A pilot randomised double blind controlled trial of the efficacy of purified fatty acids for the treatment of women with endometriosis-associated pain (PurFECT): study protocol.
A pilot randomised double blind controlled trial of the efficacy of purified fatty acids for the treatment of women with endometriosis-associated pain (PurFECT): study protocol.
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DOI：
10.1186/s40814-018-0274-8
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发表时间：
2018
影响因子：
1.7
通讯作者：
Horne AW
中科院分区：
文献类型：
--
作者：
Abokhrais IM;Saunders PTK;Denison FC;Doust A;Williams L;Horne AW
子宫内膜异位症影响6-10%的女性，并伴有盆腔疼痛。这使英国每年损失28亿英镑的生产力。子宫内膜异位症可以通过手术切除或药物抑制卵巢来治疗。然而，约75%的症状在手术后复发，现有的药物治疗有不良的副作用，并且是避孕的。Omega-3纯化脂肪酸（PUFA）已经在动物模型中被证明可以减少导致子宫内膜异位症相关疼痛的因素，副作用很小，而且对生育能力没有影响。本文提出了一项双臂平行随机对照试验（RCT）的方案，旨在为未来的多中心试验提供信息，以评估Omega-3 PUFA在治疗女性子宫内膜异位症相关疼痛方面的疗效。该研究将在英国洛希安的国民健康服务（NHS）招募患有子宫内膜异位症的妇女，为期12个月，并随机分配她们接受8周的Omega-3 PUFA或比较物（橄榄油）治疗。主要目标是评估征聘率和留职率。次要目标是确定所建议的招募/随机化/治疗/问卷方法对参与者的有效性/可接受性，为样本量计算提供信息，并为未来的大型随机对照试验完善研究方法。对治疗的反应将通过疼痛评分和评估身体和情绪功能的问卷来监测，与基线和8周进行比较。我们认识到，对子宫内膜异位症进行大规模随机对照试验以评估Omega-3 PUFA可能存在潜在困难，因为它们是一种非处方膳食补充剂，已经被患有子宫内膜异位症的女性使用。因此，我们设计了这项试点研究来评估实际可行性，并遵循“临床试验中方法、测量和疼痛评估倡议”对慢性疼痛试验设计的建议。ISRCTN44202346
Endometriosis affects 6–10% of women and is associated with debilitating pelvic pain. It costs the UK > £2.8 billion per year in loss of productivity. Endometriosis can be managed by surgical excision or medically by ovarian suppression. However, ~ 75% symptoms recur after surgery and available medical treatments have undesirable side effects and are contraceptive. Omega-3 purified fatty acids (PUFA) have been shown in animal models to reduce factors that are thought to lead to endometriosis-associated pain, have minimal side effects, and no effects on fertility. This paper presents a protocol for a two-arm, pilot parallel randomised controlled trial (RCT) which aims to inform the planning of a future multicentre trial to evaluate the efficacy of Omega-3 PUFA in the management of endometriosis-associated pain in women. The study will recruit women with endometriosis over a 12-month period in the National Health Service (NHS) Lothian, UK, and randomise them to 8 weeks of treatment with Omega-3 PUFA or comparator (olive oil). The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness/acceptability to participants of the proposed methods of recruitment/randomisation/treatments/questionnaires, to inform the sample size calculation and to refine the research methodology for a future large randomised controlled trial. Response to treatment will be monitored by pain scores and questionnaires assessing physical and emotional function compared at baseline and 8 weeks. We recognise that there may be potential difficulties in mounting a large randomised controlled trial for endometriosis to assess Omega-3 PUFA because they are a dietary supplement readily available over the counter and already used by women with endometriosis. We have therefore designed this pilot study to assess practical feasibility and following the ‘Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials’ recommendations for the design of chronic pain trials. ISRCTN44202346