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Hydrolysed formula and risk of allergic or autoimmune disease: systematic review and meta-analysis
Robert J Boyle1, Despo Ierodiakonou2, Tasnia Khan3
1Section of Paediatrics, Imperial College London, London W2 1PG, UK r.boyle@nhs.net.
Insights
Hydrolysed formula does not consistently reduce allergy or autoimmune disease risk in high-risk infants. Current guidelines recommending hydrolysed formula for allergy prevention in infants are not supported by this evidence.
Area of Science:
- Pediatric Allergy and Immunology
- Nutritional Science
- Evidence-Based Medicine
Background:
- Infant feeding practices significantly influence long-term health outcomes, including allergic and autoimmune diseases.
- Hydrolysed formulas are often recommended for infants at high risk of developing allergies.
- Previous reviews suggested potential benefits, necessitating updated analysis.
Purpose of the Study:
- To systematically review and meta-analyze evidence on the efficacy of hydrolysed formulas in preventing allergic or autoimmune diseases in infants.
- To assess the impact of partially and extensively hydrolysed formulas on infant health outcomes.
Main Methods:
- Systematic review and meta-analysis of 37 prospective intervention trials involving over 19,000 infants.
- Studies compared hydrolysed formulas with standard formula, human breast milk, or other hydrolysed formulas.
- Data extraction and quality assessment were performed independently using the Cochrane risk of bias tool.
Main Results:
- No consistent evidence found that partially or extensively hydrolysed formulas reduce the risk of allergic or autoimmune outcomes in high-risk infants.
- Analysis showed no significant protective effect against eczema for partially or extensively hydrolysed formulas compared to standard formula.
- Evidence of conflict of interest, high risk of bias, and publication bias in many included studies.
Conclusions:
- The findings do not support current guidelines recommending hydrolysed formula for allergy prevention in high-risk infants.
- Existing health claims regarding hydrolysed formula and eczema prevention lack robust supporting evidence.
- Further high-quality research is needed to clarify the role of hydrolysed formulas in infant health.
Objective:
To determine whether feeding infants with hydrolysed formula reduces their risk of allergic or autoimmune disease.
Design:
Systematic review and meta-analysis, as part of a series of systematic reviews commissioned by the UK Food Standards Agency to inform guidelines on infant feeding. Two authors selected studies by consensus, independently extracted data, and assessed the quality of included studies using the Cochrane risk of bias tool.
Data Sources:
Medline, Embase, Web of Science, CENTRAL, and LILACS searched between January 1946 and April 2015.
Eligibility Criteria For Selecting Studies:
Prospective intervention trials of hydrolysed cows' milk formula compared with another hydrolysed formula, human breast milk, or a standard cows' milk formula, which reported on allergic or autoimmune disease or allergic sensitisation.
Results:
37 eligible intervention trials of hydrolysed formula were identified, including over 19,000 participants. There was evidence of conflict of interest and high or unclear risk of bias in most studies of allergic outcomes and evidence of publication bias for studies of 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. Odds ratios for eczema at age 0-4, compared with standard cows' milk formula, were 0.84 (95% confidence interval 0.67 to 1.07; I(2)=30%) for partially hydrolysed formula; 0.55 (0.28 to 1.09; I(2)=74%) for extensively hydrolysed casein based formula; and 1.12 (0.88 to 1.42; I(2)=0%) for extensively hydrolysed whey based formula. 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 allergy to cows' milk.
Conclusion:
These findings do not support current guidelines that recommend the use of hydrolysed formula to prevent allergic disease in high risk infants.
Review Registration:
PROSPERO CRD42013004252.
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