Methods: Double-blind crossover placebo controlled test in 77 adult patients using either 5, 10 and 20mg of both placebo or tartrazine, 50 minutes interval between each dose
Results: Some clinical parameter showed significant changes when pruindividuals were challenged with tartrazine such as reduction of respiratory peak flow, angioedema, nasal congestion, runny nose, wheezing, rash, pruritus and hives. Nearly 5% of these had an increase of tartrazine IgE levels. Measurements such as arterial blood pressure, heart beat and other respiratory rate, axillary temperature, sneeze/nose itching or cough were not abnormal between the groups.
Conclusions: These adverse alergic reactions were mainly observed in the skin and just in the peak flow of patients that used tartrazine as compared with the positive control placebo tested. Significat reactions mainly occurred when an expressive number of patients a double-blind crossed-over placebo tartrazine doses were applied .