TWiki . Edumacation . MagneticHealthBaylorRebuttal	TWiki . { Main | Edumacation | TWiki | Test }
	Edumacation . { Home | Users | Changes | Search | Go }

The Baylor study is the most often-cited study in support of static magnetic therapy. The author is the founder and operator of http://quackwatch.org

Scarfed from http://quackwatch.org/04ConsumerEducation/QA/magnet.html and reprinted here without permission under the Fair Use Doctrine.

During the past few years, magnetic devices have been claimed to relieve pain and to have therapeutic value against a large number of diseases and conditions. The way to evaluate such claims is to ask whether scientific studies have been published. Pulsed electromagnetic fields -- which induce measurable electric fields -- have been demonstrated effective for treating slow-healing fractures and have shown promise for a few other conditions. However, few studies have been published on the effect on pain of small, static magnets marketed to consumers [1]. Explanations that magnetic fields "increase circulation," "reduce inflammation," or "speed recovery from injuries" are simplistic and are not supported by the weight of experimental evidence [2: http://www.hcrc.org/contrib/ramey/magnet.html ].

The main basis for the claims is a double-blind test study, conducted at Baylor College of Medicine in Houston, which compared the effects of magnets and sham magnets on knee pain. The study involved 50 adult patients with pain related to having been infected with the polio virus when they were children. A static magnetic device or a placebo device was applied to the patient's skin for 45 minutes. The patients were asked to rate how much pain they experienced when a "trigger point was touched." The researchers reported that the 29 patients exposed to the magnetic device achieved lower pain scores than did the 21 who were exposed to the placebo device [3} Although this study is cited by nearly everyone selling magnets, it provides no legitimate basis for concluding that magnets offer any health-related benefit:

• Although the groups were said to be selected randomly, the ratio of women to men in the experimental group was twice that of the control group. If women happen to be more responsive to placebos than men, a surplus of women in the "treatment" group would tend to improve that group's score.
• The age of the placebo group was four years higher than that of the control group. If advanced age makes a person more difficult to treat, the "treatment" group would again have a scoring advantage.
• The investigators did not measure the exact pressure exerted by the blunt object at the trigger point before and after the study.
• Even if the above considerations have no significance, the study should not be extrapolated to suggest that other types of pain can be relieved by magnets.
• There was just one brief exposure and no systematic follow-up of patients. Thus there was no way to tell whether any improvement would be more than temporary.
• The authors themselves acknowledge that the study was a "pilot study." Pilot studies are done to determine whether it makes sense to invest in a larger more definitive study. They never provide a legitimate basis for marketing any product as effective against any symptom or health problem.

Two better-designed, longer-lasting pain studies have been negative:

• Researchers at the New York College of Podiatric Medicine have reported negative results in a study of patients with heel pain. Over a 4-week period, 19 patients wore a molded insole containing a magnetic foil, while 15 patients wore the same type of insole with no magnetic foil. In both groups, 60% reported improvement, which suggests that the magnetic foil conveyed no benefit [4].
• More recently, researchers at the VA Medical Center in Prescott, Arizona conducted a randomized, double-blind, placebo-controlled, crossover study involving 20 patients with chronic back pain. Each patient was exposed to real and sham bipolar permanent magnets during alternate weeks, for 6 hours per day, 3 days per week for a week, with a 1-week period between the treatment weeks. No difference in pain or mobility was found between the treatment and sham-treatment periods [5].

Magnets have also been claimed to increase circulation. This claim is false. If it were true, placing a magnet on the skin would make the area under the magnet become red, which it does not. Moreover, a well-designed study that actually measured blood flow has found no increase. The study involved 12 healthy volunteers who were exposed to either a 1000-gauss magnetic disk or an identically appearing disk that was not magnetic. No change in the amount or speed of blood flow was observed when either disk was applied to their arm. [6]. The magnets were manufactured by Magnetherapy, Inc, of Riviera Beach, Florida, a company that has been subjected to two regulatory actions.

Legal and Regulatory Actions

In 1998, Magnetherapy, Inc., signed an Assurance of Voluntary Compliance with the State of Texas to pay a $30,000 penalty and to stop claiming that wearing its magnetic device near areas of pain and inflammation will relieve pain due to arthritis, migraine headaches, sciatica or heel spurs. The agreement also requires Magnetherapy 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 [7]. Ads for the company's Tectonic Magnets had featured testimonials from athletes, including golfers from the senior pro tours. Various ads had claimed that Tectonic Magnets would provide symptomatic relief from certain painful conditions and could restore range of motion to muscles and joints. The company had provided retailers with display packages that included health claims, written testimonials, and posters of sports stars. Texas Attorney General Dan Morales stated that some claims were false or unsubstantiated and others had rendered the product unapproved medical devices under Texas law. In 1997, the FDA had warned Magnetherapy to stop claiming that its products would relieve arthritis; tennis elbow; low back pain; sciatica; migraine headache; muscle soreness; neck, knee, ankle, and shoulder pain; heel spurs; bunions; arthritic fingers and toes; and could reduce pain and inflammation in the affected areas by increasing blood and oxygen flow [8].

In 1999, the FTC obtained a consent agreement barring two companies from making unsubstantiated claims about their magnetic products. Magnetic Therapeutic Technologies [ http://www.ftc.gov/os/1999/06/magneticagr.htm ], of Irving, Texas, is barred from claiming that its 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. Pain Stops Here! Inc. [ http://www.ftc.gov/os/1999/06/painagr.htm ], of Baiting Hollow, N.Y., may no longer claim that its "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.

On August 8, 2000, the Consumer Justice Center [ http://www.consumerz.com/ [Wayback archive] ], of Laguna Niguel, California filed suit in Orange County Superior Court charging that Florsheim and a local shoe store (Shoe Emporium) made false and fraudulent claims that their MagneForce shoes (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 [9]. A few days after this suit was filed, Florsheim removed the disputed ad from its Web site.

In 2001, Richard Markoll, his wife Ernestine, David H. Trock, M.D., and Bio-Magnetic Treatment Systems (BMTS) pled guilty to criminal charges in connection with a scheme involving pulsed magnetic therapy. The participants used fraudulent billing codes to seek payment from Medicare and three other insurance plans for treatment with a device (Electro-Magnetic Induction Treatment System, Model 30/30) that lacked FDA approval [10]. The treatments -- called pulsed signal therapy (PST) -- were administered in a clinical trial on an investigational basis not approved by the FDA. The Markolls were sentenced to 3 years probation, a $4,000 fine and a $100 special assessment. Ernestine Markoll was sentenced to 2 years probation, a $1,000 fine and a $25 special assessment. Magnetic Therapy, was sentenced to a 1-day summary probation and a $200 special assessment. The Markolls also signed a civil settlement under which they agreed to pay the U.S Government $4 million [11]. The device was invented by Richard Markoll, MD, PhD [ http://pstworld.com/founder.htm [Wayback archive] ], who does not have a medical license but is described in Web site biographies as a graduate of Grace University School of Medicine, a Caribbean medical school. Trock, a former principal investigator for Magnetic Therapy Center, PC, Danbury, CT, was sentenced to 6 months probation. and ordered to make restitution of $35,250 [12]. Trock has co-authored studies claiming that PST is effective for treating pain, but the device is not FDA-approved for that purpose.

In September 2002, California Attorney General Bill Lockyer charged Florida-based European Health Concepts, Inc. (EHC) with making false and misleading claims about its magnetic mattress pads and seat cushions. The complaint [ http://caag.state.ca.us/newsalerts/2002/02-105.pdf ], filed in Sacramento Superior Court, also named EHC president Kevin Todd and several sales managers and agents as defendants. The suit seeks more than $1 million in civil penalties for engaging in unfair business practices and making false claims; $500,000 in civil penalties for transactions involving senior citizens; and full restitution for purchasers of the products. The complaint alleged that prospective customers, primarily senior citizens, were invited to attend a free dinner seminar at which they were told that EHC's products could help people suffering from fibromyalgia, lupus, sciatica, herniated discs, asthma, bronchitis, cataracts, chronic fatigue syndrome, colitis, diverticulitis, heart disease, multiple sclerosis, and more than 50 other health conditions. The sales agents offered phony price discounts for immediate purchases that actually were the company's regular prices. [13].

The Commissioner called Dr. Philip Neufeld of Health Canada's Medical Devices Bureau as a witness. He explained that, under the Regulations, a product is considered a Class I medical device as long as someone makes a representation that it has a medical attribute. A product is designated as a Class I medical device because the manufacturer claims that it has medical benefits, not because Health Canada agrees with the claims or the manufacturer has proven them. All that a manufacturer has to do is supply the required identifying information and declare that its product is safe and effective for the purposes claimed; it is not required to submit any evidence that this is the case.

The Bottom Line

There is no scientific basis to conclude that small, static magnets can relieve pain or influence the course of any disease. In fact, many of today's products produce no significant magnetic field at or beneath the skin's surface.

1. Livingston JD. Magnetic therapy: Plausible attraction [ http://www.csicop.org/si/9807/magnet.html ]. Skeptical Inquirer 25-30, 58, 1998.
2. Ramey DW. Magnetic and electromagnetic therapy [ http://web.archive.org/web/20010806030159/hcrc.org/contrib/ramey/magnet.html ]. Scientific Review of Alternative Medicine 2(1):13-19, 1998.
3. Vallbona C, Hazelwood CF, Jurida G. Response of pain to static magnetic fields in postpolio patients: A double-blind pilot study Magnetic Health Baylor Study Abstract . Archives of Physical and Rehabilitative Medicine 78:1200-1203, 1997.
4. Caselli MA and others. Evaluation of magnetic foil and PPT Insoles in the treatment of heel pain [ http://www.japmaonline.org/cgi/content/abstract/87/1/11 ]. Journal of the American Podiatric Medical Association 87:11-16, 1997.
5. Collacott EA and others. Bipolar permanent magnets for the treatment of chronic low back pain Magnetic Health Prescott Study Abstract . JAMA 283:1322-1325, 2000.
6. Mayrovitz HN and others. Assessment of the short-term effects of a permanent magnet on normal skin blood circulation via laser-Doppler flowmetry. Scientific Review of Alternative Medicine 6(1):9-12, 2002.
7. Morales halts unproven claims for magnet therapy. News release, April 9, 1998.
8. Gill LJ. Letter to William L. Roper Magnetic Health Fda Magnetherapy Opinion , Feb 3, 1997.
9. Jeff Wynton and the Consumer Justice Center v. Florsheim Group, Inc., Shoe Emporium [ http://www.consumerz.com/MAGNEFORCE.htm [Wayback archive] ]. Superior Court of California, Orange County, Case #00CC09419, filed Aug 8, 2000.
10. Burns EB. Omnibus ruling on defendants' motion to strike and motions to dismiss [ http://www.ctd.uscourts.gov/Opinions/012401.EBB.Markoll.pdf ]. 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.
11. Defense Criminal Investigative Service press release, Aug, 2001.
12. Defense Criminal Investigative Service press release, June, 2001.
13. Barrett S. California Attorney General sues magnetic mattress pad sellers [ http://quackwatch.org/02ConsumerProtection/AG/CA/ehc.html ]. Quackwatch, Sept 24, 2002.

Topic MagneticHealthBaylorRebuttal . { Edit | Ref-By | Attach | Diffs | r1.2 | > | r1.1 }

You must register before editing pages or using other extended features on this TWiki system.

Revision r1.2 - 31 Aug 2004 - 04:00 by User.eli Privacy Policy

Copyright © 2000-2005 by the contributing authors. All material on this collaboration tool is the property of the contributing authors. Collect email addresses here. Ideas, requests, problems regarding TWiki? Send feedback.