The effect of metformin on fat distribution and the metabolic syndrome in women with polycystic ovary syndrome - a randomised, double-blind, placebo-controlled trial

Objective To establish whether metformin has a significant action in reducing visceral fat and improving other metabolic parameters in women with polycystic ovary syndrome (PCOS). Design Randomised, double-blind, placebo-controlled trial. Setting Reproductive medicine clinic. Population Forty women with anovulatory PCOS. Methods Participants were randomised into receiving metformin 500 mg three times a day or placebo for 3 months. Main outcome measures Fat distribution was measured by computed tomography scan. Secondary outcome measures included serum indices of the metabolic syndrome and evidence of ovulation. Results We found no significant differences in any of the measures of fat distribution between the placebo and metformin groups. The metformin group had significantly lower total cholesterol (P=0.02), low-density lipoprotein cholesterol (P=0.02) and cholesterol:high-density lipoprotein cholesterol ratio (P=0.05), but there was no statistically significant treatment effect on androgens, insulin, insulin resistance, triglycerides, ovulation or pregnancy. Conclusions Metformin has no clinically significant effect in reducing visceral fat mass, although it does have a beneficial effect on lipids. This trial lends support to the growing evidence that metformin is not a weight loss drug. Metformin might therefore be used as an adjunct to lifestyle modification in women with PCOS, but not as a substitute for it.