EFFECTIVENESS OF PRIMARY CARE- RELEVANT TREATMENTS FOR OBESITY IN ADULTS: A SYSTEMATIC EVIDENCE REVIEW FOR THE U.S PREVENTIVE SERVICES LEBLANC ES, OCONNOR E, WHITLOCK EP, PATNODE CD, KAPKA T ANN INTERN MED. 2011;155:434-4 FUNDING: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY Terry Son Mercer University October 28, 2011

O BJECTIVE To summarize the effectiveness and harms of primary care-relevant weight-loss interventions for overweight and obese adults

B ACKGROUND Obesity (BMI > 30 kg/m2) is high in the U.S. exceeding 30% in most age and sex-specific groups % men and 36% women were obese Prevalence of obesity and of overweight have increased by 134% and 48%, respectively since

B ACKGROUND Obesity is associated with: increased mortality, especially in adults <65 years Coronary heart disease Type 2 diabetes Certain types of cancer

B ACKGROUND In 2003, the U.S. Preventive Services Task Force (USPSTF) recommended that clinicians: Screen all adults for obesity and Offer intensive counseling and behavioral interventions neuroscene.com/wp-content/uploads/2011/08/obesity.jpg

B ACKGROUND According USPSTF: Insufficient evidence to recommend for or against moderate or low-intensity counseling together with behavior interventions to promote sustained weight loss in obese adults Evidence was insufficient to recommend for or against counseling of any intensity and/or behavioral interventions to promote sustained weight loss in over-weight adults

B ACKGROUND The study did a systematic review to help update the recommendations Developed an analytic framework with 4 key questions

KQ1 Asked whether primary care screening programs to identify obesity or over-weight in adults improved health or physiologic outcomes or resulted in weight loss. KQ2 Asked whether primary care weight-loss interventions (behaviorally based with or without pharmacologic adjuncts) improved health outcomes. KQ3 Asked whether primary care weight-loss interventions (behaviorally based with or without pharmacologic adjuncts) resulted in short-term (12 to 18 months) or long term (>18 months) weight loss, with or without improved physiologic measures KQ4 Asked whether primary care weight-loss interventions (behaviorally based with or without pharmacologic adjuncts) caused harm or adverse events

D ESIGN 6498 abstracts reviewed 648 articles reviewed against pre-specified inclusion and exclusion criteria Included trials were appraised as good, fair, or poor quality

DESIGN Key Questions 1-3 Randomized controlled clinical trials with interventions focused on weight loss in adults 18 years in settings relevant to primary care settings Key Question 4 Large cohort or case-control studies Large event monitoring Systematic evidence reviews of RCTs (randomized controlled trials) Did not require 12 months of follow-up

R ESULTS Key Question 1: Screening for Obesity/Overweight No trials identified in comparing screening vs no screening for adult obesity

R ESULTS Behavioral trial participants: Mean BMI 25 –39 kg/m² years-old 60% female <40% non-white Orlistat trial participants: 66% female <12% non-white Metformin trial participants: Only one reported ethnicity; 45.3% non-white Baseline BMI across all trials: 31.9 kg/m² 55% of behavioral trials and 57% orlistat trials had clinical or subclinical cardiovascular risk factors Metformin trials examined participants with diabetes risk factors Patient Characteristics for KQs 2&3

R ESULTS Key Questions 2 & 3: Benefits of Weight-Loss Interventions 58 trials (identified benefits of weight- loss interventions) 38 trials (13,495 P*) 18 trials (11,256P*) 3 trials (2,652 P*) BI** Orlistat + BI** Metformin + BI** * P = Participants **BI = Behavioral interventions k 1/3 of trials: not included in a weight-loss meta-analysis due to missing information kk

R ESULTS Key Question 4: Harms of Weight-Loss Interventions Behavioral Intervention Studies: Total participants: not specified 10 studies used (not specified) Weight loss reduced total or hip bone mineral density in 3 fair-to good- quality trials Orlistat (+ Behavioral Interventions): Total participants: 12, RCTs included from KQs2 &3 5 additional studies not included in KQs 2 &3 Metformin (+ Behavioral Interventions): Total participants : 2,712 4 trials included (3 from KQs 2&3 and 1 additional RCT)

A UTHORS C ONCLUSION No direct evidence on benefits and harms of primary care- based obesity screening Behavioral weight-loss interventions with or without orlistat or metformin yielded clinically meaningful weight loss

C OMMENTARY Strengths Contained analytic framework with 4 key questions Included meta-analysis Included sufficient trials for meta-analysis of behavioral interventions on weight change data Limitations: Few studies reported health outcomes Behaviorally based treatments were heterogeneous and specific elements were not well-described Medication trials were inadequately powered for rare adverse effects Meta-analysis were not performed on some studies Did not specifically define behavioral interventions Limited good quality trials

C OMMENTARY Long-term weight and health outcomes data were lacking and should be studied Research should clarify which benefits are derived specifically from weight loss itself or from behavioral mediators, such as physical activity or dietary changes Weight loss of 6.6 lbs in months may be clinically significant in pre-diabetes patients Caution: Orlistat and metformin may cause GI adverse events Behavioral intervention treatments were safer

A closer look at classification of recommendations and level of evidence CLASS IIa Benefit >> Risk Additional studies with focused objectives needed It is REASONABLE to perform procedure/administer treatment CLASS IIb Benefit risk Additional studies with broad objectives needed; additional registry data would be helpful Procedure/Treatment MAY BE CONSIDERED LEVEL A Multiple populations evaluated Data derived from MULTIPLE randomized clinical trials or META-ANALYSES Recommendation in favor of treatment or procedure being useful/effective Some conflicting evidence from multiple randomized trials or meta-analyses Recommendations usefulness/efficacy less well established Greater conflicting evidence from multiple randomized trials or meta-analyses LEVEL B Limited populations evaluated Data derived from a SINGLE randomized trial or NONRANDOMIZED studies Recommendation in favor of treatment or procedure being useful/effective Some conflicting evidence from a single randomized trial or nonrandomized studies Recommendations usefulness/efficacy less well established Greater conflicting evidence from a single randomized trial or nonrandomized studies LEVEL C Very limited populations evaluated Only consensus opinion of experts, case studies, or standard or care Recommendation in favor of treatment or procedure being useful/effective Only diverging expert opinion, case studies, or standard of care Recommendations usefulness/efficacy less well established Only diverging expert opinion, case studies, or standard of care Recommendation in favor of treatment or procedure being useful/effective Some conflicting evidence from multiple randomized trials or meta- analyses

EFFECTIVENESS OF PRIMARY CARE- RELEVANT TREATMENTS FOR OBESITY IN ADULTS: A SYSTEMATIC EVIDENCE REVIEW FOR THE U.S PREVENTIVE SERVICES LEBLANC ES, OCONNOR E, WHITLOCK EP, PATNODE CD, KAPKA T ANN INTERN MED. 2011;155:434-4 FUNDING: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY Terry Son Mercer University October 28, 2011