Table 1.
Control (n=46) | Active (n=39) | p value | |
---|---|---|---|
First phase | |||
Number desensitised | 0 | 24 | <0·001* |
Number not desensitised | 46 | 15 | |
Proportion desensitised | 0 (0 to 0·091) | 0·62 (0·45 to 0·78) | .. |
Proportion able to tolerate daily ingestion | 0 | 0·84 (0·70 to 0·93) | .. |
Median absolute change in NOAEL, mg | 0 (−95 to 45) | 1345 (45 to 1400) | 0·002, <0·001† |
Median fold change in NOAEL, mg | 0·81 (0·05 to 1·82) | 25·5 (1·82 to 280) | 0·003, <0·001† |
Median NOAEL after first phase, mg‡ | 5 (5 to 400) | 1400 (100 to 1400) | <0·001§ |
Second phase | |||
Proportion desensitised | 0·54 (0·35 to 0·72) | .. | .. |
Proportion able to tolerate daily ingestion | 0·91 (0·79 to 0·98) | .. | .. |
Median change in FAQLQ-PF score from baseline to post-treatment | −1·41 (−4·83 to 1·38)¶ | −1·61 (−4·87 to 0·24)‖ | <0·001, <0·001** |
Data are proportion (95% CI) or median (range). NOAEL=no observed adverse effect level. FAQLQ-PF=Food Allergy Quality of Life Questionnaire—Parent Form for 5–12 years.
From Fisher's exact test.
From Wilcoxon signed rank tests.
Median difference in NOAEL between groups was 1395 mg (95% CI 395 to 1395); p<0·001 (from Mann Whitney U test).
From Mann Whitney U test.
n=20.
n=19.
From Wilcoxon signed rank tests.