True Hope for Bipolar Disorder Sufferers?

Monday, April 21, 2008 by: Adam Miller
Tags: bipolar disorder, health news, Natural News

(NewsTarget) A new supplement from Truehope Nutritional Support, Ltd. may hold promise for people suffering from bipolar and other mood disorders. EMPowerplus is a supplement sporting a blend of 36 vitamins, minerals and amino acids, and it's making waves in the Canadian and American psychiatric communities. To its critics it is an unproven treatment that could prove dangerous, but to those who claim to have been helped by the supplement it is nothing short of a scientific breakthrough in the treatment of mood disorders.

Bipolar disorder is characterized by distinct periods of elevated mood and euphoria (known as mania) followed by periods of sometimes agonizing depression. In mania, extreme creativity is not uncommon, and it is believed that many brilliant people in history may have suffered from the illness. In times of depression, victims often suffer through intense sorrow, hallucinations, disembodied voices, disconnect with reality, and uncontrollable fixations on death. Because of the debilitating nature of the disease, voices of support are loud and passionate in support of a potentially new way to treat it.

The theory behind EMPowerplus is that bipolar and other mental disorders stem from massive nutritional deficiencies resulting from genetic abnormalities or environmental weaknesses and can be treated by addressing that deficiency.

The Story

After losing his wife in 1994 to suicide resulting from Bipolar Affective Disorder, Anthony Stephan watched helplessly as the disorder revealed itself in two of his ten children. After setting out to find a way to help them he would soon cross fates with David Hardy, a man with 20 years experience controlling rage and behavioral disturbances in animals through nutritional intervention. David mentioned a feed supplement that deterred aggressive behavior in pigs. Seeing the potential relationship between animal and human behavioral disorders, the pair adapted the regimen to human grade standards and administered it to Mr. Stephan's affected children. Amazingly, both of the children showed significant improvement, and the two men set out to begin manufacturing the blend as a nutritional supplement.

The next few years were spent refining the product and arranging for research to be performed on it. Opposition, however, was already mounting.

Health Canada is the Canadian government agency that performs most of the tasks that the FDA performs in the U.S. After completing two very promising clinical trials in 2001 and receiving a massive grant from the Alberta Science and Research Authority, a third trial was shut down by Health Canada in 2002. The claim was that EMPowerplus was an unregistered drug that needed to obtain a Drug Identification Number (DIN). Truehope was faced with a problem that is all too familiar in the supplement industry. Due to high cost and inherent incompatibilities between supplement and drug testing procedures, Stephan and Hardy would be unable to complete the necessary drug approval process.

Health Canada was relentless. EMPowerplus was being manufactured in the U.S., so agents set up on the border and seized the product as it came across. On July 15, 2003 Health Canada raided the Truehope office, seizing private virtual and physical documents.

In 2004 Pierre Pettigrew, the Canadian Minister of Health, granted the company sanction effectively putting an end to the border seizures. Truehope won official government approval to distribute its product legally after championing the Natural Health Products Directorate (referred to by some as Canada's DSHEA) in the same year and being issued a Natural Health Product Number (NPN) in 2005. A judge later ruled that the company had done no wrong in distributing the product without drug approval, and even went on to say that it would be a violation of criminal code to withhold the product from those who needed it.

As you may suspect, the controversy has hardly boiled over. What we are looking at is a seemingly unremarkable blend of basic vitamins and minerals that is claimed to be having an extraordinary effect on the health of patients who have been diagnosed with 'incurable' psychiatric conditions. It goes without saying that there are entrenched interests that would like to see any product that threatens their market share to quietly retreat out of the mainstream and back into the often confusing and hard-to-navigate world of alternative medicine. Still, just because a product or modality is under attack from the mainstream does not necessarily mean it is effective. There are many products that are attacked by established medicine for good reason. So what does the science say?

The Studies

To date there have been five clinical studies or commentaries published in scientific journals regarding the effectiveness of the EMPowerplus supplement. The following is a brief synopsis of the conclusions reached by each.

Effective Mood Stabilization With a Chelated Mineral Supplement: An Open-Label Trial in Bipolar. Journal of Clinical Psychiatry 62:12, December 2001.

The first study was performed by Dr. Bonnie Kaplan of the University of Calgary on 14 bipolar patients. According to Dr. Kaplan, "For those who completed the 6-month open trial, symptom reduction ranged from 55% to 66%... the need for psychotropic medications decreased by more than 50%." 80% of participants saw significant improvement in overall symptoms according to scores recorded on the depression (HAM-D), mania (YMRS), and general psychiatric status (BPRS) scales, according to the TrueHope website.

Commentary: Do Vitamins or Minerals (Apart From Lithium) Have Mood-Stabilizing Effects? Journal of Clinical Psychiatry 62:933-935, December 2001.

Dr. Charles Popper of Harvard University reported his clinical results with 22 patients. Dr. Popper reports that "Among 22 patients... who clinically met criteria for bipolar disorder, 19 showed what I judged to be a positive response." Further, he states that "Among the 15 patients who were being treated with medications when they began the nutritional supplement, 11 patients have been stable for 6 to 9 months without psychiatric medications."

Treatment of Mood Lability and Explosive Rage with Minerals and Vitamins: Two Case Studies in Children. Journal of Child and Adolescent Psychopharmacology Volume 12(3): 203-218, Fall 2002.

This was another study by Dr. Bonnie Kaplan on two children exhibiting explosive rage and mood disorder. "Both children with mood lability and explosive rage showed clinically significant improvements while taking a nutrient supplement consisting of minerals and vitamins," stated Dr. Kaplan on conclusion of the study.

Letters to the Editor: Nutritional Approach to Bipolar Disorder. Journal of Clinical Psychiatry 64:3, March 2003.

This trial was conducted by Dr. Miles Simmons on 19 patients from his private practice. He reports that "12 of the 19 patients showed marked clinical improvement, 3 showed moderate improvement, and 1 showed mild improvement." In all, 13 of the 19 patients were able to completely discontinue use of their pharmaceutical medication.

Improved Mood and Behavior During Treatment with a Mineral-Vitamin Supplement: An Open-Label Case Series of Children. Journal of Child and Adolescent Psychopharmacology. Volume 14, Number 1, Spring 2004.

Dr. Bonnie Kaplan and four other researchers found that of nine children diagnosed with various psychiatric disorders, all of them saw significant improvement in mood and anxiety using the supplement. The results were consistent with the results of previous studies.

Examined comprehensively, this early research seems to indicate an approximate 80% success rate using EMPowerplus to treat psychiatric conditions (specifically bipolar). This by no means translates to a cure or consensus in the scientific community over the effectiveness of the product, but it certainly suggests that further research is warranted – a conclusion reached by every researcher who has studied the supplement to date.

The Skeptics

TrueHope is not short on critics. Health Canada continues to pursue the company, stating in a 2007 press release that there have been nine reports of serious adverse effects attributed to the product, which may have been due to users discontinuing use of prescription drugs or combining them with the supplement. As we all know, any time prescription drugs are involved there is potential for unintended synergies and incompatibilities with supplements, herbs, or other drugs. There is no doubt that no person should augment their own prescription routine without consulting a qualified physician.

Terry Polevoy, M.D., co-author of the dissenting e-book Pig Pills, Inc., has been another vocal critic of the claims made by TrueHope. He describes the founders of the company as "seasoned sales people with dubious tragic stories to help them focus their pitch on others in need." More information on Terry and his views on EMPowerplus can be found at the HealthWatcher website, referenced at the bottom of this article.

Schizophrenia.com has also urged caution in use of the supplement. Their position is that "Schizophrenia.com considers this product to be unproven, with risks that currently outweigh possible benefits. The product is, in our opinion, burdened by excessively positive marketing claims given the minimal testing the product has received, as well as by lack of information..." There is some evidence that TrueHope marketing claims may be leading to skewed perceptions of the product's efficacy in vulnerable populations. In one case, a schizophrenic man threw out his medication in favor of the new perceived 'miracle cure', and upon return of uncontrollable psychosis wound up in jail for assault.

Skepticism of any product is always to be expected and is certainly useful for a contrary point of view. Consumers should view any nutritional supplement with a healthy dose of skepticism, because it is always in a company's interest to promote their product in the most positive terms, whether a small supplement manufacturer or a colossal pharmaceutical company.

The Summation

The point of substance here is that naturopathic and allopathic medicine work to treat disease in two completely different ways. The naturopathic approach attempts to address underlying causes such as a nutritional deficiency, while the allopathic approach for the most part attempts to ameliorate symptoms. One should never try to replace drug therapy with a supplement straight up, because they are often treating two different sides of the condition. If medication is discontinued, symptoms may show their ugly face immediately, while the naturopathic treatment is only beginning to do its job. This is an especially fitting precept in cases of psychiatric disorders, where patients can lose control of their normal thought process and act in ways that put themselves or others in danger.

Additionally, naturopathic treatments benefit from what is referred to as an additive effect. What this means is that problems are looked at from many different angles, and are addressed using different complementary tools that work in unison. A patient may receive nutritional therapy, herbal treatment, and acupuncture. If each of these had a 20% success rate, then the patient's chances for success could be as high as 60%. Allopathic treatments take a reductionist approach, and are often subtractive in nature. If a patient is on an immunosuppressant drug, adjuvant treatments that might otherwise prove useful may be contraindicated, namely those that augment immune function. It is worth noting that this is why we so often see nutrients being tested one at a time; it is a drug-oriented, reductionist mindset being applied to an entirely different theory of medicine. Supplements do not typically work in the same way as drugs where one pill is expected to act as a 'magic bullet.' A patient should not expect to stop taking prescription drugs and replace them with a single supplement overnight.

The EMPowerplus label enumerates a deceptively dull list of ingredients. It is a simple formula that contains no novel or exotic compounds, and upon reading the label you might even be fooled into thinking that you're looking at the back of a bottle of Centrum. The vitamins in the mix include A, C, D, E, B1, B2, B3, B4, B5, B6, B9, B12, and H. The mineral blend consists of calcium, phosphorous, magnesium, potassium, iodine, zinc, selenium, copper, manganese, chromium, molybdenum, and iron. Add a dash of TrueHope's "CNS Proprietary Blend" (dl-phenylalanine, glutamine, citrus bioflavanoids, grape seed, choline bitartrate, inositol, ginkgo biloba, methionine, germanium sesquioxide, boron, vanadium, nickel), and you have the most controversial supplement ever to come out of Canada.

EMPowerplus is working, above all else, to address a nutritional deficiency. This is an area with little research to reference, and nutritional deficiency may or may not be at the root of bipolar disorder in general. Even if the disease is caused by some deficiency we know that one supplement will not meet this need for all people. Keeping in mind that this is only a nutritional supplement (regardless of what Health Canada says), the research suggests that it may be worth it for someone suffering from bipolar or other psychiatric disorders to look into trying this approach. However, this should be treated as a nutritional supplement and not an immediate replacement for medication. Treat it like an overpriced multivitamin. If symptoms begin to dissipate then a patient may be able to lessen his or her use of medication responsibly under the close guidance of a qualified physician. As they say – it is important to keep an open mind, but not so open that your brain falls out.

Please Note: This article is not to be construed as an endorsement of EMPowerplus by either myself or Natural News. This article is intended for informational purposes only to assist the reader to be informed and empowered to make his or her own decisions based upon the conclusions of his or her own personal research and counsel obtained from a qualified health professional.

Sources of Interest:

(http://www.truehope.com)

(http://www.healthwatcher.net/Quackerywatch/S...)

(http://www.newswithviews.com/Meininger/eliss...)

(http://www.schizophrenia.com/sznews/archives...)

(http://www.healthyplace.com/Communities/Thou...)

(http://discovermagazine.com/2005/may/vitamin...)

(http://www.circare.org/FOIA/atipindex7.htm)

Available Public Abstracts of Referenced Studies:

(http://www.ncbi.nlm.nih.gov/pubmed/15142398?...)

(http://www.ncbi.nlm.nih.gov/pubmed/12427294?...)

(http://www.ncbi.nlm.nih.gov/pubmed/11780873?...)

About the author

Adam Miller is a student of life who has dedicated literally thousands of hours of personal research on top of formal institutional training in Dietetics to learn the secrets of achieving vibrant health and extended lifespan. His passion and dedication is in bringing the best ideas for self-empowerment through nutrition and nutraceuticals as well as alternative therapies, technology, and information to the public through various means.