by Bonnie Kaplan, PhD & Julia Rucklidge, PhD
When Julia published her first open-label trial of the mineral/vitamin formula sometimes called EMPowerplus, she received this email: “I am 34 yrs old and have had anxiety/depression/hypo/mood issues for as long as I can remember. The biggest problem I have is constant erratic racing thoughts which never allow me to get proper sleep. I have seen so many doctors, sleep specialists, Psych’s and tried many drugs. I need to finally fix this as I have a lot to live for. I guess what I am asking is Can we get EMP+ in New Zealand? and do you believe it is worth a try? Or do you think (like a lot of internet discussions) that it is a waste of time?”
Four years later, we could finally and confidently say, they are not a waste of time. Over 20 studies using other experimental designs (within-subject crossover, etc.) had provided extensive preliminary evidence of that, but now Julia’s group has finally completed the type of trial that scientists and physicians pay attention to, which hopefully might filter down to the consumer.
Julia had received a lot of media attention as a result of her blinded RCT published in a prominent journal, the British Journal of Psychiatry, showing that micronutrients were better than placebo at improving ADHD and mood symptoms in adults (http://bjp.rcpsych.org/content/204/4/306.full).
But what interests us far more is the amount of emails we get as a result of this work. And the theme running through almost every email is that a child/adult/husband/wife has tried all kinds of medications, and the symptoms are still there and, often, getting worse. Could the micronutrients help?
While they may be a select portion of the population (and to date the two of us have received over 3000 emails from the public), it is a portion of the population we need to listen to. As Bob Whitaker has shown repeatedly and often, we aren’t always helping them with medications or other conventional treatments. Will nutrients help? We hope so, but the messages from the public tell us that medications aren’t working for them and scientists have to try harder to find a different approach for their struggles.
So what did Julia’s RCT find, and were the results important?
This study investigated, using a randomized double-blind placebo-controlled trial, the efficacy and safety of a broad-spectrum mineral and vitamin formula in the treatment of adults with ADHD. The product is sold under various names – including EMPower, EMPowerplus and Daily Essential Nutrients – with some small differences in formulation.
The trial was conducted between May 2009 and July 2012 in Christchurch, New Zealand. Out of 136 community and self-referrals, 80 medication-free adults diagnosed with ADHD (using standardized instruments) were randomly allocated in a 1:1 ratio to receive micronutrients (n=42) or placebo (n=38) for eight weeks. Primary outcomes were the Conners Adult ADHD Rating Scale (CAARS), self, observer and clinician forms, clinical global impression (CGI) and Montgomery-Asberg Depression Rating Scale (MADRS).
The first key finding was of a treatment effect. This means that when we broke the blind, it was clear that overall the group of people who were taking the micronutrients did better than the group who were taking the placebo. This is a remarkable and important finding given there is so much scepticism associated with taking nutrients to treat mental illness. Because no one knew whether they were taking the real thing or the placebo, this outcome is regarded highly in the scientific literature. This is the first trial to show that the benefit of micronutrients for the treatment of ADHD symptoms is not simply due to the placebo effect.
The second key finding was that there were no group differences in reported side effects. This means that there were no adverse effects associated with taking the nutrients. Typical side effects reported were mild nausea or headaches, but as many people in the placebo group reported these side effects as in the micronutrient group. This finding suggests that the side effects were not specific to the nutrients, but may have more to do with taking pills or close monitoring of these types of symptoms over time. We found that as long as the pills were taken with food and water, these problems generally resolved. The lack of side effects is great news, as many of the medications prescribed for ADHD come with side effects that people find intolerable and can often be the reason why people stop medications.
Other notable findings included:
- There were significant group differences favouring the micronutrient treatment on self-ratings and observer (that is spouse or parent) ratings of ADHD symptoms, but not based on clinician observation. This latter finding isn’t necessarily surprising as clinicians only saw the participants very briefly once every two weeks.
- Clinician ratings favoured micronutrient treatment over placebo in terms of overall improvement in psychiatric functioning over the 8 week trial.
- Clinicians rated 48% of those taking the micronutrients as “much” or “very much” improved as compared with 21% of those taking the placebo.
- Based on an average across raters, micronutrients normalized hyperactivity/impulsivity symptoms.
- For those who entered the trial with a moderately to severely low mood, we found a greater improvement in mood in those taking the micronutrients as compared with those taking the placebo.
- Six months after the trial was completed, we observed that those who stayed on the nutrients were doing better than those who chose to come off. We also found continued improvement over time for those who stayed on, suggesting that the benefit of micronutrients takes time to reach its full potential.
In summary, this study is the first placebo-controlled RCT to investigate the efficacy and safety of a broad-based vitamin/mineral formula in the treatment of ADHD in adults. We demonstrated that micronutrient treatment induced robust improvements in several areas, from ADHD symptoms, to depression, to global assessment of functioning, compared to placebo. Indeed, the effect of micronutrients is comparable, if not better than, other non-pharmacological treatments for ADHD, including omega-3s and food restriction diets, making it a serious alternative for those who choose not to take medications. It now needs further replication in larger samples.
We know we won’t be able to help everyone with these symptoms, but we certainly think that a substantial proportion of the population will benefit from this approach. Let’s hope that this publication moves us in the direction where micronutrients become a part of the mainstream approach to treating mental health disorders. Then the next step would be to tackle the very political challenge, which is that *if* this approach works for you and medications don’t, and your insurance or the government or whoever was willing to pay for the medications, will they be willing to pay for an alternative that actually does work? Can we make that happen?
Rucklidge, J. J., Frampton, C., Gorman, B., & Boggis, A. (2014). Vitamin-mineral treatment of ADHD in adults: A double-blind, randomized, placebo controlled trial. British Journal of Psychiatry.
Rucklidge, J. J., Johnstone, J., Gorman, B., & Boggis, A., & Frampton, C. (2014). Moderators of treatment response in adults with ADHD to micronutrients: demographics and biomarkers. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 50, 163–171.
Frist published in Mad In America