Terry Son Mercer University October 28, 2011

1. EFFECTIVENESS OF PRIMARY CARE-RELEVANT TREATMENTS FOR OBESITY IN ADULTS: A SYSTEMATIC EVIDENCE REVIEW FOR THE U.S PREVENTIVE SERVICESLEBLANC ES, O’CONNOR E, WHITLOCK EP, PATNODE CD, KAPKA T ANN INTERN MED. 2011;155:434-4FUNDING: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY Terry Son Mercer University October 28, 2011

2. Objective • To summarize the effectiveness and harms of primary care-relevant weight-loss interventions for overweight and obese adults

3. Background • Obesity (BMI > 30 kg/m2) is high in the U.S. exceeding 30% in most age and sex-specific groups • 2007-2008—32% men and 36% women were obese • Prevalence of obesity and of overweight have increased by 134% and 48%, respectively since 1976-1980 http://resources0.news.com.au/images/2011/03/30/1226030/4795

4. Background • Obesity is associated with: • increased mortality, especially in adults <65 years • Coronary heart disease • Type 2 diabetes • Certain types of cancer http://medicineworld.org/news/news-archives/438941683-April-15-2009.html

5. Background • 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 http://neuroscene.com/wp-content/uploads/2011/08/obesity.jpg

6. Background • 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

7. Background • The study did a systematic review to help update the recommendations • Developed an analytic framework with 4 key questions

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

10. 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

11. Results • Key Question 1: Screening for Obesity/Overweight • No trials identified in comparing screening vs no screening for adult obesity

12. Results Patient Characteristics for KQs 2&3 • Behavioral trial participants: • Mean BMI 25 –39 kg/m² • 34-70 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

13. Results • Key Questions 2 & 3: Benefits of Weight-Loss Interventions k k k 1/3 of trials: not included in a weight-loss meta-analysis due to missing information * P = Participants **BI = Behavioral interventions

18. Results • 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, 174 • 18 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)

20. Authors’ Conclusion • 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

21. Commentary • 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

22. Commentary • 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 12-18 months may be clinically significant in pre-diabetes patients • Caution: Orlistat and metformin may cause GI adverse events • Behavioral intervention treatments were safer

23. A closer look at classification of recommendations and level of evidence • Recommendation in favor of treatment or procedure being useful/effective • Some conflicting evidence from multiple randomized trials or meta-analyses

24. EFFECTIVENESS OF PRIMARY CARE-RELEVANT TREATMENTS FOR OBESITY IN ADULTS: A SYSTEMATIC EVIDENCE REVIEW FOR THE U.S PREVENTIVE SERVICESLEBLANC ES, O’CONNOR E, WHITLOCK EP, PATNODE CD, KAPKA T ANN INTERN MED. 2011;155:434-4FUNDING: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY Terry Son Mercer University October 28, 2011