BACKGROUND:

Debate exists regarding to whether thiopurine therapy is as effective in ulcerative colitis (UC) as it is in Crohn's disease.

AIM:

To review systematically the efficacy of azathioprine (AZA) and mercaptopurine (MP) in UC, and to conduct a meta-analysis of randomized clinical trials evaluating the efficacy of AZA/MP for the induction or maintenance of UC clinical remission.

METHODS:

Selection of studies: Evaluating AZA/MP for induction and/or maintenance of clinical remission of UC. Randomized-controlled-trials comparing AZA/MP with placebo/5-aminosalicylates were included in the meta-analysis. Search strategy: Electronic and manual. Study quality: Independently assessed by two reviewers. Data synthesis: By 'intention-to-treat'.

RESULTS:

Thirty noncontrolled studies (1632 patients) were included in the systematic review. Mean efficacy of AZA/MP was 65% for induction and 76% for maintenance of the remission. Seven controlled studies were included in the meta-analysis. (i) Induction of remission: four studies (89 AZA/MP-treated patients) showed mean efficacy of 73% vs. 64% in controls (OR = 1.59; 95% CI = 0.59-4.29). (ii) Maintenance of remission: six studies (124 AZA/MP-treated patients) showed mean efficacy of 60% vs. 37% in controls (OR = 2.56; 95% CI = 1.51-4.34). When only studies comparing AZA/MP vs. placebo were considered, OR was 2.59 (95% CI = 1.26-5.3), absolute risk reduction was 23% and number-needed-to-treat (NNT) to prevent one recurrence was 5.

CONCLUSION:

Thiopurine drugs (AZA/MP) are more effective than placebo for the prevention of relapse in UC, with an NNT of 5 and an absolute risk reduction of 23%.