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.
Grohol, J. (2012). Nutritional Supplements to Treat ADHD, Bipolar, Depression: EMPowerplus. Psych Central. Retrieved on May 23, 2015, from http://psychcentral.com/blog/archives/2011/08/29/nutritional-supplements-to-treat-adhd-bipolar-depression-empowerplus/