A randomized clinical trial of the efficacy and safety of clotrimazole vaginal tablet versus oral fluconazole in treating severe vulvovaginal candidiasis

Xiaoping Liu, Shangrong Fan

Abstract: 

Background: Vulvovaginal candidiasis (VVC), which affects up to 75% of child-bearing age women at least once in their lifetime, is predominantly caused by Candida albicans.1,2 Sobel et al.3 classified VVC into complicated VVC and uncomplicated VVC. The Centers for Disease Control (CDC) recommended VVC therapy in the sexually transmitted disease treatment guideline on the basis of this classification.4 Women with SVVC may not adequately respond to a single dose.4 The CDC recommended two doses of oral fluconazole 150 mg for the treatment of severe VVC (SVVC).4 Several other guidelines recommend using clotrimazole vaginal tablet 500 mg for treating uncomplicated VVC and recurrent VCC (RVVC).1,5,6 Few studies and guidelines recommend the use of clotrimazole vaginal tablet 500 mg for the treatment of SVVC. Accordingly, we performed a prospective, randomized study in patients with SVVC to determine whether two doses of clotrimazole vaginal tablet 500 mg was as effective as two doses of oral fluconazole 150 mg.

Material/methods: The aim of this study was to compare the efficacy and safety of two doses of clotrimazole vaginal tablet 500mg with two doses of oral fluconazole 150 mg in treating severe vulvovaginal candidiasis (SVVC). In this prospective, randomized case control study, 240 consecutive patients with SVVC were studied at the Department of Obstetrics and Gynaecology of Peking University Shenzhen Hospital between June 1, 2014, and September 31, 2015. Patients with SVVC were randomly assigned in a 1:1 ratio to receive treatment with either two doses of clotrimazole vaginal tablet or two doses of oral fluconazole 150 mg. The patients were followed up at 7–14 days and 30–35 days following the second dose of therapy.

Results: The clinical cure rates in the clotrimazole group and the fluconazole group at days 7–14 of follow-up were 88.7% (102/115) and 89.1% (98/110), respectively; the clinical cure rates at days 30– 35 in the two groups were 71.9% (82/114) and 78.0% (85/109), respectively. The mycological cure rates at days 7–14 follow-up in the two groups were 78.3% (90/115) and 73.6% (81/110), respectively. The mycological cure rates of the patients at days 30–35 in the two groups were 54.4% (62/114) and 56.0% (61/109), respectively (p > 0.05). A higher percentage of patients in the clotrimazole group experienced relief of symptoms at the first 12 hour time point compared to the fluconazole group. The adverse events of clotrimazole were mainly local.

Conclusions: This study demonstrated that two doses of clotrimazole vaginal tablet 500mg were as effective as two doses of oral fluconazole 150 mg in the treatment of patients with SVVC and could be an appropriate treatment for this disorder.

2016

abstract No: 

#2307

Full conference title: 

26th European Congress of Clinical Microbiology and Infectious Diseases
    • ECCMID 26th (2016)