Saturday, October 11, 2008

What's the hoopla with "healing" lopps?

Originally posted Wednesday, February 28, 2007 on
Ionized wrist bracelets are popular over-the-counter alternative treatments for pain.
Originally "developed" by Dr. Manuel Porto in 1973, only 4 million bracelets have been sold worldwide to counteract the damaging effects of positive ions.

Negative ions are generally abundant in nature through plants, waterfalls, rain storms and forests—all of which might offer a natural good feeling.

These ions, unfortunately, might be depleted in urban areas as a result of modern technology, pollution and the greenhouse effects.

The human body is exposed to positive ions from electronic equipment, cell phones, electrical wiring, and machinery encountered in everyday modern life
Physical stress and exposure to Ultraviolet (UV) Rays may also elevate the positive ion levels within the body.

Research suggests that excessive positive ion levels might be associated with chronic fatigue syndrome (CFS) lack of concentration, muscle and joint aches, and feeling of nausea, etc.

Contrary to my opinions in the initial (2006) report on the subject, further review of relevant literature and research clearly demonstrate that there is no clear and/or convincing evidence as to the effectiveness of the ionized bracelets and the mechanisms of their action remains in dispute.

In 2002, the Scientific Assembly of the American Association of Family Physicians (AAFP) was presented with an original prospective study by Robert Bratton, MD, from the Mayo Clinic in Jacksonville, Florida on the effect of ionized wrist bracelets on musculoskeletal pain.

Patients were then randomized to receive either ionized bracelets, or placebo bracelets that exactly matched the appearance of the ionized bracelets.

Patients were reporting pain at baseline and while wearing the bracelet for up to 4 weeks. At the outset of the study, 80% of subjects believed that the ionized bracelets would help pain.
After the 4 week trial, both groups did report significant reductions in pain from baseline at all study points, despite the fact that there was no significant difference in the pain scores.
These findings echoed those of a 2002 prospective trial of magnetized bracelets for carpal tunnel syndrome pain. (Carter R, Hall T, Aspy CB, Mold J.

The effectiveness of magnet therapy for treatment of wrist pain attributed to carpal tunnel syndrome. J Fam Pract. 2002;51:38-40.)

Two years later (Dec.17,2004), Medscape Medical News reported that magnetic bracelets may reduce the pain associated with osteoarthritis of the hip and knee, suggest the results of a multicenter, randomized, placebo-controlled study published in the December issue of the British Medical Journal (BMJ. 2004;329:1450-1454) and sponsored by the Netherlands Heart Foundation and the Netherlands Organization for Scientific Research.

Investigators from the Peninsula Medical School evaluated the effects of bracelet therapy in 194 patients aged 45 to 80 years with osteoarthritis of the hip and knee.

Comparative analysis showed greater reduction of pain in the standard magnet group as compared with placebo.

Unfortunately, the study does not resolve the extent to which the effect of magnetic bracelets is specific or due to placebo.

Also, in 2004, there was a British study (Harlow T, Greaves C, White A, et al. Randomized controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee. BMJ 2004; 329:1450-1454) devoted to the effects of magnetic bracelets on knee pain in patients with osteoarthritis.

The study "documented" the specific therapeutic effects of the bracelets evident by the reduction of pain, stiffness and improvement in the functioning score.

Unfortunately, again and again, the investigators were not able to conclude if their data was due to specific effects on bracelets, a placebo, or both. (!)

To address the issues of bracelet-induced v. placebo effect a definitive study was conducted by the University of British Columbia, Vancouver, D.C. , Canada in 2005 and reported in the Journal of Evidence-based Nursing (Evid Based Nurs. 2005; 8(3):89 (ISSN: 1367-6539).

It "suggested" that patients who wore bracelets reported reduced pain from osteoarthritis of the hip or knee compared with patients wearing placebo bracelets.

There is a working "hypothesis" that thee positive metallic ions could, possibly, increase the level of allergen-mediated mast cell activation, which might be one of the mechanisms mediating exacerbation of allergen-driven asthma symptoms by air pollution, as well as chronic fatigue, nausea, headaches, general malaise, and, probably, recent stock market declines.(?)

However, there is no clear & convincing evidence of such correlation.

Further, a recent study from the University of Kentucky (Brain Behav Immun. 2005; 19(3):195-200 (ISSN: 0889-1591) was dedicated to the effects of "dispositional optimism"."

"Dispositional optimism" is defined by "...generalized positive expectations for the future, on physical health showed that it is more likely to be a positive consequence of optimists' greater engagement during difficult stressors...”

Fortunately for health consumers, US Government disagrees with presented "evidence", and is pursuing manufacturers of different magnetic/ionized bracelets with "dispositional pessimism":
In 2000, the Consumer Justice Center sued QT, Inc., and its owners for false advertising.The suit was settled with a nondisclosure agreement.

However, it is safe to assume that the settlement agreement included payment and a pledge to stop making most of the claims that the suit challenged.

A class-action suit is pending, and a false advertising suit is pending against the marketers of a similar device called the Balance Bracelet.In June 2003, the FTC charged QT, Inc, Q-Ray Company, Bio-Metal, Inc., and their principals, Que Te (Andrew) Park and Jung Joo Park, with false advertising, and the federal district court in Chicago issued a temporary restraining order freezing their assets and prohibiting further use of misleading claims.

In May 2004, the FTC filed a similar suit against Balance Bracelet marketers Media Maverick, Inc., of San Luis Obispo, California, and its officers Mark Jones and Charles Cody.

Among other things, the company's Web site had claimed:"...The Balance Bracelet is designed to aid the body in helping itself through electro-polarization. This helps the body return to its normal ionic balance. The Balance Bracelet acts on the body absorbing the static electricity that causes changes in different parts of the body..."

In September 2006, the Chicago court sided with the FTC and ordered Que Te Park and his companies to turn over $22.5 million in net profits and provide up to $64.5 million more in refunds to consumers who had bought the bracelets.

During the trial, Park testified that he "...could not define the term "ionization" but picked it because it was simple and easy to remember...”

The court concluded that his testimony on ionization was "contradictory and full of obfuscation" and that "he is a clever marketer but a poor witness."Park also acknowledged that QT had at least a 25% refund rate from dissatisfied customers (more than 100,000 people).

The FTC has set up a hotline number, 202-326-2063, for consumers with questions about the court’s opinion and order.

The bottom line:

Armed with the "scientific" evidence above, my natural "dispositional optimism" (probably a placebo effect!?), and my deep appreciation of its artistic (and conversation starting) value, I will continue to wear my "negative ionic" pink-on-pink wristbands.

Be well!

This article is to be used for education and general discussion purposes only. It does not constitute medical opinion and should not be used for or relied upon as medical advice. Publication of this newsletter does not create physician-patient relationship between the reader and the author. The article does not contain comprehensive description of the subject issues discussed. It is based on present medical knowledge which is subject to change and is unclear in numerous respects. Statements regarding the bio-efficacy of any and all bracelets (ionic, magnetic, decorative), and/or wristbands have not been evaluated by the FDA. They are not intended to diagnose, treat, cure or prevent any disease. The issues discussed can not be resolved without specific analysis of the specific circumstances of each person. The readers should consult with their individual health care/wellness professional to resolve their individual situation.

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