Randomised controlled trial to study the efficacy of exercise with and without metformin on women with polycystic ovary syndrome
Abstract
OBJECTIVES
1. 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 DESIGN
A 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.
RESULTS
In 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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