A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms
Article first published online: 19 AUG 2005
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 105, Issue 8, pages 904–911, August 1998
How to Cite
Hammar, M., Christau, S., Nathorst-Böös, J., Rud, T. and 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. BJOG: An International Journal of Obstetrics & Gynaecology, 105: 904–911. doi: 10.1111/j.1471-0528.1998.tb10237.x
- Issue published online: 19 AUG 2005
- Article first published online: 19 AUG 2005
- Received 17 January 1997 Returned for revision 19 May 1997 & 30 January 1998 Accepted 15 April 1998
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 17β-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.