Department of Pediatric Gastroenterology, Emma Children's Hospital/Academic Medical Center, PO Box 22700, 1100 DD Amsterdam, The Netherlands.
BMC Pediatr. 2014 Jun 4;14:140. doi: 10.1186/1471-2431-14-140.
Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S).
METHODS/DESIGN: 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies.
If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability.
Dutch Trial Register number NTR2725 (date of registration: 1 February 2011).
肠易激综合征（IBS）和功能性腹痛（综合征）（FAP(S)）是常见的儿科疾病，其特征为慢性或复发性腹痛。治疗具有挑战性，特别是对于持续存在症状的儿童。由治疗师进行的针对肠道的催眠疗法（HT）已被证明对这些儿童有效，但由于费用、缺乏合格的儿童催眠治疗师以及需要儿童和（或）父母大量时间投入，许多儿童仍无法获得该治疗。通过 CD 进行的基于家庭的催眠治疗也已被证明有效，并且具有降低成本和减少时间投入等潜在益处。本随机对照试验（RCT）的目的是比较由合格治疗师进行的个体 HT 与通过 CD 在家中进行自我练习的 HT 在 IBS 或 FAP(S) 儿童中的成本效益。
方法/设计：目前正在进行一项 RCT，纳入了 260 名年龄在 8-18 岁之间、符合罗马 III 标准的 IBS 或 FAP(S) 儿童，随访期为一年。儿童被随机分配到 3 个月内接受 6 次由合格治疗师进行的个体 HT 或在家中通过 CD 进行 3 个月的自我练习 HT。主要结局是治疗结束时和一年随访结束时治疗成功的患者比例。治疗成功定义为腹痛频率和强度评分至少降低 50%。次要结局包括充分缓解、成本效益以及两种疗法对抑郁和焦虑评分、躯体化评分、生活质量、疼痛信念和应对策略的影响。
如果基于 CD 的家庭 HT 的有效性与治疗师进行的 HT 相当或略低，那么由于其低成本和直接可用性，这种治疗方法可能成为 IBS 或 FAP(S) 儿童的一种有吸引力的治疗形式。
荷兰试验注册编号 NTR2725（注册日期：2011 年 2 月 1 日）。
