Wright 1993.
Methods | Randomized, double‐blind, placebo‐controlled trial. Patients were assessed at entry, after 3 weeks, and after 3, 6, 9 and 12 months. Sigmoidoscopy was performed at each visit. Biopsy was taken at entry, 6 months and 1 year | |
Participants | Patients, ages 18 to 75 years, with inactive ulcerative colitis who were asymptomatic for not less than one week and not more than one month prior to entry (N = 101). Steroid or SASP therapy was stopped at least one week prior to entry | |
Interventions | Olsalazine 2 g/day (500 mg capsules 4 times per day; n = 49) or matching placebo (n = 52) for 1 year | |
Outcomes | Clinical relapse was defined as a relapse of diarrhea (with or without blood and mucous) thought by the attending physician to warrant introduction of rectal or oral corticosteroids | |
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: matching placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 patients from the placebo group did not complete the study (1 lost top follow up, 1 lost to compliance, 1 initial protocol exclusion) |
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 |
UC‐DAI = Ulcerative Colitis Disease Activity Index