15 Oct Peppermint Oil Based IBgard® Found Efficacious In Some Patients With Irritable Bowel Syndrome with Mixed Bowel Habits
MedicalResearch.com Interview with:
Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E.
Professor of Medicine and
Chief of the USA Gastroenterology Division
Director, Motility and Physiology Service
University of South Alabama
MedicalResearch.com: What is the background for this study?
Response: Irritable Bowel Syndrome (IBS) among patients with IBS-M (mixed diarrhea and constipation) is a challenging and difficult to diagnose and treat sub-type of IBS. Patients with IBS-M represent a dissatisfied group of IBS patients due to the lack of proven therapies. It is an area of high unmet medical need.
Among adult patients with IBS, a sizeable proportion suffers from IBS-M with prevalence rates estimated to be between 44 to 66 percent of IBS sufferers,,. IBS-M patients carry a heavy burden, characterized by bouts of constipation interrupted by diarrhea and vice versa. Physicians find IBS-M challenging to manage because of the difficulty in avoiding ‘overshoots’ when diarrhea management can turn into constipation and vice versa.
MedicalResearch.com: What are the main findings?
Response: A global, peer-reviewed medical journal, Internal Medicine Review, has published the first-ever clinical data analysis on the favorable effects of IBgard® among Irritable Bowel Syndrome (IBS) patients with mixed diarrhea and constipation (IBS-M). This IBS-M-only analysis was derived from the previously published IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study, where favorable results were observed in a combined population of IBS-M plus IBS-D (diarrhea predominant) patients.
IBgard® is a clinically studied, medical food specially formulated for the dietary management of IBS.
This analysis is significant because there are no U.S. Food and Drug Administration-approved interventions for IBS-M.
The study entitled, “Peppermint Oil with Site Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits,” is published in the September issue of Internal Medicine Review, and accessible through open access on the home page of the journal’s web site.
This clinical analysis of only the IBS-M patients in IBSREST™ demonstrated that there was a statistically significant reduction vs. placebo in the Total IBS Symptom Score (TISS) at 4 weeks. TISS is a composite score of eight individual IBS symptoms. When evaluating the individual symptoms at 4 weeks, there was a reduction versus placebo on both major types of bowel dysfunction (diarrhea and constipation), as well as a favorable reduction versus placebo in viscerosensory symptoms, such as abdominal pain.
Overview of Clinical Sub-Analysis of Only IBS-M Patients in IBSREST™ Clinical Trial
The previously published randomized clinical trial, called IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), showed favorable results in a combined group of IBS-D and IBS-M patients.
In view of the unmet need in IBS-M, a post hoc analysis was conducted to test the efficacy of IBgard® in patients specifically with IBS-M in the IBSREST™ study. The analysis showed that in the composite score of all eight symptoms measured, IBgard® demonstrated a significant reduction vs. placebo. It also showed favorable results for individual IBS symptoms, including diarrhea and constipation, where it showed significance (P=0.0085) despite the small sample size.
Specifically, the analysis of IBS-M patients in the IBSREST™ study showed that after four weeks of daily intake of IBgard®, patients experienced the following:
Reduction in Total IBS Symptom Score (TISS):
- 3% reduction of Total IBS Symptom Score (TISS) from baseline. Statistically significant compared to placebo (P=0.0298).
- 1% reduction in frequency of IBS symptoms from baseline. Statistically significant compared to placebo (P=0.0349).
- 2% reduction in intensity of IBS symptoms from baseline.
Reduction in Overall Constipation Score:
- 1% reduction in overall constipation symptoms from baseline. Statistically significant compared to placebo (P=0.0085).
- 3% reduction in frequency of constipation from baseline. Statistically significant compared to placebo (P=0.0137).
- 64% reduction in intensity of constipation from baseline. Statistically significant compared to placebo (P=0.0221).
Reduction across the Syndrome of Symptoms (abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus):
- Greater reduction in all eight symptoms of IBS comprising the TISS, compared to placebo, with significance reached in abdominal pain (P=0.0426), constipation (P=0.0085), urgency (P=0.0364), and sense of incomplete evacuation (P=0.0422).
- The largest reduction was seen with constipation versus placebo (P=0.0085).
- Numerical reduction versus placebo in both constipation (P=0.0085) and diarrhea (P=0.2296) in IBS-M.
- Improvement with pain at evacuation was numerically superior (P=0.0720).
MedicalResearch.com: What should readers take away from your report?
Response: Publication of the clinical data analysis involving only IBS-M patients represents a novel advance in the IBS literature. This sub-analysis in IBS-M patients was designed to answer a very important scientific question about the efficacy of a novel formulation of peppermint oil with Site Specific Targeting® technology, called IBgard® in IBS patients with mixed diarrhea and constipation.
This analysis demonstrated dramatic symptom reduction among IBS-M patients, who experience a high burden in terms of symptoms and quality of life, demonstrating the effectiveness of the novel delivery system of peppermint oil in IBgard®.
Also, our data analysis of only IBS-M patients showed IBgard®, compared to placebo, significantly reduced the Total IBS Symptom Score (TISS) and showed favorable effects on all 8 measured individual IBS symptoms, including constipation, diarrhea, and abdominal pain.
It has been posited that l-Menthol, the principal component found in IBgard®, works via several different mechanisms of action in the gut, including exerting anti-inflammatory, smooth muscle relaxation, and anti-nociceptive effects. Immune-activated gut barrier disturbance in the small intestine is believed to be associated with IBS-related symptoms in some individuals diagnosed with IBS.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Continued studies on the effect of IBgard® in various patient populations will add to our existing body of knowledge.
Disclosures: Disclosures: Dr. Cash is a consultant to IM HealthScience®, the company that markets IBgard®.
The web site is www.ibgard.com for further information on the product.
Editor’s Note: IBgard® is a non-prescription product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state, sustained release microspheres of Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions help manage IBS.
IBgard® is available to patients in the digestive aisle at most Walmart, Target, CVS/pharmacy, Walgreens and Rite Aid stores nationwide as well as in independent drug stores and grocery stores across the country.
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Peppermint Oil with Site Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits
Brooks D. Cash, Michael S. Epstein, Syed M. Shah
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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