RESUMEN
BACKGROUND: Polycystic ovary syndrome (PCOS) afflicts at least 5% of women. Both metformin and statin have been used as methods to ameliorate symptoms and improve prognosis. AIM: To test the efficacy of concomitant usage of metformin and statins in PCOS patients. MATERIALS AND METHODS: This is a prospective, randomized, double-blinded, placebo controlled study. 37 patients received rosuvastatin (10 mg/day) for a period of 3 months, then the patients were randomly allocated to one of two groups: the first group (or intervention group) received rosuvastatin (10 mg/day) plus metformin (850 mg twice daily after meals), and the second group (referred to as control group hereafter) received rosuvastatin (10 mg/day) plus placebo for a period of 3 months. Biochemical and clinical data were collected at each time point. RESULTS: There were no significant differences between the intervention and control groups for baseline lipid profile (LDL, HDL, triglycerides, total cholesterol), CRP, homocysteine, DHEAS, testosterone and insulin (p > 0.05 for all variables). There were no significant differences in lipid profile, CRP, homocysteine, DHEAS, testosterone and insulin between the intervention and placebo groups at 3 and 6 months after treatment (p > 0.05 for all). Significant differences in the outcome variables of LDL, total cholesterol and FBS emerged within the intervention group, with significantly higher levels at 6 months compared to 3 months. We also did not find any significant group differences in unit change of the outcome variables between baseline and 3 months. CONCLUSIONS: We found that the combination of statin and metformin has no advantage in PCOS management. In fact, the increase of LDL, total cholesterol and FBS within the intervention group warrants reassessment of current regimens to avoid any patient harm.