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 prescription 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
7 individual 30-minute sessions of
of therapist-recorded GDH3
Symptom tracking via the validated IBS-Symptom Severity Scale, with an end-of-treatment report that details symptom changes over time and patient adherence to therapy3
Self-administered every other week over 12 weeks3
Optional practice sessions to reinforce treatment3
CLINICALLY PROVEN RESULTS
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
Significantly more patients treated with Regulora (29.3%) were abdominal pain responders compared to those in the control group (18.8%) during the 12-week on-treatment period3,*
*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
FOSTERING BETTER
MIND-GUT
COMMUNICATION
GDH has been helping IBS
patients find relief for nearly
four decades.1
PRESCRIBING
MADE SIMPLE
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References:
- Donnet AS, Hasan SS, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions. Therap Adv Gastroenterol. 2022;15:17562848221074208.
- 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.
- 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.
- Data on file. metaMe Health; 2022.
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.