Tuesday, April 10, 2007

Menopause, HRT and the PMJ



Here we go again.

HRT is back in the news and, if the PMJ (People’s Medical Journal) is to be believed, it is time, once again, for doctors on the front line to change our position on HRT.

We have always known that HRT may increase the risk of breast cancer and it is likely that that risk, though still low, is higher than originally thought. It used to be said, however, that HRT decreased women’s risk of heart attacks and strokes and so, even allowing for the breast cancer, it was a good overall bet. Then, in 2002, the Women’s Health Initiative in the USA published a landmark meta-analysis of HRT (see here) which concluded:
Compared with the placebo, estrogen plus progestin resulted in:

• Increased risk of heart attack
• Increased risk of stroke
• Increased risk of blood clots
• Increased risk of breast cancer
• Reduced risk of colorectal cancer
• Fewer fractures
• No protection against mild cognitive impairment and increased risk of dementia (study included only women 65 and older)
Hard to sell that to the customers. There was an immediate and radical change in HRT prescribing. The drug that had been near compulsory in the 1980’s (“if your GP won’t prescribe it, make sure you see a specialist screamed all the women’s magazines) suddenly fell into disfavour.

Family doctor’s still prescribed HRT but did so now with an air of reluctance, and lots of caveats and warnings. Not for more than five years…you must stop it when you are 55…there are better things for osteoporosis prevention…and so on and so forth. Lots of “gut feeling” here, not much science. We could not get an agreed policy in our practice of ten doctors. In particular, two of the female partners had entrenched and disparate views, one continuing to put women on HRT willy-nilly and the other taking them off it. If our normally cohesive practice could not agree, nationwide there must have been confusion and erratic prescribing.

Dr Crippen has always been cynical about trends and fashions in medicine. Just as he worries now about putting the world and his wife on statins, he worried then about putting the wives of the world on HRT, even though the menopause experts were saying it should be in the tap-water.

The sad fact of the matter is that I did not have a clue about the validity of the claims made for HRT ten years ago, and I do not have a clue about the current state of knowledge. So, I try to steer an uncertain middle course, and probably thus make everyone unhappy.

Time to call in the specialist. If you, Crippen, are telling your patients that you do not know the definitive answer about medication, then kindly sent your patients to someone who does. Good idea. But first, before I make the referral, I have to ask the patient if she wants to go on HRT. Does that not rather beg the question? Certainly it does. But if I refer a patient to a menopause clinic, to a menopause “expert” they will prescribe HRT. They always do. They are believers. HRT is their stock-in-trade. Dr Crippen has never known a menopause expert not to recommend HRT. They even give it to women who have had breast cancer. You do not believe that, do you? But it is true.

HRT is big business for Big Pharma. There are a lot of menopause clubs and societies to which the menopause “experts” belong. And they meet regularly in “congenial environments” to discuss the pros and pros of HRT.

Now the PMJ reports some good news on HRT.
U-turn on the risks of HRT as experts say it CAN cut heart disease

A new study disputes health scares over Hormone Replacement Therapy, saying the treatment used by millions of post-menopausal women may reduce, rather than increase, the risk of heart disease.

British experts said the revised analysis of the Women's Health Initiative Study virtually reversed the 2002 warning that led millions of women to stop HRT or not start it.

Dr John Stevenson, an HRT expert from London's Royal Brompton Hospital, launched a furious attack on the original researchers and warned that women who stopped taking hormones would go on to suffer heart attacks and other illnesses they 'didn't deserve'. He said:

"This is a U-turn of dramatic proportions. These conclusions are at complete variance with the widely-publicised 2002 results on which our guidance on prescribing is based. We are astonished that a study which made such a claim for the dangers of HRT is now showing just the opposite. It is an affront to science, adding insult to injury for the thousands of women in the UK alone who abandoned HRT."
Strong stuff indeed. The original study, quoted above, is dismissed in “a furious attack” as “an affront to science.”

What does the American Woman’s Health Iniative actually say? The report, Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause, should be read in full, but in summary says:
1. Risk of heart attack from hormones may not be increased in women who start the hormones less than 10 years after menopause, but there is increasing risk in women who are more distant from menopause
2. Risk of stroke from hormones does not depend on when a woman starts hormone therapy; strokes are increased regardless of years since menopause
3. Risk of death from any cause appeared to be reduced in women who were 50-59 years at the time they started hormones in the two WHI trials
There may be a little good news here for those wanting HRT, but Dr Crippen would not describe this as a “U turn of dramatic proportions”.

Let us therefore go to the original source which is in one of the most respected medical journals in the world, the Journal of the American Medical Association (JAMA) .
Objective To explore whether the effects of hormone therapy on risk of cardiovascular disease vary by age or years since menopause began.

Conclusions Women who initiated hormone therapy closer to menopause tended to have reduced CHD risk compared with the increase in CHD risk among women more distant from menopause, but this trend test did not meet our criterion for statistical significance. A similar non-significant trend was observed for total mortality but the risk of stroke was elevated regardless of years since menopause. These data should be considered in regard to the short-term treatment of menopausal symptoms.

JAMA. 2007;297:1465-1477.
Read the first sentence of the conclusion carefully. The trend observed “did not meet our criterion for statistical significance.”

I cannot reconcile that with the outspoken statements attributed to Dr John Stevenson in the PMJ. Dr Stevenson has been in the news before. Three years ago a Swedish study of breast cancer survivors taking HRT was stopped prematurely as too many women in the trial developed recurrent cancer.

British menopause experts were more relaxed.
Experts have moved to reassure former breast cancer patients taking HRT, after researchers said it could raise the risks of a new tumour.

A Swedish study of breast cancer survivors was halted early after cancer came back more often in HRT users. However, consultants treating women for severe menopausal problems said that other, unpublished, research had found no evidence of an extra risk.

Dr John Stevenson, from the Royal Brompton Hospital in London, and a past chairman of the British Menopause Society, said:

"We have some patients whose symptoms are so severe that their quality of life is very low. We explain the possibility that HRT may increase their risk of breast cancer recurrence, and they choose HRT. Provided the patient makes an informed choice, that is right for them."


A spokesman for the Department of Health said that the general advice was for women with a history of breast cancer to avoid HRT - and had been for some years. (BBC)
What does a GP do if an eminent consultant recommends a course of treatment with which the GP disagrees? Does he tell his patient, thus undermining the consultant? Does he prescribe drugs which he considers to be inappropriate? When a GP prescribes a drug he takes responsibility for that prescription and for any problems that may arise. It may go to mitigation to plead that prescription was on the recommendation of a learned Professor, but that would not absolve the GP if there were to be a disaster.

Dr Crippen is a believer in freedom of choice, and has no problem with women who have had breast cancer taking HRT if they understand the risks. Dr Crippen will not himself be prescribing it for them as he personally does not understand the risks and, despite his libertarian views on freedom of choice, struggles with the idea of prescribing on the basis of “unpublished research.”

Returning specifically to Dr John Stevenson, his full c.v. is displayed on the internet, and is impressive:


Dr Stevenson is a highly respected endocrinologist with particular expertise in the cardiovascular risks of both HRT and the menopause. He is a Consultant at the Royal Brompton, in London.

He is currently:
  • Chairman of the charity Women’s Health Concern
  • Executive Committee member of the British Menopause Society
  • Fellow of the European Society of Cardiology
  • Member of the Scientific Advisory Board of the National Osteoporosis Society (UK)
  • Non-US Section Head, Cardiovascular diseases in women (reproductive and post-reproductive age), Women's Health, Faculty of 1000 Medicine
And in the past he has been:
  • Chairman of the British Menopause Society
  • Treasurer of the UK Bone and Tooth Society
  • Executive Committee Member of the International Menopause Society
  • Executive Committee Member of the European Menopause and Andropause Society
  • Member of the Medical Research Council (UK) Advisory Board
He has been happily married to Bonnie, previously a Nursing Sister, since 1977. They have 3 children. The family is completed by Paddy (a large flat-coated retriever), Gizmo (a Persian cat), Mopsy (a Dutch rabbit) and Maximus (a Guinea Pig)!

He sees private patients in London, Woking and Guildford.
Dr Crippen will bumble on steering his uncertain course through the middle ground. He will cautiously recommend HRT to women with significant menopausal symptoms and will do his best to give a thumbnail sketch of the pros and cons. He will not be saying that HRT reduces the risk of heart disease and, when the PMJ article is waved under his nose, as surely it will be, he will say that it is too early too tell. He will continue to say that HRT slightly increases the risk of breast cancer. And he will neither recommend nor prescribe it for women who have had breast cancer.

He will, on request, refer women to menopause “specialists”, but will continue to advise that such a referral always results in a prescription for HRT.

And finally, Dr Crippen’s heart will continue to sink when patients arrive with their copy of the PMJ carefully folded to display the medical pages.

+++++++++++++

Those who have missed some of the PMJ leading articles on HRT and the menopause may care to look at some of the following – chosen with care from the hundreds that are available. Try a little exercise for me. Think about your own views and beliefs on HRT and then try to reconcile them with all the PMJ articles below. All in a day's work for a GP.

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4 Comments:

Blogger Dr Grumble said...

This post has been removed by the author.

Sunday, February 24, 2008 5:17:00 PM  
Blogger Dr Grumble said...

Dr Crippen has always been cynical about trends and fashions in medicine. Just as he worries now about putting the world and his wife on statins....
******
It may be OK for the world but you were right to worry about your wife, Dr Crippen.
http://online.wsj.com/article/SB120277403869360595.html?mod=home_health_right

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