Published 21 August 2008, doi:10.1136/bmj.a1190
Cite this as: BMJ 2008;337:a1190

Research

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

¹ MRC General Practice Research Framework, Stephenson House, London NW1 2ND, ² London School of Hygiene and Tropical Medicine, London, ³ MRC Clinical Trials Unit, London, ⁴ Women’s Health Research Centre, Department of Primary Health Care and General Practice, Wellington School of Medicine and Health Sciences, New Zealand, ⁵ Discipline of Obstetrics and Gynaecology, School of Paediatrics and Reproductive Medicine, University of Adelaide, Women’s and Children’s Hospital, Adelaide SA 5005, Australia

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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• Garratt, A. (2009). Patient reported outcome measures in trials. BMJ 338: a2597-a2597 [Full text]  
• (2008). Hormone Therapy and Postmenopausal Quality of Life. JWatch Women's Health 2008: 6-6 [Full text]  
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Rapid Responses:

Read all Rapid Responses

Quality of life improved by menopausal hormones?

Martina Dören
bmj.com, 22 Aug 2008 [Full text]

No minimal benefits of HRT can justify increasing cancers and numerous serious illnesses

Ellen CG Grant
bmj.com, 26 Aug 2008 [Full text]

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