Table 7.
Published Studies of Alternative Treatments in Preschool Children with Attention-Deficit/Hyperactivity Disorder: Elimination Diets
| Authors | Age Range in years (Mean age ± SD in years) | N/n < 6 years | Procedure for ADHD Diagnosis; Inclusion Criteria | Type of intervention | Study Design/Duration | Outcome Assessment (for ADHD and disruptive behaviors) | Study Outcome |
|---|---|---|---|---|---|---|---|
| Egger et al., 1985 | 2–15 years (7.31) | 76/10 | Clinical assessment, dimensional cutoff score on short form of the Conners' Rating Scale; Hyperkinetic syndrome or behavioral disturbance with overactivity | Oligoantigenic (few-foods) diet2 | Elimination diet followed by challenge, 3-phase design: 4-week open elimination diet (oligoantigenic diet), open weekly reintroduction of foods and synthetic colorings, 4-week or longer double-blind, placebo-controlled crossover challenge trial of one incriminated food/Information about duration of the open reintroduction phase not provided | Conners' Abbreviated Scale, actometer recording | Improvement on parent ratings on the Conners' scale during placebo compared to the active substance in the double-blind crossover phase. 62/76 (82%) improved in the open elimination phase, no treatment effect on actometer readings. IgE levels were in the atopic range for age in 68% of the responders and 20% of the non-responders |
| Rowe, 1988 | 3–15 (7.7 ± 2.9) | 55/n < 6 not specified | Clinical assessment; Suspected hyperactivity | Feingold diet (no synthetic food colorings) | Elimination diet followed by challenge, 3-phase design: 6-week open elimination diet (Feingold diet with no synthetic food colorings), open sequential liberalization of the diet, double-blind, placebo-controlled crossover challenge trial with azo dyes (carmoisine and tartrazine)/18 weeks | Daily 8-item parent- and teacher-completed checklist of ADHD and behavioral symptoms | 40/55 (72%) improved on open Feingold diet; 26/55 (47%) showed placebo effect as they remained improved after discontinuing the Feingold diet; 14/40 (35%) had an adverse reaction to the open-reintroduction of synthetic additive; 2/8 (25%) children completing the double-blind trial reacted adversely to the dye challenge. |
| Kaplan et al., 1989 | 3.5–6 (4.48 ± 1.04) | 24/24 | Clinical interview, Conners' Parent Rating Scale rating > 1 SD; DSM-III criteria for ADDH along with sleep problems and physical complaints | No food dyes, flavors, preservatives, monosodium glutamate, chocolate, caffeine and any suspected food, little sugar | Elimination design: 3-week baseline diet, double-blind, placebo-controlled crossover phase on 3-week placebo control (equivalent) diet and 4-week experimental diet counterbalanced across subjects/10 weeks | Conners' Abbreviated Symptom Questionnaire (CASQ), 10-item physical signs and symptoms questionnaire, Visual Attention Span Test | Significantly lower parent scores on the CASQ during experimental diet phase compared to the baseline and placebo diet phases. 14/24 (58%) had behavioral and sleep improvement with negligible placebo effect |
| Pollock & Warner, 1990 | 2.8–15.3 (8.91) | 39/n < 6 not specified | No clinical assessment for a diagnosis of ADHD: History of improvement in ADHD symptoms with a diet free of artificial food colors prior to study entry | Artificial food coloring free elimination diet | Challenge design: Double-blind placebo controlled, crossover challenge with artificial food colors. Maintenance of food additive elimination diet of each child for the duration of the trial/7 weeks | Connors' Hyperactivity Index | Mean daily Connors' Hyperactivity Index scores during the 2 active weeks were higher than placebo. However, the changes were small, were not clinically significant and were not detected by parents. Outcome results are reported for 19/39 (48.7%) completers. |
| Egger et al., 1992 | 3–15 (9.31) | 40/n < 6 not specified | Clinical assessment, cutoff threshold on parent rated short form of Conners' Rating Scale; DSM III-R diagnosis of hyperkinetic syndrome | Oligoantigenic (few-foods diet) water, calcium, magnesium, zinc and vitamins | Desensitization. 4-phase design: Open elimination diet, open sequential reintroduction, double-blind placebo controlled, 2-parallel groups trial of enzyme-potentiated desensitization with 3 intradermal injections of mixed food antigens and food additives (food colors and food preservatives) every 2 months followed by open reintroduction of provoking foods/7 or more months | Parent rated short form of Conners' Rating Scale | Conners's scores decreased from a mean of 23 at baseline to 7.5 after open-elimination diet. Significantly more children in the active group (n = 15) were able to continue to eat the previously identified provoking food versus in the placebo group. |
| Carter et al., 1993 | 3–123 | 78/n < 6 not specified | Standardized psychiatric interview, ratings on the Conners' Rating Scale Parent and Teacher (CRS-P and CRS-T); DSM III criteria for ADHD | Few-foods diet2 bottled water, sunflower oil. milk-free margarine, and already suspected foods were avoided | Elimination diet followed by challenge, 3-phase design: Open restricted (few foods) diet for 3–4 weeks, open sequential reintroduction of the offending foods, 4-week double-blind, placebo-controlled crossover challenge trial/10–12 weeks | CRS-P, global rating of severity of behavior problems by the parent, direct behavior observation for ADHD symptoms | 76% (59/78) improved on open restricted diet, 80% (47/59) relapsed with open challenges, 74% (14/19) completers in the double blind trial showed reductions in parent-rated symptoms of hyperactivity and irritability (mean difference between active and placebo CRS-P scores = 5.2), and directly observed ADHD symptoms while on placebo compared to the incriminated food |
| Rowe and Rowe, 1994 | 2–14 (7.1 ± 3.5)4 | 200/25 | No clinical assessment for a diagnosis of ADHD; Children referred for suspected hyperactivity in association with diet | Synthetic coloring free elimination diet | Elimination diet followed by challenge. 2-stage study: 6-week open trial of a diet free of synthetic colorings, double-blind, placebo-controlled, crossover randomized trial with 6 different doses of tartrazine/9 weeks | Conners' Abbreviated Parent-Teacher Questionnaire (CAPTQ), Behavior Rating Inventory (BRI) | 150/200 (75%) improved with elimination diet in the open trial. Worsening of CAPTQ and BRI scores reported during the dye challenge with tartrazine. Younger preschool children were described as restless, disruptive, easily distracted and excited high as a kite, out of control, and displayed constant crying, tantrums, irritability, and severe sleep disturbance. |
| Boris and Mandel, 1994 | 3–11 (7.5 ± 2.2) | 16/6 | No information provided on the procedure for diagnosing ADHD: DSM-III diagnosis of ADHD, cutoff threshold for Conners' Rating Scale-Parent-48 (CRS-P-48) | Elimination diet (dairy products, wheat, corn, yeast, soy, citrus, egg, chocolate, and peanuts) and artificial colors and preservatives prohibited | Elimination diet followed by challenge: 2-week open elimination diet, 1-month open sequential food challenges, 7-day double-blind placebo controlled food challenge (DBPCFC)/7 weeks | CRS-P-48 | 73% (19/26) improved on open elimination diet, 79% (15/19) responders were atopic. During the DBPCFC mean CRS-P-48 Hyperactivity index score on challenge days was 18 ± 7 compared to 8.4 ± 4.9 on placebo days. Atopic subjects were more likely to respond to the elimination diet. |
| Bateman et al. 2004 | 3.2–4 (3.71) | 277/277 | Cutoff threshold on the EAS Activity Scale and Weiss-Werry-Peters Activity Scale (WWPAS); 3–4 year old children living on the Isle of Wight | Artificial food coloring and sodium benzoate free diet | Elimination diet followed by challenge in 4 groups of children with hyperactivity crossed with atopy (Hyperactive [HA]/Atopic [AT] not-HA/AT, HA/not- AT, and not- HA/not-AT): 1-week artificial food coloring and sodium benzoate free diet, double-blind, placebo controlled challenge with 1-week of 20 mg of artificial food colorings and 45 mg of sodium benzoate or placebo separated with one week of washout/4 weeks | Parent completed daily WWPAS ratings, weekly in-clinic assessments on structured tasks for inattention, activity and impulsivity | Reduction in parent-rated hyperactivity between baseline and end of the week of elimination diet. Greater increase in parent-rated hyperactivity during the dye challenge period compared to the placebo challenge period. No effect detected with direct behavioral observation. No effect of atopy or severity of hyperactivity symptoms. |
1
SD not provided.
2
Few-Foods diet included two meats (e.g., lamb and chicken), two carbohydrates sources (e.g., potatoes and rice), two fruits (e.g., banana and apple or pear), vegetables (cabbage, sprouts, cauliflower, broccoli, cucumber, celery, carrots, parsnip), salt, pepper, water, calcium, and vitamins.
3
Mean age not provided.
4
Mean age reported for the 34 children participating in the double-blind trial.
ADHD = attention-deficit-hyperactivity scale.