PDF(Pubmed)
Abstract：
To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain.
The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial.
34 UK hospitals.
405 women of reproductive age undergoing conservative surgery for endometriosis.
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.
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).
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).
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.
ISRCTN registry ISRCTN97865475.
The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial.
34 UK hospitals.
405 women of reproductive age undergoing conservative surgery for endometriosis.
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.
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).
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).
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.
ISRCTN registry ISRCTN97865475.
摘要：
评价长效孕激素与联合口服避孕药预防子宫内膜异位症相关疼痛复发的临床效果。
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。
英国34家医院。
405名育龄妇女因子宫内膜异位症接受保守手术。
使用安全的互联网设施，将参与者以1：1的比例随机分配给长效孕激素（醋酸甲羟孕酮或左炔诺孕酮宫内释放系统）或联合口服避孕药。
主要结局是使用子宫内膜异位症健康概况30（EHP-30）问卷的疼痛领域进行随机化后3年测量的疼痛。次要结果（在六个月时评估，一,两个,和三年）包括EHP-30的四个核心和六个模块化领域，以及治疗失败（进一步的治疗性手术或二线医疗）。
405名妇女随机接受长效孕激素（n=205）或联合口服避孕药（n=200）。三年后，两组之间的疼痛评分没有差异（调整后的平均差-0.8，95％置信区间-5.7至4.2，P=0.76），与术前相比，两组均提高了约40％（长效孕激素和联合口服避孕药组平均24和23分，分别)。与术前评分相比，EHP-30的大多数其他领域在所有时间点也显示出改善，没有任何组间差异的证据。与随机分配给联合口服避孕药组的妇女相比，随机分配给长效孕激素的妇女接受的外科手术或二线治疗较少（73v97；风险比0.67，95％置信区间0.44至1.00）。
术后处方长效孕激素或联合口服避孕药可在3年时改善子宫内膜异位症相关疼痛。与术前水平相比，两组均显示约40％的改善。虽然妇女可以放心，这两种选择都是有效的，子宫内膜异位症和子宫切除术的重复手术风险降低,可能使一些人更喜欢长效可逆孕激素.
ISRCTN注册表ISRCTN97865475。
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。
英国34家医院。
405名育龄妇女因子宫内膜异位症接受保守手术。
使用安全的互联网设施，将参与者以1：1的比例随机分配给长效孕激素（醋酸甲羟孕酮或左炔诺孕酮宫内释放系统）或联合口服避孕药。
主要结局是使用子宫内膜异位症健康概况30（EHP-30）问卷的疼痛领域进行随机化后3年测量的疼痛。次要结果（在六个月时评估，一,两个,和三年）包括EHP-30的四个核心和六个模块化领域，以及治疗失败（进一步的治疗性手术或二线医疗）。
405名妇女随机接受长效孕激素（n=205）或联合口服避孕药（n=200）。三年后，两组之间的疼痛评分没有差异（调整后的平均差-0.8，95％置信区间-5.7至4.2，P=0.76），与术前相比，两组均提高了约40％（长效孕激素和联合口服避孕药组平均24和23分，分别)。与术前评分相比，EHP-30的大多数其他领域在所有时间点也显示出改善，没有任何组间差异的证据。与随机分配给联合口服避孕药组的妇女相比，随机分配给长效孕激素的妇女接受的外科手术或二线治疗较少（73v97；风险比0.67，95％置信区间0.44至1.00）。
术后处方长效孕激素或联合口服避孕药可在3年时改善子宫内膜异位症相关疼痛。与术前水平相比，两组均显示约40％的改善。虽然妇女可以放心，这两种选择都是有效的，子宫内膜异位症和子宫切除术的重复手术风险降低,可能使一些人更喜欢长效可逆孕激素.
ISRCTN注册表ISRCTN97865475。
