Desogestrel versus danazol as preoperative treatment for hysteroscopic surgery: a prospective, randomized evaluation

Abstract The aim of this single-center, prospective, randomized, parallel-group study was to compare desogestrel and danazol as preoperative endometrial preparation for hysteroscopic surgery. We enrolled 200 consecutive eligible patients, in reproductive age, with endouterine diseases. Pre- and post-treatment characterization of endometrium was performed by hysteroscopic visual observation and histologic confirmation. The enrolled patients were randomly assigned to two groups: 100 were treated with 75 μg of desogestrel/die, 100 with 100 mg of danazol/die, both orally for 5 weeks, starting on Day 1 of menstruation. We recorded intraoperative data (cervical dilatation time, operative time, infusion volume and severity of bleeding) and drugs' side effects. Post-treatment comparison of endometrial patterns showed a significant more marked effect of desogestrel, respect to danazol, in atrophying endometrium (“normotrophic non-responders” versus “hypotrophic”—“atrophic”, p = 0.031). Intraoperative data showed no significant differences between the two groups for cervical dilatation time (p = 0.160), while in the desogestrel group we found a significant reduction of operative time (p = 0.020), infusion volume (p = 0.012), and severity of bleeding (p = 0.004). Moreover, desogestrel caused less side effects (p = 0.031). According to our data analysis, desogestrel showed most marked effect in inducing endometrial atrophy, allowed a better intraoperative management and caused less side effects during treatment. Chinese abstract 这一单中心、前瞻性、随机、平行研究的目的是比较宫腔镜手术前应用去氧孕烯和达那唑做子宫内膜准备的差异。我们招募了200名育龄期宫内病变患者，通过宫腔镜检查肉眼观察和组织学活检来确定治疗前后子宫内膜的特征。受试者被随机分为两组：100名应用去氧孕烯治疗，75μg/天，另100名用达那唑治疗，100mg/天，均从月经第一天开始，治疗5周。我们记录了两组手术过程中的数据（宫颈扩展时间、手术时间、输液量、阴道出血严重程度）和药物不良反应。治疗后比较子宫内膜形态显示在子宫内膜萎缩方面去氧孕烯作用比达那唑强（“正常营养状况”与“营养不良”—“ 萎缩”， p=0.031）。术中数据显示两组之间宫颈扩张时间无显著差异（p=0.160），但去氧孕烯组的手术时间（p=0.020）、输液量（p=0.012）、阴道出血严重程度（p=0.004）显著缩短。另外，去氧孕烯的副作用更小（p=0.031）。根据我们的数据分析，去氧孕烯在子宫内膜萎缩方面作用最为明显，为手术提供更好的条件，且治疗副作用小。