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. 2020 Aug 12;2020(8):CD000543. doi: 10.1002/14651858.CD000543.pub5

Kruis 1998.

Study characteristics
Methods Multicenter, randomized, double‐blind, double‐dummy, parallel‐group study
Participants Adults (18 to 75 years) with a mild‐to‐moderate (endoscopic score < 4) attack of ulcerative colitis (N = 168)
Interventions Olsalazine 3 g/day (n = 88) or mesalazine (claversal) 3 g/day (n = 80) for 12 weeks
Outcomes Primary outcome: Endoscopic remission (defined as a score of 0 or 1 on the Rachmilewitz index)
Secondary outcomes: Clinical remission (< 1 on modified Rachmilewitz index), physician's global assessment on 4‐point scale
Notes This study was supported by a grant from Pharmacia & Upjohn AB, Uppsala, Sweden
Conflicts of interest were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk Centralized randomization
Blinding (performance bias and detection bias)
All outcomes Low risk Double‐blind, double‐dummy
Incomplete outcome data (attrition bias)
All outcomes Low risk 25% dropout rate, but dropouts balanced across intervention groups with similar reasons for withdrawal
Selective reporting (reporting bias) Low risk Expected outcomes were reported
Other bias Low risk The study appears to be free of other sources of bias