A Random Comparative Study of Terbinafine Versus Griseofulvin in Patients with Tinea Capitis in Western China

Abstract

To compare the efficacy and safety of terbinafine with griseofulvin in the treatment of tinea capitis in Western China. Children (2-14 years of age) with clinically diagnosed and potassium hydroxide microscopy-confirmed tinea capitis were randomized into three groups: group GRI4 received 4 weeks of griseofulvin; group TBF2 received 2 weeks of terbinafine; and Group TBF4 received 4 weeks of terbinafine. Clinical and mycological evaluations were done in 0, 2, 4, and 8 weeks and 1 year after therapy started. The isolated pathogenic fungi were evaluated for in vitro susceptibility by detecting the minimal inhibitory concentration (MIC) against terbinafine, griseofulvin, itraconazole, and ketoconazole. The clinical effectiveness rate of GRI4, TBF2, and TBF4 were 100% (95% CI-confidence interval: 82-100%), 96.3% (95% CI: 81-100%), and 100%(95% CI: 85-100%), respectively, at week 8 and 100% after 1 year for the 3 groups; clinical cure rates were 84.2%(95% CI: 77-99%), 85.2%(95% CI: 71-98%), and 78.3%(95% CI: 61-95%), respectively, at week 8 and 100% after 1 year for all agents; mycological cure rates were 100%(95% CI: 74-100%), 95.0%(95% CI: 74-100%), and 94.1%(95% CI: 50-93%) at week 8 and 100% after 1 year for the 3 groups. In vitro, all patient-derived cultures were sensitive to the four antifungal agents. Data from the clinical trial and in vitro antifungal activity indicated that terbinafine is efficacious and well tolerated in the treatment for Trichophyton infections (T. violaceum; Arthroderma vanbreuseghemii; and T. tonsurans) of the scalp, i.e., a 2- to 4-week course of terbinafine is as effective as a 4-week course of griseofulvin; in fact, a 2-week course of terbinafine is sufficient. Terbinafine is an effective alternative to griseofulvin against tinea capitis of Trichophyton infections.