title: A randomized, double-blind, multiple-dose escalation study of a Chinese herbal medicine preparation (Dang Gui Buxue Tang) for moderate to severe menopausal symptoms and quality of life in postmenopausal women.
abstract: OBJECTIVE
  This study is a phase II clinical trial that aims to investigate the dose-response relationship of a Chinese herbal medicine preparation, Dang Gui Buxue Tang (DBT), with short-term menopausal symptoms and quality of life in local postmenopausal women.
  
  
  METHODS
  A randomized, double-blind, multiple-dose escalation trial was performed in 60 postmenopausal women experiencing severe hot flashes and night sweats. The participants were randomized to receive DBT preparations at 1.5, 3.0, or 6.0 g/day for 12 weeks. The primary outcomes were vasomotor symptoms, Greene Climacteric Scale (GCS) score, and Menopause-Specific Quality of Life (MENQOL) score. Secondary outcomes included serum hormones and lipids.
  
  
  RESULTS
  There were between-group differences in psychological/psychosocial (P = 0.015, GCS; P = 0.013, MENQOL) and somatic/physical (P = 0.019, GCS; P = 0.037, MENQOL) domains, and improvement was significantly greatest (P < 0.05) in the 6.0 g/day dose group. The frequency and severity of hot flashes and night sweats were significantly reduced in the 3.0 g/day (14.5%-21.2%, P < 0.05, hot flashes; 28.6%-39.6%, P < 0.05, night sweats) and 6.0 g/day (34.9%-37.4.0%, P < 0.01, hot flashes; 10.1%-12.8%, P < 0.01, night sweats) dose groups. The female hormones follicle-stimulating hormone, luteinizing hormone, and 17β-estradiol, as well as the lipids total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol, were not significantly different within groups and between groups.
  
  
  CONCLUSIONS
  DBT preparations at 6.0 g/day significantly improve physical and psychological scores and significantly reduce vasomotor symptoms from baseline. The treatment was well tolerated, with no serious adverse events noted during the 12-week intervention period. The changes do not affect hormones and lipid profiles.
authors.affiliation: Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR.
authors.forename: Chi Chiu
authors.initials: CC
authors.lastname: Wang
authors.forename: King Fai
authors.initials: KF
authors.lastname: Cheng
authors.forename: Wing Man
authors.initials: WM
authors.lastname: Lo
authors.forename: Cindy
authors.initials: C
authors.lastname: Law
authors.forename: Lu
authors.initials: L
authors.lastname: Li
authors.forename: Ping Chung
authors.initials: PC
authors.lastname: Leung
authors.forename: Tony Kwok Hung
authors.initials: TK
authors.lastname: Chung
authors.forename: Christopher John
authors.initials: CJ
authors.lastname: Haines
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008055:Lipids / Q000097:blood; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D017698:Postmenopause; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013546:Sweating
chemical_list: D004365:Drugs, Chinese Herbal; D008055:Lipids; C477279:danggui buxue decoction; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone