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Prenatal and postnatal administration of Lactobacillus GG reduced the occurrence of atopic disease in offspring

Design
Randomised (unclear allocation concealment^*), blinded (clinicians, patients, and outcome assessors),^*) controlled trial with 2 years of follow up.

Setting
Antenatal clinics in Turku, Finland.

Patients
159 pregnant women who had atopic disease, or 1 first-degree relative (mother, father, or older sibling), or partner with atopic eczema, allergic rhinitis, or asthma. 132 women (83%) and 132 children completed follow up.

Intervention
Mothers were allocated to LGG (1 x 10¹⁰ colony-forming units [Valio Limited, Helsinki, Finland]) (n=77) or to placebo (microcrystalline cellulose) (n=82). The capsules were taken daily for 2 to 4 weeks before expected delivery. After delivery, breastfeeding mothers continued to take the capsules, or the children received the contents mixed with water by spoon. The capsules were taken postnatally for 6 months.

Main outcome measures
A diagnosis of atopic eczema, the main outcome measure, required pruritis or facial or extensor involvement, or both, and a chronic relapsing course (eczema for 1 mo at the 24 mo study visit and on 1 previous visit).

Main results
Atopic eczema occurred in fewer children who had received probiotics than in those who received placebo (p=0.008) (table).

View this table: [in this window] [in a new window]   Lactobacillus GG v placebo for prevention of atopic disease in children up to 2 years of age

Footnotes
Sources of funding: Finnish Foundation for Paediatric Research; National Technology Agency of Finland; Allergy Research Foundation in southwest Finland.

For correspondence: Dr M Kalliomäki, Department of Paediatrics, Turku University Hospital, P.O. Box 52, FI-20521 Turku, Finland.

^* See glossary.

Commentary

Centre of Evidence-Based Dermatology Queen's Medical Centre Nottingham, UK

The study by Kalliomäki et al found an impressive halving of the risk for atopic eczema at 2 years in those given probiotics—cultures of potentially beneficial bacteria of the healthy gut microflora. 2 questions need to be answered: are the results valid, and, if so, should clinicians modify their practice now?

3 methodological concerns exist with the study. The first is that the method of concealing allocation to the intervention groups is not clear. Second, despite a high follow up rate, an intention to treat analysis was not carried out. Third, the method used to define atopic eczema was non-specific (eg, simple irritant contact dermatitis could have been included),¹ and other validated definitions could have been used. These methodological concerns are unlikely to invalidate the study, but we do not know for sure unless we have more information or the study findings are replicated.

With respect to changing practice, 2 points are noteworthy. First, the results should not be generalised to those without a positive family history of atopy. The lack of change in atopic markers suggests that a study in non-atopic families might be worthwhile. Second, it remains to be seen whether the initial benefit in the intervention group is a sustained one, as opposed to merely delaying the onset of symptoms as other prevention studies have found.² Long term data are also awaited on asthma, hay fever, and safety risk.

So, would I recommend probiotics to the families with atopic eczema that I care for? Not yet. Although this is an exciting study, history teaches me to be cautious about changing my practice on the basis of 1 moderately sized randomised controlled trial, the results of which are entirely dependent on 1 assessor. Additional studies are needed to confirm the findings, and longer follow up is needed to see whether the benefits are sustained.

References

1. Williams HC, Burney PG, Pembroke AC, Hay RJ. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. III. Independent hospital validation. Br J Dermatol 1994; 131:406–16.[Medline]
2. Mar A, Marks R. Prevention of atopic dermatitis. In: Williams HC, ed. Atopic dermatitis: the epidemiology, causes and prevention of atopic eczema. New York: Cambridge University Press, 2000:205–20.

This Article Extract Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Add article to my folders Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Williams, H. C Search for Related Content PubMed Articles by Williams, H. C