What IS the truth about HRT? Read the latest eye-opening evidence — and you be the judge

Millions of menopausal women shun it after a major study said it could cause cancer and strokes But now a new book suggests that report was wrong — and it could actually save lives. So . . .

Wary of hormone replacement therapy (HrT)? Join the club. Ever since a report by a massive U.S. study called the Women’s Health Initiative (WHI) claimed in 2002 that it carried a significant risk of breast cancer and heart disease, most menopausal women remain scared of taking it.

Before the alarming news made headlines, around one in four British women was taking HrT. The WHI study’s heavily publicised warning sent shockwaves throughout the world. Suddenly a therapy which promised to banish debilitating menopausal symptoms such as night sweats and hot flushes was demonised as a lady-killer.

Prescriptions for HrT more than halved in the ensuing two years in the UK, plummeting from around six million a year to just 2.3 million — where the numbers remain today, according to the British Menopause Society.

Indeed, many patients and doctors remain wary of the health risks associated with taking HrT pills or using patches, which contain a combination of the hormones oestrogen and progesterone.

as a consequence, only one in ten of those going through the menopause is currently prescribed the treatment. according to the British Menopause Society’s latest factsheet, ‘almost a generation of women have mostly been denied the opportunity of improved quality of life during their menopausal years’. This is despite strong guidelines issued three years ago by the UK treatment watchdog NICE, which urged that twice as many women could benefit from HrT.

Why is fear so prevalent? The plain answer is confusion. Menopausal women’s dilemmas about the therapy are fuelled by the constant Punch and Judy effect of research headlines proclaiming ‘HrT is safe’ one day, and ‘HrT is dangerous’ the next.

Now comes a broadside in a new book that claims to have the definitive answer: HrT is safe.

What’s more, it is not just safe for the short-term, to treat women’s menopausal symptoms, but throughout their post-menopausal lives — even for women who have had breast cancer.

The authors — Dr avrum Bluming, a leading breast cancer specialist, and Dr Carol Tavris, a social psychologist — argue that the original WHI study was flawed as it was based on women who were too old and unhealthy to provide meaningful results. Moreover, they claim that the researchers warped the data to make the results look alarming because they were convinced HrT was harmful and wanted to confirm that hypothesis.

WOMEN TOLD THEY’D BE ‘FEMININE FOREVER’

THE WHI study’s results, which were initially published in 2002, killed a dream that had begun six decades before. In the early Forties, chemists discovered how to extract industrial quantities of oestrogen from the urine of pregnant mares.

From this, ayerst Laboratories in Canada produced the first oestrogen pills. It called the drug Premarin, after ‘pregnant mare’s urine’, and marketed it as a panacea for menopausal symptoms. The idea was that it would make up for the drop in oestrogen which occurs during the menopause and underlies many of its symptoms.

The New york-based gynaecologist robert Wilson’s bestselling book Feminine Forever boosted demand in the Sixties. He promised that oestrogen would suffuse menopausal women with renewed youth, beauty and a full sex life. Dr Wilson’s son later told The New york Times that ayerst Laboratories paid his father’s expenses for writing the book.

The optimism was tempered in the Seventies by reports in The New England Journal of Medicine that taking oestrogen raised the risk of endometrial cancer — cancer of the uterus — by up to eight times.

Subsequent studies found this could be prevented by adding the female hormone progesterone ( which helps to regulate the menstrual cycle and changes in early pregnancy, but is not produced after a woman’s final period).

Since the early Eighties, women on hormone therapy who have had hysterectomies have mostly been given oestrogen alone, while those who have not receive oestrogen plus progesterone (known as HrT).

Until the millennium there was little cause for concern regarding oestrogen and any link to breast cancer. Studies by the U.S. National Cancer Institute found no statistically significant increased risk of breast cancer in women on Premarin — even those who had taken it for more than 20 years.

In 1992, a 22-year study by New york University, which randomly assigned 168 postmenopausal female mental institution inmates to receive either HrT or a placebo, reported that 11.5 per cent of the women taking the placebo developed breast cancer. The Obstetrics & Gynecology journal reported that the women on HrT remained free of the disease.

Then, in July 2002, came the bombshell. a press release reported that the WHI study, a major clinical trial of the risks and benefits of HrT in more than 16,000 healthy postmenopausal women, had been halted early due to an increased risk of breast cancer.

The WHI researchers said they had abandoned the trial in order to save participants’ lives.

an ensuing announcement in the Journal of the american Medical association said that the WHI study was stopped not only because of the increased risk of breast cancer, but also of heart disease, stroke, and pulmonary embolism (a potentially fatal blood clot in an artery running from the heart to the lungs).

It was the first huge prospective study, where thousands of women were randomly selected to take either hormones or unwittingly take a placebo, then followed for years.

This is the ‘gold standard’ of research. If you simply compare women who chose to take hormones with those who chose not to, the results can’t show whether HrT makes women sicker or if it is simply that sicker women take HrT.

THEN CAME THE BOMBSHELL . . .

THE news made headlines across the world. The BBC declared: ‘HrT linked to breast cancer.’ Millions of women dumped their pills.

But according to Dr Bluming and Dr Tavris, the WHI study announcement — and the headlines — were utterly wrong. The WHI study researchers, they say, were pursuing a ‘campaign of fear’.

In their new book, Oestrogen Matters, they argue that the WHI study’s finding that HrT increased the risk of breast cancer was not ‘statistically significant’. The figures indicated a 26 per cent increase in the risk of breast cancer. But the study acknowledged this increase ‘almost reached nominal statistical significance’ — the numbers were not firm enough to prove a strong link. It may have been coincidental instead. Why report this when it might be spurious?

Garnet anderson, the WHI study co-principal investigator and statistician justified her decision in a press release at the time, saying: ‘Because breast cancer is so serious an event, we set the bar lower to monitor for it. We pre-specified that the change in cancer rates did not have to be that large to warrant stopping the trial.’

Dr Bluming and Dr Tavris claim that this should be interpreted as: ‘We set the bar low enough to monitor for non-significant results if we could squeak out any.’

They add that the WHI study’s . ORIGINAL COPY . ORIGINAL COPY . ORIGINAL COPY . ORIGINAL COPY ORIGINAL COPY