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## Complete Summary

#### GUIDELINE TITLE

Pharmacologic and surgical management of obesity in primary care: a
clinical practice guideline from the American College of Physicians.

#### BIBLIOGRAPHIC SOURCE(S)

Snow V, Barry P, Fitterman N, Qaseem A, Weiss K. Pharmacologic and
surgical management of obesity in primary care: a clinical practice
guideline from the American College of Physicians. Ann Intern Med 2005
Apr 5;142(7):525-31. \[36 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15809464)

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 2, 2007, Antidepressant
    drugs](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant):
    Update to the existing black box warning on the prescribing
    information on all antidepressant medications to include warnings
    about the increased risks of suicidal thinking and behavior in young
    adults ages 18 to 24 years old during the first one to two months of
    treatment.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Obesity (body mass index \[BMI\] [\>]{.underline}30 kg/m^2^)

#### GUIDELINE CATEGORY

Management\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Nutrition\
Surgery

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To provide recommendations based on a review of the evidence on
    pharmacologic and surgical treatments of obesity

-   To complement the guidelines on screening for obesity developed by
    the U.S. Preventive Services Task Force

#### TARGET POPULATION

Patients with a body mass index (BMI) [\>]{.underline}30 kg/m^2^

**Note**: The target patient populations vary according to the
intervention under consideration, since pharmacologic and surgical
trials have used different selection criteria with differing BMIs and
comorbid conditions. This guideline does not apply to patients with BMIs
below 30 kg/m^2^.

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Patient education and counseling

    -   Lifestyle and behavioral modifications (i.e., diet and exercise)

    -   Individual weight loss goals

    -   Possible side effects of medication and surgical options

2.  Adjunctive drug therapy

    -   Sibutramine

    -   Orlistat

    -   Phentermine

    -   Diethylpropion

    -   Fluoxetine

    -   Bupropion

> **Note**: Refer to the original guideline document for medications
> that were considered but not recommended.

3.  Surgical options

    -   Roux-en-Y gastric bypass (RYGB)

    -   Biliopancreatic bypass

    -   Laparoscopic adjustable gastric band

    -   Vertical band gastroplasty

4.  Referral as appropriate for surgery to high volume centers

#### MAJOR OUTCOMES CONSIDERED

-   Weight loss

-   Incidence and severity of weight-related comorbidities

-   Post-operative mortality

-   Adverse events (e.g., surgical complication rates)

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: This guideline
is based on the evidence reports and accompanying background papers
developed by the Southern California Evidence-Based Practice Center
(EPC) (see the \"Companion Documents\" field).

**Search Strategy**

EPC staff searched numerous electronic databases electronically,
including MEDLINE® and EMBASE, for potentially relevant studies. They
scanned the reference lists of recent extensive reviews on sibutramine,
orlistat, and bariatric surgery. They also contacted experts in the
field.

**Inclusion Criteria**

The Technical Expert Panel (TEP) suggested that the EPC assessment of
pharmacological agents include U.S. Food and Drug Administration
(FDA)-approved weight loss medications and other medications for which
reports have begun to appear regarding their use as weight loss agents.
The FDA-approved weight loss drugs are phentermine, sibutramine,
orlistat, diethylpropion, and mazindol; however, the TEP advised the EPC
to ignore mazindol, because it is no longer used. The TEP instructed
them to include only studies with treatment durations of 6 months or
longer.

To be accepted for analysis, the study had to be a randomized controlled
trial (RCT) or controlled clinical trial (CCT). For the analysis of
surgical studies, EPC staff broadened these inclusion criteria to
encompass cohort studies and case series, since the TEP and a brief scan
of the literature suggested that RCTs and CCTs would be few in number.
While acknowledging that inferences about efficacy could not be easily
made from case series, the EPC staff did judge that such studies
provided useful information in the absence of trial data, and,
furthermore, would be useful to assess complications and adverse events
of surgery. To avoid reviewing potentially numerous case reports, they
set a threshold of 10 or more patients for inclusion in the review.

#### NUMBER OF SOURCE DOCUMENTS

Staff from the Southern California Evidence-Based Practice Center (EPC)
screened 1,063 articles. They quality-reviewed 78 medication studies
that reported on sertraline (1 article), zonisamide (1 article),
orlistat (49), bupropion (5), topiramate (9), and fluoxetine (13).
Meta-analysis was performed for all medications except sertraline and
zonisamide which are summarized in the text. They quality-reviewed 159
surgery studies reporting on weight loss and considered an additional 8
surgery studies reporting only on complications, for a total of 167
surgery studies. Of these 167 studies, 20 were duplicate publication of
an already included study. Of the remaining 147 studies, 89 contributed
to the weight loss analysis, 134 contributed to the mortality analysis,
and 128 contributed to the complications analysis. Studies could
contribute to one or more surgery analyses.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis\
Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: This guideline
is based on the evidence reports and accompanying background papers
developed by the Southern California Evidence-Based Practice Center
(EPC) (see the \"Companion Documents\" field).

EPC staff abstracted data from the articles onto a specialized form,
containing questions about the study design, the number of patients and
comorbidities, dosage, adverse events, the types of outcome measures,
and the time from intervention until outcome measurement.

**Meta-Analysis: Pharmacologic Treatment**

Meta-analysis was performed for all medications except sertraline,
zonisamide, and fluoxetine, which were summarized narratively. All
pooled weight loss values were reported relative to placebo. With one
exception, long-term studies of health outcomes were lacking.
Significant side effects that varied by drug were reported (see the
\"Companion Documents\" field for detailed information on the
meta-analysis).

**Meta-Analysis: Surgical Treatment**

EPC staff assessed 147 studies. Of these, 89 contributed to the weight
loss analysis, 134 contributed to the mortality analysis, and 128
contributed to the complications analysis. The EPC identified 1 large,
matched cohort analysis that reported greater weight loss with surgery
than with medical treatment in individuals with an average body mass
index (BMI) of 40 kg/m^2^ or greater (see the \"Companion Documents\"
field for detailed information on the meta-analysis).

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published costs analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Comparison with Guidelines from Other Groups\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This guideline was approved by the American College of Physicians (ACP)
Board of Regents in October 2004.

Recommendations of Others: Recommendations from the U.S. Preventive
Services Task Force (USPSTF) were discussed.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Recommendation 1**: Clinicians should counsel all obese patients
(defined as those with a body mass index \[BMI\] [\>]{.underline}30
kg/m^2^) on lifestyle and behavioral modifications such as appropriate
diet and exercise, and the patient\'s goals for weight loss should be
individually determined (these goals may encompass not only weight loss
but also other parameters, such as decreasing blood pressure or fasting
blood glucose levels).

**Recommendation 2**: Pharmacologic therapy can be offered to obese
patients who have failed to achieve their weight loss goals through diet
and exercise alone. However, there needs to be a doctor--patient
discussion of the drugs\' side effects, the lack of long-term safety
data, and the temporary nature of the weight loss achieved with
medications before initiating therapy.

**Recommendation 3**: For obese patients who choose to use adjunctive
drug therapy, options include sibutramine, orlistat, phentermine,
diethylpropion, fluoxetine, and bupropion. The choice of agent will
depend on the side effects profile of each drug and the patient\'s
tolerance of those side effects.

**Recommendation 4**: Surgery should be considered as a treatment option
for patients with a BMI of 40 kg/m^2^ or greater who instituted but
failed an adequate exercise and diet program (with or without adjunctive
drug therapy) and who present with obesity-related comorbid conditions,
such as hypertension, impaired glucose tolerance, diabetes mellitus,
hyperlipidemia, and obstructive sleep apnea. A doctor--patient
discussion of surgical options should include the long-term side
effects, such as possible need for reoperation, gall bladder disease,
and malabsorption.

**Recommendation 5**: Patients should be referred to high-volume centers
with surgeons experienced in bariatric surgery.

#### CLINICAL ALGORITHM(S)

A clinical algorithm for managing obesity is provided in the original
guideline document.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by data from randomized controlled
trials and meta-analyses. See the evidence report and accompanying
background papers listed in the \"Availability of Companion Documents\"
field.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate pharmacologic and surgical management of obesity in primary
care

#### POTENTIAL HARMS

**Side Effects of Medications**

-   *Sibutramine*: Modest increase in heart rate and blood pressure,
    nervousness, insomnia

-   *Phentermine*: Cardiovascular, gastrointestinal

-   *Diethylpropion*: Palpitations, tachycardia, insomnia,
    gastrointestinal

-   *Orlistat*: Diarrhea, flatulence, bloating, abdominal pain,
    dyspepsia

-   *Bupropion*: Paresthesia, insomnia, central nervous system effects

-   *Fluoxetine*: Agitation, nervousness, gastrointestinal

**Surgery**

-   Mortality

-   Surgical complications

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The existing literature is almost bereft of data regarding either
    pharmaceutical or surgical treatment of adolescent and pediatric
    patients. To the extent that existing data on adults are judged to
    be inapplicable to adolescents or children, new studies will need to
    be performed.

-   Pharmacological treatment: Publication bias may exist despite a
    comprehensive search and despite the lack of statistical evidence
    for the existence of bias. Evidence of heterogeneity was observed
    for all meta-analyses.

-   Surgical treatment: Only a few controlled trials were available for
    analysis. Heterogeneity was seen among studies, and publication bias
    is possible.

-   This guideline is not intended to be used by commercial weight loss
    centers or for direct-to-consumer marketing by manufacturers.

-   Clinical practice guidelines are \"guides\" only and may not apply
    to all patients and all clinical situations. Thus, they are not
    intended to override clinicians\' judgment. All American College of
    Physicians (ACP) clinical practice guidelines are considered
    automatically withdrawn or invalid 5 years after publication or once
    an update has been issued.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Patient Resources

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Snow V, Barry P, Fitterman N, Qaseem A, Weiss K. Pharmacologic and
surgical management of obesity in primary care: a clinical practice
guideline from the American College of Physicians. Ann Intern Med 2005
Apr 5;142(7):525-31. \[36 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15809464)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 Apr 5

#### GUIDELINE DEVELOPER(S)

American College of Physicians - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American College of Physicians

#### GUIDELINE COMMITTEE

Clinical Efficacy Assessment Subcommittee (CEAS)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Vincenza Snow, MD; Patricia Barry, MD, MPH; Nick Fitterman,
MD; Amir Qaseem, MD, PhD, MHA; Kevin Weiss, MD, MPH

*Clinical Efficacy Subcommittee Members*: Kevin Weiss, MD, MPH
(*Chair*); Mark Aronson, MD; Patricia Barry, MD, MPH; Donald E. Casey
Jr., MD, MPH, MBA; J. Thomas Cross Jr., MD, MPH; Nick Fitterman, MD; E.
Rodney Hornbake, MD; Douglas K. Owens, MD; and Katherine D. Sherif, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

**Potential Financial Conflicts of Interest**: Employment: P. Barry
(Merck Institute of Aging and Health); Stock ownership: P. Barry (Merck
& Co., Inc.); Grants received: P. Barry (Merck Co. Foundation)

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Annals of Internal Medicine Web
site](http://www.annals.org/cgi/content/full/142/7/525).

Print copies: Available from the American College of Physicians (ACP),
190 N. Independence Mall West, Philadelphia PA 19106-1572.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Shekelle PG, Morton SC, Maglione M, Suttorp M, Tu W, Li Z, Maggard
    M, Mojica WA, Shugarman L, Solomon V. Pharmacological and surgical
    treatment of obesity. Summary, Evidence Report/Technology Assessment
    No. 103. (Prepared by the Southern California--RAND Evidence-based
    Practice Center, under Contract No. 290-02-0003.) AHRQ Publication
    No. 04-E028-1. Rockville, MD: Agency for Healthcare Research and
    Quality. July 2004. Electronic copies: Available from the [Agency
    for Healthcare Research and Quality (AHRQ) Web
    site](http://www.ahrq.gov/clinic/epcsums/obesphsum.htm).

-   Shekelle PG, Morton SC, Maglione MA, Suttorp M, Tu W, Li Z, Maggard
    M, Mojica WA, Shugarman L, Solomon V, Jungvig L, Newberry SJ, Mead
    D, Rhodes S. Pharmacological and Surgical Treatment of Obesity.
    Evidence Report/Technology Assessment No. 103. (Prepared by the
    Southern California-RAND Evidence-Based Practice Center, Santa
    Monica, CA, under contract Number 290-02-0003.) AHRQ Publication No.
    04-E028-2. Rockville, MD: Agency for Healthcare Research and
    Quality. July 2004. Electronic copies: Available from the [Health
    Services/Technology Assessment Text (HSTAT) Web
    site](http://www.ncbi.nlm.nih.gov/books/bv.fcgi?call=bv.View..ShowSection&rid=hstat1a.chapter.19289).

-   Li Z, Maglione M, Tu W, Mojica W, Arterburn D, Shugarman LR, Hilton
    L, Suttorp M, Solomon V, Shekelle PG, Morton SC. Meta-analysis:
    pharmacologic treatment of obesity. Ann Intern Med. 2005 Apr
    5;142(7):532-46. Electronic copies: Available from the [Annals of
    Internal Medicine Web
    site](http://www.annals.org/cgi/content/full/142/7/532).

-   Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugarman HJ,
    Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S,
    Morton SC, Shekelle PG. Meta-analysis: surgical treatment of
    obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. Electronic
    copies: Available from the [Annals of Internal Medicine Web
    site](http://www.annals.org/cgi/content/full/142/7/547)

Print copies: Available from the American College of Physicians (ACP),
190 N. Independence Mall West, Philadelphia PA 19106-1572.

#### PATIENT RESOURCES

The following is available:

-   Summaries for patients. Treating obesity with drugs and surgery: a
    clinical practice guideline from the American College of Physicians.
    Ann Intern Med 2005 Apr 5; 142(7):I-55

Electronic copies: Available from the [Annals of Internal Medicine Web
site](http://www.annals.org/cgi/content/full/142/7/I-55).

Print copies: Available from the American College of Physicians (ACP),
190 N. Independence Mall West, Philadelphia PA 19106-1572.

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on April 14, 2005. The
information was verified by the guideline developer on June 3, 2005.
This summary was updated by ECRI Institute on November 9, 2007,
following the U.S. Food and Drug Administration advisory on
Antidepressant drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

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Guidelines represented on the NGC Web site are submitted by guideline
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Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008