Feurle 1989.
Study characteristics | ||
Methods | Double‐blinded, placebo‐controlled, and centrally‐randomized, with stratification in blocks of 10 for each of the 12 centres | |
Participants | Outpatients with mild‐to‐moderate ulcerative colitis recruited in West Germany between 1984 and 1986 (N = 105) | |
Interventions | Olsalazine 2 g/day (4 doses of 2 gelatin capsules each; n = 52) or 8 placebo capsules with identical appearance (n = 53). Participants were advised to start with fewer than 8 pills and reach complete dosage by the third or fourth day and continue for 4 weeks. Compliance was verified by laboratory tests | |
Outcomes | Clinical and laboratory examinations were performed at recruitment, after 2 weeks, and at the end of 4 weeks. Endoscopy and biopsy were performed on days 0 and 28. Clinical observations were made on days 0, 14, and 28 Endoscopic score was the mean of redness/hyperemia, contact bleeding, spontaneous bleeding and erosions, each graded on a 3‐point scale. Clinical status was based on number of stools, presence of blood in stool, stool consistency, and mucous in stool. The clinical score was considered improved when at least 3 of the 4 parameters increased. Occurrence of withdrawals and side effects was also tabulated |
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Notes | Funding support and conflicts of interest were not reported | |
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: identical placebo capsule |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts 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 |