Background: To summarize and quantify the evidence supporting rectal 5
- or 4-aminosalicylate (ASA) therapies for disease exacerbation or rem
ission maintenance in distal ulcerative colitis, we performed a meta-a
nalysis. Methods: All randomized, double-blind controled trials involv
ing aminosalicylate therapy were retrieved from a MEDLINE search, revi
ew articles on ulcerative colitis therapy or their bibliographies. Of
55 studies retrieved, 19 met the inclusion criteria, Appraisal and dat
a extraction were performed by two observers and scoring disagreements
were resolved by consensus. Results: Eleven trials tested 5-ASA and t
hree tested 4-ASA in active ulcerative colitis. 5-ASA was superior to
placebo for inducing remission or symptomatic improvement in active ul
cerative colitis with a pooled odds ratio of 7.36 (95% Confidence inte
rval (CI): 4.72-11.47). In four trials the pooled odds ratio for endos
copic improvement was 10.04 (95% CI: 5.72-17.61) and for histological
improvement 10.31 (95% CI: 5.85-18.18). Studies evaluating 4-ASA sugge
st a benefit similar to prednisolone in treating active disease. Five
trials assessed remission maintenance with 5-ASA, and when compared to
placebo gave a pooled odds ratio of 16.22 (95% CI: 4.71-55.92). No do
se-response relationship was observed. ASA compounds were not therapeu
tically superior to other treatments. Conclusions: We conclude that re
ctal 5-ASA is effective therapy for active distal ulcerative colitis.
More trials are needed to assess 4-ASA, dose-response effects and the
ideal regimen for remission maintenance.