Study characteristics |
Methods |
Prospective, double‐blinded, multicenter trial comparing Olsalazine and Sulfasalazine. Participants were centrally randomized |
Participants |
People with active ulcerative colitis (N = 55) |
Interventions |
6 g/day SASP (n = 28) or 3 g/day Olsalazine (n = 27) in externally‐indistinguishable capsules, for 6 weeks |
Outcomes |
Remission was assessed on the basis of clinical and endoscopic criteria. Withdrawals and occurrence of adverse events were also measured |
Notes |
Abstract ‐ funding support and 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: externally‐indistinguishable capsules |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
6 participants from each group were withdrawn because of adverse events or increasing severity of disease |
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 |