McCann Donna, Barrett Angelina, Cooper Alison, Crumpler Debbie, Dalen Lindy, Grimshaw Kate, Kitchin Elizabeth, Lok Kris, Porteous Lucy, Prince Emily, Sonuga-Barke Edmund, Warner John O, Stevenson Jim
School of Psychology, Department of Child Health, University of Southampton, Southampton, UK.
Lancet. 2007 Nov 3;370(9598):1560-7. doi: 10.1016/S0140-6736(07)61306-3.
We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour.
153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.
16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behaviour. Mix A had a significantly adverse effect compared with placebo in GHA for all 3-year-old children (effect size 0.20 [95% CI 0.01-0.39], p=0.044) but not mix B versus placebo. This result persisted when analysis was restricted to 3-year-old children who consumed more than 85% of juice and had no missing data (0.32 [0.05-0.60], p=0.02). 8/9-year-old children showed a significantly adverse effect when given mix A (0.12 [0.02-0.23], p=0.023) or mix B (0.17 [0.07-0.28], p=0.001) when analysis was restricted to those children consuming at least 85% of drinks with no missing data.
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.
我们进行了一项随机、双盲、安慰剂对照的交叉试验，以测试人工食用色素和添加剂（AFCA）的摄入是否会影响儿童行为。
153名3岁儿童和144名8/9岁儿童纳入本研究。激发饮料含有苯甲酸钠和两种AFCA混合物（A或B）之一或安慰剂混合物。主要结局指标是一个综合多动总量（GHA），基于观察到的行为的汇总z分数以及教师和家长的评分，此外，对于8/9岁儿童，还有一项注意力的计算机化测试。该临床试验已在当前对照试验注册（注册号ISRCTN74481308）。分析按方案进行。
16名3岁儿童和14名8/9岁儿童因与儿童行为无关的原因未完成研究。对于所有3岁儿童，混合物A与安慰剂相比在GHA方面有显著不良影响（效应量0.20 [95% CI 0.01 - 0.39]，p = 0.044），但混合物B与安慰剂相比则没有。当分析仅限于饮用超过85%果汁且无缺失数据的3岁儿童时，该结果仍然存在（0.32 [0.05 - 0.60]，p = 0.02）。当分析仅限于饮用至少85%饮料且无缺失数据的8/9岁儿童时，给予混合物A（0.12 [0.02 - 0.23]，p = 0.023）或混合物B（0.17 [0.07 - 0.28]，p = 0.001）时显示出显著不良影响。
饮食中的人工色素或苯甲酸钠防腐剂（或两者）会导致普通人群中3岁和8/9岁儿童多动增加。
