Thoughts on The Safety of HRT
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The history of clinical medicine
is strewn with fashionable treatments supported by experts,
the unscrupulous or the downright eccentric that have subsequently
been discredited to become an odd footnote of medical history.
The many biochemical placental function tests and the surgical
ventrosuspension for all cases of infertility are examples
in my specialty. We must not forget that bleeding for anaemia
was fashionable for centuries. Will this be the fate of
HRT for problems related to the menopause?
Over the last 20 years it has been believed that HRT had
a hugely beneficial effect on post-menopausal women
without being complicated by many major side-effects.
There was some anxiety that there could be a very small
increase in breast cancer but, as the survival was very
much greater in women receiving HRT, it was easy to believe
that it was not a major problem and that possibly the apparent
increase was the result of over-stimulation of breast cancer
with oestrogens rather than a malignancy. It was believed
that oestrogens not only treated the hot flushes, insomnia,
vaginal dryness and depression that occurred around the
time of the menopause, but that it also prevented many heart
attacks, strokes, colon cancer, Alzheimer's disease and
osteoporotic fractures of the spine and the hip. There was
also good evidence that women on HRT lived longer probably
about 2.5 years longer hopefully in a state of less dependency,
with less dementia or Alzheimer's disease.
There was always a little doubt that these optimistic observational
studies were biased because physicians would tend to give
oestrogens to healthy, thin, non-diabetic, non-hypertensive,
non-smoking women. But the enthusiasm was such that in some
countries, particularly the United States, oestrogens were
given out to as many as 50% of the aged population in order
to prevent strokes and dementia. It is for this reason that
a huge randomised trial - the Women's Health Initiative
(WHI) was set up in order to test the hypothesis that oestrogen
therapy prevented these cardiovascular complications.
Almost 20,000 women were recruited from the age of 50-79
with the average age of 63 and 23% over the age of 70. Note
that in the UK 96% of our patients start HRT below the age
of 60. They used conjugated equine oestrogens (Premarin)
which is the major oestrogen used in the USA but much less
frequently used in Europe where the natural human oestradiol
by tablet, patch, gel, intra-nasal spray or implant is used.
The patients in the WHI study were overweight, more hypertensive
with 40% receiving either statins or anti-hypertensive drugs.
7.7% had suffered a previous heart attack. Thus, they were
not a healthy population and not at all comparable with
the patients usually treated with HRT in this country. They
were unbelievably selected for the study only if they had
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John STUDD, DSc, MD, FRCOG
Professor of Gynaecology
18th January 2005