Brooks D. Cash
IBgard peppermint oil capsules effectively reduced symptoms in irritable bowel syndrome patients with mixed diarrhea and constipation, according to a subgroup analysis of the IBSREST trial.
IBgard (IM HealthScience) is an over-the-counter medical food product that delivers purified peppermint oil to the small intestine using site specific targeting technology. Its principal component, l-Menthol, is believed to work by “exerting anti-inflammatory, smooth muscle relaxation, and anti-nociceptive effects,” according to a press release, which added that “immune-activated gut barrier disturbance in the small intestine is believed to be associated with IBS-related symptoms in some individuals diagnosed with IBS.”
The previously published IBSREST trial showed IBgard reduced symptoms as early as 24 hours in a combined population of IBS patients with mixed diarrhea and constipation (IBS-M) and patients with diarrhea-predominant IBS (IBS-D). This subgroup analysis showed benefit in just IBS-M patients, the most common form of IBS and the most challenging to treat and diagnose.
“Publication of this analysis involving only IBS-M patients represents a novel advance in the IBS literature,” Brooks D. Cash, MD, professor of medicine at the University of South Alabama in Mobile, Ala., and chief of IM HealthScience’s USA Gastroenterology Division, said in the press release. “This sub-analysis was designed to answer a very important scientific question about the efficacy of a novel formulation of peppermint oil with a site-specific targeting technology in IBS patients with mixed diarrhea and constipation. The study outcome is contrary to conventional thinking, where peppermint oil is often viewed as an adjunctive therapy.”
In the IBSREST trial, Cash and colleagues randomly assigned 72 IBS-M and IBS-D patients to receive IBgard (n = 35) or placebo (n = 37) for 4 weeks. All participants had average daily IBS-related abdominal pain scores of at least 4/10, and Total IBS Symptom Scores (TISS) of at least 2/4. The present analysis included the 34 patients with IBS-M only, 16 of whom received IBgard and 18 of whom received placebo.
Cash and colleagues found that IBgard significantly reduced mean TISS from baseline compared with placebo (43% vs. 24%; P = .0298). It also significantly reduced mean frequency of IBS symptoms (37% vs. 18%; P = .0349), and numerically reduced mean intensity of IBS symptoms (51% vs. 33%).
Further, IBgard showed a benefit on all eight individual IBS symptom components of the TISS, four of which reached significance, including abdominal pain or discomfort (43% vs. 21%; P = .0426), constipation (57% vs. 22%; P = .0085), urgency (44% vs. 22%; P = .0364) and sensing incomplete evacuation (38% vs. 14%; P = .0422). Additionally, IBgard significantly reduced the frequency (51.3%; P = .0137) and intensity (64%; P = .0221) of constipation from baseline, which were significant relative to placebo.
“Changes in all other individual symptom scores,” including diarrhea, bloating, passage of gas or mucus, and pain at evacuation, “trended in factor of [IBgard], but did not reach statistical significance compared with placebo,” Cash and colleagues wrote.
They concluded that IBgard “is a promising addition to the unmet need for a rapidly acting, safe, and effective pharmacotherapy for patients with IBS-M.” – by Adam Leitenberger
Disclosures: All the authors report they are affiliated with IM Health Science.