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

摘要

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?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 .001). After 4?weeks of treatment, pain and discomfort scores improved by 7.6±4.8 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 & 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 .