Effects of metformin plus simvastatin on polycystic ovary syndrome: a prospective, randomized, double-blind, placebo-controlled study.

OBJECTIVE

To evaluate the effect of a combination of simvastatin and metformin on biochemical parameters in women with polycystic ovary syndrome (PCOS).

DESIGN

A prospective, randomized, double-blind, placebo-controlled study.

SETTING

University hospital.

PATIENT(S): Eighty-four women with PCOS randomly divided to two study groups.

INTERVENTION(S): Patients were randomly assigned to receive metformin (500 mg three times a day) plus simvastatin (20 mg/day, n=42; group 1) or metformin (500 mg three times a day) plus placebo (once a day, n=42; group 2) for 12 weeks. Blood samples were obtained before and after treatment.

MAIN OUTCOME MEASURE(S): Testosterone.

RESULT(S): After 12 weeks of treatment, serum T levels decreased by 25.5% in group 1 and by 16.8% in group 2. There was a greater decrease of LH (45.5% vs. 6.7%) and a greater decline of the LH/FSH ratio (38.3% decreased vs. 4.4% increased) in the first group. In group 1 there was a greater decrease of total cholesterol (29.5% vs. 4.2%), low-density lipoprotein (LDL; 18.5% vs. 1.5%), and triglycerides (32% vs. 5.3%). High-density lipoprotein (HDL) increased in the first group by 14%, whereas it decreased by 1% in the second group.

CONCLUSION(S): This report has demonstrated that the combination of metformin and simvastatin could lead to a better reduction of T and LH levels and thus reversing the LH:FSH ratio, lipid profile, and insulin resistance in patients with PCOS and may be an appropriate management option for patients with PCOS.