Abstract
Background
We previously reported that Probiotic and Peanut Oral Immunotherapy (PPOIT) was effective at inducing sustained unresponsiveness compared with placebo in a double-blind, placebo-controlled randomized trial. This study evaluated the impact of PPOIT on health related quality of life (HRQL).
Method
Fifty-one participants (PPOIT 24; Placebo 27) from the PPOIT trial completed Food Allergy Quality of Life Questionnaire (FAQLQ-PF) and Food Allergy Independent Measure (FAIM) at pre-treatment, end-of-treatment and 3-months after end-of-treatment. 42 participants (20 PPOIT; 22 Placebo) completed measures at 12 months post-treatment. Changes over time in PPOIT and Placebo groups were examined by repeated measures analysis of variance and paired t-tests.
Results
PPOIT was associated with significant improvement in FAQLQ-PF (F=3.63, p=0.02), with Mean Difference 0.8 at 3 months post-treatment (p=0.05) and 1.3 at 12 months post-treatment (p=0.005), exceeding the 0.5 minimal clinically important difference for FAQLQ-PF. For FAIM, mean difference was 0.5 (p=0.03) at 3 months and 0.4 (p=0.04) at 12 months. In placebo group, post-treatment FAQLQ and FAIM remained unchanged from pre-treatment. Improvement in FAQLQ-PF and FAIM scores related specifically to acquisition of sustained unresponsiveness rather than to receiving PPOIT treatment or participation in the trial.
Conclusions
PPOIT has a sustained beneficial effect on psychosocial impact of food allergy at 3 months and 12 months after end-of-treatment. Treatment was not associated with reduced HRQL relative to baseline in either PPOIT or placebo groups, indicating that PPOIT was well tolerated and psychological wellbeing was not negatively impacted. Improved HRQL was specifically associated with acquisition of sustained unresponsiveness.
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