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Black-and white portrait of woman looking upward with superimposed gut illustration on her forehead and the tagline, “Rethink IBS pain.”

Addressing brain-gut dysregulation

with behavioral modalities

Black-and white portrait of woman looking upward with superimposed gut illustration on her forehead and the tagline, “Rethink IBS pain.”

Addressing brain-gut

dysregulation with

behavioral modalities

While there are many causes of IBS, most people suffering from the condition demonstrate brain-gut dysregulation.1 Gut-directed hypnotherapy (GDH) is a verbal intervention encouraging focused attention and deep relaxation during which the mind is more receptive to therapeutic suggestions.2 These suggestions help address hypervigilance and attentional bias and allow the re-interpretation of visceral signals from the gut as routine and unimportant.3

The imagery, metaphors, and suggestions used in gut-directed hypnotherapy are specifically tailored to address patients’ GI symptoms, which can result in reduced pain sensitivity in the bowels, normalized motility, reduced stress reactivity in the body, and increased overall sense of well-being.2

The most studied behavioral therapies for IBS are gut-directed hypnotherapy and cognitive behavioral therapy (CBT).2 While CBT involves the effort to change thinking and behavior patterns, GDH requires no conscious behavioral changes.4,5

FROM OUT OF REACH TO THE PALM OF THEIR HAND

Access to trained clinical hypnotherapists has been the major barrier to widespread use of behavioral therapies like GDH in the treatment of IBS.3

Few clinicians are trained to administer the modality and many patients live far from a gastropsychologist.6

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FOUR DECADES OF CLINICAL RESEARCH
SUPPORTS THE EFFECTIVENESS OF GDH

Durable effects of gut-directed hypnotherapy are similar to those of the low FODMAP diet for relief of gastrointestinal symptoms. Hypnotherapy has superior efficacy to the diet on psychological indices.”7

Peters SL, et al.
Aliment Pharmacol Ther, July 2016

Review the evidence

Gut-directed psychotherapies (GDPs) are low risk when used by qualified health professionals—(i) no studies to date have reported serious AEs or negative outcomes; (ii) there are long-term benefits of these therapies even after they are discontinued; and (iii) GDPs are IBS-subtype agnostic and can address the large group of patients with IBS-M or IBS-U for whom fewer pharmacological treatments are available.”1

Lacy BE, et al.
Am J Gastroenterol, January 2021

Review the evidence

Level 1 evidence (high-quality, randomized controlled trials [RCTs]) supports the use of brain-gut psychotherapies, particularly GI CBT and gut-directed hypnotherapy, with a number-needed-to-treat between 3 and 4 and long-term maintenance of efficacy up to 2 years for GI CBT and 6 years for gut-directed hypnotherapy.”3

Chey WD, et al.
Gastroenterology, June 2021

Review the evidence
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References:

  1. Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021;116(1):17-44.
  2. The Rome Foundation. Brain-Gut Psychotherapy Referral Guide. Accessed July 29, 2022. https://theromefoundation.org/wp-content/uploads/Rome-Foundation_GastroPsych-referral-project.pdf
  3. Chey WD, Keefer L, Whelan K, Gibson PR. Behavioral and Diet Therapies in Integrated Care for Patients With Irritable Bowel Syndrome. Gastroenterology. 2021;160(1):47-62.
  4. Palsson OS, Whitehead WE. Psychological treatments in functional gastrointestinal disorders: a primer for the gastroenterologist. Clin Gastroenterol Hepatol. 2013;11(3):208-216.
  5. Palsson OS. Standardized hypnosis treatment for irritable bowel syndrome: the North Carolina Protocol. Int J Clin Exp Hypn. 2006;54(1):51-64.
  6. Riehl ME. The Emerging Role of Brain-Gut Therapies for Irritable Bowel Syndrome. Gastroenterol Hepatol (N Y). 2018;14(7):436-438.
  7. Peters SL, Yao CK, Philpott H, Yelland GW, Muir JG, Gibson PR. Randomised clinical trial: the efficacy of gut-directed hypnotherapy is similar to that of the low FODMAP diet for the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 2016;44:447-459.
  8. Palsson OS. Hypnosis and IBS. American Society of Clinical Hypnosis Workshop presentation. August 22, 2020.
  9. Regulora® Instructions for Use for Patients and Physicians. metaMe Health, Inc.; April 2022.
  10. Miller V, Carruthers HR, Morris J, Hasan SS, Archbold S, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: an audit of one thousand adult patients. Aliment Pharmacol Ther. 2015;41(9):844-855.

IMPORTANT INFORMATION

Regulora® is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with irritable bowel syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

US federal law restricts this mobile application device to sale by or on the order of a physician. Regulora is intended for patients who speak and read English. Regulora may not be appropriate for patients with mental or physical impairment that would prevent interacting with a mobile video application. Regulora may not be appropriate for patients with evidence of intestinal illness that better explains IBS symptoms such as celiac disease or inflammatory bowel disease. Regulora should not be used in lieu of your patient’s current IBS medication or therapy. In a clinical trial of Regulora, side effects were low. About 1% of patients experienced abdominal pain, constipation, fatigue, or headache which was thought to be related to using Regulora.

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