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Placebo reactions in double-blind, placebo-controlled food challenges in children
B J Vlieg-Boerstra1, S van der Heide, C M A Bijleveld
1Division of Paediatric Pulmonology and Paediatric Allergy, Department of Paediatrics, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Insights
Placebo events occur in 12.9% of double-blind, placebo-controlled food challenges (DBPCFCs) in children, impacting diagnostic accuracy. These events help identify false positives and ensure reliable food allergy diagnoses.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Diagnostics
- Food Hypersensitivity Research
Background:
- Double-blind, placebo-controlled food challenges (DBPCFCs) are a key diagnostic tool for food allergies.
- The role and impact of placebo events in DBPCFCs have not been thoroughly investigated.
Purpose of the Study:
- To analyze the occurrence and characteristics of placebo events during DBPCFCs.
- To evaluate the contribution of placebo events to the diagnostic accuracy of DBPCFCs in pediatric populations.
Main Methods:
- Conducted 132 DBPCFCs in 105 children (aged 0.7-16.6 years) with suspected allergies to common foods.
- Administered placebo and active food challenges separately to assess reactions.
Main Results:
- 17% (12.9%) of placebo challenges resulted in positive events, with varied onset and presentation (immediate/late, objective/subjective).
- Placebo challenges identified 5.4% of active food challenges as false positives, contributing 3% to overall false positive diagnoses.
- Statistical modeling indicated a 12.9% false positive rate across all challenges.
Conclusions:
- Placebo events are common in pediatric DBPCFCs and exhibit diverse clinical features.
- Placebo challenges are crucial for identifying false positive diagnoses and maintaining the integrity of DBPCFCs.
- Statistical analysis of placebo events can refine diagnostic accuracy and guide decisions on repeating challenges.
Background:
A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented.
Objective:
To analyse the occurrence and features of placebo events in DBPCFCs and to assess their contribution to the diagnostic accuracy of the DBPCFC in children.
Methods:
The study population consisted of 132 challenges in 105 sensitized children (age range 0.7-16.6 years, median 5.3 years), who underwent DBPCFCs with cow's milk, egg, peanut, hazelnut and soy. Placebo and active food challenges were performed on different days.
Results:
A total number of 17 (12.9%) positive placebo events occurred, which could be classified as immediate (9/17), late-onset (8/17), objective (11/17) or subjective (6/17). Four of 74 (5.4%) positive active food challenges were revealed to be false positive by administration of a placebo challenge. This is 3% (4/132) of all challenges. When computed by a statistical model, the false positive rate was 0.129 (12.9% of all challenges).
Conclusion:
Placebo events with diverse clinical characteristics occur in DBPCFCs in a significant number of children. The diagnostic significance of the administration of a placebo challenge is first, to identify false positive diagnoses in DBPCFCs by refuting false positive tests in individual patients. Secondly, to allow for blinding of the active food challenge. Thirdly, applying a statistical model demonstrates that some positive challenges may be false positive and that the test may need to be repeated in selected cases.
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