Coadministration of metformin or spironolactone enhances efficacy of rosiglitazone in management of PCOS

Abstract

The aim of this study was to compare the efficacy and safety of adding metformin or spironolactone to rosiglitazone in women with polycystic ovary syndrome (PCOS). This is a prospective non-randomized study in a tertiary care with at in a tertiary care endocrine clinic. Women (n = 138) diagnosed with PCOS on the basis of Rotterdam criteria 2003 were categorized into three groups on the basis of drug intake as – rosiglitazone (R), rosiglitazone with spironolactone (R + S), and rosiglitazone with metformin (R + M). Clinical, biochemical, hormonal, and insulin sensitivity parameters were assessed at baseline and after six months of follow up. There was a significant improvement in number of menstrual cycles per year and Ferriman Gallwey (FG) score in all three groups after 6 months. Plasma insulin (0, 2 h), HOMA-IR and serum total testosterone levels decreased after six months in all the three groups. The inter group comparison showed higher efficacy of R + S in improving hyperandrogenism whereas R + M was most effective in decreasing body weight and plasma insulin levels compared to R and R + S (p<.05). Treatment of women with PCOS using rosiglitazone alone and in combination with spironolactone or metformin is safe and efficacious with limited adverse events however randomized trials with longer duration of follow up are warranted.

摘要

这项研究的目的是比较应用罗格列酮的多囊卵巢综合征（PCOS）患者联合二甲双胍或螺内酯的疗效和安全性。本研究为在三级护理内分泌诊所的三级护理中进行的前瞻性非随机研究。根据2003年鹿特丹标准诊断为PCOS患者（n = 138）以药物应用分为三类：罗格列酮（R）, 罗格列酮与螺内酯（R + S）和罗格列酮与二甲双胍（R + M）。在基线和随访六个月后评估临床, 生化, 激素和胰岛素敏感性的参数。六个月后, 三个组的每年的月经周期数和Ferriman Gallwey（FG）得分均有显着改善。在三个组中, 六个月后的血清胰岛素（0、2 h）, HOMA-IR和血清总睾丸激素水平均下降。组间比较显示, 与R相比R + S在改善高雄激素症方面具有更好的功效, 而R + M在降低体重和血清胰岛素水平方面最有效（p <.05）。单独使用罗格列酮, 亦或是与螺内酯或二甲双胍联合治疗PCOS患者是安全有效的, 不良事件的发生率有限, 但仍需进行随访时间更长的随机试验。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Rosiglitazone
• metformin
• spironolactone
• PCOS

Acknowledgements

We are highly grateful to the study subjects for the compliance to drugs and Dept. of Biostatistics, SKIMS, Srinagar, Jammu and Kashmir for assisting in data analysis.

Disclosure statement

The authors declare that there is no conflict of interest regarding the publication of this paper.