By Walter Alexander
WASHINGTON, D.C. — May 20, 2015 — A novel delivery system that releases peppermint oil into the small intestine demonstrated reduction in the symptoms of irritable bowel syndrome (IBS) when compared with placebo, according to 24-hour results of Irritable Bowel Syndrome Reduction Evaluation & Safety Trial (IBSREST™), presented at Digestive Disease Week (DDW) 2015.
A triple coating allows solid beads of highly purified (about 50%) L-menthol to pass through the pylorus, releasing them slowly in the small intestine at a pH greater than 5.0. In small-intestine simulation models, 80% of the system’s L-menthol is released in a 4-hour period.
“Once it reaches the mucosa, its antispasmodic, antiinflammatory, 5HT3 agonist, and antibacterial effects occur locally,” explained lead investigator Michael Epstein, MD, IM Health Science LLC, Boca Raton, Florida, speaking here on May 17.
The IBSREST trial objective was to evaluate this delivery system for effectiveness and safety in the management of patients with IBS-M (mixed diarrhoea and constipation) and IBS-D (diarrhoea).
IBSREST investigators included males and females meeting ROME III IBS criteria (IBS-D or -M) with average daily IBS-related abdominal pain of 4.0 or greater on a 0-to-10 scale for each week of a 2-week baseline period. Patients also had Total IBS Symptom Scores (TISS) of 2.0 or greater (0 to 4 scale). TISS scores are based on intensity and frequency of 8 IBS symptoms: abdominal pain or discomfort, bloating or distention, pain at evacuation, urgency, constipation, diarrhoea, mucus or gas, and sense of incomplete evacuation.
Dr. Epstein and colleagues randomised 35 patients (mean age 40.6 years) to the novel peppermint-delivery system at 180 mg three times daily 30 to 90 minutes before meals and 37 subjects to placebo. Patients in both groups were divided roughly evenly between IBS-M and IBS-D.
The first evaluation, at 24 hours, revealed a significantly greater reduction in TISS in the treatment group (-18.8% vs -9.8% placebo, P = .0092). While reductions were greater for treatment than for placebo for each of the TISS components, only abdominal pain or discomfort was significantly reduced (-21% vs -10% for placebo, P < .05). For the subcategory of intensity of bowel-movement urgency at 24 hours, the reduction with the peppermint-oil treatment was also significant (-25.2% vs -5.7%, P = .0374). The peppermint oil was well tolerated. The investigators observed no treatment-emergent adverse events in the first 24 hours. “The results are promising for on-demand application for IBS-M/D symptom relief,” Dr. Epstein noted. He underscored that IBgard is a medical food product and not a drug or dietary supplement. A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3) as “a food which is formulated to be consumed or administered internally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation.” Other formulations of mint oil may cause heartburn, nausea, and anal burning, because they tend to remain in the stomach (dose-dumping) or pass all the way to the colon, Dr. Epstein cautioned. Digestive Disease Week 2015 is cosponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT). [Presentation title: 24 Hour Results From a Placebo-Controlled Trial, to Evaluate a Novel Peppermint Oil Delivery System, Targeting Release in the Small Intestine. Results From the US Based, 4-week, Randomized, Placebo Controlled, Multi-Centered IBSREST™ Trial. Abstract 314].