Kushen Gel Combined with Antifungal Drugs for the Treatment of Vulvovaginal Candidiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Ethnopharmacological relevance: Vulvovaginal candidiasis (VVC) represents the most prevalent form of candidal infections, imposing a significant societal burden. Kushen gel, a chinese patent medicine, has demonstrated favorable outcomes in the treatment of VVC. In clinical practice, Kushen gel is often used in conjunction with antifungal drugs. However, the clinical evidence supporting the combined use of Kushen gel with antifungal drugs for the treatment of VVC is currently limited.

Aim of the study: This study aimed to evaluate the effectiveness and safety of Kushen gel combined with antifungal drugs in the treatment of vulvovaginal candidiasis (VVC).

Materials and methods: Databases namely CNKI, Wanfang Database, VIP Database, CBM, PubMed, Cochrane Library, and Embase were searched from their inception to January 2024. Randomized controlled trials (RCTs) applying Kushen gel combined with antifungal drugs for the treatment of VVC were included. Methodological quality assessment was performed using the Cochrane risk of bias assessment tool (RoB 1.0). A Meta-analysis was performed using RevMan 5.4 software. The primary outcomes were total efficacy rate, recurrence rate, secondary outcomes included adverse events and time to clinical symptom resolution.

Results: A Meta-analysis of 42 RCTs, encompassing a total of 4259 VVC patients was conducted. The results indicated that compared to antifungal drugs alone, Kushen gel combined with antifungal drugs increased the effectiveness (RR=1.20, 95%CI [1.17, 1.23], P<0.00001) and reduced the recurrence rate (RR=0.21, 95%CI [0.13, 0.34], P<0.00001), with no significant difference in safety (RR=0.56, 95%CI [0.30, 1.03], P=0.11).

Conclusions: Based on the available results, it appears that the combination of Kushen gel with antifungal drugs may increase the effectiveness and reduce the recurrence rate. However, due to the poor methodological quality of the included studies, more high-quality evidence from large-sample and well-designed research is needed in the future.