One double-blind RCT compared three pulses of itraconazole with placebo.180 The mycological cure rate was 62% with itraconazole, which was significantly higher than that in the placebo group (P<0-0001). There was also a significant difference between the clinical response rate in the active treatment (65%) compared with the placebo group (P<0-001).
Four double-blind randomised comparative studies evaluated itraconazole pulse treatment, three compared with continuous terbinafine treatment,35,160,161 and one compared with continuous itraconazole treatment.181 The mycological cure rates for the itraconazole pulse groups, with a follow up of no more than 72 weeks, ranged from 38% to 69%. The corresponding range for clinical response rates were 28-81%.
Five open randomised comparative studies168,169,171,183,184 reported mycological cure rates with itraconazole of 61-75%, and clinical response rates of 77-88%. One randomised study182 compared three-pulse therapy with four pulses; however, since the number of treatment cycles had little effect on cure rates, a combined mycological cure rate of 77% was reported; hence this study was not included in the table.
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