LAS VEGAS and BOCA RATON, Fla., Oct. 17, 2016 /PRNewswire/ -- IM HealthScience® (IMH) today announced the complete and final results of IBSACT™ (Irritable Bowel Syndrome Adherence and Compliance Trial), a real-world observational study of 630 patients who took IBgard®, a medical food for the dietary management of Irritable Bowel Syndrome (IBS). The final results from IBSACT™ did not differ materially from the interim results, which were presented during the American College of Gastroenterology's (ACG) 80th Annual Scientific Meeting in October 2105. ACG is the pre-eminent professional organization that works on delivering evidence-based health care to gastroenterology patients through scientific investigation, education, prevention and treatment.
Data from IBSACT™ showed that there was a high level of patient satisfaction with the product even among those patients taking several capsules on a daily basis. One out of two IBS patients taking IBgard® needed only 1 to 2 capsules per day to obtain individualized relief from IBS symptoms. In addition, 70 percent of the patients felt relief of abdominal pain, discomfort and/or bloating within 2 hours while 94 percent of patients reported relief within 24 hours after taking IBgard®. The high responder rate seen in IBSACT™ reconfirmed the pattern of effectiveness and high patient satisfaction seen in the IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), the landmark, randomized, double-blind placebo controlled study of IBgard®. IBSREST™ was accepted for publication by a prestigious, peer-reviewed medical journal, Digestive Diseases and Sciences, and published in February 2016.1
"Irritable bowel syndrome is an important health issue which drastically affects quality of life," Darren M. Brenner, M.D., a prominent scientific leader, Associate Professor of Medicine, Gastroenterology Division, and Director of the Gastrointestinal Motility Program, Feinberg School of Medicine at Northwestern University in Chicago. "People with IBS need to be proactive about their condition and talk to their doctor about helping them manage their IBS symptoms. In my experience, IBgard® fills an unmet need among IBS patients for rapid and well-tolerated relief of IBS symptoms. As a gastroenterologist, I appreciate having this effective, non-prescription option for my patients suffering from IBS and I am seeing excellent results with the product."
IBS Affects One in Six Americans
Individuals with IBS have a significant burden affecting their daily quality of life and point to the need for a more proactive approach in managing their condition. In fact, IBS is a disorder that affects one in six Americans. It is 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 also a common symptom experienced by patients with IBS. Recent understandings of the root causes of IBS point to gut mucosal barrier dysfunction and malabsorption. IBS can be severe – even unbearable – for some patients. IBgard® has been clinically supported to manage the symptoms of IBS in as early as 24 hours.
IBSACT™ (Irritable Bowel Syndrome Adherence and Compliance Trial) was a real-world observational study of 630 patients taking IBgard®. The survey collected information on dosing frequency, onset of action and satisfaction with the product. Patients were directed via cards in IBgard® samples distributed through physician offices to www.ibgardoffers.com to complete a survey. The survey was conducted from December 13, 2013 until May 5, 2016. Interim results from IBSACT™ were selected by a committee of gastroenterologists for presentation during last year's American College of Gastroenterology's (ACG) 80th Annual Scientific Meeting in October 2105.
Results Show Significant Improvement and Patient Satisfaction
In patients taking IBgard®, the final IBSACT™ report showed:
- 2 out of 3 patients suffer from IBS symptoms daily;
- 1 out of 2 patients took only 1 to 2 capsules of IBgard® per day; and
- 1 out of 2 patients took IBgard® before a meal and 1 out of 4 patients took IBgard® after a meal.
Key findings from the final IBSACT™ report included:
- More than 96% reported major to moderate improvement of their IBS symptoms;
- More than 91% reported a major or moderate improvement in their quality of life;
- More than 94% reported a major or moderate improvement in their abdominal pain/cramping;
- 81% reported major or moderate improvement in their bowel regularity; and
- 70% of patients felt relief from abdominal pain/discomfort/bloating within 2 hours.
Additionally, patients taking IBgard® were asked how likely they were to recommend IBgard® and to continue taking IBgard®:
- 95% were very likely or likely to recommend IBgard® to family or friends who have IBS; and
- More than 98% reported that they were very likely or likely to continue taking IBgard® for their IBS.
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, 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. Peppermint oil can help toward normalizing the digestion of food and the absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to 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™). The study findings were accepted by a leading, peer-reviewed scientific journal, called Digestive Diseases and Sciences, and published in February 2016. 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 a flare-up.
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. 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.
IBgard® is available to patients in the digestive aisle at most CVS/pharmacy, Walgreens and Rite Aid stores nationwide and now increasingly in independent drug stores and grocery stores across the country.
About IM HealthScience®
IM HealthScience® (IMH) is the innovator of IBgard® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of 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, August 29, online; 2016, February 1, print). A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences, 61(2): 560-571. doi: 10.1007/s10620-015-3858-7.
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SOURCE IM HealthScience