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Randomized Controlled Trial
. 2008 Aug 21:337:a1190.
doi: 10.1136/bmj.a1190.

Health related quality of life after combined hormone replacement therapy: randomised controlled trial

Amanda J Welton  1 , Madge R Vickers, Joseph Kim, Deborah Ford, Beverley A Lawton, Alastair H MacLennan, Sarah K Meredith, Jeannett Martin, Tom W Meade; WISDOM team
Collaborators, Affiliations
Randomized Controlled Trial

Health related quality of life after combined hormone replacement therapy: randomised controlled trial

Amanda J Welton et al. BMJ. .

Abstract

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.

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Conflict of interest statement

Competing interests: AHM has received research grants and lecture honoraria from various pharmaceutical companies but not in association with this study. BAL has received research and travel grants and lecture honoraria from various pharmaceutical companies but not in association with this study.

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Flow of participants after randomisation
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