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 |
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Notes | This study was supported by a grant from Pharmacia & Upjohn AB, Uppsala, Sweden Conflicts of interest were not reported |
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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 |