A double-blind assessment of additive intolerance in children using a 12 day challenge period at home.
Alleged food-additive intolerance (respiratory, dermatological, behavioural or abdominal) was assessed in 19 children using daily challenge drinks of either, base product alone, base product plus sunset yellow/tartrazine, or base product plus sodium metabisulphite/sodium benzoate. The same type of drink was given for 12 days, double-blind and in random order. During the trial the children were maintained on an additive-free diet under supervision. Diary cards were used to record symptoms and medication usage. If there was an apparent association between symptoms and drink ingredient the trial was repeated, again double-blind. Additive intolerance was confirmed by a consistent deterioration of symptoms in only three children. In one, urticaria was induced by the colourings, in another extremely abnormal behaviour was induced by the preservatives and a third child was only free of asthma and abdominal pain on placebo. This form of individual trial, using 12 daily drinks, overcomes some of the objections to a single challenge study. Despite this, intolerance to the additives was only confirmed in 3/19 children in whom it had been believed to occur.
Wilson
N
N
Department of Paediatrics, Royal Postgraduate Medical School, Hammersmith Hospital, London.
Scott
A
A
D000293:Adolescent; D000367:Age Factors; D001249:Asthma / Q000150:complications; D001391:Azo Compounds / Q000008:administration & dosage; D001565:Benzoates / Q000008:administration & dosage; D019817:Benzoic Acid; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005503:Food Additives / Q000009:adverse effects*; D005512:Food Hypersensitivity / Q000209:etiology*; D006801:Humans; D008297:Male; D011897:Random Allocation; D013447:Sulfites / Q000008:administration & dosage; D013645:Tartrazine / Q000008:administration & dosage; D014581:Urticaria / Q000150:complications
D001391:Azo Compounds; D001565:Benzoates; D005503:Food Additives; D013447:Sulfites; C005200:sodium metabisulfite; D019817:Benzoic Acid; C005842:6-hydroxy-5-((p- sulfophenyl)azo)-2-naphthalenesulfonic acid disodium salt; D013645:Tartrazine