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

Abstract

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, 2 P<0.01) and oedemas (from 0.59±0.04 to 0.43±0.04, 2 P=0.02) decreased with age while the occurrence of incontinence increased (from 0.43±0.03 to 0.52±0.04, 2 P<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.