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Original Article
November 2003

A Randomized, Double-blind, Placebo-Controlled Study of Sibutramine in the Treatment of Binge-Eating Disorder

Author Affiliations

From the Obesity and Eating Disorders Group, Institute of Psychiatry, Federal University of Rio de Janeiro, and the Institute of Endocrinology and Diabetes of Rio de Janeiro (Drs Appolinario, Godoy-Matos, and Coutinho), and the Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro (Dr Sichieri), Rio de Janeiro, Brazil; and the Eating Disorders Program, Federal University of São Paulo, São Paulo, Brazil (Drs Bacaltchuk, Claudino, and Zanella and Ms Morgan). Dr Appolinario has received research support from Abbott Laboratórios Brasil and has been on the speakers' bureau of Janssen-Cilag Farmacêutica Brasil. Dr Bacaltchuk is an employee of Janssen-Cilag Farmacêutica Brasil. Dr Godoy-Mattos has received research support from Abbott Laboratórios Brasil, Roche Brasil, and GlaxoSmithKline Brasil and has served as a consultant for Abbott Laboratórios Brasil and Roche Brasil. Dr Zanella has received research support from Abbott Laboratórios Brasil, Roche Brasil, Pfizer, Novartis, and Merck Sharp & Dohme and has been on the advisory board of Roche Brasil. Dr Coutinho has received research support from Abbott Laboratórios Brasil and Roche Brasil and is on the advisory board of Abbott Laboratories.

Arch Gen Psychiatry. 2003;60(11):1109-1116. doi:10.1001/archpsyc.60.11.1109
Abstract

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.

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