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Table 2 Characteristics of DBPCFC positive and DBPCFC negative subjects

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

  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 typea 19
(33.9% [24.5; 48.8])
0
(0% [0; 4.5])
Significant
Major placebo reactions subjective typea 27
(48.2% [35.7; 61.0])
10
(12.2% [6.8; 21.0])
Significant
  1. 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)
  2. n.s. not significant
  3. aFor definition of Major placebo reactions see Table 1