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. 2016 May 9;2016(5):CD000544. doi: 10.1002/14651858.CD000544.pub4

Nilsson 1995.

Methods Multicenter, randomized, double‐blind, double‐dummy comparison of SASP and olsalazine. Clinical assessments were performed after every 3 months or more frequently if relapse was suspected. Rigid sigmoidoscopy was performed at entry and after 6 and 18 months
Participants Patients with ulcerative colitis in remission, with at least 2 episodes of active disease during the last 5 years. No other concomitant medications were permitted (N = 322)
Interventions Olsalazine, 1 g/day, with SASP‐matched placebo (n =161) or active SASP, 2 g/day, with olsalazine‐matched placebo (n = 161) for either 6, 9, 12, 15 or 18 months. Patients were instructed to take medication with meals. Full treatment regimen was reached after 7 days. Compliance was verified by pill counts
Outcomes Relapse was defined as macroscopic changes in the rectum of grade 3 or 4 on a 4‐point scale. Other measures of efficacy were changes in number of stools per day, blood in stools, and consistency of stools. The failure rates were reported on an intention‐to‐treat basis
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 A ‐ Adequate
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind, double‐dummy (matched placebos)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Drop‐outs 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