| Methods |
Randomized, double‐blind, double‐dummy, parallel group, multi‐centre, phase III non‐inferiority study assessing the efficacy and safety of mesalazine (Salofalk granules) 3.0 g once daily dosing versus 1 g three times daily dosing for the treatment of active ulcerative colitis. Adherence with study medication was checked by counting the medication returned at study visits |
| Participants |
Adult patients (aged 18 to 75 years) with active ulcerative colitis (CAI ≥ 6 and EI ≥ 4; Rachmilewitz criteria) were recruited from 54 centers in 13 countries for an eight week induction trial (N = 380) |
| Interventions |
Mesalazine 3.0 g once daily (n = 191) or 1 g three times daily (n = 189) |
| Outcomes |
The primary outcome was the percentage of patients achieving clinical remission at the end of the study (defined by CAI < 4). Secondary outcomes included clinical improvement (decrease in CAI by at least 1 point baseline), disease activity index (DAI) , endoscopic index, histological index (HI, based on Riley), time to first resolution of clinical symptoms, physician’s global assessment (PGA) and patient preference |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy |
| 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 |
