The Addition of Vitamin C Vaginal Tablets to Oral Metronidazole and Its Effects on the Treatment of Bacterial Vaginosis: a Randomized Triple-Blind Clinical Trial

Abstract

Abstract : Introduction: Vaginitis's are infectious and inflammatory diseases affecting vagina or vulva and appearing in the form of unnatural discharge in the genital area. Bacterial vaginosis is one of the most salient alternations, which is recognized by decrease of vaginal lactobacilli and growth of other anaerobic bacteria species. Relation between BV and increase vaginal PH ,has made using acidifier substances for correction vaginal environment as a logical treatment . Given that, many research studies were conducted on the vaginal consumption of ascorbic acid (vitamin C) in BV treatment and some of them have indicated the influence this material in BV treatment. The aim of the present study is to determine the effect of vitamin c vaginal, as a supplementary treatment with oral metronidazole, on the treatment and recurrent of bacterial vaginosis. Material and Methods : this randomized triple blind clinical trial study was carried out in 2015 on 160 married women scuffed from BV, who attended women’s clinic of Samen Hospital of Mashhad and were not affected from other vaginal infections. Subjects were randomized two groups of intervention and control based on randomized blocking design. Patients intervention group were taken 500mg of oral metronidazole twice a day along with a vaginal vitamin C tablet 250 mg for seven days and the control group were taken the same dose of oral metronidazole along with vaginal placebo for seven days. Patients’ complaints, pre-treatment amsel and Nugent criteria were checked on days 10±3 and 3±30. Data analyzing were conducted by SPSS software , Chi-square and binary logistic regression and Independent t-test were used for data analysis . Result : there was no significant difference between two groups in terms of socio-demographic characteristics , clinical complains, the results of clinical and laboratory tests (except pH and the number of lactobacilli) at the beginning of the study (p<0.05) In day 10 and 30 after the treatment all four components of Amsel criteria, including Whiff test, homogeneous discharge, Clue cells, and vaginal pH in the intervention group have shown higher improvement than that of the control group. The difference between two groups was significant. The microscopic examination of samples revealed that members of the intervention group have obtained better Nugent score than the control group. This difference was statistically significant,. About the clinical complaints, the elimination of malodorous discharge and itch in both follow up sessions (day 10 and 30 after the treatment) was higher in intervention group than the control group and statistical difference was significant. In terms of elimination of dyspareunia and supra pubic pain in day 10 and 30 after treatment, the statistical difference was not significant. The percentage of treated patients based on Amsel and Nugent criteria in day 10±3 in the interruption and the control group was 85.9% and 52.3%, respectively. [Odd Ratio (OR) 5.3, 95% confidence Interval (CI)2.4 to 11.6]. Moreover, in day 3±30 the percentage of treated patients based on amsel and Nugent criteria in the interruption and the control group was 87.7% and 41.9%, respectively. [Odd Ratio (OR) 9. 8, 95% CI 4.2 to 22.4]. Conclusion: Based on the obtained results, it seems that the treatment of bacterial vaginosis using oral metronidazole plus vaginal vitamin C is more effective than single oral metronidazole treatment in improving the signs and recurrence within one month.