Nutritional Supplements to Treat ADHD, Bipolar, Depression: EMPowerplus
EMPowerplus is a nutritional supplement that consists of 14 vitamins, 16 minerals, 3 amino acids, and 3 antioxidants. According to its makers, TrueHope Nutritional Support, EMPowerplus “works by giving the brain the right balance of vitamins and trace minerals on a regular basis.”
It backs up that statement with a link to 11 research studies which it says demonstrates the effectiveness of this supplement to help people with attention hyperactivity disorder (ADHD), bipolar disorder, and depression.
It’s been selling the supplement for over a decade now from Canada, to hundreds of thousands of people. Many people swear by it. Others have questioned whether it is really any better than placebo.
So does it work? Let’s find out…
First, we have to look at the rationale for treating mental illness with the equivalent of vitamins & minerals. According to the folks at TrueHope, our bodies need a balance of vitamins and minerals, or else it will impact our brain chemistry:
Deficiency of one nutrient can make you unable to absorb other nutrients properly, which leads to multiple, inter-related deficiencies. These deficiencies seem to disrupt the brain chemical function in people with illnesses such as bipolar disorder, depression, ADHD, and schizophrenia.
But as we all know by now, mood disorders are not caused simply by a chemical imbalance. To suggest that bringing your chemicals “in balance” will cure these disorders is a ludicrously simplistic way of looking at mental illness.
Is EMPowerplus Just the Placebo Effect?
Of course, the first criticism might be that this is simply the placebo effect at work. But the makers argue that, despite not having any clinical evidence to the contrary, EMPowerplus’ effects don’t look like the placebo effect (as they define it):
Numerous studies on the placebo effect have shown that a placebo effect only lasts a short time. Then the effect disappears and symptoms return. EMPowerplus does not “stop working.” Even the first EMPowerplus users, who started in 1996, remain symptom-free and drug-free.
We don’t really know this to be true. The placebo effect has not been shown to simply “wear off” (according to my reading of the literature), especially if a person continues to use the product.
I find it more than a little astonishing that after more than a decade on the market, the manufacturers of this product haven’t done a single placebo-controlled trial. The surest answer to “Is it the placebo effect?” is being able to look at just such data.
Effectiveness of EMPowerplus
So what data has been collected on EMPowerplus?
According to their website, there are 11 studies — but some of that research is nothing more than a letter to the editor of a journal, describing the clinician’s own experiences with the supplement. Such letters are not considered evidence or research by the scientific community; they are simply anecdotes.
Some of the published research comes from researchers who have used the company’s own data collection routines through a “Self-Monitoring Form” that’s filled out by customers of the product (a form whose psychometric properties we know nothing of). The majority of customers stop filling out the form after two weeks, however (Rucklidge et al., 2010), suggesting they’ve either stopped using the product or stopped enjoying any positive effects from it.
In the aforementioned study, 120 families (out 709) agreed to monitor symptoms of their children who were taking EMPowerplus over 6 months’ time. Naturally, the researchers found a positive effect for the supplement — a 46% decrease in mean bipolar symptom severity scores at LOCF and a 40% decrease in ADHD symptoms.
But what’s that LOCF thing? Well, it’s a technique called Last Observation Carried Forward that researchers use that carries forward drop-out scores as though they had completed the entire study (in this case, observation of scores over 6 months’ time). In this study, only 49 percent of the participants kept providing the researchers data at 6 months — meaning the majority of them dropped out of the study before the 6 months were up!
LOCF is generally frowned upon in good research unless there’s a very good rationale for its use. Why? Because research conducted on the effects of LOCF shows that this method gives a biased estimate of the treatment effect while underestimating the variability of the result. In other words, it stacks the deck to demonstrate a treatment’s effectiveness — even when the treatment might not be effective. It’s a research slight of hand.
The bigger problem with this study and most of the studies cited by TrueHope is that they all suffer from significant design problems. All are open-label designs with biased, self-selected samples. Good, reliable research starts out with a randomized sample from a demographically-diverse population. It’s also important that both the person taking the supplement and the researchers don’t know who is receiving an active ingredient and who is receiving a placebo.
In contrast, the studies cited by TrueHope rely almost exclusively on self-report of symptoms (and in some, it’s parental report). There is little to no monitoring of patients to ensure they are taking the supplement as prescribed. There are no medical or laboratory tests of vitamin strengths in the individuals in the studies. There is no attempt to tease out or understand the underlying mechanisms for behavioral or mood change.
Of the remaining studies cited by the company, they consist primarily of case reports or small, unscientific studies describing the use of the supplement in practice with less than a dozen patients. Naturally clinicians who prescribe something and then find a positive result in their patients are going to attribute the change to what they prescribed (that’s called prescriber bias). While these are all data points we should be aware of, they don’t really help us judge the effectiveness of EMPowerplus.
As for the safety, researchers using the results of the 6 published studies on this supplement (which included a total of 157 patients) found no significant adverse effects to be concerned about (Simpson et al., 2011). So it appears to be a safe thing to take according to this one study.
The Invention of EMPowerplus
It’s also interesting to learn of how EMPowerplus came to be, according to court documents filed in Canada:
As an animal nutritionist, Mr. Hardy discovered that feeding certain nutrients to pigs helped alleviate their ear and tail biting syndrome. [Emphasis added.] Mr. Hardy observed that certain behaviors in humans such as hyper-irritability as well as symptoms related to bipolar disorder are similar to what he observed in pigs and speculated that if people were given certain nutrients, their symptoms could also be alleviated.
In 1995, Mr. Anthony Stephan, also a co-founder of TrueHope, sought Mr. Hardy’s advice about treating the poor mental health of his children: his daughter Autumn was delusional and suicidal, and his son, Joseph suffered from bursts of uncontrollable rage. Given Mr. Hardy’s positive experience with treating similar conduct in pigs as a nutrient deficiency, they placed Autumn and Joseph on a course of off-the-retail-shelf nutrients. The mental health of both improved.
EMPowerplus comes from a pig nutritionist who wanted to alleviate some negative pig behaviors. It’s also interesting to note that Mr. Stephan saw such significant improvement in his children through the use of simple, off-the-shelf nutrients. This suggests a more affordable and direct route for people who want to try the “vitamin and mineral” cure — go down to your local pharmacy and pick some up!
Where Does That Leave Us With EMPowerplus?
The U.S. Food and Drug Administration (FDA) defines a drug under their purview for regulation as something that’s intended for “use in the diagnosis, cure, mitigation, treatment or prevention of a disease.” It doesn’t matter if that thing is a naturally occurring mineral or not. Once you start making the claim that your product can cure something like a mental disorder such as bipolar or ADHD, it’s something the FDA wants to look at carefully, scientifically and systematically.
Apparently, the last attempt to do so through a NIH clinical trial was terminated with the following reasons cited: “Unable to recruit large enough sample; large expectancy effects; No adverse events recorded; results uninformative with respect to efficacy.”
TrueHope makes the claim that its EMPowerplus product can help treat bipolar disorder and ADHD, among other mental health concerns. It is my opinion that these claims are unfounded based upon the current research that suffers from a wide range of methodological problems.
Is it safe to try? Apparently, yes. Can you potentially gain some benefit from trying it? Sure, it’s possible — the web and the company’s website are littered with testimonials from people who say it works for them. That means it may also work for you.
But so may any sugar pill. Or any off-the-shelf vitamin supplement. I wouldn’t pay a premium ($75 for 228 pills — and you have to take 15 capsules/day, meaning you’ll need 2 bottles/month) for a mix of vitamins and minerals that haven’t been shown to be more effective than placebo. I would just take a daily supplement that’s already available (and is more affordable).
I will end with this — I have respect for both Mr. Hardy and Mr. Stephan for trying to help people in need with something they believe works to help alleviate mental illness. It’s my opinion that their intentions are apparently good and well-grounded, but their follow-through with adequate research and the over-hyping of their product leaves much to be desired.
Editor’s note: We hope to continue this series looking into the benefits and drawbacks of nutritional supplements for mental health and mental illness in the weeks to come. Stay tuned!
Truehope: Nutrition for Mental Health – Also features information about the Truehope Program
Rucklidge, Julia J.; Gately, Dermot; Kaplan, Bonnie J.; (2010). Database analysis of children and adolescents with bipolar disorder consuming a micronutrient formula. BMC Psychiatry, 10.
A. Simpson, J. Steven; Crawford, Susan G.; Goldstein, Estelle T.; Field, Catherine; Burgess, Ellen; Kaplan, Bonnie J.; (2011). Systematic review of safety and tolerability of a complex micronutrient formula used in mental health. BMC Psychiatry, 11.
Grohol, J. (2012). Nutritional Supplements to Treat ADHD, Bipolar, Depression: EMPowerplus. Psych Central. Retrieved on April 21, 2015, from http://psychcentral.com/blog/archives/2011/08/29/nutritional-supplements-to-treat-adhd-bipolar-depression-empowerplus/