| Methods |
Multicenter, double‐blind, placebo‐controlled, randomized, dose‐response trial conducted at 20 sites. In addition to daily patient diaries, clinical assessments and sigmoidoscopy were performed at weeks 1, 4, 8 or upon withdrawal |
| Participants |
Patients, over 18 years old, with mild to moderate active ulcerative colitis confirmed by clinical and colonoscopic evidence with a score of 5 or greater on a 15‐point index, were selected from March 6, 1987 to August 4, 1988. Patients were stratified according to extent of disease. Therapies of steroids, SASP, or other mesalamine formulations were stopped at least 7 days before trial. Immunosuppressives were stopped at least 90‐days before study (N = 374) |
| Interventions |
Mesalamine (Pentasa) 1 (n = 92), 2 (n = 97) or 4 g per day (n = 95), or placebo (n = 90), in 250 mg capsules in identical blister cards for 8 weeks. Loperamide (2 mg) was dispensed to patients when absolutely necessary for control of diarrhea |
| Outcomes |
Clinical improvement was assessed using the physician's global assessment, assessment of treatment failure, sigmoidoscopic index, biopsy score, patients' perceptions, and trips to the toilet. Induction of remission was assessed by more stringent criteria for physician's assessment, sigmoidoscopic index and biopsy score |
| 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 |
Sequentially numbered drug containers of identical appearance |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind: study drug was supplied in 250 mg capsules in identical blister cards to ensure blinding of both the investigator and the patient |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Four patients were lost to follow‐up. More patients withdrew from the placebo group due to insufficient therapeutic effect |
| 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 |
