Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial
Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial
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DOI：
10.1016/s2468-1253(19)30243-2
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发表时间：
2019-11-01
影响因子：
35.7
通讯作者：
Moss-Morris, Rona
中科院分区：
文献类型：
--
作者：
Everitt, Hazel A.;Landau, Sabine;Moss-Morris, Rona
背景 肠易激综合症 (IBS) 很常见，影响着全球 10-20% 的成年人，许多人报告尽管接受一线治疗，症状仍持续存在。难治性肠易激综合征指南推荐认知行为疗法 (CBT)，但 CBT 治疗 IBS 的机会不足，且疗效是否能长期持续存在不确定性。评估 IBS 认知行为治疗 (ACTIB) 是一项针对难治性 IBS 患者的两种形式的 CBT 的大型随机对照试验。 ACTIB 结果显示，12 个月时，两种形式的 IBS CBT 在减轻难治性 IBS 成人患者的 IBS 症状严重程度方面均比常规治疗更有效。这项后续研究旨在评估 ACTIB 试验参与者的 24 个月临床结果。 方法 在 ACTIB 三组随机对照试验中，558 名患有难治性 IBS 的成人被随机分配接受治疗师提供的电话 CBT（电话 CBT 组）、需要最少治疗师支持的基于网络的 CBT（网络 CBT 组）或照常治疗（TAU 组），并随访 12 个月。参与者是患有难治性IBS的成年人（尽管接受了一线治疗，但临床显着症状持续> = 12个月），通过信件和机会主义方式从2014年5月1日至2016年3月31日期间从伦敦和英格兰南部（英国）的74家全科诊所和三个胃肠病学中心招募。主要结局指标是IBS症状严重程度评分（IBS-SSS）以及工作和社会适应量表(WSAS)，通过多重插补在意向治疗 (ITT) 人群中进行评估。这项研究是对 ACTIB 试验参与者在 24 个月时进行的非预先指定的自然随访和分析，评估与原始试验相同的结果。结果测量由参与者在线完成或发布纸质调查问卷，或进行电话随访。 ACTIB 试验已在国际标准随机对照试验编号登记处注册，编号 ISRCTN44427879。结果对 558 名参与者中的 323 名参与者（58%）进行了 24 个月的结果随访：电话 CBT 组中的 119 名参与者（64%），网络 CBT 组中的 185 名参与者中的 99 名参与者（54%），以及 105 名参与者TAU 组 187 人中（56%）。 24 个月时，电话 CBT 组的平均 IBS-SSS 比 TAU 组低 40.5 分（95% CI 15.0 至 66.0；p=0.002），网络 CBT 组的平均 IBS-SSS 低 12.9 分（-12.9 至 38.8；p=0.33）。电话 CBT 组 119 名参与者中有 84 名 (71%) 参与者、网络 CBT 组 99 名参与者中有 62 名参与者 (63%) 以及 TAU 组 105 名参与者中有 48 名参与者 (46%) 从基线到 24 个月的 WSAS 平均得分为 3.1 分（1.3 至 4.9；p = 50 分）。 12 至 24 个月期间总共报告了 41 起不良事件：电话 CBT 组 11 起，网络 CBT 组 15 起，TAU 组 15 起。其中，八项报告与胃肠道相关，五项与心理相关，六项与肌肉骨骼相关。没有与治疗相关的不良事件。 解释 在 24 个月的随访中，与 TAU 相比，两个 CBT 组的 IBS 持续改善，尽管与 12 个月的结果相比，之前的一些进展有所减少。 IBS 特异性 CBT 有可能在通常的临床环境中实现 IBS 的长期改善。增加 CBT 治疗 IBS 的机会可以为患者带来长期利益。版权所有 (C) 2019 作者。由爱思唯尔有限公司出版
Background Irritable bowel syndrome (IBS) is common, affecting 10-20% of the adult population worldwide, with many people reporting ongoing symptoms despite first-line therapies. Cognitive behavioural therapy (CBT) is recommended in guidelines for refractory IBS but there is insufficient access to CBT for IBS and uncertainty about whether benefits last in the longer term. Assessing Cognitive behavioural Therapy for IBS (ACTIB) was a large, randomised, controlled trial of two forms of CBT for patients with refractory IBS. ACTIB results showed that, at 12 months, both forms of CBT for IBS were significantly more effective than treatment as usual at reducing IBS symptom severity in adults with refractory IBS. This follow-up study aimed to evaluate 24-month clinical outcomes of participants in the ACTIB trial.Methods In the ACTIB three-group, randomised, controlled trial, 558 adults with refractory IBS were randomly allocated to receive either therapist-delivered telephone CBT (telephone-CBT group), web-based CBT with minimal therapist support (web-CBT group), or treatment as usual (TAU group) and were followed up for 12 months. Participants were adults with refractory IBS (clinically significant symptoms for >= 12 months despite being offered first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and the south of England (UK) between May 1, 2014, and March 31, 2016. Primary outcome measures were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation. This study was a non-prespecified naturalistic follow-up and analysis of the participants of the ACTIB trial at 24 months assessing the same outcomes as the original trial. Outcome measures were completed online by participants or a paper questionnaire was posted, or telephone follow-up undertaken. The ACTIB trial is registered with the International Standard Randomised Controlled Trial Number registry, number ISRCTN44427879.Findings 24-month follow-up of outcomes was achieved for 323 (58%) of 558 participants: 119 (64%) of 186 in the telephone-CBT group, 99 (54%) of 185 in the web-CBT group, and 105 (56%) of 187 in the TAU group. At 24 months, mean IBS-SSS was 40.5 points (95% CI 15.0 to 66.0; p=0.002) lower in the telephone-CBT group and 12.9 points (-12.9 to 38.8; p=0.33) lower in the web-CBT group than in the TAU group. The mean WSAS score was 3.1 points (1.3 to 4.9; p= 50 points) from baseline to 24 months was found in 84 (71%) of 119 participants in the telephone-CBT group, in 62 (63%) of 99 in the web-CBT group, and in 48 (46%) of 105 in the TAU group. In total 41 adverse events were reported between 12 to 24 months: 11 in the telephone-CBT group, 15 in the web-CBT group, and 15 in the TAU group. Of these, eight were reported as gastrointestinal related, five as psychological, and six as musculoskeletal. There were no adverse events related to treatment.Interpretation At 24-month follow-up, sustained improvements in IBS were seen in both CBT groups compared with TAU, although some previous gains were reduced compared with the 12-month outcomes. IBS-specific CBT has the potential to provide long-term improvement in IBS, achievable within a usual clinical setting. Increasing access to CBT for IBS could achieve long-term patient benefit. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd.