DOUBLE-BLIND, PARALLEL-GROUP COMPARISON OF TERBINAFINE AND GRISEOFULVIN IN THE TREATMENT OF TOENAIL ONYCHOMYCOSIS

Background: Griseofulvin has been used in the treatment of toenail ony chomycosis with limited success. Evidence suggests that terbinafine ma y be more effective. Objective: In a double-blind, parallel-group stud y we compared 250 mg/day terbinafine for 16 weeks with 500 mg/day gris eofulvin for 52 weeks (or for shorter periods in cured patients) in pa tients with toenail onychomycosis. Methods: Eighty-nine patients with culture-proved tinea unguium were included, and 43 in the terbinafine group and 41 in the griseofulvin group were assessable for efficacy. P atients who had not improved after 16 weeks were entered into an open study and were given 250 mg/day terbinafine for 16 weeks with the stud y code still blinded and were then followed up for 20 weeks. Results: Terbinafine was significantly more effective than griseofulvin, with 4 2% being completely cured and 84% mycologically cured compared with on ly 2% with total cure and 45% with mycologic cure in the griseofulvin- treated group. The number of side effects was significantly lower in t he terbinafine group (11%) compared with the griseofulvin group (29%). Conclusion: Terbinafine is significantly more effective than griseofu lvin in the treatment of toenail onychomycosis.