GBIS - Global Innovative Systems, Inc. (fka GBIS)

[jmhollen]

ENERMED RESEARCH REPORTS

Research to date has focused on the use of the Enermed for the treatment of two chronic conditions for which conventional medicine has no solutions: multiple sclerosis (MS) and migraine headaches.
The Company has undertaken a number of studies over the past five years.

Multiple Sclerosis (MS) Research
In 1996 we conducted a preliminary study of the effectiveness of the Enermed for the symptoms of MS. This research, conducted at the University of Washington in Seattle with partial funding from the National Institutes of Health (NIH), resulted in the following publications and presentations:


Richards TL, Lappin MS, Acosta-Urquidi J, Kraft GH, Heide AC, Lawrie FW, Merrill TE, Melton GB, Cunningham CA (1997). Double-blind study of pulsing magnetic field effects on multiple sclerosis. Journal of Alternative and Complementary Medicine, 3(1): 21-29.


Richards TL, Acosta-Urquidi J, Merrill TE, Kraft GH, Lappin MS, Lawrie FW (1997). Pulsing Magnetic Field Treatment Effects on Brain Electrical Activity in Multiple Sclerosis. Paper presented at the Consortium of Multiple Sclerosis Centers Conference, Systems of Care in Multiple Sclerosis, Sep 5-7, 1997, Calgary, Alberta Canada. Abstract appears in Multiple Sclerosis, 3(3), 1997.


Richards TL, Acosta-Urquidi J (1998). Pulsing Magnetic Field Effects on Brain Electrical Activity in Multiple Sclerosis in Biologic Effects of Light 1998: Proceedings of a Symposium, Basel, Switzerland November 1-3, 1998. Micheal F. Holick and Ernst G. Jung, Eds., Boston: Kluwer Academic Publishers, pp 337-342.

The promising results of the preliminary University of Washington study laid the groundwork for a larger, second study conducted at three research sites across the USA. This larger study, also a double-blind, placebo controlled trial, was generously supported by the Multiple Sclerosis Association of America, in Cherry Hill, New Jersey. Three publications have resulted from this effort, including a journal article currently undergoing peer review:


Lappin, MS (1998). Evaluation of a Pulsed Electromagnetic Therapy (Enermed) on Multiple Sclerosis (MS) Patient Symptoms and Quality of Life. Final Report submitted to the Multiple Sclerosis Association of America, Cherry Hill, NJ.


Richards TL, Lappin MS, Lawrie FW, Stegbauer KC (1998). Bioelectromagnetic applications for multiple sclerosis. Physical Medicine and Rehabilitation Clinics of North America, 9(3): 659-674.


Lappin MS, Lawrie FW, Richards TL, Kramer ED (2001). Effects of a pulsed electromagnetic therapy on multiple sclerosis fatigue and quality of life: A double-blind, placebo controlled trial. Under review.

Migraine Research

Our early research on the possible effectiveness of the Enermed for migraine headaches consisted of two patient surveys. Although the results are not as reliable as those obtainable from a carefully controlled clinical trial, they clearly demonstrated the promise of the Enermed as a preventive therapy for migraine sufferers.


Lappin, MS. (1995). Research on the Utility of the Enermed Device as Treatment for Migraines. (EMD Research Report #1). Energy Medicine Developments (North America) Inc., Vancouver, British Columbia.


Lappin MS. (1999). 1999 Enermed Patient Survey Results. (EMD Research Report #4). Energy Medicine Developments (North America) Inc., Vancouver, BC.

Clicking on the links below will take to a copy of these two reports:



#1 Research on the Utility of the Enermed Device as a Treatment for Migraines. April 1995

#4 1999 Enermed Patient Survey Results November 1999

We subsequently conducted a small, exploratory study of the effectiveness of the Enermed for women suffering from hormonally based migraines at clinical centers in Wisconsin and Virginia. What we learned paved the way for the development of a grant application we submitted to the NIH National Center for Complementary and Alternative Medicine.

This proposal was subsequently funded, allowing us to conduct our first controlled trial of the effectiveness of the Enermed for migraines.

Preliminary results were recently presented at a conference. A manuscript reporting the complete and final analyses is under preparation.



Lappin MS, Lawrie FW (2001). Preliminary Assessment of the Effects of a Pulsed Electromagnetic Field Therapy on Migraine Headaches. Presentation at the 9th Annual Society for Neuronal Regulation Conference, October 27-30, 2001, Monterey CA.
Abstract available at: http://www.snr-jnt.org/NewsPlus/2001/2001-Papers.htm

Other Applications

EMD is currently developing research protocols to capitalize on the growing interest in combining the Enermed therapy with neurofeedback in the treatment of depression. A pilot study presented at the 2000 Society for Neuronal Regulation conference suggested that this may be a very productive approach.


Baehr, E., Lappin, MS, Baehr, R., Matsumoto, MA. Neurofeedback and Pulsed Electromagnetic Therapy: A Match Made in Heaven. Paper presented at the Society for Neuronal Regulation Conference, September 2000, Minneapolis, MN. Abstract in the Journal of Neurotherapy, 4(4) 2001, 78-79. We expect to be able to report the results of additional studies in this area within the next year.



EMD Research Report #1
"Research on the Utility of the Enermed Device as a Treatment for Migraines"
prepared by Dr. Martha Lappin for Energy Medicine Developments (North America) Inc.

Background

For several years now, clinics in Great Britain have been treating migraine sufferers with a device known in North america as the Enermed, a device developed by the British engineer, Stephen Walpole. Enermed is a small, battery-powered device that emits a continuous, pulsed flow of extremely low frequency (ELF) electromagnetic energy. The device was developed after Walpole, who was subject to intense migraines himself, discovered that migraine sufferers tend to have lower than average levels of brainwave activity in the low frequency end of the electromagnetic spectrum. The Enermed device is worn close to the body and exposes the migraine sufferer to a continuous pulsed flow of energy in the deficient or low activity frequencies.

Walpole's personal experience, plus anecdotal data from several early case studies, suggested that exposure to this kind of electromagnetic energy reduced the incidence of migraines in chronic sufferers (Walpole, 1993). In 1988, a pilot study of the practical applications of electromagnetic therapy yielded similar results (Young, 1993). Young, an independent researcher from the Koestler Foundation in London, tracked a sample of 54 migraine sufferers for three months after they received one of Walpole's early versions of the Enermed device. She found that the average number of migraines reported by subjects dropped by half, from 1.2 to .6 per week, once they started wearing their devices. Pain levels and the average duration of subjects' headaches also dropped significantly. The treatment effects were immediate and enduring.

The results of Young' s study support the potential practical application of electromagnetic therapy in the treatment of migraines. However, before launching Enermed in North America, the directors of Energy Medicine Developments (North America) Inc. requested that users in Great Britain be polled to determine their perceptions of effectiveness of the most recent version of the device. The procedure and results of this study are reported below.

Research Method:

During the summer of 1994, Walpole's company mailed out one page surveys to approximately 1,200 individuals who had purchased Enermed devices from clinics in the United Kingdom in the preceding fifteen months. By mid-August, approximately 500 surveys had been returned, for a response rate of 42%. A total of 269 of the respondents had been treated for migraines; the rest had been treated for one or more of a variety of other disorders. This report addresses results for the migraine patients only.

The survey asked respondents to use a 10 point scale to indicate how they felt before and after they started wearing their Enermed devices ("1" = "perfectly well" , "10" = "extremely bad"). High scores for the migraine sample are assumed to reflect the seriousness of migraine related symptoms (nausea, light sensitivity, etc.), as well as the severity of the patients' headaches.

Over half (58%) of the respondents had pre-treatment well-being scores in the "extremely bad" range (9 or 10). We call these 155 individuals the "severe symptom" group. Just over one third (36%) had pre-treatment scores of 7 or 8; these 96 individuals constitute the "serious symptom" group. The "moderate symptom" group consists of the 14 people (5%) with pre-treatment scores at or near the midpoint of the scale (5 or 6). Four respondents had pre-treatment scores in the positive end of the scale (2 to 4) and were dropped from the analyses. This resulted in a final analysis sample of 265 moderate to severe migraine sufferers.

Research Results:

The large majority of respondents (82%) reported at least a modest improvement (two points or more) in their overall well-being after receiving the Enermed device. More striking, however, is large number of individuals who experienced dramatic improvements after treatment. In the Severe Symptom group, for example, over one fourth (28%) indicated that their migraine symptoms virtually disappeared once they started using Enermed - pain scores dropped from the very highest levels (9-10) to the very lowest (1-2) levels possible. Another 32% in this group experienced a 5 to 7 point improvement, with post-treatment scores in the "mild discomfort" range (3-4). Overall, then, fully 60% of the patients with the most debilitating symptoms prior to treatment experienced dramatic improvements after receiving the Enermed device. Another 25% reported modest improvements, and only 15% failed to improve at all.

Post-Treatment Symptom Ratings for Patients with Severe/Serious Pre-Treatment Symptoms
SEVERE
9-10) SERIOUS
(7-8) MOD
(5-6) MILD
(3-4) NEGLIGIBLE
(1-2)
SEVERE Migraine Group (n=155) 15% 8% 17% 32% 28%
SERIOUS Migraine Group (n=96) 4% 12% 15% 39% 29%



Comparable results were obtained for the 96 patients in the Serious Symptom group (those with pre-treatment scores of 7 or 8). Over two thirds (68%) of the respondents in this group reported well-being levels in the positive end of the scale after treatment, including 39% who indicated only mild discomfort after treatment and 29% who said they felt "perfectly well" once they started using Enermed. The small number of respondents (n=14) seeking treatment for only moderate symptoms render the results for this particular group somewhat unreliable; the trend, however, was similar to that observed for the more serious migraine sufferers.

Discussion and Recommendations:

The results of this study are very encouraging. Overall, almost two thirds of the respondents reported substantial improvements in their well-being after they started using Enermed. The results do not reveal how Enermed alleviates suffering, nor can this research offer clues as to why treatment failed to work for about 15% of the sample. Combined with similar findings from previous research, however, the results do attest to the promise electromagnetic therapy holds for the typical migraine patient. The strength, consistency, and apparent duration of the effect make it highly unlikely that the improvements reported by respondents simply reflect a placebo effect or retrospective bias.

Sampling error is probably the most serious concern with respect to the validity of the research. Although a response rate of 42% is considered respectable for a mail out survey, it does not eliminate the possibility that survey respondents are not representative of the population of migraine sufferers seeking treatment. Only follow-up research can establish with certainty that the success rates reported here are typical, and thus likely to be replicated.

Additional data on patient characteristics and symptom patterns would also be useful, both to further our understanding of how the Enermed device works and to fine-tune efforts to program the most effective frequencies for individual patients. Currently, Enermed devices are programmed based on the results of a brain wave activity analysis and a largely anecdotal, but expanding, body of knowledge about the frequency ranges likely to be effective for individuals with particular symptoms or onset factors. This method works very well in many, but clearly not all cases. The key to more efficient diagnosis and treatment may lie in the systematic collection and analysis of personal and medical history data.

The ideal study would also include randomized assignment to blind treatment and control groups and/or provisions for assessing the impact of withholding treatment from patients for whom it appears to be successful. These research designs are very expensive, however, and likely to be impractical outside of large, well-funded research laboratories.

In the meantime, efforts to make this novel, promising treatment available to a wider audience appear warranted.
Exposure to extremely low frequency electromagnetic radiation has already helped hundreds of migraine sufferers in Great Britain. Distribution of the Enermed in North America, combined with serious efforts to better understand when and how it is most effective, could alleviate suffering for many of the millions of migraine victims in Canada and the US.

References


Walpole, Stephen (1993). Medigen and the brain frequency analyser. International Journal of Alternative and Complementary Medicine. October, 1993.


Young, Sophie (1993). Pilot study concerning the effects of extremely low frequency electromagnetic energy on migraine (from The Koestler Foundation, London, 1988). International Journal of Alternative and Complementary Medicine. October, 1993.

About the Author

Dr. Lappin received her bachelor's degree from Colgate University and her master's degree and doctorate in psychology from Michigan State University. She spent 15 years as a research psychologist for the U.S. Army Research Institute (ARI), where she was the leader of the Special Forces research team. She authored numerous technical reports and conference papers, and was awarded the Superior Civilian Service Award for her work in 1997.

Dr. Lappin began working as a consultant to Energy Medicine Developments (North America) Inc. in 1994, and since May of 1997 has served as their research director, as well as the president of Alternative Health Care Research, Inc. Current research activities include follow-up research on migraine patients treated in Canada and coordinating the multi-site clinical trials EMD is sponsoring on the effectiveness of the Enermed as a symptomatic treatment for multiple sclerosis.



Note: The Enermed device was formerly called "Medigen" in Great Britain.

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NOTE:

The Enermed is a complementary therapy and is not to be regarded as a substitute for the attention of the user's doctor or medical advisor, and such attention should not be withheld on the grounds of the use of the Enermed. The Enermed is not to be used by people with a pacemaker, or those suffering from epilepsy, cancer, diabetes or with heart or kidney disease and should be removed in the case of pregnancy.

The patient must have received a diagnosis from their doctor prior to visiting an Enermed location.

Individuals with a pacemaker, suffering from epilepsy, cancer, diabetes insipidus, or heart or kidney disease will not be eligible for treatment with the Enermed.