| Methods |
Multicenter, single‐blind, randomized, non‐inferiority study comparing once daily mesalazine to conventionally dosed mesalazine (TID) for maintenance of remission in UC |
| Participants |
Adult UC patients taking mesalazine or sulphasalazine in remission for > 4 weeks and < 2 years (N = 213) |
| Interventions |
Asacol 2.4 g/day given once daily (3 x 800 mg tablets; n = 103) versus Asacol 2.4 g/day given three times daily (1 X 800 mg tablet 3 times per day, n = 110) for one year |
| Outcomes |
The primary end‐point was the difference between groups in relapse rates over one year. Relapse was defined as typical symptoms of relapse with a Baron sigmoidoscopy score of 2 or 3. Secondary outcomes: adherence |
| Notes |
Investigator‐blinded. Adherence was self‐reported by patients. Adherence also was calculated in subgroup of patients (n = 58) using "Medication Event Monitoring System (MEMS®)" based in a bottle cap which records each time the bottle is opened |
| 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 |
High risk |
Investigator‐blinded, outcomes assessed by blinded investigator |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Not described |
| 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 |
