Table 3.
Severity of disease (CGI item 1)—change during double-blind treatment (mean ± SD, or ratio of means and 95% CI)
| Total dataset | Patients with IBS | ||
|---|---|---|---|
| Trial A | Menthacarin | −1.79 ± 1.27 (n = 19) |
−1.67 ± 1.23 (n = 12) |
| Placebo | −1.10 ± 1.33 (n = 20) |
−1.11 ± 1.45 (n = 9) |
|
| Ratio of means | 1.63 [0.90, 3.68] | 1.50 [0.61, 9.26] | |
| Trial B | Menthacarin | −1.50 ± 1.25 (n = 108) |
−1.35 ± 1.27 (n = 40) |
| Enteric-soluble formulation | −1.40 ± 1.11 (n = 104) |
−1.71 ± 1.22 (n = 42) |
|
| Ratio of means | 1.07 [0.86, 1.34] | 0.79 [0.53, 1.13] | |
| Trial C | Menthacarin | −2.10 ± 1.35 (n = 60) |
−0.80 ± 0.84 (n = 5) |
| Cisapride | −1.88 ± 1.40 (n = 58) |
−1.33 ± 1.53 (n = 3) |
|
| Ratio of means | 1.12 [0.87, 1.45] | 0.60 [−∞, +∞] | |
Menthacarin® is the active ingredient of the product Carmenthin® (Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany)
CGI clinical global impressions scale, SD standard deviation, CI confidence interval, IBS irritable bowel syndrome