Ulipristal acetate for uterine fibroids: a systematic review and meta-analysis

Abstract

Ulipristal acetate (UA), a selective progesterone modulator, has been approved for short-term therapy for symptomatic fibroids. We decided to undertake a systematic review of the best available evidence and draw a more definitive conclusion regarding the efficacy of UA for the management of uterine fibroids. The outcomes included symptomatic relief, quality of life-related parameters, reduction in fibroid size, side effects and recurrence rate. We included four randomised controlled trials which consisted of three trials which compared UA with placebo, and one trial compared it with gonadotropin-releasing hormone analogues for symptomatic relief. The three trials comparing UA with placebo reported significant improvement in symptoms related to excessive uterine bleeding as evidenced by the attainment of amenorrhea or reduction in pictorial blood assessment chart. However, due to the heterogeneity of the available data, a meta-analysis was possible only for one the outcomes – attainment of amenorrhea which indicated improvement in symptoms [57.88 (19.81–169.16); p < 0.00001]. The improved quality of life parameters and reduction in fibroid size was noted in the UA group. With regards to adverse events, even though the three included studies reported increased non-physiological endometrial-related changes following UA, these changes reverted back to normal within 6 months. Short-term use of UA seems to be an effective and safe method of treating uterine fibroids.

Chinese abstract

醋酸乌利司他(UA)是一种选择性孕酮受体调节剂，已被证实可以用于有症状的子宫肌瘤的短期治疗。拟系统性回顾既往研究中醋酸乌利司他治疗子宫肌瘤的有效性证据，从而得出更加确切的结论。观察指标包括：症状缓解、生活质量改善、肌瘤体积缩小、副反应及复发率。我们分析了四个随机对照试验，其中三个试验是分为UA与安慰剂组，另一个是以UA组和GnRH-a组为研究对象。前三个试验报道，UA组闭经发生率明显增加，或月经失血图分数下降，从而证实UA组中患者月经过多的症状可以得到明显改善。然而，由于现存数据的异质性，meta分析只能用于闭经这一个观察指标❲57.88(19.81-169.16)；p＜0.00001❳。同样，UA组的生活质量评分改善与肌瘤体积缩小也已明确；副反应方面，尽管这三个研究均报道服用UA后不伴临床症状的子宫内膜改变，但这些变化在6个月内即可恢复正常。短期应用UA成为治疗子宫肌瘤的安全有效的方法。

• Acetate
• fibroids
• myomas
• ulipristal

Declaration of interest

All the authors report no declarations of interest.