WILMINGTON, Del. and BOCA RATON, Fla., July 7, 2016 /PRNewswire/ -- IM HealthScience® (IMH) today announced that the International Journal of Digestive Diseases, a peer-reviewed scientific journal in the field of digestive diseases, has published an analysis of results from two important studies -- the IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) clinical study and the IBSACT™ (Irritable Bowel Syndrome Adherence & Compliance Trial) real-world, observational study.
These two studies support the increasing body of evidence demonstrating the benefits of IBgard®. IBgard® is a novel formulation of peppermint oil for the dietary management of irritable bowel syndrome (IBS), which has demonstrated rapid and significant IBS symptom improvement, especially in abdominal pain, bloating and urgency, as well as consistently high levels of patient satisfaction and enhanced quality of life.
The journal article entitled, "Patient Satisfaction with IBS Symptom Relief Using a Novel Peppermint Oil Delivery System in a Randomized Clinical Trial and in the General Population,"1 is now accessible to the public via open access on the home page of the International Journal of Digestive Diseases website. The International Journal of Digestive Diseases publishes original medical research articles, comprehensive review articles and news about scientific developments on digestive diseases.
"The results of these studies, which have received considerable attention and discussion at major scientific gastroenterology meetings, further adds to the body of medical evidence supporting the utility of IBgard®, a novel formulation of peppermint oil, in improving the symptoms, patient satisfaction and quality of life of patients with IBS," said lead study author Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.C.P., F.A.S.G.E., Professor of Medicine in the Gastroenterology Division at the University of South Alabama in Mobile, Ala. "Patients with severe IBS are often not satisfied with common interventions even in the presence of improvement of individual IBS symptoms. Against this backdrop, the overall satisfaction rate of greater than 80 percent for IBgard® for all survey questions is promising."
The IBSREST™ study demonstrated that IBgard® provided reduction in eight hallmark symptoms of IBS: 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. This clinical study also included an end-of-study questionnaire for patients in the active arm to evaluate overall satisfaction with IBS symptom relief.
Dr. Cash continued, "The IBSREST™ study was designed to answer a very important scientific question about the effectiveness, safety and tolerability of a novel formulation of peppermint oil for managing IBS over an extended period. In the study, IBgard® was found to be effective, safe and well tolerated (comparable to placebo). Patient satisfaction in the treatment arm was an important endpoint of the trial and on this measure satisfaction reached a 93 percent level."
The IBSACT™ study, which was a real-world, observational study of 285 IBS patients taking IBgard®, showed that 60.8 percent of these IBS patients needed only 1 to 2 capsules per day to obtain individualized relief from IBS symptoms. In addition, 75.6 percent of the patients reported relief within 2 hours. This patient population was allowed flexible dosing.
"The delivery of l-Menthol, the principal component in peppermint oil, to the small intestine using the Site Specific Technology (SST®) delivery technology is an important advance in the management of IBS and may be a valued option for doctors and their patients who desire rapid relief of IBS symptoms," said Dr. Cash. "Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during a flare-up."
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.
About the IBSREST™ Clinical 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 2 capsules three times 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). The TISS represents a composite score of the eight individual IBS symptoms.
About the IBSACT™ Real-World, Observational Study
The post-marketing IBSACT™ study surveyed an initial group of over 285 IBS patients who were using IBgard® to assess satisfaction and dosing frequency. When asked how long it takes for relief from abdominal pain, discomfort and/or bloating after taking IBgard®, patients in IBSACT™ reported:
- 33.7% reported relief in less than 1 hour
- 41.9% reported relief in 1 to 2 hours
- 14.4% reported relief in 3-8 hours
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 and it is likely that there are numerous etiologies that manifest as a similar syndrome of symptoms. There is currently no cure for IBS and management options are limited.
IBgard® is a specially formulated, non-prescription medical food intended to contribute toward addressing the distinct nutritional requirements that are unique for the dietary management of IBS. IBgard® capsules contain l-Menthol, the principal component in peppermint oil, which has been shown to have significant impact on the dietary management of IBS symptoms, especially abdominal pain in as early as 24 hours. 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 toward normalizing 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. In a recent nationwide survey of gastroenterologists, IBgard® was the number one recommended peppermint oil for IBS. While IBgard® does not require a prescription, it must 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 available to patients in the digestive aisle at most CVS/pharmacy, Rite Aid and Walgreens stores nationwide.
About IM HealthScience®
IM Health Science® (IMH) is a privately held company based in Boca Raton, Florida, that developed IBgard® for the dietary management of irritable bowel syndrome and 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 Cash, B.D., Epstein, M.S., & Shah, S.M. (2015, May 25, online). Patient Satisfaction with IBS Symptom Relief Using a Novel Peppermint Oil Delivery System in a Randomized Clinical Trial and in the General Population. International Journal of Digestive Diseases, 2(2): 1-6.doi: 10.4172/2472-1891.100027.
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SOURCE IM HealthScience