Randomized controlled trials of antibiotic prophylaxis in severe acute pancreatitis: relationship between methodological quality and outcome.

Aim: To evaluate the methodological quality of randomized controlled trials (RCTs) of systemic antibiotic prophylaxis in severe acute pancreatitis in relation to outcome. Methods: The MEDLINE, EMBASE and Cochrane databases were searched for RCTs that studied the effectiveness of systemic antibiotic prophylaxis in severe acute pancreatitis. A meta-analysis was performed with a random effects model. Methodological quality was quantified by a previously published scoring system (range 0-17 points). Results: Six studies, with a total of 397 participants, obtained a methodological score of at least 5 points and were included. Systemic antibiotic prophylaxis had no significant effect on infection of pancreatic necrosis (absolute risk reduction (ARR) 0.055; 95% CI -0.084 to 0.194) and mortality (ARR 0.058, 95% CI -0.017 to 0.134). Spearman correlation showed an inverse association between methodological quality and ARR for mortality (correlation coefficient -0.841, p = 0.036). Conclusions: The inverse relationship between methodological quality and impact of antibiotic prophylaxis on mortality emphasizes the importance of high-quality RCTs. At present, adequate evidence for the routine use of antibiotic prophylaxis in severe acute pancreatitis is lacking. Copyright (c) 2007 S. Karger AG, Basel and IAP.