Pueraria mirifica herb on vaginal health in menopause
Beneficial Estrogenic Effects of Pueraria mirifica on Vaginal Health in Postmenopausal Women
Menopause. 2007; 14(5):919-924.
Manonai J, Chittacharoen A, Theppisai U, Theppisai H.
the Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
To evaluate the effect of Pueraria mirifica on vaginal symptoms, vaginal health index, vaginal pH, and vaginal cytology in healthy postmenopausal women.
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 was proven to exhibit estrogenicity on vaginal tissue, to alleviate vaginal dryness symptoms and dyspareunia, to improve signs of vaginal atrophy, and to restore the atrophic vaginal epithelium in healthy postmenopausal women.
Urogenital atrophy can develop in postmenopausal women due to declining levels of estrogen. This condition is associated with vaginal dyspareunia (painful sexual intercourse), dryness, itching, and burning and abnormal discharge, which often result in a diminished libido. A meta-analysis clearly showed the beneficial effects of estrogen therapy on urogenital atrophy; however, the results of the Women’s Health Initiative (WHI), published in July 2002, raised concerns about the adverse effects of estrogen therapy. As a result of the WHI, estrogen-replacement therapy has decreased worldwide, and the interest in alternative therapies for the treatment of menopausal symptoms has increased.
Kwao Krua (also spelled as Kwao Kreu, Pueraria mirifica), an herb indigenous to Thailand, has been consumed by Thai women for more than 100 years to alleviate the symptoms of menopause. This herb contains several compounds with phytoestrogenic activity, such as phenol miroestrol and deoxymiroestrol. Miroestrol has been estimated to have estrogenic activity one fourth [2.5 x 10-1] that of 17beta-estradiol, the highest activity among known phytoestrogens. The objective of this study was to evaluate the effect of Pueraria mirifica consumption on vaginal symptoms, vaginal cytology, and vaginal pH in postmenopausal women.
Healthy, postmenopausal, nonhysterectomized women of age 45-60 years with untreated vaginal atrophy were recruited from the general population of Thailand between 2001 and 2004 for this randomized, double-blind, placebo-controlled study. The women were randomly assigned to consume 20, 30, or 50 mg of Pueraria mirifica extract or placebo in capsule form once daily for 24 weeks. The women were interviewed about their vaginal health at baseline and after 12 and 24 weeks of treatment, and vaginal symptoms were rated according to their intensity on a scale from 0 (none) to 3 (severe). A vaginal health index was calculated on the basis of vaginal moisture, fluid volume, elasticity, epithelial integrity, and vaginal pH on a scale ranging from 1 (poorest) to 5 (best) by the same blinded investigator. A vaginal smear and an endometrial biopsy sample were collected from each subject before and after the intervention. A maturation value was determined under light microscopy, and the biopsy samples were examined histologically.
Seventy-one women completed the examination, 51 in the 3 Pueraria mirifica groups and 20 in the placebo group. No significant differences were observed between groups at baseline. Vaginal dryness symptoms improved significantly (P < 0.05) in the Pueraria mirifica groups after 12 weeks of treatment and were maintained over the 24-week treatment period. However, no other significant differences in symptoms between the Pueraria mirificagroups and the placebo group were found. Vaginal dryness symptom scores decreased from 2.47 plus/equal to 1.32 at baseline to 1.44 plus/equal to 1.29 after 12 weeks to 1.28 plus/equal to 1.22 after 24 weeks in the Pueraria mirifica groups. [These values are given in the text but each differ from those given in Table 2] Dyspareunia frequency in the study group was reduced from 56.9% to 39.2% but did not change in the placebo group.
The vaginal health index total score improved significantly from baseline in the Pueraria mirifica groups after 12 and 24 weeks of treatment (P < 0.05). After 12 weeks of treatment, most measures of vaginal health were significantly greater in the Pueraria mirifica groups than in the placebo group, except for vaginal elasticity and pH. The pH score did increase significantly in the study group compared to baseline and placebo values (P < 0.05). In the intention-to-treat analysis, all measures of vaginal health were significantly better in the Pueraria mirifica groups than in the placebo group. After 12 and 24 weeks of treatment, the mean maturation value increased significantly (P < 0.05) in the Pueraria mirifica groups and was significantly greater in the Pueraria mirifica groups than in the placebo group. No significant differences in endometrial measures or in occurrence of adverse effects were observed between the Pueraria mirifica and placebo groups. All adverse effects were mild; urticaria was the most common in the study group, occurring in 9 (17.6%), but was not found in the placebo group.
Pueraria mirifica had an estrogenic effect on vaginal tissue and ameliorated the symptoms of vaginal dryness, dyspareunia, and signs of vaginal atrophy and decreased vaginal pH in the postmenopausal women in this study. Furthermore, Pueraria mirifica treatment restored the atrophic vaginal epithelium. Due to concerns about proliferative effects from estrogenic agents on sensitive tissues, large-scale, long-term studies that carefully monitor phytoestrogen content and hormonal activity are important to establish its safety. While the endometrial biopsies were within the normal range at 24 weeks, this would likely be too soon to note hyperplasia.
The authors of this study conclude that Pueraria mirifica may be helpful and safe in the management of postmenopausal vaginal atrophy.
Pueraria mirifica studies
Efficacy comparison of Pueraria mirifica (PM) against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of climacteric symptoms in perimenopausal women: phase III study
The effect of Pueraria mirifica on cytologic and urodynamic findings in ovariectomized rats.Effects and safety of Pueraria mirifica on lipid profiles and biochemical markers of bone turnover rates in healthy postmenopausal women.
Challenges in the conduct of Thai herbal scientific study: efficacy and safety of phytoestrogen, pueraria mirifica (white kwao krua) phase I, in the alleviation of climacteric symptoms in perimenopausal women.