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Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis: a double-blind randomized trial
Affiliation:1. Research Centre of Infectious & Tropical Diseases, Department of Midwifery, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran;2. Social Security Organization, East Azerbaijan Treatment''s Management, Jolfa Social Security Clinic, Jolfa, Iran;3. Department of Midwifery, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran;4. Pharmaceutics Department, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
Abstract:ObjectiveTo 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).MethodsIn 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.ResultsAt 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.ConclusionsH. perforatum could be a good option for treatment of BV. However, further studies are needed for its public use.
Keywords:Metronidazole  Vaginosis  Bacterial  Therapy  Recurrence
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