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Comparative efficacy of oral lactobacillus rhamnosus (protexin) against metronidazole (flagyl) in the treatment of bacterial vaginosis: A ramdomized clinical trial

Marianne Rose L. Go, MD and Rosendo R. Roque, MD, FPOG
Department of Obstetrics and Gynecology, University of Santo Tomas Hospital

Background: Bacterial vaginosis (BV) is a very common gynecologic infection associated with a vast number of complications both in gynecologic and obstetric patients. One of the major concerns in its treatment is a high recurrence rate which was multifactorial and the choice of the suitable antimicrobial is important to decrease the treatment failure.

Methods: All gynecologic patients aged 18 years old and above in a tertiary hospital diagnosed with bacterial vaginosis according to Amsel’s criteria. A total of 80 patients were randomly assigned into two groups; one group to receive oral Probiotics (Protexin) while the other group to receive Metronidazole. The patients will be followed up accordingly on Days 1, 3, 7 and 30 and will be graded according to Amsel’s criteria. The primary endpoint of the study is the treatment of bacterial vaginosis based on the mentioned criteria. (Anukam, 2006)

Results: The results showed that there was a significant improvement in the character of the vaginal discharge based on the Amsels criteria on Day 1 of treatment for the Metronidazole group (0/40; 100%, p value <0.001) and Day 3 for Oral Lactobacillus arms. (7/40; 20%, p value 0.01). The Metronidazole arm showed a significant improvement in the fishy odor on vaginal examination with addition of 10% KOH on day 1 (0/40; 100%, p value <0.001) and Day 3 for oral Lactobacilus (0/40; 100%, p value 1.00). Then vaginal pH was noted to be more acidic in the Metronidazole compared to the Protexin arm on Day 1 of treatment (0/40; 0% and 40/40; 100% p value <0.001 respectively). However, both groups had no significant difference of vaginal pH in Days 3-30 (0/40; 100% p value 1.0). There was a note of less number of recurrence rate under the Protexin arm after 30 days of treatment (5/40; 12.5% p value <0.001 ) as reflected in the decreased number of clue cells.

Conclusion: The Metronidazole remains to be the standard treatment for Bacterial vaginosis. There was also faster recovery and clinical improvement in the character of the vaginal discharge, amount and smell based on the Amsel’s criteria as early as Day 1 of follow-up; however, there was a small number of population with poor compliance resulting to higher recurrence rate which was evident on the 30 th day of follow-up. The oral lactobacillus rhamnosus showed advantage over Metronidazole due to lower recurrence rate of BV as noted on Day 30 of follow up.