Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health

Abstract

This observational study was conducted in premenopausal women who presented themselves at the Obstetrics and Gynecology Department of the University Hospital of Cagliari (Italy), for heavy menstrual bleeding (HMB) dependent on uterine myomas. After a screening visit, 19 women without contraindications to ulipristal acetate (UPA) treatment, were included in the study that envisaged 12 months of observation in which each subject was asked to assume UPA (tablet of 5 mg, ESMYA^®, one tablet a day for 3 months: first cycle) two menstrual cycles of interruption and a second ESMYA^® cycle, followed by 3 months of observation (third follow-up month, visit 4). The significant decrease of myoma volume, diagnosed after the first ESMYA^® cycle, persisted until the visit 4. The HMB significantly decreased during the ESMYA^® treatment and persisted until visit 4. The quality of life (QoL), evaluated with the questionnaire SF-36, significantly improved during the study. The values of estradiol (E2), biochemical parameters of bone metabolism, as well as those of lumbar and hip bone mineral density, did not change during the study in comparison with basal levels. The efficacy of two repeated ESMYA^® cycles to treat uterine myomas and their related symptoms improves the QoL without interfering with bone health.

Chinese abstract

这项观察性研究是在意大利卡利亚里大学医院的妇产科进行, 研究对象是绝经期的女性因子宫肌瘤引起的严重月经量多（HMB）而就诊。筛选访问之后, 19位女性没有应用醋酸乌利司他（UPA）的禁忌证, 这项研究是12个月的观察, 每位受试者使用UPA（每片5mg, ESMYAV^®, 3个月中每日一片：第一周期）, 停止应用2个月经周期, 随后3个月的观察（后续的3个月, 访视4）。在第一ESMYAV^®治疗周期后, 肌瘤体积显著下降, 这种现象一直持续到第4次访视。HMB在ESMYAV^®治疗期间显著下降, 并持续到第4次访视。生活质量（QoL）在研究期间显著改善, 采用SF-36问卷进行评估。与基础水平相比, 雌二醇（E2）、骨代谢的生化指标、腰椎和髋部骨密度指标在研究过程中无明显变化。两次重复ESMYAV^®周期有治疗子宫肌瘤的疗效及改善相关症状及生活质量, 而且不影响骨骼健康。

Keywords:

• Ulipristal acetate
• heavy menstrual bleeding
• uterine myomas
• osteocalcin
• osteoprotegerin
• β crosslaps
• RANKL
• bone mineral densitometry
• quality of life
• ESMYA^®

Acknowledgments

Special thanks should be addressed to the staff of the secretariat of the Department of Obstetrics and Gynecology of the University of Cagliari (Franca Fadda, Maria Frongia, and Laura Di Pietro). The authors thank Kate Jenkins for revising the English language of the manuscript. All the authors remember with affection, gratitude, and esteem their colleague and friend, Dr, Marisa Orrù, who left us before the end of the study.

Disclosure statement

The Authors report no conflicts of interest.