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In
postmenopausal women, appropriate lowdose estrogen reduces
all disease and death risks: The latest evidence from
the Women's Health Initiative WHI study June 2007 (1)
As
we have known from evolution, physiology, and for the
past 50 years since Masters and Johnsons’ pioneering
studies, appropriate balanced bio-identical (BID) human
sex hormone (HuSH) replacement does nothing but good.(2)
The
WHI was badly designed (possibly in the commercial interests
of the USA, Wyeth); and the WHI design caused gloom when
published in 1998 (we stopped using such Premarin-type
combinations where possible some 7years earlier). Fortunately
the WHI did relatively little harm (although no good)
for the elderly fat women so unwisely put on HT. But WHI
confirms what we long knew - that in the under-sixties
-from the earliest WHI (2002/4) papers, even PremPro lowered
all-cause mortality, and breast cancer incidence, by 1/3.
This correlates perfectly in the latest WHI paper with
60% reduction in coronary artery calcification in WHI
with appropriate HT.
The
disaster is that WHI hysteria in the feral media, fed
by the far more flawed Million Women "Study"
and abreaction from the medical hierarchy and Regulators,
frightened possibly millions of women and physicians off
appropriate HRT and HT, causing endless human misery and
expense. This was no doubt to the gain of eg cardiologists,
and marketers of wannabe substitutes like biphosphonates,
NSAIDs, SERMS, prozacs and phytoestrogens. (Administrators,
Regulators are seldom experienced active menopause clinicians:
eg Prof Professor Muller-Oerlinghausen -who pronounced
HRT "the new thalidomide disaster" in 2003 -
has authored hundreds of papers on psychopharmacology,
but apparently none on HRT).
Make no mistake, vascular disease (heart, kidney, stroke,
blindness, even some dementia) is by far the commonest
crippling killer of the well-off aging, with most deaths
(whatever the run-up) being sudden ie by cardiac arrest
rather than decades later by cancer, dementia, involution,
old age etc.
It is common cause that estrogen promotes arrhythmia (which
triggers sudden death) whereas testosterone is anti-arrhythmogenic;
and that together in physiological balance (+-/or progesterone),
they minimize thrombosis, frailty, cancer, loss of cognitive
function, bone and muscle, - reducing all-cause premature
major disease and mortality ie ageing by at least 1/3
ie adding at least a decade to health and longevity.
The only other intervention (apart from HRT) which alone
gives so much long term benefit is:
>>metformin – which almost halves type 2 diabetic
deaths and is also the only agent that (in the overweight,
those at risk) reduces incidence of new diabetes by half;
>>mineral-vitamin-conditioned essential (biological)
supplement; and
>> fish oil which uniquely reduces sudden death
by 50%, all major chronic degenerative diseases by 1/3,
and all-cause mortality by only 20%.
Before this Manson WHI paper, the unique 9year Oulu Finland
RCT (Heikkinen ea 2006) confirmed that in sturdy women
(BMI 25kg) starting HT at age ~56yrs (HALF of whom had
already been on HRT for a mean of >4yrs), after another
9 yrs on HT there had been zero cardiovascular events
in 3771 women years on continuous HT - either 0.7 or 1.4mg
E2/day plus 2.5-5mg MPA/d vs the peer local CVD rate of
0.21%pa - .ie. 1.8% = 71 events could have been expected.
But more important, there had been zero major adverse
effects in the 69 women on conservative HT (0.7mg E2 +
2,5mg MPA/day orally), whereas in 280 women on 1.4mg E2/d
with 2.5 or 5mg MPA, there were major adverse events in
6.8% - 2.1% got BRCA, 1% died and 1% had pulm emboli.
This confirms that lower-dose HT equivalent to 0.45mg
premarin plus 2.5mg MPA is much safer than double that
dose- and even the high-dose women had zero CVD. This
RCT had no placebo arm, and no arm on solo ERT; but it
gives the lie to the myth that appropriate conservative
HRT (even orally with estradiol + MPA) for a mean of about
11 yrs) gives ANYTHING but major reduction in all disease
and death.
And it confirms evolution and 60 years of experience,
that systemic BID balanced testo-esto-progesterone replacement
at perhaps 5% of the oral doses will be proven to have
even less longterm risks and even more benefits than low
dose oral estrogen+ synthetic progestin – which
together already has proven major long term benefits for
women as in the long term Byrd & Burch; Schleyer-Saunders;
Greenblatt; Gambrell; Nurses'; Cache County; Whitehead-Studd;
and now the WHI and the Oulu studies - when started appropriately
and permanently to patient tolerance.
References:
(1) NEJM:June 21, 2007: 356:2591-2602
Women's Health Initiative study: Estrogen Therapy and
Coronary-Artery Calcification
Jo Ann E. Manson, Jacques E. Rossouw, et al for the WHI
and WHI-CACS Investigators
Background Calcified plaque in the coronary arteries is
a marker foratheromatous-plaque burden and is predictive
of future risk of cardiovascular events. We examined the
relationship between estrogen therapy and coronary-artery
calcium in the context of the WHI trial.
Results The mean coronary-artery calcium score after trial
completion was lower among women receiving estrogen (83.1)
than among those receiving placebo (123.1) (P=0.02 by
rank test). After adjustment for coronary risk factors,
the multivariate odds ratios for coronary-artery calcium
scores of more than 0, 10 or more, and 100 or more in
the group receiving estrogen as compared with placebo
were 0.78 (95% confidence interval, 0.58 to 1.04), 0.74
(0.55 to 0.99), and 0.69 (0.48 to 0.98), respectively.
The corresponding odds ratios among women with at least
80% adherence to the study estrogen or placebo were 0.64
(P=0.01), 0.55 (P<0.001), and 0.46 (P=0.001). For coronary-artery
calcium scores of more than 300 (vs. <10), the multivariate
odds ratio was 0.58 (P=0.03) in an intention-to-treat
analysis and 0.39 (P=0.004) among women with at least
80% adherence.
Conclusions among women 50 to 59 years old at enrolment,
the calcified-plaque burden in the coronary arteries after
trial completion was lower in women assigned to estrogen
than in those assigned to placebo. However, estrogen has
complex biologic effects and may influence the risk of
cardiovascular events and other outcomes through multiple
pathways.
(2) based on Masters and Grody's first RCT in 1953 with
what became Schering AG and Organon's gold-standard depot
testosterone- estradiol injection HRT for women;
and based on careful decades-long observation of probably
millions of women since then in responsible HRT clinics
worldwide including in N America - Byrd & Burch; Greenblatt;
Gelfand; Naftolin; Notelovitz; Shifrin; Utian; Vliet;
Clarkson;Harman, Shippen ; in Denmark- Tvedegard Moller
& Hansen, Christiansen & Riis; in Germany - Schneider,
Nieschlag & Behre ea; in UK - Schleyer-Saunders; Ginsberg
& Prevelic, Whitehead & Studd, Stephenson, Trinick,
Al-Azzawi ea, Purdie;Sturdy; many others in all of Europe,
Israel, the Middle East, Asia and South America; in Australia-
Burger & Davis, Bondy ea; and in Cape Town under the
leadership of Prof Dennis Davies et al.
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