| Methods |
Multicenter, randomized, double‐blind trial |
| Participants |
Patients with ulcerative colitis in clinical (minimal or no symptoms) and sigmoidoscopic (non‐friable mucosa) remission (N = 133) |
| Interventions |
Balsalazide 2 g/day (n = 65) or 4 g /day (n = 68) |
| Outcomes |
Relapse at 12 months and adverse events. Symptomatic relapse was defined as recurrence of previous symptoms with increased stool frequency and associated blood |
| 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: The placebo and trial drug were in identical hard gelatin capsules |
| 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 were reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
