Treatment of Functional Dyspepsia with a Fixed Peppermint Oil and Caraway Oil Combination Preparation as Compared to Cisapride

Abstract

The therapeutic equivalence of a fixed combination preparation consisting of peppermint oil and caraway oil (PCC, Enteroplant) and the prokinetic agent cisapride (CIS, CAS 81098-60-4) was investigated in a four-week randomized controlled double-blind study with planned adaptive interim analysis. The study comprised 120 outpatients with functional dyspepsia. The efficacy was evaluated in 118 patients. Of these, 60 patients received the enteric-coated combination preparation (2 x 1 capsule containing 90 mg peppermint oil +50 mg caraway oil per day) and 58 patients received the reference preparation cisapride (3 x 10 mg/day). The mean reduction of the pain score (primary variable) recorded on a visual analog scale (VAS) during the four-week treatment was 4.62 points with the peppermint oil/caraway oil preparation. This score was comparable with the mean reduction under cisapride (4.60 points) (p = 0.021; test for equivalence). Equivalence was also found in the secondary variable "frequency of pain" with a reduction by 4.65 points under PCC and by 4.16 points under cisapride carried out on an exploratory basis (p = 0.0034). Comparable results were attained with both treatments in the Dyspeptic Discomfort Score which included the other dyspeptic symptoms as well as intestinal and extraintestinal autonomic symptoms, in the prognosis as appraised by the physician and in the CGI scales (Clinical Global Impressions). Corresponding results were also found in Helicobacter pylori-positive patients and patients with initially intense epigastric pain in the two treatment groups. The combination preparation consisting of peppermint oil and caraway, oil appears to be comparable with cisapride and provides an effective means for treatment of functional dyspepsia. Both medications were tolerated well (adverse events were reported in 12 patients of the PCC group and in 14 patients of the CIS group).

Relaxant effect of ethanol extract ofCarum carvion dispersed intestinal smooth muscle cells of the guinea pig

“…It is not known whether this effect can include also responses of gastro-intestinal SMC to other excitatory stimuli including neurotransmitters released by enteric neurons. The involvement of visceral sensation in the mechanism of dyspepsia and the decrease in pain sensation in dyspeptic patients to phytotherapeutic combination containing caraway extract may indicate also effects on neural cells (Madisch et al, 1999;May et al, 1996;Thumshirn, 2002;Timmons et al, 2004). Future studies should be aimed at investigating the effects on enteric neurons, to clarify the mechanism by which caraway extract has caused relaxant effect on SMC and to identify and test the active materials that caused this effect.…”

“…In clinical studies, phytotherapeutic combinations containing caraway oil exhibited beneficial effects on gastro-intestinal symptoms, such as dyspepsia and functional dyspeptic syndrome (Coon & Ernst, 2002;Freise & Kohler, 1999;Madisch et al, 1999Madisch et al, , 2004Mascher et al, 2001;May et al, 1996May et al, , 2000Micklefield et al, 2003). None of these studies clearly defined the effects of caraway on gastro-intestinal motor activities, as the clinical dyspeptic syndrome is a complex pathophysiological process in which alteration of motility, alteration of sensation as well as psychosocial factors are involved in the generation of dyspepsia (Camilleri, 2001).…”

Transient Receptor Potential Channels as Drug Targets: From the Science of Basic Research to the Art of Medicine

“…Caraway oil is used as a dietary supplement for digestive problems, including bloating and mild spasms of the stomach and intestines. In a multicenter, double-blind clinical study, the combination of peppermint and caraway oil was reported to provide symptomatic relief in patients with FD (Madisch et al, 1999). Peppermint oil (and its active ingredient, menthol) is a known TRPM8 agonist.…”

Effectiveness of Menthacarin on symptoms of irritable bowel syndrome

“…[17]Freise and Köhler [13]Madisch et al. [15]Treatment3 × 1 enteric-coated capsule/day Menthacarin (total daily dose of 270 mg peppermint oil and 150 mg caraway oil) or placebo for 4 weeks3 × 1 enteric-coated capsule/day Menthacarin (total daily dose of 270 mg peppermint oil and 150 mg caraway oil) or enteric-soluble comparator for 4 weeks (total daily dose of 108 mg peppermint oil and 60 mg caraway oil)2 × 1 enteric-coated capsule/day Menthacarin (total daily dose of 180 mg peppermint oil and 100 mg caraway oil) or 3 × 10 mg cisapride for 4 weeksPatients with IBS/total (ITT)Menthacarin: 12/22 (55%)Menthacarin: 40/108 (37%)Menthacarin: 5/60 (8%)Placebo: 10 a /23 (44%)Comparator: 42/105 (40%)Comparator: 3/58 (5%)Primary selection criteriaAdult outpatients suffering from FD, with or without concomitant IBS symptoms; presence of at least two dyspeptic and/or bowel associated symptoms for at least 14 days; absence of an organic cause of symptoms; informed consent prior to study participationPrimary outcome measureChange in intensity of painChange in intensity of painChange in intensity of painCGI Item 2Secondary outcome measures with relevance to IBSFlatulence; feelings of pressure/heaviness/fullness; diarrheaFlatulence; feelings of pressure/heaviness/fullness; diarrheaFlatulence; feelings of pressure/heaviness/fullness; diarrheaCGI items 1 + 3CGI items 1–3CGI items 1–3Menthacarin® is the active ingredient of the product Carmenthin® (Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) IBS  irritable bowel syndrome, FD  functional dyspepsia, ITT  intention-to-treat, CGI  clinical global impressions scale a One patient out of 10 was not evaluable because of missing data under therapy…”