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FDgard rapidly improves functional dyspepsia symptoms
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CHICAGO — FDgard, a medical food containing caraway oil/l-Menthol designed to help manage functional dyspepsia, showed symptom reduction and relief in patients with functional dyspepsia within 24 hours, according to findings presented at Digestive Disease Week.
Three posters presented at the meeting revealed data that support the novel use of combination caraway oil/l-Menthol (FDgard, IM HealthScience) in patients with functional dyspepsia (FD), showing reduction in both postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS) symptoms.
“Functional dyspepsia can have a significant impact on a patient’s quality of life,” William D. Chey, MD, FACG, co-director of the Michigan Bowel Control Program at the University of Michigan and Healio Gastroenterology Peer Perspective Board member, said in a press release. “These study results suggest that FDgard can provide rapid relief to subset of patients with functional dyspepsia – a condition for which there are few effective treatments.”
William D. Chey
Researchers evaluated the use of a novel formulation (FDgard) of combined caraway oil and peppermint oil (l-Menthol) with site specific targeting (COLM-SST), previously shown as effective for FD, to compare its efficacy against placebo in patients taking usual FD medication. They enrolled 100 participants aged 18 to 60 years with symptoms of FD in a post-marketing, parallel group study, called FDREST, conducted at 8 university-based or gastroenterology research-based centers in the U.S. between July 1, 2015, to Sept. 14, 2016. Participants randomly received 2 capsules of FDgard or matching placebo in the morning and at dinner time 30 minutes to an hour before a meal in combination with each patient existing FD medication regimen, including PPIs, histamine receptor 2 antagonists and anticonvulsants.
The investigators found that patients with FD who received FDgard experienced statistically significant reduction in PDS and improved EPS symptoms within 24 hours compared with those who received placebo. At the end of treatment, 77.7% of patients with PDS and 72.2% of those with EPS reported either a “much” or “very much” improved assessment of the Clinical Global Impressions (CGI) scale verses 50% and 40% in the control groups. FDguard also helped further improve symptoms at 4 weeks, with roughly 75% of the PDS and EPS patients in the FDgard arm reporting substantial symptom improvement compared with half in the control arm. At 24 hours, 9.9% and 14% overall participants experienced improvements in PDS and EPS symptoms compared with the control group. Reduction of PDS and EPS symptoms from baseline in 24 hours was 15.8% and 19.5% in the PDS group, and reduction was 13.2% and 20.7% in the EPS group.
“These study results are uniquely important and represent an advance in the management of functional dyspepsia,” Michael S. Epstein, MD, AGAF, FACG, chief medical advisor for IM Health Science, said in the press release. “We believe that FDgard possesses anti-inflammatory, analgesic, and gastro-protective properties, which likely are responsible for the rapid relief and steady improvement of FD symptoms in patients even when used as an add-on therapy to commonly used, off-label medications to treat FD. … In particular, many FD symptoms flare within 2 hours after a meal, so the fast action seen in this FDgard study is an important advance.” – by Savannah Demko
References:
Chey WD, et al. Abstract Sa1618. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.
Chey WD, et al. Abstract Sa1619. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.
Lacy BE, et al. Abstract Sa1620. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.
Disclosure: Epstein is employed by IM HealthScience. Chey reports he is a consultant for Allergan and Takeda.