title: Continuous combined hormone replacement therapy relieves climacteric symptoms and improves health-related quality of life in early postmenopausal women.
abstract: OBJECTIVE
  Hormone replacement therapy (HRT) relieves menopausal symptoms but its effect on health related quality of life (HRQoL) is uncertain. The aim of this study was to assess the effect of three dose regimens of continuous combined HRT, consisting of estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) on HRQoL in early postmenopausal women (last menstrual period 1-3 years before study entry).
  
  
  METHODS
  This was a 52-week, randomized, double-blind, multinational study comparing E2V (1 mg or 2 mg) plus MPA (2.5 mg or 5 mg) in different dose combinations. The intention-to-treat population comprised 459 women (average age 51.5 years).
  
  
  METHODS
  HRQoL was assessed by the Women's Health Questionnaire (WHQ), the 15D Questionnaire and a visual analogue scale (VAS).
  
  
  RESULTS
  There were improvements on eight of the nine domains of the WHQ with all dose regimens during the first 12 weeks (P<0.0001) and an improvement in the remaining domain (menstrual symptoms) with the lower-dose regimens (P<0.05). These initial improvements in HRQoL were then maintained or augmented over the remainder of the study (P<0.0001 for change from baseline at 52 weeks for all domains and dose regimens). Mean 15D total score had improved meaningfully and significantly by 12 weeks (P<0.0001 versus baseline) in all treatment groups and this improvement was maintained thereafter. This improvement in 15D total score was most marked among previous non-users of HRT (P<0.05 versus previous users). VAS scores recorded significant (P<0.05) reductions in hot flushes, sweating and sleep disturbances in all groups after week 1 and highly significant (P<0.0001) relief of all climacteric symptoms at week 52.
  
  
  CONCLUSIONS
  Continuous combined HRT was associated with pronounced improvement of vasomotor symptoms and HRQoL in this population of early postmenopausal women.
authors.affiliation: The Menopause Clinical and Research Unit, Northwick Park Hospital, Harrow, Middlesex, UK.
authors.forename: Joan
authors.initials: J
authors.lastname: Pitkin
authors.forename: Vera Petrovna
authors.initials: VP
authors.lastname: Smetnik
authors.forename: Péter
authors.initials: P
authors.lastname: Vadász
authors.forename: Mika
authors.initials: M
authors.lastname: Mustonen
authors.forename: Kaisa
authors.initials: K
authors.lastname: Salminen
authors.forename: Stiina
authors.initials: S
authors.lastname: Ylikangas
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage*; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D017698:Postmenopause; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016387:Women's Health