Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome

Background: Polycystic ovarian syndrome (PCOS) characterized by anovulation and features of hyperandrogenism (clinical or biochemical) and insulin resistance. Metformin and myoinositol being insulin sensitizers improve clinical and biochemical parameters. This study was done to compare the effects of these drugs on clinical features and biochemical profile.Methods: A randomized, comparative, clinical study was conducted on 72 patients. The patients were randomized with the help of computer-generated random numbers and were allocated to either of the three treatment groups A, B and C. Patients in group A received metformin 500 mg TDS, group B received myoinositol 1000 mg BD, group C received combination of metformin 500 mg and myoinositol 550 mg BD for 24 weeks. At first visit patients detailed history and baseline investigations were recorded. Follow up was done 24 weeks after start of therapy to assess the improvement in clinical and biochemical profile.Results: There was significant improvement in menstrual irregularities, cutaneous manifestations, pregnancy rate, LH/FSH ratio, insulin sensitivity and HOMA-IR after 24 weeks of treatment in all three groups (p value <0.05), although there was greater improvement in cases treated with combination of metformin and myoinositol than metformin and myoinositol alone.Conclusions: The combination of metformin and myoinositol has resulted in more significant reduction in insulin resistance and improvement in metabolic and hormonal profile along with regularization of menstrual cycles and spontaneous conception than metformin and myoinositol alone