Health related quality of life after combined hormone replacement therapy: randomised controlled trial.
OBJECTIVE
To assess the effect of combined hormone replacement therapy (HRT) on health related quality of life.


METHODS
Randomised placebo controlled double blind trial.


METHODS
General practices in United Kingdom (384), Australia (94), and New Zealand (24).


METHODS
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.


METHODS
Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year.


METHODS
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.


BACKGROUND
ISRCTN 63718836.
Welton
Amanda J
AJ
MRC General Practice Research Framework, Stephenson House, London NW1 2ND.
Vickers
Madge R
MR
Kim
Joseph
J
Ford
Deborah
D
Lawton
Beverley A
BA
MacLennan
Alastair H
AH
Meredith
Sarah K
SK
Martin
Jeannett
J
Meade
Tom W
TW
D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004967:Estrogens / Q000008:administration & dosage*; D005260:Female; D006304:Health Status; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000523:psychology*; D011372:Progestins / Q000008:administration & dosage*; D011379:Prognosis; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016387:Women's Health
D004967:Estrogens; D011372:Progestins