Baseline demographic and clinical characteristics at randomisation into the double-blind phase
| Budesonide (n=44) | Placebo (n=48) | p Value* | |
|---|---|---|---|
| Gender, n (%) | 0.151 | ||
| Male | 4 (9.1) | 10 (20.8) | |
| Female | 40 (90.9) | 38 (79.2) | |
| Age (years), mean (SD) | 56.7 (9.9) | 60.8 (11.7) | 0.079 |
| Body mass index (kg/m2), mean (SD) | 26.0 (4.5) | 24.6 (3.8) | 0.104 |
| Smoking habit, n (%) | 0.081 | ||
| Current | 17 (38.6) | 21 (43.8) | |
| Former | 18 (40.9) | 10 (20.8) | |
| Never | 9 (20.5) | 17 (35.4) | |
| Caffeine intake, n (%) | 41 (93.2) | 44 (91.7) | 1.000 |
| New diagnosis, n (%) | 4 (9.1) | 2 (4.2) | 0.421 |
| Time since diagnosis (years), median (IQR) | 1.5 (0.2; 4.8) | 0.4 (0.1; 3.7 | 0.073 |
| Duration of current symptoms (months), median (IQR) | 3.4 (1.6; 10.5) | 3.7 (1.5; 8.7) | 0.656 |
| <2 | 14 (31.8) | 18 (37.5) | |
| 2 to <6 | 14 (31.8) | 13 (27.1) | |
| ≥6 months | 16 (36.4) | 17 (35.4) | |
| Number of previous episodes, mean (SD) | 1.9 (2.8) | 1.2 (2.0) | 0.223 |
| Duration of last acute episode (months), median (IQR) | 4.5 (2.0; 7.0) | 5.0 (3.0; 11.0) | 0.550 |
| Duration of last remission phase (months), median (IQR) | 9.0 (4.0; 15.0) | 8.0 (2.5; 32.0) | 0.962 |
| Treatment of last acute episode, n (%) | |||
| Budesonide | 14 (31.8) | 15 (31.3) | 1.000 |
| Antidiarrhoeals | 8 (18.2) | 5 (10.4) | 0.373 |
| Cholestyramine | 9 (20.5) | 0 (0.0) | 0.001 |
| Antibiotics | 2 (4.5) | 0 (0.0) | 0.226 |
| Bulking agents | 0 (0.0) | 1 (2.1) | 1.000 |
| Previous maintenance therapy, n (%) | |||
| Budesonide | 7 (15.9) | 7 (14.5) | 1.000 |
| Cholestyramine | 4 (9.1) | 1 (2.1) | 0.189 |
| Antidiarrhoeals | 2 (4.5) | 0 (0.0) | 0.226 |
*Univariate testing performed by Fisher tests, t tests and Wilcoxon tests (depending on the data structure).