CLINICAL TRIALS IN THE 1980S

VII. CLINICAL TRIALS IN THE 1980S

As well as double-blind studies, this author believes it has been important that clinical trials of dietary treatment of ADHD children occur. From 1984–1989, 516 children attending a

(LAALS) diet as part of management of behavior, learning, and hyperactivity prob- lems. As well as perfumes, smells such as paint were investigated. A positive response was obtained in 79.5% of children, with a normal range of behavior achieved in 54.5%. The proportion of responders in the under 9 years old group was significantly higher (p ⬍ 0.005). As well almost 50% benefited by limiting or excluding other foods such as milk, wheat, and chocolate. Change occurred in behavioral, social, learning, activity, sleep, and allergic problems. It was concluded that suspect diet substances and smells are better thought of as aggravating the underlying predisposition in susceptible children (66).

A second group of 112 children with ADHD symptoms was followed over 18 months. More data particularly on additive and chemical tolerance were collected, and a questionnaire designed by Rowe (RBRI) was used to provide more detail on outcome. A ‘‘diet detective’’ approach was used. That is, patients were told that it was not possible to predict outcome, which presenting problems may change nor the degree of change. Other studies had not investigated interacting psychosocial issues, so clinical issues that arose were recorded with progress notes. The sample presented with sleep problems oc- curring in 74%, developmental problems in 65%, and allergic symptoms, such as asthma or eczema, in 53%. Parent assessment of the value of the diet was substantiated (Fig. 1) with 69.7% reporting benefit. The most significant finding provided by analysis of the questionnaire was that diet was reported to change many problem areas, with the greatest change being in irritability (see Fig. 2 ). This was followed by poor concentration, impul- sivity, unreasonableness, and restlessness, with hyperactivity itself a less significant change. Two-thirds of all responders under 6 years old improved into the normal range. Parents consistently reported that children under 5 years had clearer reactions and that these resolved faster. There was a positive correlation between a history of reports of reactions to food at the first visit and a positive outcome (p ⬍ 0.005). Thirty-two percent reported other family members benefiting from the diet.

An important part of this research involved trials of individual challenge foods rein- troduced for 7 days to test tolerance. Only trials which were uncomplicated by other factors were recorded (see Fig. 3 ). While this allowed expansion of included foods, the significant number who did not tolerate tomato sauce and chocolate is noteworthy. Additional benefit from limiting dairy foods occurred in 25%, but only 3.6% needed to exclude it. Sugar, in the absence of suspect chemicals, caused reactions in less than 2%. While tolerance of

Figure 2 Diet effects for all responders.

fruit containing salicylate generally followed predictions from data on salicylate content, this did not always occur. There was variation between varieties with the least acidic better tolerated. Ripeness was important with salicylates decreasing with ripening (e.g., in bland apples), and amines increasing with ripening (e.g., in bananas). As well, smells (perfumes, petrol, etc.), infections, inhalants (especially pollen), contact dye (face and finger paints), and stress were identified as equally potent sources of reactions. Their ac- fruit containing salicylate generally followed predictions from data on salicylate content, this did not always occur. There was variation between varieties with the least acidic better tolerated. Ripeness was important with salicylates decreasing with ripening (e.g., in bland apples), and amines increasing with ripening (e.g., in bananas). As well, smells (perfumes, petrol, etc.), infections, inhalants (especially pollen), contact dye (face and finger paints), and stress were identified as equally potent sources of reactions. Their ac-

Clinical research shows that problems in child psychiatry are not neat and tidy. Investigation of diet effect revealed diet interacting with many clinical issues such as individual variation in presenting problems; family coping skills and motivation; manage- ment of fussy, often underweight children; as well as psychodynamic factors. From this study it is suggested that food-sensitive ADHD children are better described as hyper- reactive than hyperactive; reacting to many aspects of the environment, of which the food components form one part, depending on susceptibility.

VIII.

A NEW VIEW OF THE DIET

The research during the 1980s allowed updating of the diet. Most fruit and vegetables high in natural amines or glutamates are also high in salicylates (67). Overall, chemicals implicated were added natural and artificial colors, artificial flavors, and most preserva- tives; added and natural MSG; and natural and medicinal salicylates and amines. A diet with these chemical exclusions formed the initial exclusion diet.

In the 1990s a second part to the initial diet became clearer. This is the role of whole foods. Their limitation or exclusion can be based on a history of a family member having problems with a whole food or from skin prick tests. Research which does not significantly restrict all the chemical groups and family sensitivities will not show maximum possible effect.

After the initial trial and challenge (or off-diet week), and washout period if deterio- ration occurs, individual foods containing various additives, suspect chemicals, or whole foods can be reintroduced one at a time to determine which are tolerated. Each individual

Table 1 Some Factors Contributing to Adverse Reactions: The Total Body Load Food

Natural food chemicals: salicylates, amines, monosodium glutamate, flavors Additives: added natural and artificial colors and flavors, benzoates, BHA and BHT, sulphites, nitrates, propionates Whole foods: consider if a problem to any family member Environment Stress, if significant for the child or in the family Infections: viral, bacterial, parasitic, and fungal Inhalants: pollen, house dust mite, dander, grasses Perfumes and smells: paint, air fresheners, glue, bubble bath Contacts: dyes in finger paint, preservatives in creams Excess sensory stimuli: shopping centers, crowds Biology Genetic susceptibility to ADD or ADHD Genetic susceptibility to food sensitivity (allergy or food intolerance) Age and developmental level Temperament Other medical problems

Note : Individual variation in susceptibility to different factors occurs. When the cumulative effect of several Note : Individual variation in susceptibility to different factors occurs. When the cumulative effect of several