Long-term effects of combined simvastatin and metformin treatment on the clinical abnormalities and ovulation dysfunction in single young women with polycystic ovary syndrome.

The aim of the current work was to investigate the value of the long term effects of combined use of simvastatin and metformin treatment for a year versus the effects of their individual treatment on the clinical, biochemical abnormalities, and ovulation dysfunction in young single women with polycystic ovary syndrome (PCOS). It was a randomized, double-blind controlled study. Where two hundreds (n = 200) single young women with PCOS were randomized into seventy (n = 70) women using simvastatin 20 mg daily combined with metformin 500 mg three times daily considered as group A (study group), and another 2 sixty five (n = 65) women groups using simvastatin and metformin individually as a single treatment use, and considered as groups (B & C), respectively. Medications period extended for twelve months treatment period. The primary outcome measures were the changes in serum androgen levels (testosterone, androstendione, and dehydro-epiandrostenion sulfate-DHEAS), LH, FSH, LH/FSH ratio, and insulin resistance (IR), in addition to menstrual regularity, hirsutism, BMI, and W/H ratio. Spontaneous ovulation, confirmed with both trans-abdominal sonography (TAS) and luteal serum progesterone as well had been also evaluated. After 12 months' treatment, in group A serum testosterone showed significant decline by 37%, with significant drop in LH serum level (51%) and a marked decline of the LH/FSH ratio (53%). IR showed a significant improvement in groups A and C but still relatively higher in group B. There was also a clear decrease of total cholesterol (36%), low-density lipoprotein (LDL; 48%), and triglycerides (26%), and increased high-density lipoprotein (HDL) by 24% in groups A and B. Improved menstrual regularity and decreased hirsutism, acne, ovarian volume, and BMI had been significantly noticed in the study groups A and C, although still relatively higher in group C. Spontaneous ovulation had been confirmed in group A: songoraphically (TAS), and biochemically (progesterone >10 ng) in 10 women after the first six months treatment, and 26 at the end of 12 months treatment, compared to 5 & 8 in group B, and 2 & 5 in group C, respectively. Combined simvastatin and metformin treatment showed significant improvement of PCOS clinical and ovarian dysfunction abnormalities much better than their individual treatment.

RCT Entities:   Population Interventions Outcomes