Efficacy of an Herbal Vaginal Tablet Containing Oregano and Lemon Balm on Bacterial Vaginosis in Comparison to Metronidazole: a non-inferiority triple-blind active-controlled trial.

Objectives: Bacterial vaginosis (BV) stands as one of the most prevalent causes of vaginal discharge and infection among women of reproductive age. Various medications, including metronidazole, are commonly recommended. Factors such as diminishing effectiveness and the emergence of new, resistant strains underscore the urgent need for research into alternative treatment options, including herbal remedies. This study aims to compare the efficacy of an herbal vaginal tablet (HVT) containing extracts of oregano and lemon balm to that of a metronidazole vaginal tablet. Methods: A non-inferiority randomized triple-blind controlled trial was conducted to compare the effects of HVT with metronidazole on BV. HVT was formulated using alcoholic extracts from the aerial parts of oregano and lemon balm leaves. The primary and secondary outcomes of the study were BV clinical manifestations and Amsel's criteria, respectively. Clinical and laboratory outcome measures for both groups were assessed at three time points the beginning of the study, and again on days 5 and 10. Results: Among the 130 participants, 54 patients from the metronidazole group and 51 from the HVT group completed the 5-day treatment period. Subsequently, 28 patients in the metronidazole group and 31 in the HVT group completed the 10-day treatment period.Regarding the clinical signs and symptoms, as well as laboratory measurements observed at the onset and on days 5 and 10 of treatment, no significant differences were found between the two groups. Conclusion: This trial demonstrated that HVT can alleviate the clinical manifestations of BV and normalize Amsel's criteria, equal to metronidazole. Therefore, HVT can be used as a complementary herbal medicament in the management of BV.