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

• DOI: 10.1111/nmo.13132
• Publication Date: 2017-07-11T04:56:47Z
• Authors: G. Rich; A. Shah; N. Koloski; P. Funk; B. Stracke; S. Köhler; G. Holtmann
• Keywords: caraway oil; Adult; Male; Functional dyspepsia; peppermint oil; 610; Nepean Dyspepsia Index; Severity of Illness Index; 03 medical and health sciences; 0302 clinical medicine; Double-Blind Method; Humans; Multicenter Studies as Topic; Plant Oils; 2715 Gastroenterology; Prospective Studies; Dyspepsia; Peppermint oil; Caraway oil; Menthacarin; Mentha piperita; 1314 Physiology; Middle Aged; functional dyspepsia; Abdominal Pain; 3. Good health; 2807 Endocrine and Autonomic Systems; Treatment Outcome; Quality of Life; Female

AbstractBackgroundFunctional 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 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 ResultsAfter 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 & 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.