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Consensus Development Conference Statement January 13-15, 1982
This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/. This statement was originally published as: Defined Diets and Childhood Hyperactivity. NIH Consens Statement 1982 Jan 13-15;4(3):1-11. For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Defined Diets and Childhood Hyperactivity. NIH Consens Statement Online 1982 Jan 13-15 [cited year month day];4(3):1-11.IntroductionA Consensus Development Conference was held at the National Institutes of Health on January 13, 14, and 15, 1982, to seek positions on issues involving defined diets and childhood hyperactivity. At NIH, Consensus Development Conferences bring together biomedical investigators, practicing physicians, consumers, and health advocacy groups to provide a scientific assessment of technologies, including drugs, devices, and procedures, and to seek agreement on their safety and effectiveness. On the first two days of the meeting, experts presented evidence to a Consensus Development Panel and members of the audience on the following key questions:
Panel members were drawn from the lay public, biomedical research, pediatrics, nutrition, immunology and allergy, clinical pharmacy, psychiatry and behavioral sciences, genetics, education, epidemiology, biostatistics, environmental health, and law, all relevant to a discussion of diets and childhood hyperactivity. Childhood hyperactivity, officially termed the "attention deficit disorder with hyperactivity," but variously referred to as "hyperkinetic reaction of childhood," "hyperkinetic syndrome," "hyperactive child syndrome," "minimal brain damage," "minimal brain dysfunction," "minimal cerebral dysfunction," and "minor cerebral dysfunction," is an important health concern affecting afflicted children, their families, and those around them. Traditional therapy for this condition has included behavior modification, educational techniques, psychotherapy, and pharmacotherapy--most prominently amphetamine-like medications. The 1973 report by Feingold of clinical observations on the benefit of a diet free of salicylates and food additives on hyperactivity focused attention on this new treatment approach. The publication of the Feingold diet in book form came at a time of increasing public concern about environmental pollution and a desire for full knowledge of all additives found in prepared food and the presence of such substances in the diet. These trends, along with a heightened aversion to habitual use of medication, an increase in awareness of the possible causative role of nutritional factors in diseases of many types, a desire for self-involvement in health care, and the frustration encountered in managing childhood hyperactivity, led to the widespread experimentation with the Feingold regimen and other defined diets. Some controlled, double-blind studies
indicate that these diets are only occasionally efficacious. Apparent
discrepancies between some clinical impressions of efficacy and much of
the available scientific evidence prompted the scheduling of this
Consensus Development Conference. What Constitutes the Hyperactivity Syndrome in Children? Is It a Single Disease or a Cluster of Diseases? Can It Be Graded or Scaled in Quantifiable Variables Such as Attention Span, Learning Ability, and Social Adjustment and By Whom (Teachers, Parents, Medical Personnel)?Innumerable definitions have been offered for the hyperactivity syndrome in children. The latest of these, in Diagnostic and Statistical Manual III (DSM III) (the American Psychiatric Association), delineates the varied symptomatology in this behavioral syndrome. According to DSM III,"the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity." Other diagnostic qualifiers include onset prior to the age of 7, a duration of no less than 6 months, and a proven absence of mental illness or mental retardation. The cluster of symptoms does not represent a single disease, nor is it likely that the etiology is singular; rather, the syndrome may be secondary to (1) organic factors such as trauma, infection, lead intoxication, and significant perinatal hypoxia; (2) predisposing genetic (familial) factors; or (3) psychosocial factors such as anxiety, inadequate parenting, and environmental stresses. In most cases the etiology is unknown and may be the result of synergism of several of the predisposing factors listed above. The diagnostic process optimally includes the participation of parents, medical personnel, teachers, psychologists, and social workers. Several useful tests and rating scales for quantification of important variables such as attention span, learning ability, and social adjustment are available to those involved in the process; however, a need for more concise assessment tools is apparent. The recent development of electronic devices for measuring motor activity may prove helpful in providing a more refined quantitation of attention span and hyperactivity. If progress is to continue in treatment of
hyperactivity, it will be necessary to improve accuracy in diagnosis and
to develop objective methods to monitor the effect of each approach to
treatment and the course of the patient. What Are the Defined Diets?The term "defined diets" includes several dietary modifications. The basic diet described by Feingold eliminated two groups of foods: Group I consists of almonds, cucumbers, tomatoes, berries, apples, oranges, and several other fruits. These were excluded because of high levels of naturally occurring salicylates. Group II includes foods known or thought to contain artificial colors and flavors (most of these latter foods were perceived by the public as "processed"). This category was largely selected on the basis of ingredient (including additive) labeling and standards of food identity. With the exception of BHT (butylated hydroxytoluene), foods containing preservatives were not excluded from the original Feingold diet. No restrictions were placed on homemade sweets, but commercially prepared desserts and other foods to which relatively high amounts of sucrose had been added were usually disallowed on the basis of their content of artificial color and/or flavors. Defined diets came to include certain modifications of the Feingold diet. Excluded from experimental diets were foods containing BHA (butylated hydroxyanisole) and sodium benzoate; certain Group I foods containing artificial preservatives were not excluded. Another modification appears to have occurred in some home settings. Parents of children whose behavior improved on dietary modification explained that the Feingold diet was, at times, further restricted by excluding milk, normally a permitted food, or on the basis of adverse personal experiences with individual dietary items. Other types of studies and therapeutic
trials used defined diets in which nonnutritive additives were excluded,
as well as foods such as corn, wheat, and milk regardless of additive
content. After a preliminary trial, this type of defined diet was then
modified by reintroducing individual food items one at a time and
evaluating the effects of such additions upon the subject's behavior. Is There Empirical Evidence for an Effect of These Diets on Hyperactivity?Parents and other observers have frequently reported dramatic improvements in many hyperactive children during uncontrolled trials of various defined diets. However, such dramatic improvements were not observed in a number of controlled trials reported at the conference. While differences and inadequacies in the design of the controlled trials make analysis difficult, these studies did indicate a limited positive association between "the defined diets" and a decrease in hyperactivity. Some hyperactive children demonstrated less evidence of hyperactivity on defined diets, or modifications thereof, than on an appropriate control diet. Such decreases involved only a small proportion of patients; furthermore, the decreases in hyperactivity were not observed consistently. Studies also indicated that some hyperactive children on a defined diet experienced an increase in hyperactivity when given moderate doses of artificial food dyes, and did not experience similar increases after receiving a placebo. This increase in hyperactivity was also experienced by only a small group of patients, and the increase was not consistently reported by teachers, parents, and other observers. Clinical observations also indicated that
children who were successfully managed on a defined diet experienced
hyperactivity after dietary noncompliance. Controlled challenge studies
have primarily involved the administration of food dyes to children, but
have not included other food flavors or preservatives that are allegedly
implicated in the causation of hyperactivity. Therefore, these controlled
challenge studies do not appear to have addressed adequately the role of
diet in hyperactivity. Is There Any Biological Explanation to Support an Effect of Defined Diets on Hyperactivity?Only one specific biological explanation has been proposed--that the food dye erythrosine (FDC Red No. 3) inhibits neurotransmitter uptake. Experimental studies first suggested that Red No. 3 could inhibit the uptake of dopamine and other neurotransmitters in vitro. If true, this observation presented a mechanism by which this food additive could affect behavior. However, more recent studies suggested that this effect of Red No. 3 was the result of nonspecific interactions, and these studies raised doubts about whether Red No. 3 would affect the behavior of the intact organism. In support of this latter idea, data from three groups using the laboratory rat found that Red No. 3 caused no increase in activity or had effects only at near-lethal doses. Additionally, one study in children found that the minor behavioral changes apparently caused by challenge with a mixture of food colors were a result of food colors other than Red No. 3. Despite these negative preliminary data, it was recognized that further research, especially pharmacokinetic studies, were needed before these questions could be answered conclusively about Red No. 3 or other dietary agents. Moreover, other explanations of why a defined diet lacking food dyes, flavorings, preservatives, salicylates, and major food antigens may be beneficial can only be suggested. Direct toxic effects, idiosyncratic reactions to such agents, and hypersensitivity (allergic) responses (both IgE-mediated and non-IgE-mediated) to food antigens also could cause the observed findings. This might be by direct effects on the central nervous system or by indirect effects on other systems. However, no direct evidence for the operation of these mechanisms in treated patients is available at this time. Placebo effects and observer bias inherent
to any major therapeutic intervention (when not controlled by appropriate
blinded procedures), may also account for some of the reported benefits. If Defined Diets Are Effective, How and Under What Circumstances Should They Be Employed?Case reports of a subset of responding patients presented to this panel by parents and physicians documented improvement in the hyperactive child's condition with the use of defined diets. Because insufficient evidence is available to permit identification beforehand of this small group of individuals who may respond and to determine under what circumstances they may derive benefits, the Panel cannot answer this question unequivocally. The Panel believes the defined diets should not be universally used in the treatment of childhood hyperactivity at this time. However, the Panel recognizes that initiation of a trial of dietary treatment or continuation of a diet in patients whose families and physicians perceive benefits, may be warranted. A defined diet should not be initiated until thorough and appropriate evaluation of the children and their families and full consideration of all traditional therapeutic options (described in the Introduction) have taken place. The ability to describe "defined diets" precisely and to ensure proper and effective clinical use, to measure compliance, and to design studies and compare the findings from one study to another depends upon making available to consumers and investigators food and food products that are completely labeled. The Panel understands that existing law does not require identifying on the label, completely and accurately, all ingredients in food. The Panel, therefore, recommends changes in the law to require the listing on labels of all ingredients of food and food products, and that this label include substances that may migrate from wrappers and containers that come in contact with foods. The Panel also believes that special
attention must be given to individual cultural, ethnic, and socioeconomic
factors to ensure the proper implementation of the diet. Since the defined
diets differ from traditional dietary patterns, it is the physician's
responsibility to be specific and impart the knowledge and support that
individual families need in implementing these diets. What Are the Directions for Research?The Panel identified a number of critical gaps in knowledge which affect interpretation of the results of dietary intervention in the management of the hyperactivity syndrome. These deficiencies include nonuniform diagnostic standards and inadequate information regarding the natural history of this syndrome, lack of availability of optimal measurement instruments (behavioral, cognitive, and other), and other significant limitations in the research study designs employed to date. In addition, the full potential of animal and in vitro studies for generating relevant biologic information has not been realized. Therefore, further research in each of these areas is needed to be able to conduct meaningful investigations of the potential benefits of dietary management of hyperactivity. The following directions for further research are recommended:
Consensus Development Panel
(Panel Chairman) Professor of Pediatrics University of North Carolina School of Medicine Chapel Hill, North Carolina
Professor and Chairman Department of Epidemiology Johns Hopkins University School of Hygiene and Public Health Baltimore, Maryland
Perry W. Lesh Professor and Chairman Department of Pediatrics Indiana University School of Medicine Indianapolis, Indiana
Visiting Professor of Biostatistics Department of Biostatistics Harvard School of Public Health Boston, Massachusetts
Hispanic Affairs Advisor for the Chief Administrative Officer Montgomery County Rockville, Maryland
Attorney at Law Youth Law Center San Francisco, California
Professor, Departments of Pediatrics and Medicine University of California at Los Angeles School of Medicine Associate Chief, Division of Medical Genetics Harbor-UCLA Medical Center Torrance, California
Associate Professor of Environmental Health, Division of Toxicology University of Cincinnati College of Medicine Cincinnati, Ohio
Assistant Professor, Nutrition University of Illinois School of Public Health Chicago, Illinois
Former President, Kentucky Parent/Teachers Association Louisville, Kentucky
Professor, Head, Division of Pediatric Immunology/Allergy Department of Pediatrics University of California School of Medicine Associate Director University of California at Los Angeles Center for Interdisciplinary Research and Immunologic Diseases Los Angeles, California
Associate Professor of Clinical Pharmacy and Psychiatry University of Southern California Schools of Pharmacy and Medicine Los Angeles, California
Executive Director Greater Kansas City Mental Health Foundation Associate Dean University of Missouri School of Medicine Kansas City, Missouri Speakers
Director of Research Department of Psychiatry Children's Hospital National Medical Center Washington, D.C.
Emeritus, Department of Allergy Kaiser Permanente Medical Center San Francisco, California
Director of Psychology The New York State Psychiatric Institute Professor of Clinical Psychology Columbia University College of Physicians and Surgeons New York, New York
Associate Bureau Director for Toxicological Sciences Bureau of Foods Food and Drug Administration Washington, D.C.
Associate Professor of Psychiatry and Pharmacology University of North Carolina Chapel Hill, North Carolina
Chief, Unit on Childhood Mental Illnesses Biological Psychiatry Branch National Institute of Mental Health National Institutes of Health Bethesda, Maryland
Deputy Director of the Bureau of Foods Food and Drug Administration Washington, D.C.
Associate Professor of Pediatrics and Neurology Yale University School of Medicine New Haven, Connecticut
Chief, Section on Neurotoxicology National Institute of Neurological and Communicative Disorders and Stroke National Institutes of Health Bethesda, Maryland
Ida P. Haller Professor of Child Psychiatry University of Iowa College of Medicine Iowa City, Iowa
Psychologist University of California at Irvine Fairview State Hospital Costa Mesa, California
Assistant Professor and Director of the Psychoteratology Laboratory Institute for Developmental Research Children's Hospital Research Foundation Department of Pediatrics University of Cincinnati College of Medicine Cincinnati, Ohio
Professor of Toxicology Deputy Director of Environmental Health Science Center University of Rochester School of Medicine and Dentistry Rochester, New York
Professor of Psychiatry McGill University Director of Psychiatry The Montreal Children's Hospital Montreal, Quebec CANADA
Associate Professor of Pediatrics University of Utah College of Medicine Salt Lake City, Utah
Director, Health Care Research Unit University of Toronto Toronto, Ontario CANADA Conference Coordinator
National Institute of Allergy and Infectious Diseases Bethesda, Maryland Conference SponsorsNational Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development Office of Medical Applications of Research |
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