CHICAGO — Digital gut hypnotherapy produced greater improvements in abdominal pain and bowel symptoms in patients with irritable bowel syndrome compared with digital muscle relaxation, according to a study.
“This study shows that gut-targeting hypnotherapy, an FDA-approved digital therapy, improved abdominal pain and bowel habits in about one-third of patients. [of patients] Approximately two-thirds of IBS patients experienced adequate relief of their gastrointestinal symptoms.” William D. Chay, MD, AGAF, FACG, FACP, RFF, H. Marvin Pollard, professor of gastroenterology and chief of the gastroenterology division at the University of Michigan Medicine, told Healio, “GDH delivered via mobile app produced similar improvements to muscle relaxation delivered via mobile app.”
Chey and colleagues conducted a randomized, double-blind, controlled trial at 26 sites in the United States comparing the safety and effectiveness of a self-administered gut-guided hypnosis (GDH) program with digital muscle relaxation in adults with IBS, and published the results at Digestive Disease Week. They enrolled patients aged 18 to 70 years who met the Rome IV criteria for IBS and reported an average worst daily pain severity score of at least 3 on an 11-point scale during a 4-week run-in period.
The researchers randomly assigned 378 patients to 12 weeks of treatment with either digital gut-guided hypnotherapy according to the North Carolina protocol or digital muscle relaxation using a mobile app, of which 362 were included in the efficacy analysis.
The primary outcome of interest was a reduction of at least 30% from baseline in mean intensity of abdominal pain 4 weeks after treatment, and secondary outcomes included mean changes from baseline in abdominal pain, stool consistency, and bowel movement frequency.
Results showed that 30.4% of patients treated with GDH achieved the primary endpoint compared with 27.1% of patients treated with muscle relaxation, but the difference was not significant ( P = 0.5352).
In addition, more patients in the GDH group had abdominal pain responses during the last 4 weeks of treatment (30.9% vs. 21.5%, P = .0232) and throughout the treatment period (29.3% vs. 18.8%, P = .0254), and stool consistency responses 13 to 16 weeks after treatment were reported in 44.9% of the GDH group compared with 41.3% of the muscle relaxant group. The researchers reported no adverse events in either group.
“This study supports adding evidence-based behavioral health digital therapeutics to the toolbox for people with IBS,” Choi told Healio. “Digital therapeutics may enable us to provide behavioral health services to all patients with IBS.”
Sources/Disclosures
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Berry R, et al. Abstract 606: A randomized, parallel-group comparison study of self-administered digital gut-guided hypnotherapy versus muscle relaxation for irritable bowel syndrome. Location: Digestive Disease Week, May 5-9, 2023, Chicago (Hybrid Conference).
Disclosure: Chey reports financial relationships with AbbVie, Allakos, Alnylam, American Medical Laboratories, Ardelyx, Arena, Bayer, Biomerica, Cosmo, Commonwealth Diagnostics International, Gemelli, IM Health, Ironwood, Isothrive, Modify Health, Nestle, Preogenity, QOL Medical, Redhill, Ritter, Salix/Valeant, Takeda, Urovant Sciences, and Vibrant.
