| Methods |
Multicenter, randomized trial |
| Participants |
Adult patients (19 to 69 years) with mild to moderate active ulcerative colitis confirmed by endoscopic evaluation (N = 90) |
| Interventions |
Balsalazide 4.5 g/day (n = 30) or Balsalazide 2.25 g/day + VSL#3 (n = 30) or Asacol 2.4 g/day (n = 30) for 8 weeks |
| Outcomes |
The primary outcome was the proportion of patients in symptomatic remission based on clinical evaluation and diary card at 2, 4 and 8 weeks. Symptomatic remission was defined as patient functional assessment ratings of normal bowel movements and absence of rectal bleeding. Secondary outcomes included time to symptomatic remission, the proportion of patients achieving improvement in endoscopic evaluation score at 8 weeks, change in CAI from baseline at 8 weeks, improvement in histology at 8 weeks, and adverse events |
| Notes |
For the purposes of this review only the comparison between Balsalazide 4.5 g/day and Asacol 2.4 g/day was utilized (N = 60) |
| 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 |
Open‐label. Physicians and patients were not blinded. Histological specimens were examined and graded for inflammation by one histopathologist blind to the treatment |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
4 patients withdrew from the Balsalazide group (13%) compared to 8 in the Asacol group (26%). Reasons for withdrawal are similar expect that 2 patients from the Asacol group withdrew for adverse events |
| 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 |
