Attention Research Update

January 2011

"Helping parents, professionals and educators stay informed about new research on ADHD"

David Rabiner, Ph.D.  Associate Research Professor, Duke University



A Promising Micronutrient Intervention for Adults with ADHD

In a prior issue of Attention Research Update  - www.helpforadd.com/2010/august.htm - I reviewed a study of a compound herbal treatment for children with ADHD.  This was a randomized, placebo-controlled trial that yielded very promising results. 

In response to this study, I received a number of inquiries from subscribers asking about similar work with adults. I was thus pleased to recently learn about a study testing a micronutrient formula in adults with a combination of ADHD and severe mood problems.

As with children, there is a pressing need to develop new ADHD treatments for adults that have demonstrated efficacy.  Unfortunately, the number of peer reviewed studies on alternative treatments is limited. There has been some promising work looking at vitamin and mineral supplementation for individuals with ADHD, e.g., zinc and magnesium, but these studies have typically investigated one ingredient at a time. 

Some have argued that this single nutrient approach may be overly simplistic, as individual nutrients work in combination with one another.  Therefore, a more effective nutrient intervention may be one that combines a wide array of balanced nutrients.  The idea behind this approach is that "...minerals, vitamins, and amino acids are critical to the synthesis of neurotransmitters and often are required in combination for optimal benefit."

An initial test of a compound micronutrient treatment for adults with ADHD was reported in a recent issue of the Journal of Attention Disorders [Rucklidge, J.A., Taylor, M., & Whitehead, K. (2010). Effect of micronutrients on behavior and mood in adults with ADHD: Evidence from an 8-week open label trial with natural extension. Journal of Attention Disorders, 15, 79-91]. 

Participants were 14 medication-free adults (9 men and 5 women) ages 18-55 all of whom had been diagnosed with ADHD based on a comprehensive assessment.  In addition to ADHD, all but one had at least one other diagnosis and all were described as having severe mood dysregulation, defined as either chronic or episodic symptoms of irritable, low or elevated mood.  This captures the type of mood instability that is often seen in adults with ADHD.

Prior to beginning the micronutrient trial, an extensive array of measures was collected on participants.  This included measures of:

1. core ADHD symptoms;
2. depression, anxiety, and stress;
3. anger;
4. interpersonal relations and social functioning; and,
5. overall level of functioning.

These measures were obtained from participants themselves and by someone who was close to the participant; ratings were also acquired from clinicians working with the participants. These measures were collected a second time following the 8-week trial and once again 2 months after the trial ended.  The latter assessment enabled the researchers to assess the duration of any positive effects found at the immediate post-test.


Micronutrient Intervention

The intervention consisted of an 8-week open label trial using a multinutrient formula distributed under the name EMPPowerplus.  This is a 36-ingredient micronutrient formula consisting mainly of vitamins and minerals.  (You can learn more at http://www.truehope.com - As noted above, I have absolutely no relationships with this company whatsoever and include the link for subscribers interested in learning more about the product.)

During this time, participants were carefully monitored each week to insure that they were taking the micronutrient as instructed, as well as to monitor possible adverse effects.

As on open-label trial, everyone involved, i.e., the participant, the clinician, and each participants' 'observer', were aware that the participant was being treated.  Open-label trials are clearly inferior to randomized, double-blind trials for evaluating the efficacy of any type of treatment, but are generally used as an initial test to determine whether a treatment is potentially effective. 

When positive findings occur in an open-label trial it supports the value of a better controlled follow-up study.  Results from open-label trials by themselves, however, can only establish that a treatment may be effective, but offer no conclusive scientific proof.


 Results

To evaluate the impact of the micronutrient treatment, baseline ratings were compared to those obtained after 8 weeks.  These comparisons indicated significant improvement in measures assessing mood, emotional lability, and core ADHD symptoms, according to both self and observer reports.  For core ADHD symptoms, ratings of attention difficulties continued to fall in a clinically elevated range even though they had diminished.  This was not the case, however, for hyperactive-impulsive problems where the group average declined into the normative range.

Using the commonly used metric of at least a 30% reduction in ADHD symptoms to identify a trial participant as having a positive response, 4 of 14 participants met this criterion for inattentive symptoms and 10 of 14 met it for hyperactive-impulsive symptoms. 

On the depression rating scale, where a 50% reduction in symptoms is required to identify a positive response, 12 of 14 participants showed this improvement.  Significant and clinically meaningful reductions in anger were also found and clinicians following the participants rated 12 of the 14 as either moderately or markedly improved.  Participants also reported an improved quality of life and better interpersonal functioning; these benefits were echoed in the reports of observers.

Reports of adverse events were minimal and none were troubling enough to lead to a discontinuation of the trial.


Two month follow-up

After 8 weeks, participants were given the option of continuing on the micronutrient formula or discontinuing; 7 opted to continue.  Two months later, those who continued had maintained the gains evident at follow-up - or reported additional improvements - and were doing better than those who had stopped.


Summary and Implications

This open-label trial of a micronutrient treatment for adults with ADHD and severe mood problems yielded very encouraging findings.  Across all the outcome domains evaluated, the improvements were statistically significant and clinically meaningful.  This was true not only for self-reports, but in clinician and observer reports as well. Furthermore, virtually no adverse reactions were reported and compliance with the treatment regimen was quite good.  Finally, the fact that participants had complex difficulties beyond ADHD is important, because such clients are frequently 'screened out' in clinical trials.  This can undermine the clinical relevance of the findings, something that was not the case here.

As encouraging as these findings are, it is important to place them in the appropriate context.  First, attention difficulties - although significantly diminished - remained in a clinically elevated range for most participants. 

Second, and this cannot be overemphasized, the open-label nature of this trial prevents any conclusions about the efficacy of the micronutrient treatment from being made.  Expectations in participants and observers that benefits would be forthcoming may have biased the ratings they provided.  Furthermore, participants had weekly visits with clinicians who were monitoring the trial, and this contact - which has nothing to do with the micronutrient treatment per se - may at least partially account for the improvements reported. A variety of other factors could also have influenced participants' outcomes, which is why a randomized-controlled trial is so important.

The authors themselves clearly recognize the limitations of their study but make a very compelling case that the data are strong enough to "...warrant replication and controlled studies to better elucidate the changes that may be occurring."  Let's hope that such studies are already underway and will soon be available to review.  When such work does appear, I will do my best to cover it for you in Attention Research Update.



(c) 2011 David Rabiner, Ph.D.

Information presented in Attention Research Update is for informational purposes only, and is not a substitute for professional medical advice.  Although newsletter sponsors offer products and services that I believe will be of interest to subscribers, sponsorship of Attention Research Update does not constitute a specific endorsement or guarantee of any company's product or services.