Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis: A double-blind randomized trial
چکیده
Objective: To compare effect of Hypericum perforatum (H. perforatum) vaginal gel with metronidazole on bacterial vaginosis (BV) in terms of initial response to treatment and preventing recurrence (primary outcomes) and also patient complaints (secondary outcomes). Methods: In this double-blind, double dummy trial, married women aged 18-49 with BV were randomized into two groups and administered 5 g of 3% H. perforatum and placebo of metronidazole (n=82), or 5 g of 0.75% metronidazole and placebo of H. perforatum (n=80) vaginally for 5 d. Amsel criteria were used for diagnosis and assessing cure and recurrence of BV. The comparisons was done using Chi-square, Fisher's exact and logistic regression. Results: At 10-12 d, cure rate was 82% in the H. perforatum and 85% in metronidazole group (risk ratio 0.9, 95% confidence interval 0.6 to 1.3). Among the cured women, recurrence rate was 9% in the H. perforatum and 13% in the metronidazole group at the 30-35 d visit (risk ratio 0.8, 95% confidence interval 0.4 to 1.3). There was no statistically significant difference between the groups regarding any patient complaints, except itching which was less in H. perforatum group (5% vs. 16%, P=0.018 at the first and 13% vs. 43%, P < 0.001 at the second follow-up). No significant adverse event was reported at any groups. Conclusions: H. perforatum could be a good option for treatment of BV. However, further studies are needed for its public use. © 2014 by the Asian Pacific Journal of Tropical Biomedicine.