Efficacy and Safety of Metformin versus Myoinositol in improving Clinicometabolic profile in patients diagnosed with Polycystic Ovary syndrome: A Randomized Controlled trial

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is frequently associated with insulin resistance, menstrual irregularities, hyperandrogenism, and metabolic abnormalities. Metformin is widely used as an insulin-sensitizing agent for the management of PCOS; however, its use may be limited due to gastrointestinal side effects and poor patient adherence. Myo-inositol, a naturally occurring insulin sensitizer involved in insulin signaling pathways, has emerged as a potential alternative therapy with fewer adverse effects.This study aims to compare the efficacy and safety of myo-inositol and metformin in improving the clinicometabolic profile among women diagnosed with PCOS. The study will be conducted as an open-label randomized controlled trial at AIIMS Patna and will include 126 women aged 18–40 years diagnosed with PCOS according to the Rotterdam criteria. Participants will be randomly allocated in a 1:1 ratio to receive either myo-inositol 1 g twice daily or metformin 500 mg twice daily for one week followed by thrice daily dosing for a total duration of 24 weeks.The primary outcome will be the change in insulin resistance measured by HOMA-IR score at 12 weeks. Secondary outcomes will include changes in HOMA-IR at 24 weeks, lipid profile, body mass index, menstrual cycle regularity, acne, hirsutism, and treatment tolerability. The findings of this study may help determine whether myo-inositol can serve as an effective and safer alternative to metformin for the management of PCOS.