An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis.
BACKGROUND
Onychomycosis is a recalcitrant disease of the nails caused by dermatophytes, yeasts, and molds.


OBJECTIVE
To compare the clinical efficacy of oral itraconazole pulse therapy and oral terbinafine pulse therapy in onychomycosis.


METHODS
A randomized single-blind clinical comparative study was undertaken on 120 patients of onychomycosis during the period March 1999-February 2002. Sixty patients were randomly assigned to receive oral itraconazole 100 mg, two capsules twice daily for seven days a month and the other group of sixty patients received oral terbinafine 250 mg, one tablet twice daily for seven days every month. Four such monthly pulses were administered for each drug. The patients were evaluated at 4-weekly intervals till sixteen weeks and then at 24, 36 and 48 weeks.


RESULTS
We observed a clinical cure rate of 82% and mycological cure rate of 90% in the group of patients treated with itraconazole while the group with terbinafine showed clinical and mycological cure rates of 79% and 87% respectively. This difference was not statistically significant.


CONCLUSIONS
Both oral itraconazole and terbinafine are effective in the treatment of onychomycosis when administered in the pulse dosage form. Terbinafine is more cost effective while itraconazole has a broader spectrum of antimycotic activity.
Mishra
Minati
M
Department of Dermatology and Venereology, S.C.B.Medical College, Cuttack, Orissa, India. minatimishra@yahoo.com
Panda
P
P
Tripathy
Satyabrata
S
Sengupta
Sujata
S
Mishra
Kaushik
K
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000175:diagnosis / Q000188:drug therapy*; D011336:Probability; D020551:Pulse Therapy, Drug; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D000077291:Terbinafine; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D017964:Itraconazole; D000077291:Terbinafine