Efficacy and safety of Multi-Gyn ActiGel 2in1 in bacterial vaginosis

BACKGROUND: Bacterial vaginosis (BV) is a condition affecting 20-30% of women in reproductive age worldwide. The aim of this multicentric single-arm study was to evaluate the efficacy and safety of a medical device based on an Aloe barbadensis leaf extract for treatment of BV.METHODS: Fifty women of 18 years or older with BV completed a course of treatment with Multi-Gyn ActiGel 2in1 (twice-a-day for 7 consecutive days; Karo Healthcare, Rotterdam, the Netherlands). Symptom evaluation as per self-questionnaires and expert opinion was performed on day 0 and 21 after treatment initiation. The primary outcome was the clinical cure rate of BV on day 21.RESULTS: From the 50 subjects included in the study, 46 were eligible for efficacy analysis. In this group, the clinical cure rate was 82.6% (CI: 69.3%, 90-9). Relief of burning sensation within a few seconds of the first application was observed in 33.3% of subjects. No major adverse events were reported.CONCLUSIONS: The results of this study showed that Multi-Gyn AciGel 2in1 is a safe and effective treatment of BV.