Objectives: The objective of this review is to identify and evaluate the evidence of efficacy for topical treatments for fungal infections of the skin and nails of the human foot. To establish the effectiveness of topical treatments in achieving a cured condition and in preventing recurrence
Search strategy: Randomised controlled trials were identified from the MEDLINE, EMBASE and CINHAL databases, from the beginning of these databases to December 1997. Also we screened the Cochrane Controlled Trials Register, the Science Citation Index BIOSIS, CAB - Health, Healthstar and Economic databases. References and unpublished studies were searched, podiatry journals handsearched and the pharmaceutical industry contacted.
Selection criteria: Only randomised controlled trials (RCTs) using participants who have mycologically diagnosed fungal infections of the skin and nails of the human foot are included in the analysis.
Data collection and analysis: Two reviewers independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool which assessed 12 quality criteria.
Main results: Of 126 trials identified in 121 papers, 72 met the inclusion criteria. Placebo-controlled trials yielded the following pooled relative risks of failure to cure (RRFC) for skin infections: allylamines 0.30 (95% confidence interval 0.23 to 0.37); azoles 0.53 (0.42 to 0.68); undecenoic acid 0.28 (0.11 to 0.74); tolnaftate 0.46 (0.17 to 1.22). Though meta-analysis of 11 trials comparing allylamines and azoles showed an RRFC of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidence of language bias. Seven English language reports favoured allylamines (RRFC = 0.79; 0.68 to 0.93) but four foreign language reports showed no difference between the two drugs (RRFC = 1.00; 0.90 to 1.12). The two trials of nail infections did not provide any evidence of benefit for topical treatments compared with placebo.
Conclusions: In placebo-controlled trials allylamines, azoles and undecenoic acid were efficacious. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive. The most cost-effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails.