| Methods |
Single‐center, randomized, double‐blind comparison of Claversal and SASP. Clinical, endoscopic and histological examinations were performed at entry, after 6 months, and after 12 months |
| Participants |
Patients, aged 18 to 61 years, with clinical and endoscopically quiescent ulcerative colitis, who had an episode of active disease requiring systemic corticosteroids at least once in the previous 12 months (N = 88) |
| Interventions |
5‐ASA (Claversal), 1 g daily (n = 44), or SASP, 2 g daily (n = 44), for 1 year. Topical corticosteroids were permitted for short‐term treatment of mild distal relapses |
| Outcomes |
Relapse of disease was defined as the appearance of bloody diarrhea with endoscopic signs of inflammation requiring systemic steroids (major relapse). "Minor relapses" were defined as those requiring a few days of topical corticosteroids. The number of withdrawals due to adverse effects was also reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind |
| 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 |
Expected outcomes reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
