IBgard reduces IBS symptoms within 24 hours

CHICAGO —IBgard showed significant efficacy in a combined group of patients with irritable bowel syndrome with both diarrhea and constipation, and patients with diarrhea-predominant IBS, at 24 hours and at 4 weeks, according to data from two posters presented at Digestive Disease Week.

“The data presented at DDW demonstrating a degree of clinical benefit with peppermint oil as a therapy for two difficult to treat conditions such as functional dyspepsia and irritable bowel syndrome with a mixed stool pattern are important and intriguing,” Brooks D. Cash, MD, AGAF, professor of medicine in the gastroenterology division at the University of South Alabama, and Healio Gastroenterology Peer Perspective Board member, told Healio Gastroenterology. “These data add to the body of literature supporting the use of peppermint oil based therapies for some functional gastrointestinal disorders and additional research regarding the mechanism of action of this therapy and confirmation of its effects is eagerly awaited.”

Brooks D. Cash

Researchers aimed to assess the effects of IBgard, a medical food specially formulated with peppermint oil (l-Menthol, IM HealthScience) that uses site specific targeting to help manage IBS, in patients with IBS mixed diarrhea and constipation (IBS-M) and IBS diarrhea predominant (IBS-D). In the study, known as the Irritable Syndrome Reduction Evaluation and Safety Trial (IBSREST), investigators randomly allocated 180 mg of IBgard to 16 IBS-M participants 3 times a day and identical placebo to 18 participants for 4 weeks. They based primary analysis on the total IBS symptom score (TISS) and assessed change from baseline in frequency and intensity of individual IBS symptoms. Additionally, they performed supportive analysis classifying participants as responders if they experienced 40% or greater improvement in TISS or abdominal pain.

The results showed that a higher percentage of patients responded to IBgard compared with placebo, and additional analysis of only the IBS-M patients in IBSREST demonstrated statistically significant reduction in the TISS at 4 weeks. At 24 hours, the response rate for 40% and greater improvement in TISS was 14% in patients receiving IBgard vs. 0% receiving placebo (P = .017), and 77% in the IBgard group had “any improvement” vs. 62% in the placebo group.

Analysis of IBS-M in patients given IBgard revealed a 43.3% reduction of TISS from baseline vs. placebo (P = .0298), a 37% reduction in frequency of IBS symptoms vs. placebo (P = .0349) and a 51.2% reduction in intensity of IBS symptoms vs. placebo (P = .0528). The researchers saw that the overall constipation score showed a statistically significant reduction in symptoms from baseline vs. placebo (57.1%; P = .0085), as well as a 51.3% and 64% reduction in frequency and intensity of constipation vs. placebo (P = .0137; P = .0528). IBgard also showed a greater reduction in all 8 symptoms of IBS comprising the TISS compared with placebo including abdominal pain (P = .0426), constipation (P = .0085), urgency (P = .0364) and sense of incomplete evacuation (P = .0422).

These results correlate with data presented at Digestive Disease Week that found FDgard, a medical food also containing peppermint oil designed to help manage functional dyspepsia (FD), showed symptom reduction and rapid relief in patients with FD within 24 hours.

“Over the last several years, we in the gastroenterology community have tended to bracket IBgard as an anti-spasmodic for IBS-D similar to prescription antispasmodics, but with minimal side effects,” Cash said in a press release. “The current findings raise the possibility that there may be broader clinical approaches for IBgard in reducing IBS-M symptoms as well. This is an important observation that needs further research in terms of the most important mechanisms of action of l-Menthol.”– by Savannah Demko

References:

Cash BD, et al. Abstract Tu1600. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Cash BD, et al. Abstract Tu1601. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosure: Cash is a consultant of IM HealthScience.