Topical treatments for fungal infections of the skin and nails of the foot.

The trial of oxiconazole (n = 155, Ellis 1989) had an observed
relative reduction in treatment failure at 2 weeks of 21% (RR
0.79, 95% CI 0.61 to 1.02; Analysis 2.1) which was not quite
statistically significant. Overall the pooled estimated relative risk
of treatment failure (n = 329, 5 trials) of 1% azoles (bifonazole
or oxiconazole) versus placebo at 2 weeks was 41% (RR 0.59,
95% CI 0.43 to 0.82; Analysis 2.1), though there was considerable
variation between the results for the 2 different azoles (overall I 2
= 50%).
Medium-term outcome (six weeks)
All azoles versus placebo
There was statistically significant evidence of effectiveness for each
of the azoles individually except miconazole nitrate, which was
studied in only 54 people, providing inconclusive results (RR of
treatment failure 0.41, 95% CI 0.14 to 1.14; Analysis 2.2) (Gentles
1974; Mandy 1974). The results were generally fairly consistent
both between individual studies for each azole, and between different
azoles. Overall, a meta-analysis of data from 13 trials (n
= 1235, Akers 1989; Bagatell 1986; Coffey 1986; Elewski 1996;
Ellis 1989; Izuno 1986; Gentles 1974; Mandy 1974; Smith 1977;
Smith 1986; Smith 1988a; Spiekermann 1976a; Spiekermann
1976b) comparing azoles with placebo estimated the pooled relative
reduction in treatment failure as 60% (RR 0.40, 95% CI 0.35
to 0.46; Analysis 2.2).
Sensitivity analysis
Topical treatments for fungal infections of the skin and nails of the foot. (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A sensitivity analysis based only on data collected in the 6 trials
with at least 80% follow up at 6 weeks (n = 448, Akers 1989; Ellis
1989; Gentles 1974; Mandy 1974; Smith 1977; Smith 1988a)
showed very similar results (RR of treatment failure 0.43 (95% CI
0.34 to 0.53; Analysis 2.3).
A L’Abbé plot of the outcomes at 6 weeks (Figure 2) demonstrates
that the azoles generally had treatment failure rates of around
25%, compared to around 50 to 90% for placebos (see Methods,
statistical analysis for more details of L’Abbé plots and how to
interpret them).
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