Department of Pediatric Gastroenterology and Nutrition, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Department of Pediatrics, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
J Crohns Colitis. 2021 Jul 5;15(7):1106-1113. doi: 10.1093/ecco-jcc/jjaa241.
Many inflammatory bowel disease [IBD] patients in remission have persisting symptoms, compatible with irritable bowel syndrome [IBS-type symptoms]. We aimed to compare the effectiveness of gut-directed hypnotherapy vs standard medical treatment [SMT] for IBS-type symptoms in IBD patients.
In this multicentre, randomized, controlled, open-label trial, patients aged 12-65 years with IBD in clinical remission [global assessment] and biochemical remission [faecal calprotectin ≤100 µg/g, or ≤200 µg/g without inflammation at endoscopy] with IBS according to Rome III criteria were randomized to hypnotherapy or SMT. Primary outcome was the proportion with ≥50% reduction on a visual analog scale for symptom severity, as measured with the Irritable Bowel Syndrome Severity Scoring System [IBS-SSS] at week 40 [i.e. 6 months after finishing the intervention], compared to baseline. Secondary outcomes included total IBS-SSS score, quality of life, adequate relief, IBS-related cognitions, and depression and anxiety scores.
Eighty patients were included, of whom 70 received at least one session of the allocated treatment and were included in the modified intention-to-treat-population. Seven patients were excluded because of missing baseline data required for the primary outcome. The primary outcome was met in nine [27%] of 33 patients randomized to SMT and nine [30%] of 30 patients randomized to hypnotherapy [p = 0.81]. Adequate relief was reported in 60% and 40% of subjects, respectively. Exploratory analyses of secondary outcomes revealed no apparent differences between the two treatment groups.
Hypnotherapy was not superior to SMT in the treatment of IBS-type symptoms in IBD patients. Both treatment strategies are reasonable options from a clinical perspective.
许多处于缓解期的炎症性肠病 [IBD] 患者仍存在持续性症状,与肠易激综合征 [IBS 型症状] 相符。我们旨在比较针对 IBD 患者 IBS 型症状的肠道导向催眠疗法与标准医学治疗 [SMT] 的疗效。
在这项多中心、随机、对照、开放标签试验中,我们招募了年龄在 12-65 岁之间、符合罗马 III 标准的 IBD 缓解期患者 [整体评估] 和生化缓解期患者 [粪便钙卫蛋白≤100 µg/g,或内镜下无炎症时≤200 µg/g],且存在 IBS 型症状,他们被随机分配至接受催眠疗法或 SMT。主要结局是在第 40 周(即干预结束后 6 个月)时,使用肠易激综合征严重程度评分系统 [IBS-SSS] 评估症状严重程度的视觉模拟量表上,症状严重程度减轻≥50%的患者比例,与基线相比。次要结局包括 IBS-SSS 总评分、生活质量、充分缓解、IBS 相关认知和抑郁焦虑评分。
共纳入 80 例患者,其中 70 例患者至少接受了一次分配的治疗,并纳入改良意向治疗人群。7 例患者因主要结局所需的基线数据缺失而被排除。33 例随机接受 SMT 的患者中有 9 例(27%)和 30 例随机接受催眠治疗的患者中有 9 例(30%)达到主要结局[P = 0.81]。分别有 60%和 40%的患者报告了充分缓解。对次要结局的探索性分析显示,两组治疗之间没有明显差异。
催眠疗法在治疗 IBD 患者的 IBS 型症状方面并不优于 SMT。从临床角度来看,这两种治疗策略都是合理的选择。