title: Effects of a continuous-combined regimen of low-dose hormone therapy (oestradiol and norethindrone acetate) and tibolone on the quality of life in symptomatic postmenopausal women: a double-blind, randomised study.
abstract: OBJECTIVE
  This study compared the effects of a continuous-combined regimen of low-dose hormone therapy (LD-HT) versus tibolone and supplemental calcium/vitamin D3 (control) on quality of life (QoL) in symptomatic postmenopausal women.
  
  
  METHODS
  This study was a prospective, randomised, double-blind, comparative trial with a control group.
  
  
  METHODS
  The study was conducted in a climacteric outpatient clinic in the University Hospital of Federal University of Juiz de Fora, Brazil.
  
  
  METHODS
  A total of 174 postmenopausal women under 60 years of age who attended the climacteric outpatient clinic between June 2009 and June 2011 were recruited. These women complained of moderate or intense vasomotor symptoms and exhibited no contraindications for the use of hormone therapy.
  
  
  METHODS
  The patients were randomised into three groups: (1) daily treatment with 2.5mg tibolone (n=64), (2) 50mg calcium carbonate+200 IU vitamin D3 (Ca/Vit D3, n=54) or (3) 1mg oestradiol+0.5mg norethindrone acetate (E2/NETA, n=56) for 12 weeks.
  
  
  METHODS
  The primary outcome was the evaluation of QoL using the Women's Health Questionnaire (WHQ) in all subjects at baseline and after 4, 8 and 12 weeks of treatment.
  
  
  RESULTS
  A total of 130 women in the following groups completed the study: tibolone (n=42), Ca/Vit D3 (n=44) and E2/NETA (n=44). An improved QoL based on the WHQ was observed at T0 (80.12±14.04, 77.73±15.3, 77.45±15.4) and T12 (57.0±15.5, 55.7±16.7, 58.4±12.6) for the tibolone, E2+NETA and Ca/Vit D3 groups, respectively (p values <0.05). The three groups exhibited significantly different scores at T12 for sexual behaviour and vasomotor symptoms. The tibolone group exhibited better sexual function compared with the E2/NETA and Ca/Vit D3 groups (4.2±26, 5.6±2.8, 5.4±2.8, respectively, p values <0.05). LD-HT was superior to tibolone and Ca/Vit D3 treatment for improvements in vasomotor symptoms (3.2±1.5, 4.0±1.8, 4.3±2.0, respectively, p values <0.05). Adverse effects were few and mild.
  
  
  CONCLUSIONS
  An improved QoL was observed in the three study groups. Tibolone primarily improved sexual function, and E2/NETA exhibited a superior response for vasomotor symptoms.
authors.affiliation: Department of Gynecology, Faculty of Medicine, Federal University of Juiz de Fora, Minas Gerais, Brazil. afpoli@powerline.com.br
authors.forename: Alvaro Fernando
authors.initials: AF
authors.lastname: Polisseni
authors.forename: Amaury Teixeira Leite
authors.initials: AT
authors.lastname: Andrade
authors.forename: Luiz Claudio
authors.initials: LC
authors.lastname: Ribeiro
authors.forename: Isabela Queirós
authors.initials: IQ
authors.lastname: Castro
authors.forename: Marcos
authors.initials: M
authors.lastname: Brandão
authors.forename: Fernanda
authors.initials: F
authors.lastname: Polisseni
authors.forename: Martha de Oliveira
authors.initials: Mde O
authors.lastname: Guerra
mesh_terms: D000339:Affect; D002119:Calcium Carbonate / Q000627:therapeutic use; D002762:Cholecalciferol / Q000627:therapeutic use; D003280:Contraceptives, Oral, Synthetic / Q000627:therapeutic use; D019587:Dietary Supplements; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000627:therapeutic use*; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004967:Estrogens / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077563:Norethindrone Acetate; D009652:Norpregnenes / Q000627:therapeutic use*; D017698:Postmenopause; D011788:Quality of Life; D012725:Sexual Behavior; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D003280:Contraceptives, Oral, Synthetic; D020847:Estrogen Receptor Modulators; D004967:Estrogens; D009652:Norpregnenes; D014815:Vitamins; D002762:Cholecalciferol; D004958:Estradiol; D000077563:Norethindrone Acetate; C027385:tibolone; D002119:Calcium Carbonate; D009640:Norethindrone