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Comparison of the efficacy of metronidazole and metronidazole plus probiotics capsule in the treatment of bacterial vaginosis among non-pregnant patients seen at the outpatient department of a tertiary hospital: A single blind randomized controlled trial

Mary Rose Muñoz-Cruz, MD; Jennifer T. Co, MD, FPOGS and Lylah D. Reyes, MD, FPOGS
Department of Obstetrics and Gnecology, Far Eastern University - NRMF Hospital

Background: Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginitis. In the Philippines, prevalence of BV is at 28.16%. The mainstay for the treatment of BV is Metronidazole. Although antibiotic therapy has been shown to eliminate BV associated organisms, there is extremely high recurrence rate.

Objective: To compare the efficacy of metronidazole and metronidazole plus lactobacilli tablet in the treatment of bacterial vaginosis among non-pregnant patients seen at the outpatient department of a tertiary medical center.

Methodology: The population included non-pregnant women ages 15 to 44 years old, with bacterial vaginosis diagnosed by Amsel’s criteria and Nugent’s scoring. The participants were randomly assigned to their treatment group, one is Metronidazole only and the other received Metronidazole plus Lactobacillus tablet. All participants followed up on day 8, 15, 22 and 56 from initiation of treatment resolution or persistence of symptoms and collection of vaginal specimen for gram stain and inquire on adverse effects.

Results: On day 8 of treatment, there were significantly more participant in the metronidazole plus probiotic arm with an estimated lactobacilli count of more than 30/hpf as compared to metronidazole alone. On day 15 post treatment, there was no statistically significant difference with the estimated Gardnerella vaginalis count, lactobacilli count, presence or absence of malodorous vaginal discharge between the metronidazole plus probiotic and the metronidazole alone arm. With metronidazole plus probiotic group, the proportion of women with less than 30 per hpf Gardnerella vaginalis count and absent foul smelling vaginal discharge were accounted among 100% of the participants from day 8 to 56 post treatment. The early reduction in the causative agent and symptoms can be attributed to an increase in the estimated lactobacilli count sustained until 56 days post treatment metronidazole plus probiotic. However, from day 15 to 22 and 56 post-treatment, the proportion of participants who had a nugent’s score of less than 4 were greater for both the metronidazole plus probiotic (100%) and metronidazole alone (95%) arm, when compared to day 8 post-treatment. This finding for the metronidazole plus probiotic group is due to sustained reduction in the Gardnerella vaginalis count and increase in lactobacilli counts. Potentially, the metronidazole plus probiotic treatment was found to be more favorable in sustaining the normal flora and probiotic can be used as an adjunct may enhance the efficacy of metronidazole in the treatment of BV.

Conclusion: Metronidazole plus probiotic and metronidazole only treatment are comparable in treating bacterial vaginosis. In terms of restoring and maintaining the normal flora, metronidazole plus probiotic appears to be more significantly efficacious. Probiotic in the form of lactobacilli is a promising adjunct to enhance the efficacy of metronidazole in the treatment of bacterial vaginosis.

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