Comparison of Combination Therapy of Myoinositol and Metformin with Myoinositol Monotherapy and Metformin Monotherapy in the Treatment of Polycystic Ovary Syndrome: A Prospective Randomized Controlled Trial

Myoinositol and Metformin in PCOS: A Comparative Trial

Abstract

Background: Polycystic ovarian syndrome (PCOS) is a prevalent endocrine and metabolic disorder in women of reproductive age, characterized by reproductive, metabolic and hormonal disturbances. Metformin (MET) and myo-inositol (MI) are two frequently used drugs. Objective: To evaluate the effectiveness of combination therapy with MI and MET compared to monotherapy with either MI or MET in enhancing metabolic and reproductive outcomes in women with PCOS. Study Design: Prospective randomized controlled. Settings: Department of Gynecology & Obstetrics, FTH, Faisalabad Pakistan. Duration: Six months from 01-08-2025 to 31-01-2026. Methods: Study was performed with 122 women diagnosed with PCOS allocated in three groups: Group A (MI + MET, n=41), Group B (MI alone, n=41), and Group C (MET alone, n=40). Participants monitored for six months, including evaluations of menstrual regularity, body mass index (BMI), and pregnancy rates. Results: Combination therapy exhibited enhanced results across all endpoints. Menstrual regularity was most pronounced in Group A (80.5%), followed by Group B (73.2%) and Group C (70%). The greatest substantial drop in BMI occurred in Group A (25.0 ± 4.6 kg/m²), followed by Group B (23.9 ± 5.83 kg/m²) and Group C (25.12 ± 4.63 kg/m²). Group A exhibited the greatest pregnancy rates at 43.9%, compared to Group B at 34.1% and Group C at 27.5%. All intergroup disparities were statistically significant (p < 0.001). Conclusion: Combination therapy of MI and MET is significantly effective than either monotherapy in enhancing menstrual regularity, decreasing BMI and improving fertility in women with PCOS.