NEW YORK and BOCA RATON, Fla., Jan. 14, 2016 /PRNewswire/ -- IM HealthScience® today announced that Digestive Diseases and Sciences, a prestigious, peer-reviewed medical journal in the fields of gastroenterology and hepatology, has published an on-line editorial on December 21, 2015, entitled, "Treating Irritable Bowel Syndrome: A Fresh and Minty Approach to an Old Therapy." The editorial is a review of the clinical data from an on-line article published in September 2015 entitled, "A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms," by Brooks D. Cash, M.D., et al. The September article reported the results from a landmark clinical study of IBgard®, a novel, non-prescription, medical food for the dietary management of IBS. Both the article and the accompanying editorial will be published in hard copy in an upcoming issue of the journal.
Describing the landmark clinical trial known as IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), as "small but noteworthy," Lucinda A. Harris, M.D., author of the editorial and Associate Professor of Medicine in the Gastroenterology Division at the Mayo Clinic in Scottsdale, commented favorably on the efficacy results observed in the trial. "Not only were global (IBS symptom) scores significantly improved at 24 hours (19.6 vs. 10.3 percent) and at 4 weeks (40 vs. 24.3 percent), but additionally 4 out of 8 secondary endpoints (abdominal pain, bloating/distension, pain at evacuation and urgency) were significantly improved."
In her editorial, Dr. Harris also acknowledged the potential advantage in efficacy and tolerability of the novel delivery system for peppermint oil in IBgard®. "One point that is striking is that the peppermint oil product used by Cash, et al., is an innovative, patented targeted delivery system called Site Specific Targeting (SST®) technology that embeds the active component in a matrix that stays intact until it reaches the small intestine, which is thought to be an important site of primary IBS symptoms. Other formulations have been associated with adverse events, such as nausea, heartburn, and anal burning as well as inconsistent breakdown."
Commenting on the editorial, Brooks D. Cash, M.D., lead study author and Professor of Medicine in the Gastroenterology Division at the University of South Alabama in Mobile, said, "The editorial written by Dr. Harris is a thoughtful and balanced review of the IBSREST™ study and the effectiveness, safety and tolerability of a novel formulation of peppermint oil for managing symptoms of IBS."
"The fact that the article is accompanied by an editorial is recognition by the journal reviewers that the results from this high-quality study represent an advance in the management of IBS," Dr. Cash noted. "IBgard® addresses a significant unmet need for products that manage the symptoms of the disease."
Growing Medical Support for Peppermint Oil in the Management of IBS
This support from the medical community builds on a review article about the use of peppermint oil in gastrointestinal disease. This article, entitled "Peppermint Oil: Clinical Uses in the Treatment of Gastrointestinal Diseases," was published on January 15, 2015, in Gastroenterology and Hepatology, another peer-reviewed publication. The authors concluded, "Peppermint oil appears to be a safe and a well-tolerated treatment for symptomatic improvement in IBS…. While long-term data on the efficacy of peppermint oil is not available, clinicians should consider peppermint oil as a treatment option for those suffering from IBS due to its proven short-term efficacy and minimized adverse effects in randomized controlled trials."
"The IBSREST™ study adds to the growing body of evidence supporting the use of peppermint oil in the management of IBS," said Michael S. Epstein, M.D., an author of the IBSREST™ study and Chief Medical Advisor, IM HealthScience® LLC.
About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, underdiagnosed and undertreated condition characterized by abdominal pain associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS. Doctors are not sure what causes IBS. It is likely that there are numerous causes that manifest as the syndrome of symptoms called IBS (where there is no known organic cause). There is currently no cure for IBS and management options are limited.
IBgard® capsules contain L-menthol, the principal component in peppermint oil, which has been shown to have significant impact on the management of IBS symptoms. In multiple clinical studies, peppermint oil has been shown to provide relief from IBS symptoms. With its patented SST® technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, in the small intestine. Peppermint oil can help normalize the digestion of food and absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to normalize intestinal transit time.
Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. While IBgard® does not require a prescription, it should be used under medical supervision. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.
IBgard® is now accessible to consumers in the digestive aisle at most CVS/pharmacy and Walgreens stores nationwide.
About the Study
The IBSREST™ study was a 4-week, randomized, placebo-controlled, double-blind clinical trial conducted at multiple centers in the U.S. in which 72 patients were randomized to IBgard® (n = 35) or placebo (n = 37) with 3 doses daily for four weeks. Analysis of IBSREST™ data showed that treatment with IBgard® demonstrated a 20 percent reduction in the Total IBS Symptom Score (TISS)* from baseline in as early as 24 hours, which was a statistically significant reduction compared to placebo (P= 0.0092), and a 40 percent reduction in the TISS from baseline at four weeks, which was also significant compared to placebo (P = 0.0246).
About IM HealthScience®
IM HealthScience® is a privately held company based in Boca Raton, Florida, that developed IBgard®. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Ulcerative Colitis, and Crohn's Disease. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.IBgard.com to learn more about IBgard®.
*Based on Total IBS Symptom Score (TISS), a composite score of the eight individual IBS symptoms.
SOURCE IM HealthScience