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. 2016 Apr 21;2016(4):CD000543. doi: 10.1002/14651858.CD000543.pub4

Sutherland 1990.

Methods Double‐blind, placebo‐controlled, multicenter, parallel trial with random allocation of placebo or drug. Patients were initially screened with a baseline history, physical exam, and flexible sigmoidoscopy or colonoscopy in order to calculate the activity index (see 'Participants'). Follow‐up was assessed by telephone contact at end of week 1, 2, 4 and 5 and by clinical exam at the ends of weeks 3 and 6. Each clinic visit included flexible sigmoidoscopy and a physician's global assessment
Participants Male and non‐pregnant female patients, at least 18 years of age, with ulcerative colitis of variable extent, from five American and two Canadian centres and all enrolled between July 1985 and September 1986 (N = 136). Ulceration had to extend at least 20 cm proximal to the anus. Patients had to have a minimum score of 4 measured by Disease Activity Index (four subgroups for each of bowel frequency, presence of blood, sigmoidoscopic appearance, and physician's assessment of severity for a maximum score of 12)
Interventions Random allocation of Rowasa (250 mg tablets) taken as four tablets, four times per day, for a total of either 4 g/day (n = 47) or 2 g/day (n = 45), and an identical‐appearing placebo (n = 44) for 6 weeks. Compliance was measured by pill counts
Outcomes Efficacy was assessed by changes in the disease activity index and physician's global assessment. The change in physician's global assessment was described as 'much or somewhat improved', 'unchanged', or 'somewhat worse or much worse'. The change in the disease activity index score was evaluated in terms of end of study score minus 'baseline'
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 All assignments to treatment and subsequent assessments of response to treatment were under double‐blind conditions
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind: identical placebo
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 34% drop‐out rate, however drop‐outs appear to be balanced across intervention groups with similar reasons for withdrawal
Selective reporting (reporting bias) Low risk All expected outcomes were reported
Other bias Low risk The study appears to be free of other sources of bias