IBgard, a new, more purified formulation of IBgard, an over-the-counter medical food containing a blend of L-menthol and peppermint oil, improved IBS symptoms within 4 weeks, according to data presented at the AGA’s 2015 James W. Freston Conference in Chicago.
“This single-arm 2015 IBSRRET trial confirmed the outcomes from the 2014 IBSREST trial,” Michael S. Epstein, MD, chief medical advisor for IM HealthScience, said in a press release. “This trial demonstrated that targeted delivery of L-menthol decreased the symptoms of IBS over the 4 weeks of treatment. By deploying the novel Site-Specific Targeting technology, IBgard delivers L-menthol quickly and reliably to the small intestine where it is needed most in IBS.”
Epstein and colleagues evaluated 18 adults with mixed and diarrhea-predominant IBS who received two IBgard LPB capsules (41.5 mg L-menthol per capsule) three times per day for 4 weeks. Patients reported intensity and frequency of IBS symptoms (abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus) via questionnaire and daily diaries.
Among the 16 patients who completed the study, mean Total IBS Symptom Score (TISS) decreased after 28 days compared with baseline (P = .001), as did TISS frequency (P = .017) and intensity (P = .0005). There was also a significant reduction in frequency of three symptoms and in intensity of seven out of the eight total symptoms evaluated. There were no reported adverse events related to the treatment.
According to the press release, all participants reported “they would likely or definitely recommend the medical food to family or friends who have IBS, were likely or very likely to continue taking the study product and were willing to be contacted in the future about the study product,” in a post-study evaluation.
“This single arm study confirms the utility of delivering 41.5 mg of L-menthol via [site-specific targeting] technology, which was seen with the previous [randomized controlled trial],” the researchers wrote. – by Adam Leitenberger
Epstein M, Shad S. Presented at: James W. Freston Conference; August 29-30, 2015; Chicago.
Disclosure: Epstein reports he is an employee of IM HealthScience.