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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

Rich G, Shah A, Koloski N, et al. (2017)

Neurogastroenterol Motil · PMID 28695660

Abstract

BACKGROUND: Functional 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). METHODS: In a prospective, double-blind, multicenter trial, 114 outpatients with chronic or recurrent FD were randomized and treated for 4&#xa0;weeks with the proprietary peppermint- and caraway-oil-preparation Menthacarin or placebo (2&#xd7;1 capsule/day). Improvement of abdominal pain and discomfort were used as co-primary efficacy measures (scores measured with the validated Nepean Dyspepsia Index). KEY RESULTS: After 2 and 4&#xa0;weeks, active treatment was superior to placebo in alleviating symptoms consistent with PDS and EPS (P all <.001). After 4&#xa0;weeks of treatment, pain and discomfort scores improved by 7.6&#xb1;4.8 and 3.6&#xb1;2.5 points (full analysis set; mean&#xb1;SD) for Menthacarin and by 3.4&#xb1;4.3 and 1.3&#xb1;2.1 points for placebo, respectively. All secondary efficacy measures showed advantages for Menthacarin. CONCLUSIONS &amp; INFERENCES: Menthacarin 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.