Treatment of Complicated Candida Vaginitis: Comparison of Single and Sequential Doses of Fluconazole

Abstract

Candida vaginitis is commonly described as uncomplicated, for which the recommended treatment is single-dose antimycotic therapy, and complicated, for which the recommended dose is short-course antimycotic therapy. This study was performed to evaluate the necessity of multidose therapy in women with severe or recurrent Candida vaginitis. Severity of disease was determined using a semiquantitative scale in which a score of 1 to 10 was assigned according to the severity of pruritus and the presence of vulvar or vaginal erythema, edema, and excoriation or fissure formation. Only women with scores greater than 4 were included. For the purposes of this report, disease severity was rated mild in women with a score of 4 to 6 and severe in those with a score greater than 7. Of the 309 patients who met all of the study criteria, 157 women were identified with mild Candida vaginitis, and 152 had severe disease. Patients in each group were randomly assigned to receive either a single done of 150 mg fluconazole or two sequential doses of 150 mg fluconazole given 3 days apart. Follow-up examinations were conducted on day 14 and day 35 of the trial. There were no significant differences in the demographic or clinical characteristics of the two groups, with more 90% (N = 283, 91.6%) of all cases diagnosed as C. albicans. Other strains identified included 13 cases of C. glabrata, 7 of C. parapsilosi, 3 of C. tropicalis, and 1 each of C. guiliermondii, C. krusei, C. lipolytica, and C. zeylandoides. A greater number of patients with non-albicans lesions were randomly assigned to the two-dose group (N = 21) than to the single-dose group (N = 6). Of the 13 women with C. glabrata, which is resistant to fluconazole, 12 received two sequential doses and only 1 received a single dose of fluconazole. The one woman with C. krusei, another strain resistant to fluconazole, was in the two-dose group. The C. albicans species was eradicated on the day 14 visit in 78% of the patients in the single-dose group and 86% of the women in the two-dose group. Compared with C. albicans, non-albicans species were significantly more likely to be present in both the single- and dual-dose groups on the day 14 follow-up visit (79 vs. 46%, respectively; P = .097) and on the day 35 follow-up visit (65 vs. 23%, respectively; P <.001). The patient with C. krusei had a negative culture at day 14. The cure rate achieved on both days 14 and 35 was significantly higher in the women receiving two doses of fluconazole compared with those receiving a single dose after a logistic regression analysis of the two treatment regimens (P =.049). The two-dose regimen was also more likely to be successful (improved or eradicated disease) on day 14 in patients with severe disease compared with the single-dose regimen (P =.15). By day 35, the advantage had lost its significance but remained. Logistic regression analysis of the results of patients with C. albicans compared with those with non-albicans strains showed a significant difference in the improvement/cure rate for the patients in the two-dose group at both the day 14 and day 35 visit (P =.02 and.03, respectively). For 94 patients with severe disease, this was their first diagnosis of Candida vaginitis. At day 14, these patients had significantly better results with the two-treatment regimen than with the single dose (P =.028). Patients with recurrent disease, whether severe or mild, responded to both treatment regimens equally.