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Meta-Analysis
. 2017 May 25;5(5):CD003664.
doi: 10.1002/14651858.CD003664.pub5.

WITHDRAWN: Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy

David A Osborn  1 , John Kh Sinn  2 , Lisa J Jones  1   3
Affiliations
Meta-Analysis

WITHDRAWN: Infant formulas containing hydrolysed protein for prevention of allergic disease and food allergy

David A Osborn et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Allergy is common and may be associated with foods, including cow's milk formula (CMF). Formulas containing hydrolysed proteins have been used to treat infants with allergy. However, it is unclear whether hydrolysed formulas can be advocated for prevention of allergy in infants.

Objectives: To compare effects on allergy and food allergy when infants are fed a hydrolysed formula versus CMF or human breast milk. If hydrolysed formulas are effective, to determine what type of hydrolysed formula is most effective, including extensively or partially hydrolysed formula (EHF/PHF). To determine which infants at low or high risk of allergy and which infants receiving early, short-term or prolonged formula feeding may benefit from hydrolysed formulas.

Search methods: We used the standard search strategy of the Cochrane Neonatal Review Group supplemented by cross referencing of previous reviews and publications (updated August 2016).

Selection criteria: We searched for randomised and quasi-randomised trials that compared use of a hydrolysed formula versus human milk or CMF. Trials with ≥ 80% follow-up of participants were eligible for inclusion.

Data collection and analysis: We independently assessed eligibility of studies for inclusion, methodological quality and data extraction. Primary outcomes included clinical allergy, specific allergy and food allergy. We conducted meta-analysis using a fixed-effect (FE) model.

Main results: Two studies assessed the effect of three to four days' infant supplementation with an EHF whilst in hospital after birth versus pasteurised human milk feed. Results showed no difference in infant allergy or childhood cow's milk allergy (CMA). No eligible trials compared prolonged hydrolysed formula versus human milk feeding.Two studies assessed the effect of three to four days infant supplementation with an EHF versus a CMF. One large quasi-random study reported a reduction in infant CMA of borderline significance among low-risk infants (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.38 to 1.00).Prolonged infant feeding with a hydrolysed formula compared with a CMF was associated with a reduction in infant allergy (eight studies, 2852 infants; FE RR 0.82, 95% CI 0.72 to 0.95; risk difference (RD) -0.04, 95% CI -0.08 to -0.01; number needed to treat for an additional beneficial outcome (NNTB) 25, 95% CI 12.5 to 100) and infant CMA (two studies, 405 infants; FE RR 0.38, 95% CI 0.16 to 0.86). We had substantial methodological concerns regarding studies and concerns regarding publication bias, as substantial numbers of studies including those in high-risk infants have not comprehensively reported allergy outcomes (GRADE quality of evidence 'very low').Prolonged infant feeding with a hydrolysed formula compared with a CMF was not associated with a difference in childhood allergy and led to no differences in specific allergy, including infant and childhood asthma, eczema and rhinitis and infant food allergy. Many of the analyses assessing specific allergy are underpowered.Subroup analyses showed that infant allergy was reduced in studies that enrolled infants at high risk of allergy who used a hydrolysed formula compared with a CMF; used a PHF compared with a CMF; used prolonged and exclusive feeding of a hydrolysed formula compared with a CMF; and used a partially hydrolysed whey formula compared with a CMF. Studies that enrolled infants at high risk of allergy; used a PHF compared with a CMF; used prolonged and exclusive feeding of a hydrolysed formula compared with a CMF; and used a partially hydrolysed whey formula compared with a CMF found a reduction in infant CMA.

Authors' conclusions: We found no evidence to support short-term or prolonged feeding with a hydrolysed formula compared with exclusive breast feeding for prevention of allergy. Very low-quality evidence indicates that short-term use of an EHF compared with a CMF may prevent infant CMA.In infants at high risk of allergy not exclusively breast fed, very low-quality evidence suggests that prolonged hydrolysed formula feeding compared with CMF feeding reduces infant allergy and infant CMA. Studies have found no difference in childhood allergy and no difference in specific allergy, including infant and childhood asthma, eczema and rhinitis and infant food allergy.Very low-quality evidence shows that prolonged use of a partially hydrolysed formula compared with a CMF for partial or exclusive feeding was associated with a reduction in infant allergy incidence and CMA incidence, and that prolonged use of an EHF versus a PHF reduces infant food allergy.

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Conflict of interest statement

DO and JS have been invited speakers at industry‐organised scientific meetings. Neither has accepted an honorarium. LJ has no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Study flow diagram: review update.
Figure 2
Figure 2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 3
Figure 3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figure 4
Figure 4
Funnel plot of comparison: 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, outcome: 4.1 Any allergy.
Figure 5
Figure 5
Funnel plot of comparison: 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, outcome: 4.3 Eczema.
Figure 6
Figure 6
Funnel plot of comparison: 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, outcome: 4.6 Cow's milk allergy.
Analysis 1.1
Analysis 1.1
Comparison 1 Early short‐term feeding: hydrolysed formula versus human milk feeding ‐ low‐risk infants, Outcome 1 Any allergy.
Analysis 1.2
Analysis 1.2
Comparison 1 Early short‐term feeding: hydrolysed formula versus human milk feeding ‐ low‐risk infants, Outcome 2 Asthma.
Analysis 1.3
Analysis 1.3
Comparison 1 Early short‐term feeding: hydrolysed formula versus human milk feeding ‐ low‐risk infants, Outcome 3 Eczema.
Analysis 1.4
Analysis 1.4
Comparison 1 Early short‐term feeding: hydrolysed formula versus human milk feeding ‐ low‐risk infants, Outcome 4 Food allergy.
Analysis 1.5
Analysis 1.5
Comparison 1 Early short‐term feeding: hydrolysed formula versus human milk feeding ‐ low‐risk infants, Outcome 5 Cow's milk allergy.
Analysis 2.1
Analysis 2.1
Comparison 2 Early short‐term feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 1 Any allergy.
Analysis 2.2
Analysis 2.2
Comparison 2 Early short‐term feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 2 Asthma.
Analysis 2.3
Analysis 2.3
Comparison 2 Early short‐term feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 3 Eczema.
Analysis 2.4
Analysis 2.4
Comparison 2 Early short‐term feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 4 Food allergy.
Analysis 2.5
Analysis 2.5
Comparison 2 Early short‐term feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 5 Cow's milk allergy.
Analysis 4.1
Analysis 4.1
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 4.2
Analysis 4.2
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 4.3
Analysis 4.3
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 4.4
Analysis 4.4
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 4.5
Analysis 4.5
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 5 Food allergy.
Analysis 4.6
Analysis 4.6
Comparison 4 Prolonged feeding: hydrolysed formula versus cow's milk formula, Outcome 6 Cow's milk allergy.
Analysis 5.1
Analysis 5.1
Comparison 5 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 1 Any allergy.
Analysis 5.2
Analysis 5.2
Comparison 5 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 2 Asthma.
Analysis 5.3
Analysis 5.3
Comparison 5 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 3 Eczema.
Analysis 5.4
Analysis 5.4
Comparison 5 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ low‐risk infants, Outcome 4 Rhinitis.
Analysis 6.1
Analysis 6.1
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 1 Any allergy.
Analysis 6.2
Analysis 6.2
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 2 Asthma.
Analysis 6.3
Analysis 6.3
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 3 Eczema.
Analysis 6.4
Analysis 6.4
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 4 Rhinitis.
Analysis 6.5
Analysis 6.5
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 5 Food allergy.
Analysis 6.6
Analysis 6.6
Comparison 6 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ high‐risk infants, Outcome 6 Cow's milk allergy.
Analysis 7.1
Analysis 7.1
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 7.2
Analysis 7.2
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 7.3
Analysis 7.3
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 7.4
Analysis 7.4
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 7.5
Analysis 7.5
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 5 Food allergy.
Analysis 7.6
Analysis 7.6
Comparison 7 Prolonged feeding: partially hydrolysed formula versus cow's milk formula, Outcome 6 Cow's milk allergy.
Analysis 8.1
Analysis 8.1
Comparison 8 Prolonged feeding: extensively hydrolysed formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 8.2
Analysis 8.2
Comparison 8 Prolonged feeding: extensively hydrolysed formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 8.3
Analysis 8.3
Comparison 8 Prolonged feeding: extensively hydrolysed formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 8.4
Analysis 8.4
Comparison 8 Prolonged feeding: extensively hydrolysed formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 8.5
Analysis 8.5
Comparison 8 Prolonged feeding: extensively hydrolysed formula versus cow's milk formula, Outcome 5 Food allergy.
Analysis 9.1
Analysis 9.1
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 1 Any allergy.
Analysis 9.2
Analysis 9.2
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 2 Asthma.
Analysis 9.3
Analysis 9.3
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 3 Eczema.
Analysis 9.4
Analysis 9.4
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 4 Rhinitis.
Analysis 9.5
Analysis 9.5
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 5 Food allergy.
Analysis 9.6
Analysis 9.6
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 6 Cow's milk allergy.
Analysis 9.7
Analysis 9.7
Comparison 9 Prolonged feeding: extensively hydrolysed formula versus partially hydrolysed formula, Outcome 7 Urticaria.
Analysis 10.1
Analysis 10.1
Comparison 10 Prolonged exclusive feeding: hydrolysed formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 10.2
Analysis 10.2
Comparison 10 Prolonged exclusive feeding: hydrolysed formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 10.3
Analysis 10.3
Comparison 10 Prolonged exclusive feeding: hydrolysed formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 10.4
Analysis 10.4
Comparison 10 Prolonged exclusive feeding: hydrolysed formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 10.5
Analysis 10.5
Comparison 10 Prolonged exclusive feeding: hydrolysed formula versus cow's milk formula, Outcome 5 Cow's milk allergy.
Analysis 11.1
Analysis 11.1
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 1 Any allergy.
Analysis 11.2
Analysis 11.2
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 2 Asthma.
Analysis 11.3
Analysis 11.3
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 3 Eczema.
Analysis 11.4
Analysis 11.4
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 4 Rhinitis.
Analysis 11.5
Analysis 11.5
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 5 Food allergy.
Analysis 11.6
Analysis 11.6
Comparison 11 Prolonged feeding: hydrolysed formula versus cow's milk formula ‐ studies with blinded measurement, Outcome 6 Cow's milk allergy.
Analysis 13.1
Analysis 13.1
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 13.2
Analysis 13.2
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 13.3
Analysis 13.3
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 13.4
Analysis 13.4
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 13.5
Analysis 13.5
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 5 Food allergy.
Analysis 13.6
Analysis 13.6
Comparison 13 Prolonged feeding: partially hydrolysed whey formula versus cow's milk formula, Outcome 6 Cow's milk allergy.
Analysis 14.1
Analysis 14.1
Comparison 14 Prolonged feeding: partially hydrolysed casein‐containing formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 14.2
Analysis 14.2
Comparison 14 Prolonged feeding: partially hydrolysed casein‐containing formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 14.3
Analysis 14.3
Comparison 14 Prolonged feeding: partially hydrolysed casein‐containing formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 14.4
Analysis 14.4
Comparison 14 Prolonged feeding: partially hydrolysed casein‐containing formula versus cow's milk formula, Outcome 4 Rhinitis.
Analysis 14.5
Analysis 14.5
Comparison 14 Prolonged feeding: partially hydrolysed casein‐containing formula versus cow's milk formula, Outcome 5 Food allergy.
Analysis 15.1
Analysis 15.1
Comparison 15 Prolonged feeding: extensively hydrolysed whey formula versus cow's milk formula, Outcome 1 Any allergy.
Analysis 15.2
Analysis 15.2
Comparison 15 Prolonged feeding: extensively hydrolysed whey formula versus cow's milk formula, Outcome 2 Asthma.
Analysis 15.3
Analysis 15.3
Comparison 15 Prolonged feeding: extensively hydrolysed whey formula versus cow's milk formula, Outcome 3 Eczema.
Analysis 16.1
Analysis 16.1
Comparison 16 Prolonged feeding: extensively hydrolysed casein formula versus cow' milk formula, Outcome 1 Any allergy.
Analysis 16.2
Analysis 16.2
Comparison 16 Prolonged feeding: extensively hydrolysed casein formula versus cow' milk formula, Outcome 2 Asthma.
Analysis 16.3
Analysis 16.3
Comparison 16 Prolonged feeding: extensively hydrolysed casein formula versus cow' milk formula, Outcome 3 Eczema.
Analysis 17.1
Analysis 17.1
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 1 Any allergy.
Analysis 17.2
Analysis 17.2
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 2 Asthma.
Analysis 17.3
Analysis 17.3
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 3 Eczema.
Analysis 17.4
Analysis 17.4
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 4 Rhinitis.
Analysis 17.5
Analysis 17.5
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 5 Food allergy.
Analysis 17.6
Analysis 17.6
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 6 Cow's milk allergy.
Analysis 17.7
Analysis 17.7
Comparison 17 Prolonged feeding: extensively hydrolysed casein formula versus extensively hydrolysed whey formula, Outcome 7 Urticaria.
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References

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References to other published versions of this review

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    1. Osborn DA, Sinn J. Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants. Cochrane Database of Systematic Reviews 2006, Issue CD003664. [DOI: 10.1002/14651858.CD003664.pub3] - DOI - PubMed

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