| Methods |
Multicenter, randomized, double‐blind trial |
| Participants |
Adult patients (aged 18 to 70 years) with mild to moderate (CAI 6 to 12; EI > 4) attack of UC with at least 1 previous episode or persistently bloody diarrhea at least 14 days preceding entry (N = 316) |
| Interventions |
Mesalamine (Salofalk pellets) 1.5 g/day (0.5 g three times daily; n = 103); 3.0 g/day (1.0 g three times daily; n = 107) or 4.5 g/day (1.5 g three times daily; n = 106) for 8 weeks |
| Outcomes |
Primary outcome: clinical remission (CAI < 4). Secondary outcomes: endoscopic remission (EI < 4); endoscopic improvement (reduction of EI by at least 1 point); clinical improvement (CAI decreased by at least 3 points), life quality index; physician's global assessment; and adverse events |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
The pellets were dispensed by sachets containing mesalamine pellets or a mixture of mesalamine and placebo pellets. The pellets with active drug and placebo pellets were identical in outward appearance. To ensure blindness, the sachets of the 3 different dose groups contained the same number and volume of pellets. In the sachets with the highest dose all pellets consisted of the active drug |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Drop out rate in 1.5 g/day group was 32.0% (33/103) compared to 19.6% (21/107) in the 3.0 g/day group and 19.8% (21/106) in the 4.5 g/day group. The most frequent reason for premature termination was inefficiency of treatment (23%, 17%, and 13%, respectively). No other reasons for withdrawal were provided |
| 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 |
