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.

ABSTRACT

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 non-hysterectomized/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.