A comparison of double-blind, placebo-controlled food challenge and open food challenge. 2023

Frederik Bloch Jessen, and Charlotte G Mortz, and Esben Eller, and Julie H Gudichsen, and Emil A Baekdal, and Carsten Bindslev-Jensen
Department of Dermatology and Allergy Centre, Odense Research Center for Anaphylaxis (ORCA), Odense University Hospital, Odense, Denmark.

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.

UI MeSH Term Description Entries
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005502 Food Substances taken in by the body to provide nourishment. Foods
D005512 Food Hypersensitivity Gastrointestinal disturbances, skin eruptions, or shock due to allergic reactions to allergens in food. Allergy, Food,Food Allergy,Hypersensitivity, Food,Allergies, Food,Food Allergies,Food Hypersensitivities,Hypersensitivities, Food
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000485 Allergens Antigen-type substances that produce immediate hypersensitivity (HYPERSENSITIVITY, IMMEDIATE). Allergen
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D021183 Peanut Hypersensitivity Allergic reaction to peanuts that is triggered by the immune system. Hypersensitivity, Peanut,Peanut Allergy,Allergy, Peanut,Groundnut Hypersensitivity,Allergies, Peanut,Hypersensitivity, Groundnut,Peanut Allergies

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