A randomized, controlled trial comparing the metformin, oral contraceptive pills and their combination in patients with polycystic ovarian syndrome.

Background: Polycystic ovarian syndrome (PCOS) is a condition characterized by insulin resistance (IR) and hormonal dysfunction. We conducted a randomized, controlled trial comparing the effects of metformin, oral contraceptive pills (OCP) and their combination in PCOS.

Materials and Methods: We randomized 90 newly diagnosed PCOS (age 18-40 year, symptom duration >6 months) patients into three groups (Group 1-Metformin, Group 2-OCP, and Group 3- Metformin + OCP) in this prospective study. We excluded patients with past use of insulin sensitizers and hormone therapy. We evaluated for the hyperandrogenism (acne, acanthosis, hirsutism, and hormone panel), IR by homeostasis model assessment (HOMA-IR), inflammation (high-sensitivity C-reactive protein, fibrinogen, and ferritin), and body composition (% fat, android/gynoid ratio) markers at baseline and 6 months after therapy. The data were analyzed using appropriate statistical methods and P < 0.05 was considered statistically significant.

Results: The study population had a mean age 23.2 ± 4.4 years and body mass index of 28.4 ± 6.1 kg/m2 . The improvement in the clinical parameters was similar in all the groups. The combination therapy showed a better response in reducing inflammatory markers, IR, and body composition than either of the groups using a single drug. Metformin alone has resulted in a minor reduction of the androgens. None of the patients developed significant adverse effect to the given therapy.

Conclusion: PCOS is managed with either metformin or OCP in many patients. The combination improves the hyperandrogenism, body composition, and reduces the inflammatory markers.