Reprinted in part by permission of Dr. David Rabiner from his newsletter at www.helpforadd.com
However, a study published recently in the Journal of Developmental and Behavioral Pediatrics largely addresses this concern, and provides new evidence on the promising nature of this treatment approach (Sinn, N., & Bryan, J. . Effect of supplementation with polyunsaturated fatty acids and micronutrients on learning and behavior problems associated with child ADHD. JDBP, 28, 82-92.].
The study began with 167 7-12 year old children in South Australia – 128 boys and 38 girls – who had been recruited through media ads, school newspapers looking for children with “ADHD-related learning and behavioral difficulties”. Parents who inquired about their child’s participation were asked to complete the 12-item Conners ADHD index on their child; children whose scores fell in the top 2.5% of the regular population were eligible provided they had not used stimulant medication or any form of omega-3 supplementation in the prior 3 months.
The study employed a placebo-controlled design in which children were randomly assigned to 1 of 3 groups:
Group 1 – These children received omega-3 fatty acid supplementation capsules containing 400 mg fish oil and 100 mg evening primrose oil with active ingredients eicosapentaenoic acid (EPQ, 93 mg), docosahexaenoic acid (DHA, 29 mg), gammalinolenic acid (GLA, 10 mg), and vitamin E (1.8 mg). Children in this group received 6 capsules per day. In addition, to learn whether a multi-vitamin enhanced any benefits of the fatty acid supplementation treatment, they also received a daily multi-vitamin tablet. ** Please note that I do not know the brand used or where these capsules can be obtained. **
Group 2 – These children received the omega-3 fatty acid supplementation as described above with no multi-vitamin supplement.
Group 3 – These children received placebo capsules that appeared identical to the fatty acid supplementation capsules received by children in groups 1 and 2. The placebo capsules contained palm oil, which was not expected to have any impact on ADHD symptoms.
Capsules were administered by parents who did not know whether their child was receiving the fatty acid supplement or placebo. Before treatment, and 15 weeks after treatment began, parents and teachers completed the Conners Rating Scale, a standardized behavior rating form that inquires about ADHD symptoms along with a number of other emotional and behavioral difficulties including oppositional behavior, cognitive problems, social problems, and anxiety.
At the beginning of week 16, children in the placebo group were switched to the active fatty acid supplement for the next 15 weeks. Parents were not aware that this switch had occurred. Children in groups 1 and 2 continued with their treatment regimen during this time. At the end of 30 weeks, parents and teachers completed the Conners Rating Scale for a third and final time.
The design of this study enabled the researchers to learn whether: 1) omega-3 fatty acid supplementation was associated with reduced ADHD symptoms, as well as other difficulties, reported by parents and teachers; 2) whether adding a multi-vitamin supplement enhanced any benefits associated with fatty acid supplementation alone; and, 3) whether any gains that emerged after 15 weeks remained stable, or even increased, during 15 additional weeks of treatment.
Parent Ratings – Of the 167 children who began in the study, 35 dropped out during the first 15 weeks and an additional 23 children dropped out during the second 15 weeks. Dropouts occurred with equal frequency across the 3 groups; however, those who withdrew during the initial 15 weeks had higher scores on the Conners ADHD Index at study entry. Thus, although all participants had extremely high ratings on the Conners when the study began, those whose problems were most severe were more likely to drop out.
Parent ratings obtained at baseline and after 15 weeks indicated that children receiving fatty acid supplementation (groups 1 and 2) showed significant improvement compared to children receiving placebo. Specifically, significant improvements were found for inattentive symptoms, hyperactive-impulsive symptoms, cognitive problems, and oppositional behavior. Group differences in social problems and anxiety were not evident. In general, the treatment effects, although statistically significant, were modest in size and smaller than what has generally been reported for medication treatment. There was no evidence that adding a multi-vitamin to the fatty acid supplementation treatment was associated with any additional benefit.
As noted above, children in groups 1 and 2 continued receiving supplements for an additional 15 weeks and children who had been receiving placebo were switch to active supplements for weeks 16-30. Parent ratings provided after 30 weeks indicated that children switched to active treatment now showed significant reductions in inattentive symptoms, hyperactive-impulsive symptoms, cognitive problems, and oppositional behavior. The magnitude of these changes was comparable to what was seen in groups 1 and 2 during the initial 15 weeks.
Of particular note is that children in groups 1 and 2 continued to show reduction in parent reported symptoms during the second half of the study. Thus, although the benefits evident at the end of week 15 were significant but modest, by the end of week 30 the benefits had increased in magnitude and were now roughly similar to what is commonly observed in studies of medication treatment. Specifically, inattentive and hyperactive-impulsive symptoms showed a reduction of about 1 standard deviation from what had been reported prior to treatment.
Teacher Ratings – In stark contrast to the significant and clinically meaningful results found for parent ratings, no significant improvements were observed for teacher ratings at either 15 or 30 weeks.
Summary and Implications
For parents and professionals interested in the use of fatty acid supplementation as a treatment for children’s ADHD symptoms, results from this study present somewhat of a dilemma.
On the one hand, parents who were blind to their child’s treatment status observed significant improvement in their child’s core ADHD symptoms, as well as reductions in cognitive problems and oppositional behavior. By the end of 30 weeks, the magnitude of this improvement was substantial, and not dissimilar from what is often seen in medication treatment studies. As noted above, these benefits were linked to fatty acid supplementation alone, as the addition of a multi-vitamin provided no additional benefit.
On the other hand, however, no comparable improvements were evident in the teacher ratings of children’s behavior. Thus, despite clear improvements observed by parents, children’s behavior at school did not change, at least as reported by their teachers.
The authors suggest that the parent ratings may have been more valid than those provided by teachers because many children had multiple teachers, some children changed schools, class sizes were large (about 30 children per teacher), and children were out on holiday for a substantial time during the study.
While these factors may have contributed to unreliability in the teacher ratings, it is problematic to use this as a basis for discounting the absence of benefits observed in school. Instead, a more prudent conclusion is that treatment was not associated with behavioral improvements for children at school. Perhaps benefits at school would have been evident had the treatment continued beyond 30 weeks, but there is no way to know whether this would have been the case.
Because school-related problems are such an important part of the impairment experienced by children with ADHD, this represents an important limitation on the use of omega-3 fatty acid supplementation. However, significant results for teacher ratings as well as for reading and spelling achievement have been reported in a prior study and it is premature to conclude that this approach does not help with symptoms in the school setting.
The authors discuss several limitations to their study. First, as described above, children with more severe ADHD symptoms when the study began were more likely to drop out. The authors note that because treatment with fatty acid supplementation can take 8-12 weeks before any improvement is observed, it would not be advisable as a stand alone treatment when a child’s symptoms are especially severe, and where more immediate symptomatic relief is required.
They also note that because they were unable to take biochemical analyses of children’s nutritional status prior to treatment, they do not know whether participants had nutritional deficiencies to begin with and whether the supplementation eliminated those deficiencies. As this is supposed to be the active mechanism of this treatment approach, such analyses are necessary to document the reason for the apparent benefits.
Finally, a nice addition to this study would have been the inclusion of standardized academic achievement measures, which should be incorporated into future research on this intervention approach.
The authors conclude their report by noting that omega-3 fatty acid supplementation could provide a “…safe health option for some children with ADHD symptoms”. Certainly, results from this trial, as well as from prior studies of this approach, indicate that this is an extremely promising intervention and one that warrants further investigation. It would be particularly important to replicate the results obtained with parents, to document that improvements in behavioral and/or academic functioning at school are also obtained, and to identify those children with elevated ADHD symptoms who are most likely to benefit from this approach. Finally, documenting that the treatment is most helpful for children with fatty acid deficiencies to begin with would be a significant addition to the current literature on this approach.
In the interim, parents interested in this intervention should carefully discuss the pros and cons with their child’s health care provider. It is also important to recognize that while promising results have been obtained with this approach, the efficacy of this method has not yet been conclusively established. Based on the results obtained in this study, it should be clear that any benefits that are evident at home may not translate to observable benefits at school.
As with any treatment for ADHD, many children would be expected to have residual difficulties even if the supplementation proved to be helpful, and would thus require additional intervention methods. Careful monitoring of the child’s ongoing response to this treatment, or to any treatment, is thus essential so that any such residual difficulties can be identified and addressed.