I’m not impressed by any company who sells a product telling people it treats a mental illness, but has never bothered to go through the U.S. Food and Drug Administration’s process to have their claims validated. You cannot say, “Our product is not intended to treat any disease” then also say “EMPowerplus helps alleviate symptoms of bipolar disorder.” Yet that’s exactly what Truehope does.
I’m even less impressed when someone takes a vitamin supplement as directed, writes about their experiences, and then receives a letter threatening to sue that person from the company who sold them the supplement. Yet that’s exactly what Truehope did.
What’s the story with Truehope? Do they want people to take their vitamin supplement or not? Do they treat mental disorders with it or not? And why would a company sue a blogger just for writing about their experience with EMPowerplus?
If you want all of the gory details about Truehope’s background and formulation, I highly recommend this post from Jane Alexander (copy here). Here’s a snippet about Truehope’s founding by two guys, one a property manager and the other a salesman:
The story involves a conversation between two Canadian Mormons, Anthony Stephan and David Hardy. The story goes something like this. Mr Stephen, a property manager was complaining to his fellow church goer Mr Hardy about his children’s behavior. Namely some symptoms of ADD and some manic components of bipolar. Mr Hardy, whose experience as a cattle feed salesman informed him, stated that some of these behaviors sounded similar to a condition that occurs to domestic pig farms, Ear and Tail Biting Syndrome.
Mr Hardy offered up that information that introducing vitamins and minerals into pig food seemed to clear up ETBS. Some theorycrafting between the two of these men soon resulted with the conclusion that by introducing vitamins and minerals to Mr Stephen’s children that the human version of Ear and Tail Biting Syndrome might just clear up and what did he have to lose but to try?1
So Truehope is two guys who came together with a theory about pig behavior (that apparently turns out to be both untrue and irrelevant), and somehow “figured out the precise metabolic and nutritional differences between otherwise healthy people and people with ADHD, schizophrenia, Tourette’s, Bipolar Disorder, Obsessive Compulsive and many more mental health problems,” says the blogger, Jane Alexander. (I should note that Tony Stephan has also spoken about his wife’s tragic suicide in 1994; she was apparently diagnosed with bipolar disorder.)
There’s no magic to Truehope’s formulation (despite what they would have you believe through the marketing on their website). It’s a simple combination of 36 vitamins and minerals — a recipe that has changed throughout Truehope’s life.2 You can get similar multivitamin supplements from any drugstore.
24 Research Studies: One Magic Bullet?
Out of the 24 research studies conducted on EMPowerplus, only a single study was a double-blind, placebo-controlled clinical trial. (While their website declares they have 26 studies, one is actually just a letter and another is an op-ed piece. And also they appear to mistakenly claim to have two double-blind studies, while only one is listed on the website.)
Two of the biggest proponents of micronutrients (e.g., multivitamin supplements) as a “magic bullet” for mental illness are Bonnie Kaplan and Julia Rucklidge. Out of the 24 studies listed on Truehope’s website, one or both of their names appear on 21 of the studies listed. That’s not a coincidence — Kaplan was Rucklidge’s PhD supervisor and got interested in the topic while studying under her. While Kaplan and Rucklidge claim there is no magic bullet to treat mental illness, they seem to hang their hat on one anyway: nutrient supplements. You know, the kind Truehope just happens to sell (and they’ve spent a lot of their own professional careers studying).
There is some concern with just two researchers (out of the tens of thousands of researchers who are dedicated to studying mental illness around the world) conducting the vast majority of research on a single product’s efficacy. Both researchers, on their Mad in America blog, make it clear they believe in the important role of vitamin supplements in our mental health. (And just to be clear, neither have any apparent financial ties with the company.) How does one control for such a bias while conducting a new study?
The 2014 Double-Blind, Randomized Placebo-Control Study
Since most of the studies Truehope cites are either case studies or open-label studies, they aren’t of much benefit dissecting (you’re welcomed to read my previous analysis and the Neurocritic’s analysis of such studies promoted by Truehope). The best study to-date is the placebo-controlled study published early last year (Rucklidge et al., 2014).
In it, 80 people with attention deficit hyperactivity disorder (ADHD) were assigned to either a micronutrient group (receiving EMPowerplus) or a placebo group. They were tested at baseline and then at an 8-week followup for their ADHD symptoms on the Conners Adult ADHD Rating Scales, using the self-report, observer and clinician versions. The study was well-designed and implemented in the manner you’d expect a randomized placebo-control trial to be conducted.
All people reported improvement on their ADHD symptoms after 8 weeks (a reminder of the powerful effects of placebo). However, according to both self-report and observer ADHD measures, those taking the micronutrient improved their scores over twice as much as those taking the placebo. Oddly, the clinician ratings between the two groups showed no significant differences.
Hyperactivity and impulsivity symptoms showed greater improvement on both self-report and observer scores, while inattention symptoms only showed significance on self-report measures. The researchers explain this discrepancy: “The varied findings across reporters on attention highlight the difficulties in reliably measuring attention, which is generally more difficult to observe than behavioural changes.”
The researchers also gathered data on blood results on each participant in the study. Those data examined nutrient levels and found on that out of the 9 nutrients measured, only 3 had statistical significance between the two groups: Vitamins D, B12 and B9 (folate). If you want a quick and cheaper multivitamin supplement to try, look for something that simply delivers at least those three.
As the authors say, “This study provides preliminary evidence of efficacy for micronutrients in the treatment of ADHD symptoms in adults, with a reassuring safety profile” (emphasis added). That’s a far cry from the marketing messages on Truehope’s website.
More such rigorous research is needed to confirm these results. This is the only double-blind, placebo-controlled scientific study in the world that supports the use of this formulation, and just for a single disorder, ADHD. All the other claims the company makes about its supplement treating other disorders have much less scientific basis.
- The blog entry continues, “Unfortunately, Mr Hardy failed to mention that there is no scientific evidence whatsoever which indicates that ETBS is caused by mineral or vitamin deficiency. In fact, what production pig farmers have found is that ETBS was remedied by changing the taste of the pig feed, by adding or removing pigs from the population and giving pigs toys to play with. The consensus among production pig farmers is that boredom seems to be the most likely cause of ETBS and shaking up the pigs routine with new stimulus seems to clear ETBS up promptly.” [↩]
- Because the formulation has changed over the course of its development, many of the studies done on earlier versions of their formulation may no longer accurately describe or be relevant its current formulation. Yet the company makes no mention of that when promoting its 26 studies. [↩]