Z Gastroenterol 2015; 53 - KG253
DOI: 10.1055/s-0035-1559279

Menthacarin for the Treatment of Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (PDS): Data of a placebo-controlled trial revisited

G Holtmann 1, G Rich 1, V Wieland 2, P Funk 3, M Kieser 4, S Koehler 5
  • 1University of Queensland, Princess Alexandra Hospital, Department of Gastroenterology and Hepatology, Brisbane, Australien
  • 2Praxis fuer Allgemeinmedizin, Mannheim, Deutschland
  • 3Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Deutschland
  • 4Universitätsklinikum Heidelberg, Medizinische Biometrie, Heidelberg, Deutschland
  • 5Clinical Research Department, Pharmaceuticals, Dr. Willmar Schwabe, Karlsruhe, Deutschland

Introduction: The Rome III criteria have been proposed to categorise patients with FD into epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). This categorisation is intended to better target therapy. However, very little is known if specific symptom-types respond better to specific treatments. We thus analysed the data from a prospective, double-blind, multicentre clinical trial with Menthacarin* (a proprietary combination of essential oils of a specified quality from Mentha x piperita L. (90 mg WS® 1340) and Carum carvi (50 mg WS® 1520)) with regard to the efficacy of Menthacarin in EPS and PDS.

Material and Methods: Patients with functional dyspepsia were recruited in Germany by 20 primary care physicians and specialists in internal medicine. In total, 114 male or female, adult outpatients suffering from functional dyspepsia were randomised and treated for 4 weeks with Menthacarin or placebo (2 × 1 capsule/day). An EPS sub-score was defined as the sum of the intensity ratings of the symptoms 'pain or ache in upper abdomen' and 'burning sensation in upper abdomen' whereas a PDS sub-score was computed as the sum of the intensity ratings of the items 'inability to finish a regular meal' and 'fullness after eating or slow digestion'.

Results: For both categories, EPS and PDS, Menthacarin was superior to placebo after 4 weeks of treatment (p < 0.001). EPS and PDS scores improved by 3.0 ± 2.6 and 2.6 ± 2.3 points (full analysis set; mean ± SD) for Menthacarin and by 1.0 ± 2.1 and 1.0 ± 2.4 points for placebo, respectively.

Conclusions: This study demonstrates that Menthacarin significantly improves symptoms consistent with EPS and PDS. Rome III based categorisation of patients does not appear to improve response rates.