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 5,021- to 6,276-kJ/d diet (1,200 to 1,500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4,184-kJ/d diet (1,000-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 < 0.05) 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 < 0.05) 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 < 0.05 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 < 0.05 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.

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