A systematic review including 3 studies with a total of 615 subjects was abstracted in DARE. Adult patients were treated with Pentasa 4 g/day for active Crohn's disease. The study duration was 16 weeks. For the intent-to-treat patients in the Pentasa groups, the overall mean reduction of the Crohn's Disease Activity Index (CDAI) from baseline to the final visit was -63 points in the Pentasa group. The corresponding CDAI change in the placebo groups was -45 points; the net difference was -18 points (95% CI –35 to -1, P=0.04). This result was confirmed when the analysis was repeated for the protocol-correct patients (WMD -25, 95% CI –46 to -3, P=0.02). The clinical significance of the magnitude of the observed difference is not clear.
Comment: The quality of evidence is downgraded by limitations in review quality (limited search and lack of reporting of review methods) and by imprecise results (wide confidence intervals).