Bakhsh, F.R. (Faisal) (2018) The Eliciting Dose Curves of Placebo Reactions During Milk and Peanut Double-Blind Placebo-Controlled Food Challenges in Children. thesis, Medicine.
Full text available on request.Abstract
Introduction: Food allergy is an important health issue because of its risks on health and its increasing prevalence. There are different methods to diagnose food allergy; the double-blind placebocontrolled food challenge (DBPCFC) is the gold standard to diagnose food allergy. Several factors influence patient’s allergic reaction, one of which is eliciting dose, i.e. the dose of allergen to which a patient reacts. Previous population threshold studies were based on verum reactions, and little is known on placebo threshold distribution curves. Objectives: To produce threshold distribution curves based on placebo reactions in milk and peanut challenges, to compare placebo threshold curves to previous verum threshold curves and assess whether there is a need to modify the interpretation of verum threshold curves. Methods: Only double blinded challenges were included. Placebo reactions were classified into: ‘objective only’ and ‘any’ reactions (includes subjective symptoms). Interval-censoring survival analysis was used for data analysis and to determine subjects’ no observed and low observed adverse effect levels. The Statistical Analysis Software (SAS) was used to fit parametric models to the interval-censored data based on results from previous studies. Pvalue of 0.05 and 95% CI were used to determine significance Results: Placebo ‘objective only’ reactions occurred in 66 and 58 in milk and peanut challenges, respectively. Placebo ‘any’ reactions occurred in 67 and 58 in milk and peanut challenges. In milk and peanut challenges, there was no clumping of placebo reactions at the first or last dose. Although a significant difference was predicted in only one distribution model for objective reactions in milk (i.e. Weibull p=0.005), the difference was of no biological relevance indicated by the 95% CI. Conclusion: No significant differences were predicted when comparing placebo to verum distribution curves. Placebo reactions occur across the entire dose range in challenges. Therefore, there is no need to correct or re-interpret verum population threshold distribution curves.
| Item Type: | Thesis (Thesis) |
|---|---|
| Supervisor name: | Head supervisor and Dubois, A.E.J. and Secondary supervisor and Pettersson, M.E. and Pediatric Pulmonology and Pediatric Allergy Department and University Medical Centre Groningen and University of Groningen |
| Faculty: | Medical Sciences |
| Date Deposited: | 25 Jun 2020 10:58 |
| Last Modified: | 25 Jun 2020 10:58 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/1876 |
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