Comparing the effects of Hypericum Perforatum and Metronidazole vaginal gel in treatment of bacterial vaginosis: A Randomized Controlled Trial.

Abstract

Abstract: Background and Objective: Hypericum Perforatum is an herb which in various forms is used widely by women to eliminate vaginal infections and leucorrhea in the research environment and most people are very satisfied with it. In vitro studies have shown anti –bacterial effect of Hypericum Perforatum. However, we found no in –vivo studies about its anti –bacterial effect. Its safety has already been shown in some studies in human for treatment of other disorder. Due to not found the research in this field, this study was conducted with the purpose of comparing the effects of Hypericum Perforatum and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age. Subjects and Methods: In this clinical triple blind trial 162 married women, aged 18-49 referred to health centers with bacterial vaginosis diagnosed by Amsel's criteria but not suffering with candida or trichomonas infection through block randomized assigned into two groups, intervention (n=82) to receive 5 gr of 3% Hypericum Perforatum and placebo of metronidazole vaginal gel and control (n=80) to receive 5 gr of 0.75% metronidazole and placebo of Hypericum Perforatum vaginal gel for 5 days. Participants were evaluated in two follow –up visits (10-12 days and 30-35 days after start of the treatment period) and patient complaints, clinical observation and Amsel's criteria rechecked and the side –effects were registered. Therapeutic success was defined as the presence of one or none of Amsel's criteria. For statistical analysis software SPSS 13 and Chi –square test, Fisher's exact test, Mann –Whitney U, X2 for trend and T test was used. Results: There were no difference between the two groups in terms of demographic characteristics and fertility, patient complaint, clinical observations and Amsel's criteria before the intervention. 10-12 days after treatment, apart from itching the difference between the two groups was not statistically significant (p=0.022). Complained of itching in group of Hypericum Perforatum was less than the metronidazole group (4.9% compared with 16.3%) (p=0.018). The improved of abnormal discharge in clinical Examination the difference between the two groups was not significant, but Hypericum Perforatum vaginal gel further to improve the consistency, appearance and color of the discharge. Also Amsel's clinical criteria improved in both treatment groups and no significant difference was found between the two groups. Cure rate in the intervention and control groups were 81.7% and 85% respectively and the difference between the two groups was not statistically significant. At the second follow –up visit recurrence rate was observed in the intervention and control groups 9.1% and 13.2% respectively (p=0.586). Greater percentage of the control group complained of pruritus (42.6% vs 12.1%) (p<0.001). In clinical examination, higher number of control group had an inflamed vagina (26.5% in the control group compared with 10.6% in the intervention group) (p=0.026). Abnormal discharge was seen more in the control group. Also in terms of Amsel's criteria were not seen significantly different between the two groups. 11 patients of the intervention group and 2 control subjects who complained of vaginal irritation when taking the drug that did not inhibit use it. Conclusion: The results of study showed that Hypericum Perforatum vaginal gel can be effective as metronidazole vaginal gel in the treatment of bacterial vaginosis. Therefore it could be as a good option to BV treatment. However, further studies are needed for public use.