| Methods |
Randomized, multicenter, double‐blind, parallel group study. Clinical and laboratory examinations were performed at recruitment, and weeks 2, 4 and 8 |
| Participants |
Adults with newly diagnosed or recently relapsed ulcerative colitis confirmed by sigmoidoscopy in conjunction with a negative stool culture (N = 50) |
| Interventions |
Sulfasalazine, 3 g daily (n = 24), or balsalazide, 6.75 g daily (n = 26) according to a double‐dummy protocol for 8 weeks |
| Outcomes |
Remission was defined as a stool frequency of two or less per day without blood and with a sigmoidoscopic appearance of normal rectal mucosa or minimal erythema |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy, identical gelatine capsules |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No patients were lost to follow‐up. More patients were withdrawn from the SASP due to adverse events than the balsalazide group. Othe drop‐outs were balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes were reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
