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Comparison of the effects of Pueraria mirifica gel and of placebo gel on the vaginal microenvironment of postmenopausal women with Genitourinary Syndrome of Menopause (GSM).

  • 2020-10
  • Maturitas 140
    • Chuleekorn Sritonchai
    • Jittima Manonai
    • Areepan Sophonsritsuk
    • Wichai Cherdshewasart

Study Design

Type
Randomized Controlled Trial (RCT)
Population
60 postmenopausal women
Methods
randomized, double-blinded, placebo-controlled study; 12-week course of either 5% Pueraria mirifica gel or identical placebo gel
Blinding
Double-blind
Duration
12 weeks

Objective

To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women.

Study design

In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel.

Main outcome measure

Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment.

Results

After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (p =  0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p <  0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).

Conclusion

A 12-week course of treatment with 5 % P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.

Research Insights

  • Pueraria Mirifica→Improved Genitourinary Symptoms

    There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05)

    Effect
    Neutral
    Effect size
    Small
    Dose
    5% P. mirifica vaginal gel
  • Pueraria Mirifica→Increased Vaginal Lactobacilli Levels

    The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p <  0.05)

    Effect
    Beneficial
    Effect size
    Small
    Dose
    5% P. mirifica vaginal gel
  • Pueraria Mirifica→Reduced Bacterial Vaginosis

    the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (p =  0.006)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    5% P. mirifica vaginal gel
  • Pueraria Mirifica→Reduced Fungal Infection

    Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5% P. mirifica vaginal gel
  • Pueraria Mirifica→Reduced Nugent Score

    The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p <  0.05)

    Effect
    Beneficial
    Effect size
    Small
    Dose
    5% P. mirifica vaginal gel
  • Pueraria Mirifica→Reduced Vaginal pH

    Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment.

    Effect
    Neutral
    Effect size
    Small
    Dose
    5% P. mirifica vaginal gel
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