The Role of Partially Hydrolyzed Whey Formula for the Prevention of Allergic Disease

Evidence and Gaps

Adrian J Lowe; Shyamali C Dharmage; Katrina J Allen; Mimi LK Tang; David J Hill

Expert Rev Clin Immunol. 2013;9(1):31-41.

Conclusion

The use of pHWF for allergic disease prevention is controversial with a long and chequered history. Only if pHWF is proven to be protective against the development of clinical disease should it be recommended. The evidence concerning the effect of these formulae is mixed, and there are a number of important methodological limitations described here that have not been fully taken into consideration in formulating the existing guidelines. Given these significant methodological limitations, and recently published evidence,^[18] updating of systematic reviews and existing guidelines on the use of pHWF for allergic disease prevention is warranted and timely. Until more definitive evidence is obtained, overstating the potential for pHWF to prevent allergic disease should be avoided, and we recommend continuing to advocate that 'breast is best'.

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Table 1. Selected recommendations and statements concerning the role of hydrolyzed formulae for the prevention of allergic disease.
Organization	Recommendation/statement	Ref.
US FDA^† (May 2011)	"For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% whey protein partially hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the first year of life and up to 3 years of age. FDA has concluded that the relationship between 100% whey protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship."	[102]
AAP (January 2008)	"In studies of infants at high risk of atopy and who are not exclusively breastfed for 4–6 months, there is modest evidence that the onset of atopic disease may be delayed or prevented by the use of hydrolyzed formulas compared with formula made with intact cow milk protein, particularly for atopic dermatitis."	[11]
ASCIA (2010)	"If infant formula is required in the first months of life before solid foods are introduced, there is some evidence that hydrolyzed formulas may reduce the risk of allergic disease in high-risk infants, with a history of allergy in their parents or siblings …. In Australia and New Zealand only partially hydrolyzed formulas (usually labeled 'HA' or Hypoallergenic) are recommended for allergy prevention."	[101]
ESPACI and ESPGHAN	"In bottle fed infants with a documented hereditary atopy risk (affected parent or sibling), the exclusive feeding of a formula with a confirmed reduced allergenicity is recommended because it can reduce the incidence of adverse reactions to food, especially to cows' milk protein. There is no conclusive evidence to support the use of formulas with reduced allergenicity for preventive purposes in healthy infants without a family history of allergic disease."	[77]
Section on Pediatrics, EAACI	"A dietary regimen is effective for prevention of allergy to the avoided food, in high-risk infants, particularly in early infancy regarding food allergy (cow's milk allergy) and eczema (atopic or nonatopic). Evidence that such avoidance affects the later allergic manifestations such as asthma and rhinitis is lacking. The most effective dietary regimen is exclusively breastfeeding for at least 4–6 months or, in case of lack of breast milk, formulas with documented reduced allergenicity for at least 4 months, combined with avoidance of solid food and cow's milk for the same period may be considered."	[12]

†This statement is an extract from a letter of reply by the US FDA in response to a petition to allow a health claim concerning partially hydrolyzed whey formula, submitted on behalf of Nestlé Nutrition. The FDA approved four wordings of a health claim concerning the use of pHWF [102]. This is the third of these approved provisional health claims. AAP: American Academy of Pediatrics; ASCIA: Australasian Society of Clinical Immunology and Allergy; EAACI: European Academy of Allergology and Clinical Immunology; ESPACI: European Society for Paediatric Allergology and Clinical Immunology; ESPGHAN: European Society for Paediatric Gastroenterology, Hepatology and Nutrition.

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The Role of Partially Hydrolyzed Whey Formula for the Prevention of Allergic Disease

Evidence and Gaps

Conclusion

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