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.
RCT Entities:
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: Wouter W de Weger; Aline B Sprikkelman; Catherina E M Herpertz; Gerbrich N van der Meulen; Judith M Vonk; Arvid W A Kamps; Gerard H Koppelman Journal: Pediatr Allergy Immunol Date: 2021-09-09 Impact factor: 5.464
Authors: Anders van Thuijl; Anne-Fleur Schoemaker; Stef Menting; Jennifer van Dulmen; Janne Boeting; Wim van Aalderen; Gerben ter Riet; Aline Sprikkelman Journal: Eur J Pediatr Date: 2012-12-08 Impact factor: 3.183
Authors: Alessandro Fiocchi; Jan Brozek; Holger Schünemann; Sami L Bahna; Andrea von Berg; Kirsten Beyer; Martin Bozzola; Julia Bradsher; Enrico Compalati; Motohiro Ebisawa; Maria Antonieta Guzman; Haiqi Li; Ralf G Heine; Paul Keith; Gideon Lack; Massimo Landi; Alberto Martelli; Fabienne Rancé; Hugh Sampson; Airton Stein; Luigi Terracciano; Stefan Vieths Journal: World Allergy Organ J Date: 2010-04-23 Impact factor: 4.084