OBJECTIVE--To compare the clinical and mycological efficacy and patient acceptability of the oral antifungal itraconazole with vaginal clotrimazole in the treatment of vaginal candidosis. DESIGN--A multicentre, single-blind, randomised, parallel group comparison of itraconazole and clotrimazole. SETTING--17 Genito Urinary Medicine clinics in UK hospitals. SUBJECTS--Women with symptomatic, culture positive vaginal candidosis. METHODS--Patients were randomly allocated 2 x 100 mg itraconazole capsules to be taken twice in a 24 hour period, or a 500 mg clotrimazole vaginal tablet. Clinical and mycological assessments were made at entry and after approximately seven and 35 days. OUTCOME MEASURES--Cure rate was defined in terms of mycological results, and patients were questioned on their opinion of treatment. RESULTS--Of 214 patients, 109 received itraconazole and 105 clotrimazole with similar improvement in clinical signs and symptoms. Mycological cure rates one week after treatment were obtained in 72 of 97 patients (74%) in the itraconazole group and 64 of 89 patients (72%) in the clotrimazole group. Identical mycological cure rates six weeks after treatment were obtained with 40 of 79 patients (51%) receiving itraconazole and 39 of 78 patients (50%) receiving clotrimazole. CONCLUSION--Clotrimazole and itraconazole were found to be equally effective. A majority of patients receiving the latter preferred it to previous treatments.
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