Randomized Controlled Trial Comparing Effects of Metformin vs Myoinositol vs Metformin and Myoinositol on Ovarian Functions and Metabolic Factors in PCOS

Abstract Aim: The aim of the study is to compare the effects of metformin, myoinositol, and their combination on ovarian function and metabolic factors in women with polycystic ovary syndrome (PCOS). The study seeks to evaluate their relative efficacy in improving ovulation, hormonal balance, insulin resistance, and other metabolic parameters, while also assessing side effects and tolerability to guide optimized management of PCOS. Materials and methods: This study evaluated women with irregular cycles, oligo/amenorrhea, infertility, hirsutism, and acne, diagnosing Polycystic Ovary Syndrome (PCOS) using the Rotterdam criteria. A total of 60 participants, including lean and obese patients, were randomly assigned to receive myoinositol (Group A, 1g/day), metformin (Group B, 1000mg/day), or a combination of both (Group C). Inclusion criteria included oligomenorrhea/amenorrhea and polycystic ovaries, with or without hyperandrogenism or obesity. Patients with abnormal TSH, PRL, or AMH levels, chronic illnesses, or prior chemotherapy/radiotherapy were excluded. Data analysis was done using SSPS software. Results: The average age of participants ranged from 20.32 to 24.14 years, with no significant difference between groups (p = 0.121). Amenorrhea was observed in 47.9% to 56.2% of patients, and infertility ranged from 35.6% to 51.2% across the groups. Irregular cycles were reported by up to 12.32% of participants (p = 0.125), while hirsutism was more common, affecting 45.3% to 79.23% of patients (p = 0.421). Acne prevalence ranged from 24.1% to 35.4% (p = 0.321). None of the differences between the groups were statistically significant. Conclusion: Metformin improves insulin sensitivity and ovarian function, while myoinositol enhances ovulatory and hormonal regulation. Their combination offers synergistic benefits, but personalized treatment and further research are needed to optimize outcomes in PCOS management.