Medscape — September 10, 2007

Lancet. Published online September 6, 2007.

Artificial Food Additives May Increase Hyperactivity in Children

Laurie Barclay, MD

Artificial food color and additives commonly found in children's food increase the mean level of hyperactivity in children aged 3 years and 8 to 9 years, according to the results of a community-based, randomized, double-blind, placebo-controlled food challenge study published online September 6 in The Lancet. "Artificial food colours and other food additives (AFCA) have long been suggested to affect behaviour in children," write Donna McCann, PhD, from the University of Southampton in the United Kingdom, and colleagues. "Despite the failure of early studies to identify the range of proposed adverse affects, a recent meta-analysis of double-blinded, placebo-controlled trials has shown a significant effect of AFCA on the behaviour of children with ADHD [attention-deficit/hyperactivity disorder]. The possible benefit in a reduction in the level of hyperactivity of the general population by the removal of AFCA from the diet is less well established. The investigators randomized 153 three-year-old and 144 eight- to nine-year-old children to receive a challenge drink containing sodium benzoate and 1 of 2 artificial-food-color-and-additive mixes (A or B) or a placebo mix. The primary outcome measure was a global hyperactivity aggregate, derived from aggregated z scores of observed behaviors and teacher and parent ratings, as well as from a computerized test of attention for 8- to 9-year-old children. For reasons not related to childhood behavior, 16 three-year-old children and 14 eight- to nine-year-old children dropped out of the study. Compared with placebo, mix A, but not mix B, had a significantly adverse effect on the global hyperactivity aggregate for all 3-year-old children (effect size, 0.20; 95% confidence interval [CI], 0.01 - 0.39; P = .044). When the analysis was restricted only to those 3-year-old children who consumed more than 85% of juice and had no missing data, the findings were similar (effect size, 0.32; 95% CI, 0.05 - 0.60; P = .02). For 8- to 9-year-old children who consumed at least 85% of drinks and had no missing data, there were significantly adverse effects compared with placebo for either mix A (effect size, 0.12; 95% CI, 0.02 - 0.23; P = .023) or mix B (effect size, 0.17; 95% CI, 0.07 - 0.28; P = .001). "Artificial colours or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population," the authors write. "We recorded substantial individual differences in the response of children to the additives. For both age groups, no significant effect of social and demographic factors was seen on the initial level of GHA [global hyperactivity aggregate] or in the moderation of the challenge effects." Study limitations include inability to determine specific compounds in the mix that are harmful and lack of control over when the challenges are ingested in relation to the timing of measures of hyperactivity. "Although the use of artificial colouring in food manufacture might seem superfluous, the same cannot be said for sodium benzoate, which has an important preservative function," the authors conclude. "The implications of these results for the regulation of food additive use could be substantial." The Food Standards Agency funded this study. The authors have disclosed no relevant financial relationships.

Clinical Context

According to the authors of the current study, artificial food colors and additives have been shown to affect behavior in children, with an increase in overactive, impulsive, and inattentive behavior, (ie, hyperactivity, similar to that seen in children with ADHD). A recent meta-analysis showed a significant effect of artificial food color and additives on the behavior of children with ADHD, with an effect size of 0.21 to 0.28. This is a community-based, double-blind, placebo-controlled, within-subject, crossover, food challenge study designed to examine the effect of 2 types of artificial food color and additive preparations (representing typical consumption of sweets or candies) on 3- and 8- to 9-year-old children.

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