A double-blind, randomised trial comparing the effects of tibolone and continuous combined hormone replacement therapy in postmenopausal women with menopausal symptoms.
OBJECTIVE
To compare the effects of two postmenopausal regimens on menopausal symptoms, bleeding episodes, side effects and acceptability.


METHODS
Double-blind, randomised controlled trial.


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


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


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


METHODS
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.
Hammar
M
M
Department of Obstetrics and Gynaecology, University Hospital, Linköping, Sweden.
Christau
S
S
Nathorst-Böös
J
J
Rud
T
T
Garre
K
K
D045930:Anabolic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D009640:Norethindrone / Q000627:therapeutic use*; D009652:Norpregnenes / Q000627:therapeutic use*; D017698:Postmenopause; D045167:Progesterone Congeners / Q000627:therapeutic use*; D012725:Sexual Behavior; D013546:Sweating / Q000187:drug effects; D014592:Uterine Hemorrhage / Q000139:chemically induced; D014623:Vaginal Diseases / Q000139:chemically induced
D045930:Anabolic Agents; D009652:Norpregnenes; D045167:Progesterone Congeners; C027385:tibolone; D009640:Norethindrone