Table 2.
Changes in primary and secondary outcome measures.
| Mebeverine n = 44 [59] |
Placebo n = 43 [56] |
P value | |
|---|---|---|---|
| Change of pain score | |||
| Week 4 | −1.9 ± 1.5 [−1.4 ± 1.6] | −1.6 ± 1.5 [−1.2 ± 1.5] | 0.285 [0.786]∗ |
| Week 12 | −2.2 ± 1.1 [−1.5 ± 1.4] | −1.8 ± 1.4 [−1.4 ± 1.5] | 0.151 [0.544]∗ |
| Change of CGI-S | |||
| Week 4 | −3.1 ± 1.3 [−2.3 ± 1.7] | −3.0 ± 1.7 [−2.4 ± 1.9] | 0.723 [0.630]∗ |
| Week 12 | −3.1 ± 1.7 [−2.2 ± 1.9] | −3.1 ± 1.5 [−2.5 ± 1.8] | 0.870 [0.336]∗ |
| CGI-I score at week 4 | 2.0 ± 1.2 [2.6 ± 1.3] | 2.5 ± 1.4 [2.8 ± 1.4] | 0.057 [0.368]∗ |
| CGI-I score at week 12 | 2.0 ± 1.4 [2.6 ± 1.4] | 2.4 ± 1.4 [2.7 ± 1.4] | 0.183 [0.634]∗ |
| Response rate at week 4 | 24 (54.5) [24 (40.6)] | 17 (39.5) [30.3] | 0.117 [0.469]∗∗ |
| Response rate at week 12 | 32 (72.7) [32 (54.2)] | 23 (53.4) [23 (41.0)] | 0.0503 [0.416]∗∗ |
Data are presented as mean ± SD. Data of the intention to treat analysis are shown in []. CGI-S, CGI-I: Clinical Global Impression Severity and Improvement Scales. ∗Mann-Whitney U test; ∗∗Chi-square test.