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IMPORTANT INFORMATION Regulora® is a digital therapeutic intended to provide behavioral therapy through gut-directed hypnotherapy for adults 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. 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 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.
References: 1. Digital Therapeutics Alliance. Digital Therapeutics Definition and Core Principles Fact Sheet. Accessed July 29, 2022. https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf 2. Regulora® Instructions for Use for Patients and Physicians. metaMe Health, Inc.; April 2022. 3. Riehl ME. The Emerging Role of Brain-Gut Therapies for Irritable Bowel Syndrome. Gastroenterol Hepatol (N Y). 2018;14(7):436-38. 4. 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. 5. The Rome Foundation. Brain-Gut Psychotherapy Referral Guide. Accessed July 29, 2022. https://theromefoundation.org/wp-content/uploads/Rome-Foundation_GastroPsych-referral-project.pdf 6. Palsson OS. Hypnosis and IBS. American Society of Clinical Hypnosis Workshop presentation. August 22, 2020. 7. Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021;116(1):17-44. 8. Palsson OS, Whitehead WE. Psychological treatments in functional gastrointestinal disorders: a primer for the gastroenterologist. Clin Gastroenterol Hepatol. 2013;11(3):208-216. 9. Donnet AS, Hasan SS, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions. Therap Adv Gastroenterol. 2022;15:17562848221074208. 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.
