BACKGROUND & AIMS: Gut-directed hypnotherapy (GDH) is effective for treating irritable bowel syndrome (IBS), but access limits its widespread use. We report the first randomized controlled trial comparing the safety and efficacy of a self-administered, digital GDH treatment program with that of digital muscle relaxation (MR) in adults with IBS.

METHODS

After a 4-week run-in period, patients were randomized to 12 weeks of treatment with digital GDH (Regulora), or digital MR accessed via a mobile app on a smartphone or tablet. The primary endpoint was abdominal pain response, defined as ≥30% reduction from baseline in average daily abdominal pain intensity in the 4 weeks following treatment. Key secondary outcomes included mean change from baseline in abdominal pain, stool consistency, and stool frequency.

RESULTS

Of 378 randomized patients, 362 were treated and included in the efficacy analysis. A similar proportion of the GDH (30.4%) and MR (27.1%) groups met the primary endpoint, with no significant difference between the groups (P = .5352). Significantly more patients treated with GDH than MR were abdominal pain responders during the last 4 weeks of treatment (30.9% vs 21.5%; P = .0232) and over the entire treatment period (29.3% vs 18.8%; P = .0254). Improvements in abdominal pain, stool consistency, and stool frequency were consistent across IBS subtypes. No patients experienced serious adverse events or adverse events leading to study discontinuation.

CONCLUSIONS

Treatment with a digital GDH program led to an improvement in abdominal pain and stool symptoms in patients with IBS, supporting a role for this intervention as part of integrated care for IBS.

CLINICALTRIALS

gov identifier NCT04133519.