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A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms.
Br J Obstet Gynaecol. 1998 Aug; 105(8):904-11.BJ

Abstract

OBJECTIVE

To compare the effects of two postmenopausal regimens on menopausal symptoms, bleeding episodes, side effects and acceptability.

DESIGN

Double-blind, randomised controlled trial.

SETTING

Twenty-nine sites in Denmark, nine in Norway and six in Sweden.

PARTICIPANTS

Four hundred and thirty-seven postmenopausal women with menopausal complaints. None of these women had had a hysterectomy.

INTERVENTIONS

Daily treatment with tibolone 2.5 mg (n = 218) or 17beta-oestradiol 2 mg plus norethisterone acetate 1 mg (E2/NETA) (n = 219).

MAIN OUTCOME MEASURES

Hot flushes, sweating episodes, vaginal dryness, assessment of sexual life and bleeding patterns; at baseline and after 4, 12, 24 and 48 weeks.

RESULTS

Treatment with either preparation significantly reduced mean scores for hot flushes, sweating episodes and vaginal dryness. The overall discontinuation rate was 28% (tibolone 25%, E2/NETA 31%; P = 0.14), mostly during the first six months. There was a markedly lower cumulative incidence of bleeding or spotting episodes with tibolone compared with E2/NETA (P < 0.0001), mainly during the first six treatment cycles.

CONCLUSIONS

Both tibolone and E2/NETA effectively alleviate menopausal symptoms. However, tibolone caused significantly fewer bleeding or spotting episodes, which were reflected by lower overall rates of bleeding, as well as lower drop-out rates due to bleeding.

Authors+Show Affiliations

Hammar M
Department of Obstetrics and Gynaecology, University Hospital, Linköping, Sweden.
Christau S
No affiliation info available
Nathorst-Böös J
No affiliation info available
Rud T
No affiliation info available
Garre K
No affiliation info available

MeSH

Anabolic AgentsDouble-Blind MethodEstrogen Replacement TherapyFemaleHot FlashesHumansMenopauseMiddle AgedNorethindroneNorpregnenesPostmenopauseProgesterone CongenersSexual BehaviorSweatingUterine HemorrhageVaginal Diseases

Pub Type(s)

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

Language

eng

PubMed ID

9746385

Citation

Hammar, M, et al. "A Double-blind, Randomised Trial Comparing the Effects of Tibolone and Continuous Combined Hormone Replacement Therapy in Postmenopausal Women With Menopausal Symptoms." British Journal of Obstetrics and Gynaecology, vol. 105, no. 8, 1998, pp. 904-11.
Hammar M, Christau S, Nathorst-Böös J, et al. A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms. Br J Obstet Gynaecol. 1998;105(8):904-11.
Hammar, M., Christau, S., Nathorst-Böös, J., Rud, T., & Garre, K. (1998). A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms. British Journal of Obstetrics and Gynaecology, 105(8), 904-11.
Hammar M, et al. A Double-blind, Randomised Trial Comparing the Effects of Tibolone and Continuous Combined Hormone Replacement Therapy in Postmenopausal Women With Menopausal Symptoms. Br J Obstet Gynaecol. 1998;105(8):904-11. PubMed PMID: 9746385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms. AU - Hammar,M, AU - Christau,S, AU - Nathorst-Böös,J, AU - Rud,T, AU - Garre,K, PY - 1998/9/24/pubmed PY - 1998/9/24/medline PY - 1998/9/24/entrez SP - 904 EP - 11 JF - British journal of obstetrics and gynaecology JO - Br J Obstet Gynaecol VL - 105 IS - 8 N2 - OBJECTIVE: To compare the effects of two postmenopausal regimens on menopausal symptoms, bleeding episodes, side effects and acceptability. DESIGN: Double-blind, randomised controlled trial. SETTING: Twenty-nine sites in Denmark, nine in Norway and six in Sweden. PARTICIPANTS: Four hundred and thirty-seven postmenopausal women with menopausal complaints. None of these women had had a hysterectomy. INTERVENTIONS: Daily treatment with tibolone 2.5 mg (n = 218) or 17beta-oestradiol 2 mg plus norethisterone acetate 1 mg (E2/NETA) (n = 219). MAIN OUTCOME MEASURES: Hot flushes, sweating episodes, vaginal dryness, assessment of sexual life and bleeding patterns; at baseline and after 4, 12, 24 and 48 weeks. RESULTS: Treatment with either preparation significantly reduced mean scores for hot flushes, sweating episodes and vaginal dryness. The overall discontinuation rate was 28% (tibolone 25%, E2/NETA 31%; P = 0.14), mostly during the first six months. There was a markedly lower cumulative incidence of bleeding or spotting episodes with tibolone compared with E2/NETA (P < 0.0001), mainly during the first six treatment cycles. CONCLUSIONS: Both tibolone and E2/NETA effectively alleviate menopausal symptoms. However, tibolone caused significantly fewer bleeding or spotting episodes, which were reflected by lower overall rates of bleeding, as well as lower drop-out rates due to bleeding. SN - 0306-5456 UR - https://www.unboundmedicine.com/medline/citation/9746385/A_double_blind_randomised_trial_comparing_the_effects_of_tibolone_and_continuous_combined_hormone_replacement_therapy_in_postmenopausal_women_with_menopausal_symptoms_ L2 - https://medlineplus.gov/anabolicsteroids.html DB - PRIME DP - Unbound Medicine ER -