Bio-Magnetic Therapy

February 2008

BIO-MAGNETIC THERAPY

HEALTH TECHNOLOGY ASSESSMENT UNIT

MEDICAL DEVELOPMENT DIVISION

MINISTRY OF HEALTH MALAYSIA

002/08

Prepared by: Puan Noormah Darus Principal Assisstant Director Health Technology Assessment Unit Medical Development Division Ministry of Health Malaysia

Reviewed by: Datin Dr. Rugayah Bakri Deputy Director Health Technology Assessment Unit Medical Development Division Ministry of Health Malaysia

EXECUTIVE SUMMARY OF BIO-MAGNETIC THERAPY

INTRODUCTION

Bio-magnetic healing is the therapy that helps the body heals itself. Magnetic healing is nothing new. Early records in scientifically advanced civilizations, tell us that magnetic forces have long been prized for their restorative properties. Chinese manuscripts dating back thousands of years describe the Eastern belief that the life force, termed "qi", is generated by the earth's magnetic field.

Bio-magnetic therapy is the art and science of application and removal of magnetic fields for therapeutic benefit. Magnetic field is an invisible region of space around a magnet or electric current in which a detectable force is exerted from the body of the magnet.

TECHNICAL FEATURES

It is important to distinguish between static magnet therapy and electromagnetic therapy which is not the same. Research into magnet therapy is divided into two distinct areas: pulsed bioelectric magnetic therapy and fixed magnetic therapy.

Static magnet therapy: A fixed magnet emits a magnetic field which is caused by electrical charges in motion. Static magnet therapy is a form of alternative medicine claiming that certain medical disorders can be effectively treated by exposure to static magnetic fields, produced by permanent magnets. Static magnet generates a field which penetrates the skin, tissues and bones, increasing the flow of blood, oxygen and nutrients which in turn promotes healing.

iii body go out of balance, disease and illness occurs. By applying electromagnetic energy from outside the body, usually with electronic devices, practitioners claim they can correct the imbalances in the body. Practitioners claim that these methods can treat ulcers, headaches, burns, chronic pain, nerve disorders, spinal cord injuries, diabetes, gum infections, asthma, bronchitis, arthritis, cerebral palsy, heart disease, and cancer.

CONCLUSION

Bio-magnetic therapy such as in the form of band or bracelet is not a registered medical device with the U.S. Food and Drug Administration.

The review showed that there were evidences of no effectiveness when using bio-magnetic therapy to treat chronic low back pain and pressure ulcers. However poor quality evidences showed that there was some pain reduction in the treatment of knee pain and improved leg ulcer healing.

RECOMMENDATION

Based on the above review, biomagnetic therapy in the form of band or bracelet cannot be recommended. It is not a replacement for standard medical treatment.

More clinical research is warranted to provide evidence of effectiveness for its use in treating any medical condition.

TITLE: BIO MAGNETIC THERAPY

1. INTRODUCTION

Bio-magnetic healing is the therapy that helps the body heals itself. Previously it was used in ancient Egypt, rediscovered by NASA and is now accessible to all. Take the fact that iron makes up about 4 percent of our blood content and then imagine magnets attracting metal and you have the basis of the therapy. Magnets placed on the body increase blood flow in a specific area, much as exercising does; indeed often giving a similar feeling of euphoria. Early astronauts returned from brief bursts into gravity-free space with diminished bone density and compromised immunity. Nowadays space suits are lined with magnetic material and astronauts suffer no ill effects after months aloft [2] level III.

Magnetic healing is nothing new and can be seen by looking at early records of scientifically advanced civilizations, which tell us that magnetic forces have long been prized for their restorative properties. Ancient Greece discovered the very first natural magnet in the form of the lodestone, and Hippocrates, the father of medicine, noted its healing powers. Chinese manuscripts dating back thousands of years describe the Eastern belief that the life force, termed "qi", is generated by the earth's magnetic field. Today, many believe that certain places on earth, such as Lourdes, France, and Sedona, Arizona, owe their healing powers to naturally high levels of this qi, or bio-magnetic energy [3] level III.

2. OJECTIVE/ OBJECTIVES

To determine the safety, adverse events and effectiveness of the Bio Magnetic therapy

3. TECHNICAL FEATURES

Static magnet therapy: A fixed magnet emits a magnetic field; and a magnetic field is caused by electrical charges in motion, as opposed to an electric field, which is produced by electrical charges in different concentrations, more in one place than the other, regardless of whether or not they are moving. In a static magnet, the electrical current moves in terms of electrons orbiting around the atomic nuclei. An iron body is magnetized when the electrons become aligned to a greater degree. Static magnet therapy is a form of alternative medicine claiming that certain medical disorders can be effectively treated by exposure to static magnetic fields, produced by permanent magnets. Static magnet generates a field which penetrates the skin, tissues and bones, increasing the flow of blood, oxygen and nutrients which in turn promotes healing.

Electromagnetic therapy: It involves the application of electromagnetic waves to the patient to diagnose or treat disease. An electromagnetic apparatus gives off an electric and magnetic field. Electric fields are associated with the displacement of charged particles, usually electrons, but sometimes charged particles called ions. Electromagnetic therapy, which includes several different approaches, is claimed to use electromagnetic, microwave, or infrared energy to diagnose or treat an illness by detecting imbalances in the body's energy fields and then correcting them. Electronic devices, which emit some form of low-voltage electrical current or radio frequency, are often involved. Magnets and other unconventional treatments may also be a part of electromagnetic and energy field therapy [2] level III.

The effectiveness of magnetic treatment depends largely on four factors, according to Dr. John Zimmerman: strength, thickness, number of magnets used, and spacing. Magnets vary in strength, and it's important to remember that stronger magnets penetrate more deeply than do weak ones and that the reading at the surface of the magnet is different from the reading at its core. In other words, a magnet that is a 2000 gauss at its core may only be 200 gauss at its surface [3] level III.

Practitioners claim that when electromagnetic frequencies or energy fields within the body go out of balance, disease and illness occurs. They claim that these imbalances disrupt the body's chemical makeup. By applying electromagnetic energy from outside the body, usually with electronic devices, practitioners claim they can correct the imbalances in the body. Practitioners claim that these methods can treat ulcers, headaches, burns, chronic pain, nerve disorders, spinal cord injuries, diabetes, gum infections, asthma, bronchitis, arthritis, cerebral palsy, heart disease, and cancer [2-4] level III.

4. METHODOLOGY

4.1 SEARCH METHODS

PUBMED, PROQUEST and MEDLINE via EBSCO were searched using the keywords magnetic therapy, bio-magnetic therapy, electromagnetic therapy, static magnet therapy, magnetic therapy safety, magnetic therapy effectiveness and efficacy, magnetic therapy adverse events either singly or in combination, with the limits to human study, year of publication from 2000 – 2008. In addition websites for existing HTA agency, society websites and cross- referencing of the articles retrieved were also carried out accordingly to the topic.

5. RESULTS AND DISCUSSION

While very little research on magnet therapy has been done in the United States, there has been a lot of work in this field in Russia, Czechoslovakia, and the Western European nations over the past 30 years. In the 1980’s and 1990’s a lot of research has been done by the Russians, but the studies were mostly case reports, case series and testimonials. This review focuses on the latest scientific evidence from year 2000 until 2008.

From the search, 39 articles were retrieved. Only eighteen studies were relevant and taken as references. However, only one systematic review, five randomized control trials and one experimental study were reviewed.

A systematic review of all relevant literature was done and the evidence graded according to the US/Canadian Preventive Services Task Force (Appendix)

5.1 EFFECTIVENESS

In a systematic review by Olyaee Manesh A et al, two randomized controlled trials were identified for inclusion in the original review (total of 60 participants). Neither study found a statistically significant difference between the healing rates of pressure ulcers in people treated with electromagnetic therapy compared with those in the control group. The results provide no evidence of benefit in using electromagnetic therapy to treat pressure ulcers [5] level I. In a randomized, double-blind, placebo-controlled, crossover pilot study in an ambulatory care physical medicine and rehabilitation clinic at a Veterans Affairs hospital, application of 1 variety of permanent magnet had no effect on the group of subjects with chronic low back pain [6] level I. Hence, the retrieved evidence above showed that using electromagnetic therapy for pressure ulcers and static magnet therapy for chronic back pain were not effective as a magnetic therapy.

In a randomized controlled trial by Kenkre JE et al on nineteen patients with leg ulcers, patients treated with electromagnetic therapy at 800 Hz were found at day 50 to have significantly greater healing (P < 0.05) and pain control (P < 0.05) than placebo therapy or treatment with 600 Hz

[7] level I. In another randomized controlled trial, by Jerry I Jacobsob et al, exposure to low Amplitude, extremely low frequency magnetic fields for the treatment of osteoarthritis knee, showed the magnet-on group (n=171) on average, reported experiencing a 46% reduction in level of pain. The magnet-off group (n=75) on average, reported experiencing an 8% reduction in level of pain [8] Level I. Hence the retrieved articles showed that electromagnetic therapy at 800 Hz did improved leg ulcer healing and low frequency magnetic fields reduced pain of patients with osteoarthritis knee pain. However both studies had small sample sizes and the study by Jerry I Jacobsob et al had more than double the amount of patients on the electromagnet therapy compared to placebo.

In randomized control trials by Martha et al and Peter Wolsko et al on the effects of static magnet on chronic knee pain and physical function, the application of static magnet over painful knee joint appears to reduce pain and enhance functional movement. However the sample size was small to determine efficacy and pain reduction was not sustained when not using the static magnet [9-10] level I.

Most magnets are distributed to the public without any indications of field flux density. In a study done by Abraham M Blechman et al, to test the discrepancy between claimed field flux density of some commercially available magnets and actual gaussmeter measurement, the 5 commercial magnets studied showed lower field flux density than the values claimed by manufacturers [11] level II-3. The field flux density measured on the magnets’ surface can be regarded as the primary measurement of dosage and contributes to the determination of the depth of tissue penetration of the magnetic field and therefore the effective dosage. Over the counter magnets, suppliers are not providing reliable information and therefore clinical replication of published reports is difficult. In this study, the field flux of the tested magnet decreased significantly at a distance of 2.5 cm from the magnet suggesting minimal tissue penetration

Hence, it is important that people treat magnets with caution. They can be very powerful and one do need to know what you are doing, knowing what is needed, where and of what intensity

5.2 SAFETY

In randomized control trials by Kenkre JE et al and Jerry I Jacobsob et al using electromagnetic therapy for the treatment of venous leg ulcers and osteoarhritic knee, electromagnet therapy was well tolerated by patients, with no adverse events reported [7,8] level I.

In randomized control trials by Martha et al and Peter Wolsko on the effects of static magnet on chronic knee pain and physical function, the application of static magnetic field appears to be safe with no adverse events reported [9,10] level I.

While magnets are generally safe, there are times when they should not be used. Pregnant women should not wear magnets; particularly over the abdominal area. Individuals wearing heart pacemakers or other electronic implanted devices should not use magnets near the apparatus. Magnets lessen the stickiness of platelets, blood components that make a scab after one cut oneself. So, if one uses a magnet when one have an active bleeding wound, one may actually increase the amount of bleeding in the wound. Do not use magnets if one is on anticoagulants or if one has a condition, called polycythemia that increases the likelihood of bleeding. People with cancer or any sort of infection, like candida, fungi, viruses, or bacteria, should avoid exposure to bipolar magnets. Many believe from their observations and clinical experiences that the South Pole accelerates the growth of cancer cells, bacteria, viruses, and fungi. Not all practitioners and manufacturers agree, but until the research proves otherwise, it is prudent to err on the side of caution, and only use products with north-facing magnetic fields [3] level III.

5.3 LEGAL IMPLICATIONS

Legal and Regulatory Actions

Since 1998 until 2002, several companies in USA such as Magnetherapy Inc, Magnetic Therapeutic Technologies, Tectonic Magnets, Pain Stops Here! Inc., Florham, Bio-Magnetic Treatment Systems and European Health Concepts Inc., are barred from making the following claims [12-18] level III: • that wearing its magnetic device near areas of pain and inflammation will relieve pain due to arthritis, migraine headaches, sciatica or heel spurs and to stop making claims that its magnets can cure, treat, or mitigate any disease or can affect any change in the human body, unless its devices are FDA-approved for those purposes

• magnetic sleep pads or other products: (a) are effective against cancers, diabetic ulcers, arthritis, degenerative joint conditions, or high blood pressure; (b) could stabilize or increase the T-cell count of HIV patients; (c) could reduce muscle spasms in persons with multiple sclerosis; (d) could reduce nerve spasms associated with diabetic neuropathy; (e) could increase bone density, immunity, or circulation; or (f) are comparable or superior to prescription pain medicine.

• "magnetized water" or other products are useful against cancer, diseases of the liver or other internal organs, gallstones, kidney stones, urinary infection, gastric ulcers, dysentery, diarrhea, skin ulcers, bed sores, arthritis, bursitis, tendinitis, sprains, strains, sciatica, heart disease, circulatory disease, arthritis, auto-immune illness, neuro- degenerative disease, and allergies, and could stimulate the growth of plants.

• MagneForce shoes can a) correct "magnetic deficiency," (b) "generate a deep-penetrating magnetic field which increases blood circulation; reduces leg and back fatigue; and provides natural pain relief and improved energy level."; and (c) their claims are established and proven by scientific studies

6. CONCLUSION

Bio-magnetic therapy such as in the form of band or bracelet is not a registered medical device with the U.S. Food and Drug Administration.

7. RECOMMENDATION

Based on the above review, bio-magnetic therapy in the form of band or bracelet cannot be recommended. It is not a replacement for standard medical treatment.

More clinical research is warranted to provide evidence of effectiveness for its use in treating any medical condition.

8. REFERENCES

1. http://www.biomagnetic.org/magnetic%20vocabulary.html 2. Lilias Curtin What is Bio-Magnetic Therapy? Alternative Medicine, Complementary Health Directory & Resources 07 March 2007 3. http://www.garynull.com/Documents/magnets.htm 4. Anonymous Magnet therapy attracts interest--but does it work? nHealth News; Aug/Sep 2001; 19, 4; Health Module pg. 1 5. Olyaee Manesh A, Flemming K, Cullum NA, Ravaghi H. Electromagnetic therapy for treating pressure ulcers. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD002930. DOI: 10.1002/14651858.CD002930.pub3. 6. Edward A. Collacott, MD, John T. Zimmerman, PhD, Donald W. White, PT Joseph P. Rindone, PharmD . Bipolar Permanent Magnets for the Treatment of Chronic Low Back Pain A Pilot Study JAMA, March 8, 2000—Vol 283, No. 10 7. Kenkre JE, Hobbs FDR, Carter YH, Holder RL and Holmes EP. A randomized controlled trial of electromagnetic therapy in the primary care management of venous leg ulceration. Family Practice 1996; 13: 236-241. 8. Jerry I Jacobsob, Roger Gorman et al. Low Amplitude, extremely low frequency magnetic fields for the treatment of osteoarhritic knee: a double blind clinical study.Altern. Ther. Health Med2001;7(5): 54-69. 9. Martha R.Hinman, Jeniffer Ford and Heather Hyel.Effects of statinc magnet on chronic knee pain and physical function: A double-blind study. Alternative therapies July/Aug 2002Vol 8. No 4 10. Peter Wolsko, David M Eisenburg et al. Double blind placebo controlled trial n static magnets for the treatment of osteoarthritis of the knee : results of a pilot study. Altern. Ther. Health Med2004;10(2): 36-43 11. Abraham M Blechman; Mehmet C Oz; Vijaya Nair; Windsor Ting Discrepancy between claimed field flux density of some commercially available magnets and actual gaussmeter measurement Alternative Therapies in Health and Medicine; Sep/Oct 2001; 7, 5; Health Module pg. 92

12. Morales halt unproven claims for magnet therapy. News release, April 9, 1998. 13. Gill LJ. Letter to William L. Roper, Feb 3, 1997. 14. Jeff Wynton and the Consumer Justice Center v. Florsheim Group, Inc., Shoe Emporium. Superior Court of California, Orange County, Case #00CC09419, filed Aug 8, 2000. 15. Burns EB. Omnibus ruling on defendants' motion to strike and motions to dismiss. United States of America v Richard Markoll, Ernestine Binder Markoll, and Bio-Magnetic Systems, Inc. U.S. District Court, District of Connecticut, No. 3:00cr133(EBB), Jan 2001. 16. Defense Criminal Investigative Service press release, Aug, 2001. 17. Defense Criminal Investigative Service press release, June, 2001. 18. Barrett S. California Attorney General sues magnetic mattress pad sellers. Quackwatch, Sept 24, 2002.

9. APPENDICES 9.1. Appendix I- Levels of evidence scale

I Evidence obtained from at least one properly designed randomized controlled trial.

II-I Evidence obtained from well-designed controlled trials without randomization..

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees.

SOURCE: US/CANADIAN PREVENTIVE SERVICES TASK FORCE(Harris 2001)