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4 "Studies" on EMPower
These studies were emailed to anyone who
requested them off of the Brainstorm Message Board in August 2005 by a person
who said their daughter was taking EMP, to show the research underway on the
EMPower supplements, and this analysis was complied to analyze the strength of
the evidence provided. If anyone has other studies positive or negative we would
be happy to include those in this analysis, email
webmaster at bpinfo.net.
The first PDF file
contains a commentary article by Dr. Charles Popper from the December 2001
Journal of Clinical Psychiatry. I was unable to find a link to this commentary
available to the public on the internet. But I was able to find a link to the
citation.
Dr. Popper's Letter
The Truehope website refers to sections favoring their product quite heavily in
the “Research” section of their site.
Summary: Dr. Popper’s commentary describes his communication with the founders
of Truehope/EMPower, as well an open label study of 14 adult patients (which is
the second article, see below). Dr. Popper raises questions about the inherent
problems with the study’s methodology (open label) and the problem of testing a
substance with many ingredients (which one is causing any benefits/harm?) but he
concludes that it is better to find if it works first through more research, and
then try to sort through the formula and find the active ingredients, etc. Dr.
Popper speculates on the mechanism of action for the EMPower formula and then
describes his experience in his practice using this supplement with his own
patients on an open label basis, 19 out of 22 patients having a favorable
response and relatively minor side effects. He then comments on the possibility
of problems from having higher than the RDA allowance of a number of the
ingredients, concluding that further research is needed on this topic as well.
Dr. Popper then discusses his experience with changing patients from
pharmaceutical medications to micronutrient treatment. He calls this process
“exceedingly tricky to manage”, and he concludes that more research is necessary
on this point as well and cautions that clinicians (doctors who work with
patients as opposed to research) who see this current information as
encouragement to use pharmaceuticals and micronutrients (micronutrients: n, a
substance needed only in small amounts for normal body function (e.g., vitamins
or minerals) from Dictionary.com) together are “stepping into a serious
quagmire”. Dr.Popper cites promising research on Omega3 and Omega6 fatty acids,
and other single micro and macronutrients (n. a nutrient required in large
amounts for the normal growth and development of an organism; from
Dictionary.com) Next, Dr. Popper spends several paragraphs discussing questions
raised by the use of micronutrients, and the research and clinical implications
and points out the huge task to sort through the scientific process in
controlled, well designed studies, and coming to a beneficial formula through
this process if undertaken with speed, would take many years. Dr. Popper then
gives a strong caution against rushing into treating patients with
micronutrients without proper research, and against doctor’s doing their own
“empirical studies” with patients in their practice. The conclusion of this
commentary raises questions about the financial impact of micronutrient
treatments for Bipolar and other brain disorders on both the patient and the
pharmaceutical industry, and the observation that although the research is in
the “very early stages” if this line of research develops, it may be necessary
to “rethink traditional bias against nutritional supplements”.
Several things struck me as I read this article. First, this is not a research
study of any kind. This is an editorial comment regarding Dr. Popper’s
interaction with the originators of EMP and subsequent private dabbling with the
EMP product in his practice. His statistics about the patients who tried the
product don’t even begin to approach valid scientific research because the were
open label. His musings on EMP are interesting, but they are just that, musings
and speculation. His conclusions are valid….. Preliminary data are intriguing,
but MUCH more study needs to be done. He himself states this over and over, and
cautions clinical doctors from jumping ahead of scientific knowledge. I am very
concerned that parts of Dr.Popper article are being taken out of context in the
Truehope site. Only the parts that are positive for the supplements are quoted
and the parts where Dr. Popper warns people to go slow, wait for the
scientifically valid studies on efficacy and safety are left out.
This is the essence of the arguments against EMPower~ There may be benefits for
people but it is impossible to know for sure until scientifically valid research
is done. What is scientifically valid research? Check out the article on
Study Validity
and see if the “studies” on EMP meet the criteria for scientific validity.
To say, as I have heard many proponents of EMP say, that they are working on the
large double blind studies…. I want to know where are these studies?
Lamictal/Bipolar has 203 articles dating back to 1996 including large randomized
double blind studies listed on pub med, compared to 4 small samples or editorial
essays for EMPower. At $70 a bottle you’d think they could afford to do some
studies.
Any thinking person can see that there *may* be something to micronutrient
treatment of brain disorders, but there is no proof, and in my opinion promoting
it to people who do not understand the scientific method and believe that case
reports are convincing it just plain wrong.
The second article in the PDF file is available on PubMed at this address:
14 Case Studies
This is a series of case reports on adults diagnosed with Bipolar Disorder that
was published in 2001. The 11 patients were give EMP for six months and their
bipolar symptoms decreased significantly, and many were able to reduce their
pharmaceutical medication, some even went off them and remained well. The
article stated: “A randomized, placebo-controlled trial in adults with bipolar I
disorder is currently underway, as well as open trials in children.” I have not
been able to find any such studies published.
Again, this *is* intriguing, but a study with 11 participants is generally
called “pilot study” not conclusive evidence. (Duke
University) The purpose of a pilot study is to suggest direction for further
study, not prove a point. Please compare this EMP study to the 3 characteristics
of valid scientific research (from
Study
Validity)
1)First, it is self-correcting. Scientists do not assume that this method
discovers absolute truth but rather that it produces conclusions that subsequent
studies may modify. In this sense, science is cumulative.
The study seems to comply with this characteristic, but did not follow through
with bigger and better constructed studies.
2) Second, the scientific method requires objectivity. Findings must not be
contaminated by the personal beliefs, perceptions, biases, values, or emotions
of the researcher. Only when the results speak for themselves should the
conclusions be considered valid. Research results often lead to new questions
that need exploration.
Bonnie Kaplan is the only doctor (and a PhD psychologist at that) to do actual
“research” on EMP, and she, is obviously a "true believer". From her Application
for Funding:
As explained in the Executive Summary, the entity that will benefit financially
the most from a successful demonstration of the efficacy of these supplements is
our Provincial Government. A simple look at the economics of even one patient
should be convincing. The cost of the supplement ranges from $100-$400/month
(depending on dosage). In some cases, the patients whose mental health has
normalized on this supplement had previously spent weeks or months as inpatients
on psychiatric hospital wards. The potential for savings is staggering.
Let me just conclude by saying that a revolutionary paradigm shift is occurring
in the field of mental illness. In the US., the National Institutes of Health
are currently commencing clinical trials of nutritional supplements for
schizophrenia and bipolar disorder. Clinical trials are going on in the U.K.,
Japan, France, and elsewhere. From the preliminary results, it appears that the
intervention we are investigating in Alberta has the potential to be far more
therapeutic: hence, Alberta could be a major guiding light in this area if we
move quickly.
Open label studies, the only kind so far presented, are notorious in the
scientific community for being biased toward the substance being investigated.
3) Third, experiments must be reproducible. One study, taken alone, seldom
proves anything. To be valid, one researcher's findings must be repeatable by
others.
So far we have seen 2 studies and two editorial letters referencing the studies.
Pharmaceutical medications have hundreds of studies, such as the example of
Lamictal where there have been 203 studies according to a search on PubMed since
1996, including double blind placebo controlled studies.
Third Article in PDF is also available at PubMed
11 Case Studies
This March 2004 article is about a series of 11 case studies of children with
mood and behavioral problems. Nine Children completed the trial of 8 weeks of
EMP supplements, and while the article states that there was significant
improvement, it is not broken down by how much for each child, nor is it
mentioned if there were non-responders. “The findings suggest that formal
clinical trials of broad nutritional supplementation are warranted in children
with these psychiatric symptoms” which is apparently, what we already knew.
Again, this is a tiny study, and really only good for suggesting future lines of
investigation, and no where near enough information is presented to see if it is
even valuable in that regard, it does not advance the level of information in
any way about the safety and efficacy of EMPower products.
The last PDF file contained a “Letter to the Editor” of the Journal of Clinical
Psychiatry dated March 2003. I was not able to find this letter available freely
on the internet, but you can see the citation on PubMed
Dr. Simmon's Letter
Dr. Simmons letter appears of page 338 of the Journal of Clinical Psychiatry,
and can be found in the table of contents. Following Dr. Simmons letter is a
reply from Drs. Kaplan and Simpson. Dr. Simmons was commenting favorably on the
first study that had 14 patients. Dr. Simmons subsequently used EMP with 19
patients in his practice and 16 of those reported mild to marked improvement.
Simmons concludes that the effectiveness and safety of EMP remain to be
established, “but it does appear to present an exciting new direction for
research”. A happy report, but again, even the author is not saying that his
personal experiment with his patients is evidence that EMP works and is safe. To
date there is only anecdotal and case report evidence, and not scientifically
valid studies at all, except for one which I was unable to find on the
Treuhope.com website. It is as follows:
Randomized Controlled Study EMP for Fibromyalgia
Fibromyalgia Study
This is the only study that I know of that is randomized and controlled, and it
was negative for any benefit for EMP.
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