A randomized, double-blind, placebo-controlled study. Healthy postmenopausal women, age 45 to 60 years old, were enrolled voluntarily and randomly received 20, 30, or 50 mg of Pueraria mirifica in capsules or placebo in identical capsules once daily for 24 weeks. After 24 weeks of treatment, 71 women were evaluated. Fifty-one of 71 randomly received one of the three doses of Pueraria mirifica, and the remaining 20 received placebo. The mean vaginal dryness symptom in the Pueraria mirifica group decreased after 12 weeks of treatment. Pueraria mirifica increased vaginal maturation index (parabasal:intermediate:superficial cells) from 46:43:11 to 11:65:24 after 24 weeks of treatment. There was no significant difference of adverse effects between the Pueraria mirifica and placebo groups in this study.
Pueraria mirifica in doses of 20, 30, and 50 mg/day for a 24-week period was proven to exhibit estrogenicity on vaginal tissue, that is, to alleviate symptoms of vaginal dryness and dyspareunia, to improve signs of vaginal atrophy, and to restore the atrophic vaginal epithelium in healthy postmenopausal women. There were mild adverse effects that occurred after both Pueraria mirifica and placebo treatment. From the clinical point of view, Pueraria mirifica may be helpful and safe in the management of postmenopausal vaginal atrophy. Because of some serious side effects of hormone therapy, menopausal management is currently challenged by an alternative therapy using phytoestrogens, and Pueraria mirifica is the most promising in treating symptoms of vaginal atrophy.
The Journal of The North American Menopause Society
Jittima Manonai, MD, Apichart Chittacharoen, MD, Urusa Theppisai, MD, and Hathai Theppisai, MD
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