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Comparison of open and double-blind placebo-controlled food challenges in diagnosis of food hypersensitivity amongst children

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Abstract Background 

Correct diagnosis of food hypersensitivity (FHS) is important to ensure appropriate patient care and to accurately establish the population prevalence and incidence. Food challenges play a very important role in the diagnosis of FHS, but it is unclear when open food challenges (OFCs) opposed to double-blind placebo-controlled food challenges (DBPCFCs) should be used. This study investigated the use of OFCs and DBPCFCs when diagnosing FHS. Methods 

Children with a reported history of FHS or with sensitization to a food without known previous consumption were invited to undergo food challenges. Children of consenting parents underwent an OFC and those with a positive OFC were approached to undergo a DBPCFC. Food challenges were either performed as 1-day or 1-week challenges depending on sensitization status and clinical history. Results 

Forty-one children underwent both OFCs and DBPCFCs. The positive predictive values for 1-day and 1-week OFCs were 73% (8/11; 95% CI: 39–94%) and 57% (20/35; 95% CI: 39–74%) respectively. There was no evidence to indicate that the younger children were more likely to have a positive OFC confirmed by a DBPCFC compared to older children (Fisher’s exact P = 0.53). In the 1-day challenges parents indicated a preference for OFC rather than DBPCFC. By contrast, in the 1-week challenge parents indicated a preference for DBPCFC (P = 0.0192). Conclusion 

Open food challenge may be suitable for diagnosing immediate objective symptoms, whereas DBPCFC may be needed for the diagnosis of delayed and mainly subjective symptoms, irrespective of the child’s age.

Keywords: diagnosis of food allergy/intolerance; double-blind placebo-controlled food challenges; food challenges; food hypersensitivity in children; open food challenges

Document Type: Research Article


Affiliations: 1: The David Hide Asthma and Allergy Research Centre, St Mary’s Hospital, Newport, Isle of Wight, UK 2: School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, UK

Publication date: 2007-12-01

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