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

Appolinario JC, Bacaltchuk J, Sichieri R, et al. — Sat, 01 Nov 2003 00:00:00 GMT

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.

JAMA Psychiatry: Obesity Treatment Topic Collection

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