Older women should not start taking hormone replacement therapy many years after the menopause because of the health risks, researchers say.

The results of a study examining the effects of HRT in postmenopausal women were finally published online by the British Medical Journal yesterday, five years after the trial was abandoned because of fears of increased risks of heart disease and cancer.

The women’s international study of long-duration oestrogen after menopause (Wisdom) began in 1999 but was halted in 2002 after the first signs of health problems caused by HRT.

But the researchers, who have had to compile the results in their own time, maintain that HRT is a safe short-term treatment for thousands of younger women in early menopause to relieve symptoms — such as hot flushes, vaginal dryness and night sweats — and to improve their quality of life.

HRT was promoted strongly by doctors in the 1970s and many women claimed that it transformed their lives. But in recent years the number of users has plummeted after a series of health scares. According to the GP Research Database of anonymised patient records, the number of women in Britain on HRT fell from two million in 2002 to one million in 2005.

The Wisdom study confirms earlier findings that women in their sixties who take HRT may suffer from heart and cardiovascular problems.

The team identified 5,692 healthy women with an average age of 63, who were 15 years after their menopause, and who were registered with doctors in Britain, Australia and New Zealand.

The women who had not had a hysterectomy were allocated to one of two groups. One group was given a daily dose of combined hormone therapy (oestrogen and progestogen) and the other received a placebo pill.

Women who had had a hysterectomy were divided between combined hormone treatment, oestrogen only and a placebo.

All the women were monitored for an average of 12 months, and the main outcomes, such as cardiovascular disease, osteoporotic fractures, breast cancer and deaths, were recorded.

There was a significant increase in the number of serious cardiovascular events and blood clots in the group who took the combined hormone therapy, compared with the placebo group. However, the rates for cerebro-vascular disease, breast or other cancers, fractures and overall deaths were not significantly different in these two groups.

In 2002 the Women’s Health Initiative trial, a 15-year research programme to address the most common causes of death, disability and poor quality of life in postmenopausal women, found that those taking HRT had more heart attacks and strokes than nonHRT users.

That study reported in June 2002 that HRT increased the risk of breast cancer, heart disease and stroke. The trial was halted early and millions of women around the world stopped taking the therapy. The Wisdom trial stopped too.

In August 2003 the Million Women Study, a national study of women’s health, found that the risk of breast cancer was doubled if HRT was taken for ten years — suggesting that it could have been responsible for an extra 20,000 cases in Britain alone.

But scientists now believe that some of these risks may apply only to older women who do not routinely take HRT. The Wisdom study authors say that more research is needed to assess conclusively the long-term benefits and risks. “The follow-up period in Wisdom was short because of the early closure, and the power of the study was greatly reduced by the curtailed recruitment, which also led to relatively few women being in the younger age groups,” they write.

In an editorial, Helen Roberts, of the University of Auckland, says that the new findings do not change advice to postmenopausal women. “Healthy women in early menopause are unlikely to face substantially increased risks when using hormones for a few years,” she writes.

“However, long-term use of hormone replacement therapy to prevent chronic disease is no longer recommended as the available randomised evidence shows that the negative outcomes outweigh the positive benefits.”

The figures

Heart disease In every 1,000 women, aged 50 to 59, who’ve been on HRT for five years, there will be one extra case of stroke. For women in their 60s, it goes up to four extra cases

Blood clots Women over 50 who take HRT have a slightly increased risk of DVT (blood clots in the veins). There will be an extra four cases per 1,000 women after five years

Breast cancer Between two to six extra cases of breast cancer per 1,000 women could be expected due to combined HRT (oestrogen and progesterone) use after five years

Ovarian cancer One extra case for every 2,500 women on HRT

Source: Wisdom; Women’s Health Institute; The Million Women Study, Oxford University

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