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Objective: This meta-analysis of randomized controlled trials was conducted to evaluate the efficacy and tolerability of two drug groups (immunoregulators and antibiotics) in the treatment of fistula in Crohn's disease (CD). Methods: PubMed, Embase, Scopus, Google Scholar, and Web of Science were searched for clinical trial studies investigated the effects of immunoregulators and antibiotics in the treatment of fistulizing CD. Clinical response and adverse effects were the key outcomes of interest. Data were searched from the time period of 1966 through June 2010. Result: Eleven randomized placebo-controlled clinical trials that met our criteria (nine in different immunoregulators and two in antibiotics) were included in the analysis. Pooling of data showed that immunoregulators and antibiotics are significantly effective for at least a 50% reduction from baseline in the number of open actively draining fistulas with …