TY - JOUR
T1 - Skills or Pills
T2 - Randomized Trial Comparing Hypnotherapy to Medical Treatment in Children With Functional Nausea
AU - Browne, Pamela D
AU - de Bruijn, Clara M A
AU - Speksnijder, Esther M
AU - den Hollander, Bibiche
AU - van Wering, Herbert M
AU - Wessels, Margreet M S
AU - Groeneweg, Michael
AU - Goede, Joery
AU - Frankenhuis, Carla
AU - Tromp, Ellen
AU - Benninga, Marc A
AU - Vlieger, Arine M
N1 - Funding Information: The authors acknowledge the great work and contributions by Nanja Bevers (Department of Pediatrics, Zuyderland Medical Center, Heerlen, The Netherlands), Maartje M. van den Berg (Department of Pediatrics, Haaglanden Medical Center, Den Haag, The Netherlands), Elvira K. George (Department of Pediatrics, Northwest Clinics, Alkmaar, The Netherlands), and Walther Tjon A. Ten (Department of Pediatrics, Maxima Medical Center, Veldhoven, The Netherlands). The authors appreciate the contribution in data processing by Eliza Vermeulen and Aaltje Lei. The authors thank all clinicians, patients, and parents who took part in this study and the hypnotherapists who performed the individual hypnotherapy sessions. Pamela D. Browne, MD PhD (Conceptualization: Supporting; Data curation: Lead; Investigation: Lead; Project administration: Lead; Writing ? original draft: Equal; Writing ? review & editing: Equal), Clara Marieke Andrea de Bruijn, MD (Data curation: Equal; Formal analysis: Lead; Investigation: Equal; Project administration: Equal; Validation: Lead; Visualization: Lead; Writing ? original draft: Equal; Writing ? review & editing: Equal), Esther M Speksnijder, BSc (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting), Bibiche den Hollander, MD (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting; Writing ? review & editing: Supporting), Herbert M van Wering, MD (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting; Writing ? review & editing: Supporting), Margreet M. S. Wessels, MD (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting; Writing ? review & editing: Supporting), Michael Groeneweg, MD PhD (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting; Writing ? review & editing: Supporting), Joery Goede, MD (Data curation: Supporting; Investigation: Supporting; Project administration: Supporting; Writing ? review & editing: Supporting), Carla Frankenhuis, BSc (Data curation: Supporting; Investigation: Supporting; Methodology: Supporting; Writing ? review & editing: Supporting), Ellen Tromp, MD (Formal analysis: Supporting; Methodology: Supporting; Supervision: Supporting; Validation: Supporting; Writing ? review & editing: Supporting), Marc A. Benninga, MD PhD (Conceptualization: Lead; Data curation: Supporting; Formal analysis: Supporting; Funding acquisition: Lead; Investigation: Lead; Methodology: Lead; Project administration: Supporting; Supervision: Lead; Validation: Supporting; Visualization: Supporting; Writing ? original draft: Supporting; Writing ? review & editing: Supporting), Arine M. Vlieger, MD PhD (Conceptualization: Lead; Data curation: Supporting; Formal analysis: Supporting; Funding acquisition: Lead; Investigation: Supporting; Methodology: Lead; Project administration: Supporting; Supervision: Lead; Validation: Supporting; Visualization: Supporting; Writing ? original draft: Supporting; Writing ? review & editing: Supporting) Funding Information: Funding Supported by the Dutch Digestive Foundation and the Christine Bader Foundation. The funding sources had no role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. Publisher Copyright: © 2021 AGA Institute
PY - 2021/10/27
Y1 - 2021/10/27
N2 - Background & Aims: The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT). Methods: One hundred children (ages, 8–18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea. Results: After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P =.052; and 57% vs 40%, P =.099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P =.667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P =.014; parents: 79% vs 53%; P =.016), but not at the 12-month follow-up evaluation. Conclusions: HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).
AB - Background & Aims: The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT). Methods: One hundred children (ages, 8–18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea. Results: After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P =.052; and 57% vs 40%, P =.099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P =.667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P =.014; parents: 79% vs 53%; P =.016), but not at the 12-month follow-up evaluation. Conclusions: HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).
KW - Children
KW - Functional Nausea
KW - Hypnotherapy
KW - RCT
UR - http://www.scopus.com/inward/record.url?scp=85120737755&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cgh.2021.10.029
DO - https://doi.org/10.1016/j.cgh.2021.10.029
M3 - Article
C2 - 34718171
SN - 1542-3565
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
ER -