Standardization of double blind placebo controlled food challenge with soy within a multicentre trial

Table 2 Characteristics of DBPCFC positive and DBPCFC negative subjects

	DBPCFC negative (n)	DBPCFC positive (n)	differences with α = 5% between groups
Number of subjects	56 (40.6%)	82 (59.4%)
Maximum soy challenge meal level 9 applied	53 (94.6% [85.4; 98.2])	51 (62.2% [51.4; 71.9])	Significant
Maximum placebo challenge meal level 9 applied	48 (85.7%[74.3; 92.6])	77 (93.9% [86.5; 97.4])	n.s.
Objective signs (O1-10) at soy challenge meal (in n patients)	5 (8.9% [3.9; 19.3])	58 (70.7% [61.4; 80.5])	Significant
Subjective symptoms (S1–8) at soy challenge meal (single type or sum type)	20 (35.7% [24.5; 48.8])	70 (85.4% [76.1; 91.4])	Significant
Major placebo reactions objective type^a	19 (33.9% [24.5; 48.8])	0 (0% [0; 4.5])	Significant
Major placebo reactions subjective type^a	27 (48.2% [35.7; 61.0])	10 (12.2% [6.8; 21.0])	Significant

Maximum dose levels applied and occurrence of objective signs, subjective symptoms and major placebo reactions in DBPCFC positive and DBPCFC negative patients at soy and placebo challenge meals. 95% confidence intervals are given (per cent based on the number of patients per group; in case of non-overlapping confidence intervals significant differences with α = 5% between populations exist)
n.s. not significant
^aFor definition of Major placebo reactions see Table 1

ISSN: 2045-7022