Monday, February 25, 2008

Erchonia Low Level Lasers Really Work

CONCLUSION:
All low level lasers are not created equal. Erchonia’s lasers are the only low level lasers (a.k.a. cold lasers) that have been repeatedly, scientifically proven to be effective in accelerating healing and reducing pain,. When discussing low level lasers, Erchonia lasers should not be confused with or lumped in with other low level lasers that operate differently, and which have never been scientifically proven to be effective. Science demands that decisions made by insurance companies, Medicare, and allopathic medical practitioners and researchers regarding the efficacy of low level laser therapy (“LLLT”) be based solely upon studies that use Erchonia low level lasers. To do otherwise is a disservice to the millions in mankind who can benefit greatly from LLLT using Erchonia lasers.

CURRENT ALLOPATHIC OPINON REGARDING LLLT
There exists a prevailing opinion against the effectiveness of low level laser therapy in the allopathic / Western medical profession, using the argument that LLLT is scientifically unproven. Wikipedia expresses it this way:
“Although low-level laser therapy is claimed to be useful for relieving pain, reducing inflammation, and helping to heal wounds, strong scientific proof of these effects is still needed.”
Insurance companies and Medicare refuse to pay for LLLT. Cigna Health Care is a good example of how insurance companies justify their refusal to reimburse for LLLT. In a Coverage Position Paper published in July 2007, it stated: “CIGNA HealthCare does not cover low level laser therapy (LLLT) for any indication because it is considered experimental, investigational or unproven.”

In its Coverage Position Paper, CIGNA cited numerous studies discussing low level laser therapy, none of which identified the type of laser used, the power output, wavelength or frequencies used in the treatment of patients. Without this information, it is impossible to evaluate the validity of these studies. All low level lasers are not made alike, and all low level lasers are not as effective as all other low level lasers. It would surprise the author if any of the studies cited in the Cigna Coverage Position Paper utilized Erchonia lasers.

CIGNA’s report list six different “FDA-cleared” low level lasers from five different companies, four of which it said were FDA-cleared only for the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. It is interesting to review the status and background of the low level lasers that CIGNA chose as representative, just eight months after CIGNA published its Position Paper.

Microlight 830. This is the only company that conducted its own clinical study which it used to obtain FDA-clearance to market their laser for temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. Unfortunately, the results of the study do not seem to be very significant. The difference in results after five weeks of three times per week treatment was only 15% higher than the placebo group. This is in sharp contrast to the 65% difference that Erchonia lasers achieved in their clinical studies as later discussed..

Axiom BioLaser LLLT Series -3. This is a device that is no longer being marketed by its manufacturer, Axiom WorldWide. This laser apparently received FDA-clearance to market their laser for temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This approval was based on a finding that the laser was substantially equivalent to the Microlight laser. There is no evidence that this company ever conducted any clinical studies with the laser it formerly marketed.

Acculaser Pro4 from Proto Thera. A Google search did not locate any web site discussing or marketing Proto Thera or this laser. It appears that this laser is no longer being marketed. According to the CIGNA article, this laser was FDA cleared for temporary relief of paid associated with iliotibial band syndrome, a common runner’s knee injury. It is unknown whether Proto Thera performed any clinical studies to obtain FDA clearance.
Thor DD II IR Lamp from Thor International. This device is an infrared lamp only. It is not a low level laser, and never should have been included in a review of studies regarding low level lasers.

Thor DD II 830 CL 3 Laser System from Thor International. .. This laser received FDA-clearance to market their laser for temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This approval was based on a finding that the laser was substantially equivalent to the Microlight laser. This company did not conduct any clinical studies with its own laser to receive FDA clearance.

Luminex LL Laser from Medical Laser System. This laser received FDA-clearance to market their laser for temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This approval was based on a finding that the laser was substantially equivalent to the Microlight laser. This company did not conduct any clinical studies with its own laser to receive FDA clearance.

Erchonia is the only company that has spent millions of dollars performing scientific research that confirms the efficacy of its low level lasers. It is interesting to note, though not very surprising, that CIGNA did not include Erchonia lasers in its list of FDA-cleared low level lasers published in its Coverage Position Paper. CIGNA’s Coverage Position Paper is therefore faulty to the point of absurdity, and is a disservice to the millions of its members who faithfully pay their medical insurance premiums.

WHAT’S THE DIFFERENCE BETWEEN ERCHONIA AND OTHER LOW LEVEL LASERS?

There are several differences, starting with wavelength. Erchonia’s lasers all operate at the 635 nm wavelength, which extensive studies have shown is the optimal wavelength for helping to heal the body. All of the lasers listed in CIGNA’s Coverage Position Paper operate at the 830 nm wavelength. Erchonia’s lasers allow users to program an unlimited number of frequencies, from 1 hz to 10,000 hz, and treat a patient with six different frequencies, simultaneously. Erchonia manufactures all components used in their lasers, and assembles them in their own ISO 9000 manufacturing facility in Texas. Erchonia has spent millions of dollars on research and development of their products, and funding multiple IRB-approved double-blind studies with placebo. The other manufacturers of lasers do not and cannot make the same claims.

WHY IS IT A CERTAINTY THAT ERCHONIA LASERS ARE EFFECTIVE MOST OF THE TIME?

A. FDA APPROVAL PURSUANT TO DOUBLE-BLIND STUDIES.
Erchonia’s lasers (5 to 7 Mw of power at 635 nm wavelength) obtained three separate FDA approvals, each based upon separate IRB-approved, randomized double-blind studies with placebo. Erchonia was the first low level laser approved by the FDA in 2001 - for the treatment of chronic neck and shoulder pain. The double-blind study produced pain relief in 80 % of the test group using the laser, vs. pain relief in only 15 % of the group treated with a placebo/sham laser.

B. PROVEN EFFECTIVE IN BURN UNITS TO REDUCE PAIN AND ACCELERATE HEALING.
Erchonia’s lasers have been proven effective by medical doctors in major burn centers (St. Mary’s Hospital in Tuscon, Arizona – Dr. Jeffrey Nelson, director) reducing pain of second degree burns on average by 60% after a two minute laser treatment, in addition to accelerated healing.

C. PROVEN EFFECTIVE IN LIPOSUCTION IN LIQUIFYING FAT, R EDUCING SURGERY TIME, REDUCING PAIN AND INFLAMMATION.
Erchonia’s LipoLaser is the only low level laser that is FDA-approved for assisting liposuction procedures. Numerous published articles discuss clinical studies that confirm the laser’s ability to: enhance the ease of performing liposuction procedures, reduce the time in surgery, enhances the emulsification of fat, decreases the patients’ degree of postoperative discomfort, decreases swelling, and decreases the use of pain medication. Numerous published articles have confirmed the effectiveness of this laser in liposuction procedures including a peer-reviewed paper describing the double-blind clinical study that was submitted to obtain FDA approval that was published in the American Journal of Cosmetic Surgery in 2004, as well as other articles describing clinical studies that were published in Plastic & Reconstructive Surgery and the Aesthetic Surgery Journal confirming the same results.

D. PROVEN EFFECTIVE TO TREAT SEVERE ACNE
Erchonia’s DermaLaser is the only low level laser that is FDA approved for the treatment of severe acne, which it obtained after proving its ability to kill the bacteria that causes severe acne in randomized double-blind studies.

WHAT IS THERE LEFT FOR ERCHONIA TO PROVE?
Erchonia has provided strong scientific proof of its healing effects to the satisfaction of the FDA and numerous researchers. Unfortunately, there are low level lasers being sold by other manufacturers, that do not operate at the same wavelength, frequencies and power output, that do not have the same beneficial effects as Erchonia lasers. Until now, there has been no distinction that has been made between the one brand of low level lasers that have actually been proven effective, and the rest of the pack that manufacture low quality copycat lasers without the science and research behind them.

CALL FOR ACTION
It is long past time for the marketplace, especially physicians and insurance companies, to realize this most important fact. Erchonia Low Level Lasers accelerate the healing process and reduces pain on a consistent verifiable basis. I would like this memo to be the start of a movement that helps force insurance companies to acknowledge the efficacy of Erchonia low level lasers and to pay for LLLT administered to their insured. Cigna should be the first target. Please contact me if you want to join this movement.

If you disagree with my conclusions, please tell me why and let's have a debate about it.

I can be reached at lesisko@aol.com