Effect of Viola odorata vaginal suppository on menopausal vaginal atrophy: a triple-blind randomised clinical trial

Abstract

IntroductionVaginal atrophy is an often neglected symptom of menopause, which affected about 90% of women. Women tend to use alternative medicine such as herbs rather than estrogen replacement therapy to alleviate it. Viola odorata contains flavonoids in the form of phytoestrogens and probably can be effective in treatment of vaginal atrophy. This study was conducted to investigate the effect of V. odorata vaginal suppository on menopausal vaginal atrophy. MethodsThis approved triple-blind randomised clinical trial, 8 weeks, study was conducted on 60 postmenopausal women from September 2022 until January 2023. Eligible participants were divided randomly into two groups of treatment (V. odorata suppository) and placebo (glycerine suppository) after obtaining informed consent. Data of the socio-demographic questionnaire, vaginal pH, and vaginal maturation index (VMI) were collected before and at the end of the study. Subjective symptoms of vaginal atrophy (dryness, irritation, itching, and dyspareunia) were assessed before, 4th, and 8th weeks of intervention period by self-assessments. Data were analysed using Independent t-test, Chi-square, Mann Whitney U, and Wilcoxon test by SPSS ver 23. ResultsThere were no significant differences between the two groups at the beginning of the study in vaginal atrophy symptoms, vaginal pH, and VMI. Subjective symptoms of vaginal atrophy (P < 0.001), vaginal pH (P < 0.001), and VMI (P < 0.001) were improved in the V. odorata group 8 weeks of treatment. ConclusionV. odorata vaginal suppository reduced the menopausal vaginal atrophy symptoms. Considering V. odorata is a natural product with low cost, it can use in menopausal vaginal atrophy treatment.