Assessing the treatment effect in cranberry type A proanthocyanidins for the vulvovaginal candidiasis：A randomized controlled clinical trial

Objective: To test whether A-PACs in cranberry juice have an anti-Candida effect in the vagina of women. Design An open, randomized, parallel design study. Setting West China Second Hospital of Sichuan University in China. Population 300 women with Vulvovaginal candidiasis (VVC). Methods At baseline, all patients were randomly divided into three groups. Patients in Group1 were treated with standard antifungal therapy; Patients in Group2 received oral Azmasol® (cranberry juice) 16ml daily for 6 days based on the treatment regimen of Group1; Patients in Group3 were given oral Azmasol® 16ml daily for 6 days and vaginal Miconazole suppository 400mg at bedtime for 3 days. Patients who were clinically cured at 7th day follow-up in Group2 received maintenance therapy by oral Azmazol® 8ml every day. Main Outcome Measures The clinical cure rate and disease-free survival were the primary outcomes, and the secondary outcomes included microbiological eradication rates and symptom scores. Results At the 7th day follow-up, both the clinical cure rate in group 2 and group 3 were not-inferior to group 1. Cox regression analysis showed maintenance therapy was not significantly associated with short-term recurrence (HR 0.44 [0.11–1.67]; P=0.23) but significantly associated with long-term recurrence (HR 0.57 [0.33–0.99]; P<0·05). Conclusions A-PACs in cranberry juice can be used as an oral alternative to azole antibiotics for the treatment and prevention of VVC.