Comparison of ethinyl-estradiol/drospirenone tablets alone or in combination with orlistat on ovulation recovery rate and metabolic indices in overweight/obese patients with polycystic ovary syndrome

doi:10.3969/j.issn.1006-7795.2025.04.004

Abstract

Abstract: Objective To compare ovulation recovery rate and metabolic indicators between ethinyl-estradiol/drospirenone (EE/DRSP) combined with orlistat and EE/DRSP alone in overweight/obese patients with polycystic ovary syndrome (PCOS). Methods This study was a randomized controlled clinical trial conducted based on the 2004 Rotterdam criteria. From October 2020 to December 2023, 180 overweight/obese PCOS patients aged 20-40 were recruited from the Department of Department of Gynecological Endocrinology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University. The patients were randomly divided into two groups in a 1∶2 ratio. Among them, 60 patients received treatment with EE/DRSP (EE20 μg,DRSP 3 mg), while 120 patients received a combination treatment of EE/DRSP and orlistat (360 mg/d). The height, weight, waist circumference, hip circumference, and blood pressure of the patients were measured before treatment and after 12 weeks of treatment. Laboratory tests included measurements of follicle-stimulating hormone (FSH), luteinizing hormone (LH), fasting insulin（FINS）, homeostasis model assessment of insulin resistance (HOMA-IR), free androgen index (FAI), alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), fasting plasma glucose (FPG), total cholesterol (TC), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), lipoprotein(a) ［Lp(a)］, sex hormone-binding globulin (SHBG), total testosterone (T), and free testosterone (FT). After 12 weeks of treatment, the medication was discontinued, and natural ovulation was observed. Results After 12 weeks of treatment, the ovulation rate of the EE/DRSP combined with orlistat group reached 70.8%, while the natural ovulation rate of the EE/DRSP group alone was only 35%, indicating that the ovulation rate was significantly increased after EE/DRSP combined with orlistat treatment. After 12 weeks of treatment, both groups showed a significant decrease in total testosterone, free testosterone, and low-density lipoprotein levels (all P<0.05), and the decrease in BMI, waist circumference, fasting insulin, and HOMA-IR in the EE/DRSP combined with orlistat group was greater than that in the EE/DRSP group alone (P<0.05). After treatment, both groups showed a significant increase in high-density lipoprotein and triglyceride levels (all P<0.05), with no significant changes in total cholesterol and fasting blood glucose (all P>0.05). Conclusion After 12 weeks of treatment, EE/DRSP combined with orlistat can significantly improve the ovulation rate of PCOS patients. It is superior to EE/DRSP alone in reducing androgen levels, body weight, insulin resistance, and low-density lipoprotein levels.

Key words: polycystic ovary syndrome, ethinyl-estradiol/drospirenone (EE/DRSP), metabolism, orlistat, obesity, ovulation recovery rate

CLC Number:

Jiang Lingling, Ruan Xiangyan, Li Yanqiu, Zhang Mingzhen, Wang Zecheng, Jin Jing, Tian Xuanxuan, Liu Anming, Alfred O. Mueck. Comparison of ethinyl-estradiol/drospirenone tablets alone or in combination with orlistat on ovulation recovery rate and metabolic indices in overweight/obese patients with polycystic ovary syndrome[J]. Journal of Capital Medical University, 2025, 46(4): 607-613.

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