Is Digital Gut-Directed Hypnotherapy Better Than Muscle Relaxation in Patients With Irritable Bowel Syndrome?

In addition to dietary modification and pharmacologic therapy, behavioral therapy has become a recognized treatment for irritable bowel syndrome (IBS) and is now integrated into clinical management guidelines. This randomized controlled trial compared the safety and efficacy of digital gut-directed hypnotherapy (GDH) treatment with that of digital muscle relaxation (MR) in adult patients with IBS.  

The efficacy analysis included 362 patients from 26 U.S. centers. All patients met Rome IV diagnostic criteria for IBS and reported an Average Worse Daily Pain Severity score of >3 on an 11-point numeric rating scale over a 4-week run-in period of the study. All patients maintained their baseline IBS medications throughout the study. Patients were stratified by IBS subtype and randomized to 12 weeks of treatment with digital GDH or a digital progressive MR program accessed via a mobile app on a smartphone or tablet. The primary endpoint was ≥30% reduction from baseline in average daily abdominal pain intensity in the 4 weeks after treatment. Secondary outcomes included mean change from baseline in abdominal pain, stool consistency, and stool frequency. 

A comparable percentage of patients who underwent GDH (30.4%) or MR (27.1%) met the primary endpoint, with no significant difference between the groups (P=.5352). Considerably more treated patients responded to GDH than MR 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. Digital GDH was well tolerated, and while 6 patients in the GDH group (versus 2 in the MR group) experienced mild or moderate adverse events, no patients experienced severe adverse events.