DIETARY-SUPPLEMENTS AND A BEHAVIOR-MODIFICATION PLAN IMPROVE THE SAFETY AND EFFICACY OF PHARMACOTHERAPY

In both clinical and research settings, evaluation of the safety and e fficacy of pharmacotherapy has traditionally relied upon changes in sc ale weight, ignoring measures of body composition changes, such as in body fat and fat-free mass (FFM). No FDA studies reported changes in b ody composition during the approval process for fenfluramine and dexfe nfluramine, nor were any body composition studies reviewed in an artic le by the National Task Force on the Prevention and Treatment of Obesi ty on the safety and efficacy of long-term pharmacotherapy to manage o besity. Changes in scale weight can distort and obscure both positive and negative changes that occur in fat and FFM, which constitute an im portant screen for the safety and efficacy of a weight loss program. F urthermore, using loss of scale weight as the outcome criterion for we ight loss programs can discourage the use of a behavior modification p lan that affects scale weight losses through preservation of FFM. This study examined this potential source of bias and the extent to which integration of a behavior modification plan (which includes increased physical activity, improved dietary intake, and phytochemical glyconut ritional dietary supplements) may improve the safety and efficacy of p harmacotherapy. Dual-energy x-ray absorptiometry measurements of body composition were performed in three groups of patients before and afte r a 60-day treatment period. Results of the study demonstrate that, al though pharmacotherapy effected a significant reduction in scale weigh t, much of the loss was at the expense of FFM with no improvement in b ody composition. Conversely, the use of nutritional supplements and a behavior modification plan led to a preservation of FFM and significan t improvement in body composition. In view of the widespread disregard of behavior modification programs in weight loss treatment plans that incorporate pharmacotherapy, these results offer another perspective on the success or failure of a weight loss program.