COMPARISON OF THE EFFICACY AND SAFETY OF SULFASALAZINE AND MESALAZINES IN THE MAINTENANCE TREATMENT OF ULCERATIVE-COLITIS - A METAANALYSIS

Objective: To compare the overall efficacy and safety of sulphasalazin e and mesalazines in the maintenance treatment of ulcerative colitis b y means of a meta-analysis. Data identification: Trials were identifie d by a Medline search and manual review of the proceedings of the main international meetings. Study selection: Trials were selected if they comprised randomized, controlled studies comparing the efficacy of su lphasalazine and mesalazines in the maintenance treatment of ulcerativ e colitis. Data extraction: The main end points were: (1) the number o f patients relapsing during follow-up (efficacy) and (2) the number of patients who withdrew because of side effects (safety). Results of da ta analysis: The pooled risk difference for relapse (Der Simonian and Laird method) was -2% in favour of sulphasalazine (95% confidence inte rval -8 to +5%). All patients in whom drug safety was assessed had bee n previously treated with sulphasalazine. In these patients, the safet y of sulphasalazine and mesalazines did not differ significantly. Conc lusions: There is no difference in efficacy between equipotent doses O f sulphasalazine and mesalazines in preventing relapse in patients wit h ulcerative colitis. Thus, further trials addressing this issue are u nwarranted. The question whether mesalazines are safer than sulphasala zine in previously untreated patients remains unresolved.