title: The effects of a double blind, placebo controlled, artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children.
abstract: OBJECTIVE
  To determine whether artificial food colourings and a preservative in the diet of 3 year old children in the general population influence hyperactive behaviour.
  
  
  METHODS
  A sample of 1873 children were screened in their fourth year for the presence of hyperactivity at baseline (HA), of whom 1246 had skin prick tests to identify atopy (AT). Children were selected to form the following groups: HA/AT, not-HA/AT, HA/not-AT, and not-HA/not-AT (n = 277). After baseline assessment, children were subjected to a diet eliminating artificial colourings and benzoate preservatives for one week; in the subsequent three week within subject double blind crossover study they received, in random order, periods of dietary challenge with a drink containing artificial colourings (20 mg daily) and sodium benzoate (45 mg daily) (active period), or a placebo mixture, supplementary to their diet. Behaviour was assessed by a tester blind to dietary status and by parents' ratings.
  
  
  RESULTS
  There were significant reductions in hyperactive behaviour during the withdrawal phase. Furthermore, there were significantly greater increases in hyperactive behaviour during the active than the placebo period based on parental reports. These effects were not influenced by the presence or absence of hyperactivity, nor by the presence or absence of atopy. There were no significant differences detected based on objective testing in the clinic.
  
  
  CONCLUSIONS
  There is a general adverse effect of artificial food colouring and benzoate preservatives on the behaviour of 3 year old children which is detectable by parents but not by a simple clinic assessment. Subgroups are not made more vulnerable to this effect by their prior levels of hyperactivity or by atopy.
authors.affiliation: Infection, Inflammation and Repair Division, University of Southampton, Southampton, UK.
authors.forename: B
authors.initials: B
authors.lastname: Bateman
authors.forename: J O
authors.initials: JO
authors.lastname: Warner
authors.forename: E
authors.initials: E
authors.lastname: Hutchinson
authors.forename: T
authors.initials: T
authors.lastname: Dean
authors.forename: P
authors.initials: P
authors.lastname: Rowlandson
authors.forename: C
authors.initials: C
authors.lastname: Gant
authors.forename: J
authors.initials: J
authors.lastname: Grundy
authors.forename: C
authors.initials: C
authors.lastname: Fitzgerald
authors.forename: J
authors.initials: J
authors.lastname: Stevenson
mesh_terms: D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000009:adverse effects*; D001565:Benzoates / Q000008:administration & dosage / Q000009:adverse effects*; D002675:Child, Preschool; D018592:Cross-Over Studies; D004032:Diet / Q000009:adverse effects*; D005260:Female; D005503:Food Additives / Q000009:adverse effects; D005505:Food Coloring Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005512:Food Hypersensitivity / Q000178:diet therapy / Q000209:etiology; D006801:Humans; D006948:Hyperkinesis / Q000178:diet therapy / Q000209:etiology*; D008297:Male
chemical_list: D000890:Anti-Infective Agents; D001565:Benzoates; D005503:Food Additives; D005505:Food Coloring Agents