[Sucrose Gel for the treatment of bacterial vaginosis: a phase II clinical trial].

OBJECTIVE

To evaluate the effective dose and safety of S-Gel in the treatment of bacterial vaginosis.

METHODS

Clinical research method of multi- center, randomly double-blind, and dose group parallel comparison was adopted. In the study, 96 bacterial vaginosis patients were randomized into three groups: Group A, S-Gel 5.0 g, 32 patients; Group B, S-Gel 7.5 g, 32 patients; Group C, placebo, 32 patients. The patients were treated with different methods. Safety and efficacy were analyzed 3 to 4 days and 8 days after the treatment, respectively.

RESULTS

The efficacy of comprehensive clinical treatment showed that: 8 days after the treatment, the cure rates of group A (5.0 g), group B (7.5 g), and group C (placebo) were 84.38%, 86.67%, and 3.13% respectively. No difference of statistic significance was found in groups A and B, difference of statistical significance was found in group A and group C, group B and group C respectively (P<0.001).

CONCLUSION

As compared with placebo, S-Gel 7.5 g and 5.0 g bid (in the morning and evening) could obviously improve the clinical efficacy index and laboratory index of bacterial vaginosis. Other effects included the release of clinical symptoms, and the recovery of the normal micro-environment in the vagina. No significant difference was found in the cure rates of the two dose groups.