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document
Pulse versus continuous terbinafine for onychomycosis : a randomized , double-blind , controlled trial . BACKGROUND Effective treatments for onychomycosis are expensive . Previous studies suggest that less costly , pulsed doses of antifungal medications may be as effective as standard , continuous doses . Terbinafine is the current treatment of choice for toenail onychomycosis . OBJECTIVE Our purpose was to determine whether pulse-dose terbinafine is as effective as standard continuous-dose terbinafine for treatment of toenail onychomycosis . METHODS We conducted a double-blind , randomized , noninferiority , clinical intervention trial in the Minneapolis Veterans Affairs Medical Center . The main inclusion criteria for participants were a positive dermatophyte culture and at least 25 % distal subungual clinical involvement . Six hundred eighteen volunteers were screened ; 306 were randomized . Terbinafine , 250 mg daily for 3 months ( continuous ) or terbinafine , 500 mg daily for 1 week per month for 3 months ( pulse ) was administered . The primary outcome measure was mycological cure of the target toenail at 18 months . Secondary outcome measures included clinical cure and complete ( clinical plus mycological ) cure of the target toenail and complete cure of all 10 toenails . RESULTS Results of an intent-to-treat analysis did not meet the prespecified criterion for noninferiority but did demonstrate the superiority of continuous-dose terbinafine for : mycological cure of the target toenail ( 70.9 % [ 105/148 ] vs 58.7 % [ 84/143 ] ; P =.03 , relative risk [ RR ] of 1.21 [ 95 % confidence interval ( CI ) , 1.02-1.43 ] ) ; clinical cure of the target toenail ( 44.6 % [ 66/148 ] vs 29.3 % [ 42/143 ] ; P =.007 , RR =1.52 [ 95 % CI , 1.11-2.07 ) ; complete cure of the target toenail ( 40.5 % [ 60/148 ] vs 28.0 % [ 40/143 ] ; P =.02 , RR=1.45 [ 95 % CI , 1.04-2.01 ) ; and complete cure of all 10 toenails ( 25.2 % [ 36/143 ] vs 14.7 % [ 21/143 ] ; P =.03 , RR =1.71 [ 95 % CI , 1.05-2.79 ) . Tolerability of the regimens did not differ significantly between the groups ( chi2 =1.63 ; P =.65 ) . LIMITATIONS The study population primarily consisted of older men with severe onychomycosis . CONCLUSIONS This study demonstrated the superiority of continuous- over pulse-dose terbinafine . We also found this expensive therapy to be much less effective than previously believed , particularly for achieving complete cure of all 10 toenails .
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Intervention_Pharmacological
Pulse
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Intervention_Control
continuous terbinafine
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Intervention_Pharmacological
antifungal medications
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Intervention_Pharmacological
pulse-dose terbinafine
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Intervention_Control
standard continuous-dose terbinafine
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Intervention_Pharmacological
Terbinafine
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Intervention_Pharmacological
terbinafine
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Intervention_Control
continuous-dose terbinafine
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Intervention_Pharmacological
pulse-dose terbinafine
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Outcome_Physical
mycological cure
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Outcome_Other
of the target toenail at 18 months
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Outcome_Other
clinical cure and complete ( clinical plus mycological ) cure of the target toenail
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Outcome_Other
complete cure of all 10 toenails
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Outcome_Physical
mycological cure
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Outcome_Physical
clinical cure
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Outcome_Other
complete cure
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Outcome_Other
complete cure
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Outcome_Mental
Tolerability
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Participant_Condition
onychomycosis
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Participant_Condition
positive dermatophyte culture and at least 25 % distal subungual clinical involvement
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Participant_Sample-size
Six hundred eighteen
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Participant_Sample-size
306
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Participant_Age
of older
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Participant_Sex
men
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Participant_Condition
severe onychomycosis