Tag Archives: Appropriate HRT

UPDATE FEB 2012: WANNABE ALTERNATIVE HRT eg TIBOLONE LIVIFEM IS INFERIOR TO APPROPRIATE HORMONE REPLACEMENT.

24 Feb 2012  Sharifah Zainab asks about safety of tibolone after more than 10 years on it; and whether and how to wean off it.
 
No new singnificant studies change the hard evidence that tibolone may
do more harm (than good) eg may increase stroke, breast cancer, fatness and vaginal bleeding. The comprehensive Cochrane review of last week affirms this:          Cochrane Database Syst Rev. 2012 Feb 15;2:CD008536.Short and long term effects of tibolone in postmenopausal women. Formoso G ea WHO Collaborating Centre ,  Modena, Italy.  “Tibolone is an option available for the treatment of menopausal symptoms, based on short-term data on its efficacy. However, there is a need to consider the balance between the benefits and risks of tibolone as there are concerns about breast and endometrial cancer as well as stroke.   MAIN RESULTS: When compared to placebo, tibolone was more effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 847; OR 0.42), although only the 2.5 mg/day dose of tibolone was significantly better than placebo; but with increased vaginal bleeding (seven RCTs, n = 7462; OR 2.75). When compared to equipotent doses of combined HT, tibolone reduced vaginal bleeding (15 RCTs, n = 6342; OR 0.32) but was less effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 545; OR 4.16).As for long term safety, two major RCTs of tibolone versus placebo provided the most relevant data. An RCT of 3098 women with breast cancer and menopausal symptoms was halted after 3.1 years because of increased tumour recurrence (OR 1.50). However, in another RCT that selected osteoporotic women with negative mammograms (n = 4506) tibolone was associated with a reduction in breast cancer compared to placebo after 2.8 years (OR 0.32) although the trial was not specifically designed to assess that outcome and the number of overall events was low. In the same RCT, an excess risk of stroke was observed (OR 2.18). There was no clear evidence of a tibolone effect on endometrial cancer compared with placebo given the low number of events (seven RCTs, n = 8152; OR 1.98).There was no evidence of a difference in long term safety between tibolone and combined HT. AUTHORS’ CONCLUSIONS: Tibolone, used at the daily dose of 2.5 mg, may be less effective than combined HT in alleviating menopausal symptoms although it reduced the incidence of vaginal bleeding. There was evidence that treatment with combined HT was more effective in managing menopausal symptoms than was tibolone. Available data on the long term safety of tibolone is concerning given the increase in the risk of breast cancer in women who had already suffered from breast cancer in the past and in a separate trial the increase in the risk of stroke in women whose mean age was over 60 years. Similar concerns may exist for estroprogestins but their overall benefit-risk profile is better known and is more directly related to women with menopausal symptoms.”

Why use a risky synthetic  drug designed for profit when as this column repeatedly stresses, there are so many safe natural supplements that reduce all risks?

update : Jan 2010:  WEIGHT GAIN ON TIBOLONE:

Hester asks about a better option HRT since she has gained 5kg in a few months on Livifem tibolone.

One cannot treat an unseen patient by email based on a one-line history.

all one can advise is,  read about the serious risks and deficiencies of quick-fix heavily marketed snakepills compared to finely tuned natural products eg human hormones and other natural supplements evolved/designed over millennia rather than recently in for-profit laboratories.

There are  two  new  illuminating papers on tibolone since the November review:

Dr Peter Kenemans writes from the Netherlands Vrije Universiteit:  Tibolone revisited: ‘still a good treatment option for healthy, early postmenopausal women‘.

Drs de Melo and Pompei from Sao Paolo UniversityTibolone reduces osteoporotic fracture risk and breast cancer risk, but increases the risk of stroke.

The Ziaei paper detailed below  addressed only weight issues, and describes average results.

In the  Royal Free Hospital  study in London in 1995, they found that  in their 300-patient experience over 8 years ie medium term –  an impressive 2400 patient years- that  “The major side effect was weight gain and/or a tendency to bloating and oedema which occurred in 11.28% of our women”.

This doesnt mean that tibolone increases fatness- most women inexorably get fatter and frailer once past menopause. Certainly they dont do this if they maintain good balance of human hormones- testosterone, estradiol, progesterone, thyroid and insulin-  with a sensible blend of  all the other other scores of useful  supplements, and  diet and exercise.

By contrast, shortterm controlled trials – 6 months from Turkey (2006, and 2009) and  Ziaei’s 9month trial- show that in the short term, tibolone reduced body fat and waist.

BEAR IN MIND THAT MANY STUDIES SHOW THAT EVEN JUST 10 YEARS OF APPROPRIATE SEXHORMONE THERAPY FROM EARLY IN MENOPAUSE HAS MAJOR LONGTERM BENEFITS ON REDUCING ALL RISKS eg FRACTURE, CARDIOVASCULAR AND DEMENTIA RISKS IN LATER LIFE – without any significant adverse effects. . There do not appear to be published any studies of tibolone or any other wannabe substitute  over  a mean of more than 5 years. But women now often survive more than one-third of  their lifespan post menopause- that is another 35+ years. No modern designer chronic drug  has been used and observed reasonably continuously to be safe for much more than 10years .  The only designer drugs which have been used continuously for much longer are perhaps the old diuretics and some  antihypertensives.

Tibolone is yet another designer progestin- and the Women’s Health Initiative showed that, even when started appropriately soon after menopause,  progestin (medroxyprogesterone MPA)  reversed the myriad benefits of  premarin alone  in respect of worsening fracture, breast and cardiovascular risks.

This contrasts with natural supplements like eg minerals and vitamins, the plant extracts reserpine and the  prohormone metformin,  and all the human hormones- thyroid, insulin, cortisone, testosterone, estradiol- which many patients have used continuously for over 40 years with nothing but benefits in appropriate doses.

So as always its up to  you the patient to decide whose advice, what to try. All any doctor can do is (in a brief consultation) offer advice from his experience and ongoing update studies – which may not be up to the minute. You have to decide about shortterm benefits versus long-term possible risks. In the few months on tibolone, are you just swollen-eg  needing to reduce salt?- or fatter  waist with higher bodyfat,  bloodpressure, insulin resistance etc?

Nov 18, 2009
a new study last month bears out the futility of spin,  focussing only on benefits in abstracts. The small short (9month) trial by Ziaei ea in Tehran Iran  on Comparative effects of continuous combined hormone therapy and tibolone on body composition in postmenopausal women concludes  that The effect of tibolone on body composition is favorable and therefore tibolone may be regarded as an alternative to continuous combined postmenopausal hormone therapy MHT .  Tibolone significantly increased weight, BMI and FFM and decreased WHR after the treatment in comparison with baseline (p < 0.05). However, only weight and BMI increased significantly in the CEE/MPA group after the treatment (p < 0.05). There were significant increases in weight, BMI and fat mass in the control group after 9 months..  So they confirmed what has been obvious all along: that postmenopausal women gain weight and fat post menopause, and on xenohormones (premarin+provera) gain even more fat at the expense of losing lean mass. A synthetic xenohormone progestin like tibolone increases weight, BMI,  and FFM (it’s androgenic property) –   but they ignored the multiple deficiencies of tibolone (unlike appropriate HRT), that it increases breast cancer,    stroke, vaginal bleeding and endometrial cancer and perhaps CVD, and fails to reduce either all-cause or breast cancer mortality, or depression or  dementia. .

SUMMARY: No published trials have yet shown any alternatives as good as appropriate HRT (ie estrogen -progesterone- testosterone) for overall long term benefits post menopause.
eg  with  the synthetic progestin tibolone – the 3 year LIFT trial had to be stopped early due to strokes, and in  the 3year LIBERATE trial breast cancer recurrence increased 44%. As the International Menopause Society IMS keeps stressing, all synthetic sex hormones are inferior to appropriate balanced sex hormone replacement for eg menopause symptom relief, and against osteoporosis fractures. Many different modalities relieve the short-term menopause symptoms, but these matter far less than the long term preventable degenerative effects of hormone deficiency- which are the primary concern of patients, carers, internists and geriatricians. The average gynecologist (surgeon) deals only with  menopause symptoms, which mostly subside well within 10 years ie by age 60years – but that’s when all aging medical not gynecological problems start,   increasing  incapacity problems – vascular, cancer, fracturing, mental, mood, fattening, frailty, sex, incontinence and thus loss of decades of quality life.

Analysis To August 18, 2008 ·

The LIFT trial report by Steve Cummings et al (NEJM   August 14, 2008  The Effects of Tibolone in over 4000 Older Postmenopausal Women -mean 68years)  is another nail in the coffin of tibolone.

The LIFT trial was stopped after a median of just 34 months because Tibolone doubled strokes – up from 0.34% to 0.66% per year. .

Tibolone,  unlike appropriate HRT, has no significant reported benefit on all-cause mortality, on cardiovascular disease (which increased by 37% – p0.28), on memory/ dementia and on depression , although  it almost halved fractures –  but  it doubled the risk of stroke, trebled rate of breast discomfort and vaginal bleeding- which  rose from 2.9% to 9.5%; even the incidence of cervical dysplasia rose from 3.2% to 7.6%. And it increased weight in this already overweight cohort by an excess of 0.6kg in 3years..

Breast and colon cancer rates were too low to draw conclusions about benefit. “The tibolonegroup also had a decreased risk of invasive breast cancer (relativehazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer(relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04)” – but the incidence of these and coronary artery disease were each only 2 – 3% pa on placebo..

So it finally  confirms tibolone as just another synthetic progestin looking for a disease to treat, much inferior to real supplements including  appropriate HRT (vitamin D and   lowdose parenteral human estradiol-testosterone-progesterone) for reduction of all the major diseases of aging. There are no contraindications to, only benefits from  such long term appropriate  steroid hormone replacement.

Update November 2009:

In a further LIFT trial report (Ettinger & Cummings Sept 2008), Tibolone treatment for 3 years minimally increased endometrial thickness, hyperplastic polyps, and endometrial carcinoma.

In a Danish trial , tibolone had no benefit on cartilage degeneration. whereas appropriate HRT has benefit (Forsblad Scandanavia 2004).

In the massive 31-country 2002-4 LIBERATE trial (Feb 2009 Kenemans ea ) in over 3000 women after breast cancer, recurrent breast cancer increased 44% with tibolone over a mean of 3.1yrs. Tibolone was not different from placebo with regard to other safety outcomes, such as mortality (respectively 72  vs 63 patients), cardiovascular events (14 vs 10), or gynaecological cancers (10 vs 10).

A report in September 2009 from Health and Human Services’ Agency for Healthcare Research and Quality suggests that tamoxifen, raloxifene, and tibolone used to treat breast cancer significantly reduce invasive breast cancer in midlife and older women, but also increase the risk of adverse side effects.

Regretfully, tibolone has not fulfilled early  hope that it might be the first designer drug since metformin to be another panacea, reduce all-cause morbidity and mortality even in postmenopausal  women.

It appears that despite 40years  use elsewhere, tibolone (not invented and marketed by a US corporate)  has still not been  and is unlikely to be licensed for use in USA – like SERMS (tamoxifen, raloxifene) its benefits are so limited that they are not  enough to balance it’s risks. .. doubling the risk of stroke and increasing the already high  general risk of breast cancer by 44% in only 3 years. Whereas  all (ie multisystem) risks and frailty are reversed by the safe threescore mix of natural supplements plus appropriate balanced physiological human hormone replacement as regularly set out in this column. .


update: BISPHOSPHONATES AND MALIGNANT BONE PAIN: REBUTTAL AND COUNTER-REBUTTAL

 neil.burman@gmail.com

update 2 Oct 2010: a practitioner asks what to do for a  white female 58years:
1998 ductal cell. lumpectomy, radiation, 15 nodes removed.  Tamoxifen  5 yrs.
2009  lobular cell. double mastectomy, nodes removed.  Aromasin  for next 5 yrs.
Osteopenia -2.3  found inside  1 yr .    on
Boniva ibandronate  4 yrs, stopped recently. 
 Doesn’t want to take IV drug for osteoporosis. 24 hr urine calcium  normal.  High vitamin d levels.
takes a lot of calcium,  vit d, vit c, vit b complex sups. Takes Prilosec omeprazole for reflux and hiatal hernia. chronic insomnia.
The questioner does not reveal her bodymass index or resting morning cortisol level or insulin resistance- all of which may well be raised; nor give her crucial vitamin D and C  intake or vitamin D  blood level. It is a question of evidence, not opinion – dogma- or laboratory average population ranges , as to what are optimal intakes and blood levels.

This column  has regularly reviewed the conflicting views and evidence  on osteoporosis;  BNP and breast cancer; and the safe multisystemic efficacy of using the score of natural supplements- including appropriate combined hormone replacement therapy – that safely oppose both osteoporosis – bone and muscle frailty-  and the associated chronic major involutionary diseases of aging especially vascular disease, dementia  and cancer. .

 The antireflux proton pump inhibitors PPI drugs notoriously aggravate osteoporosis; and for average reflux are not necessary with use of slippery elm, apple cider vinegar, simple calmag  and sensible diet and lifestyle.  It has been known for years that PPIs  more than double risk of osteoporosis, so why take them?. 

On the other hand, the pluripotential hormones of darkness and light –  vitamin D3 and  Melatonin – combined with the other mulibeneficial natural supplements that synergistically relieve/ reduce insomnia,  reflux pain,  cancer, depression, memory loss  and all other significant major chronic degenerative diseases of aging.

As this column regularly updates, Metformin too is a natural supplement (plant) co-hormone- a veritable panacea-  that reduces all major chronic disease and mortality by about a third- including cancer; and  dementia perhaps via reducing serum amyloid levels.let alone tissue oxidation, glycation, vasculopathy. BPN has none of these extraosseous benefits, only deadly risks.  

 Similarly, appropriate transdermal human estrogen but not oral xenoestrogen- CEE-  reduces serum amyloid in postmenopausal women,  while low testosterone raises serum amyloid in men.

So middleaged patients are at terrible risk of anxiety depression hypercortisolemia, frailty fractures, vascular disease , cancer and dementia after cancer, especially with sex hormone suppression or blockade. They do not need the myriad risky designer drugs touted for prevention of more cancer etc, all they need urgently and permanently is the scores of appropriate natural balanced supplements as this column regularly reviews- most of which supplements can simply be mixed in a tub of customized powder blend to be drunk twice daily. .

:Feb 13, 2009    In response to  Death-knell-for-bisphosphonates-for-osteoporosis-breast-cancer-time-for-class-action-against-bisphosphonate-damage last week,  a world-renown emeritus professor of radio-oncology comments:

“the action of the bisphosponates BPN is to inhibit osteoclastic action and thus reduces bone resorption; the patients tell the story- they get immediate and sustained relief from bone pain; if they  are on opiates the need is much reduced. Of course palliative RT is valuable, but often if pain recurs after RT the BPN give welcome relief, at least in my experience.

The  IV BPNs are also very useful in the oft-times encountered hypercalcemia often threatening myeloma- and other cancer patients. I am not however, too conversant with D3 in this setting!” But the first reference links are the latest in the clinical field of BPN and cancer.

Other than  in terminal cancer cases- when it doesn’t matter what convenient pain relief is used-  the problem with bone pain in cancer always is, what is the cause? either bone resorption from the catabolic effect of cancer (via eg high parathyroid hormone PTH);  OR cancer eating away at bone itself, OR something else common OP  unrelated to the cancer.?

But FOR CANCER-RELATED bone pain lesions – whether directly from cancer there, or from remote metabolic effect –  where are the trials comparing BPN with other antiresorptive antineoplastic ANTIINFLAMMATORY ANALGESIC ANABOLICS ie testosterone (or occasionally estrogen/ other antiandrogen)  and vitamin D3?

Obviously bone metastases are attacked with appropriate chemo-/ xray XRT, cortisone, testosterone AND if deficient, vitamin D3.

To put it the other way round: where is the evidence that BPN – at cumulative cost and risk-  adds benefit to the multiple attack? where the evidence that- unlike testosterone and vitamin D3- BPN has any benefit except on bone pain? Hypotheses based on in vitro and animal and human cell culture studies have  not translated into even good observational comparative evidence favouring BPN as good benefit:cost ratio for osteoporosis or cancer.

The oncologist answers in the traditional mode, by experience that BPN works. But evidence-based medicine EBM asks where is the comparative evidence for BPN to challenge the evidence that we have better multi-attack without BPN – when these supplements are not equally commercially promoted and tested in controlled trials for the usual commercial  reason ?

The dream of drug manufacturers is eternal, that their raincheque designer drug- statin or BPN or antihypertensive- will prove to be a safe multisystem panacea as is metformin and many  other supplements like vitamin D3 or testosterone. But after more than 30 years of BPN and statins, no trial in humans has yet shown this for BPN or  statin or any other original designer drug.

update: ACQUIRING/JUGGLING THE BEST SEX HORMONE HRT REGIME FOR WOMEN.

Joey Basson writes January 28, 2010

I used Primogyn Depot for about 20 years, but I believe it has been discontinued in South Africa. I am now really struggling to find something that really works for me.

The injection was perfect. Do you have any suggestions?

reply: Hi Joey,
DRUG COMPANIES GANG UP  TO SUPPRESS CHEAP EFFECTIVE AGENTS -AS THEY DID FOR 25 YEARS EACH WITH LITHIUM AND METFORMIN IN USA, STILL BLOCKING HUGELY BENEFICIAL USE OF CANNABIS; AND  at the end of 2008, without notice or warning,  they conspired to abolish  CHEAP APPROPRIATE  NON-ORAL HRT IN RSA- the depot injections MIXOGEN, DEPOTRONE, even PRIMODIAN DEPOT, PRIMOGYN DEPOT.

NOW APPROPRIATE NON-ORAL HRT COSTS ALMOST 5 TIMES AS MUCH TO USE, AS eg CREAMS, PATCHES, SPRAYS, IMPLANTS FOR BOTH MEN AND WOMEN- AND FOR WOMEN WITH FAR MORE BOTHER.

Now the only way we are going to get such injections back in RSA is if there is enough interest to fight through the red tape to import from overseas. But South African administration is now so degenerate   under the corrupt  Zumas that it takes 2 years to get desperately needed doctors and sisters registered here – and who cares about appropriate HRT for the aging? Certainly not the notorious “doctor” or “Rev”  Zumas since they dont give a fig for evidence or human -especially  the poor and womens’-  rights..

if you live too far away, we can do a personal consult by email+- phone +- skype – via the necessary questionnaire by email- for you to discuss and implement with your local GP.

see numerous updates the past year at  https://healthspanlife.wordpress.com/?s=HRT

22 March 2009

An update review by Barry Wren from an Australian Menopause Clinic again debunks the myth that appropriate HRT in postmenopausal women PMW increases the risk of breast cancer, cardiovascular  disease CVD and thrombosis. It  stresses that “benefits of HRT include  less:  symptoms of menopause;  osteoporotic fractures,  ischaemia and cardiovascular-related death, forgetfulness, dementia and colorectal cancer; and  improved well-being, quality of life,  vagina, sexual enjoyment and bladder capacity,  with increased longevity. Oral  OHT doubles the risk of thromboembolism”. But on it’s own  in the young women in the Womens’ Health Initiative, oral equine estrogen (premarin)  reduced all major risks even new breast cancers and death from breast cancer.

As we hear regularly in women who have unwisely followed hysterical advice to stop HT,  stopping appropriate HT leads to fairly rapid loss of many of the above benefits. It has been  obvious for a century if not millennia   that permanent appropriate Human Hormone Replacement HRT of any of the dozens of our hormones that run out   is  (like a complete supplement of all the vitamins, minerals and the biologicals other than HRT)  prudent if not essential.

But we have to understand the reasons, risks and different regimes available. Nobody may prescribe or administer any sex HT Hormone Therapy without the necessary up-to-date training and experience, ensuring that the patient is having the necessary periodic examinations to ensure both safety and that the SHRT is appropriate. So patients must not self-treat with over-the-counter  supplements.

But only doctors and pharmacists who have costly current dispensing licenses may dispense and compound any hormone creams. And oral HT including phyto/plant hormones are  under suspicion of promoting cancer long term, let alone hepatic first pass effects like thrombosis and gallstones, and fluid retention oedema and hypertension (Genazzani ea 2008) .

INJECTION: tiny safe self-injection of combined hormone subcutaneously  (like insulin) is easy every one to three weeks, as most men use for HRT.  Monthly injection of depot preparations that last about three weeks  is not advised for anyone, especially not women with a womb as they are liable to have break-through periods. But unlike men, many women prefer to use hormone creams daily. The Depot hormone injections have climbed in price – what is now available averages about R75 per month. BUT (unless she gets the injection from her doctor regularly & proportionately every 1 to 3 weeks), women have to lay out about R1000 for self-injection (since  pharmacists will not likely  split a multi-vial or a set of three vials).

Provided that they ensure that they are appropriately trained in such therapy, all doctors are licensed to give periodic chronic injections – which should always be exclusively by tiny subcutaneous injection to avoid the notorious ie potentially crippling complications of intramuscular injections. But if nothing else is required, doctors are entitled to charge about R100 fee for the responsibility of an injection visit. Like insulin, patients easily learn to give it themselves- for men about 160mg depot-testosterone every 2wks (as opposed to 1gm testosterone undecanoate Nebido every 3 months- or about 1/10th of the male dose for women deficient in testosterone).

Synthetic ie xenohormones – those not normally produced by humans- eg progestins, ethinylestradiol-  may be invaluable (although by no means essential)  for birth control; but should not be used for PMW, especially not orally.

USING CREAMS: it is indeed best for women to (initially) juggle the balance of the three hormones  (all of which are made to the highest standard in South Africa)  until you have determined what ratio and quantity suits you best.

For the slim small older woman who needs both hot flash control and energizing, memory, ache relief:  the first priority is to control hot flashes, skin & hair without arousing breast and womb discomfort:

so try the 0.25% Bies(trogen) (E2 + E3- usually 1:4 ratio)  initially 1/2 ml scoop 1 – 2 x/day with the progesterone 3% cream initially just ¼ to 1/3 ml scoop a day ie 4 to 1 or 3:1 . This is ideally rubbed into the face as makeup- or if you like, dilute them in simple aqueous cream. Increase the combined dose to double if necessary to get control of the flashes – but the higher the Biest dose, the higher the risk of waking the breasts and womb, or getting thrombosis and ankle swelling.

And (unless your androgen level is still high) use just enough Testosterone cream 0.5% eg 1/2 to 1 scoop once (or twice) a day – below the waist ie vaginally or between the thighs or on the soft sole of the foot – to energize, improve alertness, libido, muscle and bone strength. Supplementing estrogen and progesterone alone may suppress necessary androgen.

In the bigger plump younger woman, who desires memory, energy, fat loss and libido rather than hot flash and skin improvement, using testosterone below the waist and progesterone on the face in the above gradually increasing doses often suffices, without the fattening and breast-womb arousing risks of extra estrogen. Such women often make enough estrogen from testosterone and in their excess fat stores.

But once the average women is well past 60yrs, low-dose estrogen often becomes advisable anyway for balance.

Old women benefit from and tolerate perhaps 1/6th to 1/10th the doses of appropriate balanced  human sex hormones of younger women.

THE THREE PRIME HUMAN SEX HORMONES: there are no risks from any appropriate HRT, only risks from avoiding it. Progesterone alone lacks some of the benefits of testosterone and estrogen eg on muscle- bone and hearing. Of the three hormone types, only androgen protects and improves muscle mass and strength. Testosterone excess (hairy face, acne, anger, clitoris growth, husky voice) is easily avoided with sensible balanced dose adjustment. Progesterone and testosterone have major benefits that estrogen may lack eg on hyperimmunity and inner hostility- issues that may not concern the gyne surgeon.

(Bi)Estrogen excess-  especially if used  alone-  does the reverse (of testosterone): promotes endometriosis and breast activation; excess actually weakens muscle eg bladder leak by melting collagen; it fattens; has little benefit directly on depression (although it does reduce dryness and pain); may promote thrombosis since unlike testosterone it does not diminish clotting; and may promote anxiety, hostility- this is why progesterone cream is often the best for monthly PMS and for perimenopausal anxiety (against the raging hostility from estrogen swings).

Above all else, remember that estrogen stimulates both breasts and womb- so estrogen must always be balanced by enough progesterone and(/or) testosterone. And if the hormones are allowed to run out by widening the gap between injections beyond two weeks, or between cream doses by more than two days, vaginal bleeding likely will occur.

The initial outlay cost of the three different hormone creams is up to R500 retail- you find out for yourself how long each tub lasts; as opposed to having an experienced pharmacy eg the manufacturing AntiAging pharmacy in Gauteng  compound ie mix what you want in one or two tubs that will last a few months. Try your local pharmacy – but finding one with experience is difficult.

PREVENTION? OR WAITING FOR DISEASE FROM NEGLECT TO CRIPPLE YOU? Many  gynecologists (like urologists) are primarily surgeons concerned with reproduction, menstrual, pelvic and cancer problems, and treat the menopause years often with fattening hormone pills (HT- which have more risks) and surgery..  They do not have to deal with the much wider irreversible medical problems of old age (obesity-diabetic, insulin resistance, lipidemia, vascular, immune, fracturing, arthritic, visual and hearing loss,  depression, and dementias – and no least, common sudden premature death)# – which are largely AVOIDABLE with appropriate natural supplements from the beginning, including balanced non-oral human sex hormones. As a BBC news report this month  says, memory (ie cellular) deterioration  begins on average  before age thirty.

It is not the gynecologist, but patients  and Family/ general practitioners GPs and specialist physicians including endocrinologists and geriatricians who have to deal long term and medically (not surgically)  with these easily preventable crippling killer diseases..  Surgery cannot address the basic pathogenic cause of chronic degenerative disease.

The discomfort and fattening of the 5-10 MENOPAUSE years is a concern for all doctors – and the earlier the menopause (whether natural or surgical), the more important it is to start appropriate simple balanced non-oral HRT and other effective medical prevention of fattening and diabetes eg other insulin sensitizers like metformin. Avoiding the late postmenopausal  silent killer degenerative diseases of aging (# above) is crucial  essential duty of doctors – but mostly of patients themselves,  since- obstetrics and trauma  aside-  most doctors earn more by disease than by prevention..

ndb

BREAST CANCER OVERDIAGNOSIS BY COMMERCIALIZED SCREENING MAMMOGRAPHY: IS THE DOWNSIDE WORTH IT?

It is a no-brainer that mammography is invaluable diagnostically for

– a new breast lump, pain/discomfort  or bleeding.

– for followup of any pathology already present or likely eg the woman with obvious genetic risk of breast cancer;

– And for monitoring at baseline  and periodically on permanent appropriate physiological  HRT.

Rare women do present with distant spread of breast cancer before such cancer presents in the breast. But the hot chestnut* is:  how many well women  with clinically normal breasts at average risk of breast cancer  benefit or suffer by having screening – their apparently healthy ‘chestnuts’   squashed and irradiated regularly for decades looking for  preclinical cancer?

when the downsides also include time, pain, cost,  possible  increased risk from  cancer by both irradiation, pressure and needling, six unnecessary biopsies for each cancer found, and no clear evidence  that the resultant anxiety and  cancer therapy extends wellness and life?

A *chestnut includes an “old or stale joke (British)”, or ” music of sentimental value”!. The joke may indeed be on average-risk older women who are conned into having repeated- and risky-  screening mammography on their often most cherished ornaments.

The Breast Cancermongers – the screening mammography SMG  activists- now proclaim that 1 in 8 women ie 12.5%  will get breast cancer in her lifetime; but between 40 and 59yrs that number reduces to 1:15 ie about 7%. Without screening mammography of “normal” breasts, does breast cancer  actually present as a disease  in even   5% of sensible average-risk  women in the average at-risk middle decades?  and will prompt removal of such early  cancer before it presents itself to her/ the doctor with lump/pain/bleeding avoid  shortened lifespan  in any asymptomatic woman screened? Especially if appropriate balanced postmenopausal systemic human HRT is  continued lifelong to  reduce by 1/3 the  the far more common other major causes of  disease and deaths as well as deaths from breast cancer?

Note the disturbing figures  from Wiki:  “Of every U.S. woman screened, about 7% will be called back for a diagnostic session (although some studies estimate the number closer to 10%-15%). About 1% of those screened  will be referred for a biopsy; the remaining 6% are found to be of benign cause. Of the 1% referred for biopsy, about 0.35% will have a cancer and 0.65%will not. Of the  0.35% who do have cancer, about 0.2% have a low stage ie noninvasive cancer that will be essentially cured after treatment.” But who is to say that these 0.2% would ever have presented with cancer in their lifetime- ie are these the 2 out of 3 per 1000 overdiagnosed by SMG?

The incidence of BRCA in USA women in the 50-65yr agegroup is claimed to have risen  almost 50%  from 0.23 to 0.33% between 1975 and 2000, and has since fallen back about 25%. That almost 50% increase can only have been from the introduction of almost compulsory SMG. Despite advances in treatment, breast cancer mortality took almost 15years to start falling ie after plateau at about 0.07% for decades  till 1988, it has fallen steadily to 0.045% in 2006. A report in about 2002 says that ‘ Breast cancer incidence increased more or less steadily between 1940 and 1987 and has since stabilized at 0.1%.’

So we have a major credibility gap in reports from the USA: some authority says an overall incidence between 50 and 69yrs of 1%, another  say 0.25%.

More important, in 1999 Mettlin noted that “ some of the decline  in BRCA incidence and mortality is attributable to the lower mortality rates for women born between 1924 and 1938, who have reached the age where their breast cancer mortality experience most affects the overall rate; the  hypothesis being  that  increased fertility rates  following World War II reduced their risk of developing breast cancer and, therefore, of dying of breast cancer.”

The reality, not disease-mongering to promote SMG, was  simply put in 1995: “Between 1940 and 1982, breast cancer incidence rates in the United States increased by approximately 1% per year, largely in women over 40 years old. From 1982 through 1987, the rate of increase accelerated to around 4% per year and then leveled off – the rising rate  mainly attributable to early detection, due to the increase in breast cancer screening. The increase in breast cancer cases (with no change in incidence rates) among women 20 to 39 years old during 1970 to 1990 was due to a shift in the age distribution of the population. However, breast cancer mortality rates have remained fairly stable, with almost no change from 1950 to 1990 [42], increasing only about 0.2% per year [3]”

The issue remains a hot chestnut: like screening  colonic imaging and prostatic screening,  is this massive  universal individual screening of the apparent low-risk good, indifferent or bad for women, their men, families  and whoever has to pay the financial cost?

What the Wiki review does not say is that there are almost 20 000 articles already listed on Medline the past 50 years; and some 400 articles on screening mammography in asymptomatic women since 1966. Yet 60 year after mammography was invented,  the cost-benefit for women of the $billion SMG  industry is being increasingly questioned:

(paraphrased) Editorial “Overdiagnosis and mammography screening” 9 July 2009,    BMJ 2009;339:b1

The UK NHS recently scrapped its leaflet inviting well women to undergo mammography since it failed to mention the major harm of screening—overdiagnosis. The question is no longer whether, but how often, this occurs.

In a  new BMJ special on breast cancer,  Jorgensen  ea, Gotzche ea and Zahl ea,   again discuss evidence that screening has led to overdiagnosis of breast cancer not only in the UK, but also in Canada, Australia, Sweden, and Norway.

Overdiagnosis refers to detection of abnormalities that will never cause symptoms or death during a patient’s lifetime- when the cancer grows so slowly that the patient dies of other causes before it produces symptoms or when the cancer remains dormant (or shrinks).   

Because doctors don’t know which patients are overdiagnosed, we tend to treat them all.

Overdiagnosis therefore results in unnecessary treatment – perhaps in one in two (or even 2 in 3) women.

With   widespread efforts to diagnose cancer earlier, over-diagnosis has become an increasingly vexing problem.

H Gilbert Welch, professor of medicine, USA.

new from HealthSpan Life! UNFAIR TO WOMEN: STILL THE WRONG SPIN ON APPROPRIATE HRT – IT’S NOT CRICKET!

Kathy Martin &  JoAnn Manson’s excellent review The Patient with Menopause Symptoms   stresses the importance of not initiating oral hormone therapy  OHT many years after menopause; and the grave doubts about continuing Wyeth  HT (premarin +-  progestin) long after age 60yrears ie for much more than 12 – 15years. .
 
But  while they emphasise the benefits of  progesterone over synthetic progestins; and  of  starting HT for menopause symptoms early rather than late  (the timing hypothesis), and the  numerous greater risks of oral estrogen therapy OET (versus parenteral estrogen replacement ERT), they do not point out  the latter risks in their abstract, 
the far fewer benefits of  oral ET  (pop-a-pill convenience; marginally better HDL/LDL ) – ie two benefits;
 versus
physiological parenteral ERT :  less adverse effects than OET :.- ie at least a dozen  extra benefits parenterally versus orally:..
risk of OET on SHBG; triglyceride; CRP; fibrinogen; factor VII; PAI1; testosterone, uterus; endometrium; breast density; collagen dissolution ); 
 and thus greater risk of  OET (compared to parenteral ERT) overall for :
fluid retention, hypertension, deep vein thrombosis, coronary artery and cerebrovascular thrombosis, dysrhythmia,  heart failure (Mercuro 1999; Regitz-Zagrosek 2007); biliary disease, libido, depression, adiposity, and thus urinary incontinence, insulin-glucose intolerance, breast cancer ; and skeletal muscle frailty.
 
This Harvard review thus bypasses the prime reasons for not extrapolating  the uniquely valuable WHI Womens’ Health Initiative -notwithstandng it was misguidedly planned, gave overhasty initial  wrong  statistics, and caused foolish sometimes hysterical generalizations (“a thalidomide disaster“).
The WHI was not about menopause – it tested mostly elderly obese “asymptomatic” but already high-risk Caucasian women on oral HT with xenohormones- premarin, provera – when xenohormones have for good reason  no longer been used  in any other branch of endocrinology. 
Why should older women be treated any differently for the commonest acquired endocrine deficiency of all, that affects 100% of womankind? Especially when postgonadopausal men (and women)  have already for over a decade been advised to use solely physiological parenteral human HRT?
 
What the WHI was about was assessing the benefits of appropriate  medium  term convenience sex hormone therapy . As in all other endocrinology -restoring physiological hormone balance – the aging woman (and man) requires appropriate balanced HRT (preferably parenteral testosterone +- ERT+-  progesterone) started early and permanently for permanent multisystem protection  against CVD; cancers; fractures;  arthritis; depression;  urinary incontinence; loss of sexuality; dementia; and thus against premature devastating disability and death.
The small under-sixties cohort of the WHI actually confirmed these multiple benefits for up to almost ten years for  solo oral premarin- but ten years is not long term since women  can now live the second (and potentially the best) half of their lives – up to sixty years- post menopause.
And it is common cause that many benefits of HRT eg on bone, skin, sexuality etc are lost as soon as HRT stops.
So it is never too late to start  and never too long to continue appropriate HRT under supervision.
 
See other recent  reviews of appropriate  HRT .

THE HYSTERICAL BANNING OF APPROPRIATE HRT SEXHORMONE REPLACEMENT AFTER AGE 60YRS

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 doctor@healthspanlife.com
 
see also