Abstract
A total of 273 patients with proven vulvovaginal candidiasis were enrolled and randomized to treatment with either a single dose of tioconazole 6.5% vaginal ointment or a 3-day course of terconazole 0.8% vaginal cream. The objectives of this multicenter trial were to compare the safety, effectiveness (mycological and clinical cures), and patient acceptance of the two products. A single bedtime dose of tioconazole or three nightly doses of terconazole yielded a negative Nickerson culture and clinical cure that was evident in at least 88% of the evaluable patients from both treatment groups 1 month after drug treatment. Qualitatively and quantitatively, the adverse experiences reported in association with the two drugs were comparable.
Patient acceptance was favorable for both drugs in that the applicators for administration were comfortable, easy to use, and the therapy effective. However, there were significant differences (p ≤.05) on other aspects favoring tioconazole over terconazole. A significantly greater proportion (p <.01) of the tioconazole patients was able to use all of the drug therapy, with a significantly smaller proportion (p <.03) finding tioconazole messy upon application. Likewise, the tioconazole patients found their therapy preferable over previous treatment they had used. Because of its equivalent efficacy and similar safety profile, a single dose of tioconazole offers a significant advantage in the management of vulvovaginal candidiasis to both physicians and patients.
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