- Title
- 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
- Creator
- Rich, G.; Shah, A.; Koloski, N.; Funk, P.; Stracke, B.; Köhler, S.; Holtmann, G.
- Relation
- Neurogastroenterology and Motility Vol. 29, Issue 11, no. e13132
- Publisher Link
- http://dx.doi.org/10.1111/nmo.13132
- Publisher
- Wiley-Blackwell
- Resource Type
- journal article
- Date
- 2017
- Description
- 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, alth ough 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.
- Subject
- caraway oil; functional dyspepsia; Menthacarin; Nepean Dyspepsia Index; peppermint oil
- Identifier
- http://hdl.handle.net/1959.13/1397208
- Identifier
- uon:34216
- Identifier
- ISSN:1350-1925
- Language
- eng
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