Lifestyle treatments in randomized clinical trials of pharmacotherapies for obesity.
OBJECTIVE
This meta-analysis evaluated the types of lifestyle treatments used in published obesity drug studies and assessed their contribution to weight losses associated with pharmacological interventions.


METHODS
Randomized, placebo-controlled, double-blind clinical trials of anti-obesity agents that are/were Food and Drug Administration-approved for the treatment of obesity (both prescription and over-the-counter), and drugs that are Food and Drug Administration-approved and are used off-label for obesity were included. Studies were located by computer searches of databases (e.g., Medline, PsychInfo) and reviewing tables of content/reference sections of journals, abstracts, previous reviews, past empirical studies, relevant book chapters, and recent issues of journals that regularly publish obesity research. In addition, a number of individuals who regularly publish in the obesity literature were asked to provide personal lists of obesity-drug studies. Based on the above criteria, a total of 108 randomized clinical trials were located.


RESULTS
Balanced-deficit diets, low-calorie diets, and self-monitoring were the most used lifestyle treatments in published obesity studies. They were incorporated into 40.7%, 25%, and 23.1% of pharmacotherapy studies, respectively. Physical activity and other behavioral or psychotherapeutic interventions rarely were used. A substantial portion of weight loss experienced by patients was attributable to both "placebo effects" and to the lifestyle treatments.


CONCLUSIONS
Obesity-pharmacotherapy trials do not use lifestyle treatments with the frequency expected based on the official positions of most professional organizations concerned with the comprehensive management of obesity.
Poston
W S
WS
Center for the Study of Health Outcomes Research and Evaluation, Mid America Heart Institute, St Luke's Hospital and University of Missouri-Kansas City, Kansas City, Missouri 64110, USA. postonwa@umkc.edu
Haddock
C K
CK
Dill
P L
PL
Thayer
B
B
Foreyt
J P
JP
D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D004038:Diet, Reducing; D006801:Humans; D008019:Life Style; D016239:MEDLINE; D009765:Obesity / Q000178:diet therapy / Q000188:drug therapy / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015431:Weight Loss / Q000502:physiology
D019440:Anti-Obesity Agents