Effect of Probiotic Yoghurt as a Complementary Treatment of Bacterial Vaginosis: A Randomized Double –Blind Placebo –Controlled Trial.

Abstract

Abstract: Background and Objective: Bacterial vaginosis (BV) is one of the most widespread vaginal infection that characterized by an imbalance of the vaginal micro flora, lactobacilli reduction and increase growth of anaerobic Gram –negative pathogens. Therefore, we hypothesized that probiotic yoghurt with Lactobacillus acidophilus and Bifidobacterium bifidum provide an adjunct antimicrobial treatment and improve cure rates. Materials and Methods: This randomized, double –blind, placebo –controlled trial was conducted among 100 women referring to Pap centers of Taleghani Educational and Treatment Center, Tabriz, Iran. Women with recognized bacterial vaginosis (with both Amsel and Nugent criteria) were called and asked to return to the center. All participants received 500 mg of oral metronidazole twice daily for 7 days. In addition, subjects in the intervention group received oral probiotics yoghurt and it the control group conventional yoghurt three times a day (300 mg/day) for 60 days starting from the first day of the metronidazole intake. Allocation sequence was determined with a computer –generated system using block randomization with block sized of 4 and 6. To ensure blinding, two codes were assigned to the yoghurts, one for conventional and another for probiotic yoghurts. Subjects returned for two follow –up visits at 10± 2 and 90± 7 days after starting the treatment. Which included assessment of BV symptoms, Amsel criteria, collection of vaginal smear, and reporting of adverse events. The primary outcome was cure rate at day 90± 7 after treatment. The secondary outcomes were cure rate at day 10± 2 and proportion of BV symptoms at the both visits. Data analysis was done by SPSS 17 and independent t –test, chi –square and trend Chi –square, Logistic regression and Kappa were used. Results: The subjects in the groups were similar in terms of demographic and reproductive characteristics. There was no loss follow up. Probiotic treatment was very well tolerated and no serious adverse event has been reported. Compared with the control group, the probiotic group had significantly higher cure rate at day 90± 7{56% vs. 12%, OR 9.3 (95%CI 3.4 to 25.9)}. Also, at day 10± 2, the probiotic group had higher cure but the difference was not statistically significant {26% vs. 20%, OR 1.4 (95% CI 0.55 to 3.59)}. Rate of some symptoms; irritation during intercourse, abdominal pain, dyspareunia and abnormal discharge in the probiotic group at both visits were statistically less than the control group. Conclusion: Probiotic yoghurt enriched in lactobacilli combined with the oral metronidazole can improve the signs and symptoms of BV and augment effect of metronidazole on BV treatment. Therefore, probiotic yoghurts are recommended as a complementary effective treatment of BV.