| Methods |
Multi‐centre, randomized, double‐blind, double‐dummy, placebo‐controlled trial. Patients were evaluated at baseline and week 8 or at early withdrawal |
| Participants |
Patients (aged > 16 to < 65 years) with mild to moderately active ulcerative colitis. Disease activity was assessed using the ulcerative colitis disease activity index (UC‐DAI; Sutherland 1987). Patients with mild to moderate active ulcerative colitis who had a score of 3 to 8 on the UC‐DAI with a bloody stool score of > 1 were eligible for the study (N = 229) |
| Interventions |
The objective of the study was to demonstrate the superiority of Asacol 3.6 g/day and non‐inferiority of Asacol 2.4 g/day against Pentasa 2.25 g/day. Patients were randomized to Asacol 3.6 g/day (n = 65), Asacol 2.4 g/day (n = 66), Pentasa 2.25 g/day (n = 65) or placebo (n = 33) for eight weeks |
| Outcomes |
The primary outcome was reduction in UC‐DAI score from baseline. Secondary outcomes included reduction in each UC‐DAI item score, the proportion of patients achieving remission (a UC‐DAI score of < 2 and zero points for bloody stool score); the proportion of patients achieving efficacy (remission or patient who did not achieve remission but whose reduction of UC‐DAI score is > 2) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Biased‐coin minimization algorithm. |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization: A person independent from the study was in charge of the random allocation. The randomization code was sealed and stored until the blind was removed |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy: the appearance of the medication was identical |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
