Effect of butoconazole nitrate 2% vaginal cream and miconazole nitrate 2% vaginal cream treatments in patients with vulvovaginal candidiasis
Lappin, M.A.; Brooker, D.C.; Francisco, C.A.; Dorfman, J.
Infectious Diseases in Obstetrics and Gynecology 4(6): 323-328
In a multicentre, randomized, investigator-blind, parallel study, 398 women from California, USA, were dispensed topical butoconazole nitrate 2% cream for 3 days (n=199) or miconazole nitrate 2% cream for 7 days (n=199) for the treatment of vulvovaginal candidosis. Efficacy analyses included 254 patients with culture-confirmed Candida (119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approx. 8 and 30 days post-treatment included Candida cultures, KOH wet mounts and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiological cure (based on cultures and wet mounts) and therapeutic cure (both clinical and microbiological cures) were assessed and were similar between the regimens. C. albicans was the causative organism in the majority of cases; 18 patients had non-albicans isolates, including Torulopsis glabrata, C. tropicalis, C. parapsilosis and C. stellatoidea. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. It is concluded that 3-day butoconazole treatment is as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidosis.