Takaisin

Azoles and toenail onychomycosis

Näytönastekatsaukset
Hannele Heikkilä
4.3.2021

Level of evidence: B

Azoles 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. Participants of all ages 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. Nine studies (N = 3440) compared azole (N = 2651) with placebo (N = 789), including four studies with itraconazole two studies with fluconazole and one study each for posaconazole, albaconazole and ravuconazole. Albaconazole and ravuconazole are drugs under development which are not commercially available. Therefore the results are presented without these two studies.

All the nine studies reported clinical cure as an outcome. In the pooled placebo group, 11 (13.9 %) participants achieved clinical cure compared to 810 (30.5 %) participants in the pooled azole group. There was high-quality evidence that participants in the azole group were 22 times more likely to achieve clinical cure compared to participants receiving placebo (RR 22.18, 95 % CI 12.63 to 38.95, 9 studies). When excluding the studies using unregistered medications (albaconazole and ravuconazole) participants in the azole group were 25 times more likely to achieve clinical cure compare to participants receiving placebo (RR 25.28, 95 % CI 13.64 to 46.85).

In the pooled placebo group 58 (7.4 %) participants achieved mycological cure compared to 924 (34.8 %) participants in the intervention group. There was high-quality evidence that participants in the azole group were almost six times more likely to achieve mycological cure compared to participants receiving placebo (RR 5.86, 95 % CI 3.23 to 10.62, 9 studies, 3440 participants; I² = 76 %).

  • Study quality: High
  • Applicability: Good
  • Comment: The most of the studies were assessed being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'

References

  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