Intervention Review

Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants

  1. David A Osborn2,
  2. John KH Sinn1,*

Editorial Group: Cochrane Neonatal Group

Published Online: 18 OCT 2006

Assessed as up-to-date: 26 JUL 2006

DOI: 10.1002/14651858.CD003664.pub3

How to Cite

Osborn DA, Sinn JKH. Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD003664. DOI: 10.1002/14651858.CD003664.pub3.

Author Information

  1. 1

    Royal North Shore Hospital, Neonatal Unit, St Leonards, New South Wales, Australia

  2. 2

    Royal Prince Alfred Hospital, RPA Newborn Care, Camperdown, New South Wales, Australia

*John KH Sinn, Neonatal Unit, Royal North Shore Hospital, Level 5, Douglas Building, Pacific Hwy, St Leonards, New South Wales, 2065, Australia. jsinn@med.usyd.edu.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 OCT 2006

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Allergies and food reactions are common and may be associated with foods including adapted cow's milk formula. Formulas containing hydrolysed proteins have been used to treat infants with allergy or food intolerance. However, it is unclear whether hydrolysed formula can be advocated for prevention of allergy and food intolerance in infants without evidence of allergy or food intolerance.

Objectives

To determine the effect of feeding hydrolysed formulas on allergy and food intolerance in infants and children compared to adapted cow's milk or human breast milk. If hydrolysed formulas are effective, to determine what type of hydrolysed formula is most effective including extensively and partially hydrolysed formulas. To determine which infants benefit, including infants at low or high risk of allergy and infants receiving early, short term or prolonged formula feeding.

Search methods

The standard search strategy of the Cochrane Neonatal Review Group was used. The review was updated with searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), MEDLINE (1966 - March 2006), EMBASE (1980 - March 2006) and CINAHL (1982 - March 2006) and previous reviews including cross references.

Selection criteria

Randomised and quasi-randomised trials that compare the use of a hydrolysed infant formula to human milk or cow's milk formula. Trials with >80% follow up of participants were eligible for inclusion.

Data collection and analysis

Eligibility of studies for inclusion, methodological quality and data extraction were assessed independently by each review author. Primary outcomes included clinical allergy, specific allergies and food intolerance. Meta-analysis was conducted using a fixed effects model.

Main results

Two trials compared early, short term hydrolysed formula to human milk feeding. No significant difference in infant allergy or childhood cow's milk allergy (CMA) were reported. No eligible trial compared prolonged hydrolysed formula to human milk feeding. Two trials compared early, short term hydrolysed formula to cow's milk formula feeding. No significant benefits were reported. One large quasi-random study reported a reduction in infant CMA of borderline significance in low risk infants (RR 0.62, 95% CI 0.38, 1.00).

Ten eligible studies compared prolonged feeding with hydrolysed formula versus cow's milk formula in high risk infants. Meta-analysis found a significant reduction in infant allergy (seven studies, 2514 infants; typical RR 0.79, 95% CI 0.66, 0.94), but not in the incidence of childhood allergy (two studies, 950 infants; typical RR 0.85, 95% CI 0.69, 1.05). There was no significant difference in infant eczema (eight studies, 2558 infants, typical RR 0.84, 95% CI 0.68, 1.04), childhood eczema incidence (two studies, 950 infants, typical RR 0.83, 95% CI 0.63, 1.10), childhood eczema prevalence (one study, 872 infants; RR 0.66, 95% CI 0.43, 1.02), or infant or childhood asthma, rhinitis and food allergy. One study reported a significant reduction in infants with CMA with confirmed atopy (RR 0.36, 95% CI 0.15, 0.89). Subgroup analysis of trials blinded to formula found no significant difference in infant allergy (four studies, 2156 infants; typical RR 0.87, 95% CI 0.69, 1.08) or childhood allergy incidence (one study, 872 infants; RR 0.91, 95% CI 0.73, 1.14). No eligible trial examined the effect of prolonged hydrolysed formula feeding on allergy beyond early childhood. There is evidence that preterm or low birthweight infants fed a hydrolysed preterm formula have significantly reduced weight gain, but not in other growth parameters (head circumference or length). Studies in term infants report no adverse effects on growth.

Subgroup analysis of trials of partially hydrolysed versus cow's milk formula found a significant reduction in infant allergy (six studies, 1391 infants; typical RR 0.79, 95% CI 0.65, 0.97) but not childhood allergy, or infant or childhood asthma, eczema or rhinitis. Methodological concerns were the same as for the overall analysis. Analysis of trials of extensively hydrolysed formula versus cow's milk formula found no significant differences in allergy or food intolerance. Infants fed extensively hydrolysed formula compared with partially hydrolysed formula had a significant reduction in food allergy (two studies, 341 infants; typical RR 0.43, 95% CI 0.19, 0.99), but there was no significant difference in all allergy or any other specific allergy incidence. Comparing extensively hydrolysed casein containing formula with cow's milk formula, one study (431 infants) reported a significant reduction in childhood allergy incidence (RR 0.72, 95% CI 0.53, 0.97). Meta-analysis found a significant reduction in infant eczema (three studies, 1237 infants; typical RR 0.71, 95% CI 0.51, 0.97). One study reported a significant reduction in childhood eczema incidence (RR 0.66, 95% CI 0.44, 0.98) and prevalence (RR 0.50, 95% CI 0.27, 0.92).

Authors' conclusions

There is no evidence to support feeding with a hydrolysed formula for the prevention of allergy compared to exclusive breast feeding. In high risk infants who are unable to be completely breast fed, there is limited evidence that prolonged feeding with a hydrolysed formula compared to a cow's milk formula reduces infant and childhood allergy and infant CMA. In view of methodological concerns and inconsistency of findings, further large, well designed trials comparing formulas containing partially hydrolysed whey, or extensively hydrolysed casein to cow's milk formulas are needed.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants

When babies are not exclusively breastfed, use of hydrolysed infant formula instead of ordinary cow's milk formula may reduce allergies in babies and children, although further studies are needed to confirm this. Infant formulas have been designed to try to lower the chances of developing allergy or food intolerance. These include hydrolysed cow's and soy milk formulas. Hydrolysed formulas break down the milk proteins into smaller, potentially less allergy producing proteins. The review of trials found that there is no evidence to support feeding with a hydrolysed formula to prevent allergy in preference to exclusive breastfeeding. In infants at high risk for allergy who are unable to be completely breastfed, there is limited evidence that feeding with a hydrolysed formula compared to a cow's milk formula reduces allergies in babies and children, including cow's milk allergy. Concerns regarding quality of the evidence and consistency of the results indicates further studies are needed.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

為了降低嬰兒過敏和食物不耐的水解蛋白配方奶粉

過敏與食物反應是常見的問題,可能和食物包括牛奶製成的配方奶有關係。水解蛋白配方奶已被用於治療過敏和食物耐受不良的嬰兒。然而,尚不清楚水解配方是否能夠用於預防沒有相關症狀過敏和食物不耐症狀的嬰兒。

目標

比較嬰兒餵食水解配方和一般牛奶配方或母奶對過敏和食物耐受不良的效果。若水解配方有效果,則要找出哪一種水解配方包括完全和部分水解配方,效果最佳。也要比較哪一些嬰兒,包括過敏的低危險或高危險群,以及早期、短期或長期餵食牛奶配方是否有所不同。

搜尋策略

使用Cochrane Neonatal Review Group的標準搜尋。更新回顧資料取自於Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006) 、MEDLINE (1966  March 2006) 、EMBASE (1980  March 2006) 和CINAHL (1982  March 2006) 及之前回顧包括交互參考資料。

選擇標準

隨機和半隨機試驗來比較使用嬰兒水解配方和人奶或牛奶配方。超過80% 追蹤率的試驗將被納入分析。

資料收集與分析

研究被納入與否其方法品質和資料拮取被兩位評論作者獨立評估。原始預後包括臨床上過敏表現、特定的過敏和食物不耐受。使用固定效果模式來進行整合分析。

主要結論

兩個試驗比較了早期及短期餵食水解配方和母奶,在嬰兒過敏或兒童期牛奶過敏沒有明顯差異。沒有長期餵食水解配方和母奶的比較。有兩個試驗比較了早期及短期餵食水解配方和牛奶配方,兩者也沒有差別。一個大型近似隨機試驗報告了在低危險嬰兒可邊緣性明顯減少嬰兒牛奶過敏 (RR 0.62, 95% CI 0.38, 1.00) 。 十個研究比較了高危險嬰兒長期餵食水解配方和牛奶配方。整合分析發現可明顯減少嬰兒過敏 (七個試驗,2514個嬰兒,typical RR 0.79, 95% CI 0.66, 0.94) ,但對兒童期過敏發生率沒有影響 (兩個試驗,950個嬰兒,typical RR 0.85, 95% CI 0.69, 1.05) 。在嬰兒濕疹 (八個研究,共有2558個嬰兒,typical RR 0.84, 95% CI 0.68, 1.04) 、兒童濕疹發生率 (兩個研究,950個嬰兒,typical RR 0.83, 95% CI 0.63, 1.10) 、兒童濕疹盛行率 (一個研究,872個嬰兒,RR 0.66, 95% CI 0.43, 1.02) 、嬰兒或兒童氣喘、鼻炎和食物過敏都沒有明顯差異。一個研究報告可以明顯降低過敏嬰兒的牛奶過敏 (RR 0.36, 95% CI 0.15, 0.89) 。 次群體分析在不曉得何種配方的前提下,發現嬰兒過敏 (四個研究,共2156位嬰兒,typical RR 0.87, 95% CI 0.69, 1.08) 或兒童過敏發生率 (一個研究,872位嬰兒,RR 0.91, 95% CI 0.73, 1.14) 沒有明顯差異。研究並沒有檢視長期水解配方對兒童早期過敏有何影響。證據顯示早產兒和低出生體重嬰兒餵食水解早產兒配方會明顯減少體重增加,但沒有影響其他生長參數 (頭圍或身高) 。於足月嬰兒的研究顯示對生長發育沒有不良影響。研究的次群體分析部分水解和牛奶配方,發現前者可明顯降低嬰兒過敏 (六個研究,共1391位嬰兒,typical RR 0.79, 95% CI 0.65, 0.97) ,但對兒童過敏、嬰兒及兒童氣喘、濕疹或鼻炎無差異。對所有的分析在方法學上是採相同的考量。完全水解配方和牛奶配方的試驗分析顯示兩者對過敏或食物不耐受沒有差別。嬰兒餵食完全水解配方比起部分水解配方可明顯降低食物過敏 (兩個研究,341位嬰兒,typical RR 0.43, 95% CI 0.19, 0.99) ,但對所有的過敏和其他特定過敏的發生率並沒有明顯差別。比較完全水解含酪蛋白配方和牛奶配方,一個研究 (431位嬰兒) 報告了可以明顯降低嬰兒過敏發生率 (RR 0.72, 95% CI 0.53, 0.97) 。整合分析發現可以明顯降低嬰兒濕疹 (三個研究,1237位嬰兒,RR 0.72, 95% CI 0.53, 0.97) 。一個研究報告認為可以降低兒童濕疹發生率 (RR 0.66, 95% CI 0.44, 0.98) 和盛行率 (RR 0.50, 95% CI 0.27, 0.92) 。

作者結論

沒有證據顯示支持餵食水解配方比起純母乳可預防過敏。在沒有辦法完全哺育母奶的高風險嬰兒,有限的證據指出長期餵食水解配方比起牛奶配方可減少嬰兒和兒童過敏和嬰兒牛奶過敏。考量到方法學和各個研究結果並不一致,需要之後良好設計的大型試驗來比較部分水解乳清蛋白配方、完全水解酪蛋白配方和牛奶配方。

翻譯人

本摘要由馬偕醫院張龍翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

當嬰兒沒有餵食純母奶時,使用嬰兒水解配方來替換牛奶配方,可能可以減少嬰兒和兒童期的過敏,雖然仍需要後繼更多的研究來證實此論點。某些嬰兒配方設計用於減少產生過敏和食物不耐的機會,包括了水解牛奶和豆奶配方。水解配方將牛奶蛋白分解成更小分子,潛在性可減少對蛋白過敏的機會。這回顧研究發現沒有證據可支持比起母乳,使用水解配方更可避免過敏。對於沒有辦法完全餵食純母奶的過敏高危群嬰兒,有限證據顯示水解配方比起牛奶配方可減少嬰兒及兒童過敏,包括牛奶過敏。考慮到證據的品質和結果的一致性,仍需要後續更進一步的試驗。