Objectives To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. Setting 34 UK hospitals. Participants 405 women of reproductive age undergoing conservative surgery for endometriosis. Interventions Participants were randomised in a 1:1 ratio using a secure internet facility to a long acting progestogen (depot medroxyprogesterone acetate or levonorgestrel releasing intrauterine system) or the combined oral contraceptive pill. Main outcome measures The primary outcome was pain measured three years after randomisation using the pain domain of the Endometriosis Health Profile 30 (EHP-30) questionnaire. Secondary outcomes (evaluated at six months, one, two, and three years) included the four core and six modular domains of the EHP-30, and treatment failure (further therapeutic surgery or second line medical treatment). Results 405 women were randomised to receive a long acting progestogen (n=205) or combined oral contraceptive pill (n=200). At three years, there was no difference in pain scores between the groups (adjusted mean difference −0.8, 95% confidence interval −5.7 to 4.2, P=0.76), which had improved by around 40% in both groups compared with preoperative values (an average of 24 and 23 points for long acting progestogen and combined oral contraceptive pill groups, respectively). Most of the other domains of the EHP-30 also showed improvement at all time points compared with preoperative scores, without evidence of any differences between groups. Women randomised to a long acting progestogen underwent fewer surgical procedures or second line treatments compared with those randomised to the combined oral contraceptive pill group (73 v 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). Conclusions Postoperative prescription of a long acting progestogen or the combined oral contraceptive pill results in similar levels of improvement in endometriosis related pain at three years, with both groups showing around a 40% improvement compared with preoperative levels. While women can be reassured that both options are effective, the reduced risk of repeat surgery for endometriosis and hysterectomy might make long acting reversible progestogens preferable for some. Trial registration ISRCTN registry [ISRCTN97865475.][1] All data requests should be submitted to bctudatashare@contacts.bham.ac.uk for consideration. Access to anonymised data might be granted after review. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN97865475.

中文翻译：

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长效孕激素与复方口服避孕药预防子宫内膜异位症相关疼痛复发的比较：PRE-EMPT 实用、平行组、开放标签、随机对照试验


目的 评估长效孕激素与复方口服避孕药相比在预防子宫内膜异位症相关疼痛复发方面的临床效果。设计 PRE-EMPT（预防子宫内膜异位症复发）实用、平行组、开放标签、随机对照试验。设置34家英国医院。参与者为 405 名接受子宫内膜异位症保守手术的育龄妇女。干预措施 使用安全的互联网设施将参与者按 1:1 的比例随机分配至长效孕激素（长效孕激素醋酸甲羟孕酮或左炔诺孕酮宫内缓释系统）或复方口服避孕药。主要结果指标 主要结果是随机分组三年后使用子宫内膜异位症健康概况 30 (EHP-30) 问卷的疼痛领域测量的疼痛。次要结局（在六个月、一年、两年和三年时评估）包括 EHP-30 的四个核心和六个模块领域，以及治疗失败（进一步治疗性手术或二线药物治疗）。结果 405 名女性被随机分配接受长效孕激素 (n=205) 或复方口服避孕药 (n=200)。三年时，两组之间的疼痛评分没有差异（调整平均差 -0.8，95% 置信区间 -5.7 至 4.2，P=0.76），与术前值相比，两组均改善了约 40%（长效孕激素组和复方口服避孕药组的平均分分别为 24 分和 23 分）。与术前相比，EHP-30 的大多数其他领域在所有时间点也显示出改善，但没有证据表明组间存在任何差异。 与随机分配到联合口服避孕药组的女性相比，随机分配到长效孕激素组的女性接受的外科手术或二线治疗较少（73 vs 97；风险比 0.67，95% 置信区间 0.44 至 1.00）。结论 术后服用长效孕激素或复方口服避孕药可使子宫内膜异位症相关疼痛在三年内得到相似程度的改善，两组均较术前水平改善约 40%。虽然可以让女性放心，这两种选择都是有效的，但子宫内膜异位症和子宫切除术重复手术的风险降低可能会使长效可逆孕激素对某些人来说更可取。试用注册 ISRCTN 注册表 [ISRCTN97865475.][1] 所有数据请求均应提交至 bctudatashare@contacts.bham.ac.uk 供考虑。审查后可能会授予对匿名数据的访问权限。 [1]：/external-ref?link_type=ISRCTN&access_num=ISRCTN97865475。