This Tuesday, February 22, I was quoted in a very fair and balanced article in the Wall Street Journal by Science Reporter Laura Johannes dealing with laser treatment of onychomycosis.
During my interview with Ms. Johannes I bemoaned the lack of published evidence, not only for laser therapy of onychomycosis, but for any of the recently promoted treatments, either device or solution. I questioned the ubiquity of the claims of 70-80% efficacy that seem rampant and asked her, as I now ask you: What does it mean to you if I say a product is “80% effective”? Think about that. Does it mean that 80% of the treated toenails became 100% cured? Or that 80% of patients treated were satisfied? Or, did 80% of toenails reach some undefined clinical endpoint? None of this is ever spelled out. Let me share with you some claims right from onychomycosis promotions I have seen recently:
Right in the article in the WSJ there is a quote from a Dr. Khoury using the Nomir laser who states “My patients and I are very happy with it” and it goes on to state that Dr. Khoury “..says it works in about 80% of his patients”
Also in the article it mentions how PinPointe supplied the WSJ with a summary of unpublished (my emphasis) data claiming “71.4% of patients experienced continuous improvement over a year…”
In a “testimonial” (the HIGHEST level of medical evidence, I am sure) on a Formula 3 topical solution brochure a podiatrist from Nebraska states “I would estimate 80-90% success rate”
In an advertisement for Fungasil solution seen in a doctor’s office recently it claims “50-80% cure rate within one year”
Speaking to a sales representative at the Cool Touch Laser booth during the recent Desert Foot meeting “The efficacy is 79.8%”
From a direct mailing of a local podiatrist using laser therapy: 88% Effective, Proven Clinical Results.
If I read a paper of a randomized, controlled clinical trial on an antibiotic therapy and there is a result showing 90% success, it is clearly spelled out as to what the endpoint was. It may have been 90% microbiologic cure (defined as negative culture) or 90% clinical cure (no residual clinical evidence of infection), etc. Even in the onychomycosis literature, when proper studies were performed on terbinafine, itraconazole or ciclopirox lacquer, you could read the studies and KNOW exactly what the endpoint was, be it mycologic cure, complete cure or something in-between. This is what is lacking in many of these claims. I find it hard to believe they all can be so incredibly close in efficacy and, frankly how they can be…so effective! I think we will all agree that the “gold standard” in the treatment of onychomycosis is oral terbinafine, followed closely by oral itraconazole. Yet, if you actually look at the FDA approved CLINICAL CURE numbers (clearly defined in the criteria as mycologic cure plus 100% normal nail appearance at the end of the study) terbinafine only had a 38% cure rate and itraconazole, only 14%. Has medical science advanced so rapidly in the past 10-15 years that now we can double that success rate?
So, why is 70-80% used as the claimed efficacy rates for all of these various promotions against onychomycosis. I guess some may be based in clinical trials, published or not. Some of these efficacies may be absolutely true…I just don’t know since, other than the published Nomir study, I haven’t seen any data, my point in the WSJ. Maybe docs and companies feel that they need to claim 70-80% to feel comfortable selling a treatment or a product to a patient. I welcome your thoughts.