心理干预可改善子宫内膜异位症患者的生活质量，尽管其持续存在疼痛：一项三臂随机对照试验的结果。
Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial.
机构信息
Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus, Denmark.
Department of Psychology and Behavioral Sciences, School of Business and Social Sciences, Aarhus University, 8000, Aarhus, Denmark.
出版信息
Qual Life Res. 2023 Jun;32(6):1727-1744. doi: 10.1007/s11136-023-03346-9. Epub 2023 Feb 17.
PURPOSE
Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.
METHODS
This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.
RESULTS
Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.
CONCLUSIONS
Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.
TRIAL REGISTRATION
12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.
目的
尽管采用了标准的医学治疗，子宫内膜异位症仍常伴有使人丧失能力的疼痛和较差的生活质量（QoL）。研究表明，心理干预（PIs）可能改善疼痛和 QoL，但针对子宫内膜异位症女性的 PIs 效果的研究较少且受到低质量研究设计的限制。因此，本研究旨在采用严格的三臂设计，评估 PIs 对子宫内膜异位症女性慢性盆腔疼痛（CPP）和 QoL 的影响。
方法
这项三臂平行、多中心随机对照试验纳入了 58 名报告严重 CPP（疼痛强度用 0-10 点数字评定量表[NRS]测量≥5）的子宫内膜异位症患者。患者被随机分配到（1）特定的正念和接受为基础的心理干预（MY-ENDO）、（2）精心匹配的非特定心理干预（非特异性）或（3）等待名单对照组（WL）。主要结局是 NRS 测量的盆腔疼痛强度/不适。次要结局包括与子宫内膜异位症相关的生活质量、工作能力、疼痛接受度和与子宫内膜异位症相关的症状。使用混合线性模型分析组间治疗后随访时结局的差异。分析基于意向治疗。
结果
与 WL 相比，心理干预（MY-ENDO+非特异性）并未显著减轻疼痛。然而，心理干预显著改善了 QoL 子量表“控制和无力感”、“情绪健康”和“社会支持”以及与子宫内膜异位症相关的症状“排便困难”和“便秘”。MY-ENDO 并不优于非特异性。
结论
尽管持续存在严重 CPP，子宫内膜异位症女性可能会因心理干预而对 QoL 产生显著且较大的影响。
试验注册
2016 年 4 月 12 日，clinicaltrials.gov（NCT02761382），回溯注册。
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