Comparison of efficacy criteria across onychomycosis trials: need for standardization.
BACKGROUND
The last 10 years have seen a substantial increase in the number of studies reporting the efficacy of the various antifungal agents used to treat onychomycosis.


OBJECTIVE
To examine the definitions of efficacy parameters reported in clinical studies on the treatment of onychomycosis and discuss the importance of standardized reporting.


METHODS
We searched MEDLINE (1966-2001) for studies in which oral treatments, griseofulvin, ketoconazole, terbinafine (continuous and pulse), itraconazole (continuous and pulse), and fluconazole, were used to treat dermatophyte onychomycosis.


RESULTS
Mycologic cure was predominantly defined as negative microscopy and culture. Unlike mycologic cure, clinical parameters (e.g. clinical response, clinical cure) were variably defined. Subjective terms, such as "cure" or "markedly improved," were used; although these terms appear to be explicit, what is considered to be "cured" or "markedly improved" by one evaluator may not be by another. Also, infected nails were clinically evaluated to determine the response to treatment. Studies measured the distance between the proximal nail fold and a notch in the nail plate, at the junction between the diseased and normal-appearing nail, or in some cases estimated the diseased nail plate involvement.


CONCLUSIONS
This review of the literature on systemic agents used to treat onychomycosis shows that standard and explicit definitions are required for the accurate comparison of the effectiveness of the various therapies.
Gupta
Aditya K
AK
Division of Dermatology, Department of Medicine, Sunnybrook and Women's College Health Science Center (Sunnybrook site), Toronto, Ontario, Canada. agupta@execulink.com
Ryder
Jennifer
J
Summerbell
Richard C
RC
D000935:Antifungal Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D014009:Onychomycosis / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents