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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.
Maturitas. 2013 Feb; 74(2):172-8.M

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.

DESIGN

This study was a prospective, randomised, double-blind, comparative trial with a control group.

SETTING

The study was conducted in a climacteric outpatient clinic in the University Hospital of Federal University of Juiz de Fora, Brazil.

POPULATION

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.

INTERVENTIONS

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.

PRIMARY OUTCOME MEASURES

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+Show Affiliations

Department of Gynecology, Faculty of Medicine, Federal University of Juiz de Fora, Minas Gerais, Brazil. afpoli@powerline.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23201326

Citation

Polisseni, Alvaro Fernando, et al. "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." Maturitas, vol. 74, no. 2, 2013, pp. 172-8.
Polisseni AF, Andrade AT, Ribeiro LC, et al. 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. Maturitas. 2013;74(2):172-8.
Polisseni, A. F., Andrade, A. T., Ribeiro, L. C., Castro, I. Q., Brandão, M., Polisseni, F., & Guerra, M. d. e. . O. (2013). 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. Maturitas, 74(2), 172-8. https://doi.org/10.1016/j.maturitas.2012.11.001
Polisseni AF, et al. 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. Maturitas. 2013;74(2):172-8. PubMed PMID: 23201326.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Polisseni,Alvaro Fernando, AU - Andrade,Amaury Teixeira Leite, AU - Ribeiro,Luiz Claudio, AU - Castro,Isabela Queirós, AU - Brandão,Marcos, AU - Polisseni,Fernanda, AU - Guerra,Martha de Oliveira, Y1 - 2012/11/30/ PY - 2012/09/04/received PY - 2012/11/01/revised PY - 2012/11/02/accepted PY - 2012/12/4/entrez PY - 2012/12/4/pubmed PY - 2013/6/28/medline SP - 172 EP - 8 JF - Maturitas JO - Maturitas VL - 74 IS - 2 N2 - 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. DESIGN: This study was a prospective, randomised, double-blind, comparative trial with a control group. SETTING: The study was conducted in a climacteric outpatient clinic in the University Hospital of Federal University of Juiz de Fora, Brazil. POPULATION: 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. INTERVENTIONS: 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. PRIMARY OUTCOME MEASURES: 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. SN - 1873-4111 UR - https://www.unboundmedicine.com/medline/citation/23201326/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(12)00369-6 DB - PRIME DP - Unbound Medicine ER -