Objective: To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS).
Design: Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial.
Setting: Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice.
Patient(s): Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study.
Intervention: Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification.
Main outcome measure(s): The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors.
Result(s): After 6 months the sibutramine group had lost 7.8 +/- 5.1 kg compared with a weight loss of 2.8 +/- 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.
Conclusion(s): Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.