Kriplani Alka, Tank Parikshit, Singh Purnima, Maini Neha, Kaitala Shymala, Kantha G Lakshmi, Paul Joydip, Shah Sushma, Bhatara Urvashi, Sinha Archana, Singh Taruna, Srivastava Shalini, Malvi Abhijeet
Department of Obstetrics and Gynecology and Assisted Reproductive Technology, Paras Health, Gurugram, IND.
Department of Obstetrics and Gynecology and Assisted Reproductive Technology, All India Institute of Medical Sciences, New Delhi, New Delhi, IND.
Cureus. 2024 Dec 12;16(12):e75616. doi: 10.7759/cureus.75616. eCollection 2024 Dec.
Background Polycystic ovary syndrome (PCOS) poses a significant health concern among reproductive-aged women and is characterized by ovarian dysfunction, hyperandrogenism, and insulin resistance. This study aims to assess the efficacy and safety of metformin and myo-inositol combination therapy compared to metformin monotherapy in patients with PCOS. Materials and methods This was a phase III, double-blind, randomized controlled clinical trial. A total of 196 patients with PCOS were randomized in a 1:1 ratio to receive either a fixed-dose combination of metformin hydrochloride 500 mg and myo-inositol 600 mg (Met-Myo) or metformin 500 mg alone (Met) twice daily for 24 weeks. The primary study endpoints were improvement in insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) at week 24 and improvement in menstrual cycle disturbances at 12 and 24 weeks. Results The Met-Myo combination demonstrated a significantly superior response with 63 (75%) patients showing improvement in HOMA-IR compared to 54 (60.67%) in the Met group (p = 0.049) at week 24. The improvement in the number of patients with heavy menstrual blood flow (>80 mL) was significantly greater in the Met-Myo group (four patients, 4.76%) compared to the Met group (six patients, 6.74%) at week 24 (p = 0.029). Improvement in the percentage of patients with normal menstrual frequency and infrequent menstruation from baseline to week 24 was significantly greater in the Met-Myo group compared to the Met group (p = 0.049). Safety assessments revealed a low and comparable incidence of mild adverse events. Conclusion Metformin-myo-inositol combination therapy is superior to metformin monotherapy in addressing menstrual irregularities and improving insulin resistance in PCOS patients, thereby providing a promising avenue for optimizing the management of PCOS.
多囊卵巢综合征（PCOS）是育龄期女性面临的一个重大健康问题，其特征为卵巢功能障碍、高雄激素血症和胰岛素抵抗。本研究旨在评估二甲双胍与肌醇联合治疗对比二甲双胍单药治疗对PCOS患者的疗效和安全性。
这是一项III期、双盲、随机对照临床试验。总共196例PCOS患者按1:1比例随机分组，分别接受盐酸二甲双胍500 mg与肌醇600 mg的固定剂量联合用药（Met-Myo）或单独使用500 mg二甲双胍（Met），每日两次，共24周。主要研究终点为第24周时胰岛素抵抗的改善情况（胰岛素抵抗稳态模型评估，HOMA-IR）以及第12周和24周时月经周期紊乱的改善情况。
在第24周时，Met-Myo联合治疗显示出显著更优的反应，63例（75%）患者的HOMA-IR有所改善，而Met组为54例（60.67%）（p = 0.049）。在第24周时，月经量多（>80 mL）患者数量的改善在Met-Myo组（4例患者，4.76%）显著大于Met组（6例患者，6.74%）（p = 0.029）。从基线到第24周，月经周期正常和月经稀发患者百分比的改善在Met-Myo组显著大于Met组（p = 0.049）。安全性评估显示轻度不良事件的发生率较低且相当。
二甲双胍-肌醇联合治疗在解决PCOS患者月经不规律和改善胰岛素抵抗方面优于二甲双胍单药治疗，从而为优化PCOS管理提供了一条有前景的途径。
