Transvaginal sonographic monitoring of the uterine effects of raloxifene and a continuous combined replacement therapy in postmenopausal women.
OBJECTIVE
To study the effect of 17beta-estradiol+norethisterone acetate and raloxifene on the endometrium and uterine volume in postmenopausal women.


METHODS
Patients were randomly assigned to 17beta-estradiol 2 mg+norethisterone acetate 1mg (E2+NETA) daily (n=90) or raloxifene HCl 60 mg (Evista) daily (n=43). Transvaginal sonography was done at baseline and at 6, 12 and 18 months, and at 6 and 12 months in-patients treated with E2+NETA and EVISTA respectively. Patients were asked to record bleeding-spotting episodes. Whenever required patients were referred for hysteroscopy+/-biopsy of the endometrium.


RESULTS
Patients under E2+NETA had a higher bleeding-spotting incidence (48.6%) compared with EVISTA (7.7%). Endometrial thickness increased significantly under E2+NETA as compared with baseline; however, at end point thickness reverted to baseline values. Evista had a non-stimulatory effect on the endometrium. Changes in uterine volume were not statistically significant.


CONCLUSIONS
Both treatment regimens provided comparable uterine safety. However, raloxifene exhibited a more favorable safety profile on the uterus as expressed in the bleeding-spotting incidence and the effect on endometrial thickness and uterine volume. Transvaginal sonography appears to be a dependable method for monitoring the effect of treatment on the uterus.
Christodoulacos
G
G
Second Department of Obstetrics and Gynecology, Aretaieion Hospital, University of Athens, Leoforos Vas. Sofias 76, GR-11528 Athens, Greece.
Panoulis
C
C
Botsis
D
D
Rizos
D
D
Kassanos
D
D
Creatsas
G
G
D000284:Administration, Oral; D000328:Adult; D004334:Drug Administration Schedule; D004717:Endometrium / Q000000981:diagnostic imaging / Q000187:drug effects; D004958:Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D000077563:Norethindrone Acetate; D017698:Postmenopause; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000494:pharmacology*; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000494:pharmacology*; D016896:Treatment Outcome; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging / Q000187:drug effects*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone