Terbinafine and toenail onychomycosis

Hannele Heikkilä

Level of evidence: B

Terbinafine appears to be more effective than placebo for toenail onychomycosis in adult patients.

In a Cochrane review «Kreijkamp-Kaspers S, Hawke K, Guo L ym. Oral antif...»1, the pooled analyses included 43 studies with 9730 participants. All studies were RCTs, and 16 had a placebo arm. Twenty-six were published 2000 or earlier. Participants with toenail onychomycosis confirmed by at least one positive culture or confirmed fungal elements on direct microscopy or histological examination of the nail. The average age of the participants across studies ranged from 36 to 68 years, and most studies included participants aged 18 and over, with only three studies accepting participants aged 14 to 16 years. The participants mainly had subungual fungal infection of the toenails. Eight studies (1006 participants) compared terbinafine monotherapy with placebo. All the studies used terbinafine 250 mg daily for 12 to 24 weeks.

All eight studies reported clinical cure as on outcome. Six studies assessed the nail for clinical cure at 52 weeks or less from start of the treatment. Two studies assessed nails at 72 and 78 weeks, respectively. In the pooled placebo group, 20 (6 %) participants achieved clinical cure compared to 329 (48 %) participants in the pooled terbinafine group. People treated with terbinafine were six times more likely to achieve clinical cure compared with people receiving placebo (RR 6.00, 95 %, CI 3.96 to 9.06, 8 studies, 1006 participants; I²=0 %; high-quality evidence.

All eight studies reported mycological cure. In the polled placebo group, 54 (16.7 %) participants achieved mycological cure compared to 401 participants in the intervention group (58.8 %). There was high-quality evidence that participants in the terbinafine group were 4.5 times more likely to achieve mycological cure compared to participants receiving placebo (RR 4.53, 95 % CI 2.47 to 8.33, 8 studies, 1006 participants; I²= 72 %).

  • Study quality: High
  • Applicability: Good
  • Comment: The main reasons to downgrade evidence were limitations in study designs in original trials, such as unclear allocation concealment and randomisation as well as lack of blinding.


  1. Kreijkamp-Kaspers S, Hawke K, Guo L ym. Oral antifungal medication for toenail onychomycosis. Cochrane Database Syst Rev 2017;7:CD010031 «PMID: 28707751»PubMed