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. 2020 Aug 12;2020(8):CD000543. doi: 10.1002/14651858.CD000543.pub5

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
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