Health Related Quality of Life after HRT

Health related quality of life after combined hormone replacement therapy: randomised controlled trial: One year results of the Women's International Study of long Duration Oestrogen after Menopause (WISDOM) trial: a randomised controlled trial. Br Med J 2008;337:a1190

 Welton AJ, Vickers MR, Kim J, et al.

 ABSTRACT:

Objective: To assess the effect of combined hormone replacement therapy 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.

COMMENT from Professor Rod Baber :

The recent publication of results from The WISDOM Study in The British Medical Journal confirm that users of HRT experienced improved quality of life.

Using validated methods of measuring well being and quality of life, this randomized controlled trial of older (mean age 64) mostly asymptomatic post menopausal women showed that after one year significant improvements were seen in vasomotor symptoms, sexual function, sleep problems and aching joints and muscles ( p<0.001 for all). Vasomotor symptoms were reduced by 77% by users of HRT compared to 52% for placebo.

 WISDOM thus showed that, even in a population of women where most were not experiencing hot flushes, there was a significant improvement in quality of life measures amongst women using HRT.

 The primary indication for HRT use is the alleviation of symptoms and randomized trials have now shown that, for women 50-59 passing through the menopausal transition,  the short term use of such therapy is safe and effective.

COMMENT from Professor Martha Hickey:

The recent publication on health related quality of life from the WISDOM study (Welton et al, Br Med J 2008;337:a1190) demonstrates an improvement in specific domains of quality of life in postmenopausal women taking HRT. Specifically, in a randomised controlled trial of 3721 women, mean age 64 years there were significant improvements in vasomotor symptoms (hot flushes and night sweats), sexual function, sleep, joint and muscle aches and vaginal dryness in combined HRT users. HRT users also experienced greater incidence of vaginal bleeding and discharge and breast tenderness compared to controls. Overall quality of life was not improved with HRT, neither were depression indices

This study indicates that there may still be a role for HRT in older postmenopausal women who continue to be symptomatic. In these cases, patients and their doctors must balance the potential risks and benefits of combined HRT

Press Statement

ISSUED ON BEHALF OF THE INTERNATIONAL MENOPAUSE SOCIETY

BY David W. Sturdee, Regine Sitruk-Ware, Tobie de Villiers and Amos Pines August 22, 2008

WISDOM study: Re-confirming improved quality of life in all HRT users

The British Medical Journal features this week another article on the effects of postmenopausal hormone therapy on parameters of quality of life (1). The WISDOM (Women's International Study of long Duration Oestrogen after Menopause) study, conducted in the UK, Australia and New Zealand, had some similarities to the Women's Health Initiative (WHI). Both studies were randomized, double-blind, placebo-controlled, and used the same combined conjugated equine estrogen-medroxyprogesterone acetate standard-dose hormonal product. As a result of the early cessation of the WHI trial in 2002, the WISDOM study was also stopped, allowing only a short follow-up period for data collection. Participants were 50-69 years old at recruitment, with a mean age of 62 years, and most women (70%) did not suffer from vasomotor symptoms or sleep disturbances (55%) at baseline.

Using validated methods of measuring well-being and quality of life, the authors showed that, after 1 year, significant improvements were observed in the following domains for those taking combined hormone therapy compared with those taking placebo: vasomotor symptoms, sexual functioning, sleep problems, aching joints or muscles (p < 0.001 for all). Analysis of the results for the subgroup of women reporting hot flushes at baseline revealed that, in 78% of hormone users, the hot flushes disappeared entirely, while this occurred only in 35% of women in the placebo group. Similarly, 67% of women with night sweats at baseline who were allocated to the hormone group became symptom-free at 1 year, as compared to 38% of those on placebo treatment. The corresponding results for the symptomatic women in the WHI study were as follows: 77% of women using hormones reported an improvement in hot flushes at 1 year as compared to 52% of women using placebo; the figures for night sweats were 71% and 53%, respectively (2).

This study has demonstrated that, even in women without hot flushes who were well past menopause, there was still a measurable improvement in quality of life and a noted improvement in sleep, sexuality and joint pain.

This study shows just how effective hormone therapy can be in alleviating hot flushes and sleep disturbances and in generally improving other components of quality of life and well-being. It is regrettable that recent misinterpretation and exaggeration of the potential risks of long-term hormone use have caused false perceptions among many physicians and women and these well-documented benefits are being ignored. In particular, the latest data from the WHI study have demonstrated the safety of hormone therapy in healthy women during the early postmenopause, so women who are symptomatic and wanting an improvement in their quality of life should be reassured and encouraged to discuss the option of hormone therapy with their physicians.

References

1. Welton AJ, Vickers MR, Kim J, et al. Health related quality of life after combined hormone replacement therapy: randomised controlled trial: One year results of the Women's International Study of long Duration Oestrogen after Menopause (WISDOM) trial: a randomised controlled trial. Br Med J 2008;337:a1190

2. Hays J, Ockene JK, Brunner RL, et al. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003;348:1839-54

http://www.imsociety.org/pdf_files/comments_and_press_statements/ims_press_statement_22_08_08.pdf?SESSID=ab1p0kete3ru7nq5jhoq1edlu6

Content Updated 26 August, 2008