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Gut-directed hypnotherapy (GDH) has helped patients get relief from IBS for nearly four decades—if they could find it.1 Few clinicians are trained to administer GDH, and that has left most patients without access to it.2 Until now.
Regulora®, the first and only digital therapeutic indicated for IBS pain, is ushering GDH into the future as a digital implementation of the standardized, fully scripted North Carolina treatment protocol—in a convenient mobile app.3,4
every other week over 12 weeks.3
with an end-of-treatment report that details symptom changes over time and patient adherence to therapy. 3
of therapist-recorded GDH.3
to reinforce treatment.3
In a randomized, controlled clinical study, Regulora has been shown to be safe and effective for the treatment of abdominal pain across all 3 subtypes of IBS (IBS-C, IBS-D, and IBS-M).3,5
of participants in the Regulora group were either a pain or stool responder3, **
of participants in the clinical trial would recommend Regulora to someone else with IBS3
of participants in the clinical trial completed at least 5 to 7 of the treatment sessions5
*During the 4-week post-treatment period, 30.4% of participants in the Regulora group and 27.1% of participants in the control group experienced at least a clinically meaningful 30% reduction in abdominal pain (abdominal pain response). The response rates were not statistically different during the off-treatment phase.3
**As measured over a 4-week post treatment period, participants experienced at least a 30% reduction in abdominal pain intensity scores (on a 1 to 10-point scale) or at least a 30% improvement in the proportion of stools with normal consistency (based on Bristol Stool Form Scale definitions).3
***Non-serious adverse events possibly related to treatment included headache, fatigue, abdominal pain, and constipation.3
GDH has been helping IBS patients find relief for nearly four decades.1
Go to referrals.regulora.ca to enter a referral for your patient.PhilRx is our online pharmacy partner.
Get answers to questions your patients may ask.
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. Donnet AS, Hasan SS, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions. Therap Adv Gastroenterol. 2022;15:17562848221074208.
2. 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.
3. Regulora® Instructions for Use for Patients and Physicians. metaMe Health, Inc.; April 2022.Palsson OS. Standardized hypnosis treatment for irritable bowel syndrome: the North Carolina Protocol. Int J Clin Exp Hypn. 2006;54(1):51-64.
4. Palsson OS. Standardized hypnosis treatment for irritable bowel syndrome: the North Carolina Protocol. Int J Clin Exp Hypn. 2006;54(1):51-64.
5. Data on file. metaMe Health; 2022.
