 

Fair 

Method of dx: 

DSM IV SCID-I/P 

for Axis I 

disorders + 

addendum for 

impulse control 

disorders at FU. 

Funding: 

McKnight Center 

Grant for Eating 

Disorders 

Research, NIH 

Obesity Center; 

NIMH; American 

Psychological 

Association; 

Minnesota 

Women 

Psychologists’ 

Association, 

University of 

Minnesota. 
C-989 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study methods 

Definitions of outcome used in different 

studies involving a FU duration of at least 

5 yrs compared. Diffs examined at 10 yr 

FU. 

Defs of outcome varied in 3 ways: 

• Duration of abstinence required for 

full remission or full recovery. 

Required abstinence varied from 2 -

12 mos across studies, with modal 

duration of 2 mos. 

• Number of categories into which 

outcome is placed varies from 2-4 

classifications. 

• How ED outcome categories prior to 

performing statistical analyses 

combined. 

Outcome measures: 

1.Hsu and Sobkiewicz (1989): Full 

recovery (no binge eating or purging over 

previous six mos) 

2. Fallon et al. (1991): Full recovery 

(Psychiatric Status Rating < 3 for 8 

consecutive wks) 

3. Collings and King (1994): Full recovery 

(no symptoms during 12 mos preceding 

assessment 

4. Fairburn et al. (1995): No ED or 

EDNOS of clinical severity that does not 

meet criteria for AN or BN 

5. Reiss and Johnson-Sabine et al. 

(1995): Good outcome (not bingeing 

and/or vomiting/ purging at all or doing so 

< 1x/mo)/ Keel et al. (1999): Full 

remission – narrow (no binge eating or 

purging over previous 6 mos and wt and 

shape cannot unduly influence selfevaluation), broad (Psychiatric Status 

Rating < 3 over 8 consecutive wks); 

partial remission (less remitted than full 

remission but more remitted than 

EDNOS)/ Abraham (1998): Recovered 

(did not meet DSM IV criteria for AN, BN, 

or EDNOS) 

6. Herzog (1999): Full recovery (episode 

is over if psychiatric status rating is less 

than 5 for 8 consecutive wks (or less than 

8 consecutive wks at psychiatric status 

rating < 3) 

Descriptive Results: 

Full recovery ranged across defs from 47% to 38% in this sample 

in a linear relationship with required duration of abstinence (P = 0.01). 

For every add mo of abstinence required for full recovery, approx 1% of

women reclassified from fully to partially remitted. Diffs in def affected 

description of outcome for 9% of the sample (N = 16). 

At the trend level, a lifetime hx of substance use disorders was 

consistently associated with ED outcome (P < 0.10). There were no other 

consistent prognostic variables across studies. 

Associations between other outcomes variables and ED outcomes 

across definitions of ED outcome: 

Depression: 

1. (P = 0.04) 2. (P < 0.001) 3. (P = 0.05) 

4. (P = 0.003) 5. (P < 0.001) 6. (P = 0.02) 

Affective: 

1. (P = 0.09) 2. (P < 0.001) 3. (P = 0.02) 

4. (P < 0.001) 5. (P < 0.001) 6. (P = 0.03) 

Substance use: 

1. (P = 0.09) 2. (P < 0.001) 3. (P = 0.02) 

4. (P < 0.001) 5. (P < 0.001) 6. (P = 0.03) 

Current therapy: 

1. (P = NS) 2. (P = NS) 3. (P = 0.008) 

4. (P = NS) 5. (P = 0.002) 6. (P = 0.04) 

Current meds: 

1. (P = 0.01) 2. (P < 0.001) 3. (P = NS) 

4. (P = 0.001) 5. (P = 0.002) 6. (P = 0.007) 

Body mass index: 

1. (P = NS) 2. (P = NS) 3. (P = NS) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Body image: 

1. (P < 0.001) 2. (P < 0.001) 3. (P < 0.001) 

4. (P < 0.001) 5. (P < 0.001) 6. (P < 0.001) 

Impulse control: 

1. (P = 0.02) 2. (P < 0.001) 3. (P = 0.02) 

4. (P = 0.01) 5. (P = 0.01) 6. (P = 0.01) 

Social adjustment: 

1. (P < 0.001) 2. (P < 0.001) 3. (P < 0.001) 

4. (P = 0.001) 5. (P < 0.001) 6. (P < 0.001) 
C-990 

Evidence Table. Authors: Keel, Mitchell, Davis et al., 2000 (LR/JS) (BN) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Keel, Mitchell, 

Davis et al., 

2000 

(continued) 

 
C-991 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Measures: 

• Hamilton Depression Rating Scale 

• Structured Clinical Interview for the 

DSM IV Axis I Disorders 

• Body Shape Questionnaire 

• SAS-SR 

• Control Scale of the Multidimensional 

Personality Questionnaire (MPQ-8) 

• Eating Disorders Questionnaire 

Analytic Strategy: 

All analyses performed with all available 

data. The specific analytic strategies 

utilized not reported. 

Associations between prognostic variables and ED outcomes 

across definitions of outcome: 

Depression: 

1. (P = NS) 2. (P = NS) 3. (P = NS) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Affective disorder: 

1. (P = 0.007) 2. (P = NS) 3. (P = 0.002) 

4. (P = NS) 5. (P = NS) 6. (P = 0.05) 

Substance use: 

1. (P = NS) 2. (P = 0.004) 3. (P = 0.04) 

4. (P = 0.005) 5. (P = 0.01) 6. (P = NS) 

Hx of AN: 

1. (P = NS) 2. (P = NS) 3. (P = NS) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Personality disorder: 

1. (P = NS) 2. (P = NS) 3. (P = NS) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Tx: 

1. (P = NS) 2. (P = NS) 3. (P = NS) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Age of onset: 

1. (P = NS) 2. (P = 0.05) 3. (P = NS) 

4. (P = 0.027) 5. (P = NS) 6. (P = NS) 

Age of present: 

1. (P = NS) 2. (P = NS) 3. (P = 0.001) 

4. (P = NS) 5. (P = NS) 6. (P = 0.009) 

Severity of symptoms: 

1. (P = NS) 2. (P = NS) 3. (P = 0.02) 

4. (P = NS) 5. (P = NS) 6. (P = NS) 

Duration of symptoms: 

1. (P = 0.004) 2. (P = NS) 3. (P = 0.01) 

4. (P = NS) 5. (P = NS) 6. (P = 0.009) 
C-992 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Keel et al., 

1999 

Companion 

article: 

Keel, Mitchell, 

Miller et al., 

2000 

Keel, Mitchell, 

Davis et al., 

2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

Mean duration 

of FU 11.5 

(1.9) 

To determine 

and describe 

predictive 

factors of longterm outcome 

for females 

with BN 

Inclusion:. 

At baseline, participants 

needed to meet DSM III 

criteria for BN and also needed 

to purge ≥ 3 times/wk during 6 

mos prior to baseline 

evaluation; needed to meet 

criteria for past BN on SCIDI/P at FU evaluation. 

Exclusion: 

NR 

Recruitment: 

Participation in two previous 

studies on BN (Mitchell, Pyle 

et al., 1988, and Mitchell, Pyle 

et al., 1990) who were initially 

evaluated at the University of 

Minnesota’s Eating Disorders 

Clinic between 1981-

1987.Subjects from 2 previous 

studies recontacted via letter 

from one of investigators. 

Final participation rate = 

80.5% 

No diff in participation rates 

between the 2 studies 

Sample Size: 

Original (N = 222) 

Not located (confirmed not 

deceased) (N = 22) 

Deceased (N = 1) 

Severely disabled and blind 

(N = 1) 

Refused (N = 21) 

Did not meet DSM IV criteria 

for BN based on initial 

assessment and SCID-I/P at 

FU (N = 4) 

Final sample (N = 173) 

Analysis sample size: 

N = 173 but varies based on 

completion of scales. 

Scales had to be 80% 

complete for inclusion. 

Mean Age 

35.3 (5.1) yrs 

Duration of FU: 

11.5 (1.9) 

Mean age at onset: 

16.8 (2.5) 

Sex: 

Female: 100% 

Race/ethnicity: 

White: 99% 

Not White: 1% 

Education: 

HS: 99% 

College: 30% 

Graduate sch: 15% 

Ever married: 75% 

Still in 1st marriage: 50% 

Vocation: 

Manual labor: < 10% 

Clerical/sales: 26.6% 

Administration: 33.5% 

Professional: 

< 10% 

Score: 

Fair 

Method of dx: 

DSM IV SCID-I/P 

for Axis I 

disorders + 

addendum for 

impulse control 

disorders at FU. 

Funding: 

McKnight Center 

grant for Eating 

Disorders 

Research; 

Obesity Center 

grant P30 

DK50456, NIH; 

research training 

grant, dissertation 

grants from APA 

and Minnesota 

Women 

Psychologists’ 

Assoc., 

dissertation 

fellowshipfrom U 

of Minn 
C-993 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods 

Questionnaires sent by mail: 

Eating Disorders Questionnaire, 

Hamilton Depression Rating Scale, 

Hamilton Anxiety Rating Scale, 

Multidimensional Personality 

Questionnaire Scale 8: 

Control/Impulsiveness, 

Body Shape Questionnaire 

Personal interview conducted either at 

the Eating Disorders Research Office or 

at home (54%), or over phone (46%). 

Structured interviews (DSM IV SCIDI/P) conducted by authors or trained 

research assistants. 

Outcome definitions 

Full Remission: 

Narrow definition: freedom from 

disordered eating for at least 6 mos; wt 

and shape could not unduly influence 

how subject felt about or evaluated 

herself 

Broad definition: absence from 

disordered eating for at least 8 wks with 

no restrictions based on influence of wt 

or shape on self-evaluation. 

Partial remission: not meeting criteria for 

full remission and not meeting DSM IV 

criteria for any ED 

Analytic Methods 

Parametric and nonparametric tests 

used to assess diff in means and 

proportions. Due to large # of tests, sig 

level = α < 0.01 and family-wise error 

controlled with Dunn test corrections. 

Outcomes 

Measured both categorically (remission 

– full and partial – or not in remission) 

and continuously (log of the number of 

mos since last binge/purge episode) 

Duration of FU between 2 subsamples 

not different for categorical variables 

(P = 0.09), but sig different (P = 0.005) 

for continuous variables so continuous 

prognostic variables controlled for the 

variance explained by duration of FU. 

Eating Disorder Outcome did not differ 

based on the narrow (P = NS) or full 

(P = NS) defs of remission or on # of 

mos since last ED symptom. 

Descriptive Results: 

Outcome for total population: 

AN: 1 (0.6%) 

BN: 19 (11%) 

BED: 1 (0.6%) 

EDNOS: 31 (17.9%) 

By narrow def of remission 

Full remission: 72 (41.6%) 

Partial remission: 49 (28.3%) 

By broad def of remission 

Full remission: 81 (46.8%) 

Partial remission: 40 (23.1%) 

Comparisons of wt variables measured at Baseline and FU: 

Change in BMI: 

Baseline: 21.2 (2.7) 

FU: 22.1 (3.6) 

(P < 0.001)

Change in actual wt: 

Baseline: 58.3 (8.5) 

FU: 60.7 (10.9) 

(P < 0.01)

Change in desired wt: 

Baseline: 53.1 (5.2) 

FU: 56.5 (6.2) 

(P < 0.001)

Change in highest wt: 

Baseline: 66.38 (11.43) 

FU, 69.79 (13.18) 

(P < 0.001) 

Change In lowest wt: 

Baseline 50.91 (7.38) 

FU: 50.91 (8.07) (P = NS) 

Change in wt not clinically sig due to aging of the sample 

Body Shape Questionnaire 

FU: Mean score = 86.8 (36.7) 

Compared to a community sample of 535 women: 81.5 (28.4) (P = NS) 

Compared to cohort with BN: 136.9 (22.5) (P < 0.001) 

Subjects with ED at FU had higher BSQ scores at FU (categorical) 

(P < 0.001), continuous (P < 0.001) 

Prognostic Factors for ED outcome (measured categorically and 

continuously): 

Remission: N = 121 

Disordered eating: N = 52 

Outcome analysis measurement approach: 

Cat: categorical 

Con: continuous 

Both: measured both ways 

Age of onset: 

16.8 (2.5) yrs 

Both (P = NS)
C-994 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Keel et al., 

1999 

(continued) 

This page intentionally left blank. 
C-995 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Duration of symptoms at baseline: 

5.9 (3.6) yrs 

Both (P < 0.01) 

Baseline severity of ED symptoms: 

Both (P = NS)

AN prior to BN: 

Cat (P = NS) 

Lifetime Mood Disorder 

Remission: 62.8% 

Disordered eating: 71.2% 

Both (P = NS) 

Baseline Depression 

Remission: 7.7% 

Disordered eating: 8.0% 

Both (P = NS) 

Lifetime Anxiety Disorder 

Remission: 29.8% 

Disordered eating: 34.6% 

Both (P = NS) 

Baseline Anxiety Disorder 

Remission: 4.6% 

Disordered eating: 6.1% 

Both (P = NS) 

Lifetime Substance Use 

Remission: 53.8% 

Disordered eating: 74.0% 

Cat (P < 0.05); Con (P < 0.01) 

Baseline Substance Use 

Remission: 19.2% 

Disordered eating: 43.8% 

Cat (P < 0.05); Con (P < 0.001) 

Lifetime Impulse Control 

Remission: 16.5% 

Disordered eating: 21.2% 

Both (P = NS) 

Baseline Impulse Control 

Remission: 46.3% 

Disordered Eating: 58.1% 

Both (P = NS) 

Multidimensional Personality Questionnaire 

Cross-sectional: 

Cat (P < 0.01); Con (P < 0.05) 

Treatment received in past 

Took meds 

Remission: 

69.4% 
C-996 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Keel et al., 

1999 

(continued) 

This page intentionally left blank. 
C-997 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Disordered eating: 

82.7% 

Cat (P = NS); Con (P < 0.05) 

Therapy in past 

Remission: 95% 

Disordered eating: 94.2% 

Both (P = NS) 
C-998 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Keel, Mitchell, 

Miller et al., 

2000 

Companion 

article: 

Keel et al., 

1999 

Keel, Mitchell, 

Davis et al., 

2000 

Design: 

Case Series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

Mean duration 

of FU: 11.5 

(1.9) 

To investigate 

the predictive 

validity of BN 

as a diagnostic 

category, using 

10+ yr FU data 

in a sample of 

women with 

BN. 

Inclusion: 

Met the DSM III criteria for BN 

and the additional criterion of 

binge eating coupled with 

vomiting or laxative abuse at 

least 3 times each wk for 6 

mos. 

Exclusion: 

None 

Recruitment: 

Participation in two previous 

studies on BN (Mitchell, Pyle 

et al., 1988, and Mitchell, Pyle 

et al., 1990) who were initially 

evaluated at the University of 

Minnesota’s Eating Disorders 

Clinic between 1981-

1987.Subjects from 2 previous 

studies recontacted via letter 

from one of investigators. 

Final participation rate = 

80.5% 

No diff in participation rates 

between the 2 studies 

Sample Size: 

Original (N = 222) 

Reasons for loss to FU: 

Not located (confirmed not 

deceased) (N = 22) 

Deceased (N = 1) 

Severely disabled and blind (N 

= 1) 

Refused (N = 21) 

Did not meet DSM IV criteria 

for BN based on initial 

assessment and SCID-I/P at 

FU (N = 4) 

Final sample (N = 173) 

Analysis sample size: 

N = 173 

Mean Age 

35.3 (5.1) 

Sex: 

Female: 100% 

Race/ethnicity: 

Caucasian (N = 176) 

98.9% 

Non-caucasian (N = 1) 

1% 

Mean duration of FU, 

yrs (SD): 

11.5 (1.9) 

Score: 

Fair 

Method of dx: 

DSM IV SCID-I/P

for Axis I disorders 

+ addendum for 

impulse control 

disorders at FU. 

Funding: 

McKnight Grant, 

Obesity Center 

grant from National 

Institute of 

Diabetes and 

Digestive and 

Kidney Diseases, 

NIMH grant, and 

dissertation grants 

from the American 

Psychological 

Association, the 

Minnesota Women 

Psychologists’ 

Association, and 

the University of 

Minnesota 
C-999 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

Participants completed the SCID-I for 

DSM IV Axis I Disorders and the HRSD. 

Outcomes: 

ED outcome was defined both as 

categorical and continuous variables. 

Categorical def: distinguished between 

those who met DSM IV criteria for an ED 

and those free from recurrent ED 

symptoms 1 mo prior to assessment. 

Continuous def: natural log of mos 

between most recent binge or purge 

episode and assessment. 

Analytic Strategy: 

Chi Square and t-tests. Tests were twotailed with an alpha of 0.01. 

Descriptive: 

At FU, 19 (11.0%) met BN criteria 

62 (35.8%) had a lifetime hx of AN 

1 had current AN. 

19 (11.0% of total sample) had a lifetime hx of BED 

1 had current BED. 

32 (18.5% of total sample) had current EDNOS. EDNOS was most 

common ED at FU (P < 0.001); Among these women, recurrent bingepurge episodes or purging alone were sig more common than recurrent 

binge eating alone (P = 0.01). 

Relation of ED Outcome to Axis I Disorders at 10-Yr FU: 

ED measured as categorical variable (Remitted versus Present) 

Remitted: N = 121; Present: N = 52 

Mood Disorder: 

Remitted: 2 (1.7%); Present: 11 (21.2%) (P < 0.001) 

Anxiety Disorder: 

Remitted: 20 (16.5%); Present: 6 (11.5%) (P = NS) 

Substance Disorder: 

Remitted: 1 (0.08%); Present: 8 (15.4%) (P < 0.001) 

Impulse Control Disorder: 

Remitted: 2 (1.7%); Present: 9 (17.3%) (P < 0.001) 

Mood disorders and HDRS scale scores: 

Data: NR (P = 0.002) 

ED measured as continuous variable (natural log of mos between 

most recent binge/purge episode and assessment): 

Mood Disorder: 

Axis I Absent: 2.6 (2.0%); Axis I Present: 0.4 (1.3%) (P < 0.001) 

Anxiety Disorder: 

Axis I Absent: 2.3 (2.0%); Axis I Present: 2.9 (2.0%) (P = NS) 

Substance Disorder: 

Axis I Absent: 2.5 (2.0%); Axis I Present: 0.2 (0.5%) (P < 0.001) 

Impulse Control Disorder: 

Axis I Absent: 2.5 (2.0%); Axis I Present: 0.5 (1.3%) (P < 0.001) 

Mood disorders and HDRS scale scores: 

Data: NR (P = 0.01) 
C-1000 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Patton, 1988 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

United 

Kingdom 

Yrs followed, 

mean (SD): 

AN: 7.6 (3.0) 

BN: 5.7 (2.1) 

Range: 4-15 

Calculate a 

standardized 

mortality rate 

for eating 

disorders in a 

large 

population 

Inclusion: 

Eating disorder dx 

AN (Russell, 1970): 

Loss of 25% of BW 

Amenorrhea 

Fear of putting on wt 

BN (Russell, 1979): 

Uncontrollable urge to 

overeat (binge) 

Self-induced vomiting or 

laxative abuse (Purge) 

Feat of becoming fat 

Exclusion: 

NR 

Recruitment: 

Reviewed records of all eating 

disordered patients assessed 

in the eating disorders unit of 

the Academic Department of 

Psychiatry at Royal Free 

Hospital, 1971-81. 

Sample Size: 

Initial: 

N = 481 

Reasons for loss to FU: 

Lost to FU: N = 21 

Deaths: N = 14 

 AN: N = 11 

 Suicide: N = 6 

 Low wt: N = 5 

 BN: N = 3 

 Car accident: N = 2 

 Low wt: N = 1 

Analysis sample: 

Located / Analyzed: N = 460 

 AN: 332 (72.1%) 

 BN: 96 (20.9%) 

 Other: 32 (7.0%) 

Mean Age (yrs): 

AN: 22.4 

BN: 23.5 

Mean Wt (kg): 

AN: 41 

BN: 58.9 

Sex: 

Female: 95.9% 

Male: 4.1% 

Race/ethnicity: 

NR 

Mean Age of Onset 

(yrs): 

AN: 18.9 

BN: 18.6 

Mean Duration of 

Illness (yrs): 

AN: 3.5 

BN: 4.9 

2nd Dx at 

Assessment: 

Depression, N = 52 

AN: N = 26 

BN: N = 26 

Score: 

Fair 

Method of dx: 

Russell diagnostic 

criteria for AN and 

BN applied 

retrospectively to 

case note 

description of 

presentation 

Funding: 

Grant from the 

Wellcome 

Foundation 
C-1001 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study methods 

Attempted to locate by: 

Contact with referring physician 

Last known address 

National Health Service Central Registry 

Located 95.6% 

FU conducted, 1985-86 

Sex specific death rates derived from 

1981 death rates for England and 

Whales 

Analysis methods 

Observed mortality rate (study 

population) 

Expected mortality rate (general 

population) 

Standardized mortality ratio (SMR) = 

observed / expected 

Stepwise linear discriminant function 

analysis: to examine the relationship of 

crude mortality to the prognostic 

variables 

Descriptive Results 

Mortality rate 

Crude mortality rate (%) 

 AN: 3.1 

 BN: 3.3 

Expected mortality rate: 

 AN: 1.83 

 BN: 0.32 

Standardized mortality rate 

 AN: 6.01 (P < 0.01) Higher than expected 

 BN: 9.38 (P = NS) 

AN mortality rate (by length of FU): 

Actual mortality 

 Overall: 11 

 After 4 yrs: 6 

 After 8 yrs: 1 

Expected mortality rate 

 Overall: 1.83 

 After 4 yrs: 1.04 

 After 8 yrs: 0.37 

Standardized mortality rate 

 Overall: 6.01 (P < 0.01) Higher than expected 

 After 4 yrs: 5.76 (P < 0.05) Higher than expected 

 After 8 yrs: 2.70 (P = NS) 

Predictors of mortality in individuals with AN 

wt < 35 kg at presentation: 

 Crude (%): 8.1 (N = 5) 

 Expected: 0.33 

 Standardized: 15.15 (P < 0.05) Higher than expected 

More than one inpatient admission: 

 Crude (%): NR 

 Expected: NR 

 Standardized: NR (P < 0.01) Higher than expected 

Age < 20 yrs at presentation: 

 Crude (%): 2.8 (N = 4) 

 Expected: 0.41 

 Standardized: 9.76 (P = NS)

Age 20-29 yrs at presentation: 

 Crude (%): 2.9 (N = 4) 

 Expected: 0.56 

 Standardized: 7.09 (P = NS)

Age ≤ 30 yrs at presentation: 

 Crude (%): 6.0 (N = 3) 

 Expected: 0.86 

 Standardized: 3.49 (P = NS)
C-1002 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Stice and 

Fairburn, 2003 

Companion 

article: 

Fairburn et al., 

2000 

Fairburn et al., 

2003 

Design: 

Prospective 

Cohort 

Comparison 

Group: 

No 

Setting: 

United 

Kingdom 

Yrs followed: 

At 15 mo 

intervals for 5 

yrs. 

Final FU: 

5.0 yrs (0.3) 

In an 

independent, 

communitybased sample, 

to replicate the 

validity of the 

prior finding 

that women 

with BN can be 

classified by 

dietary and 

dietarydepression 

subtypes. 

Inclusion: 

Female; met DSM IV criteria 

for BN; provided complete data 

at baseline. 

Exclusion: 

NR 

Recruitment: 

Community-recruited 

Sample Size: 

Baseline: 

(N = 102) 

Reasons for loss to FU: 

NR 

Analysis sample: 

(N = 82) 

Dietary: 

Dietary Restraint (N = 46) 

Dietary-Depressive: Dietary 

Restraint- Depressive Affect 

(N = 36) 

Mean Age: 

23.7 (4.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Social Class 

Social Class I or II 

(high): 47% 

Social Class III (middle): 

45% 

Social Class IV or V 

(low): 9% 

Mean BMI, kg/m2: 

24.3 (4.6) 

Received prior tx for 

ED at baseline: 

27% 

Score: 

Fair 

Method of dx: 

EDE was used to 

asses DSM IV 

criteria. 

Funding: 

Programme Grant, 

Wellcome Principal 

Research 

Fellowship, and 

NIMH Career 

Award 
C-1003 

Evidence Table 16. Bulimia nervosa outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

EDE: to asses BN and attitudinal 

disturbances at each time point; 

Depression was assessed using the BSI 

subscale; the SCID-I assessed current 

disorders at each FU; Robson SelfEsteem scale assessed general self 

worth. 

Statistical Methods 

Iterative cluster analysis of baseline 

scores relating to Restraint, Depression, 

and Self-Esteem Scales used to 

categorize participants as dietary or 

dietary-depression subtypes. 

Chi-square diffs between groups 

Cluster Analysis Results 

Dietary classification: Dietary Restraint (N = 46) 

Dietary-Depressive classification: Dietary Restraint-Depressive Affect 

(N = 36) 

Descriptive Results 

Lifetime psychiatric tx for ED at baseline: 

Dietary: 17.4% 

Dietary-depressive: 38.9% 

Diff between groups RR = 2.24 (P < 0.05) 

Psychiatric tx for ED during FU: 

Dietary: 17.4% 

Dietary-depressive: 30.6% 

Diff between groups RR = 1.76 (P = NS) 

BN symptoms: Persistence of binge eating: 

Dietary: 43.9% 

Dietary-depressive: 67.7% 

Diff between groups RR = 1.54 (P < 0.044) 

BN symptoms: Persistence of compensatory behaviors: 

Dietary: 57.1% 

Dietary-depressive: 60.6% 

Diff between groups RR = 1.06 (P = NS) 

Major depression dx 

Dietary: 60.9% 

Dietary-depressive: 80.6% 

Diff between groups RR = 1.32 (P < 0.05) 

Panic disorder dx 

Dietary: 15.2% 

Dietary-depressive: 33.3% 

Diff between groups RR = 2.19 (P < 0.05) 

OCD dx 

Dietary: 2.2% 

Dietary-depressive: 25.0% 

Diff between groups RR = 11.32 (P < 0.01) 

Social phobia dx 

Dietary: 15.2% 

Dietary-depressive: 33.3% 

Diff between groups RR = 2.19 (P < 0.05) 

Generalized anxiety disorder dx 

Dietary: 10.9% 

Dietary-depressive: 47.2% 

Diff between groups RR = 4.33 (P < 0.001) 

Agoraphobia dx 

Dietary: 4.3% 

Dietary-depressive: 36.1% 

Diff between groups RR = 8.39 (P < 0.001) 
C-1004 

Evidence Table 17. BED outcomes 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Busetto et al., 

2005 

Design: 

Case series 

Comparison 

Group: 

Yes 

Location: 

Padova, Italy 

Yrs followed: 

5 

To investigate 

5 yr outcome 

of morbidly 

obese patients 

with BED 

treated 

surgically with 

LAGB. 

Inclusion: 

Cases: BED dx based on 

proposed diagnostic 

criteria of DSM IV 

Comparisons: Obese 

non-BED patients selected 

according to the inclusion 

criteria standardized by 

the NIH for obesity. 

Exclusion: 

NR 

Recruitment of cases 

and comparisons: 

Homogeneous cohort of 

morbidly obese patients 

who underwent LAGB 

surgery at the University of 

Padova between January 

1996 and December 1998. 

Sample Size: 

379 morbidly obese 

patients 

Including: 

• Cases (BED): N = 130 

• Comparisons (No 

BED): N = 249 

Age, mean (SD): 

Cases: 36.0 (10.3) 

Comparisons: 38.3 (10.9) 

(P < 0.05) 

Height, m, mean (SD): 

Cases: 1.66 (0.09) 

Comparisons: 1.66 (0.09) 

(P = NS) 

Wt, kg mean (SD): 

Cases: 129.4 (23.9) 

Comparisons: 132.2 

(24.2) 

(P = NS) 

BMI, kg/m2, mean (SD): 

Cases: 47.6 (7.4) 

Comparisons: 46.6 (7.3) 

(P = NS) 

Female Sex (%): 

Cases: 72.9 

Comparisons: 71.5 

(P < 0.05) 

Race/ethnicity: 

NR 

Family hx of obesity 

(%): 

Cases: 65.4 

Comparisons: 62.2 

(P = NS) 

Current smokers (%): 

Cases: 39.2 

Comparisons: 36.5 

(P = NS) 

Eating behavior 

Sweet eating (%) 

Cases: 43.8 

Comparisons: 43.8 

(P = NS) 

Night eating (%) 

Cases: 10.8 

Comparisons: 0.8 

(P < 0.001) 

Grazing (%) 

Cases: 49.2 

Comparisons: 32.5 

(P < 0.01) 

Score: 

Fair 

Method of dx: 

Independent clinical 

interviews 

Funding: 

NR 
C-1005 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

All participants underwent the same LAPD 

surgery, and followed the same modified 

liquid diet for 4 wks, followed by a solid 

food diet. Band adjustments were not 

performed before 3 mos post-surgery. All 

patients with BED received brief course of 

psychological therapy before LAGB and 

psychological support was offered as 

needed during FU. 

Statistical Methods: 

Paired t-test for comparisons of pre- and 

post-surgery. 

t-tests and Chi-square tests for 

comparisons across groups 

Descriptive Results: 

Diff % excess wt loss (EWL) at any time after surgery (P = NS)

5 yr FU: 

% of patients with % EWL >50%: 

Cases: 23.1% 

Comparisons: 25.7% 

(P = NR) 

% patients with %EWL < 20%: 

Cases: 23.8% 

Comparisons: 24.1% 

Diff between groups (P = NR) 

% of patients with wt regain (at least 20% of baseline excess wt): 

Cases: 20.8% 

Comparisons: 22.5% 

(P = NR) 

Postoperative complications at FU: 

Band-related complications 

Stoma Stenosis: 

Cases: 34/130 (26.2%) 

Comparisons: 65/249 (26.1%) 

(P = NS) 

Pouch Dilatation 

Cases: 33/130 (25.4%) 

Comparisons: 44/249 (17.7%) 

(P = 0.05) 

Esophageal Dilatation 

Cases: 13/130 (10.0%) 

Comparisons: 12/249 (4.8%) 

(P = 0.05) 

Stomach Slippage: 

Cases: 11/130 (8.5%) 

Comparisons: 13/249 (5.2%) 

(P = NS) 

Erosion 

Cases: 1/130 (0.8%) 

Comparisons: 3/249 (1.2%) 

(P = NS) 

Port-related complications: 

Port Leakage 

Cases: 40/130 (30.8%) 

Comparisons: 68/249 (27.3%) 

(P = NS) 

Port twisting 

Cases: 1/130 (0.08%) 

Comparisons: 1/249 (0.4%) 

(P = NS) 
C-1006 

Evidence Table 17. BED outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and Other 

Characteristics Quality 

Authors, yr: 

Busetto et al., 

2005 

(continued) 

 
C-1007 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Port Infection 

Cases: 2/130 (1.5%) 

Comparisons: 1/249 (0.4%) 

(P = NS) 

Revisional surgery requested related to pouch dilatation: 

Cases: 33.3% 3 

Comparisons: 4.1% 

(P = NS) 

Revisional surgery requested in cases of esophageal dilatation: 

Cases: 23.1% 

Comparisons: 8.3% 

(P = NS) 

Revisional Surgery: 

Cases: 15 (11.5%) 

Comparisons: 22 (8.8%) 

(P = NS) 

Band removed: 

Cases: 7 (5.4%) 

Comparisons: 9 (3.6%) 

(P = NS) 

Band repositioned: 

Cases: 7 (5.4%) 

Comparisons: 11 (4.4%) 

(P = NS) 

Revised to a secondary operation. 

Cases: 2 (0.8%) 

Comparisons: 11 (4.4%) 

(P = NS) 

Minor portrelated surgery: 

Cases: 28 (21.5%) 

Comparisons: 54 (21.7%) 

(P = NS) 

Postoperative band adjustments: 

Cases 3.0 (2.1) 

Comparisons 2.6 (1.9) 

(P = 0.05) 

Max band fill-volume after surgery: 

Cases: 3.2 (1.2) 

Comparisons: 2.8 (1.3) 

(P < 0.01) 
C-1008 

Evidence Table 17. BED outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter, 

Quadflieg, and 

Gnutzmann, 

1998 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

Upper Bavaria, 

Germany 

Yrs followed, 

mean (SD): 

3.2 (0.8) and 

6.6 (0.9) yrs 

after tx. 

To assess 3 

and 6 yr 

course and 

outcome of 

treated 

females with 

BED. 

Inclusion: 

DSM IV criteria for BED 

Exclusion: 

NR 

Recruitment: 

Of the 635 consecutive 

admissions for inpatient tx 

to Hospital for Behavioral 

Medicine at the Klinik 

Roseneck in Upper 

Bavaria, Germany, 68 met 

criteria. 

Sample Size: 

Initial Sample 

N = 68 

3 yr FU: 

Answered questionnaires: 

61 (89.7%) 

Short telephone interview: 

2 (2.9%); Could not be 

reached: 4 (5.9%) 

Refused: 1 (1.5%) 

6 yr FU: 

N = 62 

Death: 1 (1.5%) (due to 

extrauterine pregnancy). 

Reassessed: 67 

(questionnaire and 

interview = 53; 

questionnaire and short 

interview = 1; interview = 

9; short interview = 4) 

Age at Admission, yrs, 

mean (SD): 

29.3 (8.4) 

Age of Onset, yrs, 

mean (SD): 

17.7 (8.9) 

Sex: 

Female: 100% 

Race/ethnicity: 

NR 

Duration of tx, days, 

mean (SD): 

76.7 (40) 

Duration of eating 

disturbance, ys, mean 

(SD): 

11.6 (7.3) 

Education, N (%): 

< 9 yrs: 3 (4.4%) 

At least 9 yrs: 52 

(76.5%) 

At least 13 yrs: 10 

(14.8%) 

University degree: 3 

(4.4%) 

Axis IV (severity of 

psychosocial 

stressors) at 

admission, N (%): 

Unspecified: 2 (3.1%) 

None: 2 (3.1%) 

Minimal: 5 (7.7%) 

Mild: 18 (27.7%) 

Moderate: 20 (30.8%) 

Severe: 14 (21.5%) 

Extreme: 3 (4.6%) 

Catastrophic: 1 (1.5%) 

Axis V (highest level 

of adaptive function 

for mos before 

admission, N (%): 

Superior: 0 

Very good: 2 (3.1%) 

Good: 11 (16.9%) 

Satisfactory: 27 (41.5%) 

Poor: 23 (35.4%) 

Very Poor: 2 (3.1%) 

Grossly Impaired: 0 

Score: 

Fair 

Method of dx: 

Self ratings on admission 

and discharge. 

Questionnaire used to 

determine DSM IV 

categories for BED, 

supplemented by patient 

charts and therapist dx. 

Funding: 

German 

Bundesministerium fur 

Bildung, Forschung and 

Technologie (BMBF) and 

Wilhelm-Sander-Stiftung, 

Munich, Germany 
C-1009 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic 

Strategy Main Outcomes and Results 

Study Methods: 

Tx: inpatient, behaviorally oriented 

tx. 

Assessments at admission, 

discharge, 3 yr (questionnaire), and 

6 yr (questionnaire and phone 

interview) 

Analytic Strategy: 

MANOVA with repeated measures. 

For longitudinal comparisons, only 

sets of data complete for all time 

points were analyzed. Wilcoxon 

matched-pair tests used when 

appropriate. 

Codes used: 

BT = Before Therapy 

B: Beginning of therapy 

E: End of therapy 

F3: 3 yr FU 

F6: 6 yr FU 

Discharge, N (%): 

Regular: 60 (89.6%) 

Discontinued tx prematurely: 1 (1.5%) 

Discharged prematurely: 2 (3.0%) 

Discharged prematurely by mutual agreement with patient: 4 (6.0%) 

Discharge ratings by therapists, N (%): 

Sigly improved: 11 (16.4%) 

Markedly improved: 37 (55.2%) 

Slightly Improved: 16 (23.9%) 

Unchanged: 2 (3.0%) 

Slightly worse: 1 (1.5%) 

Met criteria for BN at 6 yr FU: N = 5 

BMI, kg/m2

, mean (SD): 

B: 33.7 (9.0) 

E: 31.9 (8.7) 

F3: 31.9 (9.9) 

F6: 32.7 (10.1) 

Change over time (P = NR) 

BMI in 44 obese patients (BMI ≥ 30) at B, kg/m2

, mean (SD) 

B: 39.0 (6.8) 

E: 36.9 (6.8) 

F3: 37.0 (8.2) 

F6: 38.3 (8.1) 

Change over time (P = NR) 

Structured Interview for Anorexic and Bulimic Syndromes (SIAB) (N = 53): 

SIAB Depression Scale, mean (SD): 

BT: 2.32 (1.0) 

B: 2.33 (0.9) 

E: 1.48 (0.9) 

F3: 1.71 (0.9) 

F6 (expert rating): 0.94 (0.8) 

Change over time in BT vs E and F6 (P < 0.001); vs. F3 (P < 0.01) 

Change over time in B vs E, F3, and F6 (P < 0.001) 

Change over time in E vs F6 (P < 0.001) 

Change over time in F3 vs F6 (P < 0.001) 

SIAB Anxieties and Obsessions Scale, mean (SD): 

BT: 1.32 (0.9) 

B: 1.31 (0.8) 

E: 0.76 (0.7) 

F3: 1.00 (0.7) 

F6 (expert rating): 0.46 (0.4) 

Change over time in BT vs E and F6 (P < 0.001); vs F3 (P < 0.05) 

Change over time in B vs E and F6 (P < 0.001); vs F3 (P < 0.01) 

Change over time in E vs F3 (P < 0.01); vs F6 (P < 0.001) 

Change over time in F3 vs F6 (P < 0.001) 
C-1010 

Evidence Table 17. BED outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter, 

Quadflieg, and 

Gnutzmann, 

1998 

(continued) 

 
C-1011 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

SIAB Bulimic Behavior, mean (SD): 

BT: 1.60 (0.6) 

B: 1.48 (0.5) 

E: 1.08 (0.4) 

F3: 1.21 (0.6) 

F6 (expert rating): 0.81 (0.6) 

Change over time in BT vs E and F6 (P < 0.001); vs F3 (P < 0.01) 

Change over time in B vs E, F3, and F6 (P < 0.001) 

Change over time in E vs F6 (P < 0.001) 

Change over time in F3 vs F6 (P < 0.001) 

SIAB Laxative Abuse, mean (SD): 

BT: 1.39 (1.3) 

B: 0.82 (0.9) 

E: 0.66 (0.9) 

F3: 0.38 (0.8) 

F6 (expert rating): 0.23 (0.6) 

Change over time in BT vs B, E, and F3 (P < 0.001) 

Change over time in B vs F3 (P < 0.01) 

Change over time in B vs F6 (P < 0.01) 

Diagnostic outcome at 6 yrs, N (%): 

BED: 4 (5.9%) 

BN, purging type: 5 (7.4%) 

EDNOS: 5 (7.4%) 

No ED: 53 (77.9%) 

Outcomes at 6 yr FU (N = 62): 

Body wt, N (%): 

Good: 26 (41.9%) 

Intermediate: 22 (35.5%) 

Poor: 14 (22.6%) 

(P = NR) 

Overconcern with eating and wt, N (%): 

Good: 22 (35.5%) 

Intermediate: 20 (32.3%) 

Poor: 20 (32.3%) 

(P = NR) 

Binge eating: 

Good: 39 (62.9%) 

Intermediate: 13 (21.0%) 

Poor: 10 (16.2%) 

(P = NR) 

Counterregulatory measures, N (%): 

Good: 44 (71.0%) 

Intermediate: 11 (17.7%) 

Poor: 10 (11.3%) 

(P = NR) 

Depression, N (%): 

Good: 35 (56.5%) 

Intermediate: 12 (19.4%) 

Poor: 15 (24.2%) 

(P = NR) 
C-1012 

Evidence Table 17. BED outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Fichter, 

Quadflieg, and 

Gnutzmann, 

1998 

(continued) 

 
C-1013 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Obsessions, N (%): 

Good: 49 (79.0%) 

Intermediate: 10 (16.1%) 

Poor: 3 (4.8%) 

(P = NR) 

Anxiety, N (%): 

Good: 39 (62.9%) 

Intermediate: 19 (30.6%) 

Poor: 4 (6.5%) 

(P = NR) 

Substance abuse, N (%): 

Good: 58 (93.5%) 

Intermediate: 1 (1.6%) 

Poor: 3 (4.8%) 

(P = NR) 

Sexuality, N (%): 

Good: 24 (38.7%) 

Intermediate: 16 (25.8%) 

Poor: 22 (35.5%) 

(P = NR) 

Social Behavior, N (%): 

Good: 32 (51.6%) 

Intermediate: 15 (24.2%) 

Poor: 15 (24.2%) 

(P = NR) 

Global outcome based on reduced sample (N = 62), N (%): 

Good: 39 (62.9%) 

Intermediate: 21 (33.9) 

Poor: 2 (3.2%) 

(P = NR) 

Global outcome on total sample (N = 68), %: 

Good: 57.4% 

Intermediate: 35.3% 

Poor: 5.9% 

(P = NR) 

Comorbidity at 6 yrs, %: 

Substance use disorder: 9.7% 

Affective disorder: 51.6% 

Anxiety disorder: 40.3% 

Hospitalized in the 6 yr FU period: 

44/67 

Duration of stay, days, mean (SD): 

114 (208) 

Number of admissions, mean (SD): 

1.6 (1.6) 
C-1014 

Evidence Table 17. BED outcomes (continued) 

Study 

Description 

Research 

Objective 

Eligibility Criteria, 

Recruitment and Sample 

Size 

Demographic and 

Other Characteristics Quality 

Authors, yr: 

Wilfley, 

Friedman et 

al., 2000 

Design: 

Case series 

Comparison 

Group: 

No 

Location: 

USA 

Yrs followed: 

1 

To examine 

the relation of 

comorbid Axis 

I and Axis II 

psychopathology on tx 

outcomes at 1 

yr FU among 

BED patients 

Inclusion: 

Participated in an outpatient 

RCT and received either CBT 

or IPT conducted at 2 

outpatient, university-based 

eating disorder clinics, one in 

Northeast and one in 

Southwest 

DSM IV criteria for BED 

ages 18-65 

BMI (kg/m2

):27-48 

Exclusion: 

Inappropriate compensatory 

behaviors; pregnant or 

planning to become pregnant; 

participating in additional 

psychotherapy or wt loss 

programs; currently taking wt 

loss, psychotropic, or wtaffecting prescription meds; 

current drug or alcohol 

dependence; current 

psychiatric conditions 

warranting hospitalization 

Recruitment: 

Newspaper articles and ads 

Sample Size: 

Participated in RCT, N = 162 

# of completers at 1-yr FU: 

NR 

Mean Age (SD): 

45.2 (9.6) 

Sex: 

Women: 83% 

Race/ethnicity: 

Caucasian: 93% 

African American: 4% 

Hispanic: 3% 

Native American: 1% 

Marital status: 

Married: 60% 

Single: 15% 

Divorced: 24% 

Widowed: 2% 

Education (mean): 

15.6 yrs 

Mean Income range: 

$40,000-$50,000 

Comorbid Axis I 

general dx (current): 

Mood disorders: 22% 

Anxiety disorders: 13% 

Substance abuse 

disorders: 4% 

Comorbid Axis I 

general dx (lifetime): 

Mood disorders: 61% 

Anxiety disorders: 29% 

Substance abuse 

disorders: 33% 

Comorbid Axis II: 

Cluster A: 6% 

Cluster B: 12% 

Cluster C: 42% 

Personality disorder 

NOS: 13% 

Avg. BMI (kg/m2

) 

(SD): 

37.1 (5.1) 

Score: 

Good 

Method of dx: 

BED: EDE interview 

Comorbid Axis I and 

Axis II disorders: 

SCID and the SCIDII 

Funding: 

NIMH grants 
C-1015 

Evidence Table 17. BED outcomes (continued) 

Study Methods and Analytic Strategy Main Outcomes and Results 

Study Methods: 

EDE and SCID administered by trained 

and experienced interviewers

Statistical Methods: 

Repeated measures MANOVAs to 

assess whether the presence of Axis I or 

Axis II pathology predicts BED outcome 

at 1-yr FU. 

Dependent variables: 

# of binge days 

EDE Global Scale of Eating 

Psychopathology 

Descriptive Findings 

Mood disorder dx: 

Current: 22% 

Lifetime61% 

Anxiety disorder dx: 

Current: 13% 

Lifetime29% 

Substance abuse dx: 

Current: 4% 

Lifetime33% 

Interaction of Time X presence of Axis I psychopathology (i.e., 

mood, anxiety, and substance abuse disorders) predicting: 

# of binge days (P = NS) 

EDE Global Scale of Eating Psychopathology (P = NS) 

Interaction of Time x Presence of Axis II psychopathology (i.e., 

cluster A, B, and C) predicting: 

# of binge day (P = NS) 

EDE Global Scale of Eating Psychopathology (P = NS) 

Interaction of Time X Presence of specific Axis I psychopathology 

predicting: 

# of binge days (P = NS) 

EDE Global Scale of Eating Psychopathology (P = NS) 

Interaction of Time X Presence of Axis II Cluster A (Paranoid, 

schizoid, schizotypal) predicting: 

# of binge days (P = NS) 

EDE Global Scale of Eating Psychopathology (P = NS) 

Interaction of Time X Presence of Axis II Clusters B (narcissistic, 

borderline, histrionic, antisocial) predicting: 

# of binge days (P = 0.022) Those with Cluster B > # of binge days 

EDE Global Scale of Eating Psychopathology (P = NS) 

Interaction of Time X Presence of Axis II Cluster C (dependent, 

obsessive-compulsive, avoidant, passive-aggressive) predicting: 

# of binge days (P = NS) 

EDE Global Scale of Eating Psychopathology (P = NS) 
C-1016 

References 

Agras WS, Rossiter EM, Arnow B, et al. 

Pharmacologic and cognitive-behavioral treatment 

for bulimia nervosa: a controlled comparison. Am J 

Psychiatry 1992;149(1):82-7. 

Agras WS, Rossiter EM, Arnow B, et al. One-year 

follow-up of psychosocial and pharmacologic 

treatments for bulimia nervosa. J Clin Psychiatry 

1994;55(5):179-83. 

Agras WS, Schneider JA, Arnow B, et al. Cognitivebehavioral and response-prevention treatments for 

bulimia nervosa. J Consult Clin Psychol 

1989;57(2):215-21. 

Agras WS, Telch CF, Arnow B, et al. Does 

interpersonal therapy help patients with binge eating 

disorder who fail to respond to cognitive-behavioral 

therapy? J Consult Clin Psychol 1995;63(3):356-60. 

Agras WS, Telch CF, Arnow B, et al. Weight loss, 

cognitive-behavioral, and desipramine treatments in 

binge eating disorder: an additive design. Behavior 

Therapy 1994;25:225-38. 

Agras WS, Walsh T, Fairburn CG, et al. A 

multicenter comparison of cognitive-behavioral 

therapy and interpersonal psychotherapy for bulimia 

nervosa. Arch Gen Psychiatry 2000;57(5):459-66 . 

Appolinario JC, Bacaltchuk J, Sichieri R, et al. A 

randomized, double-blind, placebo-controlled study 

of sibutramine in the treatment of binge-eating 

disorder. Arch Gen Psychiatry 2003;60(11):1109-16. 

Arnold LM, McElroy SL, Hudson JI, et al. A 

placebo-controlled, randomized trial of fluoxetine in 

the treatment of binge-eating disorder. J Clin 

Psychiatry 2002;63(11):1028-33. 

Attia E, Haiman C, Walsh BT, et al. Does fluoxetine 

augment the inpatient treatment of anorexia nervosa? 

Am J Psychiatry 1998;155(4):548-51. 

Bailer U, de Zwaan M, Leisch F, et al. Guided selfhelp versus cognitive-behavioral group therapy in the 

treatment of bulimia nervosa. Int J Eat Disord 

2004;35(4):522-37. 

Barbarich NC, McConaha CW, Halmi KA, et al. Use 

of nutritional supplements to increase the efficacy of 

fluoxetine in the treatment of anorexia nervosa. Int J 

Eat Disord 2004;35(1):10-5. 

Ben-Tovim DI, Walker K, Gilchrist P, et al. Outcome 

in patients with eating disorders: a 5-year study. 

Lancet 2001;357(9264):1254-7. 

Beumont PJ, Russell JD, Touyz SW, et al. Intensive 

nutritional counselling in bulimia nervosa: a role for 

supplementation with fluoxetine? Aust N Z J 

Psychiatry 1997;31(4):514-24. 

Biederman J, Herzog DB, Rivinus TM, et al. 

Amitriptyline in the treatment of anorexia nervosa: a 

double-blind, placebo-controlled study. J Clin 

Psychopharmacol 1985;5(1):10-6. 

Birmingham CL, Goldner EM, Bakan R. Controlled 

trial of zinc supplementation in anorexia nervosa. Int 

J Eat Disord 1994;15(3):251-5. 

Birmingham CL, Gutierrez E, Jonat L, et al. 

Randomized controlled trial of warming in anorexia 

nervosa. Int J Eat Disord 2004;35(2):234-8. 

Birmingham C, Su J, Hlynsky J, et al. The mortality 

rate from anorexia nervosa. Int J Eat Disord 

2005;38:143-6. 

Brambilla F, Draisci A, Peirone A, et al. Combined 

cognitive-behavioral, psychopharmacological and 

nutritional therapy in eating disorders. 2. Anorexia 

nervosa--binge-eating/purging type. 

Neuropsychobiology 1995;32(2):64-7. 

Braun DL, Sunday SR, Fornari VM, et al. Bright 

light therapy decreases winter binge frequency in 

women with bulimia nervosa: a double-blind, 

placebo-controlled study. Compr Psychiatry 

1999;40(6):442-8. 

Bulik CM, Sullivan PF, Carter FA, et al. The role of 

exposure with response prevention in the cognitivebehavioural therapy for bulimia nervosa. Psychol 

Med 1998;28(3):611-23. 

Bulik CM, Sullivan PF, Fear JL, et al. Outcome of 

anorexia nervosa: eating attitudes, personality, and 

parental bonding. Int J Eat Disord 2000;28(2):139-

47. 
C-1017 

Bulik CM, Sullivan PF, Joyce PR, et al. Predictors of 

1-year treatment outcome in bulimia nervosa. Compr 

Psychiatry 1998;39(4):206-14. 

Busetto L, Segato G, De Luca M, et al. Weight loss 

and postoperative complications in morbidly obese 

patients with binge eating disorder treated by 

laparoscopic adjustable gastric banding. Obes Surg 

2005;15(2):195-201. 

Carruba MO, Cuzzolaro M, Riva L, et al. Efficacy 

and tolerability of moclobemide in bulimia nervosa: a 

placebo-controlled trial. Int Clin Psychopharmacol 

2001;16(1):27-32. 

Carter FA, McIntosh VV, Joyce PR, et al. Role of 

exposure with response prevention in cognitivebehavioral therapy for bulimia nervosa: three-year 

follow-up results. Int J Eat Disord 2003;33(2):127-

35. 

Carter JC, Fairburn CG. Cognitive-behavioral selfhelp for binge eating disorder: a controlled 

effectiveness study. J Consult Clin Psychol 

1998;66(4):616-23. 

Carter JC, Olmsted MP, Kaplan AS, et al. Self-help 

for bulimia nervosa: a randomized controlled trial. 

Am J Psychiatry 2003;160(5): 973-8. 

Channon S, de Silva P, Hemsley D, et al. A 

controlled trial of cognitive-behavioural and 

behavioural treatment of anorexia nervosa. Behav 

Res Ther 1989;27(5):529-35. 

Chen E, Touyz SW, Beumont PJ, et al. Comparison 

of group and individual cognitive-behavioral therapy 

for patients with bulimia nervosa. Int J Eat Disord 

2003;33(3):241-54; discussion 255-6. 

Cooper PJ, Steere J. A comparison of two 

psychological treatments for bulimia nervosa: 

implications for models of maintenance. Behav Res 

Ther 1995 ;33(8):875-85. 

Crisp AH, Callender JS, Halek C, et al. Long-term 

mortality in anorexia nervosa. A 20-year follow-up of 

the St George's and Aberdeen cohorts. Br J 

Psychiatry 1992;161:104-7. 

Crisp AH, Norton K, Gowers S, et al. A controlled 

study of the effect of therapies aimed at adolescent 

and family psychopathology in anorexia nervosa. Br 

J Psychiatry 1991;159:325-33. 

Crosby RD, Mitchell JE, Raymond N, et al. Survival 

analysis of response to group psychotherapy in 

bulimia nervosa. Int J Eat Disord 1993;13(4):359-68. 

Dancyger IF, Sunday SR, Eckert ED, et al. A 

comparative analysis of Minnesota Multiphasic 

Personality Inventory profiles of anorexia nervosa at 

hospital admission, discharge, and 10-year follow-up. 

Compr Psychiatry 1997;38(3):185-91. 

Dare C, Eisler I, Russell G, et al. Psychological 

therapies for adults with anorexia nervosa: 

randomised controlled trial of out-patient treatments. 

Br J Psychiatry 2001;178:216-21. 

Davis R, McVey G, Heinmaa M, et al. Sequencing of 

cognitive-behavioral treatments for bulimia nervosa. 

Int J Eat Disord 1999;25(4):361-74. 

Deter HC, Herzog W. Anorexia nervosa in a longterm perspective: results of the HeidelbergMannheim Study. Psychosom Med 1994;56(1):20-7. 

Deter HC, Schellberg D, Kopp W, et al. 

Predictability of a favorable outcome in anorexia 

nervosa. Eur Psychiatry 2005;20(2):165-72. 

Durand MA, King M. Specialist treatment versus 

self-help for bulimia nervosa: a randomised 

controlled trial in general practice. Br J Gen Pract 

2003;53(490):371-7. 

Eckert ED, Halmi KA, Marchi P, et al. Ten-year 

follow-up of anorexia nervosa: clinical course and 

outcome. Psychol Med 1995;25(1):143-56. 

Eddy K, Keel P, Dorer D, et al. Longitudinal 

comparison of anorexia nervosa subtypes. Int J Eat 

Disord 2002;31(2):191-201. 

Eisler I, Dare C, Hodes M, et al. Family therapy for 

adolescent anorexia nervosa: the results of a 

controlled comparison of two family interventions. J 

Child Psychol Psychiatry 2000;41(6):727-36. 

Eisler I, Dare C, Russell G, et al. Family and 

individual therapy in anorexia nervosa. A 5-year 

follow-up. Arch Gen Psychiatry 1997;54(11):1025-

30. 

Eldredge KL, Stewart Agras W, Arnow B, et al. The 

effects of extending cognitive-behavioral therapy for 

binge eating disorder among initial treatment 

nonresponders. Int J Eat Disord 1997;21(4):347-52. 
C-1018 

Esplen MJ, Garfinkel PE, Olmsted M, et al. A 

randomized controlled trial of guided imagery in 

bulimia nervosa. Psychol Med 1998;28(6):1347-57. 

Fairburn CG, Cooper Z, Doll HA, et al. The natural 

course of bulimia nervosa and binge eating disorder 

in young women. Arch Gen Psychiatry 

2000;57(7):659-65. 

Fairburn CG, Jones R, Peveler RC, et al. Three 

psychological treatments for bulimia nervosa. A 

comparative trial. Arch Gen Psychiatry 

1991;48(5):463-9. 

Fairburn CG, Jones R, Peveler RC, et al. 

Psychotherapy and bulimia nervosa. Longer-term 

effects of interpersonal psychotherapy, behavior 

therapy, and cognitive behavior therapy. Arch Gen 

Psychiatry 1993;50(6):419-28. 

Fairburn CG, Norman PA, Welch SL, et al. A 

prospective study of outcome in bulimia nervosa and 

the long-term effects of three psychological 

treatments. Arch Gen Psychiatry 1995;52(4):304-12 . 

Fairburn CG, Peveler RC, Jones R, et al. Predictors 

of 12-month outcome in bulimia nervosa and the 

influence of attitudes to shape and weight. J Consult 

Clin Psychol 1993;61(4):696-8. 

Fairburn CG, Stice E, Cooper Z, et al. Understanding 

persistence in bulimia nervosa: a 5-year naturalistic 

study. J Consult Clin Psychol 2003;71(1):103-9. 

Faris PL, Kim SW, Meller WH, et al. Effect of 

decreasing afferent vagal activity with ondansetron 

on symptoms of bulimia nervosa: a randomised, 

double-blind trial. Lancet 2000;355(9206):792-7. 

Fassino S, Leombruni P, Daga G, et al. Efficacy of 

citalopram in anorexia nervosa: a pilot study. Eur 

Neuropsychopharmacol 2002;12(5):453-9. 

Fichter MM, Kruger R, Rief W, et al. Fluvoxamine in 

prevention of relapse in bulimia nervosa: effects on 

eating-specific psychopathology. J Clin 

Psychopharmacol 1996;16(1):9-18. 

Fichter MM, Leibl C, Kruger R, et al. Effects of 

fluvoxamine on depression, anxiety, and other areas 

of general psychopathology in bulimia nervosa. 

Pharmacopsychiatry 1997;30(3):85-92. 

Fichter MM, Leibl K, Rief W, et al. Fluoxetine 

versus placebo: a double-blind study with bulimic 

inpatients undergoing intensive psychotherapy. 

Pharmacopsychiatry 1991;24(1):1-7. 

Fichter MM, Quadflieg N. Six-year course and 

outcome of anorexia nervosa. Int J Eat Disord 

1999;26(4):359-85 . 

Fichter MM, Quadflieg N. Six-year course of bulimia 

nervosa. Int J Eat Disord 1997;22(4):361-84. 

Fichter MM, Quadflieg N. Twelve-year course and 

outcome of bulimia nervosa. Psychol Med 

2004;34(8):1395-406. 

Fichter MM, Quadflieg N, Gnutzmann A. Binge 

eating disorder: treatment outcome over a 6-year 

course. J Psychosom Res 1998;44(3-4):385-405. 

Fluoxetine Bulimia Nervosa Collaborative Study 

Group. Fluoxetine in the treatment of bulimia 

nervosa. A multicenter, placebo-controlled, doubleblind trial. Fluoxetine Bulimia Nervosa Collaborative 

Study Group. Arch Gen Psychiatry 1992;49(2):139-

47. 

Franko DL, Keel PK, Dorer DJ, et al. What predicts 

suicide attempts in women with eating disorders? 

Psychol Med 2004;34(5):843-53. 

Garner DM, Rockert W, Davis R, et al. Comparison 

of cognitive-behavioral and supportive-expressive 

therapy for bulimia nervosa. Am J Psychiatry 

1993;150(1):37-46. 

Geist R, Heinmaa M, Stephens D, et al. Comparison 

of family therapy and family group psychoeducation 

in adolescents with anorexia nervosa. Can J 

Psychiatry 2000;45(2):173-8. 

Gendall KA, Bulik CM, Joyce PR, et al. Menstrual 

cycle irregularity in bulimia nervosa. Associated 

factors and changes with treatment. J Psychosom Res 

2000;49(6):409-15. 

Gillberg C, Råstam M, Gillberg IC. Anorexia 

nervosa: physical health and neurodevelopment at 16 

and 21 years. Dev Med Child Neurol 

1994;36(7):567-75. 

Gillberg IC, Råstam M, Gillberg C. Anorexia nervosa 

6 years after onset: Part I. Personality disorders. 

Compr Psychiatry 1995;36(1):61-9. 

Gillberg IC, Råstam M, Gillberg C. Anorexia nervosa 

outcome: six-year controlled longitudinal study of 51 
C-1019 

cases including a population cohort. J Am Acad 

Child Adolesc Psychiatry 1994;33(5):729-39. 

Goldbloom DS, Olmsted M, Davis R, et al. A 

randomized controlled trial of fluoxetine and 

cognitive behavioral therapy for bulimia nervosa: 

short-term outcome. Behav Res Ther 

1997;35(9):803-11 . 

Goldstein DJ, Wilson MG, Ascroft RC, et al. 

Effectiveness of fluoxetine therapy in bulimia 

nervosa regardless of comorbid depression. Int J Eat 

Disord 1999;25(1):19-27. 

Goldstein DJ, Wilson MG, Thompson VL, et al. 

Long-term fluoxetine treatment of bulimia nervosa. 

Fluoxetine Bulimia Nervosa Research Group. Br J 

Psychiatry 1995;166(5):660-6. 

Gorin A, Le Grange D, Stone A. Effectiveness of 

spouse involvement in cognitive behavioral therapy 

for binge eating disorder. Int J Eat Disord 

2003;33(4):421-33. 

Gowers S, Norton K, Halek C, et al. Outcome of 

outpatient psychotherapy in a random allocation 

treatment study of anorexia nervosa. Int J Eat Disord 

1994;15(2):165-77. 

Gowers SG, Weetman J, Shore A, et al. Impact of 

hospitalisation on the outcome of adolescent anorexia 

nervosa. Br J Psychiatry 2000;176:138-41. 

Griffiths RA, Hadzi-Pavlovic D, Channon-Little L. A 

controlled evaluation of hypnobehavioural treatment 

for bulimia nervosa: immediate pre-post treatment 

effects. Eur Eat Disord Rev 1994;2(4):202-20. 

Grilo CM, Masheb RM, Salant SL. Cognitive 

behavioral therapy guided self-help and orlistat for 

the treatment of binge eating disorder: a randomized, 

double-blind, placebo-controlled trial. Biol 

Psychiatry 2005;57(10):1193-201. 

Grilo CM, Masheb RM, Wilson GT. Efficacy of 

cognitive behavioral therapy and fluoxetine for the 

treatment of binge eating disorder: a randomized 

double-blind placebo-controlled comparison. Biol 

Psychiatry 2005;57(3):301-9. 

Hall A, Crisp AH. Brief psychotherapy in the 

treatment of anorexia nervosa. Outcome at one year. 

Br J Psychiatry 1987;151:185-91. 

Halmi K, Eckert E, Marchi P, et al. Comorbidity of 

psychiatric diagnoses in anorexia nervosa. Arch Gen 

Psychiatry 1991;48:712-8 

Halmi KA, Eckert E, LaDu TJ, et al. Anorexia 

nervosa. Treatment efficacy of cyproheptadine and 

amitriptyline. Arch Gen Psychiatry 1986;43(2):177-

81. 

Halvorsen I, Andersen A, Heyerdahl S. Good 

outcome of adolescent onset anorexia nervosa after 

systematic treatment. Intermediate to long-term 

follow-up of a representative county-sample. Eur 

Child Adolesc Psychiatry 2004;13(5):295-306. 

Hebebrand J, Himmelmann GW, Herzog W, et al. 

Prediction of low body weight at long-term follow-up 

in acute anorexia nervosa by low body weight at 

referral. Am J Psychiatry 1997;154(4):566-9 . 

Hedges DW, Reimherr FW, Hoopes SP, et al. 

Treatment of bulimia nervosa with topiramate in a 

randomized, double-blind, placebo-controlled trial, 

part 2: improvement in psychiatric measures. J Clin 

Psychiatry 2003;64(12):1449-54. 

Herzog DB, Dorer DJ, Keel PK, et al. Recovery and 

relapse in anorexia and bulimia nervosa: a 7.5-year 

follow-up study. J Am Acad Child Adolesc 

Psychiatry 1999;38(7):829-37. 

Herzog DB, Field AE, Keller MB, et al. Subtyping 

eating disorders: is it justified? J Am Acad Child 

Adolesc Psychiatry 1996;35(7):928-36. 

Herzog DB, Greenwood DN, Dorer DJ, et al. 

Mortality in eating disorders: a descriptive study. Int 

J Eat Disord 2000;28(1):20-6. 

Herzog DB, Sacks NR, Keller MB, et al. Patterns and 

predictors of recovery in anorexia nervosa and 

bulimia nervosa. J Am Acad Child Adolesc 

Psychiatry 1993;32(4):835-42. 

Herzog W, Deter HC, Fiehn W, et al. Medical 

findings and predictors of long-term physical 

outcome in anorexia nervosa: a prospective, 12-year 

follow-up study. Psychol Med 1997;27(2):269-79. 

Herzog W, Schellberg D, Deter HC. First recovery in 

anorexia nervosa patients in the long-term course: a 

discrete-time survival analysis. J Consult Clin 

Psychol 1997;65(1):169-77. 
C-1020 

Hilbert A, Tuschen-Caffier B. Body image 

interventions in cognitive-behavioural therapy of 

binge-eating disorder: a component analysis. Behav 

Res Ther 2004;42(11):1325-39. 

Hill K, Bucuvalas J, McClain C, et al. Pilot study of 

growth hormone administration during the refeeding 

of malnourished anorexia nervosa patients. J Child 

Adolesc Psychopharmacol 2000;10(1):3-8. 

Hoopes SP, Reimherr FW, Hedges DW, et al. 

Treatment of bulimia nervosa with topiramate in a 

randomized, double-blind, placebo-controlled trial, 

part 1: improvement in binge and purge measures. J 

Clin Psychiatry 2003;64(11):1335-41. 

Hsu LK, Rand W, Sullivan S, et al. Cognitive 

therapy, nutritional therapy and their combination in 

the treatment of bulimia nervosa. Psychol Med 

2001;31(5):871-9. 

Hudson JI, McElroy SL, Raymond NC, et al. 

Fluvoxamine in the treatment of binge-eating 

disorder: a multicenter placebo-controlled, doubleblind trial. Am J Psychiatry 1998;155(12):1756-62. 

Isager T, Brinch M, Kreiner S, et al. Death and 

relapse in anorexia nervosa: survival analysis of 151 

cases. J Psychiatr Res 1985;19(2-3):515-21. 

Ivarsson T, Råstam M, Wentz E, et al. Depressive 

disorders in teenage-onset anorexia nervosa: a 

controlled longitudinal, partly community-based 

study. Compr Psychiatry 2000;41(5):398-403. 

Johnson C, Tobin DL, Dennis A. Differences in 

treatment outcome between borderline and 

nonborderline bulimics at one-year follow-up. Int J 

Eat Dis 1990;9(6):617-27. 

Jäger B, Liedtke R, Lamprecht F, et al. Social and 

health adjustment of bulimic women 7-9 years 

following therapy. Acta Psychiatr Scand 

2004;110(2):138-45. 

Kanerva R, Rissanen A, Sarna S. Fluoxetine in the 

treatment of anxiety, depressive symptoms, and 

eating-related symptoms in bulimia nervosa. Nord J 

Psychiatry 1994;49(7): 237-42. 

Kaye WH, Nagata T, Weltzin TE, et al. Double-blind 

placebo-controlled administration of fluoxetine in 

restricting- and restricting-purging-type anorexia 

nervosa. Biol Psychiatry 2001;49(7):644-52. 

Keel PK, Mitchell JE, Davis TL, et al. Relationship 

between depression and body dissatisfaction in 

women diagnosed with bulimia nervosa. Int J Eat 

Disord 2001;30(1):48-56. 

Keel PK, Mitchell JE, Davis TL, et al. Impact of 

definitions on the description and prediction of 

bulimia nervosa outcome. Int J Eat Disord 

2000;28(4):377-86. 

Keel PK, Mitchell JE, Miller KB, et al. Long-term 

outcome of bulimia nervosa. Arch Gen Psychiatry 

1999;56(1):63-9. 

Keel PK, Mitchell JE, Miller KB, et al. Predictive 

validity of bulimia nervosa as a diagnostic category. 

Am J Psychiatry 2000;157(1):136-8. 

Keel PK, Dorer DJ, Eddy KT, et al. Predictors of 

mortality in eating disorders. Arch Gen Psychiatry 

2003;60(2):179-83. 

Kennedy SH, Goldbloom DS, Ralevski E, et al. Is 

there a role for selective monoamine oxidase 

inhibitor therapy in bulimia nervosa? A placebocontrolled trial of brofaromine. J Clin 

Psychopharmacol 1993;13(6):415-22. 

Klibanski A, Biller BM, Schoenfeld DA, et al. The 

effects of estrogen administration on trabecular bone 

loss in young women with anorexia nervosa. J Clin 

Endocrinol Metab 1995;80(3):898-904. 

Laederach-Hofmann K, Graf C, Horber F, et al. 

Imipramine and diet counseling with psychological 

support in the treatment of obese binge eaters: a 

randomized, placebo-controlled double-blind study. 

Int J Eat Disord 1999;26(3):231-44. 

Laessle RG, Beumont PJ, Butow P, et al. A 

comparison of nutritional management with stress 

management in the treatment of bulimia nervosa. Br J 

Psychiatry 1991;159:250-61. 

le Grange D, Eisler I, Dare C, et al. Evaluation of 

family treatments in adolescent anorexia nervosa: a 

pilot study. Int J Eat Disord 1992;12(4):347-57. 

Lee S, Chan YY, Hsu LK. The intermediate-term 

outcome of Chinese patients with anorexia nervosa in 

Hong Kong. Am J Psychiatry 2003;160(5):967-72. 

Lee S, Chan YY, Kwok K, et al. Relationship 

between control and the intermediate term outcome 
C-1021 

of anorexia nervosa in Hong Kong. Aust N Z J 

Psychiatry 2005;39(3):141-5. 

Levine MD, Marcus MD, Moulton P. Exercise in the 

treatment of binge eating disorder. Int J Eat Disord 

1996;19(2):171-7. 

Lock J, Agras WS, Bryson S, et al. A comparison of 

short- and long-term family therapy for adolescent 

anorexia nervosa. J Am Acad Child Adolesc 

Psychiatry 2005;44(7):632-9. 

Löwe B, Zipfel S, Buchholz C, et al. Long-term 

outcome of anorexia nervosa in a prospective 21-year 

follow-up study. Psychol Med 2001;31(5):881-90. 

McElroy SL, Arnold LM, Shapira NA, et al. 

Topiramate in the treatment of binge eating disorder 

associated with obesity: a randomized, placebocontrolled trial. Am J Psychiatry 2003;160(2):255-61. 

McElroy SL, Casuto LS, Nelson EB, et al. Placebocontrolled trial of sertraline in the treatment of binge 

eating disorder. Am J Psychiatry 2000;157(6):1004-

6. 

McElroy SL, Hudson JI, Malhotra S, et al. 

Citalopram in the treatment of binge-eating disorder: 

a placebo-controlled trial. J Clin Psychiatry 

2003;64(7):807-13. 

McIntosh VV, Jordan J, Carter FA, et al. Three 

psychotherapies for anorexia nervosa: a randomized, 

controlled trial. Am J Psychiatry 2005;162(4):741-7. 

Miller KK, Grieco KA, Klibanski A. Testosterone 

administration in women with anorexia nervosa. J 

Clin Endocrinol Metab 2005;90(3):1428-33. 

Mitchell JE, Agras WS, Wilson GT, et al. A trial of a 

relapse prevention strategy in women with bulimia 

nervosa who respond to cognitive-behavior therapy. 

Int J Eat Disord 2004;35(4):549-55 . 

Mitchell JE, Fletcher L, Hanson K, et al. The relative 

efficacy of fluoxetine and manual-based self-help in 

the treatment of outpatients with bulimia nervosa. J 

Clin Psychopharmacol 2001;21(3):298-304. 

Mitchell JE, Halmi K, Wilson GT, et al. A 

randomized secondary treatment study of women 

with bulimia nervosa who fail to respond to CBT. Int 

J Eat Disord 2002;32(3):271-81. 

Morgan HG, Purgold J, Welbourne J. Management 

and outcome in anorexia nervosa. A standardized 

prognostic study. Br J Psychiatry 1983;143:282-7. 

Møller-Madsen S, Nystrup J, Nielsen S. Mortality in 

anorexia nervosa in Denmark during the period 1970-

1987. Acta Psychiatr Scand 1996;94(6):454-9. 

Nilsson EW, Gillberg C, Gillberg IC, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

personality disorders. J Am Acad Child Adolesc 

Psychiatry 1999;38(11):1389-95. 

Patton GC. Mortality in eating disorders. Psychol 

Med 1988;18(4):947-51. 

Pearlstein T, Spurell E, Hohlstein LA, et al. A 

double-blind, placebo-controlled trial of fluvoxamine 

in binge eating disorder: a high placebo response. 

Arch Women Ment Health 2003;6(2):147-51. 

Pendleton VR, Goodrick GK, Poston WS, et al. 

Exercise augments the effects of cognitive-behavioral 

therapy in the treatment of binge eating. Int J Eat 

Disord 2002;31(2):172-84. 

Peterson CB, Mitchell JE, Engbloom S, et al. Group 

cognitive-behavioral treatment of binge eating 

disorder: a comparison of therapist-led versus selfhelp formats. Int J Eat Disord 1998;24(2):125-36. 

Peterson CB, Mitchell JE, Engbloom S, et al. Selfhelp versus therapist-led group cognitive-behavioral 

treatment of binge eating disorder at follow-up. Int J 

Eat Disord 2001;30(4):363-74. 

Pike KM, Walsh BT, Vitousek K, et al. Cognitive 

behavior therapy in the posthospitalization treatment 

of anorexia nervosa. Am J Psychiatry 

2003;160(11):2046-9. 

Pillay M, Crisp AH. The impact of social skills 

training within an established in-patient treatment 

programme for anorexia nervosa. Br J Psychiatry 

1981;139:533-9. 

Pinter O, Probst M, Vandereycken W, et al. The 

predictive value of body mass index for the weight 

evolution in anorexia nervosa. Eat Weight Disord 

2004;9(3):232-5. 

Pope HGJr, Keck PEJr, McElroy SL, et al. A 

placebo-controlled study of trazodone in bulimia 

nervosa. J Clin Psychopharmacol 1989;9(4):254-9. 
C-1022 

Råstam M, Gillberg C, Wentz E. Outcome of 

teenage-onset anorexia nervosa in a Swedish 

community-based sample. Eur Child Adolesc 

Psychiatry 2003;12 Suppl 1:I78-90. 

Råstam M, Gillberg IC, Gillberg C. Anorexia nervosa 

6 years after onset: Part II. Comorbid psychiatric 

problems. Compr Psychiatry 1995;36(1):70-6. 

Ricca V, Mannucci E, Mezzani B, et al. Fluoxetine 

and fluvoxamine combined with individual cognitivebehaviour therapy in binge eating disorder: a oneyear follow-up study. Psychother Psychosom 

2001;70(6):298-306. 

Ricca V, Mannucci E, Paionni A, et al. Venlafaxine 

versus fluoxetine in the treatment of atypical 

anorectic outpatients: a preliminary study. Eat 

Weight Disord 1999;4(1):10-4. 

Riva G, Bacchetta M, Baruffi M, et al. Virtualreality-based multidimensional therapy for the 

treatment of body image disturbances in binge eating 

disorders: a preliminary controlled study. IEEE Trans 

Inf Technol Biomed 2002;6(3):224-34. 

Riva G, Bacchetta M, Cesa G, et al. Six-month 

follow-up of in-patient experiential cognitive therapy 

for binge eating disorders. Cyberpsychol Behav 

2003;6(3):251-8. 

Robin AL, Siegel PT, Koepke T, et al. Family 

therapy versus individual therapy for adolescent 

females with anorexia nervosa. J Dev Behav Pediatr 

1994;15(2):111-6. 

Robin AL, Siegel PT, Moye A. Family versus 

individual therapy for anorexia: impact on family 

conflict. Int J Eat Disord 1995;17(4):313-22. 

Robin AL, Siegel PT, Moye AW, et al. A controlled 

comparison of family versus individual therapy for 

adolescents with anorexia nervosa. J Am Acad Child 

Adolesc Psychiatry 1999;38(12):1482-9. 

Romano SJ, Halmi KA, Sarkar NP, et al. A placebocontrolled study of fluoxetine in continued treatment 

of bulimia nervosa after successful acute fluoxetine 

treatment. Am J Psychiatry 2002;159(1):96-102. 

Ruggiero GM, Laini V, Mauri MC, et al. A single 

blind comparison of amisulpride, fluoxetine and 

clomipramine in the treatment of restricting 

anorectics. Prog Neuropsychopharmacol Biol 

Psychiatry 2001;25(5):1049-59. 

Russell GF, Szmukler GI, Dare C, et al. An 

evaluation of family therapy in anorexia nervosa and 

bulimia nervosa. Arch Gen Psychiatry 

1987;44(12):1047-56. 

Saccomani L, Savoini M, Cirrincione M, et al. Longterm outcome of children and adolescents with 

anorexia nervosa: study of comorbidity. J Psychosom 

Res 1998;44(5):565-71. 

Safer DL, Telch CF, Agras WS. Dialectical behavior 

therapy for bulimia nervosa. Am J Psychiatry 

2001;158(4):632-4. 

Schork E, Eckert E, Halmi K. The relationship 

between psychopathology, eating disorder diagnosis, 

and clinical outcome at 10-year follow-up in anorexia 

nervosa. Compr Psychiatry 1994; 35:113-23. 

Stice E, Fairburn CG. Dietary and dietary-depressive 

subtypes of bulimia nervosa show differential 

symptom presentation, social impairment, 

comorbidity, and course of illness. J Consult Clin 

Psychol 2003;71(6):1090-4. 

Strober M, Freeman R, Bower S, et al. Binge eating 

in anorexia nervosa predicts later onset of substance 

use disorder: a ten-year prospective, longitudinal 

follow-up of 95 adolescents. J Youth Adolesc 

1996;25(4):519-32. 

Strober M, Freeman R, Morrell W. The long-term 

course of severe anorexia nervosa in adolescents: 

survival analysis of recovery, relapse, and outcome 

predictors over 10-15 years in a prospective study. Int 

J Eat Disord 1997;22(4):339-60. 

Stunkard A, Berkowitz R, Tanrikut C, et al. dfenfluramine treatment of binge eating disorder. Am 

J Psychiatry 1996;153(11):1455-9. 

Sullivan PF, Bulik CM, Fear JL, et al. Outcome of 

anorexia nervosa: a case-control study. Am J 

Psychiatry 1998;155(7):939-46. 

Sundblad C, Landen M, Eriksson T, et al. Effects of 

the androgen antagonist flutamide and the serotonin 

reuptake inhibitor citalopram in bulimia nervosa: a 

placebo-controlled pilot study. J Clin 

Psychopharmacol 2005;25(1):85-8. 

Sundgot-Borgen J, Rosenvinge JH, Bahr R, et al. The 

effect of exercise, cognitive therapy, and nutritional 

counseling in treating bulimia nervosa. Med Sci 

Sports Exerc 2002;34(2):190-5. 
C-1023 

Szmukler GI, Young GP, Miller G, et al. A controlled 

trial of cisapride in anorexia nervosa. Int J Eat Disord 

1995;17(4):347-57. 

Tanaka H, Kiriike N, Nagata T, et al. Outcome of 

severe anorexia nervosa patients receiving inpatient 

treatment in Japan: an 8-year follow-up study. 

Psychiatry Clin Neurosci 2001;55(4):389-96. 

Telch CF, Agras WS, Linehan MM. Dialectical 

behavior therapy for binge eating disorder. J Consult 

Clin Psychol 2001;69(6):1061-5. 

Thackwray DE, Smith MC, Bodfish JW, et al. A 

comparison of behavioral and cognitive-behavioral 

interventions for bulimia nervosa. J Consult Clin 

Psychol 1993;61(4):639-45. 

Thiels C, Schmidt U, Treasure J, et al. Guided selfchange for bulimia nervosa incorporating use of a 

self-care manual. Am J Psychiatry 1998;155(7):947-

53. 

Thien V, Thomas A, Markin D, et al. Pilot study of a 

graded exercise program for the treatment of anorexia 

nervosa. Int J Eat Disord 2000;28(1):101-6. 

Tolstrup K, Brinch M, Isager T, et al. Long-term 

outcome of 151 cases of anorexia nervosa. The 

Copenhagen Anorexia Nervosa Follow-Up Study. 

Acta Psychiatr Scand 1985;71(4):380-7. 

Treasure J, Schmidt U, Troop N, et al. Sequential 

treatment for bulimia nervosa incorporating a selfcare manual. Br J Psychiatry 1996;168(1):94-8. 

Treasure J, Todd G, Brolly M, et al. A pilot study of 

a randomised trial of cognitive analytical therapy vs 

educational behavioral therapy for adult anorexia 

nervosa. Behav Res Ther 1995;33(4):363-7. 

Treasure JL, Katzman M, Schmidt U, et al. 

Engagement and outcome in the treatment of bulimia 

nervosa: first phase of a sequential design comparing 

motivation enhancement therapy and cognitive 

behavioural therapy. Behav Res Ther 

1999;37(5):405-18. 

Turnbull SJ, Schmidt U, Troop NA, et al. Predictors 

of outcome for two treatments for bulimia nervosa: 

short and long-term. Int J Eat Disord 1997;21(1):17-

22. 

Vandereycken W. Neuroleptics in the short-term 

treatment of anorexia nervosa. A double-blind 

placebo-controlled study with sulpiride. Br J 

Psychiatry 1984;144:288-92. 

Ventura M, Bauer B. Empowerment of women with 

purging-type bulimia nervosa through nutritional 

rehabilitation. Eat Weight Disord 1999;4(2):55-62. 

Walsh BT, Fairburn CG, Mickley D, et al. Treatment 

of bulimia nervosa in a primary care setting. Am J 

Psychiatry 2004;161(3):556-61. 

Walsh BT, Hadigan CM, Devlin MJ, et al. Long-term 

outcome of antidepressant treatment for bulimia 

nervosa. Am J Psychiatry 1991;148(9):1206-12. 

Walsh BT, Wilson GT, Loeb KL, et al. Medication 

and psychotherapy in the treatment of bulimia 

nervosa. Am J Psychiatry 1997;154(4):523-31. 

Wentz E, Gillberg C, Gillberg IC, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

psychiatric disorders and overall functioning scales. J 

Child Psychol Psychiatry 2001;42(5):613-22. 

Wentz E, Gillberg IC, Gillberg C, et al. Ten-year 

follow-up of adolescent-onset anorexia nervosa: 

physical health and neurodevelopment. Dev Med 

Child Neurol 2000;42(5):328-33. 

Wilfley DE, Agras WS, Telch CF, et al. Group 

cognitive-behavioral therapy and group interpersonal 

psychotherapy for the nonpurging bulimic individual: 

a controlled comparison. J Consult Clin Psychol 

1993;61(2):296-305. 

Wilfley DE, Friedman MA, Dounchis JZ, et al. 

Comorbid psychopathology in binge eating disorder: 

relation to eating disorder severity at baseline and 

following treatment. J Consult Clin Psychol 

2000;68(4):641-9. 

Wilfley DE, Welch RR, Stein RI, et al. A randomized 

comparison of group cognitive-behavioral therapy 

and group interpersonal psychotherapy for the 

treatment of overweight individuals with binge-eating 

disorder. Arch Gen Psychiatry 2002;59(8):713-21. 

Wilson GT, Fairburn CC, Agras WS, et al. 

Cognitive-behavioral therapy for bulimia nervosa: 

time course and mechanisms of change. J Consult 

Clin Psychol 2002;70(2):267-74. 

Wilson GT, Loeb KL, Walsh BT, et al. Psychological 

versus pharmacological treatments of bulimia 
C-1024 

nervosa: predictors and processes of change. J 

Consult Clin Psychol 1999;67(4):451-9. 

Wolk SL, Devlin MJ. Stage of change as a predictor 

of response to psychotherapy for bulimia nervosa. Int 

J Eat Disord 2001;30(1):96-100. 
Appendix D. List of Excluded Articles 

D-1 

Excluded Articles 

Full Text Article Exclusion Criteria Codes for Database 

X1 Sample size too small 

X2 No control or comparison group 

X3 No original data (e.g., letters, reviews, etc.) 

X4 Does not focus on subjects with primary problem of AN, BN, BED 

X5 Study published in abstract form only 

X6 Wrong study design (e.g., case series only) 

X7 Wrong (or no) outcome 

X8 Insufficient statistical analysis to make comparisons 

X9 Wrong year (i.e., outside of our inclusion period of 1980-2005) 

X10 Drug no longer on the market 

X11 Uses DSM-III definition for BN 

X12 Does not follow individuals (AN or BED) for at least 1 year 

X13 Does not follow BN patients 3 months 

XL Not retrievable from library 
D-2 

Excludes 

Abraham S. Sexuality and reproduction in bulimia nervosa 

patients over 10 years. J Psychosom Res 1998;44(3-4):491-

502. 

Call Number: Reason for exclusion: X1 

Adami GF, Meneghelli A, Scopinaro N. Night eating and 

binge eating disorder in obese patients. Int J Eat Disord 

1999;25(3):335-8. 

Call Number: Reason for exclusion: X1 

Affenito SG, Lammi-Keefe CJ, Vogel S, et al. Women with 

insulin-dependent diabetes mellitus (IDDM) complicated 

by eating disorders are at risk for exacerbated alterations in 

lipid metabolism. Eur J Clin Nutr 1997;51(7):462-6. 

Call Number: Reason for exclusion: X4 

Agras WS, Crow SJ, Halmi KA, et al. Outcome predictors 

for the cognitive behavior treatment of bulimia nervosa: 

data from a multisite study. Am J Psychiatry 

2000;157(8):1302-8. 

Call Number: Reason for exclusion: X2 

Agras WS, Dorian B, Kirkley BG, et al. Imipramine in the 

treatment of bulimia: a double-blind controlled study. Int J 

Eating Disorders 1987;6(1):29-38. 

Call Number: Reason for exclusion: X1 

Alger SA, Schwalberg MD, Bigaouette JM, et al. Effect of 

a tricyclic antidepressant and opiate antagonist on bingeeating behavior in normoweight bulimic and obese, bingeeating subjects. Am J Clin Nutr 1991;53(4):865-71. 

Call Number: Reason for exclusion: X1 

Ames-Frankel J, Devlin MJ, Walsh BT, et al. Personality 

disorder diagnoses in patients with bulimia nervosa: 

clinical correlates and changes with treatment. J Clin 

Psychiatry 1992;53(3):90-6. 

Call Number: Reason for exclusion: X1 

Anderson CB, Joyce PR, Carter FA, et al. The effect of 

cognitive-behavioral therapy for bulimia nervosa on 

temperament and character as measured by the 

temperament and character inventory. Compr Psychiatry 

2002;43(3):182-8. 

Call Number: Reason for exclusion: X2 

Anderson KP, LaPorte DJ, Brandt H, et al. Sexual abuse 

and bulimia: response to inpatient treatment and 

preliminary outcome. J Psychiatr Res 1997;31(6):621-33. 

Call Number: Reason for exclusion: X12 

Andrewes DG, O'Connor P, Mulder C, et al. Computerised 

psychoeducation for patients with eating disorders. Aust N 

Z J Psychiatry 1996;30(4):492-7. 

Call Number: Reason for exclusion: X8 

Andrews B, Valentine ER, Valentine JD. Depression and 

eating disorders following abuse in childhood in two 

generations of women. Br J Clin Psychol 1995;34 ( Pt 

1):37-52. 

Call Number: Reason for exclusion: X1 

Bachar E, Latzer Y, Kreitler S, et al. Empirical comparison 

of two psychological therapies. Self psychology and 

cognitive orientation in the treatment of anorexia and 

bulimia. J Psychother Pract Res 1999;8(2): 115-28. 

Call Number: Reason for exclusion: X1 

Baell WK, Wertheim EH. Predictors of outcome in the 

treatment of bulimia nervosa. Br J Clin Psychol 1992;31 ( 

Pt 3):330-2. 

Call Number: Reason for exclusion: X12 

Bara-Carril N, Williams CJ, Pombo-Carril MG, et al. A 

preliminary investigation into the feasibility and efficacy of 

a CD-ROM-based cognitive-behavioral self-help 

intervention for bulimia nervosa. Int J Eat Disord 

2004;35(4):538-48. 

Call Number: Reason for exclusion: X6 

Barbarich NC, McConaha CW, Gaskill J, et al. An open 

trial of olanzapine in anorexia nervosa. J Clin Psychiatry 

2004;65(11):1480-2. 

Call Number: Reason for exclusion: X2 

Barkmeier WW, Peterson DS, Wood LW. Anorexia 

nervosa: recognition and management. J Oral Med 

1982;37(2):33-7. 

Call Number: Reason for exclusion: X1 

Barlow J, Blouin J, Blouin A, et al. Treatment of bulimia 

with desipramine: a double-blind crossover study. Can J 

Psychiatry 1988;33(2):129-33. 

Call Number: Reason for exclusion: X11 

Bean P, Loomis CC, Timmel P, et al. Outcome variables 

for anorexic males and females one year after discharge 

from residential treatment. J Addict Dis 2004;23(2):83-94. 

Call Number: Reason for exclusion: X1 

Bergh C, Brodin U, Lindberg G, et al. Randomized 

controlled trial of a treatment for anorexia and bulimia 

nervosa. Proc Natl Acad Sci U S A 2002;99(14):9486-91. 

Call Number: Reason for exclusion: X8 

Bjorck C, Clinton D, Sohlberg S, et al. Interpersonal 

profiles in eating disorders: ratings of SASB self-image. 

Psychol Psychother 2003;76(Pt 4):337-49. 

Call Number: Reason for exclusion: X6 
D-3 

Blais MA, Becker AE, Burwell RA, et al. Pregnancy: 

outcome and impact on symptomatology in a cohort of 

eating-disordered women. Int J Eat Disord 2000;27(2):140-

9. 

Call Number: Reason for exclusion: X7 

Blouin AG, Blouin JH, Iversen H, et al. Light therapy in 

bulimia nervosa: a double-blind, placebo-controlled study. 

Psychiatry Res 1928;60(1):1-9. 

Call Number: Reason for exclusion: X1 

Blouin AG, Blouin JH, Perez EL, et al. Treatment of 

bulimia with fenfluramine and desipramine. J Clin 

Psychopharmacol 1988;8(4):261-9. 

Call Number: Reason for exclusion: X1 

Blouin J, Blouin A, Perez E, et al. Bulimia: independence 

of antibulimic and antidepressant properties of 

desipramine. Can J Psychiatry 1989;34(1):24-9. 

Call Number: Reason for exclusion: X1 

Blouin JH, Carter J, Blouin AG, et al. Prognostic indicators 

in bulimia nervosa treated with cognitive-behavioral group 

therapy. Int J Eat Disord 1994;15(2):113-23. 

Call Number: Reason for exclusion: X12 

Bossert S, Laessle RG, Meiller C, et al. Visual palatability 

of food in patients with eating disorders and dieting 

women. Behav Res Ther 1991;29(4):337-41. 

Call Number: Reason for exclusion: X1 

Bossert S, Schmolz U, Wiegand M, et al. Predictors of 

short-term treatment outcome in bulimia nervosa inpatients. 

Behav Res Ther 1992;30(2):193-9. 

Call Number: Reason for exclusion: X1 

Bossert S, Schnabel E, Krieg JC. Effects and limitations of 

cognitive behavior therapy in bulimia inpatients. 

Psychother Psychosom 1989;51(2):77-82. 

Call Number: Reason for exclusion: X1 

Box J, Arnold LE, Smeltzer DJ. Protriptyline weight loss in 

compulsive eaters: a placebo-controlled study. J Psychiat 

Treat Eval 1983;5:387-91. 

Call Number: Reason for exclusion: X4 

Brambilla F, Brunetta M, Draisci A, et al. T-lymphocyte 

concentrations of cholecystokinin-8 and beta-endorphin in 

eating disorders: II. Bulimia nervosa. Psychiatry Res 

1929;59(1-2):51-6 . 

Call Number: Reason for exclusion: X7 

Brambilla F, Brunetta M, Peirone A, et al. T-lymphocyte 

cholecystokinin-8 and beta-endorphin concentrations in 

eating disorders: I. Anorexia nervosa. Psychiatry Res 

1929;59(1-2):43-50. 

Call Number: Reason for exclusion: X7 

Brambilla F, Draisci A, Peirone A, et al. Combined 

cognitive-behavioral, psychopharmacological and 

nutritional therapy in bulimia nervosa. Neuropsychobiology 

1995;32(2):68-71. 

Call Number: Reason for exclusion: X1 

Bretz WA, Krahn DD, Drury M, et al. Effects of fluoxetine 

on the oral environment of bulimics. Oral Microbiol 

Immunol 1993;8(1):62-4. 

Call Number: Reason for exclusion: X6 

Brinch M, Isager T, Tolstrup K. Anorexia nervosa and 

motherhood: reproduction pattern and mothering behavior 

of 50 women. Acta Psychiatr Scand 1988;77(5):611-7. 

Call Number: Reason for exclusion: X7 

Bulik CM, Sullivan PF, Carter FA, et al. Initial 

manifestations of disordered eating behavior: dieting versus 

binging. Int J Eat Disord 1997;22(2):195-201. 

Call Number: Reason for exclusion: X7 

Bulik CM, Sullivan PF, Carter FA, et al. Predictors of rapid 

and sustained response to cognitive-behavioral therapy for 

bulimia nervosa. Int J Eat Disord 1999;26(2):137-44. 

Call Number: Reason for exclusion: X8 

Bulik CM, Sullivan PF, Fear JL, et al. Fertility and 

reproduction in women with anorexia nervosa: a controlled 

study. J Clin Psychiatry 1999;60(2):130-5; quiz 135-7. 

Call Number: Reason for exclusion: X7 

Cachelin FM, Striegel-Moore RH, Elder KA, et al. Natural 

course of a community sample of women with binge eating 

disorder. Int J Eat Disord 1999;25(1):45-54. 

Call Number: Reason for exclusion: X12 

Carter FA, Bulik CM, McIntosh VV, et al. Changes in cue 

reactivity following treatment for bulimia nervosa. Int J Eat 

Disord 2001;29(3):336-44. 

Call Number: Reason for exclusion: X2 

Carter FA, Bulik CM, McIntosh VV, et al. Cue reactivity as 

a predictor of outcome with bulimia nervosa. Int J Eat 

Disord 2002;31(3):240-50. 

Call Number: Reason for exclusion: X6 

Carter FA, McIntosh VV, Frampton CM, et al. Predictors 

of childbirth following treatment for bulimia nervosa. Int J 

Eat Disord 2003;34(3):337-42. 

Call Number: Reason for exclusion: X7 

Carter FA, McIntosh VV, Joyce PR, et al. Abstention 

during cue reactivity assessment is associated with better 

outcome among women with bulimia nervosa. Eating 

Behaviors 2001;2(3):273-8. 

Call Number: Reason for exclusion: X6 

Carter FA, McIntosh VV, Joyce PR, et al. Bulimia nervosa, 

childbirth, and psychopathology. J Psychosom Res 

2003;55(4):357-61. 

Call Number: Reason for exclusion: X7 
D-4 

Carter FA, McIntosh VV, Joyce PR, et al. Patterns of 

weight change after treatment for bulimia nervosa. Int J Eat 

Disord 2004;36(1):12-21. 

Call Number: Reason for exclusion: X6 

Ceccherini-Nelli A, Guidi L. Fluoxetine: the relationship 

between response, adverse events, and plasma 

concentrations in the treatment of bulimia nervosa. Int Clin 

Psychopharmacol 1993;8(4):311-3. 

Call Number: Reason for exclusion: X6 

Clinton DN, Glant R. The eating disorders spectrum of 

DSM-III-R. Clinical features and psychosocial 

concomitants of 86 consecutive cases from a Swedish 

urban catchment area. J Nerv Ment Dis 1992;180(4):244-

50. 

Call Number: Reason for exclusion: X12 

Collings S, King M. Ten-year follow-up of 50 patients with 

bulimia nervosa. Br J Psychiatry 1994;164(1):80-7. 

Call Number: Reason for exclusion: X1 

Crisp AH. Gastrointestinal disturbance in anorexia nervosa. 

Postgrad Med J 1985;61(711):3-5. 

Call Number: Reason for exclusion: X3 

Dalvit-McPhillips S. A dietary approach to bulimia 

treatment. Physiology & Behavior 1984;33(5):769-75. 

Call Number: Reason for exclusion: X1 

Davis BA, Kennedy SH, Durden DA, et al. The effect of 

the MAO-A selective inhibitor brofaromine on the plasma 

and urine concentrations of some biogenic amines and their 

acidic metabolites in bulimia nervosa. Prog 

Neuropsychopharmacol Biol Psychiatry 1993;17(5):747-63 

. 

Call Number: Reason for exclusion: X1 

de Groot JM, Rodin G, Olmsted MP. Alexithymia, 

depression, and treatment outcome in bulimia nervosa. 

Compr Psychiatry 1995;36(1):53-60. 

Call Number: Reason for exclusion: X1 

de la Piedra C, Calero JA, Traba ML, et al. Urinary alpha 

and beta C-telopeptides of collagen I: clinical implications 

in bone remodeling in patients with anorexia nervosa. 

Osteoporos Int 1999;10(6):480-6. 

Call Number: Reason for exclusion: X1 

de Zwaan M, Nutzinger DO, Schoenbeck G. Binge eating 

in overweight women. Compr Psychiatry 1992;33(4):256-

61. 

Call Number: Reason for exclusion: X4 

Deter HC, Kopp W, Zipfel S, et al. [Male anorexia nervosa 

patients in long-term follow-up]. Nervenarzt 

1998;69(5):419-26. 

Call Number: Reason for exclusion: X1 

Eckert ED, Goldberg SC, Halmi KA, et al. Behaviour 

therapy in anorexia nervosa. Br J Psychiatry 1979;134:55-

9. 

Call Number: Reason for exclusion: X9 

Fahy TA, Eisler I, Russell GF. A placebo-controlled trial of 

d-fenfluramine in bulimia nervosa. Br J Psychiatry 

1993;162:597-603. 

Call Number: Reason for exclusion: X10 

Fairburn CG, Kirk J, O'Connor M, et al. A comparison of 

two psychological treatments for bulimia nervosa. Behav 

Res Ther 1986;24(6):629-43. 

Call Number: Reason for exclusion: X1 

Fichter MM, Quadflieg N, Rief W. Course of multiimpulsive bulimia. Psychol Med 1994;24(3):591-604. 

Call Number: Reason for exclusion: X1 

Field AE, Austin SB, Taylor CB, et al. Relation between 

dieting and weight change among preadolescents and 

adolescents. Pediatrics 2003;112(4):900-6 . 

Call Number: Reason for exclusion: X4 

Field T, Schanberg S, Kuhn C, et al. Bulimic adolescents 

benefit from massage therapy. Adolescence 

1998;33(131):555-63. 

Call Number: Reason for exclusion: X1 

Franzoni F, Mataloni E, Femia R, et al. Effect of oral 

potassium supplementation on QT dispersion in anorexia 

nervosa. Acta Paediatr 2002;91(6):653-6. 

Call Number: Reason for exclusion: X7 

Freeman C. Day patient treatment for anorexia nervosa. 

British Review of Bulimia and Anorexia Nervosa 

1992;6(1):3-8. 

Call Number: Reason for exclusion: X3 

Freeman C, Sinclair F, Turnbull J, et al. Psychotherapy for 

bulimia: a controlled study. J Psychiatr Res 1985;19(2-

3):373-8. 

Call Number: Reason for exclusion: X11 

Freeman CP, Barry F, Dunkeld-Turnbull J, et al. Controlled 

trial of psychotherapy for bulimia nervosa. Br Med J (Clin 

Res Ed) 1988;296(6621):521-5. 

Call Number: Reason for exclusion: X11 

Gaillard M, Wulliemier F. [Comparative follow up study of 

2 treatments for anorexia nervosa (classical approach and 

behavioral therapy)]. J Psychosom Res 1982;26(2):113-21. 

Call Number: Reason for exclusion: X1 

Gaskill JA, Treat TA, McCabe EB, et al. Does olanzapine 

affect the rate of weight gain among inpatients with eating 

disorders? Eating Disorders Review 2001;12(6):1-2. 

Call Number: Reason for exclusion: X 14 
D-5 

Gelber D, Levine J, Belmaker RH. Effect of inositol on 

bulimia nervosa and binge eating. Int J Eat Disord 

2001;29(3):345-8. 

Call Number: Reason for exclusion: X8 

Gendall KA, Bulik CM, Sullivan PF, et al. Body weight in 

bulimia nervosa. Eat Weight Disord 1999;4(4):157-64. 

Call Number: Reason for exclusion: X6 

Gendall KA, Joyce PR, Carter FA, et al. Thyroid indices 

and treatment outcome in bulimia nervosa. Acta Psychiatr 

Scand 2003;108(3):190-5. 

Call Number: Reason for exclusion: X7 

Ghaderi A, Scott B. Coping in dieting and eating disorders: 

a population-based study. J Nerv Ment Dis 

2000;188(5):273-9. 

Call Number: Reason for exclusion: X4 

Ghaderi A, Scott B. Prevalence, incidence and prospective 

risk factors for eating disorders. Acta Psychiatr Scand 

2001;104(2):122-30. 

Call Number: Reason for exclusion: X6 

Ghaderi A, Scott B. Pure and guided self-help for full and 

sub-threshold bulimia nervosa and binge eating disorder. Br 

J Clin Psychol 2003;42(Pt 3):257-69. 

Call Number: Reason for exclusion: X1 

Goldberg SC, Casper RC, Eckert ED. Effects of 

cyproheptadine in anorexia nervosa. Psychopharmacol Bull 

1980;16(2):29-30. 

Call Number: Reason for exclusion: X8 

Goldberg SC, Halmi KA, Eckert ED, et al. Cyproheptadine 

in anorexia nervosa. Br J Psychiatry 1979;134:67-70. 

Call Number: Reason for exclusion: X9 

Goldbloom DS, Olmsted MP. Pharmacotherapy of bulimia 

nervosa with fluoxetine: assessment of clinically significant 

attitudinal change. Am J Psychiatry 1993;150(5):770-4. 

Call Number: Reason for exclusion: X13 

Goodrick GK, Pendleton VR, Kimball KT, et al. Binge 

eating severity, self-concept, dieting self-efficacy and 

social support during treatment of binge eating disorder. Int 

J Eat Disord 1999;26(3):295-300. 

Call Number: Reason for exclusion: X4 

Goodrick GK, Poston WS 2nd, Kimball KT, et al. 

Nondieting versus dieting treatment for overweight bingeeating women. J Consult Clin Psychol 1998;66(2):363-8. 

Call Number: Reason for exclusion: X4 

Gordon CM, Grace E, Emans SJ, et al. Effects of oral 

dehydroepiandrosterone on bone density in young women 

with anorexia nervosa: a randomized trial. J Clin 

Endocrinol Metab 2002;87(11):4935-41. 

Call Number: Reason for exclusion: X7 

Gordon CM, Grace E, Emans SJ, et al. Changes in bone 

turnover markers and menstrual function after short-term 

oral DHEA in young women with anorexia nervosa. J Bone 

Miner Res 1999;14(1):136-45. 

Call Number: Reason for exclusion: X7 

Greeno CG, Wing RR. A double-blind, placebo-controlled 

trial of the effect of fluoxetine on dietary intake in 

overweight women with and without binge-eating disorder. 

Am J Clin Nutr 1996;64(3):267-73. 

Call Number: Reason for exclusion: X4 

Greeno CG, Wing RR, Marcus MD. Nocturnal eating in 

binge eating disorder and matched-weight controls. Int J 

Eat Disord 1995;18(4):343-9. 

Call Number: Reason for exclusion: X1 

Griffiths RA, Channon-Little L. The hypnotizability of 

patients with bulimia nervosa and partial syndromes 

participating in a controlled treatment outcome study. 

Contemporary Hypnosis 1993;10(10):81-7. 

Call Number: Reason for exclusion: X6 

Griffiths RA, Hadzi-Pavlovic D, Channon-Little L. The 

short-term follow-up effects of hypnobehavioural and 

cognitive behavioural treatment for bulimia nervosa. 

European Eating Disorders Review 1996;4(1):12-31. 

Call Number: Reason for exclusion: X6 

Grilo CM, Sanislow CA, Shea MT, et al. The natural 

course of bulimia nervosa and eating disorder not otherwise 

specified is not influenced by personality disorders. Int J 

Eat Disord 2003;34(3):319-30. 

Call Number: Reason for exclusion: X1 

Grinspoon S, Baum H, Lee K, et al. Effects of short-term 

recombinant human insulin-like growth factor I 

administration on bone turnover in osteopenic women with 

anorexia nervosa. J Clin Endocrinol Metab 

1996;81(11):3864-70. 

Call Number: Reason for exclusion: X7 

Grinspoon S, Miller K, Herzog D, et al. Effects of 

recombinant human insulin-like growth factor (IGF)-I and 

estrogen administration on IGF-I, IGF binding protein 

(IGFBP)-2, and IGFBP-3 in anorexia nervosa: a 

randomized-controlled study. J Clin Endocrinol Metab 

2003;88(3):1142-9. 

Call Number: Reason for exclusion: X7 

Grinspoon S, Thomas L, Miller K, et al. Effects of 

recombinant human IGF-I and oral contraceptive 

administration on bone density in anorexia nervosa. J Clin 

Endocrinol Metab 2002;87(6):2883-91. 

Call Number: Reason for exclusion: X7 

Gross H, Ebert MH, Faden VB, et al. A double-blind trial 

of delta 9-tetrahydrocannabinol in primary anorexia 

nervosa. J Clin Psychopharmacol 1983;3(3):165-71. 

Call Number: Reason for exclusion: X6 
D-6 

Hall A, Slim E, Hawker F, et al. Anorexia nervosa: longterm outcome in 50 female patients. Br J Psychiatry 

1984;145:407-13. 

Call Number: Reason for exclusion: X1 

Halmi KA, Agras WS, Crow S, et al. Predictors of 

treatment acceptance and completion in anorexia nervosa: 

implications for future study designs. Arch Gen Psychiatry 

2005;62(7):776-81 . 

Call Number: Reason for exclusion: X6 

Halmi KA, Agras WS, Mitchell J, et al. Relapse predictors 

of patients with bulimia nervosa who achieved abstinence 

through cognitive behavioral therapy. Arch Gen Psychiatry 

2002;59(12):1105-9. 

Call Number: Reason for exclusion: X6 

Halmi KA, Falk JR. Anorexia nervosa. A study of outcome 

discriminators in exclusive dieters and bulimics. J Am 

Acad Child Psychiatry 1982;21(4):369-75. 

Call Number: Reason for exclusion: X1 

Hartman BK, Faris PL, Kim SW, et al. Treatment of 

bulimia nervosa with ondansetron. Arch Gen Psychiatry 

1997;54(10):969-70. 

Call Number: Reason for exclusion: X1 

Hasler WL. 5-HT(3) antagonist therapy of bulimia nervosa: 

a peripherally active agent for a central nervous system 

eating disorder? Gastroenterology 2000;119(1):271-2. 

Call Number: Reason for exclusion: X1 

Heer M, Mika C, Grzella I, et al. Bone turnover during 

inpatient nutritional therapy and outpatient follow-up in 

patients with anorexia nervosa compared with that in 

healthy control subjects. Am J Clin Nutr 2004;80(3):774-

81. 

Call Number: Reason for exclusion: X1 

Hentschel F, Schmidbauer M, Detzner U, et al. [Reversible 

changes in brain volume in anorexia nervosa]. Z Kinder 

Jugendpsychiatr 1995;23(2):104-12. 

Call Number: Reason for exclusion: X1 

Herzog DB, Sacks NR. Bulimia nervosa: comparison of 

treatment responders vs. nonresponders. Psychopharmacol 

Bull 1993;29(1):121-5. 

Call Number: Reason for exclusion: X7 

Herzog T, Hartmann A. [Psychoanalytically oriented 

treatment of anorexia nervosa. Methodology-related critical 

review of the literature using meta-analysis methods]. 

Psychother Psychosom Med Psychol 1997;47(9-10):299-

315. 

Call Number: Reason for exclusion: X3 

Holtkamp K, Hebebrand J, Mika C, et al. High serum leptin 

levels subsequent to weight gain predict renewed weight 

loss in patients with anorexia nervosa. 

Psychoneuroendocrinology 2004;29(6):791-7. 

Call Number: Reason for exclusion: X1 

Horne RL, Ferguson JM, Pope HGJr, et al. Treatment of 

bulimia with bupropion: a multicenter controlled trial. J 

Clin Psychiatry 1988;49(7):262-6. 

Call Number: Reason for exclusion: X11 

Hotta M, Shibasaki T, Sato K, et al. The importance of 

body weight history in the occurrence and recovery of 

osteoporosis in patients with anorexia nervosa: evaluation 

by dual X-ray absorptiometry and bone metabolic markers. 

Eur J Endocrinol 1998;139(3):276-83. 

Call Number: Reason for exclusion: X1 

Hsu LK, Clement L, Santhouse R, et al. Treatment of 

bulimia nervosa with lithium carbonate. A controlled study. 

J Nerv Ment Dis 1991;179(6):351-5. 

Call Number: Reason for exclusion: X11 

Hudson JI, Pope HG Jr, Jonas JM. Treatment of bulimia 

with antidepressants: theoretical considerations and clinical 

findings. Res Publ Assoc Res Nerv Ment Dis 1984;62:259-

73. 

Call Number: Reason for exclusion: X6 

Hudson JI, Pope HGJr, Keck PEJr, et al. Treatment of 

bulimia nervosa with trazodone: short-term response and 

long-term follow-up. Clin Neuropharmacol 1989;12 Suppl 

1:S38-46; Discussion S47-9. 

Call Number: Reason for exclusion: X6 

Hughes PL, Wells LA, Cunningham CJ, et al. Treating 

bulimia with desipramine. A double-blind, placebocontrolled study. Arch Gen Psychiatry 1986;43(2):182-6. 

Call Number: Reason for exclusion: X1 

Imbierowicz K, Braks K, Jacoby GE, et al. High-caloric 

supplements in anorexia treatment. Int J Eat Disord 

2002;32(2):135-45. 

Call Number: Reason for exclusion: X6 

Jacobi C. [Pharmacotherapy and behavior therapy for 

anorexia and bulimia nervosa]. Verhaltenstherapie 

1994;4(3):162-71. 

Call Number: Reason for exclusion: X3 

Jeammet P, Jayle D, Terrasse-Brechon G, et al. [Outcome 

of anorexia nervosa]. Neuropsychiatr Enfance Adolesc 

1984;32(2-3):97-113 . 

Call Number: Reason for exclusion: X6 

Jeffery RW, Sherwood NE, Brelje K, et al. Mail and phone 

interventions for weight loss in a managed-care setting: 

Weigh-To-Be one-year outcomes. Int J Obes Relat Metab 

Disord 2003;27(12):1584-92. 

Call Number: Reason for exclusion: X4 

Johnson-Sabine E, Reiss D, Dayson D. Bulimia nervosa: a 

5-year follow-up study. Psychol Med 1992;22(4):951-9. 

Call Number: Reason for exclusion: X1 
D-7 

Jonsson PH. [A study of patients with anorexia nervosa in 

Gavleborg. More boys than girls required intensive care]. 

Lakartidningen 1917;98(42):4578-82. 

Call Number: Reason for exclusion: X8 

Katz RL, Keen CL, Litt IF, et al. Zinc deficiency in 

anorexia nervosa. J Adolesc Health Care 1987;8(5):400-6. 

Call Number: Reason for exclusion: X6 

Katzman DK, Lambe EK, Mikulis DJ, et al. Cerebral gray 

matter and white matter volume deficits in adolescent girls 

with anorexia nervosa. J Pediatr 1996;129(6):794-803. 

Call Number: Reason for exclusion: X1 

Kaye WH, Greeno CG, Moss H, et al. Alterations in 

serotonin activity and psychiatric symptoms after recovery 

from bulimia nervosa. Arch Gen Psychiatry 

1998;55(10):927-35. 

Call Number: Reason for exclusion: X1 

Keel PK, Dorer DJ, Eddy KT, et al. Predictors of treatment 

utilization among women with anorexia and bulimia 

nervosa. Am J Psychiatry 2002;159(1):140-2. 

Call Number: Reason for exclusion: X6 

Keel PK, Mitchell JE, Davis TL, et al. Long-term impact of 

treatment in women diagnosed with bulimia nervosa. Int J 

Eat Disord 2002;31(2):151-8. 

Call Number: Reason for exclusion: X11 

Keel PK, Mitchell JE, Miller KB, et al. Social adjustment 

over 10 years following diagnosis with bulimia nervosa. Int 

J Eat Disord 2000;27(1):21-8. 

Call Number: Reason for exclusion: X7 

Kennedy SH, Piran N, Warsh JJ, et al. A trial of 

isocarboxazid in the treatment of bulimia nervosa. J Clin 

Psychopharmacol 1988;8(6):391-6. 

Call Number: Reason for exclusion: X1 

Kingston K, Szmukler G, Andrewes D, et al. 

Neuropsychological and structural brain changes in 

anorexia nervosa before and after refeeding. Psychol Med 

1996;26(1):15-28. 

Call Number: Reason for exclusion: X12 

Kirkley BG, Schneider JA, Agras WS, et al. Comparison of 

two group treatments for bulimia. J Consult Clin Psychol 

1985;53(1):43-8. 

Call Number: Reason for exclusion: X1 

Korndorfer SR, Lucas AR, Suman VJ, et al. Long-term 

survival of patients with anorexia nervosa: a populationbased study in Rochester, Minn. Mayo Clin Proc 

2003;78(3):278-84. 

Call Number: Reason for exclusion: X4 

Kreipe RE, Strauss J, Hodgman CH, et al. Menstrual cycle 

abnormalities and subclinical eating disorders: a 

preliminary report. Psychosom Med 1989;51(1):81-6. 

Call Number: Reason for exclusion: X1 

Lacey JH, Crisp AH. Hunger, food intake and weight: the 

impact of clomipramine on a refeeding anorexia nervosa 

population. Postgrad Med J 1980;56 Suppl 1:79-85. 

Call Number: Reason for exclusion: X8 

Lacey J. Bulimia nervosa, binge eating, and psychogenic 

vomiting: a controlled treatment study and long term 

outcome. Br Med J (Clin Res Ed) 1983;286(6378):1609-13. 

Call Number: Reason for exclusion: X11 

Laessle RG, Zoettle C, Pirke K.M. Meta-analysis of 

treatment studies for bulimia. Int J Eat Disord 1987;6:647-

54. 

Call Number: Reason for exclusion: X3 

Lee NF, Rush AJ. Cognitive-behavioral group therapy for 

bulimia. Int J Eat Disord 1986;5:599-615. 

Call Number: Reason for exclusion: X11 

Leitenberg H, Rosen JC, Gross J, et al. Exposure plus 

response-prevention treatment of bulimia nervosa. J 

Consult Clin Psychol 1988;56(4):535-41. 

Call Number: Reason for exclusion: X11 

Lewandowski LM, Gebing TA, Anthony JL, et al. Metaanalysis of cognitive-behavioral treatment studies for 

bulimia. Clin Psychol Rev 1997;17(7):703-18. 

Call Number: Reason for exclusion: X3 

Liedtke R, Jäger B, Lempa W, et al. Therapy outcome of 

two treatment models for bulimia nervosa: preliminary 

results of a controlled study. Psychother Psychosom 

1991;56(1-2):56-63. 

Call Number: Reason for exclusion: X6 

Linde JA, Jeffery RW, Levy RL, et al. Binge eating 

disorder, weight control self-efficacy, and depression in 

overweight men and women. Int J Obes Relat Metab 

Disord 2004;28(3):418-25. 

Call Number: Reason for exclusion: X4 

Loeb KL, Wilson GT, Gilbert JS, et al. Guided and 

unguided self-help for binge eating. Behav Res Ther 

2000;38(3):259-72. 

Call Number: Reason for exclusion: X8 

Lucas AR, Melton LJ3, Crowson CS, et al. Long-term 

fracture risk among women with anorexia nervosa: a 

population-based cohort study. Mayo Clin Proc 

1999;74(10):972-7. 

Call Number: Reason for exclusion: X4 

Maddocks SE, Kaplan AS, Woodside DB, et al. Two year 

follow-up of bulimia nervosa: the importance of abstinence 

as the criterion of outcome. Int J Eat Disord 

1990;12(2):133-41. 

Call Number: Reason for exclusion: X1 
D-8 

Marcus MD, Wing RR, Ewing L, et al. A double-blind, 

placebo-controlled trial of fluoxetine plus behavior 

modification in the treatment of obese binge-eaters and 

non-binge-eaters. Am J Psychiatry 1990;147(7):876-81. 

Call Number: Reason for exclusion: X4 

Marcus MD, Wing RR, Hopkins J. Obese binge eaters: 

affect, cognitions, and response to behavioural weight 

control. J Consult Clin Psychol 1988;56(3):433-9. 

Call Number: Reason for exclusion: X1 

Mark EJ, Patalas ED, Chang HT, et al. Fatal pulmonary 

hypertension associated with short-term use of 

fenfluramine and phentermine. N Engl J Med 

1997;337(9):602-6. 

Call Number: Reason for exclusion: X6 

McCann UD, Agras WS. Successful treatment of 

nonpurging bulimia nervosa with desipramine: a doubleblind, placebo-controlled study. Am J Psychiatry 

1990;147(11):1509-13. 

Call Number: Reason for exclusion: X1 

McCarthy MK, Goff DC, Baer L, et al. Dissociation, 

childhood trauma, and the response to fluoxetine in bulimic 

patients. Int J Eat Disord 1994;15(3):219-26. 

Call Number: Reason for exclusion: X8 

McElroy SL, Shapira NA, Arnold LM, et al. Topiramate in 

the long-term treatment of binge-eating disorder associated 

with obesity. J Clin Psychiatry 2004;65(11):1463-9. 

Call Number: Reason for exclusion: X6 

McKnight Investigators T. Risk factors for the onset of 

eating disorders in adolescent girls: results of the McKnight 

longitudinal risk factor study. Am J Psychiatry 

2003;160(2):248-54. 

Call Number: Reason for exclusion: X6 

Miller KK, Deckersbach T, Rauch SL, et al. Testosterone 

administration attenuates regional brain hypometabolism in 

women with anorexia nervosa. Psychiatry Res 

2004;132(3):197-207. 

Call Number: Reason for exclusion: X6 

Mitchell JE, Christenson G, Jennings J, et al. A placebocontrolled, double-blind crossover study of naltrexone 

hydrochloride in outpatients with normal weight bulimia. J 

Clin Psychopharmacol 1989;9(2):94-7. 

Call Number: Reason for exclusion: X1 

Mitchell JE, Groat R. A placebo-controlled, double-blind 

trial of amitriptyline in bulimia. J Clin Psychopharmacol 

1984;4(4):186-93. 

Call Number: Reason for exclusion: X11 

Mitchell JE, Pyle R, Eckert ED, et al. The influence of 

prior alcohol and drug abuse problems on bulimia nervosa 

treatment outcome. Addict Behav 1990;15(2):169-73. 

Call Number: Reason for exclusion: X11 

Mitchell JE, Pyle RL, Eckert ED, et al. Electrolyte and 

other physiological abnormalities in patients with bulimia. 

Psychol Med 1983;13(2):273-8. 

Call Number: Reason for exclusion: X6 

Mitchell JE, Pyle RL, Eckert ED, et al. A comparison study 

of antidepressants and structured intensive group 

psychotherapy in the treatment of bulimia nervosa. Arch 

Gen Psychiatry 1990;47(2):149-57. 

Call Number: Reason for exclusion: X11 

Mitchell JE, Pyle RL, Eckert ED, et al. Antidepressants vs. 

group therapy in the treatment of bulimia. 

Psychopharmacol Bull 1987;23(1):41-4. 

Call Number: Reason for exclusion: X11 

Mitchell JE, Pyle RL, Pomeroy C, et al. Cognitivebehavioral group psychotherapy of bulimia nervosa: 

importance of logistical variables. Int J Eat Disord 

1993;14(3):277-87. 

Call Number: Reason for exclusion: X6 

Moorhead DJ, Stashwick CK, Reinherz HZ, et al. Child 

and adolescent predictors for eating disorders in a 

community population of young adult women. Int J Eat 

Disord 2003;33(1):1-9. 

Call Number: Reason for exclusion: X6 

Mussell MP, Mitchell JE, Crosby RD, et al. Commitment 

to treatment goals in prediction of group cognitivebehavioral therapy treatment outcome for women with 

bulimia nervosa. J Consult Clin Psychol 2000;68 (3):432-7. 

Call Number: Reason for exclusion: X2 

Mussell MP, Mitchell JE, Weller CL, et al. Onset of binge 

eating, dieting, obesity, and mood disorders among subjects 

seeking treatment for binge eating disorder. Int J Eat Disord 

1995;17(4):395-401. 

Call Number: Reason for exclusion: X2 

Nauta H, Hospers H, Kok G, et al. A comparison between a 

cognitive and a behavioral treatment for obese binge eaters 

and obese non-binge eaters. Behavior Therapy 

2000;31(3):441-61. 

Call Number: Reason for exclusion: X4 

Negrao AB, Cordas TA. Clinical characteristics and course 

of anorexia nervosa in Latin America, a Brazilian sample. 

Psychiatry Res 1916;62(1):17-21. 

Call Number: Reason for exclusion: X1 

Newton JR, Freeman CP, Hannan WJ, et al. Osteoporosis 

and normal weight bulimia nervosa--which patients are at 

risk? J Psychosom Res 1993;37(3):239-47. 

Call Number: Reason for exclusion: X1 

Norring CE, Sohlberg SS. Outcome, recovery, relapse and 

mortality across six years in patients with clinical eating 

disorders. Acta Psychiatr Scand 1993;87(6):437-44. 

Call Number: Reason for exclusion: X1 
D-9 

Nussbaum M, Shenker IR, Baird D, et al. Follow-up 

investigation in patients with anorexia nervosa. J Pediatr 

1985;106(5):835-40. 

Call Number: Reason for exclusion: X12 

Okamoto A, Yamashita T, Nagoshi Y, et al. A behavior 

therapy program combined with liquid nutrition designed 

for anorexia nervosa. Psychiatry Clin Neurosci 

2002;56(5):515-20. 

Call Number: Reason for exclusion: X6 

Olmsted MP, Daneman D, Rydall AC, et al. The effects of 

psychoeducation on disturbed eating attitudes and behavior 

in young women with type 1 diabetes mellitus. Int J Eat 

Disord 2002;32(2):230-9. 

Call Number: Reason for exclusion: X4 

Olmsted MP, Davis R, Garner DM, et al. Efficacy of a brief 

group psychoeducational intervention for bulimia nervosa. 

Behav Res Ther 1991;29(1):71-83. 

Call Number: Reason for exclusion: X6 

Olmsted MP, Kaplan AS, Rockert W. Defining remission 

and relapse in bulimia nervosa. Int J Eat Disord 

2005;38(1):1-6. 

Call Number: Reason for exclusion: X1 

Olmsted MP, Kaplan AS, Rockert W, et al. Rapid 

responders to intensive treatment of bulimia nervosa. Int J 

Eat Disord 1996;19(3):279-85. 

Call Number: Reason for exclusion: X1 

Ordman AM, Kirschenbaum DS. Cognitive-behavioral 

therapy for bulimia: an initial outcome study. J Consult 

Clin Psychol 1985;53(3):305-13. 

Call Number: Reason for exclusion: X1 

Palmer RL, Birchall H, McGrain L, et al. Self-help for 

bulimic disorders: a randomised controlled trial comparing 

minimal guidance with face-to-face or telephone guidance. 

Br J Psychiatry 2002;181:230-5. 

Call Number: Reason for exclusion: X8 

Patton GC, Coffey C, Sawyer SM. The outcome of 

adolescent eating disorders: findings from the Victorian 

Adolescent Health Cohort Study. Eur Child Adolesc 

Psychiatry 2003;12 Suppl 1:I25-9. 

Call Number: Reason for exclusion: X4 

Pertschuk MJ, Forster J, Buzby G, et al. The treatment of 

anorexia nervosa with total parenteral nutrition. Biol 

Psychiatry 1981;16(6):539-50. 

Call Number: Reason for exclusion: X6 

Pope HG Jr, Hudson JI, Jonas JM, et al. Antidepressant 

treatment of bulimia: a two-year follow-up study. J Clin 

Psychopharmacol 1985;5(6):320-7. 

Call Number: Reason for exclusion: X6 

Pope HG Jr, Hudson JI, Jonas JM, et al. Bulimia treated 

with imipramine: a placebo-controlled, double-blind study. 

Am J Psychiatry 1983;140(5):554-8. 

Call Number: Reason for exclusion: X1 

Porzelius LK, Houston C, Smith M, et al. Comparison of a 

standard behavioral weight loss treatment and a binge 

eating weight loss treatment. Behavior Therapy 

1995;26:119-34. 

Call Number: Reason for exclusion: X4 

Pyle RL, Mitchell JE, Eckert ED, et al. Maintenance 

treatment and 6-month outcome for bulimic patients who 

respond to initial treatment. Am J Psychiatry 

1990;147(7):871-5. 

Call Number: Reason for exclusion: X11 

Raymond NC, de Zwaan M, Mitchell JE, et al. Effect of a 

very low calorie diet on the diagnostic category of 

individuals with binge eating disorder. Int J Eat Disord 

2002;31(1):49-56. 

Call Number: Reason for exclusion: X7 

Reeves RS, McPherson RS, Nichaman MZ, et al. Nutrient 

intake of obese female binge eaters. J Am Diet Assoc 

2001;101(2):209-15. 

Call Number: Reason for exclusion: X6 

Rissanen A, Naukkarinen H, Virkkunen M, et al. 

Fluoxetine normalizes increased cardiac vagal tone in 

bulimia nervosa. J Clin Psychopharmacol 1998;18(1):26-

32. 

Call Number: Reason for exclusion: X1 

Rivera-Nieves J, Kozaiwa K, Parrish CR, et al. Marked 

transaminase elevation in anorexia nervosa. Dig Dis Sci 

2000;45(10):1959-63. 

Call Number: Reason for exclusion: X1 

Rollins N, Piazza E. Anorexia nervosa: A quantitative 

approach to follow-up. J Am Acad Child Psychiatry 

1981;20(1):167-83. 

Call Number: Reason for exclusion: X6 

Rossiter EM, Agras WS, McCann U, et al. Are 

antidepressants appetite suppressants in bulimia nervosa? 

European Journal of Psychiatry 1991;5(4):224-31. 

Call Number: Reason for exclusion: X1 

Rossiter EM, Agras WS, Telch CF, et al. Cluster B 

personality disorder characteristics predict outcome in the 

treatment of bulimia nervosa. Int J Eat Disord 

1993;13(4):349-57. 

Call Number: Reason for exclusion: X7 

Rothschild R, Quitkin HM, Quitkin FM, et al. A doubleblind placebo-controlled comparison of phenelzine and 

imipramine in the treatment of bulimia in atypical 

depressives. Int J Eat Disord 1994;15(1):1-9. 

Call Number: Reason for exclusion: X1 
D-10 

Ruggiero GM, Mauri MC, Omboni AC, et al. Nutritional 

management of anorexic patients with and without 

fluoxetine: 1-year follow-up. Prog Neuropsychopharmacol 

Biol Psychiatry 2003;27(3):425-30 . 

Call Number: Reason for exclusion: X6 

Russell GF. Premenarchal anorexia nervosa and its 

sequelae. J Psychiatr Res 1985;19(2-3):363-9. 

Call Number: Reason for exclusion: X6 

Russell GF, Checkley SA, Feldman J, et al. A controlled 

trial of d-fenfluramine in bulimia nervosa. Clin 

Neuropharmacol 1988;11 Suppl 1:S146-59. 

Call Number: Reason for exclusion: X7 

Russell G, Dare C, Eisler I et al. Controlled trials of family 

treatments in anorexia nervosa. Halmi KAed1992:237 261. 

Call Number: Reason for exclusion: X3 

Russell JD, Mira M, Allen BJ, et al. Effect of refeeding and 

exercise in restoration of body protein in anorexia nervosa. 

Basic Life Sci 1993;60:207-10. 

Call Number: Reason for exclusion: X6 

Rytomaa I, Jarvinen V, Kanerva R, et al. Bulimia and tooth 

erosion. Acta Odontol Scand 1998;56(1):36-40. 

Call Number: Reason for exclusion: X1 

Rĺstam M. Anorexia nervosa in 51 Swedish adolescents: 

premorbid problems and comorbidity. J Am Acad Child 

Adolesc Psychiatry 1992;31(5):819-29 . 

Call Number: Reason for exclusion: X12 

Rĺstam M, Gillberg C, Garton M. Anorexia nervosa in a 

Swedish urban region. A population-based study. Br J 

Psychiatry 1989;155:642-6. 

Call Number: Reason for exclusion: X12 

Sabine EJ, Yonace A, Farrington AJ, et al. Bulimia 

nervosa: a placebo controlled double-blind therapeutic trial 

of mianserin. Br J Clin Pharmacol 1983;15 Suppl 2:195S202S. 

Call Number: Reason for exclusion: X11 

Safer DL, Lively TJ, Telch CF, et al. Predictors of relapse 

following successful dialectical behavior therapy for binge 

eating disorder. Int J Eat Disord 2002;32(2):155-63. 

Call Number: Reason for exclusion: X2 

Santonastaso P, Friederici S, Favaro A. Full and partial 

syndromes in eating disorders: A 1-year prospective study 

of risk factors among female students. Psychopathology 

1999;32(1):50-6. 

Call Number: Reason for exclusion: X6 

Santonastaso P, Friederici S, Favaro A. Sertraline in the 

treatment of restricting anorexia nervosa: an open 

controlled trial. J Child Adolesc Psychopharmacol 

2001;11(2): 143-50. 

Call Number: Reason for exclusion: X6 

Schmidt U, Cooper PJ, Essers H, et al. Fluvoxamine and 

graded psychotherapy in the treatment of bulimia nervosa: 

A randomized, double-blind, placebo-controlled, 

multicenter study of short-term and long-term 

pharmacotherapy combined with a stepped care approach 

to psychotherapy. J Clin Psychopharmacol 2004;24(5):549-

52. 

Call Number: Reason for exclusion: X3 

Schulze U, Neudorfl A, Krill A, et al. [Follow-up and 

treatment outcome of early anorexia nervosa]. Z Kinder 

Jugendpsychiatr Psychother 1997;25(1):5-16. 

Call Number: Reason for exclusion: X6 

Scrimali T, Grimali L, Corriere A, et al. [Fluoxetine in the 

pharmacological treatment of bulimia nervosa]. Rivista Di 

Psichiatria 1994;29(3):171-7. 

Call Number: Reason for exclusion: X15 

Serafinowicz E, Wasikowa R, Iwanicka Z, et al. [Bone 

metabolism in adolescent girls with short course of 

anorexia nervosa]. Endokrynol Diabetol Chor Przemiany 

Materii Wieku Rozw 2003;9(2):67-71. 

Call Number: Reason for exclusion: X1 

Serfaty MA, Turkington D, Heap M, et al. Cognitive 

therapy versus dietary counselling in the outpatient 

treatment of anorexia nervosa: Effects of the treatment 

phase. Eur Eat Disord Rev 1999;7(5):334-50. 

Call Number: Reason for exclusion: X2 

Sharp CW, Clark SA, Dunan JR, et al. Clinical presentation 

of anorexia nervosa in males: 24 new cases. Int J Eat 

Disord 1994;15(2):125-34. 

Call Number: Reason for exclusion: X6 

Smith DE, Marcus MD, Kaye W. Cognitive-behavioral 

treatment of obese binge eaters. Int J Eat Disord 

1992;12:257-62. 

Call Number: Reason for exclusion: X1 

Soomro GM, Crisp AH, Lynch D, et al. Anorexia nervosa 

in 'non-white' populations. Br J Psychiatry 

1995;167(3):385-9. 

Call Number: Reason for exclusion: X12 

Steiger H, Stotland S. Prospective study of outcome in 

bulimics as a function of Axis-II comorbidity: long-term 

responses on eating and psychiatric symptoms. Int J Eat 

Disord 1996;20(2):149-61. 

Call Number: Reason for exclusion: X1 

Steinhausen HC, Boyadjieva S, Griogoroiu-Serbanescu M, 

et al. The outcome of adolescent eating disorders: findings 

from an international collaborative study. Eur Child 

Adolesc Psychiatry 2003;12 Suppl 1:I91-8. 

Call Number: Reason for exclusion: X4 

Steinhausen HC, Seidel R. [The Berlin follow-up study of 

eating disorders in adolescence. Part 2: Intermediate-term 
D-11 

catamnesis after 4 years]. Nervenarzt 1994;65(1):26-34. 

Call Number: Reason for exclusion: X1 

Steinhausen HC, Seidel R. [The Berlin follow-up study of 

eating disorders in adolescence. Part 3: Evaluation and 

prognosis]. Nervenarzt 1994;65(1):35-40. 

Call Number: Reason for exclusion: X1 

Steinhausen HC, Seidel R, Vollrath M. [Berlin follow-up 

study of eating disorders in adolescence. I. Inpatient 

follow-up]. Nervenarzt 1993;64(1):45-52. 

Call Number: Reason for exclusion: X1 

Strasser TJ, Pike KM, Walsh BT. The impact of prior 

substance abuse on treatment outcome for bulimia nervosa. 

Addict Behav 1992;17(4):387-95. 

Call Number: Reason for exclusion: X6 

Striegel-Moore RH, Wilfley DE, Pike KM, et al. Recurrent 

binge eating in black American women. Arch Fam Med 

2000;9(1):83-7. 

Call Number: Reason for exclusion: X12 

Strober M, Freeman R, DeAntonio M, et al. Does 

adjunctive fluoxetine influence the post-hospital course of 

restrictor-type anorexia nervosa? A 24-month prospective, 

longitudinal followup and comparison with historical 

controls. Psychopharmacol Bull 1997;33(3):425-31 . 

Call Number: Reason for exclusion: X1 

Strober M, Freeman R, Morrell W. Atypical anorexia 

nervosa: separation from typical cases in course and 

outcome in a long-term prospective study. Int J Eat Disord 

1999;25(2):135-42. 

Call Number: Reason for exclusion: X1 

Swenne I, Thurfjell B. Clinical onset and diagnosis of 

eating disorders in premenarcheal girls is preceded by 

inadequate weight gain and growth retardation. Acta 

Paediatr 2003;92(10):1133-7. 

Call Number: Reason for exclusion: X6 

Szmukler GI, Brown SW, Parsons V, et al. Premature loss 

of bone in chronic anorexia nervosa. Br Med J (Clin Res 

Ed) 1985;290(6461):26-7. 

Call Number: Reason for exclusion: X6 

Telch CF, Agras WS. The effects of a very low calorie diet 

on binge eating. Behavior Therapy 1993;24:177-93. 

Call Number: Reason for exclusion: X4 

Telch CF, Agras WS, Rossiter EM, et al. Group cognitivebehavioral treatment for the nonpurging bulimic: an initial 

evaluation. J Consult Clin Psychol 1990;58(5):629-35. 

Call Number: Reason for exclusion: X4 

Theander S. Outcome and prognosis in anorexia nervosa 

and bulimia: some results of previous investigations, 

compared with those of a Swedish long-term study. J 

Psychiatr Res 1985;19(2-3):493-508. 

Call Number: Reason for exclusion: X8 

Thiels C, Schmidt U, Treasure J, et al. Four-year follow-up 

of guided self-change for bulimia nervosa. Eat Weight 

Disord 2003;8(3):212-7. 

Call Number: Reason for exclusion: X1 

Thiels C, Schmidt U, Treasure J, et al. [How effective and 

acceptable is a self-treatment manual with concomitant 

brief therapy in bulimia nervosa]. Nervenarzt 

1998;69(5):427-36. 

Call Number: Reason for exclusion: X6 

Toner BB, Garfinkel PE, Garner DM. Affective and 

anxiety disorders in the long-term follow-up of anorexia 

nervosa. Int J Psychiatry Med 1988;18(4):357-64. 

Call Number: Reason for exclusion: X1 

Toner BB, Garfinkel PE, Garner DM. Long-term follow-up 

of anorexia nervosa. Psychosom Med 1986;48(7):520-9. 

Call Number: Reason for exclusion: X1 

Treasure J, Schmidt U, Troop N, et al. First step in 

managing bulimia nervosa: controlled trial of therapeutic 

manual. BMJ 1994;308(6930):686-9. 

Call Number: Reason for exclusion: X13 

Treasure JL, Russell GF, Fogelman I, et al. Reversible bone 

loss in anorexia nervosa. Br Med J (Clin Res Ed) 

1987;295(6596):474-5. 

Call Number: Reason for exclusion: X1 

Tseng MC, Lee MB, Lee YJ, et al. Long-term outcome of 

bulimia nervosa in Taiwanese. J Formos Med Assoc 

2004;103(9):701-6. 

Call Number: Reason for exclusion: X1 

van der Ham T, van Strien DC, van Engeland H. 

Personality characteristics predict outcome of eating 

disorders in adolescents: a 4-year prospective study. Eur 

Child Adolesc Psychiatry 1998;7(2):79-84. 

Call Number: Reason for exclusion: X6 

Vandereycken W, Pierloot R. Pimozide combined with 

behavior therapy in the short-term treatment of anorexia 

nervosa. A double-blind placebo-controlled cross-over 

study. Acta Psychiatr Scand 1982;66(6):445-50. 

Call Number: Reason for exclusion: X8 

von Wietersheim J, Malewski P, Jäger B, et al. [The effects 

of psychodynamic inpatient treatments on personality data 

of patients with anorexia nervosa and bulimia nervosa - 

results of the German multicenter study (TR-EAT)]. Z 

Psychosom Med Psychother 2001;47(4):366-79 . 

Call Number: Reason for exclusion: X7 

Wadden TA, Bartlett S.J. Very low calorie diets: an 

overview and appraisal. Treatment of the Seriously Obese 

Patients. Eds. Wadden, T.A. and VanItallie, T.B. 1992;44-
D-12 

79. 

Call Number: Reason for exclusion: X6 

Waller G. Drop-out and failure to engage in individual 

outpatient cognitive behavior therapy for bulimic disorders. 

Int J Eat Disord 1997;22(1):35-41. 

Call Number: Reason for exclusion: X6 

Walsh BT, Agras WS, Devlin MJ, et al. Fluoxetine for 

bulimia nervosa following poor response to psychotherapy. 

Am J Psychiatry 2000;157(8):1332-4. 

Call Number: Reason for exclusion: X6 

Walsh BT, Gladis M, Roose SP, et al. A controlled trial of 

phenelzine in bulimia. Psychopharmacol Bull 

1987;23(1):49-51. 

Call Number: Reason for exclusion: X11 

Walsh BT, Gladis M, Roose SP, et al. Phenelzine vs 

placebo in 50 patients with bulimia. Arch Gen Psychiatry 

1988;45(5):471-5. 

Call Number: Reason for exclusion: X11 

Walsh BT, Hadigan CM, Wong LM. Increased pulse and 

blood pressure associated with desipramine treatment of 

bulimia nervosa. J Clin Psychopharmacol 1992;12(3):163-

8. 

Call Number: Reason for exclusion: X1 

Walsh BT, Stewart JW, Roose SP, et al. A double-blind 

trial of phenelzine in bulimia. J Psychiatr Res 1985;19(2-

3):485-9. 

Call Number: Reason for exclusion: X11 

Walsh BT, Stewart JW, Roose SP, et al. Treatment of 

bulimia with phenelzine. A double-blind, placebocontrolled study. Arch Gen Psychiatry 1984;41(11):1105-9. 

Call Number: Reason for exclusion: X11 

Ward A, Campbell IC, Brown N, et al. Anorexia nervosa 

subtypes: differences in recovery. J Nerv Ment Dis 

2003;191(3):197-201. 

Call Number: Reason for exclusion: X1 

Wermuth BM, Davis KL, Hollister LE, et al. Phenytoin 

treatment of the binge-eating syndrome. Am J Psychiatry 

1977;134(11):1249-53. 

Call Number: Reason for exclusion: X9 

Wheadon DE, Rampey AHJr, Thompson VL, et al. Lack of 

association between fluoxetine and suicidality in bulimia 

nervosa. J Clin Psychiatry 1992;53(7):235-41. 

Call Number: Reason for exclusion: X12 

Willi J, Giacometti G, Limacher B. Update on the 

epidemiology of anorexia nervosa in a defined region of 

Switzerland. Am J Psychiatry 1990;147(11):1514-7. 

Call Number: Reason for exclusion: X6 

Wilson GT, Eldredge KL, Smith D, et al. Cognitivebehavioral treatment with and without response prevention 

for bulimia. Behav Res Ther 1991;29(6):575-83. 

Call Number: Reason for exclusion: X1 

Wilson GT, Rossiter E, Kleifield EI, et al. Cognitivebehavioral treatment of bulimia nervosa: a controlled 

evaluation. Behav Res Ther 1986;24(3):277-88. 

Call Number: Reason for exclusion: X1 

Wisniewski L, Epstein LH, Marcus MD, et al. Differences 

in salivary habituation to palatable foods in bulimia nervosa 

patients and controls. Psychosom Med 1997;59(4):427-33. 

Call Number: Reason for exclusion: X7 

Witcher DB, Williamson DA. Duration of bulimia nervosa 

and symptom progression: a retrospective analysis of 

treatment-seeking bulimics. J Subst Abuse 1992;4(3):255-

61. 

Call Number: Reason for exclusion: X6 

Wolf EM, Crowther JH. An evaluation of behavioral and 

cognitive-behavioral group interventions for the treatment 

of bulimia nervosa in women. Int J Eat Disord 

1992;11(1):3-15. 

Call Number: Reason for exclusion: X11 

Wong JC, Lewindon P, Mortimer R, et al. Bone mineral 

density in adolescent females with recently diagnosed 

anorexia nervosa. Int J Eat Disord 2001;29(1):11-6. 

Call Number: Reason for exclusion: X6 

Wong S, Au B, Lau E, et al. Osteoporosis in Chinese 

patients with anorexia nervosa. Int J Eat Disord 

2004;36(1):104-8. 

Call Number: Reason for exclusion: X1 

Wood A. Pharmacotherapy of bulimia nervosa--experience 

with fluoxetine. Int Clin Psychopharmacol 1993;8(4):295-

9. 

Call Number: Reason for exclusion: X3 

Yanovski SZ, Gormally JF, Leser MS, et al. Binge eating 

disorder affects outcome of comprehensive very-lowcalorie diet treatment. Obes Res 1994;2(3):205-12. 

Call Number: Reason for exclusion: X4 

Yanovski SZ, Sebring NG. Recorded food intake of obese 

women with binge eating disorder before and after weight 

loss. Int J Eat Disord 1994;15(2):135-50. 

Call Number: Reason for exclusion: X2 

Zipfel S, Seibel MJ, Löwe B, et al. Osteoporosis in eating 

disorders: a follow-up study of patients with anorexia and 

bulimia nervosa. J Clin Endocrinol Metab 

2001;86(11):5227-33. 

Call Number: Reason for exclusion: X1 

Zuercher JN, Cumella EJ, Woods BK, et al. Efficacy of 

voluntary nasogastric tube feeding in female inpatients with 
D-13 

anorexia nervosa. JPEN J Parenter Enteral Nutr 

2003;27(4):268-76. 

Call Number: Reason for exclusion: X2 
Appendix E. Acknowledgments 

E-1 

Appendix E. Acknowledgments 

This study was supported by Contract 290-02-0016 from the Agency for Healthcare Research 

and Quality (AHRQ), Task No. 7. We acknowledge the continuing support of Kenneth Fink, 

J.D., M.A., former Director of the AHRQ Evidence-Based Practice Center (EPC) Program, and 

Marian D. James, Ph.D., M.A., the AHRQ Task Order Officer for this project. 

The investigators deeply appreciate the considerable support, commitment, and contributions 

of the EPC team staff at RTI International and the University of North Carolina (UNC). From 

UNC, we thank EPC Co-Director, Timothy S. Carey, M.D., M.P.H.; EPC Literature Search 

Specialist, B. Lynn Whitener, Ph.D., and Leah Randolph, M.A., and Laura Morgan, M.A., 

Research Assistants. We would like to thank the abstractors: Jennifer Best, Ph.D., Jennifer 

McDuffie, Ph.D., Thomas Raney, Ph.D., Lauren Reba, B.A., Jennifer Shapiro, Ph.D., and Hemal 

Shroff, Ph.D. We also acknowledge assistance from Kelly Beth Bowker and Michele Crisafuli. 

We express our gratitude to Loraine Monroe, EPC word processing specialist, at RTI 

International. 

Technical Expert Panel 

We extend our appreciation to the members of our Technical Expert Panel (TEP), who 

provided advice and input during our research process. The RTI-UNC EPC team solicited the 

views of TEP members from the beginning of the project. TEP members also provided insights 

into and reactions to work in progress and advice on substantive issues or possibly overlooked 

areas of research. TEP members participated in refining the analytic framework and key 

questions and discussing the preliminary assessment of the literature, including 

inclusion/exclusion criteria, and also provided input on the information and categories, including 

evidence tables. The TEP was both a substantive resource and a “sounding board” throughout 

the study. It was also the body from which expertise was formally sought at several junctions. 

TEP members are listed below: 

Lisa Begg, Dr. P.H., R.N. 

Director of Research Programs 

Office of Research on Women's Health 

Mark Chavez, Ph.D. 

Associate Director, Research Training and Career Development Program 

Chief of the Sleep, Mood, and eating Disorders Program Chief of the Side Effects of Psychiatric 

Therapeutics Program Division of Adult Translational Research and Treatment Development 

National Institute of Mental Health National Institutes of Health 

Mary Gee 

Chair, Family Action Council Eating Disorder Center 
E-2 

Craig L. Johnson, Ph.D. 

Director, Eating Disorders Program 

Laureate Psychiatric Clinic and Hospital 

Richard E. Kreipe, M.D. 

Chief of Adolescent Medicine, University of Rochester 

Society for Adolescent Medicine Representative 

James Lock, M.D., Ph.D. 

Associate Professor of Child Psychiatry and Pediatrics 

Stanford University School of Medicine 

Director, Eating Disorders Program for Children and Adolescents 

Lucile Salter Packard Children's Hospital At Stanford 

Marsha D. Marcus, Ph.D. 

Director, University of Pittsburgh Eating Disorders Program 

Cheryl L. Rock, Ph.D., R.D. 

Professor, Department of Family and Preventive Medicine 

University of California, San Diego 

Mary Tantillo, Ph.D., R.N. 

Clinical Associate 

University of Rochester 

Director of Eating Disorders Program 

Unity Health System 

Dept of Psychiatry and Behavioral Health 

B. Timothy Walsh, M.D. 

Director, Eating Disorder Research Unit 

New York State Psychiatric Institute 

Joel Yager, M.D. 

Psychiatrist, University of New Mexico 

American Psychiatric Representative 
E-3 

Peer Reviewers 

We submitted this report to external peer review to experts in the field. The names and 

affiliations of peer reviewers are listed below: 

Paula Adams Hillard, M.D. 

American College of Obstetricians and Gynecologists 

Lisa Begg, Dr. P.H., R.N. 

Director of Research Programs 

Office of Research on Women's Health 

Mark Chavez, Ph.D. 

Associate Director, Research Training and Career Development Program 

Chief of the Sleep, Mood, and eating Disorders Program Chief of the Side Effects of Psychiatric 

Therapeutics Program Division of Adult Translational Research and Treatment Development 

National Institute of Mental Health National Institutes of Health 

Jeanine Cogan, Ph.D. 

Policy Director, Eating Disorders Coalition 

Scott Crow, MD, F.A.E.D. 

Academy of Eating Disorders 

Mary Gee 

Chair, Family Action Council Eating Disorder Center 

David Herzog 

Psychiatrist and Pediatrician 

Director, Harvard Eating Disorders Center 

Past President, Eating Disorders Coalition 

Craig L. Johnson, Ph.D. 

Director, Eating Disorders Program 

Laureate Psychiatric Clinic and Hospital 

Ellen Kerber, M.D. 

Vice President, Anna Westin Foundation 

Richard E. Kreipe, M.D. 

Chief of Adolescent Medicine, University of Rochester 

Society for Adolescent Medicine Representative 

James Lock, M.D., Ph..D. 

Associate Professor of Child Psychiatry and Pediatrics 

Stanford University School of Medicine and 
E-4 

Director, Eating Disorders Program for Children and Adolescents 

Lucile Salter Packard Children's Hospital At Stanford 

Marsha D. Marcus, Ph.D. 

Director, University of Pittsburgh Eating Disorders Program 

Sabrina Matoff-Stepp, M.A. 

Director, HRSA Office of Women’s Health 

Kimberly McCallum, M.D. 

Board of Directors, International Association for Eating Disorder Professionals 

James Mitchell, M.D. 

Chairman, Department of Neuroscience 

President, Neuropsychiatric Research Institute Fargo, ND 

Pauline Powers, M.D. 

President, National Eating Disorders Association 

Sarah Pritts, M.D. 

American Academy of Family Practice 

Ruth Streigel-Moore, Ph.D. 

Co-Chair, Wesleyan University F.A.E.D. 

Mary Tantillo, Ph.D., R.N. 

Director, Unity Eating Disorders Program 

B. Timothy Walsh, M.D. 

Director, Eating Disorder Research Unit 

New York State Psychiatric Institute 

Joel Yager, M.D. 

Psychiatrist, University of New Mexico 

American Psychiatric Representative 

Susan Yanovski, M.D. 

Director, National Institute of Diabetes and Digestive and Kidney Diseases