Virojchaiwong, P., Suvithayasiri, V. and  Itharat, A. 2010. Comparison of Pueraria mirifica 25 and 50 mg for menopausal symptoms. Arch Gynecol Obstet. 284, 2: 411-419.

Abstract

PURPOSE: To compare Pueraria mirifica 25 and 50 mg dosages to relieve menopausal symptoms.

METHODS: A double-blind study was conducted on 52 hysterectomized women with menopausal symptoms who had an indication for hormone therapy. The women were randomly allocated into two groups receiving either Pueraria mirifica 25 mg tablet (Arm A; n = 26) or Pueraria mirifica 50 mg (Arm B; n = 26) for 6 months. Menopausal symptoms, physical examination findings, and laboratory data were recorded at baseline. Symptoms were reevaluated at 3 and 6 months, while physical and laboratory examinations were evaluated at 1 month and at the end of treatment. A modified Green climacteric scale was used to evaluate menopausal symptoms; a score of ≥15 indicated estrogen deficiency.

RESULTS: All women completed the study. Mean baseline climacteric scores of women who received 25 and 50 mg were: 24.19 ± 9.11 versus 23.19 ± 7.89, respectively (p = 0.674). After 3 and 6 months of treatment, scores were 17.92 ± 10.40 versus 15.35 ± 8.44 (p = 0.332) and 14.08 ± 10.30 versus 12.46 ± 6.38 (p = 0.500), respectively. No significant side effects were observed with Pueraria mirifica 25 or 50 mg.

CONCLUSIONS: Both dosages of Pueraria mirifica were similarly effective and safe in the treatment of menopausal symptoms.

............................................................................

Anthony C. Dweck. 2009. The internal and external use of medicinal plants. Clinics in Dermatology  27: 148–158.

Abstract: The term “cosmeceutical” is not defined in terms of the law. A review of some of the more commonly used dietary supplements and their chemistry and topical use confirms that there is merit in using these plants both internally and externally. The role of flavonoids, isoflavones, phytosterol, and plant hormone-related chemicals are examined for their physiological effect.

...........................................................................................................................

Okamura, S., Y. Sawada , T. Satoh, H. Sakamoto, Y. Saito, H. Sumino, T. Takizawa, T. Kogure, C. Chaichantipyuth, Y. Higuchi, T. Ishikawa and T. Sakamaki. 2008. Pueraria mirifica phytoestrogens improve dyslipidemia in postmenopausal women probably by activating estrogen receptor subtypes. J Exp Med. 216, 4: 341-51.

Abstract: Impaired lipid metabolism is an important health problem in postmenopausal women with insufficient estrogens, because dyslipidemia is a risk factor for development of atherosclerosis and the incidence of cardiovascular disease markedly increases after menopause. Pueraria mirifica (PM), a Thai herb, has been noticed as a source of phytoestrogens, estrogen-mimicking plant compounds. However, the clinical effects of PM on lipid metabolism and the underlying molecular mechanisms remain undetermined. Therefore, we examined the effects of PM on serum lipid parameters in a randomized, double-blind, placebo-controlled clinical trial. Nineteen postmenopausal women were randomly assigned to receive oral administration of PM powder or placebo. After 2 months of treatment, the PM group showed a significant increase in serum concentrations of high-density lipoprotein (HDL) cholesterol and apolipoprotein (apo) A-1 (34% and 40%, respectively), and a significant decrease in low-density lipoprotein (LDL) cholesterol and apo B (17% and 9%, respectively), compared with baseline measurements. Moreover, significant decreases were observed in the ratios of LDL cholesterol to HDL cholesterol (37%) and apo B to apo A-1 (35%). Next, we determined the effects of PM phytoestrogens on the activation of estrogen receptor (ER)-mediated transactivation by transient expression assays of a reporter gene in cultured cells. Among PM phytoestrogens, miroestrol and coumestrol enhanced both ERalpha- and ERbeta-mediated transactivation, whereas other phytoestrogens, including daidzein and genistein, preferentially enhanced ERbeta-mediated transactivation. In conclusion, PM has a beneficial effect on lipid metabolism in postmenopausal women, which may result from the activation of gene transcription through selective binding of phytoestrogens to ERalpha and ERbeta.

................................................................................................................................

Verapol Chandeying and Malinee Sangthawan. 2007. Efficacy Comparison of Pueraria mirifica (PM) against Conjugated Equine Estrogen (CEE) with/without Medroxyprogesterone Acetate (MPA) in the Treatment of Climacteric Symptoms inPerimenopausal Women: Phase III Study. J Med Assoc Thai 90, 9: 1720-6

Objective: To evaluate the efficacy comparison of Pueraria mirifica (PM), name in Thai is Kwao Kruea Khao, against conjugated equine estrogen (CEE) with/without medroxyprogesterone acetate (MPA) in the treatment of perimenopuasal women with climacteric symptoms.

Material and Method: Perimenopausal women attending the Menopausal clinic of Hat Yai Regional Hospital were voluntarily recruited. The vasomotor symptoms such as hot flushes and night sweats, as well as other unpleasant symptoms, urogenital and psychological symptoms, were also assessed. Patients were voluntarily enrolled and randomly received daily 50 mg raw material of PM, Group A, or daily 0.625 mg of conjugated equine estrogen (CEE) with/without 2.5 mg of medroxyprogesterone acetate (MPA), Group B, depend on nonhysterectomized/ hysterectomized condition.

Results: Seventy-one patients were enrolled. Eleven of those were excluded for failing to complete the initial work-up and follow-up. Sixty cases were evaluated, 30 cases in Group A and 30 cases in Group B. After medication, the mean of modified Greene climacteric scale (MGCS) in Group A/Group B had decreased from 29.0/32.26 to 17.86/18.1, 12.56/9.57 and 9.9/8.16 at 1-, 3-, and 6- month respectively. The clinical satisfaction using MGCS was not statistically significant between PM (Group A) and CEE with/without MPA (Group B) in the alleviation of climacteric symptoms (p-value > 0.05,). There were no statistically significant changes of three serum markers: estradiol, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) between both groups.

Conclusion: PM, containing phytoestrogens, has estrogenic effect as similar as CEE, and can alleviate the climacteric symptoms in perimenopausal women. PM demonstrates great promise in the treatment of climacteric symptoms. However, optimal doses should be clinically assessed to meet appropriate individual responses.

..................................................................................................................................

Verapol Chandeying and Surachai Lamlertkittikul. 2007. Challenges in the Conduct of Thai Herbal Scientific Study: Efficacy and Safety of Phytoestrogen, Pueraria Mirifica (Kwao Keur Kao), Phase I, in the Alleviation of Climacteric Symptoms in Perimenopausal Women.J Med Assoc Thai 90, 7: 1274-80.

Objective: To evaluate the preliminary efficacy and safety of Pueraria mirifica (Kwao Keur Kao), phytoestrogen, for the alleviation of climacteric symptoms.

Material and Method: Perimenopausal women attending with climacteric symptoms, such as hot flushes andnight sweats, were invited to join the present study, conducted at the Menopausal Clinic, Hat Yai Regional Hospital. The patients were voluntarily enrolled and randomly received the raw material of Pueraria mirifica, oral 50 and 100 mg capsule, once daily for six months, as an open-label study.

Results: Of the 10 enrolled patients, 8 cases were completely evaluated. The modified Greene climacteric scale (MGCS) was satisfactorily decreased in both groups. The average scale declined from 44.1 at baseline, to be 26, 17, and 11.1 at 1-, 3-, and 6- month follow-up respectively. No other laboratory abnormalities, except one case had transiently increased the creatinine level, and one case of increased blood urea nitrogen. The mean serum estradiol was slightly increased, while the mean serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were nearly stable.

Conclusion: Pueraria mirifica is relatively safe and preliminarily alleviates the climacteric symptoms in perimenopausal women, but the data is insufficient to draw definite conclusions regarding the estrogenic effect.