| Methods |
Randomized, double‐blind, double‐dummy comparison of olsalazine and SASP. Allocation of drugs was performed using a table of random numbers. Clinical and laboratory examinations were performed at entry and after 1, 2, 4, 6 and 8 weeks of treatment. Colonoscopy and biopsy were performed 3 days before treatment and within 3 days of completion |
| Participants |
Male and female patients (average age 32.6 years) with acute relapse of ulcerative colitis (N = 42) |
| Interventions |
Olsalazine 2 g/day (n = 21) or SASP 4 g/day (n = 21) for 8 weeks. Lopermide (1 to 2 pills/day) was given to patients unable to tolerate diarrhea but not for more than 10 days |
| Outcomes |
Outcomes included induction of complete remission (subsidence of clinical symptoms with a relatively normal mucous membrane on colonoscopy), induction of clinical remission (0 to 2 stools per day with no gross blood or red cells in stool), colonoscopic remission (evaluated on a 2 or 5 point scale) and histological remission (evaluated on a 5 point scale) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Table of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The number of patients who completed the trial was not reported |
| 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 |
