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Effects of Pueraria mirifica on vaginal artery vascularization in postmenopausal women with genitourinary syndrome of menopause.

  • 2022-06
  • Maturitas 160
    • Patsira Warinsiriruk
    • Chananya Tantitham
    • Wichai Cherdshewasart
    • S Abbas Shobeiri
    • Jittima Manonai

Study Design

Type
Randomized Controlled Trial (RCT)
Population
72 postmenopausal women
Methods
In a randomized, double-blinded, placebo-controlled study, 72 postmenopausal women were randomized into the P. mirifica or the placebo gel group
Blinding
Double-blind
Duration
12 weeks

Objective

To compare the effects of 6% Pueraria mirifica vaginal gel with those of placebo gel on vaginal blood flow, vaginal maturation index (VMI), vaginal health index (VHI), endometrial thickness and genitourinary symptoms in postmenopausal women.

Study design

In a randomized, double-blinded, placebo-controlled study (TCTR20200624007), 72 postmenopausal women were randomized into the P. mirifica or the placebo gel group. Both groups were followed up at week 4 and week 12.

Main outcome measure

Doppler ultrasonography pulsatility index (PI) and resistance index (RI), VMI, VHI, endometrial thickness and genitourinary symptoms were evaluated at baseline, at week 4 and week 12 of treatment.

Results

Sixty-three participants completed the study. After 4 and 12 weeks of treatment, PI and RI had significantly decreased in the P. mirifica group compared with the placebo group. At week 12, PI in the P. mirifica group and in the placebo group were 3.03 + 1.09 and 6.88 + 2.16, respectively (p = 0.002). Similar changes were also demonstrated in the resistance indices. The P. mirifica group demonstrated a markedly higher mean VMI at week 12 compared with the placebo group, 55.19 ± 18.53 and 20.29 ± 28.46 (p = 0.012). In addition, all parameters of VHI based on the vaginal physical findings at week 12 in the P. mirifica group were significantly higher than in the placebo group (p < 0.001).

Conclusion

In this study, 6% P. mirifica vaginal gel for 12 weeks in postmenopausal women with GSM appeared to increase vaginal artery circulation and restore atrophic vaginal tissue.

Clinical trial registration number

TCTR20200624007.

Research Insights

  • Pueraria Mirifica→Increased Vaginal Health Index

    All parameters of VHI based on the vaginal physical findings at week 12 in the P. mirifica group were significantly higher than in the placebo group (p < 0.001).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    6% vaginal gel
  • Pueraria Mirifica→Increased Vaginal Maturation Index

    The P. mirifica group demonstrated a markedly higher mean VMI at week 12 compared with the placebo group, 55.19 ± 18.53 and 20.29 ± 28.46 (p = 0.012).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    6% vaginal gel
  • Pueraria Mirifica→Reduced Pulsatility Index

    After 4 and 12 weeks of treatment, PI and RI had significantly decreased in the P. mirifica group compared with the placebo group. At week 12, PI in the P. mirifica group and in the placebo group were 3.03 + 1.09 and 6.88 + 2.16, respectively (p = 0.002).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    6% vaginal gel
  • Pueraria Mirifica→Reduced Resistance Index

    After 4 and 12 weeks of treatment, PI and RI had significantly decreased in the P. mirifica group compared with the placebo group. Similar changes were also demonstrated in the resistance indices.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    6% vaginal gel
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