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Meta-Analysis
. 2017 Jul 14;7(7):CD010031.
doi: 10.1002/14651858.CD010031.pub2.

Oral antifungal medication for toenail onychomycosis

Sanne Kreijkamp-Kaspers  1 , Kate Hawke, Linda Guo, George Kerin, Sally Em Bell-Syer, Parker Magin, Sophie V Bell-Syer, Mieke L van Driel
Affiliations
Meta-Analysis

Oral antifungal medication for toenail onychomycosis

Sanne Kreijkamp-Kaspers et al. Cochrane Database Syst Rev. .

Abstract

Background: Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment.

Objectives: To assess the effects of oral antifungal treatments for toenail onychomycosis.

Search methods: We searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies.

Selection criteria: RCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with toenail onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the toenails. Study duration ranged from 4 months to 2 years.We assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'.We found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence).There was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence).Terbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence).There is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea.Moderate-quality evidence shows that azoles and griseofulvin probably had similar efficacy for achieving clinical cure (RR 0.94, 95% CI 0.45 to 1.96, 5 studies, 222 participants) and mycological cure (RR 0.87, 95% CI 0.50 to 1.51, 5 studies, 222 participants). However, the risk of adverse events was probably higher in the griseofulvin group (RR 2.41, 95% CI 1.56 to 3.73, 2 studies, 143 participants, moderate-quality evidence), with the most common being gastrointestinal disturbance and allergic reaction (in griseofulvin-treated participants) along with nausea and vomiting (in azole-treated participants). Very low-quality evidence means we are uncertain about this comparison's impact on recurrence rate (RR 4.00, 0.26 to 61.76, 1 study, 7 participants).There is low-quality evidence that terbinafine may be more effective than griseofulvin in terms of clinical cure (RR 0.32, 95% CI 0.14 to 0.72, 4 studies, 270 participants) and mycological cure (RR 0.64, 95% CI 0.46 to 0.90, 5 studies, 465 participants), and griseofulvin was associated with a higher risk of adverse events, although this was based on low-quality evidence (RR 2.09, 95% CI 1.15 to 3.82, 2 studies, 100 participants). Common adverse events included headache and stomach problems (in griseofulvin-treated participants) as well as taste loss and nausea (in terbinafine-treated participants). No studies addressed recurrence rate for this comparison.No study addressed quality of life.

Authors' conclusions: We found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence).Azole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence).Only four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them.Only a limited number of studies reported adverse events, and the severity of the events was not taken into account.Overall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.

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Conflict of interest statement

Sanne Kreijkamp‐Kaspers: none known. Kate Hawke: none known. Linda Guo: none known. George Kerin: none known. Sally EM Bell‐Syer: none known. Parker Magin: none known. Sophie V Bell‐Syer: none known. Mieke L van Driel: none known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Funnel plot of comparison: 3 Azole versus terbinafine, outcome: 3.1 Clinical cure.
4
4
Funnel plot of comparison: 3 Azole versus terbinafine, outcome: 3.2 Mycological cure.
1.1
1.1. Analysis
Comparison 1 Azole versus terbinafine, Outcome 1 Clinical cure.
1.2
1.2. Analysis
Comparison 1 Azole versus terbinafine, Outcome 2 Mycological cure.
1.3
1.3. Analysis
Comparison 1 Azole versus terbinafine, Outcome 3 Adverse events.
1.4
1.4. Analysis
Comparison 1 Azole versus terbinafine, Outcome 4 Recurrence rate.
2.1
2.1. Analysis
Comparison 2 Terbinafine versus placebo, Outcome 1 Clinical cure.
2.2
2.2. Analysis
Comparison 2 Terbinafine versus placebo, Outcome 2 Mycological cure.
2.3
2.3. Analysis
Comparison 2 Terbinafine versus placebo, Outcome 3 Adverse events.
2.4
2.4. Analysis
Comparison 2 Terbinafine versus placebo, Outcome 4 Recurrence rate.
3.1
3.1. Analysis
Comparison 3 Azole versus placebo, Outcome 1 Clinical cure.
3.2
3.2. Analysis
Comparison 3 Azole versus placebo, Outcome 2 Mycological cure.
3.3
3.3. Analysis
Comparison 3 Azole versus placebo, Outcome 3 Adverse events.
3.4
3.4. Analysis
Comparison 3 Azole versus placebo, Outcome 4 Recurrence rate.
4.1
4.1. Analysis
Comparison 4 Griseofulvin versus azole, Outcome 1 Clinical cure.
4.2
4.2. Analysis
Comparison 4 Griseofulvin versus azole, Outcome 2 Mycological cure.
4.3
4.3. Analysis
Comparison 4 Griseofulvin versus azole, Outcome 3 Adverse events.
4.4
4.4. Analysis
Comparison 4 Griseofulvin versus azole, Outcome 4 Recurrence rate.
5.1
5.1. Analysis
Comparison 5 Griseofulvin versus terbinafine, Outcome 1 Clinical cure.
5.2
5.2. Analysis
Comparison 5 Griseofulvin versus terbinafine, Outcome 2 Mycological cure.
5.3
5.3. Analysis
Comparison 5 Griseofulvin versus terbinafine, Outcome 3 Adverse events.
6.1
6.1. Analysis
Comparison 6 Combination terbinafine plus azole versus terbinafine monotherapy, Outcome 1 Clinical cure.
6.2
6.2. Analysis
Comparison 6 Combination terbinafine plus azole versus terbinafine monotherapy, Outcome 2 Mycological cure.
6.3
6.3. Analysis
Comparison 6 Combination terbinafine plus azole versus terbinafine monotherapy, Outcome 3 Adverse events.
See this image and copyright information in PMC

Update of

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    1. Sigurgeirsson B, Rossem K, Malahias S, Raterink K. A phase II, randomized, double‐blind, placebo‐controlled, parallel group, dose‐ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis. Journal of the American Academy of Dermatology 2013;69(3):416‐25. [PUBMED: 23706639] - PubMed
Svejgaard 1985 {published data only}
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Svejgaard 1997 {published data only}
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    1. Svejgaard EL, Brandrup F, Kragballe K, Larsen PO, Veien NK, Holst M, et al. Oral terbinafine in toenail dermatophytosis. A double‐blind, placebo‐controlled multicenter study with 12 months' follow‐up. Acta Dermato‐venereologica 1997;77(1):66‐9. [PUBMED: 9059684] - PubMed
Tosti 1996 {published data only}
    1. Tosti A, Piraccini BM, Stinchi C, Colombo MD. Relapses of onychomycosis after successful treatment with systemic antifungals: a three‐year follow‐up. Dermatology (Basel, Switzerland) 1998;197(2):162‐6. [PUBMED: 9732167] - PubMed
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Walsoe 1990 {published data only}
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Watson 1995 {published data only}
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Won 2007 {published data only}
    1. Won CH, Lee J, Li K, Mi RC, Kim BJ, An JS, et al. The long term efficacy and relapse rate of itraconazole pulse therapy versus terbinafine continuous therapy for toenail onychomycosis ‐ a 96‐week follow‐up study. Korean Journal of Medical Mycology 2007;12(3):139‐47. [CENTRAL: CN‐00708731; EMBASE: 2008006956]

References to studies excluded from this review

Albreski 1999 {published data only}
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Alpsoy 1996 {published data only}
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Avner 2006a {published data only}
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Avner 2006b {published data only}
    1. Avner S, Nathansohn N Trau H. Onychomycosis recurrence: Long term follow‐up of 2 oral terbinafine regimens and the effect of topical bifonazole solution. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB133.
Chen 1999 {published data only}
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De Doncker 1996 {published data only}
    1. Doncker P, Decroix J, Pierard GE, Roelant D, Woestenborghs R, Jacqmin P, et al. Antifungal pulse therapy for onychomycosis. A pharmacokinetic and pharmacodynamic investigation of monthly cycles of 1‐week pulse therapy with itraconazole. Archives of Dermatology 1996;132(1):34‐41. [PUBMED: 8546481] - PubMed
Faergemann 1996 {published data only}
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Finlay 1994 {published data only}
    1. Finlay AY, Thomas R, Dykes PJ, Smith SG, Jones TC. Descriptive correlations between various doses of oral terbinafine and concentrations in nail. Journal of Dermatological Treatment 1994;5(4):193‐7. [EMBASE: 1995029315]
Gomez 1996 {published data only}
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Goodfield 1990 {published data only}
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Havu 1997 {published data only}
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Havu 1999 {published data only}
    1. Havu V, Brandt H, Heikkila H, Hollmen A, Oksman R, Rantanen T, et al. Continuous and intermittent itraconazole dosing schedules for the treatment of onychomycosis: a pharmacokinetic comparison. British Journal of Dermatology 1999;140(1):96‐101. [PUBMED: 10215775] - PubMed
Hay 1987 {published data only}
    1. Hay RJ, Clayton YM, Moore MK. A comparison of tioconazole 28% nail solution versus base as an adjunct to oral griseofulvin in patients with onychomycosis. Clinical and Experimental Dermatology 1987;12:175‐7. [EMBASE: 1987131271] - PubMed
Maleszka 2001 {published data only}
    1. Maleszka R, Adamski Z. The treatment of extensive onychomycosis in aged patients [Leczenie Rozleglej Grzybicy Dermatofitowej Paznokci U Pacjentow W Starszym Wieku]. Wiadomosci Parazytologiczne 2001;47(4):817‐22. [EMBASE: 16886433] - PubMed
Pollak 2001 {published data only}
    1. Pollak R, Billstein SA. Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations. Journal of the American Podiatric Medical Association 2001;91(3):127‐31. [PUBMED: 11266494] - PubMed
Safer 2000 {published data only}
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Schatz 1995 {published data only}
    1. Schatz F, Brautigam M, Dobrowolski E, Effendy I, Haberl H, Mensing H, et al. Nail incorporation kinetics of terbinafine in onychomycosis patients. Clinical and Experimental Dermatology 1995;20(5):377‐83. [PUBMED: 8593713] - PubMed
Shemer 1999 {published data only}
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Sommer 2003 {published data only}
    1. Sommer S, Sheehan‐Dare RA, Goodfield MJ, Evans EG. Prediction of outcome in the treatment of onychomycosis. Clinical and Experimental Dermatology 2003;28(4):425‐8. [PUBMED: 12823307] - PubMed
Tausch 1997 {published data only}
    1. Tausch I, Brautigam M, Weidinger G, Jones TC. Evaluation of 6 weeks treatment of terbinafine in tinea unguium in a double‐blind trial comparing 6 and 12 weeks therapy. The Lagos V Study Group. British Journal of Dermatology 1997;136(5):737‐42. [PUBMED: 9205509] - PubMed
van der Schroeff 1992 {published data only}
    1. Schroeff JG, Cirkel PK, Crijns MB, Dijk TJ, Govaert FJ, Groeneweg DA, et al. A randomized treatment duration‐finding study of terbinafine in onychomycosis. British Journal of Dermatology 1992;126(Suppl 39):36‐9. [PUBMED: 1531927] - PubMed
Warshaw 2001 {published data only}
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Warshaw 2005 {published data only}
    1. Warshaw EM, Fett DD, Bloomfield HE, Grill JP, Nelson DB, Quintero V, et al. Pulse versus continuous terbinafine for onychomycosis: a randomized, double‐blind, controlled trial. Journal of the American Academy of Dermatology 2005;53(4):578‐84. [PUBMED: 16198776] - PubMed
Watanabe 2004 {published data only}
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Yadav 2015 {published data only}
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Zaias 1983 {published data only}
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References to other published versions of this review

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