Global, Peer-Reviewed Medical Journal Publishes Results Of A First-Ever Data Analysis In Irritable Bowel Syndrome (IBS) Patients With Mixed Diarrhea And Constipation (IBS-M), Demonstrating Effectiveness Of The Novel Delivery System Of Peppermint Oil In IBgard®

WASHINGTON and BOCA RATON, Fla., Sept. 25, 2017 /PRNewswire/ -- IM HealthScience^® today announced that Internal Medicine Review, a global, peer-reviewed medical journal, has published the first-ever clinical data analysis on the favorable effects of IBgard® specifically among Irritable Bowel Syndrome (IBS) patients with mixed diarrhea and constipation (IBS-M). This IBS-M-only analysis was 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 now accessible to the public via open access on the home page of the Internal Medicine Review website. Established in 2016, Internal Medicine Review publishes original research, reviews and case reports for academic and professional physicians worldwide.

The clinical data 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.

IBgard^® is the first 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.

IBS-M is a challenging and difficult to diagnose and treat sub-type of IBS and represents an area of high unmet 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^1,2,3. IBS-M patients carry an undue burden, often 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.⁴

According to Brooks D. Cash, M.D., A.G.A.F., F.A.C.G., F.A.S.G.E., the lead study author, Professor of Medicine at the University of South Alabama in Mobile, Ala., and Chief of the USA Gastroenterology Division⁵, "Publication of this analysis involving only IBS-M patients represents a novel advance in the IBS literature. This sub-analysis was designed to answer a very important scientific question about the efficacy of a novel formulation of peppermint oil with a Site Specific Targeting^® technology in IBS patients with mixed diarrhea and constipation. The study outcome is contrary to conventional thinking, where peppermint oil is often viewed as an adjunctive therapy."

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.

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 sub-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):

• 43.3% reduction of Total IBS Symptom Score (TISS) from baseline. Statistically significant compared to placebo (P=0.0298).
• 37.1% reduction in frequency of IBS symptoms from baseline. Statistically significant compared to placebo (P=0.0349).
• 51.2% reduction in intensity of IBS symptoms from baseline.  

Reduction in Overall Constipation Score:

• 57.1% reduction in overall constipation symptoms from baseline. Statistically significant compared to placebo (P=0.0085).
• 51.3% 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).

IBSREST™ Clinical Trial Study Design
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).

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.

To qualify for entry in the IBSREST™ study, the participants had to meet Rome III criteria for IBS-M. They had to have average daily IBS-related abdominal pain of ≥ 4 on a 0-10 scale, and a TISS of ≥ 2 on a 0-4 scale.

In the IBS-M sub-analysis, there were 34 IBS-M participants, 16 who received IBgard^® and 18 who received placebo. Study participants were randomly allocated to receive IBgard^® 180 mg TID or identical placebo for four weeks. Primary analysis was based on the TISS score. Additional assessments included change from baseline in frequency and intensity of individual IBS symptoms.

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 another common symptom experienced by patients with IBS. Recent understanding regarding the multiple etiologies of IBS point to gut mucosal barrier dysfunction associated with reversible, low-grade inflammation as a potential contributor to abdominal pain and altered stool form.

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 (from gelatin protein), 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. The food nutrients in IBgard^® (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS and help normalize gut mucosal barrier function. Additionally, 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 flare-ups.

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^® is the number one recommended peppermint oil for IBS among gastroenterologists for the third 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. Many physicians are now recommending taking IBgard^® before a meal, as it enables the supportive effect of IBgard^® to start as early as possible.

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.

About IM HealthScience^®
IM HealthScience^® (IMH) is the innovator of IBgard^® and FDgard^® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH^® added Fiber Choice^®, a line of prebiotic fibers, to its product line via an acquisition. The sister subsidiary of IMH^®, Physician's Seal^®, also provides REMfresh^®, a well-known modified-release melatonin supplement for sleep. IMH^® is a privately held company based in Boca Raton, Florida. 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 overall health and wellness, including conditions with a high unmet medical need, such as digestive health. 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,  www.FDgard.com, www.FiberChoice.com, and www.Remfresh.com.

¹ Su, A.M., Shih, W., Presson, A.P., & Chang, L. (2014, January). Characterization of symptoms in irritable bowel syndrome with mixed bowel habit pattern. Neurogastroenterology & Motility, 26 (1):36–45. doi: 10.1111/nmo.12220. Epub 2013 Aug 29.
² Drossman, D.A., Morris, C.B., Schneck, S., Hu, Y.J., Norton, N.J., & Norton, W.F., et al. (2009, July). International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. Journal of Clinical Gastroenterology, 43(6): 541-550.  doi: 10.1097/MCG.0b013e318189a7f9.
³ Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. & Barghout, V. (2005, June 1). 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.
⁴ Swift, D., & Bilal, M. (2016, December 15). IBS Purgatory: Mixed Irritable Bowel Syndrome – Symptoms can fluctuate rapidly, and psychological burden is onerous. AGA Reading Room. Retrieved from http://www.medpagetoday.com/reading-room/aga/lower-gi/62101.
⁵ Dr. Brooks Cash is a consultant to IM HealthScience, LLC®.

SOURCE IM HealthScience

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