Effect of Complementary Therapy of Vaginal Prebiotic Gel on Treatment and Recurrence of Bacterial Vaginosis, A Randomized Controlled Trial

Abstract

Abstract: Introduction and objective: vaginitis is an inflectional and inflammatory disease, which affects the vagina and sometimes vulva and is associated with abnormal genital discharge. Bacterial Vaginosis (BV) is the most salient alteration, which is known by the decrease in vaginal lactobacilli and growth increase in other anaerobic bacterial species. Therefore, limited studies were carried out on the application of probiotic vaginal gel in BV treatment and some of them substantiated the effect of this substance. The aim of present study is to determine the effect of probiotic supplements vaginal gel on the treatment and recurrent of bacterial vaginosis along with oral metronidazole. Procedure: the study is of triple-blind randomized clinical trial type conducted on 100 married women with BV referred to Sa’adatmandi Health Center in Robat Karim Town in 2015 and were not suffered from other vaginal infections. Subject were classified into two groups of intervention and control using randomized blocking method and the intervention group were given 250mlg oral metronidazole tablets per 8hours along with 5mlg probiotic vaginal gel from 2% gel and the subjects of control group were given 250mlg oral metronidazole tablets daily per 8hours along with placebo vaginal gel. Patients’ complains, Amsel criteria and Nugent score was assessed before and 10±1 and 90±1 after the treatment. Data were analyzed using the SPSS and using Chi-square test, repeated measure, and student t-test. Findings: at the beginning, there was no significant difference between the groups in terms of social-personal characteristics, clinical complaints, and the results of clinical and laboratory criteria (except pH and number of lactobacillus) (P< 0.05). In day 10 and day 90 after the treatment, all 4 components of Amsel criteria, including Whiff test, homogeneous discharge, clue cells, vagina pH in intervention group were treated better than that of the control group. The difference between the two groups were significant. The microscopic evaluation of samples revealed that subjects of the intervention group gained better Nugent score than subjects of the control group. Such difference was significant statistically and the comparison of clinical examination and laboratory evaluation of subjects illustrated that in day 10 after the intervention the vagina and inflamed cervix, vaginal discharge, and positive whiff test in women of intervention group was significantly lower than that of the control group. Changes in the number of Gardenella in day 10 were not significant in probiotic intervention group. In terms of clinical criteria and laboratory factors, in day 90 after the intervention a significant statistical difference was seen in both groups in inflamed vagina, inflamed cervix, vaginal discharge, and positive test Whiff. This means that the score of each mentioned criteria in the intervention group was significantly lower than that of the control group. Changes in the number of Gardenella and gram negative basils (day 90) were not significant in the probiotic intervention group. The range off treatment based on Amsel and Nugent criteria in the intervention group in day 10 and in the control group was 76% and 30%, respectively [odd ration (OR) confidence interval (CI) 2.7 to 9.4]. In day 90, the range of treatment in the intervention group and the control group was 62% and 84%, respectively [OR 3.7, 95% CI 1.3 to 8.9]. Conclusion: concerning the obtained results, it seems that use of probiotic vaginal gel along with oral metronidazole in the intervention group compared with the group received the placebo vaginal gel and oral metronidazole (control group) resulted in the decrease of clinical complains as well as BV treatment based on Amsel and Nugent criteria. Hence, use of probiotic vaginal gel along with oral metronidazole tablet is more effective in vaginosis-bacterial treatment than use of oral metronidazole, alone.