Effective Mood Stabilization With a Chelated Mineral Supplement: An Open-label Trial in Bipolar Disorder
Journal of Clinical Psychiatry Articles
December 6, 2001 Edition
Read the abstract on the National Library of Medicine website or read the editorial review of the actual Journal articles below.
Summary of Journal Articles
The idea that effective mood stabilization can be achieved through the use of vitamins, trace elements and amino acids is advanced in a study conducted by a team of researchers from the University of Calgary, Alberta's Faculty of Medicine. The results of the ongoing study are published in the latest edition of the Journal of Clinical Psychiatry. The same edition also contains a commentary by Dr. Charles Popper, MD, a psychopharmacologist from Harvard University . Dr. Popper also has patients in his clinical practice who are taking the nutritional supplement.
The subject of the research is Empowerplus, a nutritional supplement formulated by the Synergy Group of Canada Inc.
In an Abstract entitled: ‘Effective Mood Stabilization with a Chelated Mineral Supplement: An Open-Label Trial in Bipolar Disorder” , the study's author, Bonnie J. Kaplan, PhD, explains the therapeutic benefit of the use of a nutritional supplement to treat bipolar disorder. Dr. Kaplan is a research psychologist who studies mood and behavioral disorders and a Professor in the Department of Pediatrics, University of Calgary . She is also Director of the Behavioral Research Unit at the Alberta Children's Hospital.
Dr. Kaplan and colleagues at the University of Calgary , along with Dr. Richard C. Ferre ( Salt Lake City , Utah ), conducted a 6-month open-label trial with 14 patients diagnosed with bipolar disorder, aged 19-46 years, who were taking an average of 2.7 psychotropic medications each at study entry.
The intervention is a broad-based nutritional supplement (Empowerplus) of dietary nutrients; primarily trace minerals and vitamins, administered in high doses. The supplement has 36 ingredients, 33 of which are natural dietary minerals and vitamins including calcium, iron, magnesium, zinc, copper, potassium, and various vitamins such as A, C, D, E, and several B vitamins.
At study entry and periodically thereafter, patients were assessed with the Hamilton-Depression Scale (Ham-D), Brief Psychiatric Rating Scale (BPRS), and the Young Mania Rating Scale (YMRS). The results of the study demonstrated symptom reductions ranging from 55% to 66% on the outcome measures, while the need for psychotropic medications decreased by more than 50%.
Dr. Kaplan wrote about the outcomes: “The effect size for the intervention was large (>.8) for each measure and the number of psychotropic medications decreased significantly to a mean of 1.0 (from 2.7). In some cases, the supplement has replaced psychotropic medications and the patients have remained well. Side effects (i.e., nausea) have been infrequent, minor, and transitory.”
Based on these findings, Dr. Kaplan concludes: “Some cases of bipolar illness may be ameliorated by nutritional supplementation.”
“We have seen significant improvement in the mental health of the participants taking part in this study,” says Kaplan. “Our early findings certainly warrant further exploration of this supplement as a new treatment for mood and temper problems. In fact, a randomized, placebo-controlled trial in adults with bipolar I disorder is currently underway , two more have been funded, and we have completed some open trials in children,” she added.
In an article that accompanied the research, Dr. Kaplan provided an overview of the study's methodology, as well as a discussion of the various factors relevant to the impact of the nutritional supplement on behavior. She made the following points:
- “Solid scientific research shows that many dietary nutrients, including minerals and vitamins, are essential for normal brain function… Less is known about the role of trace elements but there is considerable evidence that these too may be essential for normal brain function. Zinc provides a good example…”
- “The evidence supporting the importance of minerals and vitamins in central nervous system functioning provided some scientific support for our interest in studying a supplement that is gaining considerable clinical attention in Canada and in many areas of the United States. Described herein are the data collected in open trials of the first, consecutive and unselected 11 cases of bipolar disorder in adults evaluated on this supplement and followed for at least six months, testing the hypothesis that a broad-based nutritional supplement that emphasizes trace minerals would help stabilize mood.”
- “We have been exploring the possible clinical benefit of a broad-based nutritional supplement consisting of 36 items, primarily minerals. The data reported here provide the first, preliminary scientific validation of the supplement's efficacy, and suggest that further research is warranted. “
- “Although much additional research is needed…our preliminary data and the general clinical experience of psychiatrists who are monitoring patients in our trials indicate that the supplement has a beneficial psychotropic effect and is not acting in only an adjunctive manner.”
- “No problematic adverse effects were encountered from the nutrient supplement. Patients generally reported a subjective sense of improved well being when taking the supplement, and several patients described this well-being as feeling more normal than what they had experienced with psychotropic medication. “
- “Regardless of the mechanisms involved, the findings reported here suggest that the amelioration of mood instability with broad spectrum nutritional interventions warrants further exploration.”
David Hardy and Tony Stephan responded to the study results: “This study is an important step in the evolution of our efforts to help the mentally ill. While we have seen similar results with the participants in our open-label series, we knew it was crucial to the supplement's wider legitimacy to have its performance measured and scrutinized in a scientific setting. We are grateful to the University of Calgary and to Dr. Popper for taking the time to study the supplement's impact on the mentally ill. The decision to research the supplement was entirely theirs and the beneficiaries of this work will be the mentally ill.”
The Alberta Children's Hospital Foundation and the Alberta Science and Research Authority supported this study.
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