A meta-analysis of randomized controlled trials comparing antibacterial therapy with placebo in Crohn's disease.

BACKGROUND

Antibacterial therapy has been investigated in several randomized, clinical trials compared with placebo for the management of Crohn's disease. Evidences for the efficacy of intervention are increasingly required.

OBJECTIVES

To conduct a meta-analysis of randomized trials to compare the effects of antibacterial therapy versus placebo in patients with Crohn's disease.

SEARCH STRATEGY: A systematic literature search of Pubmed, EMBASE, Cochrane Library (April 1966 to July 2009) was conducted using specific search terms.

SELECTION CRITERIA: Eligible studies were randomized controlled trials comparing antibacterial (antimycobacterial and broad-spectrum antibiotic) therapy with placebo.

DATA COLLECTION AND ANALYSIS: Studies were reviewed to determine the number of participants, mean follow-up, and the odds ratios (OR) for primary end point of clinical remission and clinical response were also abstracted. The meta-analysis was performed using a fixed-effects model or a randomized-effects model according to the degree of heterogeneity.

RESULTS

Eleven randomized placebo-controlled clinical trials with 668 participants (364 patients in the treatment group and, 304 patients in the placebo group) were identified. Antimycobacterial agents were used in four of the trials and broad-spectrum antibiotics were used in the other seven trials. Pooled analysis showed no significant differences in the rates of clinical remission [OR = 1.28, 95% confidence interval (CI): 0.87-1.90, P = 0.214] and clinical response (OR = 1.52, 95% CI: 0.91-2.55, P = 0.108) after receiving antibacterial treatment for 3 months or longer.

CONCLUSION

In this meta-analysis, no evidence of benefit for antibiotics in patients with Crohn's disease was found.