Growing Body Of Evidence Within The Medical Community Supports Use Of IBgard®, A Clinically Proven Approach To The Management Of Irritable Bowel Syndrome (IBS)

NEW YORK and BOCA RATON, Fla., Feb. 2, 2016 /PRNewswire/ -- IM HealthScience^® today announced another significant clinical milestone in the growing body of evidence supporting the benefits of peppermint oil in the management of irritable bowel syndrome (IBS). In its February edition, Digestive Diseases and Sciences, a prominent medical journal in the field of gastroenterology and hepatology, published a print version of a peer-reviewed article, entitled "A Novel Delivery System of Peppermint Oil is an Effective Therapy for Irritable Bowel Syndrome."¹ The article was available online on August 29, 2015 and can be accessed through the journal's web site.

The article reports on the results of the IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study, a randomized, double-blind, placebo-controlled, multicenter trial, which demonstrated that IBgard^® provided reduction in eight hallmark symptoms of IBS:² abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus at 24 hours and at four weeks.

IBgard^® is specially formulated for the dietary management of IBS. It is the first product using a patented, breakthrough technology, called Site Specific Targeting (SST^®), to deliver sustained released microspheres of an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS.

"Our results demonstrated that this novel formulation of peppermint oil, designed to release in the small intestine, was associated with a rapid and sustained symptomatic improvement in patients with IBS," said lead author Brooks D. Cash, M.D., Professor of Medicine in the Gastroenterology Division at the University of South Alabama in Mobile. "IBgard^® was also associated with a reduction in the number of severe or unbearable IBS symptoms over four weeks of therapy and was well tolerated (compared to placebo)."

Now in its 81st year of publication, Digestive Diseases and Sciences, formerly named The American Journal of Digestive Diseases, publishes high-quality, original studies on basic research and clinical practice in gastroenterology, hepatology and related fields.

This latest article supported previous studies on peppermint oil's utility in IBS. For example, in a medical journal article, entitled "Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis,"³ which was published in 2014 in the Journal of Clinical Gastroenterology, Khanna, et al (2014) aimed to assess the efficacy and safety of enteric-coated peppermint oil capsules compared with placebo for the treatment of active IBS. The journal article, which described a systematic review and meta-analysis of nine studies that evaluated 726 patients, concluded that "peppermint oil is a safe and effective short-term therapy for active IBS." The authors also stated that "peppermint oil was found to be significantly superior to placebo for global improvement of IBS symptoms and improvement in abdominal pain."

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 Irritable Bowel Syndrome

One in six Americans experiences 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 factors without a known organic cause that manifest as a syndrome of symptoms called IBS. There is currently no cure for IBS and management options are limited.

About IBgard^®

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 help 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 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^®.

¹ Cash, B.D. , Epstein, M.S., & Shah, S.M. (2015, August 29, online; 2016, February 1, print). A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences, 61(2): 560-571. doi: 10.1007/s10620-015-3858-7.

² Based on the Total IBS Symptom Score (TISS), a composite score of the eight individual IBS symptoms.

³ Khanna, R, MacDonald, J.K., & Levesque, B.G. (2014, July). Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis. Journal of Clinical Gastroenterology, 48(6):505-12. doi: 10.1097/MCG.0b013e3182a88357.

SOURCE IM HealthScience