| Methods |
Randomized, double‐blind, placebo‐controlled trial. Patients were evaluated (clinically, sigmoidoscopically, and histologically) upon entry and completion, plus by regular telephone contact |
| Participants |
Patients, of any age, with ulcerative colitis who, after 6 months of ADS (Dipentum) therapy, were in remission (N = 102) |
| Interventions |
Azodisal sodium (ADS, Dipentum), 1 g/day (n = 52), or identical‐appearing placebo (16 mg riboflavin; n = 49) for 6 months. Compliance was tested by urine and serum analyses and pill count |
| Outcomes |
Relapse was defined as the occurrence of diarrhea with macroscopic blood, together with the finding of active inflammation on sigmoidoscopy |
| Notes |
One placebo patient was excluded from the ITT analysis for entry criteria violation |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Low risk |
Adequate |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind: identical placebo |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No drop‐outs were reported |
| 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 |
