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Oral treatments for toenail onychomycosis: a systematic review
Fay Crawford1, Philip Young, Christine Godfrey
1The Dental Health Services Research Unit, The University of Dundee, Park Place, Dundee DD1 4MR, Scotland. f.crawford@dundee.ac.uk
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.
Insights
Terbinafine is the most effective oral treatment for fungal toenail infections, showing superior mycological cure rates compared to itraconazole. Further research is needed to standardize clinical cure definitions for onychomycosis treatments.
Area of Science:
- Dermatology
- Mycology
- Pharmacology
Background:
- Onychomycosis, a fungal infection of the toenails, affects a significant portion of the population.
- Oral antifungal medications are a primary treatment modality for onychomycosis.
- Evidence synthesis is crucial for determining the most effective oral treatments.
Purpose of the Study:
- To systematically review and synthesize evidence on the efficacy of oral treatments for fungal toenail infections.
- To compare the effectiveness of different oral antifungal drugs based on mycological and clinical cure rates.
Main Methods:
- Systematic review of randomized controlled trials (RCTs).
- Inclusion of studies on oral treatments for dermatophyte toenail infections.
- Extraction of data on mycological cure (microscopy and culture) and clinical cure rates.
Main Results:
- Pooled analysis of two trials favored terbinafine over itraconazole for mycological cure rates at 11-12 months (Risk Difference: -0.23).
- Number needed to treat (NNT) for terbinafine was 5.
- Analysis of clinical cure rates was limited due to diverse definitions across studies.
Conclusions:
- Continuous terbinafine (250 mg/d for 3 months) demonstrates the highest efficacy for treating fungal toenail infections.
- A consensus on standardized definitions for clinical cure in onychomycosis research is necessary.
- Potential bias from pharmaceutical funding in reviewed trials warrants consideration.