Effect of Sibutramine on Weight Reduction in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Weight reduction, although often difficult to achieve, has been the major target for intervention in obese women with polycystic ovary syndrome (PCOS). Metformin does have salutary effects in these patients, but its value as a weight-reducing agent remains in doubt. This prospective, double-blind, placebo-controlled, multicenter trial evaluated sibutramine, a Food and Drug Administration-approved anti-obesity drug that inhibits the reuptake of serotonin and norepinephrine, thereby increasing satiety and adrenergic activity. Forty-two patients aged 18 to 40 years with confirmed PCOS and a body mass index (BMI) exceeding 27 kg/m2 were entered into the study, and 34 completed it. Participants received either 15 mg of sibutramine daily or a placebo. In addition, all patients received advice about diet and physical activity. After 6 months, patients given sibutramine had lost 7.8 kg of body weight on average, compared with 2.8 mg for placebo patients. The superiority of sibutramine became statistically significant by week 2. Similar results were obtained for BMI. Both waist and hip circumference decreased in sibutramine-treated patients, but waist/hip ratios were similar in the actively treated and placebo groups. Both sibutramine and placebo were associated with an increased number of menstrual periods. Sibutramine treatment correlated with significant reductions in levels of apolipoprotein B, the apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C. Sibutramine, when combined with lifestyle interventions, can lead to significant weight reduction in obese women with PCOS. In addition, it seems to have positive effects on metabolic and cardiovascular risk factors.