Abstract
Introduction: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder, which can cause various reproductive complications and is associated with metabolic syndrome. In India, strong comparative evidence of oral contraceptive pills (OCP), metformin or their combination in treatment of polycystic ovarian disease is lacking. Objectives: The objective of this study is to compare the efficacy and safety of metformin alone, OCP containing drospirenone or a combination of OCP and metformin in patients with PCOS. Materials and Methods: This was an open-label, randomized, parallel group, and comparative three-arm prospective study, in 60 patients. Patients either received OCPs containing etinyl estradiol plus drospirenone, metformin or combination of OCPs plus metformin for 6 months. Luteinizing hormone: Follicle stimulating hormone (LH:FSH) ratio, serum insulin level, ovarian morphology, body mass index (BMI), acceptance of treatment, regularization of the menstrual cycle and improvement in acne and hirsuitism were evaluated. Results: In patients receiving metformin either as monotherapy or in combination showed significant improvement in BMI. All the study medicines were effective in significantly decreasing ovarian volume, LH/FSH ratio and serum insulin level. Improvement in acne was better in patients receiving OCPs either as monotherapy or in combination with metformin. Improvement in hirsuitism and regularization of the menstrual cycle was highest in patients receiving combination treatment. Acceptance of treatment was maximum in patients receiving monotherapy of OCPs. The total incidence of adverse events was 16.7% (15%, 15% and 20% in OCP, metformin, and combination group, respectively). Conclusion: OCPs containing ethinylestradiol plus drospirenone, metformin, and combination of both are effective and well tolerated in the management of PCOS. Metformin either as monotherapy or combination can be preferred in cases with high BMI. Combination of metformin plus OCP regularizes menstrual cycle better than monotherapy of either drug.
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