Hormesis in tartrazine allergic responses of atopic patients: An overview of clinical trials and a raw data revision

Abstract

Controversies regarding the safety of Tartrazine in food and medicines concern globally, as it remains without any ban or restriction to allergy sufferers. Studies applying double-blind controlled by placebo/randomized controlled trials are scarce. In general, the literature refutes its adverse reactions in allergic patients when their outcomes are compared to placebo groups. The aim of this study is to review outcomes after Tartrazine consumption showing its adverse reactions, also revising the Morais et al. raw data in a dose-time dependent approach. The search comprised articles published from 1970 to 2019, selected from Medline, PubMed, Cochrane, and Libraries. Cross-references of additional papers were also reviewed. Outcomes (bronchial asthma, rhinitis, urticaria and/or sensitivity to nonsteroidal anti-inflammatory drugs) were scored accordingly using a zero-inflated statistical model. Peak expiratory flow changes were also considered. Meaningful outcomes from the articles reviewed were mostly irrelevant. Revising the raw data atopic patients, global results from placebo were 24.6% above the baseline whereas with Tartrazine groups were 47.4% over, somehow maximized by incrementing the number of volunteers. Cumulative responses were observed in patients under normal diet. Unequally, to most articles reviewed, the revised data showed statistical differences, diverging from the normal dose-response curve (S-shaped). In Tartrazine susceptible patients, conservatively representing 2.5% of the population, biological variations prevail. A hormetic U-shaped curve may suits as opposed to a sigmoid-shaped curve. It similarly occurred in mast cells where the release of 6-Hexosaminidase is inhibited by Tartrazine. Low-dose clinical trials should be performed in susceptible patients to ascertain these statements.