Observation group (n = 11) | Control group (n = 11) | Treatment difference (95%CI) | pvalue | |
---|---|---|---|---|
Simplified CDAI | ||||
Baseline | 4.3 ± 0.5 | 4.4 ± 0.7 | ||
Month 3 | 2.1 ± 0.3 | 4.9 ± 0.7 | ||
Change from baseline | 2.2 ± 0.6 | 0.5 ± 0.7 | 1.6 (1.1 to 2.2) | 0.000 |
Month 6 | 2.5 ± 1.0 | 4.6 ± 0.7 | ||
Change from baseline | 1.7 ± 1.2 | 0.5 ± 0.7 | 1.3 (0.4 to 2.1) | 0.006 |
Month 12 | 2.7 ± 1.5 | 4.7 ± 0.6 | ||
Change from baseline | 1.7 ± 1.4 | 0.5 ± 0.5 | 1.2 (0.2 to 2.2) | 0.023 |
PDAI | ||||
Baseline | 8.5 ± 1.4 | 9.5 ± 1.7 | ||
Month 3 | 1.3 ± 1.1 | 3.5 ± 0.8 | ||
Change from baseline | 7.3 ± 2.0 | 6.0 ± 1.3 | 1.3 (− 0.2 to 0.8) | 0.090 |
Month 6 | 1.7 ± 1.6 | 3.5 ± 1.5 | ||
Change from baseline | 6.8 ± 1.8 | 6.1 ± 1.9 | 0.7 (− 0.9 to 2.3) | 0.361 |
Month 12 | 1.9 ± 2.4 | 3.1 ± 2.1 | ||
Change from baseline | 6.6 ± 2.2 | 6.5 ± 2.5 | 0.2 (− 1.9 to 2.3) | 0.858 |
IBDQ | ||||
Baseline | 143.5 ± 19.8 | 137.9 ± 29.7 | ||
Month 3 | 202.1 ± 19.9 | 179.5 ± 28.0 | ||
Change from baseline | 58.6 ± 7.1 | 41.5 ± 36.6 | 17.1 (− 7.7 to 41.9) | 0.158 |
Month 6 | 193.2 ± 31.5 | 174.1 ± 19.8 | ||
Change from baseline | 49.7 ± 16.1 | 36.5 ± 32.1 | 13.2 (− 9.4 to 35.8) | 0.238 |
Month 12 | 187.8 ± 33.5 | 166.1 ± 23.4 | ||
Change from baseline | 44.4 ± 17.6 | 29.1 ± 34.6 | 15.3 (− 9.2 to 39.7) | 0.207 |
Wexner score | ||||
Baseline | 1.2 ± 1.3 | 1.5 ± 0.7 | ||
Month 3 | 0.8 ± 1.3 | 1.4 ± 0.7 | ||
Change from baseline | 0.4 ± 0.5 | 0.2 ± 0.4 | 0.1 (− 0.2 to 0.6) | 0.362 |
Month 6 | 0.6 ± 1.0 | 1.2 ± 0.8 | ||
Change from baseline | 0.5 ± 0.7 | 0.7 ± 0.6 | 0.2 (− 0.8 to 0.4) | 0.530 |
Month 12 | 0.5 ± 0.8 | 1.2 ± 0.8 | ||
Change from baseline | 0.6 ± 0.7 | 0.7 ± 0.6 | 0.1 (− 0.7 to 0.5) | 0.750 |
VAS | ||||
Baseline | 0.8 ± 1.0 | 1.1 ± 1.0 | ||
Day 1 | 1.5 ± 1.5 | 4.9 ± 0.8 | ||
Change from baseline | 0.9 ± 1.1 | 3.8 ± 1.0 | 2.9 (2.0 to 3.9) | 0.000 |
Day 3 | 1.1 ± 1.0 | 4.3 ± 0.8 | ||
Change from baseline | 0.5 ± 0.9 | 3.2 ± 1.3 | 2.7 (1.7 to 3.7) | 0.000 |
Day7 | 0.6 ± 0.5 | 3.2 ± 0.8 | ||
Change from baseline | 0.4 ± 0.7 | 2.1 ± 1.3 | 1.7 (0.8 to 2.6) | 0.001 |
Day 15 | 0.4 ± 0.5 | 2.3 ± 0.6 | ||
Change from baseline | 0.6 ± 0.9 | 1.4 ± 1.1 | 0.7 (0.2 to 1.6) | 0.112 |