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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

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Role of Lactobacillus in the prevention of antibiotic-associated diarrhea: a meta-analysis

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Review published: .

CRD summary

This review concluded that a prophylactic Lactobacillus single-agent regimen, administered during antibiotic treatment, appeared to reduce the risk of developing antibiotic-associated diarrhoea compared with placebo. The author's conclusions are suitably cautious, but need to be considered against the variation in the evidence and possible language and publication bias.

Authors' objectives

To evaluate the efficacy of a Lactobacillus probiotic single-agent regimen for preventing antibiotic-associated diarrhoea.

Searching

PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews were searched from inception to May 2008. Search terms were reported. The search was restricted to papers published in English. Reference lists of reviews were also handsearched.

Study selection

Randomised, placebo-controlled, blinded clinical trials of a Lactobacillus single-agent regimen for antibiotic-associated diarrhoea prevention in adults or paediatrics were eligible for inclusion. Eligible trials had to report on the frequency of antibiotic-associated diarrhoea. Trials of Lactobacillus combination regimens were excluded.

Included trials were in adult or paediatric inpatient or outpatient populations. Participant ages ranged from two weeks to 14 years (paediatric) and from 18 to 93 years (adults); the total proportion of males was 50.4%, where reported. Lactobacillus doses and regimens varied from 2x109 to 4x1010 colony-forming units per day (CFU/day), given as capsules twice a day to sachets four times a day. Treatment was given for between three and 14 days. Trial follow-up periods ranged from two days to three months after completion of the probiotic regimen.

Studies were selected by two reviewers independently, with discrepancies resolved by consensus.

Assessment of study quality

The Jadad scale was used to assess validity including randomisation methods; allocation concealment; and reporting of withdrawals and drop-outs (scored from 0 to 5 points).

Validity assessment was performed by two reviewers independently, with discrepancies resolved by consensus.

Data extraction

Results for the occurrence of antibiotic-associated diarrhoea and adverse events were extracted and used to calculate risk ratios (RR) with 95% confidence intervals (CI).

Data were extracted by two reviewers independently, with discrepancies resolved by consensus.

Methods of synthesis

Results were pooled used a random-effects meta-analysis. Statistical heterogeneity was measured using the I2 statistic. A funnel plot was used to evaluate publication bias.

Results of the review

Ten randomised controlled trials (RCTs) were included in the review (n=1,862 participants); four paediatrics RCTs (n=585 participants) and six adults RCTs (n=1,277 participants). Jadad scores ranged from 2 to 5.

Treatment with Lactobacillus probiotic reduced the risk of developing antibiotic-associated diarrhoea compared with placebo (RR 0.35, 95% CI 0.19 to 0.67; heterogeneity I2=79%). Subgroup analyses of the adult and paediatric populations found a similar risk reduction for adults (RR 0.24, 95% CI 0.08 to 0.75; heterogeneity I2=83%), but no difference between groups for the paediatric population. The funnel plot was asymmetric, indicating possible publication bias.

Five RCTs reported on adverse events; three of these reported no statistically significant difference between groups. One trial reported more diarrhoea and taste disturbance in the placebo group compared with the Lactobacillus group (diarrhoea 30% versus 5%, p=0.0018; taste disturbance 40% versus 9.5%, p=0.0027). Another trial also reported more diarrhoea (26.6% versus 3.3%) and taste disturbance (50% versus 23.3%), as well as an increase in nausea (36.6% versus 10%), in the placebo group.

Authors' conclusions

A prophylactic Lactobacillus single-agent regimen, administered during antibiotic treatment, appeared to reduce the risk of developing antibiotic-associated diarrhoea compared with placebo.

CRD commentary

This review had clearly stated study inclusion criteria and conducted a good literature search. All review methods (searching, study selection, data extraction and validity assessment) were performed by two people independently, and the general conduct and reporting of this review was good. The main drawbacks were the restriction to trials published in English, the lack of a full report of the quality of each trial, and pooling trials that appeared to have very heterogeneous results. The authors did assess publication bias and found some evidence for it, probably partially due to the bias caused by the language restriction. There was no investigation of possible reasons for the heterogeneity and, although the random-effects analysis was the more appropriate, sensitivity analyses would have been helpful.

The author's conclusions are suitably cautious, but need to be considered against the heterogeneity of the evidence and possible language and publication bias.

Implications of the review for practice and research

Practice: The authors stated that Lactobacillus may be a feasible option for preventing antibiotic-associated diarrhoea.

Research: The authors stated that further evaluations with standardised Lactobacillus doses and regimens that include sample size calculations and recruit enough patients, are needed.

Funding

Not stated.

Bibliographic details

Kale-Pradhan PB, Jassal HK, Wilhelm SM. Role of Lactobacillus in the prevention of antibiotic-associated diarrhea: a meta-analysis. Pharmacotherapy 2010; 30(2): 119-126. [PubMed: 20099986]

Indexing Status

Subject indexing assigned by NLM

MeSH

Adolescent; Adult; Age Factors; Anti-Bacterial Agents /adverse effects; Child; Child, Preschool; Diarrhea /chemically induced /prevention & control; Female; Humans; Infant; Infant, Newborn; Lactobacillus; Male; Models, Statistical; Probiotics /therapeutic use; Randomized Controlled Trials as Topic; Treatment Outcome

AccessionNumber

12010002034

Database entry date

29/09/2010

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

Copyright © 2014 University of York.
Bookshelf ID: NBK80631

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