Abstract
IntroductionNecrotic tissue infection can worsen the prognosis of severe acute pancreatitis (SAP), and probiotics have been shown to be beneficial in reducing the infection rate in animal experiments and primary clinical trials. However, the results of multicenter randomized clinical trials have been contradictory. Our aim in this study was to systematically review and quantitatively analyze all randomized controlled trials with regard to important outcomes in patients with predicted SAP who received probiotics.MethodsA systematic literature search of the PubMed, Embase and Cochrane Library databases was conducted using specific search terms. Eligible studies were randomized controlled trials that compared the effects of probiotic with placebo treatment in patients with predicted SAP. Mean difference (MD), risk ratio (RR) and 95% confidence interval (95% CI) were calculated using the Mantel-Haenszel fixed- and random-effects models. A meta-analysis on the use of probiotics in the treatment of critically ill patients was also performed to serve as a reference.ResultsIn this study, 6 trials comprising an aggregate total of 536 patients were analyzed. Significant heterogeneities were observed in the type, dose, treatment duration and clinical effects of probiotics in these trials. Systematic analysis showed that probiotics did not significantly affect the pancreatic infection rate (RR = 1.19, 95% CI = 0.74 to 1.93; P = 0.47), total infections (RR = 1.09, 95% CI = 0.80 to 1.48; P = 0.57), operation rate (RR = 1.42, 95% CI = 0.43 to 3.47; P = 0.71), length of hospital stay (MD = 2.45, 95% CI = −2.71 to 7.60; P = 0.35) or mortality (RR = 0.72, 95% CI = 0.42 to 1.45; P = 0.25).ConclusionsProbiotics showed neither beneficial nor adverse effects on the clinical outcomes of patients with predicted SAP. However, significant heterogeneity was noted between the trials reviewed with regard to the type, dose and treatment duration of probiotics, which may have contributed to the heterogeneity of the clinical outcomes. The current data are not sufficient to draw a conclusion regarding the effects of probiotics on patients with predicted SAP. Carefully designed clinical trials are needed to validate the effects of particular probiotics given at specific dosages and for specific treatment durations.
Highlights
Necrotic tissue infection can worsen the prognosis of severe acute pancreatitis (SAP), and probiotics have been shown to be beneficial in reducing the infection rate in animal experiments and primary clinical trials
Six were excluded: one was a retrospective study, three articles reported results of the same study, one article did not report the outcomes of mixed cohorts with severe and mild acute pancreatitis separately and, in one article, the experimental patients received probioticcontaining enteral nutrition (EN) and control patients received parenteral nutrition (PN) but not probiotic-free EN
Following the harmful effects of probiotics in SAP reported in the PROPATRIA trial [23], Sun et al reported a meta-analysis of four Randomized controlled trial (RCT) with significant heterogeneity [41]
Summary
Necrotic tissue infection can worsen the prognosis of severe acute pancreatitis (SAP), and probiotics have been shown to be beneficial in reducing the infection rate in animal experiments and primary clinical trials. The results of the PROPATRIA trial (probiotic prophylaxis in patients with predicted severe acute pancreatitis), published in 2008 (a multicenter randomized controlled trial (RCT) dominated by the Dutch Acute Pancreatitis Study Group), showed that probiotics had harmful effects [23], which deterred the initiation of other trials on probiotics. We consider that the results of the PROPATRIA trial are questionable and that further meta-analyses of the more recent RCTs is required To this end, we performed this meta-analysis on six select RCTs in order to determine the effects of probiotics on the rate of pancreatic and total infection, operation rate, length of hospital stay and mortality. We tried to determine the reason for the heterogeneous results across the different trials
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