Topiramate added to metformin for obesity control in women with polycystic ovary syndrome: a randomized clinical trial
Abstract
CONTEXT: Polycystic ovary syndrome (PCOS) is often linked with obesity, and weight management can improve endocrine and cardiometabolic features.
OBJECTIVE: This work aimed to evaluate the effects of adding topiramate (TPM) to metformin (MTF) on weight control and hormonal and metabolic outcomes in women with PCOS.
METHODS: In a randomized, double-blind, placebo-controlled trial, participants with PCOS and body mass index of 30 or greater, or 27 or greater associated with hypertension, type 2 diabetes, or dyslipidemia followed a 20 kcal/kg diet in addition to 850 mg of MTF or a previous MTF regimen. They were randomly assigned to receive either TPM or placebo (P) alongside MTF. Anthropometric measurements, blood pressure, modified Ferriman-Gallwey score (mFGS), and adverse events were assessed every 4 weeks for 6 months. The primary end point was the percentage change in body weight from baseline in both groups. Secondary end points included changes in clinical, cardiometabolic, and hormonal parameters and psychosocial features.
RESULTS: Thirty-one participants were in the MTF + P group and 30 in the MTF + TPM group. The MTF + TPM group showed greater mean weight loss at 3 months (-3.4% vs -1.6%; P = .03) and 6 months (-4.5% vs -1.4%; P = .03). Both groups had improved androgens, lipids, and psychosocial scores. Participants with 3% or greater weight loss at 6 months had improved mFGS (8.4 to 6.5; P = .026). Paresthesia was more common in the MTF + TPM group (23.3% vs 3.2%;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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