Clinical, metabolic, and endocrine parameters in response to metformin and lifestyle intervention in women with polycystic ovary syndrome: A randomized, double-blind, and placebo control trial

In a study conducted 14 years ago involving 30 women with polycystic ovary syndrome (PCOS), the combined effects of metformin and lifestyle interventions were assessed over 4 months. The participants were randomly assigned to receive either 1500 mg of metformin or a placebo, in addition to diet and exercise modifications. The study revealed that both groups showed improvements in weight and menstrual cycles. However, significant reductions in serum fasting insulin, HOMA index, waist circumference, and testosterone levels were exclusive to the metformin group. No significant changes were noted in other androgen levels, gonadotropins, lipids, hirsutism, or blood pressure. The study concluded that metformin enhances the effects of diet and exercise in reducing hyperandrogenism and insulin resistance in women with PCOS, although lifestyle changes alone could also benefit menstrual cycles. Despite these findings, no significant changes were observed in hirsutism, acne, seborrheic skin, and androgenetic alopecia. Additionally, 5 patients became pregnant after the study without medical intervention, suggesting potential fertility benefits. The study suggests that metformin may offer additional advantages in managing PCOS when combined with lifestyle changes, but further research is needed to confirm these results.