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babybottleMarch 16 2016

There is no supporting evidence to show that hydrolysed infant formulas prevent allergic conditions, a BMJ study has concluded. As such, health professionals should not recommend their use to mothers in the belief that they can help prevent conditions developing such as asthma, eczema, allergic rhinitis, food allergy, allergic sensitisation, or the autoimmune disease type 1 diabetes, it has proposed.

Following a systematic review of 37 studies into the use of special infant milk formula, the researchers concluded that “the findings do not support current guidelines that recommend the use of hydrolysed formula to prevent allergic disease in high risk infants.”

Studies included in the review were those which compared hydrolysed cows’ milk formula with another hydrolysed formula, human breast milk, or a standard cows’ milk formula, and which also reported on allergic or autoimmune disease or allergic sensitisation. The review included data relating to more than 19,000 participants from studies conducted between 1946 and 2015.

Among the concerns raised in the systematic review were the evidence of a conflict of interest and a high or unclear risk of bias in most studies of allergic outcomes. There was also evidence of publication bias in studies on eczema and wheeze.
“Overall there was no consistent evidence that partially or extensively hydrolysed formulas reduce risk of allergic or autoimmune outcomes in infants at high pre-existing risk of these outcomes,” said the study authors.

“There was no evidence to support the health claim approved by the US Food and Drug Administration that a partially hydrolysed formula could reduce the risk of eczema nor the conclusion of the Cochrane review that hydrolysed formula could prevent allergy to cows’ milk.”

The review has prompted an accompanying editorial which notes: “Given the commercially sensitive nature of this topic, it is reassuring that, when it was possible to investigate, [the researchers] did not find evidence that these conflicts of interest influenced the reported associations for individual outcomes.

“While experts might recognise the lack of evidence for the effectiveness of hydrolysed formulas in prevention of allergies, it seems that these formulas are currently recommended in the hope that they might prevent allergic disease and on the basis that they are unlikely to do any harm. The most undesirable consequence of this approach is that it can unwittingly undermine efforts to promote breast feeding.”

The editorial concludes: “It is now time for this evidence to be used for updating and clarifying current recommendations and guidelines. Furthermore, we encourage industry to pursue development of effective allergy reducing infant formulas and call for further transparent and well conducted studies in this area.”

Commenting in the findings, Professor Mary Fewtrell of the Royal College of Paediatrics and Child Health said: “All mothers should be encouraged and supported to breastfeed, whether or not their infant is at risk of allergy. Current advice is that infants who are at risk of allergy and who are not exclusively breast-fed should receive a hypoallergenic formula rather than a standard formula.

“However, this new review of the evidence suggests that there is no consistent advantage to using a hypoallergenic formula over a standard formula for preventing the development of allergy. Current advice may therefore need to change, and this is currently being reviewed by the Food Standards Agency.”

Links:

BMJ announcement

RJ Boyle at al. ‘Hydrolysed formula and risk of allergic or autoimmune disease: systematic review and meta-analysis’. BMJ 2016; 352: i974. Published online March 8 2016

CJ Lodge and SC Dharmage. ‘Do hydrolysed infant formulas reduce the risk of allergic disease?’. BMJ 2016; 352: i1143. Published online March 8 2016

RCPCH comment

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