861-P: Efficacy of Digital Intervention vs. Metformin for Women with Polycystic Ovary Syndrome—A Randomized Clinical Trial
Abstract
Objective: To evaluate the efficacy of digital intervention versus metformin treatment for women with polycystic ovary syndrome (PCOS) with insulin resistance (IR).
Methods: A total of 80 women with PCOS with IR were randomly assigned to receive either digital intervention (n = 40) or metformin (n = 40) for 12 weeks. The primary outcomes were the changes in the homeostatic model assessment for insulin resistance (HOMA-IR). Anthropometric parameters, menstruation frequency, sex hormone levels, metabolic factors, body fat distribution, and questionnaires on diet, exercise, sleep, anxiety and depression were obtained.
Results: A total of 72 participants completed the follow-up (90% follow-up rate), including 35 and 37 from the digital intervention and metformin groups, respectively. The HOMA-IR of the digital intervention group was significantly improved after a 12-week of treatment, but no statistical difference was observed between the groups. Both digital intervention and metformin significantly improved menstruation, and reduced body weight and total fat mass. Furthermore, the digital intervention had a significant advantage over metformin in improving waist circumference (WC), waist-hip ratio (WHR), total fat mass, and dehydroepiandrosterone sulfate (DHEAS). In terms of safety, the main adverse events in the digital intervention and metformin groups were sensations of hunger (5%) and gastrointestinal adverse events (30%), respectively.
Conclusion: Our data suggest that…
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. Reported size: 80 participants or records.
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