I have been asked by three of my patients over the last month what I thought about a new laser treatment for fungal nails. I had not heard of it... so I decided to do some research. Here is what I have come up with:
From MedicalNewsToday.com (March 8, 2009): A company called Nomir Medical Technologies (nomirmedical.com) has developed a "near-infrared" device for the treatment of onychomycotic nails. Nomir Medical Technologies is an optical energy technologies company developing products for medical application. The system called Noveon is a light based system that photobiologically targets bacterial and fungal infections. A study conducted by one of the co-founders of Nomir Medical, Dr. Eric Bornstein, D.M.D. has conducted a trial of 32 patients with confirmed onychomycosis of nails by culture. This was a prospective, randomized, controlled study at multiple U.S. sites. 120 day evidence indicates that 76.3 percent of those in the trial showed clinical improvement with 74 percent showing a significant drop in positive cultures. The patients received 4 treatments over a 4 month period. The company is trying to get FDA approval for use in Podiatry for the treatment of onychomycotic nails.
OK... here is my opinion:
#1: I am leery about any study conducted by someone who has a financial interest in the company. I have concerns about how controlled this study actually is and how the data may be skewed.
#2: The results state, "76.3 percent clinical improvement with 74 percent significant drop in positive cultures." Notice it does not say... CURED.
#3: There is no indication that this treatment will be reimbursed by insurance companies. Most insurance companies are not paying for oral or topical medications currently due to the low success rate of treating onychomycotic nails.
#4: What will be the cost to the patient? New technology, not very many people using it... I anticipate quite a hefty per cost treatment for this technology.
I will maintain an open mind about any new scientific breakthrough in medicine. But until I see randomized, double-blinded studies conducted by others than the people who develop the technology... I will take a wait-and-see viewpoint and not endorse it.
Until then, I feel I get 75 - 85% improvement in my patients using current topical or oral antifungal products and will continue recommending and using them.
"The journey of life is taken one step at a time... none of them should be painful." G.M. Barclay, DPM, AACFAS
1 comment:
Dr Barclay, thank you for your comments. I have spent the better part of my afternoon researching the same topic. I have come to the same conclusion. Normir appears to be taking the need for proof more seriously than PathoLase. PathoLase has even claimed FDA clearence on its website.
Commercial exposure through news stations has created a consummer demand for this type of treatment. I have had number of calls requesting Laser treatment for fungal nails.
I feel I will do the same and watch how the evidence unfolds.
A Moadab, DPM
www.fresnopodiatry.com
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