Investigating the effects of metformin and inositol in the treatment of polycystic ovary syndrome: a research protocol

Introduction: Polycystic Ovary Syndrome (PCOS), an androgen hormone excess and ovarian dysfunction disorder is linked to insulin resistance, metabolic disorders, and obesity. Inositol, a natural sugar compound is effective in regulating insulin levels and follicle stimulating hormones. Metformin, a biguanide drug which is used for Type 2 Diabetes treatment controls glucose levels and insulin resistance. Using inositol and metformin together for treatment of PCOS has been suggested to be beneficial for individuals with PCOS. The purpose of this study is to assess the effectiveness of metformin and inositol in improving insulin resistance, hyperandrogenism, weight, menstruation, and ovulation. Methods: A total of 36 women between ages of 25-35 clinically diagnosed with PCOS will be recruited to participate in a six-month double- blinded controlled trial. Participants were classified to normal BMI (18.5-24.0 kg/m2) and overweight/obese BMI (25.0-29.9 kg/m2 and >30 kg/m2) and were randomized into one of the following treatments: 500 mg of metformin with 4 g of inositol, 250 mg of metformin twice daily or two placebo sugar pills. Over the 6-month period, blood tests for blood sugar, insulin levels and testosterone levels, weight assessment on scale, menstruation questionnaire and ultrasound will be used to assess improvement in symptomology. Anticipated Results: It is anticipated that in both BMI groups, there will be a decrease in insulin resistance and hyperandrogenism with metformin and inositol use. There should be a reduction of weight in both BMI groups with increased effect seen in overweight/obese BMI. Menstruation and ovulation are anticipated to become more regular in both BMI groups using metformin and inositol. Discussion: Studies have found that metformin significantly improves insulin resistance, decrease circulating free androgens, and increases sex hormone binding globulin. Inositol has been seen to decrease insulin resistance, LH/FSH ratio and free androgen in women with PCOS. The combination of metformin and inositol is seen to improve hormonal and biochemical parameters and have a significant effect on menstrual cycle length. Conclusion: The combination of metformin and inositol may have synergistic effects that will PCOS symptomology and improve quality of life.