IM HealthScience has launched FDgard, a non-prescription medical food formulated for the dietary management of functional dyspepsia. Each capsule contains triple-coated microspheres containing caraway oil and l-Menthol (a key component of peppermint oil) allowing for more targeted delivery to the gastro-duodenal region. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage functional dyspepsia and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort and reducing the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than placebo.

Analysis of a 4-week, randomized, placebo-controlled multicenter trial of 96 functional dyspepsia patients taking a fixed combination of 90mg peppermint oil (41.5mg l-Menthol) and 50mg caraway oil twice a day resulted in:

Reduction in Sensation of Pressure, Heaviness or Fullness at 4 weeks

    — 43.5% reduction in sensation of pressure, heaviness or fullness in the active arm from baseline at 4 weeks

    — 22.3% reduction in sensation of pressure, heaviness or fullness in the placebo arm from baseline at 4 weeks (P=0.0005)

Reduction in Pain Intensity Form Baseline at 4 weeks

    — 40% reduction in pain intensity in the active arm compared to baseline at 4 weeks

    — 22% reduction in pain intensity in the placebo arm compared to baseline (P=0.0003)

Favorable Global Improvement Scores at 4 weeks

    — Over 90% in the active arm reported an improvement from start of study

    — 67% in the active arm reported very much/much improved scores from start of study (P=0.00005)

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FDgard should be used with caution in patients with a history of gallstones and has not been studied in patients who are pregnant or nursing. While the product can be obtained without a prescription, it must be used under medical supervision. Patients on antacids or H2 blockers should be instructed not to take their acid-reducing medications concomitant to FDgard use. FDgard should be taken first, with the acid reducer following one hour later. Acid reducers may lower the level of acid in the stomach which may cause a premature release of FDgard. However, the product may be taken concurrently with proton pump inhibitors (PPIs).

The gluten- and lactose-free capsules are available in 8- or 24-count boxes.

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