Randomised controlled trial to study the efficacy of exercise with and without metformin on women with polycystic ovary syndrome

Abstract

Objectives1. To study the efficacy of exercise in improving clinical symptoms, anthropometry, glucose tolerance and laboratory profile in women with Polycystic ovarian syndrome. 2. To study the combined efficacy of exercise and metformin on above parameters in women with polycystic ovary syndrome. Study designA Randomised double blinded placebo controlled trial was performed at a district hospital in New Delhi. Sixty six women were included in the study. Block randomisation was done to divide the women into two groups. Women were treated with fixed exercise schedule along with oral placebo in Group A and exercise with oral metformin in Group B. Outcomes stated in objectives were studied and statistically analysed. Quantitative variables were compared using unpaired t-test and Paired t-test within the groups across follow-ups. Qualitative variable has been compared using Chi-Square test /Fisher’s exact test. ResultsIn Group A and B significant improvement was noted in menstrual cycles, mean waist circumference, mean waist-hip ratio and body mass index. The mean weight loss was 0.78 ± 0.19 kg and 1.71 ± 0.19 kg in group A and B respectively after 3 months. The mean weight loss was 1.08 ± 0.30 kg and 1.71 ± 0.19 kg in group A and B respectively. The mean difference in modified Ferriman Gallwey score at 0, 3 and 6 months were statistically significant in both groups. On comparing group A with group B at 6 months, significant improvement was found in menstrual cycle symptoms (55.17% vs 83.33%), mean weight loss (1.08 kg vs 2.5 kg), waist circumference reduction (2.56 cm vs 4.75 cm) and change in mean waist hip ratio (0.02 vs 0.04). Significant changes were noted in OGTT and Serum testosterone level at 6 months in Group B, but not in Group A. Statistically no significant differences were found in acne, acanthosis nigricans and other biochemical parameters. ConclusionRegular exercise should be recommended for the women with PCOS. It results in statistically significant improvement in menstrual cycle pattern, hirsutism, body mass index, weight, waist circumference waist-hip ratio. Addition of metformin resulted in added benefits on menstrual cycle, hirsutism, weight, body mass index, waist circumference, waist hip ratio, serum testosterone and Oral Glucose Tolerance Test (OGTT).