- CDHF Certified Symbol of Distinction designation indicates independent, peer-reviewed assessment which confirms safety and efficacy of IBgard® for Irritable Bowel Syndrome (IBS) symptoms
- With more than 120,000 Canadians developing IBS each year, new treatment options, such as IBgard are available
- Enteric-coated peppermint oil formulation used in IBgard, a clinically studied, nonprescription natural health product for helping in the relief and improvement of IBS symptoms, uses innovative patented Site Specific Targeting (SST®) technology delivering peppermint oil in microspheres to the small intestine
MONTREAL and BOCA RATON, Fla., Aug. 13, 2018 /CNW/ -- IM HealthScience® (IMH) today announced that IBgard®, the clinically studied, nonprescription natural health product containing peppermint oil for helping in the relief and improvement of Irritable Bowel Syndrome (IBS) symptoms, has gained the Canadian Digestive Health Foundation's CDHF Certified Symbol of Distinction designation, which indicates that the Foundation acknowledges the efficacy and safety of IBgard for helping in the relief and improvement of IBS symptoms, including abdominal pain within 24 hours. CDHF is the Foundation of the Canadian Association of Gastroenterology (CAG).
The CDHF Certified Symbol of Distinction designation will be displayed prominently on IBgard consumer education materials. IBgard delivers peppermint oil in microspheres to the small intestine using patented Site Specific Targeting (SST®) technology.
"CDHF Certified was created to help the public and health care professionals make informed choices, offering reassurance that products bearing the Symbol of Distinction can be trusted to have met a standard of safety and efficacy and confers a level of benefit to the digestive health of consumers," said CDHF Chief Executive Officer Jeff Suggitt. "This designation indicates that the Foundation acknowledges the efficacy and safety of the formulation in IBgard, which contains l-Menthol, the primary component in peppermint oil, for helping in the relief and improvement of IBS symptoms including abdominal pain within 24 hours." 1
For every product bearing the CDHF Certified Symbol of Distinction, the CDHF conducts an independent, peer-reviewed assessment of the body of evidence associated with the constituent of a specific product that claims to elicit a specific outcome. This evidence must emanate from authoritative scientific or regulatory bodies and consistently support the claims of the ingredient, the product, its packaging, labelling and all related advertising in order for the product to be deemed acceptable by the CDHF Certified program to bear the CDHF Certified Symbol of Distinction.
Canada has one of the world's highest rates of IBS, with five million Canadians sufferers, and 120,000 developing this disorder each year.2 "In fact, IBS affects an estimated 13-20 percent of Canadians at any given time3," said Karen Madsen, Ph.D., Professor and Director of the Centre of Excellence for Gastrointestinal Inflammation and Immunity Research, University of Alberta (Edmonton, Alberta).
"In this area of high unmet medical need, patients and their health care providers will welcome additional confirmation of the potential of IBgard to combat distressing symptoms such as severe abdominal pain, bloating, diarrhea and constipation," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor, of IM HealthScience.
Based on patented technology, IBgard is a nonprescription natural health product that has been reviewed for efficacy and safety and, subsequently, was issued a Natural Health Product Number (NPN: 8006180) to allow for its sale in Canada for management of the overall symptoms of IBS and, specifically, for helping in the relief of abdominal pain and discomfort, abdominal bloating and distension, and urgency of bowel movement.
As noted on the CDHF website, IBgard uses "a special triple-coated, sustained-release formula that delivers a capsule containing 45 percent I-Menthol to the small intestine. It has been clinically tested and proven to help improve symptoms within 24 hours. More than 96 percent of patients surveyed indicated that they felt moderate to major symptom improvement, and 92.7 percent of patients claimed they felt moderate to major improvements in quality of life."
IBgard® is a natural health product specially formulated for helping to relieve IBS symptoms. IBgard capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, 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.
IBgard previously was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial in the United States, 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. 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.
Additionally, results from a real-word observational study in the United States of 630 patients who took IBgard, called IBSACT™ (Irritable Bowel Syndrome Adherence and Compliance Trial), showed that there was a high level of patient satisfaction with the product even among those patients taking several capsules on a daily basis. Ninety-four percent of patients reported relief within 24 hours after taking IBgard.
The Irritable Bowel Syndrome Safety Update at 24 Months (IBSSU-24) was a real-world surveillance study in the United States reporting on the safety and tolerability profile of IBgard among an estimated over 700,000 individual patients who used the product. 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, many of which were consistent with commonly reported symptoms of IBS.
Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups.
Over 10,000 healthcare practitioners in North America, including 3,000 gastroenterologists, are estimated to have already used IBgard for their patients. For the third consecutive year, IBgard continues to be the #1 recommended peppermint oil for IBS among U.S. gastroenterologists nationwide by an overwhelming margin.4
IBgard is available without a prescription and should be taken as directed on the label. The recommended adult dosage is 2 capsules, three times a day, not to exceed 6 capsules per day. It is recommended that IBgard should be taken 30 to 90 minutes before each meal, with approximately 240 mL of water. Capsules should be swallowed whole.
IBgard is available to patients in the digestive aisle in pharmacies nationwide.
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 continuous release and absorption melatonin (CRA-melatonin) supplement for sleep in the USA. 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 on www.IBgard.ca, www.FDgard.com, www.FiberChoice.com, and www.Remfresh.com.
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. This information should not be used for diagnosing a health problem or disease. Only doctors can definitively diagnose Irritable Bowel Syndrome. 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.ca. Individual results may vary.
1 Canadian Digestive Health Foundation. CDHF Certified Brands. Retrieved from http://cdhf.ca/en/cdhf-certified-/index/section/cdhf-certified-brands
2 Canadian Digestive Health Foundation. Retrieved from https://www.cdhf.ca/en/statistics
3 IBS Global Impact Report 2018. Retrieved from https://www.badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf
4 QuintilesIMS ProVoice August-September 2017 survey methodology validated the claim at a 99 percent confidence level that for the third consecutive year, "IBgard® is the #1 gastroenterologist-recommended peppermint oil for patients with IBS."
SOURCE IM HealthScience
For further information: Gail S. Thornton, West Mill Consulting, 908-392-3420, [email protected], http://www.imhealthscience.com