Leading Gastroenterologists Agree That Diagnosing And Managing Irritable Bowel Syndrome (IBS) In Patients With IBS-M (Mixed Diarrhea And Constipation) Remains A Challenging And Difficult To Treat Medical Condition

BOCA RATON, Fla., Feb. 23, 2017 /PRNewswire/ -- Gastroenterologists across the nation are looking for options to treat their patients with irritable bowel syndrome (IBS), especially those who represent the largest group of IBS sufferers with IBS-M (mixed diarrhea and constipation). Most importantly, IBS-M is a challenging and difficult to diagnose and treat sub-type of IBS. In fact, most individuals with IBS (74 percent of those medically diagnosed and 63 percent not medically diagnosed) are reported to have alternating symptoms of constipation and diarrhea (also known as IBS-A).¹

IM HealthScience^® commented on a recent article mentioning IBS-M, where there also was a positive mention of its product, IBgard^®2, a medical food for the dietary management of IBS. In a December 15, 2016, article, entitled "IBS Purgatory: Mixed Irritable Bowel Syndrome - Symptoms can fluctuate rapidly and psychological burden is onerous³," published in MedPage Today, IBgard^® was cited along with the antibiotic rifaximin and dietary modification as the only interventions identified for IBS-M. The article was a collaboration between MedPage Today and the American Gastroenterological Association (AGA).

IBS-M, also described as IBS-A or alternating IBS-D (diarrhea predominant) and IBS-C (constipation predominant) was singled out as an IBS sub-type that is distressing, difficult to diagnose and manage.

In the article, dietary modification was considered helpful but difficult. According to Ali Rezaie, M.D., assistant director, Gastrointestinal Motility Program at Cedars-Sinai Medical Center in Los Angeles, said, "…clearly, dietary restriction can affect quality of life, sometimes more than the [IBS-M] symptoms themselves."

Dr. Rezaie continued, "Alternating bowel habits can happen on a daily basis…. Intervals between the patterns [IBS-D and IBS-C] can vary widely." He added, "I have patients who say they have constipation in the morning, and then, by evening, they have loose watery stools. Even with the same bowel movement, some patients may start with hard stool that has to be pushed, and by the end, it will be watery."

In Dr. Rezaie's view, this subtype is harder on patients than either pure IBS-D or pure IBS-C. "A lot of these patients have classic pain and urgency as well as significant abdominal distension and bloating that bother them more than the alternation itself." He continued, "Alternating laxative and antidiarrheal medications can complicate the situation." He explained that an IBS-C drug may cause diarrhea and a IBS-D drug may cause "very bad constipation."

In the article, other IBS experts, including M. Bilal, M.D., Fellow, Gastroenterology and Hepatology, University of Texas Medical Branch, Galveston, Texas; L. Chang, M.D., Gastroenterology, UCLA Medical Center, Los Angeles, California, and A. Shatnawei, M.D., Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio, weighed in on their concerns and challenges in diagnosing IBS-M or in clinically testing for the condition.

"We are pleased that the courageous decision by IM HealthScience^® to include IBS-M patients in the landmark 2014 IBSREST™ trial has resulted in this important evidence regarding the utility of IBgard^® in IBS-M patients," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience^®, the innovators of IBgard^®. "IBS-M is a common IBS sub-type where there are no approved drugs available."

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About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, under-diagnosed and under-treated condition characterized by recurrent abdominal pain, often associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS. Recent understandings of the root causes of IBS point to gut mucosal barrier dysfunction and intestinal malabsorption, which can lead to reversible, low-grade inflammation, intestinal spasms and abdominal pain.

About IBgard^®  
IBgard^® is a medical food specially formulated for the dietary management of IBS. IBgard^® capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, plus fiber and amino acids, in a unique delivery system.

With its patented Site Specific Targeting (SST^®) technology, pioneered by IM HealthScience^®, IBgard^® capsules release Ultramen^®, an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS. Peppermint oil can help toward normalizing the digestion of food and the absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to help normalize intestinal transit time.

IBgard^® was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial™ (IBSREST).  Patients suffering from IBS-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. The data showed that IBgard^® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms. Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during a flare-up.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard^® for their patients. In a recent nationwide survey of gastroenterologists, IBgard^® was the number one recommended peppermint oil for IBS for the second consecutive year by an overwhelming margin. Like all medical foods, IBgard^® does not require a prescription, but it must be used under medical supervision. Only doctors can diagnose IBS. 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 available to patients in the digestive aisle at most CVS/pharmacy, Walgreens and Rite Aid stores nationwide and now increasingly in independent drug stores and grocery stores across the country.

About IM HealthScience^®
IM HealthScience^® (IMH) is the innovator of IBgard^® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of FDgard^® for the dietary management of functional dyspepsia. 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. 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.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com.

¹ Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. & Barghout, V. (2005, June 2). Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Alimentary Pharmacology and Therapeutics, 21 (11): 1365-1375.  doi: 10.1111/j.1365-2036.2005.02463.x
² 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
³ Swift, D. (2016, December 15). IBS Purgatory: Mixed Irritable Bowel Syndrome – Symptoms can fluctuate rapidly, and psychological burden is onerous. Retrieved from http://www.medpagetoday.com/reading-room/aga/lower-gi/62101

SOURCE IM HealthScience

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