A randomized, double-blind, placebo-controlled study of sibutramine in the treatment of binge-eating disorder.

Author: Appolinario JC, Bacaltchuk J, Sichieri R, Claudino AM, Godoy-Matos A, Morgan C, Zanella MT, Coutinho W

Author affiliation: Obesity and Eating Disorders Group, Institute of Psychiatry, Federal University of Rio de Janeiro, Rua Visconde de Piraja 550/2002-Ipanema, Rio de Janeiro, Brazil 22410-001. appolinario@biohard.com.br

Publication date & source: 2003.11, Arch Gen Psychiatry., 60(11):1109-16.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Although antidepressants are the pharmacological agents most often studied in the treatment of binge-eating disorder (BED), preliminary evidence from an open trial suggests that the antiobesity agent sibutramine hydrochloride may be effective. The objective of this study was to evaluate the efficacy and tolerability of sibutramine in obese patients with BED. METHODS: After a 2-week run-in period, 60 obese outpatients (body mass index [calculated as weight in kilograms divided by the square of height in meters] 30-45), who met DSM-IV criteria for BED were randomly assigned to receive sibutramine hydrochloride (n = 30), 15 mg/d, or placebo (n = 30) in a 12-week double-blind study at 2 centers. The primary outcome measure was binge frequency, expressed as the number of days with binge-eating episodes during the past week. Secondary outcome measures included Binge Eating Scale, Beck Depression Inventory scores, weight, and treatment responder status (remission and response). For each efficacy outcome, an intent-to-treat analysis was performed using random regression methods. RESULTS: There was a significant reduction in the number of days with binge episodes in the sibutramine group compared with the placebo group (t203 = 2.14; P =.03); this was associated with an important and significant weight loss (-7.4 kg) compared with a small weight gain in the placebo group (1.4 kg) (t147 = 4.88; P<.001). Sibutramine was also associated with a significantly greater rate of reduction in Binge Eating Scale (t202 = 3.64; P<.001) and Beck Depression Inventory (t201 = 3.72; P<.001) scores. Dry mouth (P =.01) and constipation (P<.001) were more common adverse reactions with sibutramine than placebo. CONCLUSIONS: Sibutramine is effective and well tolerated in the treatment of obese patients with BED. Its effects address 3 main domains of the BED syndrome, ie, binge eating, weight, and related depressive symptoms.