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Health related quality of life after combined hormone replacement therapy: randomised controlled trial
Amanda J Welton1, Madge R Vickers, Joseph Kim
1MRC General Practice Research Framework, Stephenson House, London NW1 2ND.
Objective:
To assess the effect of combined hormone replacement therapy (HRT) on health related quality of life.
Design:
Randomised placebo controlled double blind trial.
Setting:
General practices in United Kingdom (384), Australia (94), and New Zealand (24).
Participants:
Postmenopausal women aged 50-69 at randomisation; 3721 women with a uterus were randomised to combined oestrogen and progestogen (n=1862) or placebo (n=1859). Data on health related quality of life at one year were available from 1043 and 1087 women, respectively.
Interventions:
Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year.
Main Outcome Measures:
Health related quality of life and psychological wellbeing as measured by the women's health questionnaire. Changes in emotional and physical menopausal symptoms as measured by a symptoms questionnaire and depression by the Centre for Epidemiological Studies depression scale (CES-D). Overall health related quality of life and overall quality of life as measured by the European quality of life instrument (EuroQol) and visual analogue scale, respectively.
Results:
After one year small but significant improvements were observed in three of nine components of the women's health questionnaire for those taking combined HRT compared with those taking placebo: vasomotor symptoms (P<0.001), sexual functioning (P<0.001), and sleep problems (P<0.001). Significantly fewer women in the combined HRT group reported hot flushes (P<0.001), night sweats (P<0.001), aching joints and muscles (P=0.001), insomnia (P<0.001), and vaginal dryness (P<0.001) than in the placebo group, but greater proportions reported breast tenderness (P<0.001) or vaginal discharge (P<0.001). Hot flushes were experienced in the combined HRT and placebo groups by 30% and 29% at trial entry and 9% and 25% at one year, respectively. No significant differences in other menopausal symptoms, depression, or overall quality of life were observed at one year.
Conclusions:
Combined HRT started many years after the menopause can improve health related quality of life.
Trial Registration:
ISRCTN 63718836.
