General comment: According to current understanding amino acid-derived formulas are the safest choice for children with cow's milk allergy, since they contain no peptides or other macromolecules that are associated with the symptoms provoked by other types of formulas. They are expensive and there is no unequivocal evidence on their superiority over hydrolysed formulas as first-line treatment.
A two part open study 1. In Part 1of the study, four formulas commercially available (and one partially hydrolysed formula, not available in Finland) were graded for beta-lactoglobulin content, and 122 children (age 12 months, 95 % CI 12 - 15 months) with atopic eczema underwent a skin prick test and patch test. Furthermore, a double-blind, placebo-controlled diagnostic milk challenge was carried out. The challenge was positive in 60 % (74/122), and 45 children fulfilled the additional criteria of Part 2 of the study (no breast-feeding, need for formula feeding for at least six months).
In Part 2 the children were assigned, without randomisation, either to receive a whey hydrolysate formula (n = 22, Group We, age on entry 6 months, 95 % CI 4 - 7) or an amino acid-derived formula (n = 23, Group AA, age on entry 7 months, 95 % CI 5-8). The children were examined every two months (growth, determination of the severity of cutaneous symptoms, blood tests).
In Group We 68 %, and in Group AA 65 %, followed a cereal-free (wheat-barley-rye-oats) diet. The average (95 % CI) energy intake was similar in both groups at the age of 12 months: We 468 (390 - 546) kJ/kg and AA 517 (418 - 616) kJ/kg. Both formulas were equally effective in the treatment of cutaneous symptoms. The relative initial weight of the entire cohort increased 0.6 % (95 % CI -1.6 - 2.8) and height -0.3 SD (95 % CI -0.7 - -0.01). During follow-up, the relative height of the Group AA increased more than that of the Group We (ANOVA relative weight p = 0.09 and height p = 0.006). The children in Group We increased steadily in height.
Comment: The study was not randomised. The clinical significance of the differences in growth?
An open, uncontrolled study 2 describes 28 infants (age 22 - 173 days, approximately 1 - 6 months) who had received a hydrolysed formula for an average of 40 days (10 - 173) due to suspected protein intolerance and continued to have gastrointestinal symptoms (bloody stools / n = 15/, diarrhoea / n = 12/, vomiting / n = 10/, failure to gain weight / n = 4/, irritability/ n = 18/). No challenges had apparently been carried out. All infants were then fed with an amino acid-based formula for 14 days, and the parents were asked to keep a symptom diary regarding the number of formula feeds and stools as well as the sleep and crying patterns. Twenty-five of the infants demonstrated resolution of their symptoms after 14 days of treatment, and eight of them tolerated the original hydrolysate formula when reintroduced. Three infants had less symptoms whilst being fed with the amino acid-derived formula, but were not totally symptom free.
Comment: Children with fairly severe gastrointestinal symptoms. Not randomised, uncontrolled. Diagnosis not clear as far as challenge is concerned.
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