Hypnotherapy for irritable bowel syndrome-type symptoms in patients with quiescent inflammatory bowel disease: a randomized, controlled trial.

Background and aims Many inflammatory bowel disease (IBD) patients in remission have persisting symptoms, compatible with irritable bowel syndrome (IBS-type symptoms). We aimed to compare the effectiveness of gut-directed hypnotherapy versus standard medical treatment (SMT) for IBS-type symptoms in IBD patients. Methods In this multicenter, randomized, controlled, open label trial, patients aged 12-65 years with IBD in clinical remission (global assessment) and biochemical remission (fecal calprotectin ≤100 µg/g, or ≤200 µg/g without inflammation at endoscopy) with IBS according to Rome III criteria, were randomized to hypnotherapy or SMT. Primary outcome was the proportion with ≥50% reduction on a visual analogue scale for symptom severity, as measured with the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) at week 40 (i.e. 6 months after finishing the intervention), compared to baseline. Secondary outcomes included total IBS-SSS score, quality of life, adequate relief, IBS-related cognitions and depression and anxiety scores. Results Eighty patients were included, of whom 70 received at least one session of the allocated treatment and were included in the modified intention-to-treat-population. Seven patients were excluded because of missing baseline data required for the primary outcome. The primary outcome was met in 9 (27%) of 33 patients randomized to SMT and 9 (30%) of 30 patients randomized to hypnotherapy (p=0.81). Adequate relief was reported in respectively 60% and 40% of subjects. Exploratory analyses of secondary outcomes revealed no apparent differences between both treatment groups. Conclusions Hypnotherapy was not superior to SMT in the treatment of IBS-type symptoms IBD patients. Both treatment strategies are reasonable options from a clinical perspective.