Abstract
Previous studies evaluating short-term itraconazole and terbinafine therapy for onychomycosis have varied in protocol and size; this double-blind study enabled a large-scale, standardized, direct comparison. Patients with toenail onychomycosis were randomized to itraconazole 200 mg daily (n = 146) or terbinafine 250 mg daily (n = 146) for 12 weeks, with a 36-week follow-up. Mycological cure rates at the follow-up end-point were significantly equivalent (61% with itraconazole vs. 67% with terbinafine). A similar proportion of patients in each group experienced adverse events during treatment (itraconazole, 22%; terbinafine, 23%). More patients receiving terbinafine stopped treatment permanently because of treatment-related adverse events (8% vs. 1%).
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Abdominal Pain / chemically induced
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Adolescent
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Adult
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Aged
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Antifungal Agents / adverse effects
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Antifungal Agents / therapeutic use*
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Double-Blind Method
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Dyspepsia / chemically induced
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Female
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Foot Dermatoses / drug therapy
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Foot Dermatoses / microbiology
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Headache / chemically induced
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Humans
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Itraconazole / adverse effects
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Itraconazole / therapeutic use*
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Male
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Middle Aged
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Naphthalenes / adverse effects
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Naphthalenes / therapeutic use*
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Nausea / chemically induced
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Onychomycosis / drug therapy*
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Taste Disorders / chemically induced
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Terbinafine
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Treatment Outcome
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Trichophyton / drug effects
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Trichophyton / isolation & purification
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Virus Diseases / chemically induced
Substances
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Antifungal Agents
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Naphthalenes
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Itraconazole
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Terbinafine