Probiotic prophylaxis in predicted severe acute pancreatitis:
This review may be edited
Posted By: jonathan field
Posted Date: 13/3/8
Title: Probiotic prophylaxis in predicted severe acute pancreatitis:
Authors: Marc G H Besselink, Hjalmar C van Santvoort, Erik Buskens, Marja A Boermeester, Harry van Goor, Harro M Timmerman, Vincent B Nieuwenhuijs,
Reference: Lancet 2008; 371: 651每59.
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Background Infectious complications and associated mortality are a major concern in acute pancreatitis. Enteral administration of probiotics could prevent infectious complications, but convincing evidence is scarce. Our aim was to assess the eff ects of probiotic prophylaxis in patients with predicted severe acute pancreatitis.
Methods In this multicentre randomised, double-blind, placebo-controlled trial, 298 patients with predicted severe acute pancreatitis (Acute Physiology and Chronic Health Evaluation [APACHE II] score ≡8, Imrie score ≡3, or C-reactive protein >150 mg/L) were randomly assigned within 72 h of onset of symptoms to receive a multispecies probiotic preparation (n=153) or placebo (n=145), administered enterally twice daily for 28 days. The primary endpoint was the composite of infectious complications〞ie, infected pancreatic necrosis, bacteraemia, pneumonia, urosepsis, or infected ascites〞during admission and 90-day follow-up. Analyses were by intention to treat. This study is registered, number ISRCTN38327949.
Findings One person in each group was excluded from analyses because of incorrect diagnoses of pancreatitis; thus, 152 individuals in the probiotics group and 144 in the placebo group were analysed. Groups were much the same at baseline in terms of patients* characteristics and disease severity. Infectious complications occurred in 46 (30%) patients in the probiotics group and 41 (28%) of those in the placebo group (relative risk 1﹞06, 95% CI 0﹞75每1﹞51). 24 (16%) patients in the probiotics group died, compared with nine (6%) in the placebo group (relative risk 2﹞53, 95% CI 1﹞22每5﹞25). Nine patients in the probiotics group developed bowel ischaemia (eight with fatal outcome), compared with none in the placebo group (p=0﹞004).
Interpretation In patients with predicted severe acute pancreatitis, probiotic prophylaxis with this combination of probiotic strains did not reduce the risk of infectious complications and was associated with an increased risk of mortality. Probiotic prophylaxis should therefore not be administered in this category of patients.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
yes. Randomisation was done with a computer-generated permuted-block sequence and balanced by participating centre and by presumed cause (biliary vs non-biliary) in blocks of four.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
yes. all but one in each group were analysed
2b. Were patients analyzed in the groups to which they were randomized?
yes it was an intention to treat analysis
3. Were patients, health workers, and study personnel blind to treatment?
4. Were the groups similar at the start of the trial?
for baseline charactersitics yes..the editorial raises the possibilty of more prevalent organ system failure in the probiotic group on the day of randomisation... this particular characteristic was not compared in table one
5. Aside from the experimental intervention, were the groups treated equally?
we assume so
What are the Results?
1. How large was the treatment effect?
There was no significant difference in the occurrence of the composite primary endpoint between the two groups, nor were there any significant differences between the groups in its individual components (table 2).Table 3 shows the pathogens cultured from the 87 patients with an infectious complication; no significant differences between the groups were observed. There were significantly more deaths in the probiotics group than there were in the placebo group.
2. How precise was the estimate of the treatment effect?
The relative risk for the primary endpoint was 1﹞06 (95% CI 0﹞75每1﹞51). the relative risk for mortality was 2﹞53 (95% CI 1﹞22每5﹞25).(p=0﹞01)
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
yes. Dont use probiotics!
2. Were all clinically important outcomes considered?
3. Are the likely treatment benefits worth the potential harms and costs?
as above

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