Juliette M T M Rutten1, Arine M Vlieger2, Carla Frankenhuis1, Elvira K George3, Michael Groeneweg4, Obbe F Norbruis5, Walther Tjon A Ten6, Herbert M van Wering7, Marcel G W Dijkgraaf8, Maruschka P Merkus8, Marc A Benninga1. 1. Department of Pediatric Gastroenterology, Emma Children's Hospital and Academic Medical Center, Amsterdam, the Netherlands. 2. Department of Pediatrics, St. Antonius Hospital, Nieuwegein, the Netherlands. 3. Department of Pediatrics, Medical Center Alkmaar, Alkmaar, the Netherlands. 4. Department of Pediatrics, Maasstad Hospital, Rotterdam, the Netherlands. 5. Department of Pediatrics, Isala Clinics, Zwolle, the Netherlands. 6. Department of Pediatrics, Maxima Medical Center, Veldhoven, the Netherlands. 7. Department of Pediatrics, Amphia Hospital, Breda, the Netherlands. 8. Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Abstract
Importance: 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. Objective: 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. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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). Conclusions and Relevance: 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. Trial Registration: trialregister.nl Identifier: NTR2725.
RCT Entities:
Importance: 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. Objective: 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. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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). Conclusions and Relevance: 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. Trial Registration: trialregister.nl Identifier: NTR2725.
Authors: Maria Lalouni; Brjánn Ljótsson; Marianne Bonnert; Erik Hedman-Lagerlöf; Jens Högström; Eva Serlachius; Ola Olén Journal: JMIR Ment Health Date: 2017-08-10
Authors: Lusine Ambartsumyan; Julie Khlevner; Samuel Nurko; Rachel Rosen; Ajay Kaul; John E Pandolfino; Elyanne Ratcliffe; Desale Yacob; B U K Li; Jaya Punati; Manu Sood; Satish S C Rao; Marc A Levitt; Jose T Cocjin; Leonel Rodriguez; Alejandro Flores; John M Rosen; Jaime Belkind-Gerson; Miguel Saps; Jose M Garza; John E Fortunato; Rose L Schroedl; Laurie A Keefer; Joel Friedlander; Robert O Heuckeroth; Meenakshi Rao; Khalil El-Chammas; Karla Vaz; Bruno P Chumpitazi; Rina Sanghavi; Sravan K R Matta; Tanaz Danialifar; Carlo Di Lorenzo; Anil Darbari Journal: J Pediatr Gastroenterol Nutr Date: 2020-08 Impact factor: 2.839