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Fungal nail infection (onychomycosis) - Evidence
Evidence on oral terbinafine compared at different doses

Two randomized controlled trials (RCTs) found that treatment for 24 weeks was more effective than treatment for 12 or 16 weeks. Studies were of relatively short duration, and used different definitions of cure.

Systematic reviews (most recent search: June 2006) found two RCTs that assessed the effectiveness of different durations of treatment with oral terbinafine for fungal toenail infection [Crawford et al, 2002; Crawford and Ferrari, 2007].

  • One RCT (n = 353) compared treatment with terbinafine 250 mg daily for 12 weeks, terbinafine 250 mg daily for 24 weeks, and placebo.
    • Cure rates at 48 weeks were significantly increased compared with placebo:
      • Cure rate placebo: 8%.
      • Cure rate terbinafine for 12 weeks: 70%.
      • Cure rate terbinafine for 24 weeks: 87%.
      • Difference in cure rates between terbinafine for 12 weeks and placebo: 62% (95% CI 52% to 72%).
      • Difference in cure rates between terbinafine for 24 weeks and placebo: 79% (95% CI 70% to 87%).
  • One RCT (n = 109) compared treatment with terbinafine 250 mg daily for 12 weeks, terbinafine 250 mg daily for 16 weeks, terbinafine 250 mg daily for 24 weeks, and placebo.
    • Cure rates at 48 weeks were significantly increased compared with placebo:
      • Cure rate with placebo: 0%.
      • Cure rate with terbinafine for 12 weeks: 38%.
      • Cure rate with terbinafine for 16 weeks: 37%.
      • Cure rate with terbinafine for 24 weeks: 65%.
      • Difference in cure rates between terbinafine for 12 weeks and placebo: 38% (95% CI 20% to 50%).
      • Difference in cure rates between terbinafine for 16 weeks and placebo: 37% (95% CI 21% to 56%).
      • Difference in cure rates between terbinafine for 24 weeks and placebo: 65% (95% CI 46% to 81%).
  • The systematic reviews did not report if the cure rates with 24 weeks of treatment were statistically significantly higher than with treatment for 12 or 16 weeks [Crawford et al, 2002; Crawford and Ferrari, 2007].
  • The evidence was assessed as very low quality because of the possibility of publication bias, short follow up, and inconsistent definitions of cure [Crawford and Ferrari, 2007].

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