| Methods |
Randomized, double‐dummy, multicenter comparison of SASP and olsalazine. Randomization was restricted in blocks of four to ensure approximately equal numbers of patients allocated to each form of treatment. In addition to diary cards, patients were clinically assessed upon entry, after 2 weeks, and after 5 weeks. Biopsy, sigmoidoscopy, and lab tests were performed at entry and after week 5 |
| Participants |
Out‐patients with mild to moderately active ulcerative colitis, either first attack or relapse (N = 56) |
| Interventions |
Oral sulphasalazine, 3 g/day (n = 30), or oral olsalazine, 3 g/day (n = 26), each in divided doses. Dose escalation schedule was used for first week of treatment after which full‐dose therapy continued for further 4 weeks. Tablets were counted to monitor compliance |
| Outcomes |
Clinical response was evaluated in terms of changes in stool frequency and loss of blood and mucus from stools. Sigmoidoscopic and histological assessments were considered to have improved if score on a standard scale increased by at least 1 point (Grayson, Carpenter, Dick, & Petrie 1964, as cited in Willougby 1988). Withdrawals and adverse effects were also tabulated |
| 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, double‐dummy |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs appear to be 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 |
