Willoughby 1988.
Study characteristics | ||
Methods | Randomized, double‐dummy, multicenter comparison of SASP and Olsalazine | |
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 | As well as diary cards, participants 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 Clinical response was evaluated as 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 (Dick 1964). Withdrawals and adverse effects were also tabulated | |
Notes | Prarmacia UK Ltd. supplied the active and placebo drugs used in this study Funding support and conflicts of interest were not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization was not described Randomization was restricted in blocks of four to ensure approximately equal numbers of patients allocated to each form of treatment |
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 | Dropouts 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 |