Quality of Life on HRT

Summarized by Robert W. Griffith, MD
March 28, 2003

For many years, hormone replacement therapy (HRT) has been the answer to many women's health problems after the menopause - the risk of heart disease, osteoporosis, and dementia, along with the symptoms of menopause itself: hot flashes, sweating, anxiety, irritability, insomnia, vaginal dryness, and possible loss of libido. However, recent findings from several large studies, particularly the Women's Health Initiative (WHI), have shown that women taking estrogen plus progestin have a slightly increased risk of heart attack, stroke, embolism, and breast cancer (see first link below). Guidelines for the use of HRT have been revised, and the combination therapy is only recommended for short-term relief of menopause symptoms, or for preventing osteoporosis if other forms of treatment cannot be used.

Many women have stopped using HRT since July 2001, when wide publicity was given to the WHI findings. Some, however, have continued to use the combination, in the conviction that it has beneficial effect on their mood and general quality-of-life. Now, data from the WHI study have been analyzed to see if, indeed, HRT does improve health-related quality-of-life.

How the WHI study was used

The WHI study was done in over 16,500 women aged 50 to 79 with an intact uterus. Its purpose was to examine the effect of estrogen-plus-progestin on the occurrence of heart disease, hip fractures, and breast and colon cancer. In women who had lost their uterus (i.e. had a hysterectomy) estrogen alone was prescribed. Equal numbers of women were given HRT or a placebo.
Nine years after enrollment started, a safety review showed that the number of cases of breast cancer in the estrogen-plus-progestin group was increased to a significant degree. It was decided that this part of the study should be stopped immediately, and the results fully analyzed. This led to the published findings regarding breast cancer, stroke, heart attack, and blood clots (embolism).

For the purpose of the present analysis, quality-of-life assessments based on a questionnaire were made at entry and after one year in all the women, and in a sample of over 1,500 women after 3 years.

What was measured

General quality of life and functional status were assessed using a well-tested standard questionnaire. The RAND 36-Item Survey covers general health, physical functioning, limitations on activities due to physical health problems, bodily pain, energy & fatigue, limitations on activities due to emotional or mental problems, social functioning, and emotional or mental health.

Other recognized scales were used to test for depression, sleep disturbance, sexual functioning, cognitive functioning (mental ability), and classical menopausal symptoms.

The investigators measured changes in these scales from baseline (enrollment) values after one year. Differences between measurements for HRT vs. placebo patients were analyzed.

The findings

The baseline scores at enrollment on the RAND 36-item quality-of-life scale were similar in both HRT and placebo groups in the study, and were also similar to scores seen in the healthy population. There were no significant effects of HRT on general health, vitality (energy & fatigue), mental health, depressive symptoms, or sexual satisfaction after one year.

An extremely small benefit of HRT - not considered to be clinically meaningful - was seen for sleep disturbance, physical functioning, and bodily pain after one year.

After 3 years, there were no significant benefits of HRT on any quality-of-life measurements. Not surprisingly, menopause symptoms were improved by HRT in women in the 50 to 54 age-group; however, there was no effect on quality-of-life measurements in this group of women, either.

Comment

Some possible benefits of HRT were not measured in this study - e.g. self-perception of youthfulness and attractiveness, or improved skin tone. No health-related factors, however, showed any clinically important differences between HRT and placebo after 1 and 3 years. The findings, therefore, reinforce the view that the only valid reason for taking HRT is the short-term control of moderate-to-severe symptoms of menopause, or the rare need to prevent osteoporosis when an alternative therapy can't be used.

Source

• Hays J, Ockene JK, Brunner RL, et al. Effects of estrogen plus progestin on health-related quality of life. New Engl J Med 2003;348: accessed on 3/18/03 at www.nejm.org

Related Links
Hormone Replacement Therapy (HRT) - Now What to Do?
Hot Flashes - What Can be Done?
Can Herbal Remedies Douse Hot Flashes?
Can Phytoestrogens replace ERT?

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