Table 1.
Trial A | Trial B | Trial C | |
---|---|---|---|
Publication | May et al. [17] | Freise and Köhler [13] | Madisch et al. [15] |
Treatment | 3 × 1 enteric-coated capsule/day Menthacarin (total daily dose of 270 mg peppermint oil and 150 mg caraway oil) or placebo for 4 weeks | 3 × 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 weeks |
Patients with IBS/total (ITT) | Menthacarin: 12/22 (55%) | Menthacarin: 40/108 (37%) | Menthacarin: 5/60 (8%) |
Placebo: 10a/23 (44%) | Comparator: 42/105 (40%) | Comparator: 3/58 (5%) | |
Primary selection criteria | Adult 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 participation | ||
Primary outcome measure | Change in intensity of pain | Change in intensity of pain | Change in intensity of pain |
CGI Item 2 | |||
Secondary outcome measures with relevance to IBS | Flatulence; feelings of pressure/heaviness/fullness; diarrhea | Flatulence; feelings of pressure/heaviness/fullness; diarrhea | Flatulence; feelings of pressure/heaviness/fullness; diarrhea |
CGI items 1 + 3 | CGI items 1–3 | CGI items 1–3 |
Menthacarin® 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
aOne patient out of 10 was not evaluable because of missing data under therapy