Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial
Abstract
OBJECTIVES: To determine the safety and efficacy of empagliflozin compared with those of metformin in polycystic ovary syndrome (PCOS) patients with insulin resistance (IR).
METHOD: A single-center, prospective, double-blind randomized (1:1 ratio) noninferiority trial was conducted at the primary healthcare organization in slums between December 2023 and June 2024. Women aged 18-45 years with PCOS were enrolled and randomly assigned to either 10 mg (n = 41) empagliflozin daily or metformin 500 mg twice a day (n = 39) for 24 weeks. The primary outcome was changes in metabolic parameters and weight after 24 weeks of treatment. STATA software version 17 was used for statistical analysis, independent t tests were used for continuous variables, and Welch's correction was applied when variances were unequal. Categorical variables were compared via Fischer exact tests or chi-square (X2) tests. To address the significant loss to follow-up among participants and minimize bias, a mixed-model repeated-measures analysis was conducted to compare the effects of Drug A and Drug B over the 24-week treatment period.
RESULT: Comparing the outcomes before and after treatment on the basis of the mean differences (MDs) revealed significant changes in various outcomes for both Drug A (Metformin) and Drug B (Empagliflozin). For weight, the MDs were 0.9 ± 1.4 kg for Drug A and 6.7 ± 1.6 kg for Drug B. In terms of lipid profiles, total cholesterol decreased by 18.3 ± 4.7 mg/dL in the Drug A group…
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. Reported size: 41 participants or records.
Read the paper
Related studies
- Increased expression of circulating miRNA-93 in women with polycystic ovary syndrome may represent a novel, non-invasive biomarker for diagnosis
- Identification of key genes associated with polycystic ovary syndrome (PCOS) and ovarian cancer using an integrated bioinformatics analysis
- Identification of key pathways and genes in polycystic ovary syndrome via integrated bioinformatics analysis and prediction of small therapeutic molecules
- Regulation of Androgen Receptor Expression Alters AMPK Phosphorylation in the Endometrium: In Vivo and In Vitro Studies in Women with Polycystic Ovary Syndrome
- Effect of oral administration of low-dose follicle stimulating hormone on hyperandrogenized mice as a model of polycystic ovary syndrome
- Systems pharmacology to investigate the interaction of berberine and other drugs in treating polycystic ovary syndrome
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.