title: A Multi-center, Randomized, Controlled and Open Clinical Trial of Heyan Kuntai Capsule () and Hormone Therapy in Perimenopausal Women.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of Heyan Kuntai Capsule (, HYKT) and hormone therapy (HT) on perimenopausal syndromes (PMSs).
  
  
  METHODS
  From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol (E2) below 30 ng/L, and follicle stimulating hormone (FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index (KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life (MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment RESULTS: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline (P <0.01) and there was no significant difference between groups (P >0.05), except that KMI of HYKT group was higher after 3-month treatment (P <0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups (P <0.01); and HT had a better performance than HYKT in improving hot flush (P <0.05). MENQOL were significantly improved in both groups after treatment (P <0.01); but there was no significant difference between two groups (P >0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group (P <0.01).
  
  
  CONCLUSIONS
  HYKT could effectively relieve PMSs and improve patients quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.
authors.affiliation: Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China.
authors.forename: Ai-Jun
authors.initials: AJ
authors.lastname: Sun
authors.affiliation: Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China.
authors.forename: Ya-Ping
authors.initials: YP
authors.lastname: Wang
authors.affiliation: Department of Obstetrics and Gynecology, Beijing Shijitan Hospital, Beijing, 100038, China.
authors.forename: Bei
authors.initials: B
authors.lastname: Gu
authors.affiliation: Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China.
authors.forename: Ting-Ping
authors.initials: TP
authors.lastname: Zheng
authors.affiliation: Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China. shouqing_lin2003@163.com.
authors.forename: Shou-Qing
authors.initials: SQ
authors.lastname: Lin
authors.affiliation: Department of Obstetrics and Gynecology, Beijing Shijitan Hospital, Beijing, 100038, China.
authors.forename: Wen-Pei
authors.initials: WP
authors.lastname: Bai
authors.affiliation: Department of Obstetrics and Gynecology, Beijing Shijitan Hospital, Beijing, 100038, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Wei
authors.affiliation: Department of Gynecology, Obstetrics and Gynecology, Hospital of Fudan University, Shanghai, 200011, China.
authors.forename: Shao-Fen
authors.initials: SF
authors.lastname: Zhang
authors.affiliation: Department of Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100032, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D000328:Adult; D003131:Combined Modality Therapy; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008875:Middle Aged; D047648:Perimenopause / Q000187:drug effects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; C000620717:kuntai capsule
keywords: Chinese medicine; Heyan Kuntai Capsule; Kupperman Menopausal Index; Menopause-Specific Quality of Life; hormone therapy; perimenopausal syndromes