Comparison between the effects of low-dose spironolactone plus metformin and metformin alone on hormonal and biochemical parameters of insulin resistance in women with polycystic ovary syndrome

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Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive-age women, characterized by insulin resistance and hyperandrogenism. Metformin improves insulin sensitivity, while spironolactone has antiandrogenic effects. Evidence regarding the short-term benefit of combining low-dose spironolactone with metformin remains inconclusive, particularly in South Asian populations. This study aimed to compare the effects of low-dose spironolactone plus metformin versus metformin alone on hormonal and biochemical parameters of insulin resistance in women with PCOS. Methods: This randomized controlled trial was conducted at Bangabandhu Sheikh Mujib Medical University, Dhaka, from July 2023 to June 2024. Ninety women aged 18-40 years with PCOS (Rotterdam criteria), BMI 18-30 kg/m2, and HOMA-IR>2 were randomized to receive either spironolactone (50 mg/day) plus metformin (1500 mg/day) or metformin alone (1500 mg/day) for 12 weeks. Hormonal and metabolic parameters were measured at baseline and post-treatment. Results: Both groups showed significant improvements in BMI, waist circumference, serum LH, FSH, LH/FSH ratio, free testosterone, fasting glucose, fasting insulin, and HOMA-IR (p<0.05). The combination group demonstrated numerically greater reductions in LH (3.02 versus 1.92 µIU/ml), free testosterone (0.33 versus 0.22 pg/ml), and HOMA-IR (1.37 versus 1.11); however, none of the between-group differences were statistically significant (p>0.05). Conclusions: Both low-dose spironolactone plus metformin and metformin alone significantly improve hormonal and insulin resistance parameters in women with PCOS. However, the addition of spironolactone does not provide a significant short-term advantage over metformin alone.

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