American College Of Gastroenterology (ACG) 2018 IBS Monograph Reaffirms The Preceding ACG 2014 IBS Monograph's Support For Peppermint Oil's Use In IBS But Qualifies It With The Need For More Distal Delivery.

PHILADELPHIA, Oct. 9, 2018 /PRNewswire/ -- IM HealthScience^® (IMH) today announced that the 2018 ACG Monograph on Management of Irritable Bowel Syndrome (published in June 2018) reaffirms the support for peppermint oil's utility in IBS mentioned in the 2014 ACG IBS Monograph.¹ However, the 2018 Monograph identifies heartburn as an issue^2–5 and indicates it can be avoided by use of enteric-coated peppermint oil formulations with more distal delivery.

IBgard, with its solid-state, triple-coated, sustained-release microspheres, provides more distal delivery. IBgard's efficacy, safety, and tolerability profile is supported by 3 concurring studies, and with no pattern of heartburn observed. These 3 concurring studies are IBSREST, IBSACT and IBSSU24.

The 2018 ACG Monograph takes into account findings from the landmark randomized, placebo-controlled clinical trial for IBgard®: IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). This trial found that IBgard was safe and well tolerated, with significant improvements in global IBS symptoms at 24 hours and with the benefit growing at four weeks. No heartburn or anal burning was seen in the IBgard arm of this trial.

Published in The American Journal of Gastroenterology, the 2018 monograph² notes that irritable bowel syndrome is the most prevalent of the functional gastrointestinal disorders, affecting up to 10-12 percent of adults in North America. The monograph aims "to provide an updated, evidence-based document on the therapy of this common and, at times, debilitating disorder." In addition to antispasmodics and peppermint oil, 11 other categories of treatment are evaluated, including exercise, diet and dietary manipulation, fiber, and antidepressants.

"We suggest peppermint oil for overall symptom improvement in IBS patients," state the ACG monograph authors, led by Alexander C. Ford, MB, ChB, MD, FRCP, of the Leeds Institute of Biomedical and Clinical Sciences, at the University of Leeds and Leeds Gastroenterology Institute (UK). "Our analysis suggests a benefit for peppermint oil in IBS, but this recommendation is based on a small number of clinical trials involving very specific formulations."

The monograph states that "although, overall, adverse events appeared to be no more common with peppermint oil than placebo, heartburn has been reported … this may be avoided by the use of enteric coated preparations that provide more distal delivery."

"IBgard, with SST technology, has been specifically developed for more distal delivery. This technology avoids heartburn while producing fast and sustained action," said Michael S. Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. "The conclusions of the monograph add further to the expert opinion and medical evidence supporting the utility of this novel formulation of peppermint oil in helping patients with IBS. Typically, heartburn and anal burning are common side effects reported with older, 'burst release' peppermint oil products."

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 patients and help normalize gut mucosal barrier function. Additionally, peppermint oil has been shown to help normalize intestinal transit time.

As noted earlier, IBgard was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). 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.⁶ The data showed that IBgard demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours, and the benefit grew at four weeks. The TISS represents a composite score of eight individual IBS symptoms.

Additional concurring results were seen from a real-world observational study of 285 patients who took IBgard, called IBSACT™ (Irritable Bowel Syndrome Adherence and Compliance Trial).⁷ This study showed that there was a high level (85% or higher) of patient satisfaction with the product. 60.8% of the patients needed only 1 to 2 capsules per day. In addition, 75.6% of the patients felt relief of abdominal pain, discomfort and/or bloating within 2 hours, while 95.2% of patients reported relief within 24 hours after taking IBgard.

The third and most recent concurring study for IBgard's safety, tolerability, and efficacy profile was IBSSU24 (Irritable Bowel Syndrome Safety Update at 24 Months). IBSSU24 was a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 773,322 individual patients who used the product during a  two-year period. An independent call center with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events was retained to receive and record IBgard customer questions, product issues, and adverse events. The adverse events for this study were collected and processed from October 5, 2015, to September 30, 2017. An analysis of the data by reviewers showed that there were no reported serious adverse events associated with the use of IBgard during this time frame. Only 626 non-serious adverse events were received. The top-reported, non-serious adverse events were abdominal pain/discomfort/distension (65), diarrhea (59), dyspepsia (56), constipation (29), flatulence (27), and throat irritation (27). This pattern was within a range of common symptoms among populations of IBS patients.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard for their patients. For the third consecutive year, IBgard continues to be" #1 recommended" for IBS among gastroenterologists nationwide.^†

Like all medical foods, IBgard does not require a prescription, but it must be used under medical supervision. The usual dosage, when in flare, is 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 in the digestive aisle at most Walmart, Target, CVS/pharmacy, Walgreens and Rite Aid stores nationwide, as well as in independent drug 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^®, 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. Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology Monograph on the Management of Irritable Bowel Syndrome and Chronic Idiopathic Constipation. Am J Gastroenterol. 2014;109(SUPPL. 1):S2-S26. doi:10.1038/ajg.2014.187.
2. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018:S1-S18. doi:10.1038/s41395-018-0084-x.
3. 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.
4. 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.
5. Mosaffa-Jahromi M, Lankarani KB, Pasalar M, Afsharypuor S, Tamaddon AM. Efficacy and safety of enteric coated capsules of anise oil to treat irritable bowel syndrome. J Ethnopharmacol. 2016;194(November):937-946. doi:10.1016/j.jep.2016.10.083.
6. 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.
7. 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.

*Primarily based on IBSREST
**Primarily based on IBSACT
^† Among gastroenterologists recommending peppermint oil for IBS. 2017 ProVoice survey.

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.

SOURCE IM HealthScience

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