Effects of 5 years of hormonal replacement therapy on menopausal symptoms and blood pressure - a randomised controlled study

Objectives: 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. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved.