| Methods |
Randomised, double‐blind, double‐dummy, parallel group study |
| Participants |
Adult patients (aged 18 to 70 years) with active ulcerative colitis (N = 56) |
| Interventions |
Olsalazine (250 mg capsules: 4 capsules twice daily; n = 31) or SASP (250 mg tabletss, 4 tablets 4 times daily; n = 25) for 8 weeks |
| Outcomes |
Clinical improvement and adverse events |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer stratified randomization |
| Allocation concealment (selection bias) |
Low risk |
Pharmaceuticals were packed and encoded according to random numbers. The encoding process was monitored by the staff from Shanghai Pharmaceutical Affairs Bureau |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
3 patients from SASP group were unable to complete the study |
| 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 |
