Anodyne Therapy:  Is it real or just fairy dust?

 

by Al Kline DPM

Anodyne therapy is a relatively new modality in the treatment of circulatory disorders of the foot and neuropathy.  The treatment has been out since 1994, but has lately come to the forefront of podiatry as a means to improve circulation in diabetics, close diabetic wounds and decrease neuropathy in diabetics.The proponents of Anodyne thereapy say the modality is an FDA approved device for the relief of pain and to increase circulation.  

Now, I’m probably one of the biggest skeptics around.  Even Podiatry Today, reported that this ‘new’ modality has some promising results. 

The U.S. Food and Drug Administration (FDA) provided approval for the use of monochromatic infrared energy therapy in 1994 as a heating pad to provide heat therapy (e.g., temporarily relieve minor pain, stiffness and muscle spasm).  The medical literature for this indication is not strong and there have been no comparative trials of this device for this indication with other heat modalities such as electric heating pads, baths, or hot water bottles.  It is really unclear if the use of this device provides any incremental benefits over other standard methods.

Anodyne works by using “monochromatic infrared energy (MIRE) to release nitric oxide from the patient’s red blood cells. The company says this improves nerve function and is important for making new blood vessels and healing wounds. As the company notes, “low levels of nitric oxide are common in people with diabetes and are a major factor in the poor circulation, loss of sensation, chronic falls, foot ulcers and pain of diabetic peripheral neuropathy.”

What is hard to find in the literature though, is how nitrous oxide in the blood measured and how it actually affects neuropathy or circulation?  Where are the clinical trials to support such a claim?  Do all diabetics have “low levels of nitric oxide”?  Maybe we should get patients to start inhaling a little laughing gas? (NO2)  I know this all may sound funny, but this is serious, medical business!

Now , if I recall correctly from a committee meeting some time ago, Anodyne initially propose that it improved a patients circulation?  Now , the new spin is diabetic neuropathy.  Well, which is it?  The company will argue that it’s really for both: to improve circulation and treat diabetic neuropathy.

In my experience, I have talked to a few of my patients who have severe neuropathy, and they swear by it.  I always question patient beliefs, especially if its in the area of neuorpathic pain.  You see, to live with pain day in and day out, can lead to desperation for any type of pain relief, even if its dressed as a ‘blue pill’.  Does it really improve and treat neuropathy.  Well, I can say this:  It probably will work about as well as a heating pad . . . maybe.

On the darker side of this subject, it appears that some physical therapists are using this modality to overbill insurance carriers.  In actuality, anybody including Chiropractors, therapists and other health care professionals can buy the system and start billing medicare and other insurances for the service in the office setting.  Although, reimbursement is on the order of four dollars per treatment, treatments are often billed as multiple ‘sessions’ that can include 3 to 5 treatments a day, 3 to 5 days a week.  However, therapists and some scrupulous practioners are not banking on the treatments alone.  Some practitioners will even buy the unit at cost and sell it to unsuspecting neuropathics in an effort to turn a profit.   The unit costs roughly $3000, and patients are willing to pay every cent , just to get some relief of neuropathy.  It’s a large price to pay for placebo.  Aetna Health Care recently reported in November 2005:

“There is no evidence that infrared light therapy is any more effective than other heat modalities in the symptomatic relief of musculoskeletal pain. Glasgow (2001) reported on the results of a randomized controlled clinical trial of low-level infrared therapy in 24 subjects with experimentally induced muscle soreness, and found no significant differences between treatment and placebo groups.

There are no published studies of the effectiveness of low-level infrared therapy for treatment of diabetic peripheral neuropathy. The case series presented by the manufacturer of the Anodyne System on its web site have not been published in a peer-reviewed medical journal.

Finally, there is no evidence in the published peer-reviewed medical literature on the effectiveness of infrared therapy for the treatment of lymphedema. The Canadian Coordinating Office of Health Technology Assessment (2002) found that “there is little high quality controlled clinical trial evidence for these therapies.” “

Healthlink, Blue Cross Blue Shield and other insurance companies have concluded that “Anodyne therapy is basically investigational at this point and not medically necessary. 

New technology is a wonderful thing . . .however, in this day of rising health care and out of control medical costs, it appeares we have a company banking on placebo effects.  This is a multi-million dollar company selling basically infra-red heating lights as a heating pad, claiming to improve circulation, close diabetic ulcers and improve neuropathy.  I’m sure there is some good in everything, but in the health care community, these newer modalities need to be scrutinized by more clinical trials and studies.  You be the judge . . .

© Al Kline DPM, 2006