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A Randomized Trial

Thomas A. Wadden, PhD; Robert I. Berkowitz, MD; David B. Sarwer, PhD; Richard Prus-Wisniewski, MD; Carrie Steinberg, MA

Arch Intern Med. 2001;161:218-227.

Background  Weight loss medications are recommended as an adjunct to diet and exercise modification but seem to be prescribed as a monotherapy by many physicians. This practice is likely to be associated with suboptimal weight loss.

Methods  This 1-year, randomized trial compared the effects of sibutramine hydrochloride used alone (ie, the drug-alone group) to sibutramine plus group lifestyle modification, prescribed with either a 5021- to 6276-kJ/d diet (1200-1500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4184-kJ/d diet (1000-kcal/d diet (ie, drug-plus-lifestyle with a portion-controlled diet [the combined treatment] group). Participants were 53 women with a mean (±SD) age of 47.2 ± 9.8 years and weight of 101.3 ± 9.7 kg. At baseline, they reported the number of pounds they expected to lose at the end of treatment.

Results  At month 12, patients treated with the drug alone lost (mean ± SD) 4.1% ± 6.3% of their initial body weight compared with significantly (P<.05) larger losses in the drug-plus-lifestyle group of 10.8% ± 10.3% and the combined treatment group of 16.5% ± 8.0%. Women in the 2 lifestyle groups achieved a significantly (P<.05) greater percentage of their expected weight loss than those in the drug-alone group and were significantly more satisfied with the medication and with changes in weight, health, appearance, and self-esteem (P<.05 for all). Significant reductions were observed at 12 months in triglyceride and low-density lipoprotein cholesterol levels but systolic and diastolic blood pressure both increased significantly (P<.05 for all).

Conclusion  The addition of group lifestyle modification to the pharmacologic management of obesity significantly improved weight loss and patients' satisfaction with treatment outcome.

From the Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia. Drs Wadden, Berkowitz, and Sarwer have all received speaking honoraria from Knoll Pharmaceutical Company and Hoffman-La Roche Laboratories, which manufacture sibutramine and orlistat, respectively. Drs Wadden and Berkowitz have also served as consultants to both companies, as well as to the Novartis Nutrition Company.

Corresponding author and reprints: Thomas A. Wadden, PhD, Department of Psychiatry, University of Pennsylvania School of Medicine, 3600 Market St, Suite 738, Philadelphia, PA 19104 (e-mail: Wadden{at}mail.med.upenn.edu).

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