question: What are the reasons given for forbidding HRT after age 60yrs. S.
ANSWER: Hysteria on the part of self-proclaimed experts who supported the misguided plan of the Wyeth premarin-provera Womens’s Health Initiative WHI 13 years ago, then misinterpreted and swallowed the patently wrong results when they were examined in 2002-4 together with the largely meaningless Million Women Study MWS- both of which the International Menopause Society has consistently refuted. http://www.imsociety.org/pdf_files/ims_recommendations/ims_updated_recommendations_on_postmenopausal_hormone_therapy_27_02_07.pdf?SESSID=qe5239k4hiqd662fqf0h1og6a2
In 2003 no less than the chairman of the German Commission on the Safety of Medicines Professor Bruno Muller-Oerlinghausen, reportedly described HRT as a “national and international tragedy after evidence emerged that it had caused thousands of deaths. More women have probably died from the … hormone therapy than damaged children were born in the wake of the thalidomide scandal.” http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=214066. This was pure hysteria, there was no such evidence.
The N American Menopause Society (NAMS) has repeatedly since 2002 been urged to recant from the WHI – and MWS-generated hysteria (Utian 2007), and has now done so at http://www.menopause.org/PSHT08.pdf.
The gynecologist- led SA Menopause society SAMS followed the Wyeth lead of the N American Menopause Society NAMS, rather than evidence and the International Menopause Society.
Despite Dr Utian’s review last year, and the now balanced IMS and NAMS position, the SAMS website still damagingly (17 August 2008) declaims publically: “The guiding principle should be to take the smallest possible dose for the shortest time necessary. After the first five years, women – with guidance from their doctors – should try and come off hormone therapy and see how they cope without hormones.” http://www.samenopausesociety.co.za/.
As IMS and Dr Utian point out, all reason, observational and scientific evidence reject such limited approach which focuses largely on symptoms, instead of the far more important long term prevention of degeneration of mood, mind, skin, hair, bones, muscles, heart, circulation etc, which prevention appropriate physiological supplements provide for the second half of lifespan after menopause/ “andropause” – which can defer disability, add decades to health. .
The WHI tested only Wyeth’s oral HT – the xenohormones premarin and provera – in mostly overweight elderly women, it did not test physiological parenteral balanced human hormones as we have evolved on for millennia, as used in men and in all other branches of endocrinology, and has been used appropriately and safely worldwide for over fifty year. . The WHI cost almost a billion US$ (for both the HT – in 15400 women for a mean of almost 6 years- and diet and calcium trial arms), likely the costliest trial that will ever be done. The HT caused a few older women problems, but the hysteria (in USA, UK & Europe) resulted in perhaps millions of women since then suffering from stopping or avoiding HRT. But like all wars, it produced some invaluable results.
We stopped using oral HRT pills where possible here in the early ’90s because we saw such bad results overall in overweight stressed women.
Despite the warnings about high risk:benefit problems, Wyeth – like Robert Wilson’s Feminine Forever- 1966- persuaded the NIH & the American Menopause Society, the FDA and most American doctors and women- that postmenopausal women need & will benefit from premarin-provera forever, or just premarin after hysterectomy. . This was despite the massive evidence against commercial HT pills in the Seamans’ book Women and the Crisis in Sex Hormones (UK 1978).
But when the WHI trial after about 7 years was misreported to show that (at age 50-79yrs), the only benefits OVERALL were reduction in the (5 to 10year) menopause SYMPTOMS, and reduction in fracture and colon cancer BUT apparent increase in vascular disease dementia and breast cancer, the WHI panicked and stopped both trials (premarin-provera, and premarin alone) – and worse, roundly condemned all post menopausalsex hormone replacement .
It has taken the International Menopause Society 6 years to get them to understand what was obvious from the original planning paper of 1998, and the first trial result of 2002 with their poor statistics, that the results apply ONLY to those commercial oral pills they used, and to the older women they inappropriately put on horsepills despite them being overweight, smoking, hypertensive etc- ie at high risk.
When the WHI belatedly published results by age breakdown (first in 2004), it confirmed what we always knew – that horsepills STARTED FROM MENOPAUSE are ok for symptom control for up to 10 years , they reduce all deaths and most degenerative disease by almost 40% (except for insidious increase in obesity, DVT, urinary incontinence, and gallstones.- and this in an age when, as the BBC reports 14 Aug 2008,* Obesity ‘equal to terror threat’ The threat to the nation and the NHS from rising obesity is as grave as that posed by terrorism, a government adviser says”. ).
This low risk:benefit advantage was well shown in both WHI and the 10 year Oulu Finland trial (Heikkinen 2006) when even women on lowdose ie 1mg/d estradiol +- 2.5mg progestin did brilliantly.
But we have known for decades that the oral combination gradually promotes breast cancer, which increases after 12-15yrs (Henderson ea 1980).
So all HRT after age 60yrs was wrongly condemned by “Authorities” , when it has been known for decades that in lower dose started from menopause even appropriate oral HT long term does far more good than harm . The major risks are when it – ie megadose estrogen-progestin = hormone therapy -is started in the overweight or well after age 60yrs, when it is more likely to trigger already threatening thrombosis, cancer or dementia – as has been well shown with tibolone started at a mean of 68yrs (Cummings ea LIFT trial NEJM August 2008).
So all hormone-deficient people benefit from permanent physiological replacement– ie HRT- as with eg thyroid or adrenal failure, started the earlier the better.
But sex hormones for both men and women are best taken parenterally [ie not by mouth- when they are absorbed via the liver (hepatic 1st pass) , digested & broken down]. So with tablets, 10 times more is needed for symptom control, while the risks rise for hepatitis-gallstones, hypertension, thrombosis & breast cancer.
So like men, women should take permanent appropriate human HRT based on their blood levels and response- but ideally parenterally, (not orally = HT) –
estradiol around 0.025 to .07mg/d (compared to oral dose around 0.5 to 1mg/d)
– testosterone 0.3 to 1mg/d (compare the old oral methyltestosterone 1.25mg/d, or for men oral testosterone undecanoate 120mg/d vs about 8mg/d by eg fortnightly or injection)
– progesterone 1 to 5mg/d (oral 200mg/d)
by subcutaneous injection fortnightly- very cheap; or expensively by creams, implants, patches, sprays, suppositories .
Lowdose micronized human hormones are also effective and safe (Dr Lee Vliet), but only micronized estradiol is available here.Major clinics around the world have used such balanced parenteral or oral replacement for over 50 years, and seen nothing but good results- some women of over 90yrs just keep coming for eg their implants every 6 months (Gambrell 2004 personal communication). All the common degenerative diseases are reduced eg Alzheimers perhaps by 90% (Cache County Study).
Even supplements, including HRT, can never abolish death and disease permanently! only defer and minimize disease. That’s why patients have to be screened first, and then periodically thereafter, so already active disease eg cancer can be promptly dealt with.
Part of the problem with oral HT is that the synthetic progestins – while protecting the uterus- have some bad effects like blocking estrogen benefit on the heart, brain and bone. The natural human progesterone on the other hand does only good (apart from lack of benefit on bone, and association with failing hearing).
The major problem with HRT is that (in men and women), doctors and patients mostly take a shortterm view- just treat symptoms & sexual complaints. They negligently refuse to recognized that all supplements are essential for the second half of life, and act accordingly. This is the danger of focussing on symptoms instead of the whole patient’s needs. Its like ignoring a knock in the engine/bearings; or smoking, or ignoring increasing obesity till the patient dies or first gets diabetes, heart attack, stroke, cancer, dementia, fracture – when it is often too late to restore health. This is criminal negligence.
On the other hand, calcium supplement alone has slight benefit on bone, but increases coronary calcification disease.
In the WHI, Calcium plus lowdose vit D 400iu lowered hip fracture by 30%, but increased kidney stones by 17%. it is better and safer to take a complete supplement which includes calmag boron zinc manganese proline and the vitamins B,C,D & K. Adding the other trace elements plus bcarotene + vit E plus the biologicals gives major protection against not just fractures but also all major common disease. So ideally (in addition to thyroid, cortisol, insulin resistance & sex hormones), the vit D level should be measured, and if low the supplement increased to 1000 to 7000iu./day or 50 000iu/week.
Why not phyto(plant) -estrogen or drug substitutes for HRT? on the one hand, the only proven supplements that reverse osteoporosis and restore are HRT plus the basket of other supplements; and the only supplements proven to improve menopause symptoms are appropriate HRT, or the supplement GABA (the main brain neurotransmitter).,
But kava and black cohosh have been restricted/ banned because they may rarely be associated with fatal hepatitis.
Soy and other phytoestrogens may reduce menopause symptoms, but have not been shown to be safe longterm, and there is concern that they may increase breast/ prostate cancer. And no modern designer drugs– statins, prozacs, tibolone, raloxifen, biphosponates, tranquilizers, nonsteroidal anti-inflammatories, the viagras – despite all their costs, risks and heavy marketing-produced multibillion $$ sales – have shown anywhere near the global benefits of the natural supplements discussed above.- (unlike the natural supplements), none of the modern wannabe substitutes reduce all-cause mortality and morbidity as do supplements including appropriate HRT.
See the HRT and supplement papers above and below , and the recommended condition-specific supplement product information.. For specialist internist consultation on appropriate supplements including HRT for individual circumstances, email your concise health details to firstname.lastname@example.org