BMS view on the WISDOM research paper

The latest findings from the WISDOM study confirm a positive effect of HRT on certain quality of life aspects, although the identical United States Women’s Health Initiative study did not find this. Relief of hot flushes, and improvements in joint aches and sleep patterns were found in women of all ages when compared with a dummy (placebo) treatment. However, such menopausal symptoms are most commonly found in younger women around the time of menopause rather in women in their sixties and seventies. If older women develop such symptoms, then clearly HRT can be effective but the dose of HRT at initiation needs to be very low to avoid unwanted adverse effects in these women.

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Research paper: Health related quality of life after combined hormone replacement therapy: randomised controlled trial. BMJ Online First

New evidence published on BMJ.com today shows that hormone replacement therapy (HRT) can improve the health related quality of life of older women.

HRT guidelines should be reviewed in light of this evidence, say the authors.

Previous research has suggested that HRT can improve general quality of life (the way patients feel or function) and reduce the number and severity of symptoms associated with the menopause, but these studies have used general rather than more sensitive condition specific measures.

Professor Alastair MacLennan and colleagues present the findings on health related quality of life from the WISDOM trial*. The WISDOM trial began in 1999 and aimed to evaluate the long term benefits and risks of HRT in postmenopausal women over 10 years. It randomised 5 692 healthy women aged 50–69 from general practices in the UK, Australia and New Zealand to receive either combined HRT (oestrogen and progestogen) or placebo.

All women were monitored for an average of 12 months, and in addition to the main clinical outcomes of cardiovascular disease, fractures and breast cancer, a detailed assessment of the impact of HRT on quality of life was recorded.

Quality of life was measured using a modified version of the women’s health questionnaire designed to assess physical and emotional components of health such as depressed mood, memory and concentration, sleep problems and sexual functioning, and a symptoms questionnaire.

After one year, the researchers found significant improvements in sexual functioning, sleep problems and vasomotor symptoms (hot flushes and sweats) in the combined HRT group compared to the placebo group.

Significantly fewer women in the HRT group reported hot flushes (9% v 25%), night sweats (14% v 23%), aching joints and muscles (57% v 63%), insomnia (35% v 41%), and vaginal dryness (14% v 19%) than in the placebo group, but more reported breast tenderness (16% v 7%) and vaginal discharge (14% v 5%).

Other menopausal symptoms, depression, and overall quality of life were not significantly different in the two groups.

These results are consistent with the findings of the Women’s Health Initiative and support the conclusion that after one year, women who started taking combined HRT many years after the menopause, experienced reduced hot flushes and night sweats, improved sleep, and less bodily pain, say the authors.

These findings may have important benefits for many symptomatic women, claim the authors, but they caution that the health related quality of life benefits must be weighed against the risk of increased cardiac events, venous thromboembolism and breast cancer.

Notes to Editors:
*The WISDOM trial was halted early when another trial, the Women’s Health Initiative (WHI), which also initiated HRT on average 13 years after menopause, found that elderly women taking HRT had more heart attacks than non-HRT users. This was not seen when HRT was initiated near menopause, which is the common time of use.

Contact:
Professor Alastair MacLennan, Department of Obstetrics & Gynaecology, Women’s and Children’s Hospital, University of Adelaide, AUSTRALIA.
Tel: +61 8 8161 7619 / 7000 (Page) or +61 8 8338 1419 (evening number)
Please note, Adelaide is 8.5 hours ahead of the UK
Email: alastair.maclennan@adelaide.edu.au