A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia

BackgroundFunctional dyspepsia (FD) is a very common condition affecting more than 10% of the population. While there is no cure, a few drugs have been found to be effective for the relief of symptoms, although most are only effective in a subgroup of patients. We assess and compare the efficacy of a fixed peppermint/caraway-oil-combination (Menthacarin) on symptoms and quality of life (QoL) in patients with FD symptoms consistent with epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). MethodsIn a prospective, double-blind, multicenter trial, 114 outpatients with chronic or recurrent FD were randomized and treated for 4weeks with the proprietary peppermint- and caraway-oil-preparation Menthacarin or placebo (2x1 capsule/day). Improvement of abdominal pain and discomfort were used as co-primary efficacy measures (scores measured with the validated Nepean Dyspepsia Index). Key ResultsAfter 2 and 4weeks, active treatment was superior to placebo in alleviating symptoms consistent with PDS and EPS (P all <.001). After 4weeks of treatment, pain and discomfort scores improved by 7.64.8 and 3.6 +/- 2.5 points (full analysis set; mean +/- SD) for Menthacarin and by 3.4 +/- 4.3 and 1.3 +/- 2.1 points for placebo, respectively. All secondary efficacy measures showed advantages for Menthacarin. Conclusions & InferencesMenthacarin is an effective therapy for the relief of pain and discomfort and improvement of disease-specific QoL in patients with FD and significantly improves symptoms consistent with EPS and PDS.