A Cochrane review «Oral treatments for fungal infections of the skin of the foot»1 «Bell-Syer SE, Khan SM, Torgerson DJ. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev 2012;(10):CD003584. »1 included 15 studies with a total of 1 438 adult subjects. Six oral treatments were examined: terbinafine, itraconazole, ketoconazole, fluconazole, griseofulvin, and bovine lactoferrin. Two studies compared active treatments (terbinafine, itraconazole) with placebo, 1 study compared different doses of the same drug (fluconazole), 1 study compared different brands of the same drug (itraconazole), and 11 studies evaluated head-to-head comparisons.
| Outcome | Relative effect (95% CI) | Cured (intervention) | Cured (placebo) | Participants (studies) |
|---|---|---|---|---|
| Oral terbinafine 250 mg/day for 6 weeks compared with placebo | ||||
| Cured at 8 weeks | RR 24.54 (1.57 to 384.32) | 15/23 65% | 0/18
0% | 41 (1 study) |
| Oral itraconazole 400 mg/day for 1 week compared with placebo | ||||
| Cured at 9 weeks | RR 6.67 (2.17 to 20.48) | 20/36
56% | 3/36
8% | 72 (1 study) |
The studies comparing antifungal treatments (terbinafine and itraconazole) with placebo demonstrated that the cure rate continued to improve beyond the end of treatment; in the case of terbinafine, 65% of participants were cured 2 weeks after the end of the 6-week treatment period, and for itraconazole, 55% of participants were cured 8 weeks after the 1-week treatment period (table « Oral terbinafine or itraconazole compared with placebo for moccasin type tinea pedis»1).
| Outcome | Relative effect (95% CI) | Cured (terbinafine) | Cured (itraconazole) | Participants (studies) |
|---|---|---|---|---|
| *plantar type tinea pedis (1 study), moccasin type tinea pedis (1 study), and tinea pedis with no further information (1 study) | ||||
| Cured (follow up varied from 4 to over 12 weeks) | RR 1.07 (0.92 to 1.25) | 84/110
76% | 80/112
71% | 222 (3 studies*) |
No significant difference was detected between terbinafine and itraconazole (table «Allylamines versus azoles: Oral terbinafine 250 mg/day for 2 weeks versus oral itraconazole 100 mg/day for 4 weeks »2). Terbinafine had higher cure rates than griseofulvin (RR 2.26, 95% CI 1.49 to 3.44; 2 studies, n=71). No significant difference was detected between fluconazole and either itraconazole and ketoconazole; or between griseofulvin and ketoconazole, although the trials were generally small. Adverse effects were reported for all drugs, with gastrointestinal effects most commonly reported.
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding) and by imprecise results (few patients and wide confidence intervals).