Treatment with combined resveratrol and myoinositol ameliorates endocrine, metabolic alterations and perceived stress response in women with PCOS: a double-blind randomized clinical trial

The present study aimed to assess whether treatment with combined resveratrol and myoinositol is more effective in ameliorating the altered parameters associated with PCOS when compared to the combined metformin and pioglitazone therapy.One hundred and ten obese, oligo-anovulatory PCOS women, aged 20-35 years were randomly assigned into two treatment arms. Participants in arm-1 (n = 55), received combination of metformin and pioglitazone (500 mg and 15 mg, respectively), twice daily, while those in arm-2 (n = 55) received combination of resveratrol and myoinositol (1000 mg and 1000 mg, respectively) twice daily for 12 weeks. Evaluations performed at baseline were repeated after 3 months of therapy. The endocrine and metabolic derangements were assessed by measuring serum levels of testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), adiponectin and insulin using ELISA. Cohen's perceived stress scale (PSS) was employed as a subjective measure of stress.Pre-treatment PCOS women in both the arms (arm-1 and arm-2) had remarkably elevated serum testosterone and insulin concentrations, low serum adiponectin and high perceived stress response scores. The treatment reduced the altered endocrine indices in arm-2 (resveratrol and myoinositol) participants, manifested by statistically significant reduction in serum testosterone level (p = 0.001) and notably increased serum adiponectin level (p = 0.001). Interestingly, the hormonal profile, including serum LH and FSH levels also decreased (p < 0.001) along with a marked reduction in the ovarian volume (p = 0.001) in arm-2 participants. There was a significant reduction in weight (<0.001), BMI (p < 0.001) and an improvement in waist-hip ratio (p < 0.001) in arm-2 participants compared to arm-1 group. The PSS scores of the arm-2 subjects improved significantly (p < 0.001) whereas, the Ferrimen-Gallwey score was improved in both the arms (arm-1 and arm-2; p = 0.010 and 0.008 respectively) however, the change was highly significant in arm-2. Interestingly, the menstrual regularity was 81.4% in arm-2 while 18.2% in arm-1. We conclude that the therapeutic intervention with combined resveratrol and myoinositol is more effective in ameliorating altered endocrine, metabolic indices and stress burden and could be of clinical importance in high risk group of obese, oligo-anovulatory married PCOS affected women.ClinicalTials.gov Trial No: NCT04867252. Registered 24 April, 2021, https://clinicaltrials.gov/ct2/show/NCT04867252.