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September 17, 2007 — Prolonged or exclusive breast-feeding did not reduce the risk for asthma, hay fever, or eczema at the age of 6.5 years, according to results of a large cluster randomized study published in the September 11 Online First issue of BMJ.
"Whether breast feeding protects against the development of allergy and asthma has been frequently studied and hotly debated for more than 70 years," write Michael S. Kramer, from McGill University in Montreal, Canada, and colleagues from the Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. "Research findings indicating a beneficial effect have been most consistent for atopic eczema during infancy, but the evidence on asthma and other atopic outcomes (including hay fever, food allergies, and positive skin tests) has been far more mixed."
At 31 Belarussian maternity hospitals and their associated polyclinics, 17,046 mother-infant pairs were enrolled and randomized to receive or not to receive a breast-feeding promotion intervention modeled on the World Health Organization/United Nations Children's Fund baby-friendly hospital initiative. Of the 17,046 mother-infant pairs, 13,889 (81.5%) were followed up when the children were aged 6.5 years. The primary endpoints were responses on the International Study of Asthma and Allergies in Childhood questionnaire and skin prick test results for 5 inhalant antigens.
The intervention was associated with a large increase in exclusive breast-feeding at 3 months (44.3% vs 6.4%; P < .001). Prevalence of any breast-feeding was also significantly higher in this group at all ages up to and including 12 months.
Compared with the control group, the experimental group had no decrease in risk for allergic symptoms and diagnoses or in positive skin prick test results. When 6 sites (3 experimental and 3 control sites) with suspiciously high rates of positive skin prick test results were excluded, risks were 2- to 3-fold higher in the experimental group for 4 of the 5 antigens.
"These results do not support a protective effect of prolonged and exclusive breast feeding on asthma or allergy," the authors write.
Study limitations include the population being restricted to Eastern Europe; extremely low reported histories of eczema at 6.5 years, which are likely to be gross underestimates; and exceedingly high rates of positive skin test results at 6 of the study sites.
"Given these results based on a large randomised trial and the inconsistent benefits reported in previous studies, public health measures to increase the initiation, duration, and exclusivity of breast feeding seem unlikely to have a major impact on reducing the incidence of atopic diseases," the authors conclude. "The fact that most atopic outcomes have increased in incidence over the past several decades, simultaneous with the renaissance in breast feeding, strongly suggests that breast feeding does not have a potent protective effect at the population level. Thus, our results underline the importance of seeking other explanations for the recent epidemic of allergy and asthma and of investigating other potential causative factors to develop and test new preventive interventions."
The Canadian Institutes of Health funded this study. The authors have disclosed no relevant financial relationships.
BMJ. Published online September 11, 2007.
The effect of breast-feeding on the subsequent development of asthma, eczema, and allergy has not been clearly determined. In the October 21, 1995, issue of The Lancet, Saarinen and Kajosaari reported a beneficial effect of breast-feeding, whereas in the September 21, 2002, issue of The Lancet, Sears and colleagues reported no risk reduction. Methodology of studies can be challenging in that randomization of infants to breast-feeding or formula feeding is not feasible.
In the January 24-31, 2001, issue of JAMA, Kramer and colleagues described the PROBIT study, based on the World Health Organization and the United Nations Children's Fund guidelines. In the Republic of Belarus, 17,046 breast-fed infants from 31 centers were randomized to the breast-feeding intervention program or routine care. Breast-feeding was more common in the intervention vs control group at age 3 months (73% vs 60%), 6 months (50% vs 36%), 9 months (36% vs 24%), and 12 months (20% vs 11%). Exclusive breast-feeding was also more common in the intervention vs control group at age 3 months (43% vs 6%) and 6 months (8% vs 0.6%).
This study follows up subjects from the PROBIT study to assess whether those who participated in the breast-feeding intervention program have a lower risk for (1) symptoms of asthma, hay fever, and eczema and (2) positive skin prick test results at the age of 6.5 years.
