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Fungal nail infection (onychomycosis) - Evidence
Evidence on oral itraconazole compared with placebo
Weak evidence from three randomized controlled trials (RCTs) suggests that oral itraconazole may eradicate dermatophyte onychomycosis in about 60% of people. However, infection was assessed only in the short term (3 months) and, because of inconsistent definitions, data could not be pooled to assess clinical cure.
Systematic reviews (search date: up to June 2006) found three placebo-controlled RCTs that assessed the effectiveness of oral itraconazole for fungal toenail infection [Crawford et al, 2002; Crawford and Ferrari, 2007].
- Data for meta-analysis were pooled for the three RCTs (n = 433).
- After 12 weeks of itraconazole 200 mg daily, mycological cure rates were 63% compared with 4% for placebo; absolute risk difference 60% (95% CI 54% to 67%).
- The quality of evidence from these three trials was assessed as very low because of the possibility of publication bias, inconsistent definitions of cure, and outcomes measured over only 3 months [Crawford and Ferrari, 2007]. For outcomes to be clinically meaningful they should be measured after at least 9 months, and should include symptoms and appearance of the nails as well as infection.
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