IBgard peppermint oil delivery system provides rapid IBS symptom relief
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Patients with irritable bowel syndrome experienced rapid symptom relief, high satisfaction and improved quality of life with IBgard, an over-the-counter peppermint oil delivery system, according to the results of a randomized controlled trial and a post-marketing study.
“The results of these studies, which have received considerable attention and discussion at major scientific gastroenterology meetings, further adds to the body of medical evidence supporting the utility of IBgard [IM HealthScience], a novel formulation of peppermint oil, in improving the symptoms, patient satisfaction and quality of life of patients with IBS,” Brooks D. Cash, MD, AGAF, FACG, FACP, FASGE, professor of medicine in the gastroenterology division at the University of South Alabama, and Healio Gastroenterology Peer Perspective Board member, said in a press release. “Patients with severe IBS are often not satisfied with common interventions even in the presence of improvement of individual IBS symptoms. Against this backdrop, the overall satisfaction rate of greater than 80% for IBgard for all survey questions is promising.”
Brooks D. Cash
In the IBSREST study — a multicenter, double blind, randomized controlled trial — 16 patients with mixed IBS and 19 patients with diarrhea-predominant IBS received two IBgard capsules 3 times per day for 4 weeks, and 37 patients received placebo. The treatment group experienced a 20% reduction in Total IBS Symptom Score (TISS) as early as 24 hours (significant vs. placebo; P = 0.0092), and a 40% reduction in TISS at 4 weeks (also significant vs. placebo; P = 0.0246). The TISS is a composite score of eight IBS symptoms, including abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus at 24 hours and at 4 weeks.
The trial also included a patient satisfaction questionnaire at the end of the study for those in the treatment arm, 88.3% of whom reported moderate or major improvement in symptoms and in quality of life.
“In the study, IBgard was found to be effective, safe and well tolerated (comparable to placebo),” Cash said in the press release.
The post-marketing IBSACT study was a real-world observational study that surveyed 285 patients treating their IBS with varying doses of IBgard (60.8% used one or two capsules per day). Overall, 98.1% reported moderate or major improvement in symptoms, 92.7% reported moderate or major improvement in quality of life and 75.6% reported experiencing symptom relief within 2 hours.
“The delivery of l-Menthol, the principal component in peppermint oil, to the small intestine using [site specific] delivery technology is an important advance in the management of IBS and may be a valued option for doctors and their patients who desire rapid relief of IBS symptoms,” Cash said in the press release. “Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during a flare-up.” – by Adam Leitenberger
Disclosures: This study was funded by IM HealthScience, for which Cash is a consultant. Please see the full study for a list of all other researchers’ relevant financial disclosures.