Terbinafine is more effective than itraconazole in treating toenail onychomycosis: results from a meta-analysis of randomized controlled trials.

BACKGROUND

Toenail onychomycosis is a challenge for clinicians to treat, and this challenge is compounded by conflicting information in the medical literature concerning the efficacy of the two principal agents used in its treatment: terbinafine and itraconazole.

OBJECTIVE

The purpose of this meta-analysis is to compare the efficacy of terbinafinewith that of itraconazole in the treatment of toenail onychomycosis caused by dermatophytes.

METHODS

A Medline search was performed for all English language publications from 1966 to June 1999 on the use of terbinafine and itraconazole in the treatment of toenail onychomycosis. Included were randomized studies in which subjects received no less than 3 months (or cycles) and no more than 4 months (or cycles) of either terbinafine or itraconazole. Data were abstracted and statistical analyses (random effects model, fixed effects model, and Peto's method) were applied.

RESULTS

Thirteen studies were included from the original literature review of 1636 total referenced reports; four studies did not fulfill our inclusion or exclusion criteria. The primary analysis of six studies directly comparing terbinafine to itraconazole resulted in an odds ratio ranging from 1.8 (95% CI = 1.8, 2.8) to 2.9 (1.9, 4.1). The secondary analysis of three studies comparing either itraconazole or terbinafine to placebo estimated an odds ratio of 1.1-1.7. The former shows that terbinafine is 80%-190% more likely to result in mycologic cure than is itraconazole; the latter demonstrates a 10%-70% greater likelihood. The difference between the relative efficacies of terbinafine and itraconazole was highly statistically significant (p < 0.0001).

CONCLUSION

Meta-analysis of the published worldwide literature finds that terbinafine is significantly more effective than itraconazole at achieving mycologic cure of toenail onychomycosis.