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Placebo reactions in double-blind, placebo-controlled food challenges in children.
Allergy. 2007 Aug; 62(8):905-12.A

Abstract

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.

Authors+Show Affiliations

Division of Paediatric Pulmonology and Paediatric Allergy, Department of Paediatrics, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17620068

Citation

Vlieg-Boerstra, B J., et al. "Placebo Reactions in Double-blind, Placebo-controlled Food Challenges in Children." Allergy, vol. 62, no. 8, 2007, pp. 905-12.
Vlieg-Boerstra BJ, van der Heide S, Bijleveld CM, et al. Placebo reactions in double-blind, placebo-controlled food challenges in children. Allergy. 2007;62(8):905-12.
Vlieg-Boerstra, B. J., van der Heide, S., Bijleveld, C. M., Kukler, J., Duiverman, E. J., & Dubois, A. E. (2007). Placebo reactions in double-blind, placebo-controlled food challenges in children. Allergy, 62(8), 905-12.
Vlieg-Boerstra BJ, et al. Placebo Reactions in Double-blind, Placebo-controlled Food Challenges in Children. Allergy. 2007;62(8):905-12. PubMed PMID: 17620068.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo reactions in double-blind, placebo-controlled food challenges in children. AU - Vlieg-Boerstra,B J, AU - van der Heide,S, AU - Bijleveld,C M A, AU - Kukler,J, AU - Duiverman,E J, AU - Dubois,A E J, PY - 2007/7/11/pubmed PY - 2007/10/18/medline PY - 2007/7/11/entrez SP - 905 EP - 12 JF - Allergy JO - Allergy VL - 62 IS - 8 N2 - 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. SN - 0105-4538 UR - https://www.unboundmedicine.com/medline/citation/17620068/Placebo_reactions_in_double_blind_placebo_controlled_food_challenges_in_children_ L2 - https://doi.org/10.1111/j.1398-9995.2007.01430.x DB - PRIME DP - Unbound Medicine ER -