Getting Regulora

IMPORTANT INFORMATION
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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:
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1. Regulora^® Instructions for Use for Patients and Physicians. metaMe Health, Inc.; April 2022.
2. Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021;116(1):17-44.
3. International Foundation for Gastrointestinal Disorders. What is IBS? Accessed August 15, 2022. https://aboutibs.org/what-is-ibs/facts-about-ibs/
4. The Rome Foundation. Brain-Gut Psychotherapy Referral Guide. Accessed August 15, 2022. https://theromefoundation.org/wp-content/uploads/Rome-Foundation_GastroPsych-referral-project.pdf
5. 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.Digital Therapeutics Alliance.
6. Digital Therapeutics Definition and Core Principles Fact Sheet. Accessed August 15, 2022. https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf