title: Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial.
abstract: OBJECTIVE
  To assess the effects of 2 months of treatment with Femarelle for climacteric syndrome in Taiwanese postmenopausal women.
  
  
  METHODS
  A multi-center, open-label trial of 260 postmenopausal women, age ≥ 45 years with vasomotor symptoms. Women were enrolled after obtaining a detailed medical history and a thorough physical examination. They then received Femarelle (640 mg/d) twice daily for 8 weeks. The primary outcome was the changes in the frequency and severity of hot flushes from baseline to 4 weeks (1 month) and 8 weeks (2 months). Changes of general climacteric syndrome were assessed using a modified climacteric scale designed by Greene.
  
  
  RESULTS
  The frequency and severity of hot flushes were significantly improved with Femarelle use (p < 0.001). After 8 weeks of treatment, the percentage of women with various climacteric syndromes was reduced (from 100% to 20.9% for hot flushes, from 97.7% to 87.9% for psychological symptoms, from 93.8% to 78.8% for somatic symptoms, and from 87.8% to 74.9% for sexual symptoms). General climacteric syndrome scores also significantly decreased, from 20.8 ± 0.7 at the time of enrollment to 12.9 ± 0.7 after 8 weeks of Femarelle treatment (p < 0.0001). Participants experienced improvement of various climacteric symptoms and signs after 8 weeks of treatment (75.1% for hot flushes, 68.7% for psychological symptoms, 70.6% for somatic symptoms, and 69.0% for sexual problems respectively). After 4 weeks and 8 weeks of treatment with Femarelle, patients showed statistically significant improvement in climacteric symptoms (p < 0.0001). Three women (1.2%) withdrew from the study after 4 weeks of treatment due to adverse effects.
  
  
  CONCLUSIONS
  Femarelle significantly improved climacteric symptoms in Taiwanese postmenopausal women. However, further evaluation is needed regarding the safety of long-term consumption.
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan. Electronic address: fangping@cgmh.org.tw.
authors.forename: Fang-Ping
authors.initials: FP
authors.lastname: Chen
authors.affiliation: Clinical Informatics and Medical Statistics Research Center, Chang Gung University, Taoyuan, Taoyuan, Taiwan.
authors.forename: Chee Jen
authors.initials: CJ
authors.lastname: Chang
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan.
authors.forename: An-Shine
authors.initials: AS
authors.lastname: Chao
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Hong-Yuan
authors.initials: HY
authors.lastname: Huang
authors.affiliation: Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan.
authors.forename: Jian-Pei
authors.initials: JP
authors.lastname: Huang
authors.affiliation: Department of Obstetrics and Gynecology, College of Medicine and Hospital and National Cheng Kung University, Tainan, Taiwan.
authors.forename: Meng-Hsing
authors.initials: MH
authors.lastname: Wu
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Ching-Chou
authors.initials: CC
authors.lastname: Tsai
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Keelung, Linkou and Kaohsiung, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Fu-Tsai
authors.initials: FT
authors.lastname: Kung
authors.affiliation: Department of Obstetrics and Gynecology, Taipei Medical University Hospital, Taipei, Taiwan.
authors.forename: Ching-Wen
authors.initials: CW
authors.lastname: Chang
authors.affiliation: Chi-Mei Medical Center, Tainan, Taiwan; Department of Sport Management, Chia Nan University of Pharmacy and Science, Tainan, Taiwan.
authors.forename: Yung-Chieh
authors.initials: YC
authors.lastname: Tsai
mesh_terms: D000368:Aged; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D048789:Phytoestrogens / Q000009:adverse effects / Q000627:therapeutic use*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology / Q000523:psychology; D012720:Severity of Illness Index; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy; D019529:Sexuality / Q000187:drug effects; D013577:Syndrome
chemical_list: C478341:DT56a; D048789:Phytoestrogens; D010936:Plant Extracts
keywords: Femarelle; climacteric syndrome; hot flushes; postmenopausal women