Relapse rate following azathioprine withdrawal in maintaining remission for Crohn's disease: a meta-analysis.
ABSTRACT The duration of use of azathioprine (Aza) and 6-mercaptopurine (6-MP) for maintaining remission for Crohn's disease is debatable.
To examine whether Aza/6-MP can be safely withdrawn in patients with Crohn's disease who have been in remission.
The following databases were searched: MEDLINE (1950-September 2010), EMBASE (1980-September 2010), CINHAL (1981-September 2010), PubMed (1950-September 2010), and the Cochrane Central Register of Controlled Trials (CENTRAL). Randomised controlled and cohort studies comparing azathioprine continuation versus placebo or no treatment were eligible for inclusion. Primary outcomes were relapse rate after discontinuation of Aza/6-MP at 6, 12, and 18 months, and 5 and 10 years.
Five studies, with 256 patients and 168 controls, met the inclusion criteria. Stopping azathioprine/6-MP was found to significantly increase the risk of relapse at 6, 12, and 18 months with pooled odds ratios of 0.22 (95% CI 0.09-0.53), 0.25 (95% CI 0.11-0.56), and 0.35 (95% CI 0.21-0.6), respectively. Two trials examined relapse rate at 5 years with pooled OR 0.53 (95% CI 0.13-2.21). No trials looking at relapse rates beyond 5 years were identified.
There is a clear benefit of continuing Aza/6-MP for at least 18 months to maintain remission for Crohn's disease patients who established remission. There is not enough evidence to provide clear guidance on whether or not to continue Aza/6-MP treatment beyond 18 months. Well-designed randomised controlled trials addressing this issue are needed.
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ABSTRACT: The thiopurines azathioprine and 6-mercaptopurine are effective both for active disease and for maintaining remission in both Crohn's disease and ulcerative colitis. This review describes criteria for starting thiopurines (two or more courses of steroids in a calendar year, relapse as prednisolone is reduced below 15 mg/day, within 6 weeks of stopping steroids) and the benefits of continuing treatment for up to 5 years. Challenging issues, such as thiopurine intolerance, relative merits of azathioprine, 6-mercaptopurine, monitoring therapy and thiopurines in pregnancy are addressed.European Journal of Gastroenterology & Hepatology 04/2003; 15(3):219-23. · 1.92 Impact Factor
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ABSTRACT: It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.Controlled Clinical Trials 03/1996; 17(1):1-12.
- BMJ (Clinical research ed.). 10/2003; 327(7414):557-60.