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IBgard releases data to show safety, tolerability of peppermint oil for IBS
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In a post-marketing study, the manufacturer of IBgard showed that over-the-counter peppermint oil treatment effectively managed symptoms of irritable bowel syndrome without the side effect of heartburn.
In the Irritable Bowel Syndrome Safety Update at 36 Months (IBSSU36), researchers used a real-world surveillance study and reported on the safety and tolerability profile of IBgard (IM HealthScience).
“Such a long and comprehensive post-marketing safety study for a nonprescription product is very rare,” Michael S. Epstein, MD, FACG, AGAF, chief medical advisor for IM HealthScience, said in a press release. “The findings from IBSSU36 conclusively reaffirm the safety and tolerability profile of IBgard in real-world settings. In fact, it may be difficult to separate the scatter of the events from background noise associated with the IBS population.”
In the release, IM HealthScience estimated 2.48 million people took IBgard since the post-marketing surveillance began; the survey ran from October 5, 2015, to October 5, 2018. From those surveyed, there were no serious adverse events reported and there was no obvious pattern among other adverse events, including heartburn, which was previously considered a side effect of peppermint oil treatments.
In the release, Epstein said, “In the American College of Gastroenterology 2018 IBS Monograph, heartburn had been singled out as an issue among conventional peppermint oil products. It is gratifying to note that more distal delivery technology of IBgard helped avoid any significant pattern of heartburn, even after 36 months.”
Disclosure: Epstein is employed by IM HealthScience.