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

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 weeks with the proprietary peppermint‐ and caraway‐oil‐preparation Menthacarin or placebo (2×1 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 weeks, active treatment was superior to placebo in alleviating symptoms consistent with PDS and EPS (P all