NATIONAL TRENDS IN RECOMMENDED CARDIAC MEDICATIONS. R. Stafford 1 , C. Chaisson 1 ; 1 Massachusetts General Hospital, Boston, MA PURPOSE: Previous studies suggest that recommended cardiac medications are underutilized. We evaluated recent national patterns of medication use in the ambulatory care setting for warfarin use in atrial fibrillation (AF), beta blocker (BB) and aspirin (ASA) use in coronary artery disease (CAD), and ACE inhibitor use (ACEI, including angiotensin receptor blockers) in congestive heart failure (CHF). METHODS: We used the 1989 ± 1998 National Ambulatory Medical Care Surveys to identify nationally representative samples consisting of patients with AF, CAD and CHF who lacked specific contraindications to therapy. For AF, 1,370 office visits were identified; for CAD, 8,773 visits (for BB) and 8,808 visits (for ASA); and for CHF, 3,310 visits. We examined time trends in the proportion of visits reporting the selected medications, weighted to reflect national patterns. Logistic regression was used to evaluate the independent predictors of cardiac medication use in 1995 ± 1998, including patient and physician characteristics. RESULTS: In patients with AF, warfarin use increased steadily from 13% of visits in 1989 to 38% in 1994 to 50% in 1998 (see Table) . In CAD patients, BB use increased from 16% in 1989 to 19% in 1994 to 33% in 1998 . ASA use in CAD was 11% in 1989 increasing to 22% in 1992 where it plateaued, reaching 25% in 1998. In CHF patients, ACEI use increased slowly from 22% in 1989 to 28% in 1994 to 32% in 1998. Patterns of medication use for 1995 ± 98 varied by patient and physician characteristics. Women were less likely to be taking warfarin for AF (OR=0.35 P=0.06) or ASA for CAD (OR=0.79 P=0.04). Nonwhite CAD patients were less likely to take BB (OR=0.68 P=0.03) or ASA (OR=0.69 P=0.05) than were whites. The oldest and youngest patients tended to be less likely to receive medications than those aged 60 ± 69; this was most dramatic for BB in CAD in those 80+ (OR=0.57 P < 0.001). Patients with CAD visiting cardiologists were more likely to receive recommended drugs. CONCLUSION: Recommended cardiac medication use increased from 1989 to 1998, but some increases have not continued into the late 1990's and have not been uniform across subpopulations. Further adoption of these effective therapies could result in additional benefit for patients with cardiac conditions. identified by ICD-9 codes. Our outcome measure was the pattern of medication use for these conditions. In comparing indemnity and managed care, we used logistic regression to adjust for case-mix: patient age, gender, number of physician visits, Diagnostic Care Group (DxCG) risk score, and a series of DxCG co-morbidity indicators. RESULTS: With few exceptions, the use of chronic disease medications was more likely among managed care patients. For patients with DM, managed care plans had greater use of sulfonylureas than indemnity (42% vs. 37%), metformin (26% vs. 17%) and troglitizone (9% vs. 6%). In multivariate analysis to adjust for case-mix, these differences remained significant (p < 0.001). Insulin use was no different in managed care and indemnity plans. For CHF patients, managed care patients had greater use of loop diuretics (44% vs. 39%), ACE inhibitors/ARBs (50% vs. 39%), and beta-blockers (25% vs. 16%); differences that were significant in multivariate analysis (p < 0.001, except loop diuretics [p=0.003]). No differences in digoxin use were observed. For asthma patients, managed care had greater use of inhaled corticosteroids (33% vs. 28%), systemic corticosteroids (18% vs. 15%), short-acting betaagonists (41% vs. 31%), long-acting beta agonists (10% vs. 8%), and leukotriene modifiers (5.3% vs. 3.9%); differences that were significant in multivariate analysis (p < 0.001, except for long-acting beta agonists [p=0.03] and leukotriene modifiers [p=0.04]). No differences were found for cromolyn or methylxanthine use. CONCLUSION: Chronic disease patients in managed care plans are more likely to receive a broad range of medications. Three of 4 exceptions to this pattern are older medications whose use has been partly supplanted by newer therapies. The general pattern of greater medication use in managed care could reflect patient selection, reduced out-of-pocket cost barriers, or a strategy to avoid other, more costly services. Managed care plans do not appear to withhold expensive, newer medications. The emphasis on screening and minimally invasive breast techniques has led to an increase in detection of both benign and malignant breast disease. Optimal management for benign breast disease remains uncertain, and population-based studies of surgical intervetions are lacking. This study uses population-based administrative data to examine use of excisional breast procedures across 5 states and 7 years, comparing benign to malignant breast diagnoses. METHODS: Data are from the Healthcare Cost and Utilization Project, a federal-stateindustry partership in administrative data. Ambulatory surgery(AS) and inpatient(IP) data are used from CO, CT, MD, NJ and NY for 1990 ± 1996. All women with a lumpectomy(ICD-9 85.21) or subtotal mastectomy(85.22, 85.23) were extracted. Lumpectomy(LUMP) and subtotal mastectomy(STMAS) were further classified as either benign disease or cancer using diagnoses codes. Overall IP and AS age-adjusted rates per 100,000 women for each state, year and procedure were calculated using direct standardization. RESULTS: The rates of breast conserving surgery(LUMP+STMAS)for breast cancer increased across all five states, from between 33 ± 71/100,000 women in 1990 to between 70 ± 140/100,000 women in 1996. The rate of LUMP is 3 to 4 fold higher for benign disease as compared to that for cancer in every state. For instance, in 1996, the rate of LUMP in NY for cancer was 91/ 100,000 women, while for benign disease, 271/100,000. However, in contrast to cancer, the rate of LUMP for benign disease is relatively stable across all of the states and years. The overall rate of STMAS is one-tenth that of LUMP in all the states. Similar to LUMP, the rate of STMAS for benign disease was stable across time. However, there was a great deal of variation among the states in use of STMAS for benign breast disease. The rate varied from a negligible rate in CO, to as high as 50/100,000 women in CT in 1996. In addition, for CT and NJ there were equal rates of STMAS for benign and cancer diagnoses(50 and 27/100,000 respectively), while the STMAS rate for cancer was higher in the other 3 states. CONCLUSION: This is the first population-based study comparing interventions for benign breast disease to cancer. This study demonstrates unexpectedly high rates of surgical interventions (LUMP and STMAS) for benign breast disease. These rates may be explained by women and physician fear of missed cancer diagnoses, lack of best practices, upcoding of procedures, or AS data not capturing cancer at discharge for short stays. However, the latter would indicate a lack of two-stage decision-making process for women. PURPOSE: Anecdotal reports have highlighted the stories of patients who skip doses or otherwise avoid using their medications because they cannot afford the expense. However, little is known about which elderly patients without prescription coverage are at highest risk of not taking their medications because of cost, and how prescription coverage modifies this risk. METHODS: We performed a cross-sectional study of 4896 subjects in the 1995 ± 1996 wave of the Survey of Asset and Health Dynamics Among the Oldest Old (AHEAD), a population-based survey of Americans age 70 years and older. Subjects were asked the extent of their prescription coverage, and whether they had taken less medicine than prescribed for them because of cost over the prior 2 years. We used bivariate and multivariate analyses to identify risk factors for restricting one's use of medications because of cost in subjects who lacked prescription coverage. Among subjects with these risk factors, we then examined the effect of prescription coverage on rates of medication restriction. RESULTS: Of 4896 seniors who regularly used prescription medications, 39% had no prescription coverage, 44% had partial coverage, and 17% had full coverage. Not taking medications because of cost was reported by 8%, 3%, and 2% of patients with no, partial, and full prescription coverage, respectively (p < .01 for trend). Among subjects with no prescription coverage, the strongest independent predictors of foregoing medications because of cost were ethnicity (prevalence of restriction 21% for minority subjects, 6% for white subjects, P < .01), income (16% for annual income < $10,000, 8% for $10,000 to $19,999, 4% for !$20,000, P < .01), and out-of-pocket prescription drug costs (13% for monthly cost > $100, 7% for $20 to $100, 3% for < $20, P < .01). Prescription coverage markedly reduced the rate of medication restriction in these high-risk groups. For example, rates of medication restriction in minority and low-income subjects were 21% and 16% among those with no coverage, 8% and 8% among those with partial coverage, and 4% and 2% among those with full coverage, respectively (p < .001). Almost half (43%) of minority patients with low income, high drug costs, and no prescription coverage reported restricting their use of medications, compared with 12% of patients with these three risk factors and partial prescription coverage. CONCLUSION: Restricting one's use of medications because of cost is common in vulnerable groups of seniors who lack prescription coverage. Among these high-risk groups, prescription coverage markedly reduces the rate of medication restriction. PURPOSE: Hospital contact isolation policies are designed to prevent the nosocomial transmission of infectious diseases, but may inadvertently promote the neglect of isolated patients. We tested whether the frequency and quality of recorded vital signs differed between isolated and non-isolated inpatients. METHODS: We identified consecutive adults admitted to a large Canadian teaching hospital between January 1, 1999 and January 1, 2000 who were placed in contact isolation during their hospital stay (n=81). Controls were selected by identifying the two patients who occupied each isolated patient's hospital bed immediately before and after their admission (n=162). Vital signs recorded in the medical records were compared for the two groups using t tests. Adjustments for age, gender, Charlson Comorbidity Score, living status (nursing home vs. home) and admitting service (medicine vs. surgery) were done using propensity score matching. RESULTS: We found no difference in the frequency of daily vital signs ordered for isolated and non-isolated patients (2.8 vitals/day vs. 3.2 vitals/day, p > 0.20). However, isolated patients had a significantly higher percentage of their vital signs incompletely recorded (missing at least one of heart rate, blood pressure, respiratory rate or temperature) as compared to non-isolated patients (17.3% vs. 12.7%, p=0.03). Both groups had surprisingly high percentages of their respiratory rates recorded as twenty (53.2% vs. 50.9%, p > 0.20). CONCLUSION: Patients placed in contact isolation appear to have their vital signs ordered as frequently though not recorded as completely as non-isolated patients. Differences in the recording of vital signs may reflect underlying differences in the quality of care received by isolated patients and warrant further investigation. OBJECTIVE: Several studies have previously reported that patients want their physicians to address spiritual issues as part of their health care. It has also been reported that patients feel their individual spiritual faith can help them recover from illness. Surveys of physicians have shown that they often do not routinely address these issues with patients. We sought to examine patient and physician perceptions regarding inclusion of religiosity and spirituality in the medical encounter. METHODS: We surveyed primary care physicians and patients in primary care clinics at 7 sites in 4 states (NC, FL, GA, VT). For the patient survey, a trained research assistant verbally administered a 112 item survey that included questions pertaining to demographics, health status, utilization of health care, physical function (SF-36), and a religious/spiritual assessment (Spiritual Well Being, or SWB) scale. Physician surveys were mailed to primary care faculty, residents, and recent graduates at the same 7 sites. Bivariate analyses were done to examine associations between patient/physician characteristics and questions regarding the impact of prayer on health outcomes. RESULTS: 299 patients and 444 physicians were surveyed. Patients' ages ranged from 19 ± 86 years. Fifty-six percent were male, 46% were African-American, 51% Caucasian, and 63% were Protestant. Fifty-three percent of the patients surveyed had annual incomes of $20,000 or less. Of the physicians, 45% were in practice, and 55% were residents/fellows. Forty-five percent were Protestant. Fifty-three percent work in an academic setting. Of the patients, 30% felt that praying with their doctor would improve their own health. Thirty-nine percent of patients vs. 19% of physicians agreed that their doctor praying for them would improve their health. In addition, 42% felt that praying for their doctor would improve their own health, while 32% of physicians felt that patient prayer for them would help them provide better health care. Nearly half of physicians felt that patients who prayed for themselves or had strong religious/spiritual beliefs would have improved health outcomes. Fifty-three percent of patients as compared to 19% of physicians agreed that faith alone can cure disease. Bivariate analyses in the patient sample showed that the perception that prayer improves health outcomes is associated with higher attendance of organized worship services, hospitalization within the past year, higher score on the SWB scale, and lower total household income. In the physician surveys, bivariate analyses associated the equivalent perceptions with attendance of organized worship services and higher SWB score. CONCLUSION: A significant percentage of patients perceive that prayer (whether it is done by their doctor, with their doctor, or for their doctor) is linked to improvements in health. Although there are a significant number of physicians who perceive that prayer is linked to improved health outcomes, there is still a large disparity in the prevalence of physicians compared to patients who share this perception. These data suggest that a more reliable quantification of the benefit of spiritual behavior in medical encounters might be needed to bridge this gap. The prevalence of soft tissue infections among injection drug users (IDUs) is estimated between 11% ± 32% with 40% of those presenting for care requiring hospitalization. Risk factors for hospitalization from these infections are not known. This study sought to identify factors associated with increased health care utilization. METHODS: This was a cross-sectional study of all IDUs seeking initial care for soft tissue infections at an urban, public hospital emergency department (ED) from November, 1999 through April, 2000. Demographics, infection prodrome, and clinical measures were extracted from medical records. Systemic infection was defined as temperature !388C or WBC !15,000 per milliliter, prolonged hospitalization as !2 days, and delay in seeking care as !5 days of symptoms before the ED visit. RESULTS: Two hundred forty-two patients sought initial care for IDU-related soft tissue infections. Most patients were male (64%), Caucasian (69.4%), unemployed (78%), and uninsured (52%). Soft tissue infections included abscesses (74.4%), cellulitides (31%), and infected ulcers (5%) and were mainly located on the lower arm (49.6%), deltoid (14.1%), leg (22.7%), and buttock (19.8%). Ninety-seven (40.1%) patients delayed seeking care. Systemic signs of infection were identified in 118 (48.8%) patients. Of the 97 (40.1%) patients hospitalized, 70 (72.2%) stayed 2 or more days. Ethnicity, gender, age, employment status, and homelessness were not associated with having systemic infection, with hospitalization or with prolonged hospitalization. Compared to those with other types of infection, patients with abscesses were much less likely (OR 0.13, 95% CI 0.02 ± 0.73) to be hospitalized while those with cellulitides were 3.2 times more likely (95% CI 1.47 ± 6.79) to be hospitalized and 3.8 times more likely (95% CI 1.70 ± 8.57) to be hospitalized !2 days. Among patients who delayed seeking care, those with systemic signs of infection were 5.36 times (95% CI 1.67 ± 17.19) more likely to have a prolonged hospitalization compared to those without systemic signs of infection. Prolonged hospitalization was not associated with systemic infection among those who did not delay seeking care. CONCLUSION: Among IDUs seeking ED care for soft tissue infections, systemic signs of infection after delay in seeking care, and cellulitides, were each associated with increased use of health services. Gender, ethnicity, employment status, insurance status, and homelessness did not alter the risk of hospitalization, of prolonged hospitalization, or of having systemic signs of infection. PURPOSE: Stroke is the third leading cause of death and a major cause of disability among postmenopausal women in developed countries. Although postmenopausal hormone replacement therapy (HRT) is one of the most widely prescribed drugs, it is associated with increased rates of thromboembolic events and therefore may be important etiologically in stroke. We conducted a systematic evidence review and meta-analysis for the third US Preventive Services Task Force (USPSTF) to investigate the relationship between HRT and stroke. METHODS: We searched the MEDLINE database from 1992 to 2000 for all published English language studies reporting the association between HRT and stroke. In addition, reference lists of key articles were reviewed for related studies, including those predating the search. Thirty-three observational studies met inclusion criteria and were reviewed; however, only those studies considered good or fair quality based on criteria developed by the USPSTF were included in the detailed review and meta-analyses. We identified no randomized controlled trials. We used the Bayesian data analysis framework for the meta-analysis. RESULTS: The pooled relative risk of stroke mortality in women who had ever used HRT was 0.83 (95% Cl 0.64 ± 1.05). Stroke incidence was significantly increased among ever users, with a pooled relative risk of 1. 15 (1.03 ± 1.29). On subanalyses, the risk of thromboembolic stroke was significantly elevated among women who had ever used HRT (RR 1.30 [1.10 ± 1.58]); however, not subarachnoid hemorrhage (RR 0.93 [0.69 ± 1.25]) or hemorrhagic stroke (RR 0.71 [0.25 ± 1.29] ). CONCLUSION: Studies evaluating the association between URT and stroke mortality suggest no effect. Our meta-analysis suggests an increase risk of the incidence of total stroke, largely due to thromboembolic stroke, among women with exposure to HRT. These results are consistent with preliminary findings from the Women's Health Initiative. The results are limited by the observational nature of the data and randomized controlled trials will be the most valid way of clarifying the association between stroke and HRT. METHODS: A community-based, in-person survey of Chinese women was conducted in Seattle, Washington during 1999. The total estimated response rate was 64% and the cooperation rate was 72%. Four hundred and thirty-two women in the 20 ± 79 age-group were included in this analysis. The main outcome measures were a history of at least one previous Pap smear and Pap testing within the last two years. RESULTS: Nineteen percent of the respondents had never received cervical cancer screening and 36% percent had not been screened in the previous two years. Eight characteristics were independently associated with a history of at least one Pap smear: being married, thinking Pap testing is necessary for sexually inactive women, having concerns about embarrassment or cancer being discovered, having received a physician or family recommendation, having obtained family planning services in North America, and having a female provider. The following characteristics were independently associated with recent screening: thinking Pap testing is necessary for sexually inactive women, having concern about embarrassment, having received a physician recommendation, having obtained obstetric services in North America, and having a female provider. CONCLUSION: Pap testing levels among the study respondents were well below the National Cancer Institute's Year 2000 goals. The findings suggest that cancer control interventions for ethnic Chinese women are more likely to be effective if they address multiple barriers and facilitators. Results also indicate that efforts to increase Pap testing rates among Chinese should target the health care providers who serve Asian American communities. We have randomly assigned 252 women with at least 3 months amenorrhea who experience > = 35 hot flashes per week to 3 months of daily Promensil(r) (80 mg total isoflavones), Rimostil(r) (50 mg total isoflavones), or an identical placebo. At randomization and close-out visits, participants health related quality of life is evaluated using the Medical Outcomes Study 36 Item Short Form (SF-36). Non-parametric statistical tests were used as most of the SF-36 scale scores were not normally distributed. RESULTS: Participants' mean (SD) age is 52.3 (3.1) years and they average 3.3 (4.5) years since menopause. Ten percent of the participants are African American and 84% are Caucasian. Forty-two percent had completed college and all but 2 participants had completed high school. At baseline, women in the study scored higher than age and gender equivalent normative data on the Physical Component Summary (PCS mean 51.2, median 52.9) and the Mental Component Summary (MCS mean 51.9, median 54.8). Among the 8 domains of the SF-36, the participants scored lower than population norms on only the bodily pain scale. The weekly hot flash count decreased 36% for the 232 women who have completed the 12 week protocol. The PCS was unchanged over 12 weeks, while the MCS increased 6%. Change in hot flash count was not correlated with change in any of the eight SF-36 domains or with changes in the summary components. CONCLUSION: Since the blind has not been broken, it is not possible to definitively assess the effects of these dietary supplements on health related quality of life. The lack of association between the change in hot flash count and the SF-36 scales suggests that the SF-36 may not be a sensitive measure of menopausal quality of life. PURPOSE: Chronic heart failure (CBF) is costly, morbid, and common. CHF care is often suboptimal because appropriate drug regimens are complex and should be modified according to patients' symptoms. Standard measures of CHF symptoms and health status would be a valuable tool in providing CHF care. METHODS: To assess a measure of CHF symptoms and compare it with CHF-specific and generic health status and satisfaction with care, we studied 497 veterans(80% of those eligible) who had an outpatient diagnosis of CHF, objective left ventricular systolic dysfunction, and being actively treated for CHF by their primary care physicians (PCPs). We administered the Kansas City Cardiomyopathy Questionnaire (KCCQ) (to assess CHF-specific symptoms) and the SF-36 [to obtain generic summary measures: Physical Composite Score (PCS) and Mental Composite Score (MCS)]. Symptoms were used to assign New York Heart Association (NYHA5 functional class. We also assessed patients' satisfaction with their PCP and the most recent prior outpatient PCP visit using locally validated measures; higher scores denote better status or greater satisfaction. RESULTS: Patients' mean age was 69 years; 98% were men and 86% Caucasian. Patients' had moderate to severe limitations (means: NYHA=2.6, PCS=34, MCS=54). As shown in the table, KCCQ symptoms and NYHA class were highly correlated with CHF-specific physical limitations, functional status, and PCS (p < .0001 for each but less so with MCS (p < .005). KCCQ physical limitations and functional status scores and the PCS were highly correlated, but less with the MCS (p < .005 for each). There was no correlation between satisfaction with the PCP and any symptom or health status measure. Satisfaction with the most recent primary care visit was correlated modestly with PCS and MCS (p < .0001 for each) but less strongly with symptoms (p < .05). CONCLUSION: Measures of CHF-specific and generic health status are highly correlated with each other and with severity of CHF symptoms, but they tap different aspects of patient status. But there was little impact on satisfaction with their PCPs or primary care among these veterans with CHF. These health status measures can provide important data to assess and improve the care of patients with CHF. To determine the level of interest in taking tamoxifen for the primary prevention of breast cancer among women over age 50. METHODS: We conducted a cross-sectional, one-time structured interview of women over 50 years old in outpatient geriatrics and women's health clinics at an inner-city academic medical center. Data on age, race, socioeconomic factors, comorbidities using the Charlston comorbidity index, and objective/subjective risk of breast cancer and interest in taking a breast cancer chemopreventive agent were obtained. RESULTS: From the forty-eight (48) participants enrolled in this pilot study, 31 (65%) were black, 17 (35%) white, Hispanic or other, 35 (73%) were > 65 years old. A substantial proportion, 37.5%, of older women were interested in taking preventive medication for breast cancer. Interest in taking a cancer preventive agent appeared to be higher among white women (59% vs 39%), women who have had a breast biopsy (71% vs 35%), and those who believe their risk of cancer warrants taking an agent (93% vs 24%). Of women receiving Medicare, those with additional drug coverage were more willing to take a preventive agent than those without drug coverage (61% vs 38%). Interestingly, those women who paid the highest percentage of their monthly income for medications were also the most interested in taking a breast cancer preventive agent (87.5% vs 36%). No difference was observed by educational level, income, family history, number of comorbidities, objective breast cancer risk, or personal acquaintance with a person with breast cancer. CONCLUSION: A substantial number of women in our pilot study were interested in taking a chemopreventive agent for the primary prevention of breast cancer. Interest appeared to be associated with race, subjective cancer risk, breast biopsy history, and prescription drug coverage. Given our limited numbers, further study is warranted to test the robustness of these associations. To determine the level, pattern, and factors associated with preventive medication use among women over age 50. METHODS: We conducted a cross-sectional, one-time structured interview of women over 50 years old in outpatient geriatrics and women's health clinics at an inner-city academic medical center. Data on preventive medication use, age, race, socioeconomic factors, insurance status, and comorbidities using the Charlston comorbidity index were obtained. RESULTS: From the forty-eight (48) participants enrolled in this pilot study, 31 (65%) were black, 17 (35%) white, Hispanic or other, 35 (73%) were > 65 years old. All (100%) women in this study took at least one preventive agent every day (defined as a multivitamin, calcium, hormone replacement therapy, aspirin, cholesterol lowering drug or antihypertensive (to prevent myocardial infarction or stroke)). Over 55% took at least two preventive medications a day. The frequency of medications used were: antihypertensive (69%), aspirin (50%), multivitamin (50%), calcium (35%), cholesterol lowering agent (31%), and hormone replacement therapy (15%). Women with Medicare alone versus those with Medicare plus additional drug coverage were less likely to take: 1) a cholesterol lowering agent (23% vs 46%); 2) an aspirin (38% vs 61%); and 3) an antihypertensive (69% vs 84%). Lower income women were less likely to take calcium (25% vs 53%) or a multivitamin (43% vs 65%). Older women were less likely to take a cholesterol lowering agent than younger women (0% vs. 38%), even though the same older women were much more likely to be taking an antihypertensive agent (90% vs 62%). Women cited that physician recommendation was the most important factor in deciding to take a preventive medication. Conversely, women cited that cost and insurance coverage were the least important factors. CONCLUSION: There is a high level of interest in taking preventive medications among older women. However, low-cost, proven therapies such as aspirin and calcium are underutilized. Ability to pay appears to drive decisions about medication use despite the fact that women cited cost/insurance coverage as the least important decision-making factor. Women whose Medicare lacks supplemental drug coverage were less likely to take both expensive drugs (cholesterol lowering agents) and inexpensive drugs (aspirin). Lower income women were less likely to take over the counter preparations such as calcium and multivitamins. In addition, the pattern of use of some medications appeared to be inconsistent; the very elderly women in our study, at risk for coronary artery disease as evidenced by their high rate of antihypertensive use, were not taking cholesterol lowering agents. Additional study is needed to test the robustness of our findings and to help understand how women make decisions about their medication use so that inequalities due to age or ability to pay may be addressed. We performed independent duplicate review of each study for both inclusion and data extraction. Global improvement was abstracted as a dichotomous variable. Effect on pain, fatigue and sleep were abstracted as continuous variables at 4 time points (2, 4, 8 and 12 weeks) . Analysis was done using a random effects model. Quality was assessed using the methods of Jadad. RESULTS: Six randomized, placebo-controlled trials were identified of which all were appropriate for some data extraction. Overall the quality of the studies was fair (mean score: 4.7), range 0 ± 8. The odds ratio for improvement with therapy was 3.7 (95% CI: 2.2 ± 6.3). The pooled risk difference for these studies was 0.28 (95% CI: 0.16 ± 0.40), which calculates to 3.6 (95% CI 2.5 to 6.25) individuals needing treatment for one patient to experience symptom improvement. Patients experienced improvement in pain at 2 weeks (Standardized Mean Difference: 0.44, 95% CI: 0.18 ± 0.88) but none at 4, 8 or 12 weeks. There was no significant effect on patient fatigue at any time point. Patients experienced a statistically significant improvement in sleep at all time points with SMD's ranging from 0.35 ± 0.49. Eighty-five percent of patients given cyclobenzaprine reported at least one side effect.