| Methods |
Randomized, double‐blind, double‐dummy trial comparing olsalazine and SASP. Randomization was in blocks of 10, and the drugs were dispensed by the hospital pharmacy. At entry, 3, and 6 months, a history, clinical exam, sigmoidoscopy, and rectal biopsy were performed |
| Participants |
Out‐patients, aged 18 to 75 years, with ulcerative colitis in remission (without a relapse for previous 6 months) taking an average dose of 2 g/day SASP, were recruited over an 18 month period (N = 164) |
| Interventions |
SASP, 2 g/day, plus olsalazine‐matched placebo (n = 82) or olsalazine, 1 g/day, plus SASP‐matched placebo (n = 82) for 6 months |
| Outcomes |
Relapse was defined as increased stool frequency with or without blood or mucus and with evidence of inflammation on sigmoidoscopy. Withdrawals and the occurrence of side‐effects were also reported |
| 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 |
Adequate |
| 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 generally balanced across intervention groups with similar reasons for withdrawal with the exception of a greater number of patients withdrawing from the olsalazine group (n = 10) due to diarrhea (n = 3 in SASP group) |
| 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 |
