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 plusnorethisterone 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.
RCT Entities:
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: William I Fisher; Aimee K Johnson; Gary R Elkins; Julie L Otte; Debra S Burns; Menggang Yu; Janet S Carpenter Journal: CA Cancer J Clin Date: 2013-01-25 Impact factor: 508.702