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Evidence summaries

Interventions for Prevention of Post-Operative Recurrence of Crohn's Disease

Mesalamine, azathioprine/6-MP, and nitro-imidazoleantibiotics appear to be superior to placebo for the prevention of post-operative recurrence of Crohn's disease. Level of evidence: "B"

A Cochrane review [Abstract] 1 included 23 studies with a total of 2 461 subjects. The use of nitroimidazole antibioticsappeared to reduce the risk of clinical (RR 0.23; 95% CI 0.09 to 0.57, NNT=4; 2 studies, n= 140) and endoscopic (RR 0.44; 95% CI 0.26 to 0.74, NNT = 4; 2 studies, n=140) recurrence relative to placebo. However, these agents were associated with higher risk of serious adverse events (RR 2.39, 95% CI 1.5 to 3.7; 2 studies, n=140). Mesalamine therapy was associated with a significantly reduced risk of clinical recurrence (RR 0.76; 95% CI 0.62 to 0.94, NNT = 12; 4 studies, n=652), and severe endoscopic recurrence (RR 0.50; 95% CI 0.29 to 0.84, NNT = 8; 3 studies, n=297) when compared to placebo. Azathioprine/6MP was also associated with a significantly reduced risk of clinical recurrence (RR 0.59; 95% CI 0.38 to 0.92, NNT = 7; 2 studies, n=168), and severe endoscopic recurrence (RR 0.64; 95% CI 0.44 to 0.92, NNT = 4; 2 studies, n=168), when compared to placebo. Neither agent had a higher risk than placebo of serious adverse events. When compared to azathioprine/6MP, mesalamine was associated with a higher risk of any endoscopic recurrence (RR 1.45, 95% CI 1.03 to 2.06; 2 studies, n=130), but a lower risk of serious adverse events (RR 0.51; 95% CI 0.30 to 0.89; 4 studies, n=347). There was no significant difference between mesalamine and azathioprine/6MP for any other outcome. The relative risk of severe endoscopic recurrence at 12 months was not significantly different with budesonide relative to placebo (RR 0.87, 95% CI 0.5 to 1.49; 2 studies, n=212). Probiotics were not superior to placebo for any outcome measured. Among individuals at high risk of recurrence (1 study, n=24), the use of anti-TNF therapy in the form of infliximab (5 mg/kg) given as induction and maintenance therapy for 54 weeks was associated with a endoscopic recurrence rate of 9%, compared with 85% in patients on placebo. The clinical remission rates were 80% with infliximab and 54% with placebo.

Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment).

    References

    • Doherty G, Bennett G, Patil S, Cheifetz A, Moss AC. Interventions for prevention of post-operative recurrence of Crohn's disease. Cochrane Database Syst Rev 2009;(4):CD006873. [PubMed]

Primary/Secondary Keywords