Related Experiment Video
Updated: Jul 25, 2025
Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel
Sameer K Berry1, Rani Berry2, David Recker3
1New York Gastroenterology Associates, New York, New York.
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.
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