[e-drug] Probiotics and increased mortality

["Wilbert Bannenberg" <wjb@wxs.nl>]

E-DRUG: Probiotics and increased mortality
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[Probiotics are sometimes seen as innocent "alternative" medicines. They
are heavily promoted as "healthy" products. This view may have to be
changed, as the results from a surprising clinical trial in the
Netherlands show. Cross posted with thanks from DRUGINFO. WB]

Hi all,

Probiotics have been extensively marketed for a number of ailments,
including for use in diarrhoea, allergy prevention, eczema, and to
accompany antibiotic use. In many cases there is insufficient scientific
research or consensus for the claims being made. In many instances a
strain has no efficacy similar to another being investigated. Dosages
may be insufficient or gastic juices destroy the probiotic before it
reaches its target. A UCT GIT specialist pointed out that in many cases
the safety of many of these products have not been adequately tested and
led me to this interesting article, also published in the Lancet, which
concludes that in patients with predicted severe acute pancreatitis, use
of this combination of probiotic strains did not reduce the risk of
infections. Probiotic prophylaxis was associated with a more than
two-fold increase in mortality and should therefore not be administered
in this category of patients.
 

Ned Tijdschr Geneeskd. 2008 Mar 22;152(12):685-96.
Republished from:
Lancet. 2008 Feb 23;371(9613):651-9. 
Probiotic prophylaxis in patients with predicted severe acute
pancreatitis: a randomised, double-blind, placebo-controlled trial.
[Dutch]

Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H,
Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ,
Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van
Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM,
Gooszen HG; Acute Pancreatitis Werkgroep Nederland.
Collaborators (43)

Afd. Heelkunde, Universitair Medisch Centrum Utrecht, Utrecht.
m.besselink@umcutrecht.nl

OBJECTIVE: To evaluate whether enteral prophylaxis with probiotics in
patients with predicted severe acute pancreatitis prevents infectious
complications. 

DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial.
METHOD: A total of 296 patients with predicted severe acute pancreatitis
(APACHE II score > or = 8, Imrie score > or = 3 or C-reactive protein
concentration > 150 mg/l) were included and randomised to one of two
groups. Within 72 hours after symptom onset, patients received a
multispecies preparation of probiotics or placebo given twice daily via
a jejunal catheter for 28 days. The primary endpoint was the occurrence
of one of the following infections during admission and go-day
follow-up: infected pancreatic necrosis, bacteraemia, pneumonia,
urosepsis or infected ascites. Secondary endpoints were mortality and
adverse reactions. The study registration number is ISRCTN38327949. 

RESULTS: Treatment groups were similar at baseline with regard to
patient characteristics and disease severity. Infections occurred in 30%
of patients in the probiotics group (46 of 152 patients) and 28% of
those in the placebo group (41 of 144 patients; relative risk (RR): 1.1;
95% CI: 0.8-1.5). The mortality rate was 16% in the probiotics group (24
of 152 patients) and 6% (9 of 144 patients) in the placebo group (RR:
2.5; 95% CI: 1.2-5.3). In the probiotics group, 9 patients developed
bowel ischaemia (of whom 8 patients died), compared with none in the
placebo group (p = 0.004). 

CONCLUSION: In patients with predicted severe acute pancreatitis, use of
this combination of probiotic strains did not reduce the risk of
infections. Probiotic prophylaxis was associated with a more than
two-fold increase in mortality and should therefore not be administered
in this category of patients.