Effects of 5 years of hormonal replacement therapy on menopausal symptoms and blood pressure-a randomised controlled study.
OBJECTIVE
To study the effects of hormonal replacement on hot flushes, other symptoms linked to menopause, and blood pressure.


METHODS
The study included 1006 early postmenopausal women aged 45-58 years, participating in the Danish Osteoporosis Prevention Study (DOPS) randomised to Hormonal replacement therapy (HRT) (n=502) or no HRT (n=504) in an open label trial. Symptom scores were recorded at baseline, after 6 month, 1, 2, and 5 years on a modified Greene scale (range 0-4 with 0 equalling no symptoms, and 4 maximal symptoms).


RESULTS
HRT efficiently alleviated hot flushes (mean+/-S.E.M. score 0.48+/-0.04 in HRT vs. 0.83+/-0.05 in no HRT after 5 years, P<0.01 by repeated measures ANOVA), sleeping difficulties associated with hot flushes (0.21+/-0.60 vs. 0.37+/-0.86, P<0.01), vaginal dryness (0.45+/-0.04 vs. 0.73+/-0.05, P<0.01), dyspareunia (0.27+/-0.04 vs. 0.39+/-0.04, P<0.01), and libido (0.48+/-0.05 vs. 0.59+/-0.05, P=0.08). In the untreated group the occurrence of mood swings (from 0.77+/-0.05 at baseline to 0.45+/-0.04 after 5 years, 2P<0.01) and oedemas (from 0.59+/-0.04 to 0.43+/-0.04, 2P=0.02) decreased with age while the occurrence of incontinence increased (from 0.43+/-0.03 to 0.52+/-0.04, 2P<0.01). These changes were not influenced by HRT. Furthermore, HRT had no influence on presence of headache (0.54+/-0.05 vs. 0.58+/-0.05 after 5 years), voiding pattern (0.49+/-0.04 vs. 0.53+/-0.04), or blood pressure (mean systolic pressure 123+/-18 vs. 123+/-19, diastolic pressure 77+/-10 vs. 77+/-11).


CONCLUSIONS
HRT is efficient in controlling hot flushes and vaginal dryness, and symptoms related to these conditions. However, no effect on blood pressure or other menopause symptoms was recorded.
Vestergaard
Peter
P
Department of Endocrinology and Metabolism C, The Osteoporosis Clinic, Aarhus Amtssygehus, Aarhus University Hospital, Tage Hansens Gade 2, DK-8000 C Aarhus, Denmark. p-vest@post4.tele.dk
Hermann
Anne Pernille
AP
Stilgren
Lis
L
Tofteng
Charlotte Landbo
CL
Sørensen
Ole Helmer
OH
Eiken
Pia
P
Nielsen
Stig Pors
SP
Mosekilde
Leif
L
D001794:Blood Pressure / Q000187:drug effects*; D015331:Cohort Studies; D003718:Denmark; D004414:Dyspareunia / Q000188:drug therapy; D004487:Edema / Q000188:drug therapy; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D004967:Estrogens / Q000008:administration & dosage / Q000627:therapeutic use; D005242:Fecal Incontinence / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000188:drug therapy; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D017698:Postmenopause / Q000187:drug effects; D011372:Progestins / Q000008:administration & dosage / Q000627:therapeutic use; D012893:Sleep Wake Disorders / Q000188:drug therapy; D014623:Vaginal Diseases / Q000188:drug therapy
D004967:Estrogens; D011372:Progestins