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Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial

BMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39231.599815.55 (Published 12 July 2007) Cite this as: BMJ 2007;335:80

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Local incidence of Clostridium difficile associated diarrhoea to be considered.

Hickson et al conclude that consumption of a probiotic Lactobacillus
preparation drink can reduce the incidence of antibiotic associated
diarrhoea (AAD) and Clostridium difficile associated diarrhoea (CDAD),
with an estimated absolute risk reduction of 22% and 17%, and state that
this has the potential to decrease morbidity, healthcare cost, and
mortality if used routinely in patiens aged over 50 [1]. The incidence of
AAD and CDAD in the placebo group were 34% and 17%. However, there are
substantial differences in the incidence of AAD and CADC among different
hospitals that challenge the extrapolation of these results.

In the context of a randomised controlled therapeutic trial for CDAD,
we implemented an active program for the detection of AAD and CDAD cases
in a tertiary 950-bed Spanish hospital from November 2005 throughout June
2007. Infection control nurses and/or infectious diseases doctors visited
all hospital wards 5 days a week to identify patients with AAD (more than
2 liquid stools a day for more than 2 days with no other obvious cause),
and a stool sample from all these patients was sent to the microbiology
laboratory for the detection of toxins A, B or both (X/PECT Clostridium
difficile Toxin A/B, Remel, Santa Fe, USA). If the initial sample was
negative, new samples were studied whenever diarrhoea persisted. Reports
of all bowel endoscopic procedures and surgery were also routinely
reviewed. During the study period, 530 samples from 427 patients were
analysed, and 30 samples from 25 patients (5.8%) were positive for C.
difficile toxin; 15 of them were aged over 50. All patients were treated
and cured (4 had recurrences that responded to subsequent therapy) and one
died as a consequence of his underlying disease. Our infection control
program includes individual room isolation, contact precautions, and
thorough daily cleaning of rooms and bathrooms of all patients with CDAD.
There were 57,838 admissions during the study period; thus, the incidence
of CDAD was 0.43 per 1,000 admissions. Based on the Pharmacy and infection
control surveillance data, the estimated number of patients who received
antimicrobials during the period was 14,459. Thus, the estimated incidence
of antibiotic associated diarrhoea was 2.95% and of CDAD among patients
who received antimicrobials, 0.17%.

When thinking about implementing a preventive measure in a
population, the incidence of the event to be prevented in that population
needs to be considered. We think that probiotic Lactobacillus preparation
should not be routinely used in hospitals with low incidence of CDAD.

References.

1. Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, et
al. Use of probiotic Lactobacillus preparation to prevent diarrhoea
associated with antibiotics: randomised double blind placebo controlled
trial. BMJ 2007;335:80-3. (14 July).

Competing interests:
JRB has received honorariums for consultancy work from Pfizer, Merck, Wyeth and Novartis. LLC and MMP have no competing interests.

Competing interests: No competing interests

08 August 2007
Jesús Rodríguez-Baño
Associate Professor
Lorena López-Cerero, and María M. Portillo
Hospital Universitario Virgen Macarena, Avda. Dr. Fedriani, 3. 41009 Seville, Spain