Effects of Ethinylestradiol/Cyproterone Acetate and Ethinylestradiol/Desogestrel Alone and in Combination with Low-Dose Metformin on Glucose and Lipid Homeostasis and Androgenic Hormone Profile in Hirsute Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Triple-Dummy Study

摘要

Background: The effects of combined oral contraceptive pills and metformin on glucose and lipid metabolism and androgenic hormone profile of hirsute women with polycystic ovary syndrome (PCOS) are not clearly known. Aims: To determine the effect of ethinylestradiol (35 microg)/cyproterone acetate (2 mg) (EE/CPA) and ethinylestradiol (20 microg)/desogestrel 0.15 mg (EE/DES) alone and in combination with metformin on glucose and lipid metabolism and androgenic hormone profile in hirsute women with PCOS. Settings and Design: This randomised, double-blind, triple dummy study was conducted at the Department of Pharmacology, Faulty of Science, University of Peradeniya, Sri Lanka. Methods and Material: A total of 107 patients with PCOS (Rotterdam Consensus Conference Criteria 2003) having hirsutism of 8 or more in the modified Ferriman-Gallwey Score (mFGS), were randomised to receive four drug therapies (arm A: EE/CPA, arm B: EE/DES, arm C: EE/CPA plus metformin, arm D: EE/DES plus metformin). Body mass index, fasting plasma glucose, area under the curve of the oral glucose tolerance test, fasting serum insulin, serum leptin, fasting lipids, serum total testosterone, serum sex hormone-binding globulin were determined at initiation and 12 months. Homeostasis model assessment of beta cell function (HOMA-β ), homeostasis model assessment-estimated insulin resistance (HOMA-IR) and free androgen index were calculated. Statistical analysis was done with two ways ANOVA. Results: There was no significant difference in outcome measures at 12 months between the treatment arms. Within the treatment arms, there was reduction of HOMA-β in arm B, serum leptin in arm C, CHO/HDL ratio in arm D and an increase in total cholesterol and LDL-cholesterol in arms B and C. Conclusions: EE/DES and EE/CPA with and without low-dose metformin did not have a significant overall effect on glucose and lipid metabolism and androgenic hormonal profile in hirsute women with PCOS. However, desogestrel has reduced the beta-cell function and both desogestrel and cyproterone have adversely affected the lipids.