Comparison of Clinical, Metabolic and Hormonal Effects of Metformin Versus Combined Therapy of Metformin With Myoinositol Plus D-Chiro-Inositol in Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

Objective To compare the effects of metformin alone versus combined therapy of metformin with myoinositol (MI) plus D-chiro-inositol (DCI) in women with polycystic ovary syndrome (PCOS). Materials and methods This is a prospective, non-blinded randomized controlled trial conducted in newly diagnosed PCOS women aged 18 to 45 years. Group I received metformin 500 mg twice a day orally for 6 months while group II received metformin 500 mg twice a day orally along with MI 550 mg plus DCI 150 mg twice daily orally for six months. The primary outcome was a change in clinical, metabolic and hormonal parameters of the two groups from baseline to the end of six months of treatment. Results A total of 72 patients were randomized into two groups of 36 patients each. Statistically, a significant difference was seen in terms of mean global acne score (p=0.004) and cycle regularity (p=0.034) after six months of treatment in group II. A significant difference in values of luteinizing hormone (LH) (p=0.002), luteinizing hormone/follicle-stimulating hormone (LH/FSH) ratio (p=0.007), mean cholesterol (p=0.040), mean high-density lipoprotein (HDL) (p=0.049), mean low-density lipoprotein (LDL) (p=0.0001) and postprandial insulin (p=0.005) was also seen in group II at the end of treatment duration. No significant difference was seen between the two groups in terms of mean FSH, mean testosterone, mean dehydroepiandrosterone sulfate (DHEAS), mean triglyceride, mean fasting and postprandial blood sugar, fasting insulin and homeostatic model assessment of insulin resistance (HOMA-IR) index. Conclusion Combined therapy with metformin and MI plus DCI in women with PCOS and insulin resistance seems promising with the need for further studies with a greater sample size to evaluate the efficacy of this treatment.