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 sulphasalazine and mesalazines in the maintenance treatment of ulcerative colitis by means of a meta-analysis. Data identification: Trials were identified 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 sulphasalazine and mesalazines in the maintenance treatment of ulcerative colitis. Data extraction: The main end points were: (1) the number of patients relapsing during follow-up (efficacy) and (2) the number of patients who withdrew because of side effects (safety). Results of data analysis: The pooled risk difference for relapse (Der Simonian and Laird method) was -2% in favour of sulphasalazine (95% confidence interval -8 to +5%). All patients in whom drug safety was assessed had been previously treated with sulphasalazine. In these patients, the safety of sulphasalazine and mesalazines did not differ significantly. Conclusions: There is no difference in efficacy between equipotent doses Of sulphasalazine and mesalazines in preventing relapse in patients with ulcerative colitis. Thus, further trials addressing this issue are unwarranted. The question whether mesalazines are safer than sulphasalazine in previously untreated patients remains unresolved.