Comparison of Metformin and Myoinositol on Clinical, Hormonal and Metabolic Profile of Patients with Polycystic Ovarian Syndrome: An Open-label Randomised Clinical Trial

Abstract

Introduction: The prevalence of Polycystic Ovarian Syndrome (PCOS), one of the common endocrine disorders among women of reproductive age, varies from 2.2% to 26% globally. The treatment for PCOS aims to reduce Body Mass Index (BMI), improve underlying hormonal disturbances, prevent future reproductive and metabolic complications, and enhance the quality of life. Aim: To evaluate the efficacy of metformin and Myoinositol (MI) on the metabolic, hormonal, and clinical profiles in PCOS. Materials and Methods: An open-label randomised clinical trial was conducted at the Department of Obstetrics and Gynaecology, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengelpet, Tamil Nadu, India, from January 2019 to May 2020. The study included 80 women with PCOS who were randomly assigned to two groups. One group received metformin 1500 mg/day (in three divided doses), while the other group received MI 1 gram/day for three months. At the end of the 12-week therapy, the participants were evaluated for changes in clinical, metabolic, and hormonal profiles. The data were analysed using Statistical Package for Social Sciences (SPSS) version 20.0. Descriptive statistics such as frequency, proportion, mean, and standard deviation were used for quantitative data. Results: Both the metformin and MI-treated groups showed a significant reduction in BMI, fasting blood glucose, and fasting insulin. Both drugs were equally effective in changing the hormonal profile. There was a significant improvement in lipid parameters in both groups, with High-density Lipoprotein (HDL) levels being more significantly raised in the metformin group. The post-treatment HDL values in the metformin group were 75.69±19.16 mg/dL compared to 41.43±6.18 mg/dL in the MI group (p<0.0001). Both groups demonstrated similar efficacy in improving menstrual regularity, with 60% of the patients in the metformin group and 65% in the MI group having regular cycles at the end of treatment. Among infertility patients, the conception rate was 40% in the metformin group and 25% in the MI group (p=0.70). Conclusion: Both drugs were equally efficient in improving the clinical, metabolic, and hormonal profiles in PCOS. Metformin was found to be superior to MI in improving fertility and increasing HDL levels.