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Review
. 2012 Oct 17;10(10):CD003584.
doi: 10.1002/14651858.CD003584.pub2.

Oral treatments for fungal infections of the skin of the foot

Sally E M Bell-Syer  1 , Sameena M Khan, David J Torgerson
Affiliations
Review

Oral treatments for fungal infections of the skin of the foot

Sally E M Bell-Syer et al. Cochrane Database Syst Rev. .

Abstract

Background: About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed.

Objectives: To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis).

Search methods: For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers.

Selection criteria: Randomised controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture.

Data collection and analysis: Two review authors independently undertook study selection, 'Risk of bias' assessment, and data extraction.

Main results: We included 15 trials, involving 1438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95% CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95% CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear 'Risk of bias' assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as 'unclear' risk of bias because of the lack of clear statements with respect to methods of generating the randomisation sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported.

Authors' conclusions: The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.

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Conflict of interest statement

The clinical referee, Professor Rod Hay, was the first author of the following two trials within this review (one excluded and one included):

  1. Hay RJ, McGregor JM, Wuite J, Ryattk KS, Ziegler C, Clayton YM. A comparison of 2 weeks terbinafine 250mg/day with 4 weeks of itraconazole 100mg/day in plantar ‐ type tinea pedis. British Journal of Dermatology 1995;132 132:604‐8.

  2. Hay RJ, Logan RA, Moore MK, Midgely G, Clayton YM. A comparative study of terbinafine versus griseofulvin in 'dry ‐ type' dermatophyte infections. Journal of American Academy of Dermatology 1991;24(2 Pt 1):243‐6.

Figures

1
1
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
2
2
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies
1.1
1.1. Analysis
Comparison 1 Antifungal versus placebo, Outcome 1 Cured (terbinafine 250 mg/day versus placebo).
1.2
1.2. Analysis
Comparison 1 Antifungal versus placebo, Outcome 2 Cured (itraconazole 400 mg/day versus placebo).
2.1
2.1. Analysis
Comparison 2 Different types of antifungals, Outcome 1 Cured (terbinafine 250 mg/day versus itraconazole 100 mg/day).
2.2
2.2. Analysis
Comparison 2 Different types of antifungals, Outcome 2 Cured (itraconazole 100 mg/day versus fluconazole 50 mg/day).
2.3
2.3. Analysis
Comparison 2 Different types of antifungals, Outcome 3 Cured (fluconazole 50 mg/day versus ketoconazole 200 mg/day).
2.4
2.4. Analysis
Comparison 2 Different types of antifungals, Outcome 4 Cured (ketaconazole 200 mg/day versus griseofulvin 1000 mg/day).
2.5
2.5. Analysis
Comparison 2 Different types of antifungals, Outcome 5 Cured (terbinafine 250 mg versus griseofulvin 500 mg).
2.6
2.6. Analysis
Comparison 2 Different types of antifungals, Outcome 6 Cured (fluconazole 150 mg/week versus fluconazole 50 mg/day).
2.7
2.7. Analysis
Comparison 2 Different types of antifungals, Outcome 7 Cured (terbinafine 250 mg/2 weeks versus terbinafine 250 mg/4 weeks).
3.1
3.1. Analysis
Comparison 3 Presentation of tinea pedis, Outcome 1 Plantar tinea pedis.
3.2
3.2. Analysis
Comparison 3 Presentation of tinea pedis, Outcome 2 Mixed distribution of tinea pedis.
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References

References to studies included in this review

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References to studies excluded from this review

Baldari 2000 {published data only}
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References to studies awaiting assessment

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References to ongoing studies

NCT00509275 {published data only (unpublished sought but not used)}
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References to other published versions of this review

Bell‐Syer 2002
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