Efficacy and safety of Pueraria mirifica (Kwao Kruea Khao) for the treatment of vasomotor symptoms in perimenopausal women: Phase II Study.

ABSTRACT

OBJECTIVES: To evaluate the preliminary efficacy and safety of Pueraria mirifica in the treatment of vasomotor symptoms. DESIGN: Open-label study. SETTING: Hat Yai Regional Hospital, Thailand. SUBJECTS: Pre and postmenopausal women with vasomotor symptoms, such as hot flushes and night sweats. Other unpleasant symptoms, urogenital and psychological symptoms, were also evaluated. MATERIAL AND METHOD: Patients were enrolled voluntarily and randomly received 50 mg or 100 mg of Pueraria mirifica in capsules, once daily for six months. RESULTS: Of the 48 enrolled patients, 11 cases were excluded for failing to complete the initial work-up. Thirty-seven cases were evaluated. 20 of 37 (54.1%) randomly received a dose of 50 mg/day of Pueraria mirifica (Group A), and 17 of 37 (45.9%) received 100 mg/day of Pueraria mirifica (Group B). The mean of the modified Greene climacteric scale decreased from 35.6 to 26.6, 17.2 and 15.1 in group A, while group B, declined from 32.6 to 21.0, 14.8 and 13.6 at 1-, 3- and 6-month respectively. The mean serum estradiol, fluctuated from the baseline of 76.6 to 55.4, 56.7, 72.5, 69.2, 114.2 and 74.5 pg/ml at 1-, 2-, 3-, 4-, 5- and 6-month respectively. Whereas the mean serum follicle-stimulating hormone (FSH)/luteinizing hormone (LH) was stable in the range of; 27.1/12.6, 28.3/12.9 and 22.5/11.4 mIU/ml at baseline, 3- and 6-month respectively. CONCLUSIONS: Pueraria mirifica, containing phytoestrogens, relatively alleviated the climacteric symptoms in perimenopausal women. The transient negative profiles occurred in a small number of subjects that included anemia, and liver profiles. While there was a slight decrease in lipoproteins and an increase in hormonal profiles, Pueraria mirifica demonstrates great promise in the treatment of climacteric symptoms among perimenopausal women. However, optimal doses should be clinically assessed, to meet appropriate individual responses.