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.

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.

• Authors: G Rich, A Shah, N Koloski, P Funk, B Stracke, S Köhler, G Holtmann
• Journal: Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society (Neurogastroenterol Motil) Vol. 29 Issue 11 (Nov 2017) ISSN: 1365-2982 [Electronic] England
• PMID: 28695660 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2017 John Wiley & Sons Ltd.

Chemical References

• Plant Oils
• peppermint oil
• caraway oil

Topics

• Abdominal Pain (complications, drug therapy)
• Adult
• Double-Blind Method
• Dyspepsia (complications, diagnosis, drug therapy)
• Female
• Humans
• Male
• Mentha piperita
• Middle Aged
• Multicenter Studies as Topic
• Plant Oils (therapeutic use)
• Prospective Studies
• Quality of Life
• Severity of Illness Index
• Treatment Outcome