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Neurogastroenterol Motil. 2017 Nov;29(11). doi: 10.1111/nmo.13132. Epub 2017 Jul 10.

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.

Author information

1
Department of Gastroenterology & Hepatology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
2
Faculty of Medicine & Faculty of Health & Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
3
Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia.
4
Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

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.

KEYWORDS:

Menthacarin; Nepean Dyspepsia Index; caraway oil; functional dyspepsia; peppermint oil

PMID:
28695660
DOI:
10.1111/nmo.13132
[Indexed for MEDLINE]

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