Introduction: Functional dyspepsia (FD) and irritable bowel syndrome (IBS) are common functional gastrointestinal disorders affecting more than 10% of the populations. While a previous 4-week randomised, placebo controlled trial in patients with FD demonstrated a beneficial effect of Menthacarin* in relation to the improvement of FD symptoms1, very little is known about the long term treatment effects. Thus we report results of a 8-week follow-up of patients who had completed a double-blind study, and who agreed an optional continuation treatment according to the initial randomisation.
Material and methods: The trial was performed by 20 primary care physicians and internists in Deutschland. In total, 114 male or female adult outpatients suffering from FD with a history of chronic or relapsing symptoms were randomised and treated for 4 weeks with Menthacarin or placebo (2 × 1 capsule/day). 54 out of the 114 randomised patients (20 placebo, 34 active medication) decided to participate in the optional 8 week follow-up and were treated with Menthacarin or placebo for a total duration of 12 weeks (4 + 8). Primary efficacy endpoints were changes in sub-scores for pain and discomfort during 12 weeks of treatment, respectively, derived from the Nepean Dyspepsia Index (NDI), a validated self-rating scale for measuring quality of life (QoL) in FD.
Results: The NDI sub-score for pain was reduced by an average of 8.7 ± 4.9 points in the Menthacarin group and by 5.1 ± 4.9 points in the placebo group (p = 0.005) (full analysis set; mean ± SD). The sub-score for discomfort was reduced by averages of 3.7 ± 2.5 and 1.3 ± 2.6 points for the Menthacarin and placebo group, respectively (p = 0.0014). In addition, during active therapy, the NDI total score improved considerably in comparison to placebo.
Conclusion: In patients with FD, therapy with Menthacarin for up to 12 weeks yields significantly better symptom improvement compared to placebo treatment. Furthermore, the treatment resulted in an improved QoL in patients with FD.
*Menthacarin® is a proprietary combination of essential oils of a specified quality from Mentha x piperita L. (90 mg Peppermint oil WS® 1340) and Carum carvi (50 mg Caraway oil WS® 1520)
[1] Holtmann G, et al. Z Gastroenterol 2015; 53 – KG253
