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Fungal nail infection (onychomycosis) - Evidence
Evidence on oral itraconazole compared with oral griseofulvin

Three randomized controlled trials (RCTs) with methodological weaknesses found no significant difference in cure rates between oral itraconazole or oral griseofulvin. The trials used half the licensed dose (200 mg once daily) of itraconazole.

Systematic reviews (most recent search: 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].

  • An RCT (n = 19) found that itraconazole and griseofulvin were similarly ineffective in treating people with fungal toenail infection.
    • Participants were treated for 24 weeks with either itraconazole 100 mg daily or griseofulvin 500 mg daily.
    • Nobody was cured with either drug.
  • An RCT (n = 61) found that the rate of cure was higher with itraconazole than with griseofulvin, but the difference was not statistically significant.
    • Participants were treated for 6–9 months with either itraconazole 100 mg daily or griseofulvin 500 mg daily.
    • Cure rates with itraconazole and griseofulvin were 37% and 30%; absolute difference 5% (95% CI –18% to +28%).
  • An RCT (n = 108) found that the rate of cure was higher with itraconazole than with griseofulvin, but the difference was not statistically significant.
    • Participants were treated for 18 months with itraconazole 100 mg daily, griseofulvin 660 mg daily, or griseofulvin 990 mg daily.
    • Cure rates were: with itraconazole, 8%; griseofulvin 660 mg, 6%; and griseofulvin 990 mg, 6%.
      • Comparing itraconazole 100 mg daily with griseofulvin 660 mg daily: absolute difference 2% (95% CI –8% to +10%).
      • Comparing itraconazole 100 mg daily with griseofulvin 990 mg daily: absolute difference 2% (95% CI –8% to +10%).

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