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The effects of probiotic supplementation on experimental acute pancreatitis: a systematic review and meta-analysis
Carlijn R Hooijmans1, Rob B M de Vries, Maroeska M Rovers
1Radboud University Nijmegen Medical Centre, SYRCLE at Central Animal Laboratory, Nijmegen, The Netherlands. C.Hooijmans@cdl.umcn.nl
Insights
Probiotics did not improve outcomes in severe acute pancreatitis patients, and surprisingly increased mortality in the PROPATRIA trial. Animal studies showed mixed results, with some evidence of efficacy but not predicting the human trial
Area of Science:
- Gastroenterology
- Microbiology
- Clinical Trials
Background:
- The PRObiotics in PAncreatitis TRIAl (PROPATRIA) investigated probiotics for severe acute pancreatitis.
- PROPATRIA found no primary endpoint benefits and a concerning increase in mortality with probiotics.
- This contrasted with expectations from preclinical animal studies.
Purpose of the Study:
- To systematically review and meta-analyze animal studies on probiotics and pancreatitis.
- To assess the relationship between animal study findings and the PROPATRIA trial results.
- To investigate potential harm and efficacy signals from preclinical research.
Main Methods:
- Systematic review and meta-analysis of thirteen studies on probiotics in experimental acute pancreatitis.
- Data extraction included mortality, bacterial translocation, and pancreatic histology.
- Analysis focused on studies published before and after the PROPATRIA trial protocol.
Main Results:
- Meta-analysis of four pre-PROPATRIA animal studies showed probiotics did not reduce mortality.
- Probiotic use reduced pancreatic histopathological scores and bacterial translocation in animal models.
- Comparable results were observed when including all relevant studies.
Conclusions:
- Preclinical animal studies, even with meta-analysis, could not have predicted the increased mortality seen in the PROPATRIA trial.
- Meta-analysis of animal studies did indicate potential efficacy for probiotics in pancreatitis.
- A discrepancy exists between animal models and human trials, possibly due to limitations in experimental design for direct comparison.
Background:
In February 2008, the results of the PRObiotics in PAncreatitis TRIAl (PROPATRIA) were published. This study investigated the use of probiotics in patients suffering from severe acute pancreatitis. No differences between the groups were found for any of the primary endpoints. However, mortality in the probiotics group was significantly higher than in the placebo group. This result was unexpected in light of the results of the animal studies referred to in the trial protocol. We used the methods of systematic review and meta-analysis to take a closer look at the relation between the animal studies on probiotics and pancreatitis and the PROPATRIA-trial, focussing on indications for harmful effects and efficacy.
Methods And Results:
Both PubMed and Embase were searched for original articles concerning the effects of probiotics in experimental acute pancreatitis, yielding thirteen studies that met the inclusion criteria. Data on mortality, bacterial translocation and histological damage to the pancreas were extracted, as well as study quality indicators. Meta-analysis of the four animal studies published before PROPATRIA showed that probiotic supplementation did not diminish mortality, reduced the overall histopathological score of the pancreas and reduced bacterial translocation to pancreas and mesenteric lymph nodes. Comparable results were found when all relevant studies published so far were taken into account.
Conclusions:
A more thorough analysis of all relevant animal studies carried out before (and after) the publication of the study protocol of the PROPATRIA trial could not have predicted the harmful effects of probiotics found in the PROPATRIA-trial. Moreover, meta-analysis of the preclinical animal studies did show evidence for efficacy. It may be suggested, however, that the most appropriate animal experiments in relation to the design of the human trial have not yet been conducted, which compromises a fair comparison between the results of the animal studies and the PROPATRIA trial.
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