Skills or Pills - Randomized trial comparing Hypnotherapy to Medical Treatment in children with Functional Nausea.

ABSTRACT 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 Hundred children (8–18 years) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were randomly allocated (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, half-way and after treatment, and 6- and 12-month follow-up. Children scored nausea symptoms on a 7-day-diary. Primary outcome was treatment success, defined as ≥50% nausea reduction, at 12-month follow-up. Secondary outcome included adequate relief of nausea. Results After treatment and at 6-month follow-up, there was a trend toward higher treatment success in the HT group compared to the SMT group (45% vs. 26%, p = .052 and 57% vs. 40%, p =.099). At 12 months, treatment success was similar in both groups (60% (HT) and 55% (SMT); p = .667). In the FN group, significant 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 6-month follow-up (children: 81% vs. 55%, p =.014 and parents: 79% vs. 53%, p =.016), but not at 12-month follow-up. Conclusion 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 functional nausea as a treatment option; trialregister.nl ID: NTR5814.