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critical appraisal following CASP tool for systematic reviews
Objective: to determine whether feeding infants with hydrolysed formula reduces their risk of allergic or autoimmune disease
included studies of any hydrolysed formula of cows’ milk origin as the intervention of interest, compared with any non-hydrolysed cows’ milk formula, human milk, or another type of hydrolysed cows’ milk formula
studies of hydrolysed formula of milk other than cows’ milk, such as hydrolysed rice, goats’ milk, or soya formula were not included
Atopic and autoimmune outcomes were selected on the basis of their population prevalence in children and young adults in the UK and/or other affluent nations
included diseases with a prevalence of at least one in 1000 children/adolescents or young adults (aged <40)
Population
Intervention
Comparison
Outcome
excluded studies in which infants or their mothers were defined by the presence of a pre-existing
disease state, including very low birth weight or premature infants
young adults (aged <40) but did not include rarer diseases
MEDLINE
EMBASE
Cochrane Library
Web of Science
LILACS
included all studies published up to that date and studies in progress or completed but unpublished identified through http://apps.who.int/trialsearch/
included all eligible publications, regardless of the language
follow up from reference lists
unpublished as well as published studies
non-English language studies
hand search
personal contact with experts
perhaps could have looked in other databases?
perhaps could have looked at other grey literature?
Two authors assessed the quality of included studies using the Cochrane risk of bias tool
Fig 1. Summary of risk of bias and conflict of interest in included studies reporting allergic outcomes and type 1 diabetes mellitus, showing proportion of studies with high, low, or unclear risk of bias in each domain.
reasons for any variations in results are discussed
results of all the included studies are clearly displayed
Table 1: Grades of Recommendation, Assessment, Development and Evaluation (GRADE) assessment and summary of key findings of review of studies of hydrolysed formula and risk of allergic or autoimmune disease
results of the studies have been combined
a meta-analysis was performed
forest plots
The original search identified 16 289 original titles.
Screening of titles, abstracts, and full text gave 52 studies - 37 intervention trials - of hydrolysed formula, including over 19 000 participants.
There were 28 randomised controlled trials, 6 quasi-randomised controlled trials, and 3 controlled clinical trials describing allergic or autoimmune outcomes.
95% confidence intervals
Fig 3 Summary of treatment effects of hydrolysed formula on different outcome measures:
Data shown are mean risk ratios (for allergic rhinitis at age 0-4; food allergy; allergic sensitisation; diabetes) or odds ratios (all other outcomes) with 95% confidence intervals for extensively hydrolysed formula compared with standard cows’ milk formula
Limitations of the study?
In many cases study participants were infants with early full formula feeding
"so our findings might not be applicable to populations with more typical feeding patterns"
9. Were all
important outcomes considered ?
all outcomes were considered and discussed in relation to the research question
Strengths of the study
Many studies of allergic outcomes included in this review had unclear or high risk of bias and evidence of conflict of interest, often because of inadequate methods of randomisation and treatment allocation (selection bias) and support of the study or investigators from manufacturers of hydrolysed formula.
- current recommendations to use hydrolysed formula in place of standard cows’ milk formula to prevent allergy in infants at high risk should be revised
- any future trials on hydrolysed formula should be prospectively registered, independently funded, and include adequate oversight to ensure that they do not negatively impact on breastfeeding in study participants
There is no consistent evidence to support the use of hydrolysed formula for the prevention of allergic or autoimmune disease.