Six-month data from a real-world surveillance study shows over-the-counter IBgard is safe and well-tolerated in patients with irritable bowel syndrome, according to a press release from the manufacturer.
IBgard (IM HealthScience) capsules use site specific delivery technology to release highly purified peppermint oil to the small intestine to help normalize digestion, nutrient absorption and intestinal transit time.
Previous randomized controlled trial data have shown rapid IBS symptom relief, high satisfaction and improved quality of life among patients who used IBgard. In the current IBS Safety Update at 6 months (IBSSU-6) study, researchers evaluated data on adverse events and serious adverse events reported by more than 163,000 patients who used the product from October 5, 2015 through May 31, 2016.
“Real-world research is a vital component to clinical trials and helps with defining management options for patients,” Michael S. Epstein, MD, FACG, AGAF, a gastroenterologist and chief medical advisor for IM HealthScience, said in the press release. “The findings from IBSSU-6 reaffirm the safety and tolerability profile of IBgard in real-world settings and show the use of IBgard is consistent with the adverse events reported in our landmark clinical trial, IBSREST.”
In the IBSSU-6 study, no serious adverse events occurred, and non-serious adverse events occurred in 0.05% of patients. These included dyspepsia, nausea, abdominal pain and diarrhea, which occur in comparable rates and patterns in the general IBS population, according to the press release.
“Heartburn and anal burning are common side effects associated with older peppermint oil products,” Epstein said in the press release. “However, in IBSSU-6, there were no reports of anal burning and reports of heartburn were remarkably low, no different than what physicians see as existing co-morbid conditions in the patient population suffering from IBS.”
From Drug Store News: Study reaffirms safety and tolerability profile of leading IBS medical food
IM HealthScience on Monday announced favorable results from its Irritable Bowel Syndrome Safety Update at 6 Months (IBSSU-6), a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 163,165 patients who used the product. – Drug Store News, August 29, 2016