PEDIATRICS Vol. 112 No. 2 August 2003, pp. 458-459
ALLERGY TO SOY FORMULA AND TO EXTENSIVELY HYDROLYZED WHEY FORMULA IN INFANTS WITH COW’S MILK ALLERGY: A PROSPECTIVE, RANDOMIZED STUDY WITH A FOLLOW-UP TO THE AGE OF 2 YEARS
John James, MD
Fort Collins, CO
Klemola T, Vanto T, Juntunen-Backman K, Kalimo K, Korpela R, Varjonen E. J Pediatr. 2002;140:219–224
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Purpose of Study.
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To evaluate the cumulative incidence up to the age of 2 years
of allergy or other adverse reactions to soy formula and to
extensively hydrolyzed formula in infants with confirmed cow’s
milk allergy.
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Study Population.
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The study group was comprised of 170 children with cow’s
milk allergy (99 boys and 71 girls) with a mean age at the time
of diagnosis of 7 months (range: 2–11 months). All the
patients had their diagnosis confirmed by double-blind, placebo-controlled
challenge (DBPCFC) except for 4 patients with a history of an
anaphylactic reaction to cow’s milk and positive immunoglobulin
(IgE) antibodies to this protein.
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Methods.
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Infants with documented cow’s milk allergy were randomly
assigned to receive either a soy formula (Soija Tutteli, Valio
Ltd, Valio, Finland) or an extensively hydrolyzed formula (Peptidi
Tutteli, Valio Ltd, Valio, Finland). If there was a clinical
suspicion that the formula caused symptoms, a DBPCFC with the
formula was performed. The children were followed to the age
of 2 years, and soy-specific IgE antibodies were measured at
the time of diagnosis and at ages 1 and 2 years.
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Results.
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An adverse reaction to the formula was confirmed by challenge
in 8 patients (10%; 95% confidence interval: 4.4%–18.8%)
randomly assigned to soy formula and in 2 patients (2.2%; 95%
confidence interval: 0.3%–7.8%) randomly assigned to extensively
hydrolyzed formula. Adverse reactions to soy were similar in
IgE-associated and non-IgE-associated cow’s milk allergy
(11% and 9%, respectively). IgE to soy was detected in only
2 infants with an adverse reaction to soy. Adverse reactions
to soy formula were more common in younger (<6 months) than
in older (6–12 months) infants (5 of 20 vs 3 of 60, respectively;
P = .01).
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Conclusions.
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Soy formula was well-tolerated by most infants with IgE associated
and non-IgE-associated cow’s milk allergy. Development
of IgE-associated allergy to soy was rare. Soy formula can be
recommended as a first-choice alternative for infants
6 months
of age with cow’s milk allergy.
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Reviewer’s Comments.
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This is a very useful clinical investigation with practical
applications. The study data demonstrate that only 10% of infants
with cow’s milk allergy have any kind of adverse reaction
after the ingestion of soy formula. Moreover, severe allergic
reactions or development of IgE-mediated allergy to soy was
found to be very uncommon in infants with cow’s milk allergy.
This investigation is a nice corollary to a previous publication
by Zeiger et al (
J Pediatr. 1999;134:614–622.) that found
the prevalence of soy allergy in children with IgE-mediated
cow’s milk allergy to be 14%. Cow’s milk allergy
affects approximately 2.5% of infants with possible alternative
including soy formula, extensively hydrolyzed protein formulas,
or amino acid formulas. Of these choices, soy formulas provide
the most affordable and palatable choice while meeting the nutritional
needs of these infants.
PEDIATRICS (ISSN 1098-4275). ©2003 by the American Academy of Pediatrics
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Purpose of Study.
Study Population.
