For IBS patients, current formulations of mint oil may cause heartburn, nausea, and anal burning because they tend to “dose-dump” in the stomach or pass all the way through the colon. However, a novel delivery system (IBgard, IM HealthScience LLC) allows solid beads of highly purified L-menthol to pass through the pylorus to the small intestine, where they are fully absorbed. Twenty-four-hour results of the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial (IBSREST) revealed a significantly greater reduction in the Total IBS Symptom Score (TISS) for IBgard than for placebo, according to Dr. Epstein,
The IBgard system’s triple coating restrains L-menthol release until pH exceeds 5.0, which in small-intestine simulation models allows 80% release in four hours. “Once it reaches the mucosa there, its antispasmodic, anti-inflammatory, 5-HT3 agonist and antibacterial effects occur locally,” Dr. Epstein said in an interview after the oral session where he described results of the IBSREST trial.
The objective of IBSREST was to evaluate IBgard’s effectiveness and safety for the management of patients with IBS-D (diarrhea) and IBS-M (mixed diarrhea and constipation). IBSREST included men and women meeting ROME III IBS criteria (IBS-D or IBS-M) with average daily IBS-related abdominal pain of 4.0 or greater on a scale of 0–10 each week of a two-week baseline period. They also had scores of 2.0 or greater on the TISS scale of 0–4. The TISS is based on the intensity and frequency of eight IBS symptoms (abdominal pain or discomfort, bloating or distention, pain at evacuation, urgency, constipation, diarrhea, mucus or gas, and sense of incomplete evacuation).
IBSREST included 72 patients, divided roughly evenly between IBS-M and IBS-D. Their mean age was 40.6 years. Thirty-five patients were randomized to IBgard 180 mg three time daily, 30 to 90 minutes before meals, and 37 patients to placebo.
The first IBSREST endpoint was 24-hour reduction in TISS. The TISS reduction for IBgard was significantly greater than that for placebo (−18.8% for IBgard versus −9.8% for placebo, P = 0.0092). While reductions were greater for IBgard than placebo for each of the TISS components, reductions reached statistical significance only for abdominal pain or discomfort (−21% versus −10% for placebo; P < 0.05). For the subcategory of intensity of bowel movement urgency at 24 hours, the reduction with IBgard was also significantly greater (−25.2% versus −5.7%, P = 0.0374). “This is pretty powerful stuff,” Dr. Epstein commented. “It is not your mother’s peppermint oil.”
“The results are promising for on-demand application for IBSM/D symptom relief,” Dr. Epstein noted. He emphasized that IBgard is a medical food product, not a drug or dietary supplement. A medical food is defined by section 5(b)(3) of the Orphan Drug Act 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.”
IBgard was well tolerated with no treatment-emergent AEs in the first 24 hours.