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Table 2.

Abdominal pain intensity at baseline and day 7 (Recording at the visits with the GPs) in the intent to treat population

Pain intensity (Visual Analog Scale) P/TMP* Placebo* Δ** p
ITT population (n=300) n = 151 n = 149
 Day 0 (mm) 62.0 ± 9.0 61.8 ± 8.5 0.918
 Day 7 (mm) 25.9 ± 20.0 33.8 ± 23.2 0.004
 Absolute reduction (mm) (Day 7 – Day 0) 36.1 ± 21.0 28.1 ± 21.7 8.0 ± 2.5 [3.1; 12.9] 0.001
 Relative reduction (%) ((Day 7 – Day 0)/Day 0) 57.8 ± 31.7 46.3 ± 34.7 11.5 ± 3.8 [4.0; 19.1] 0.0029
 Responders (%)*** 62.3% 47.0% 15.3% 0.011
* n, Mean ± SD; visual analog scale of pain intensity ranging from 0 to 100 (maximal pain)
** Difference between groups: mean (CI95%)
*** A responder was defined as having a decrease of at least 50% of pain intensity on the visual analog scale between the assessments of baseline and day 7
Aliment Pharmacol Ther. 2007 May; 25(9): 1115–23.
doi: 10.1111/j.1365-2036.2007.03296.x.