COMPARISON OF METFORMIN VERSUS COMBINATION OF METFORMIN WITH MYO-INOSITOL FOR MENSTRUAL IRREGULARITIES IN POLYCYSTIC OVARIAN SYNDROME (PCOS): A RANDOMIZED CONTROL TRIAL

Abstract

Background: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in reproductive-age women and is frequently associated with menstrual irregularities, hyperandrogenism and metabolic dysfunction. Lifestyle measures and insulin-sensitizing agents remain the cornerstone of treatment. Metformin improves insulin resistance but gastrointestinal intolerance may limit adherence. Myo-inositol is an insulin sensitizer that may improve ovulatory function and androgen-related symptoms and may complement metformin therapy.

Objective: To compare metformin monotherapy versus a combination of metformin with myo-inositol for improvement of menstrual irregularities in women with PCOS.

Methods: This randomized controlled trial was conducted in the Department of Obstetrics & Gynaecology, Benazir Bhutto Hospital, Rawalpindi. One hundred and sixty-six women aged 18–40 years with PCOS and menstrual irregularities were randomly allocated (1:1) to receive either metformin plus myo-inositol (Group A; metformin 500 mg three times daily plus myo-inositol 2 g twice daily) or metformin alone (Group B; metformin 500 mg three times daily) for 6 months. The primary outcome was achievement of a normal menstrual cycle. Secondary outcomes included change in body mass index (BMI), modified Ferriman–Gallwey (mFG) score, and adverse events. Data were analyzed using SPSS version 25; p≤0.05 was considered significant.

Results: Baseline characteristics were comparable between groups. A normal menstrual cycle was achieved in 57/83 (68.7%) women in Group A compared with 41/83 (49.4%) in Group B (p=0.01). Post-treatment mFG score was lower in Group A (6.1±2.2) than Group B (7.8±2.4) (p=0.003). Post-treatment BMI did not differ significantly between groups (p=0.45). Nausea was less frequent with combination therapy (14.5% vs 26.5%; p=0.04).

Conclusion: In women with PCOS, the combination of metformin with myo-inositol was more effective than metformin alone in improving menstrual regularity and reducing hirsutism scores, with fewer gastrointestinal adverse effects.