Hyperkinesis and diet: a double-blind crossover trial with a tartrazine challenge. 1978

F Levy, and S Dumbrell, and G Hobbes, and M Ryan, and N Wilton, and J M Woodhill

A pilot study was conducted on 22 children (19 boys and three girls) aged between four and eight years, who were selected as hyperactive on the basis of developmental history and clinical judgement. Conners' parent-teacher ratings, objective tests of attention, standard perceptualmotor tests and subtests from the Wechsler Intelligence Scale for Children (WISC), were used as response variables. The children were tested before and after four weeks on the elimination diet, after a tartrazine and placebo challenge, and, finally, after a four-week washout period on the diet. Results showed a statistically significant improvement in the mothers' ratings of the children's behaviour after the first four weeks of the diet. The improvement was maintained in a combined analysis of the initial four-week diet period and four-week washout period. This result was not substantiated by the statistical analysis of the results from objective tests. The rating scales and objective tests for the full sample did not show a statistically significant deterioration in the children's behaviour when they were challenged under double-blind test conditions with the Yellow Dye No. 5, tartrazine, and the tests were conducted the day after a two-week challenge period. A comparison of mother ratings of behaviour during challenge and placebo double-blind trial and in the 24 hours preceding tests, in a subgroup of the children who, while on the diet, showed a 25% reduction of symptoms on the Conner's rating scale, indicated a significant challenge effect (P less than 0.025), with mothers reporting more symptoms during the challenge period. Dietary infringements with suspected trigger substances occurred throughout the trial.

UI MeSH Term Description Entries
D010349 Patient Compliance Voluntary cooperation of the patient in following a prescribed regimen. Client Adherence,Client Compliance,Non-Adherent Patient,Patient Adherence,Patient Cooperation,Patient Noncompliance,Patient Non-Adherence,Patient Non-Compliance,Patient Nonadherence,Therapeutic Compliance,Treatment Compliance,Adherence, Client,Adherence, Patient,Client Compliances,Compliance, Client,Compliance, Patient,Compliance, Therapeutic,Compliance, Treatment,Cooperation, Patient,Non Adherent Patient,Non-Adherence, Patient,Non-Adherent Patients,Non-Compliance, Patient,Nonadherence, Patient,Noncompliance, Patient,Patient Non Adherence,Patient Non Compliance,Patient, Non-Adherent,Therapeutic Compliances,Treatment Compliances
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D006948 Hyperkinesis Excessive movement of muscles of the body as a whole, which may be associated with organic or psychological disorders. Hyperactivity, Motor,Hyperkinesia,Hyperkinesia, Generalized,Hyperkinetic Movements,Generalized Hyperkinesia,Generalized Hyperkinesias,Hyperkinesias, Generalized,Hyperkinetic Movement,Motor Hyperactivity,Movement, Hyperkinetic,Movements, Hyperkinetic
D001391 Azo Compounds Organic chemicals where aryl or alkyl groups are joined by two nitrogen atoms through a double bond (R-N Azo Dye,Azo Dyes,Compounds, Azo,Dye, Azo,Dyes, Azo
D013645 Tartrazine An anionic, hydrophilic azo dye with an orange-yellow color used in fabrics, foods and cosmetics, and as a biological stain. FD & C Yellow No. 5,FD&C Yellow No. 5,Tartrazine Barium,Tartrazine Barium (2:3),Barium, Tartrazine

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