For The Fourth Year In A Row, U.S. Gastroenterologists Endorse Clinically Studied, Nonprescription IBS Product, IBgard®, By An Overwhelming Margin

BOCA RATON, Fla., Nov. 8, 2018 /PRNewswire/ -- IM HealthScience^®, innovators of patented nonprescription medical foods, revealed results of a nationwide survey conducted among gastroenterologists who, by an overwhelming margin and for the fourth consecutive year, endorsed IBgard^® as "the #1 recommended."¹ IBgard, which is a medical food specially formulated as solid-state, triple-coated microspheres of peppermint oil, enables more distal delivery via its patented SST^® (Site Specific Targeting) technology. More distal delivery of peppermint oil was recommended in the American College of Gastroenterology IBS 2018 Monograph⁵ in order to avoid the heartburn observed in older, liquid-filled peppermint oil capsules.

"The widespread adoption of IBgard among gastroenterologists over the years reflects their real-world experience in receiving positive feedback from their patients with IBS," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor of IM HealthScience. "Real-world patient feedback, coupled with compelling data from three separate studies, is why IBgard has become a popular mainstay in the management of IBS, a difficult-to-treat condition." 

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already recommended IBgard for their patients.  About one million patients are estimated to have taken IBgard since its launch in 2014.

About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, underdiagnosed and undertreated 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. This relapsing-remitting disorder needs proactive management over a long period since up to 70% of patients experience persistent symptoms, even after 10 years.⁶ Recent understanding regarding the multiple etiologies of IBS point to gut mucosal barrier dysfunction associated with reversible, often temporary, 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, triple-coated, sustained-release microspheres of Ultramen^®, an ultra-purified peppermint oil, 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, the microspheres in IBgard capsules are designed to quickly and reliably reach the small intestine, where their sustained-release action enables them to coat the entire small intestine. This more distal delivery helps manage IBS while avoiding heartburn seen in older, liquid-filled, "burst-release" peppermint oil capsules. The food nutrients in IBgard -- peppermint oil along with fiber and amino acids -- are designed to help reduce the low-grade, often temporary, reversible inflammation found in some IBS patients and to help normalize gut mucosal barrier function. Additionally, peppermint oil has been shown to help normalize intestinal transit time.⁷

Like all medical foods, IBgard does not require a prescription but must be used under medical supervision. The usual adult dose of IBgard is, when in flare, 2 capsules, 3 times a day, 30-90 minutes before meals, for 4 weeks,* and for maintenance (i.e., daily and proactive gut-health support), 2 capsules, once a day, 30-90 minutes before a meal.**  The maximum dose is 8 capsules per day.

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.

Growing Body of Convergent and Concurring Evidence on the Safety and Efficacy of IBgard^®
Data presented at the 2018 American College of Gastroenterology Meeting (ACG) on IBSSU24, (Irritable Bowel Syndrome Safety Update at 24 Months) confirms the positive safety and efficacy  results seen in  IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial).⁴ Importantly, no pattern of heartburn, a common problem observed among patients taking older formulations of peppermint oil, was reported in either study. A third important study on IBgard, IBSACT,³ again indicated no pattern of heartburn.  In this patient-reported outcomes study, 60% of patients reported beneficial response within 2 hours of taking IBgard.

IBSREST was a randomized, double-blind, placebo-controlled, multicenter trial which 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.² A statistically significant reduction of symptoms was seen at 24 hours, and the benefit expanded at four weeks.² This study was published in the February 2016 print edition of Digestive Diseases and Sciences, a prominent medical journal in the field of gastroenterology and hepatology, in an article entitled "A Novel Delivery System of Peppermint Oil is an Effective Therapy for Irritable Bowel Syndrome."²

As mentioned earlier, in addition to the converging and concurring results seen in IBSREST and IBSSU24, a third study, IBSACT, also showed concurring results.  IBSACT (IBS Adherence and Compliance Trial) was a real-world evidence study of 285 patients who took IBgard.³  In IBSACT, there was a high level (85% or higher) of patient satisfaction. Also, in IBSACT, 60.8% of the patients only needed 1 to 2 capsules per day to obtain relief of their IBS symptoms.

2018 ACG IBS Monograph Supports Use of Peppermint Oil That Provides More Distal Delivery in the Gastrointestinal Tract
Consistent with the previous 2014 ACG IBS Monograph, the newly updated June 2018 Monograph continued to include peppermint oil as a credible and viable option for IBS.⁵  For the first time, the monograph took into account findings from the landmark clinical trial for IBgard, called IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial).  In fact, IBSREST was referenced 5 times in the 2018 monograph and was listed among the two studies "with a low risk of bias."⁵ Importantly, this latest version of the Monograph provides specific support for the type of formulation used in IBgard.

Peppermint oil's safety and efficacy profile includes data published in 2014 in the Journal of Clinical Gastroenterology in a study entitled "Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis" (Khanna et al, 2014)⁸ which 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." In this study, heartburn, however, emerged as a side effect in the older formulations that were studied.  An additional meta-analysis study, mentioned in the 2018 ACG IBS Monograph, noted the challenge of heartburn in IBS patients⁹ was four times that of the non-IBS population. The Khanna study was one of two important studies^8,9 mentioned in the ACG IBS 2018 Monograph, which led to the conclusion by the panel developing the ACG IBS 2018 Monograph that enteric-coated peppermint oil formulations with  more distal delivery were needed to avoid the uncomfortable side effect of heartburn.

IBgard, with its reliable release of solid-state, triple-coated, sustained-release microspheres of peppermint oil, enables more distal delivery.

About IQVIA ProVoice Survey
ProVoice has the largest sample size of any professional healthcare survey in the U.S., with nearly 60,000 respondents across physicians, nurse practitioners, physician assistants, optometrists, dentists and hygienists, measuring recommendations across more than 120 over-the-counter categories. Manufacturers use ProVoice for claim substantiation, promotion measurement and HCP targeting.

IQVIA fielded a survey among 200 U.S. gastroenterologists between September 28th, 2018, through October 8th, 2018, for IM HealthScience. The ProVoice survey methodology validated the claim at a 99 percent confidence level that for the fourth consecutive year, "IBgard^® is the #1 gastroenterologist-recommended peppermint oil for patients with IBS."

IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry formed through the merger of IMS Health and Quintiles.

About IM HealthScience®
IM HealthScience® (IMH) is the innovator of IBgard and FDgard for the dietary management of IBS (Irritable Bowel Syndrome) and FD (Functional Dyspepsia), i.e. (reoccurring indigestion) 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 continuous release and absorption melatonin (CRA-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.

 References

1. QuintilesIMS. Alpha ImpactRx ProVoice Survey IBgard Is the #1 Gastroenterologist Recommending Peppermint Oil For Patients with IBS.; 2018.
2. Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Dig Dis Sci. 2016;61(2):560-571. doi:10.1007/s10620-015-3858-7
3. Cash BD, Epstein MS, Shah SM. Patient satisfaction with IBS symptom relief using a novel peppermint oil delivery system in a randomized clinical trial and in the general population. Int J Dig Dis. 2016;2(2):1-5. doi:10.4172/2472-1891.100027
4. Epstein M, Shah S, Corsino P. 24-Month Post Marketing Safety Surveillance Data of a Novel Peppermint Oil Formulation for IBS Designed for Site Specific Targeting (PO-SST), Confirms Favorable Safety Profile, Including Heartburn and Anal Burning. In: American College of Gastroenterology Annual Conference. Philadelphia, PA; 2018.
5. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018:S1--S18. doi:10.1038/s41395-018-0084-x
6. Ford AC, Forman D, Bailey AG, Axon ATR, Moayyedi P. Irritable bowel syndrome: A 10-yr natural history of symptoms and factors that influence consultation behavior. Am J Gastroenterol. 2007;103(5):1229-1239. doi:10.1111/j.1572-0241.2007.01740.x
7. Goerg KJ, Spilker T. Effect of peppermint oil and caraway oil on gastrointestinal motility in healthy volunteers: A pharmacodynamic study using simultaneous determination of gastric and gall-bladder emptying and orocaecal transit time. Aliment Pharmacol Ther. 2003. doi:10.1046/j.1365-2036.2003.01421.x
8. Khanna R, MacDonald JK, Levesque BG. Peppermint Oil for the Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2014;48(6):505-512. doi:10.1097/MCG.0b013e3182a88357
9. Lovell RM, Ford AC. Prevalence of gastro-esophageal reflux-type symptoms in individuals with irritable bowel syndrome in the community: A meta-analysis. Am J Gastroenterol. 2012;107(12):1793-1801. doi:10.1038/ajg.2012.336

*Primarily based on IBSREST²
**Primarily based on IBSACT³

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. Only physicians can diagnose IBS. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.IBgard.com. Individual results may vary.

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SOURCE IM HealthScience