Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial

• Published in: JAMA pediatrics Vol. 171; no. 5; p. 470
• Main Authors: Rutten, Juliette M T M, Vlieger, Arine M, Frankenhuis, Carla, George, Elvira K, Groeneweg, Michael, Norbruis, Obbe F, Tjon A Ten, Walther, van Wering, Herbert M, Dijkgraaf, Marcel G W, Merkus, Maruschka P, Benninga, Marc A
• Format: Journal Article
• Language: English
• Published: United States 01.05.2017
• Subjects: Abdominal Pain - therapy; Adolescent; Child; Exercise Therapy - methods; Female; Follow-Up Studies; Humans; Hypnosis - methods; Irritable Bowel Syndrome - therapy; Male; Netherlands; Pain Measurement; Self Care - methods; Treatment Outcome
• ISSN: 2168-6211
• DOI: 10.1001/jamapediatrics.2017.0091

Individual gut-directed hypnotherapy (HT) is effective in pediatric irritable bowel syndrome (IBS) and functional abdominal pain or functional abdominal pain syndrome (FAP[S]). It is, however, unavailable to many children. To compare the effectiveness of HT by means of home-based self-exercises using a CD with that of individual HT (iHT) performed by qualified therapists. This noninferiority randomized clinical trial with a follow-up of 1 year after the end of treatment was conducted from July 15, 2011, through June 24, 2013, at 9 secondary and tertiary care centers throughout the Netherlands. A total of 303 children were eligible to participate. Of those, 260 children (aged 8-18 years) with IBS or FAP(S) were included in this study. Children were randomized (1:1 ratio) to home-based HT with a CD (CD group) or iHT performed by qualified therapists (iHT group). No children withdrew from the study because of adverse effects. The CD group was instructed to perform exercises 5 times per week or more for 3 months. The iHT group consisted of 6 sessions during 3 months. Primary outcomes were treatment success directly after treatment and after 1-year follow-up. Treatment success was defined as a 50% or greater reduction in pain frequency and intensity scores. The noninferiority limit was set at 50% treatment success in the CD group, with a maximum of 25% difference in treatment success with the iHT group after 1-year follow-up. Modified intention-to-treat analyses were performed. A total of 132 children were assigned to the CD group and 128 to the iHT group; 250 children were analyzed (126 in the CD group and 124 in the iHT group) (mean [SD] age, 13.4 [2.9] years in the CD group and 13.3 [2.8] years in the iHT group; 94 female [74.6%] in the CD group and 85 [68.5%] in the iHT group). Directly after treatment, 46 children (36.8%) in the CD group and 62 (50.1%) in the iHT group were successfully treated. After 1-year follow-up, the 62.1% treatment success in the CD group was noninferior to the 71.0% in the iHT group (difference, -8.9%; 90% CI, -18.9% to 0.7%; P = .002). Long-term effectiveness of home-based HT with a CD is noninferior to iHT performed by therapists in pediatric IBS or FAP(S). Treatment with hypnosis using a CD provides an attractive treatment option for these children. trialregister.nl Identifier: NTR2725.