| Methods |
Multicenter, double‐blind, placebo‐controlled, randomized, dose‐ranging trial. Assessments were performed at entry, 6 and 12 weeks (or upon termination) |
| Participants |
Patients from 24 centers with mild to moderately active ulcerative colitis. No anti‐diarrheals were allowed (N = 273) |
| Interventions |
Olsalazine, 2 (n = 92) or 3 g per day (n = 91), or placebo (n = 90) for 12 weeks. Full dosage was reached after 1 week |
| Outcomes |
End‐points included induction of clinical remission (according to number of bowel movements and amount of blood in stool) and induction of endoscopic remission or endoscopic improvement (evaluated on a 5‐pt. scale, where 0 or 1 indicated remission) |
| Notes |
Abstract |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Not described |
| Selective reporting (reporting bias) |
Unclear risk |
Expected outcomes were reported, Post hoc re‐scoring of endoscopic reports were reported for endoscopic remission |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
