title: A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women.
abstract: OBJECTIVE
  The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula, Er-Xian decoction (EXD), in the treatment of menopausal symptoms among Hong Kong perimenopausal women.
  
  
  METHODS
  A randomized, double-blind, controlled trial was conducted for 12 weeks among 108 Hong Kong perimenopausal women who reported Menopause Rating Scale (MRS) total scores of 28 or higher. Posttreatment follow-up was performed 3 months after the intervention. The primary outcome measure was the frequency and severity of hot flushes. The secondary outcome measures included the MRS, the Menopause-Specific Quality of Life questionnaire, and serum hormone levels.
  
  
  RESULTS
  Among 108 participants, 101 participants finished the study. EXD significantly reduced the mean (SD) frequency of hot flushes from 5.8 (5.0) to 2.2 (3.0) in the treatment group and from 5.0 (3.8) to 2.4 (2.5) in the placebo group (P = 0.04). The mean (SD) hot flush score was also reduced from 19.6 (6.6) to 4.9 (7.8) in the treatment group and from 16.6 (5.4) to 7.0 (6.4) in the placebo group (P = 0.02). The superiority of EXD to placebo was also observed with greater improvement in the total scores for the MRS (P = 0.03) and the Menopause-Specific Quality of Life questionnaire (P < 0.01). There were no differences in serum hormone levels between the EXD group and the placebo group. There were no serious adverse events, and the safety indices of whole blood counts, renal function, and liver function were within the normal range before and after treatment.
  
  
  CONCLUSIONS
  The Chinese herbal formula EXD is superior to placebo in reducing the frequency and severity of hot flushes and in improving menopausal symptoms in Hong Kong perimenopausal women. It is well tolerated, with no serious adverse events noted during the study period.
authors.affiliation: School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pukfulam, Hong Kong SAR.
authors.forename: Linda L D
authors.initials: LL
authors.lastname: Zhong
authors.forename: Yao
authors.initials: Y
authors.lastname: Tong
authors.forename: Grace W K
authors.initials: GW
authors.lastname: Tang
authors.forename: Zhang Jin
authors.initials: ZJ
authors.lastname: Zhang
authors.forename: Wai Ki
authors.initials: WK
authors.lastname: Choi
authors.forename: Kin Lok
authors.initials: KL
authors.lastname: Cheng
authors.forename: Stephen C W
authors.initials: SC
authors.lastname: Sze
authors.forename: Kun
authors.initials: K
authors.lastname: Wai
authors.forename: Qing
authors.initials: Q
authors.lastname: Liu
authors.forename: Ben X B
authors.initials: BX
authors.lastname: Yu
mesh_terms: D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006723:Hong Kong; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D047648:Perimenopause; D010919:Placebos; D011374:Progesterone / Q000097:blood; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D004365:Drugs, Chinese Herbal; D010919:Placebos; C517980:er-xian decoction; D011374:Progesterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone