FDgard® Study Demonstrates Rapid Relief of Functional Dyspepsia Symptoms

MedicalResearch.com Interview with:

William D. Chey

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Timothy T. Nostrant Professor of Gastroenterology & Nutrition
Director, Digestive Disorders Nutrition & Lifestyle Program
Michigan Medicine
Ann Arbor, Michigan 

MedicalResearch.com: What is the background for this study?

Response: Functional Dyspepsia (FD) has been characterized as recurring indigestion with no known organic cause and is an area of high unmet medical need. This medical condition, which is non-life threatening, can have a significant impact on an individual’s quality of life. It remains poorly recognized and presents a significant management challenge for providers and patients.

Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.

Currently, there are no FDA-approved drugs for FD. Off-label medications are used to treat the condition and patient dissatisfaction remains high.[1]

In a real-world, observational study, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), we analyzed information on the frequency of FD symptoms, daily consumption of capsules, onset of action, improvement in FD symptoms, quality of life and patient satisfaction among 600 patients who took FDgard®, a nonprescription medical food specially formulated for the dietary management of FD.

MedicalResearch.com: What are the main findings?

Response: The main results from FDACT™ (Functional Dyspepsia Adherence and Compliance Trial) were presented in an oral presentation at the recent World Congress of Gastroenterology at ACG 2017 in Orlando.

Data from FDACT™ showed there was a high level of patient satisfaction and rapid improvement of FD symptoms with FDgard® (a unique combination of caraway oil and l-Menthol, the primary component in peppermint oil – COLM-SST). Caraway oil contains carvone and d-limonene, which may possess gastroprotective and prokinetic effects; l-Menthol, which may have anti-inflammatory, prokinetic, analgesic and gastroprotective effects.

The study results showed:

  • 95 percent of patients reported major or moderate improvement in their overall symptoms of FD:
    • 5 percent of patients with Epigastric Pain Syndrome (EPS, which is epigastric pain or burning) indicated improvement in their upper abdominal pain after taking FDgard®.
    • 5 percent of patients with Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness) indicated that their relief from fullness was attained in two hours or less after taking FDgard®.
    • 4 percent of patients indicated experiencing relief from symptoms within 2 hours after taking FDgard®.

Additionally, the data showed:

  • 2 percent of patients take between 1 and 4 capsules per day, and
  • 2 percent of patients take FDgard® before meals.

MedicalResearch.com: What should readers take away from your report?

Response: The findings from FDACT™, and a previously presented landmark, multi-centered, post-marketing, parallel group, U.S.-based study, FDREST™, revealed a high level of patient satisfaction and rapid relief of FD symptoms.

In FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), the study showed that patients with FD who received FDgard® versus placebo plus commonly used, off-label FD medications experienced a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (early satiety, abdominal heaviness, pressure and fullness) and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms (epigastric pain or discomfort and burning) at 24 hours.

Specifically, the FDREST™ study showed that at 24 hours, FDgard® improved FD symptoms in patients and provided rapid and significant reduction in EPS and PDS symptoms in the PDS sub-group as well as a statistically significant reduction in EPS and PDS symptoms in the EPS sub-group. At 4 weeks, approximately 75 percent of the EPS and PDS patients in the FDgard® arm had substantial symptom (clinical global) improvement vs. approximately half in the control arm.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response:   Continued studies on the effect of FDgard® in adults with FD will add additional information to our body of knowledge. In addition, mechanistic studies to help define how FDgard® improves symptoms would be of benefit. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Disclosures: Dr. Chey has served as a consultant to IM Health Science®, the company that markets FDgard®.

The novel caraway oil and peppermint oil formulation (COLM-SST) is marketed as FDgard® and available in most pharmacies nationwide. FDgard® is specially formulated for the dietary management of FD. It is the first product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state microspheres of caraway oil and l-Menthol, the primary component in peppermint oil, quickly and reliably where they are needed most in FD — the upper belly.

Citation:

ACG Oral Presentation

Dr. William Chey was the lead study author on the real-world observational study, FDACT™. His oral presentation took place at the World Congress of Gastroenterology at ACG 2017, in Orlando, Florida, on Tuesday, October 17.

Chey, W.D. (2017, October). Rapid Relief of Functional Dyspepsia Symptoms With a Novel Formulation of Caraway Oil and L-Menthol: Outcomes From a Self-Reported Patient Outcomes Study. Simultaneous Plenary Session 2B, Program No. 32 Meeting Abstract, conducted at the World Congress of Gastroenterology at ACG 2017, Orlando, Florida

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

 

 

 

[1] Lacy, B.E., Weiser, K.T., Kennedy, A.T., Crowell, M.D., & Talley, N.J. (2013). Functional dyspepsia: the economic impact to patients. Alimentary Pharmacology & Therapeutics, 38:170-177. doi: 10.111/apt.12355.

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