A comparison of double-blind, placebo-controlled food challenge and open food challenge.
double-blind, placebo-controlled food challenge
food allergy
open food challenge
severity of symptoms
threshold values
Journal
Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
revised:
12
06
2023
received:
28
12
2022
accepted:
23
06
2023
medline:
4
12
2023
pubmed:
4
8
2023
entrez:
4
8
2023
Statut:
ppublish
Résumé
Double-blind, placebo-controlled food challenge (DBPCFC) remains the gold standard for diagnosing food allergy, despite sparse comparisons to open food challenges (OpenFCs). The objective of this retrospective study was to compare severity of symptoms and threshold values (cumulative dose of food allergen eliciting a clinical reaction) in children and adults with peanut allergy, challenged in an open and/or double-blind, placebo-controlled protocol. This study included patients from the Allergy Centre, Odense University Hospital with a positive oral food challenge, defined as strict objective signs, with peanut during the period 2001-2022. Severity of symptoms was graded using the Sampson's severity score. Distribution models of threshold values were calculated using log-normal interval-censored survival analysis, and the number of placebo reactions was evaluated. In total, 318 positive OpenFCs and 86 DBPCFCs were included. There was no difference in severity of symptoms nor threshold values comparing the two challenge types, neither when stratified for age groups. However, a higher proportion of children experienced Grade 3 symptoms in the double-blind group. Only one patient had a positive reaction to a placebo challenge. Our findings do not advocate for DBPCFC being superior to OpenFC, if the latter is performed with strict objective stop criteria by trained staff.
Sections du résumé
BACKGROUND
Double-blind, placebo-controlled food challenge (DBPCFC) remains the gold standard for diagnosing food allergy, despite sparse comparisons to open food challenges (OpenFCs). The objective of this retrospective study was to compare severity of symptoms and threshold values (cumulative dose of food allergen eliciting a clinical reaction) in children and adults with peanut allergy, challenged in an open and/or double-blind, placebo-controlled protocol.
METHODS
This study included patients from the Allergy Centre, Odense University Hospital with a positive oral food challenge, defined as strict objective signs, with peanut during the period 2001-2022. Severity of symptoms was graded using the Sampson's severity score. Distribution models of threshold values were calculated using log-normal interval-censored survival analysis, and the number of placebo reactions was evaluated.
RESULTS
In total, 318 positive OpenFCs and 86 DBPCFCs were included. There was no difference in severity of symptoms nor threshold values comparing the two challenge types, neither when stratified for age groups. However, a higher proportion of children experienced Grade 3 symptoms in the double-blind group. Only one patient had a positive reaction to a placebo challenge.
CONCLUSION
Our findings do not advocate for DBPCFC being superior to OpenFC, if the latter is performed with strict objective stop criteria by trained staff.
Substances chimiques
Allergens
0
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3204-3211Informations de copyright
© 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
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