Dienogest as preoperative treatment of submucous myomas for hysteroscopic surgery: a prospective, randomized study

Abstract

The aim of this single-center, prospective, randomized, parallel-group study was to compare Dienogest and Danazol as endometrial preparation in patients who have to undergo hysteroscopic surgery for submucous myomas. We enrolled 80 consecutive eligible patients, in reproductive age, affected by submucous myomas. Pre- and posttreatment characterization of endometrium was performed by hysteroscopic visual observation and histologic confirmation. The enrolled patients were randomly assigned to two groups: 40 were treated with 2 mg of Dienogest/die, 40 with 100 mg of Danazol/die, both orally for 5 weeks, starting on day 1 of menstruation. Posttreatment comparison of endometrial patterns showed a significant more marked effect of Dienogest, respect to Danazol, in atrophying endometrium (“normotrophic non-responders” versus “hypotrophic”–“atrophic”, p = 0.028). Intraoperative data showed no significant difference between the two groups for cervical dilatation time (p = 0.326), while in the Dienogest group, we found a significant reduction of operative time (p = 0.001), infusion volume (p = 0.001), and severity of bleeding (p = 0.042). Moreover, Dienogest caused less side effects (p = 0.008). According to our data analysis, Dienogest, respect to Danazol, is more effective for the preparation of the endometrium in patients who have to undergo hysteroscopic surgery for submucous myomas, and causes less side effects.

Chinese abstract

该项单中心前瞻性随机平行分组研究是为了比较因子宫粘膜下肌瘤接受宫腔镜手术的患者分别应用地诺孕素和达那唑行子宫内膜准备。我们纳入了80名符合条件的患者，均为生育年龄患有子宫粘膜下肌瘤。治疗前和治疗后子宫内膜的特征表现通过宫腔镜视觉观察和组织学确诊获得。纳入的患者随机分为两组：40名患者服用2mg地诺孕素/日，40名患者服用100mg达那唑/日，均口服5周，从月经期第一天开始。治疗后子宫内膜形态的比较表明，与达那唑相比，地诺孕素对萎缩子宫内膜有显著作用（“营养正常无应答”对比“营养不良”-“萎缩性”，p=0.028)。术中数据表明两组的宫颈扩张时间无显著性差异(p=0.326)，而在地诺孕素组，我们发现手术时间(p=0.001)、输液量(p=0.001)、出血的严重程度(p=0.042)显著减少。此外，地诺孕素引起较少的副作用(p=0.008)。根据我们的数据分析，与达那唑相比，对因子宫粘膜下肌瘤而接受宫腔镜手术的患者，地诺孕素的子宫内膜准备作用更有效，且副作用较少。

• Danazol
• Dienogest
• hysteroscopic surgery
• preoperative treatment
• submucous myomas

Declaration of interest

All authors have no proprietary, financial, professional, or other personal interest of any nature in any product, service, or company. The authors alone are responsible for the content and writing of the paper. No specific funding was obtained.