Comparison of pueraria mirifica gel and placebo gel effects on vaginal microenvironment among postmenopausal women with genitourinary syndrome of menopause (GSM)

Introduction: Genitourinary Syndrome of Menopause (GSM)includes symptomatic vulvovaginal atrophy as well as lower urinary tract symptoms, and develops as a result of estrogen depletion. There are many therapeutic methods for genitourinary problems in postmenopausal women, but the most efficient and acceptable one is hormone therapy. There is now a new alternative to local estrogen therapy, Pueraria mirifica gel, which was found to be efficacious in alleviating vulvovaginal atrophy symptoms and significantly increases vaginal maturation index after 12 weeks of treatment compared with conjugated estrogen cream. However, there is no evidence regarding the effect of P. mirifica gel on vaginal flora, both normal flora and pathogenic organisms, of postmenopausal women with GSM. Objectives: To compare the effects of a 12-week treatment of 5% Pueraria mirifica gel and placebo gel on prevalence of bacterial vaginosis, presence of vaginal fungi, vaginal pH, vaginal maturation index (VMI), and genitourinary symptoms in postmenopausal women with GSM. Methods: In a randomized, double blinded, placebo-controlled study, 60 postmenopausal women with at least one genitourinary symptom were recruited. Participants were randomly assigned into two groups for 12-week treatment with either P. mirifica gel or identical placebo gel. Vaginal Nugent score, fungal culture, pH, VMI, and genitourinary symptoms were evaluated at the beginning and at 12 weeks following treatment. Results: After 12 weeks of treatment, bacterial vaginosis was diagnosed in 4.0% and 14.8% of the P. mirifica and the placebo group, respectively (p < 0.001). The proportion of participants in the P. mirifica group with normal Nugent score increased considerably from 24.0% (6/25)to 56.0% (14/25)and notably higher than in the placebo group (p < 0.001). Vaginal pH and VMI did not significantly change after treatment in both groups (p > 0.05). There were significantly decreases in prevalence of vaginal dryness, irritation and lack of lubrication in both groups compared with the pre-treatment period (p < 0.05)but there was no significant difference between the two groups (p > 0.05). Conclusion: Twelve-week treatment of 5% P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in restoring vaginal microenvironment compared to placebo gel.