Shelley Dua1, Monica Ruiz-Garcia2, Simon Bond3, Stephen R Durham4, Ian Kimber5, Clare Mills6, Graham Roberts7, Isabel Skypala8, James Wason9, Pamela Ewan10, Robert Boyle11, Andrew Clark12. 1. Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom. Electronic address: shelley.dua@addenbrookes.nhs.uk. 2. Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom. 3. Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom. 4. Allergy and Clinical Immunology, Section Inflammation Repair and Development National heart and Lung Institute, Faculty of Medicine, Imperial College, London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom. 5. Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom. 6. Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, United Kingdom. 7. NIHR Southampton Respiratory Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; University of Southampton Faculty of Medicine, Southampton, United Kingdom. 8. National Heart and Lung Institute, Imperial College London and Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom. 9. MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, United Kingdom; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom. 10. Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom. 11. Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; Centre of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom. 12. Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom; Department of Allergy, Addenbrooke's Hospital, Cambridge, United Kingdom.
Abstract
BACKGROUND: Peanut allergy causes severe and fatal reactions. Current food allergen labeling does not address these risks adequately against the burden of restricting food choice for allergic patients because of limited data on thresholds of reactivity and the influence of everyday factors. OBJECTIVE: We estimated peanut threshold doses for a United Kingdom population with peanut allergy and examined the effect of sleep deprivation and exercise. METHODS: In a crossover study, after blind challenge, participants with peanut allergy underwent 3 open peanut challenges in random order: withexercise after each dose, with sleep deprivation preceding challenge, and with no intervention. Primary outcome was the threshold dose triggering symptoms (in milligrams of protein). Primary analysis estimated the difference between the nonintervention challenge and each intervention in log threshold (as percentage change). Dose distributions were modeled, deriving eliciting doses in the population with peanut allergy. RESULTS: Baseline challenges were performed in 126 participants, 100 were randomized, and 81 (mean age, 25 years) completed at least 1 further challenge. The mean threshold was 214 mg (SD, 330 mg) for nonintervention challenges, and this was reduced by 45% (95% CI, 21% to 61%; P = .001) and 45% (95% CI, 22% to 62%; P = .001) for exercise and sleep deprivation, respectively. Mean estimated eliciting doses for 1% of the population were 1.5 mg (95% CI, 0.8-2.5 mg) during nonintervention challenge (n = 81), 0.5 mg (95% CI, 0.2-0.8 mg) after sleep, and 0.3 mg (95% CI, 0.1-0.6 mg) after exercise. CONCLUSION: Exercise and sleep deprivation each significantly reduce the threshold of reactivity in patients with peanut allergy, putting them at greater risk of a reaction. Adjusting reference doses using these data will improve allergen risk management and labeling to optimize protection of consumers with peanut allergy.
RCT Entities:
BACKGROUND:Peanutallergy causes severe and fatal reactions. Current food allergen labeling does not address these risks adequately against the burden of restricting food choice for allergicpatients because of limited data on thresholds of reactivity and the influence of everyday factors. OBJECTIVE: We estimated peanut threshold doses for a United Kingdom population with peanutallergy and examined the effect of sleep deprivation and exercise. METHODS: In a crossover study, after blind challenge, participants with peanutallergy underwent 3 open peanut challenges in random order: with exercise after each dose, with sleep deprivation preceding challenge, and with no intervention. Primary outcome was the threshold dose triggering symptoms (in milligrams of protein). Primary analysis estimated the difference between the nonintervention challenge and each intervention in log threshold (as percentage change). Dose distributions were modeled, deriving eliciting doses in the population with peanutallergy. RESULTS: Baseline challenges were performed in 126 participants, 100 were randomized, and 81 (mean age, 25 years) completed at least 1 further challenge. The mean threshold was 214 mg (SD, 330 mg) for nonintervention challenges, and this was reduced by 45% (95% CI, 21% to 61%; P = .001) and 45% (95% CI, 22% to 62%; P = .001) for exercise and sleep deprivation, respectively. Mean estimated eliciting doses for 1% of the population were 1.5 mg (95% CI, 0.8-2.5 mg) during nonintervention challenge (n = 81), 0.5 mg (95% CI, 0.2-0.8 mg) after sleep, and 0.3 mg (95% CI, 0.1-0.6 mg) after exercise. CONCLUSION: Exercise and sleep deprivation each significantly reduce the threshold of reactivity in patients with peanutallergy, putting them at greater risk of a reaction. Adjusting reference doses using these data will improve allergen risk management and labeling to optimize protection of consumers with peanutallergy.
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