BACKGROUND Endometriosis is defined by the presence of endometrial-like tissue (lesions) outside the uterus, commonly on the pelvic peritoneum. It affects 6-10% of women and is associated with debilitating pelvic pain. Current management options are often unsatisfactory. Omega-3 polyunsaturated fatty acids (O-PUFA) have the potential to reduce the painful symptoms associated with endometriosis, reduce lesion size, preserve the patient's ability to conceive, and have minimal side effects. We performed a two-arm, parallel double-blinded randomised controlled trial to inform the planning of a future multicentre randomised controlled trial to evaluate the efficacy of O-PUFA for endometriosis-associated pain. OBJECTIVES The primary objectives of the trial were to assess recruitment and retention rates. The secondary objectives were to determine the acceptability to women of the proposed methods of recruitment, randomisation, treatments and questionnaires, to estimate the variability in the proposed primary endpoints to inform the sample size calculation and to refine the research methodology for the future definitive trial. METHODS We recruited women with endometriosis from June 2016 to June 2017 and randomised them to eight weeks of treatment with O-PUFA or olive oil. Pain scores and quality of life questionnaires were collected at baseline and eight weeks. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to eight weeks. Acceptability questionnaires were used to evaluate women's experiences of the trial. RESULTS The proportion of eligible participants who were randomised was 45.2% (33/73) and 81.8% (27/33) completed the study. The majority of participants described their overall trial experience favourably and there were no adverse events in either group. CONCLUSION Our pilot trial supports the feasibility of a future larger trial to definitively evaluate the efficacy of O-PUFA for endometriosis-associated pain. TRIAL REGISTRATION The trial was registered on the ISRCTN registry (registration number ISRCTN44202346).

中文翻译：

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一项关于 Omega-3 多不饱和脂肪酸治疗子宫内膜异位症相关疼痛的疗效的双臂平行双盲随机对照试验试验 (PurFECT1)。

背景技术子宫内膜异位症的定义是子宫外存在子宫内膜样组织（病变），通常位于盆腔腹膜上。它影响 6-10% 的女性，并与使人衰弱的骨盆疼痛有关。当前的管理选择往往不能令人满意。Omega-3 多不饱和脂肪酸 (O-PUFA) 有可能减少与子宫内膜异位症相关的疼痛症状、减小病变大小、保持患者的受孕能力并具有最小的副作用。我们进行了一项双臂、平行双盲随机对照试验，为未来多中心随机对照试验的规划提供信息，以评估 O-PUFA 对子宫内膜异位症相关疼痛的疗效。目的 试验的主要目的是评估招募和保留率。次要目标是确定女性对所提议的招募、随机化、治疗和问卷方法的可接受性，以估计提议的主要终点的可变性，为样本量计算提供信息，并为未来的最终试验改进研究方法。方法 我们从 2016 年 6 月到 2017 年 6 月招募了患有子宫内膜异位症的女性，并将她们随机分配到使用 O-PUFA 或橄榄油进行 8 周的治疗。在基线和八周时收集疼痛评分和生活质量问卷。我们计算了随机化合格女性的比例，以及随访长达八周的随机参与者的比例。可接受性问卷用于评估女性的试验经历。结果 符合条件的随机参与者比例分别为 45.2% (33/73) 和 81.8% (27/33) 完成了研究。大多数参与者对他们的整体试验体验进行了良好的描述，并且两组均未发生不良事件。结论 我们的试点试验支持未来更大规模试验的可行性，以明确评估 O-PUFA 对子宫内膜异位症相关疼痛的疗效。试验注册 该试验已在 ISRCTN 注册（注册号 ISRCTN44202346）上注册。结论 我们的试点试验支持未来更大规模试验的可行性，以明确评估 O-PUFA 对子宫内膜异位症相关疼痛的疗效。试验注册 该试验已在 ISRCTN 注册（注册号 ISRCTN44202346）上注册。结论 我们的试点试验支持未来更大规模试验的可行性，以明确评估 O-PUFA 对子宫内膜异位症相关疼痛的疗效。试验注册 该试验已在 ISRCTN 注册（注册号 ISRCTN44202346）上注册。