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Oral Treatments for Toenail Onychomycosis
A Systematic Review
Fay Crawford, PhD;
Philip Young, PhD;
Christine Godfrey, BA;
Sally E. M. Bell-Syer, MSc;
Rachel Hart, BSc;
Elizabeth Brunt, BMBS;
Ian Russell, PhD
Arch Dermatol. 2002;138:811-816.
Objective To identify and synthesize the evidence for the efficacy of oral treatments
for fungal infections of the toenails.
Design Systematic review of randomized controlled trials.
Interventions Oral treatments for dermatophyte infections of the toenails.
Main Outcome Measures Cure confirmed by microscopy and culture results in patients with clinically
diagnosed fungal infections. Data relating to the clinical cure rates were
also extracted from the trials.
Results A pooled analysis of 2 trials comparing mycological cure rates from
continuous treatment with terbinafine (250 mg/d for 12 weeks) and continuous
treatment with itraconazole (200 mg/d for 12 weeks) found a statistically
significant difference in 11- and 12-month outcomes in favor of terbinafine
(risk difference, -0.23 [95% confidence interval, -0.32 to -0.15];
number needed to treat, 5 [95% confidence interval, 4 to 8]). An analysis
of clinical cure rates was not possible because of the diversity of definitions
used in researching the effectiveness of oral antifungal drugs for onychomycosis.
Only 3 trials gave a clear definition of clinical cure and presented data
for these outcomes.
Conclusions There is good evidence that a continuous regimen of terbinafine (250
mg/d) for 3 months is the most effective oral treatment for fungally infected
toenails. Consensus among researchers evaluating oral antifungal drugs for
onychomycosis is needed to establish meaningful definitions of clinical cure.
Most trials were funded by the pharmaceutical industry; we found little independent
research, and this may have introduced bias to the review.
From the Dental Health Services Research Unit, The University of Dundee,
Dundee, Scotland (Dr Crawford); the Department of Health Sciences and Clinical
Evaluation (Drs Young, Brunt, and Russell and Ms Godfrey) and Health Studies
(Ms Bell-Syer), The University of York, York, England; and The London Foot
Hospital and School of Podiatric Medicine, London, England (Ms Hart).
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