Low-dose spironolactone and metformin combination therapy compared with either drug alone appeared to be an effective treatment for the management of polycystic ovary syndrome, according to results from an open-label, randomized study conducted in India.
“The key findings suggest superior efficacy (menstrual cyclicity, Ferriman–Gallwey [FG] score, serum total testosterone, insulin sensitivity and compliance) of low-dose spironolactone and metformin over either drug alone in the management of PCOS, without increasing the adverse event rate,” Mohd Ashraf Ganie, MD, of the department of endocrinology and metabolism at All India Institute of Medical Sciences in Ansari Nagar, New Delhi, India, and colleagues wrote.
Women who fell under the Androgen Excess-PCOS (AE-PCOS) 2006 criteria for PCOS were randomly assigned to one of three groups: metformin 1,000 mg per day (n=56), low-dose spironolactone 50 mg per day (n=51) or a combination of both drugs (n=62) for 6 months.
Before randomization, women were given dietary counseling (30 kcal/kg to 35 kcal/kg composed of 50% to 55% carbohydrates, 20% to 25% protein and 15% to 20% fat with high fiber content) besides lifestyle advice (ie, 25 to 35 minutes of brisk walking per day).
Menstrual cycle patterns, FG score, BMI, waist-hip ratio, blood pressure, luteinizing hormone, follicle-stimulating hormone, total testosterone, glucose and insulin sensitivity indices were measured at baseline, 3 and 6 months after the intervention. Data indicate all groups had comparable mean age and BMI at baseline.
At 6 months, menstrual cycles per year increased, whereas FG scores, serum total testosterone, AUC-glucose and AUC-insulin decreased significantly (P<.05) in the combination group compared with either therapy alone, according to data.
The adverse events associated with combination therapy were not significantly high. However, some of the clinical benefits could be the result of lifestyle modifications due to the lack of a placebo arm, researchers wrote. Yet, the efficacy and compliance were apparent without an increase in adverse events.
Disclosure: The researchers report no relevant financial disclosures.