Title: Pulse versus continuous terbinafine for onychomycosis: A randomized, double blind controlled trial.
Authors: Errin Warshaw MD, Debra Fett MD, Hanna Bloomfield MD, MPH, Joseph Grill MS, David Nelson PhD, Vincente Quiterno MD, Susan Carver RN, Gary Zielke BS, and Frank Lederle MD
Source: Journal of the American Academy of Dermatologists 2005; 53:578-84
PODIATRIC RELEVANCE:
Onychomycosis is very common in the podiatric patient. There are several physical and sometimes psychological sequlae from this disease. Antifungal treatments aimed at curing onychomycosis can be very expensive. Pulsed doses for treatment can reduce cost, however, this article suggests that it may not be as effective. Also of interest, the cure rates reported in this study are significantly lower than previously reported.
METHODS:
A double blind, randomized, noniferiority, clinical intervention trial was used. The main inclusion criteria were positive dermatophyte culture and at least 25% distal subungual clinical involvement. 618 volunteers were screened, 306 randomized. Terbinafine 250mg daily for three months or 500mg daily for one week per month for three months (pulsed) was administered. Primary outcome measure was mycological cure of the nail at 18 months. Secondary measures included clinical cure, and complete (mycological and clinical cure) of the nail.
RESULTS:
Continuous dose terbinafine was found to be superior for: mycologic cure of the target toenail (70.9% vs 58.7%, P=0.03, RR 1.21, 95%CI), clinical cure of the target toenail (44.6% vs 29.3%, P=0.007, RR 1.52, CI 95%), complete cure of the target toenail (40.5% vs 28%, P=0.02, RR1.45, CI 95%), and complete cure of all 10 toenails (25.2% vs 14.7%, P=0.03, RR 1.71, 95%CI). Tolerability of regimens did not differ significantly between the two groups. (χ²= 1.63; P=0.65)
COMMENTS:
This article is a large study that shows the effectiveness of continuous vs pulse dose therapy for onychomycosis. The patient population represented here may have some small bearing on the outcome of the study (primarily older males). However, one important finding in the study was that complete cure rates were well below those previously reported. This is especially true in cases with all 10 nails involved.
________________________________________________________________________________________
Disclaimer:
Scientific Abstract Monthly postings are submitted by podiatric surgical residents. The ideas presented are not the opinions of the American College of Foot and Ankle Surgeons (ACFAS), nor are they presented as facts. ACFAS presents this information without any warranty of any kind, expressed or implied, and is not liable for its accuracy nor for any loss or damage caused by the user's reliance on information obtained in these areas.