Tag Archives: IMS

WIKIPEDIA IS INVALUABLE, BUT BEWARE IMPORTANT BIAS IN IT’S CHRONIC DISEASE ARTICLES PART 1:

Wikipedia is now the top and invaluable reference source for the public.

Wikipedia entries are commendably frequently updated; but this does not mean that the entries are both up to date, objective and unbiased, since they are constantly being altered by conflicting outside editors.

We suggest amendments in  Wiki  health entries where appropriate as follows.

It will obviously have most effect if the recommendations to Wiki are based on consensus by the relevant international leaders- eg the International Society for Aging Males ISSAM, the International Menopause Society IMS, the International Pediatric Association, and so on; NOT by drug companies and their product promoters including individual disease associations (which by definition do not take a holistic multisystemic  view) or private and academic national groups whom/which drug companies sponsor/influence- including the problem of ghost writing! Many entries on Wiki appear to suffer from this problem of vested interests.

INTRODUCTION: EBM:

The Wiki article on EBM  Evidence-based_management ie  Evidence-Based Medicine hits the nail on the head. Medical diagnosis and treatment need to be evidence- based- but as the heretical pioneers Shaughnessy and Slawson stress, this must be POEM- patient-orientated evidence that matters. However, for the Drug Industry and their state arm  the USA FDA, the chronic major degenerative diseases are the biggest money-spinners since they arguably need lifelong drugs. Hence the Disease Industry  has invented epidemics of chronic diseases that were regarded as inevitable or self-induced until drug companies came up with designer drugs for each new  disease to medicalize – eg  epidemics of erectile dysfunction, mild to moderate hyperlipidemia, anxiety, mild-to-moderate depression, mild PMS and menopause syndromes, smoking, alcoholism,  and so on. Then  they and the FDA  generated trials and procedures  testing these patients with new “diseases”, and convinced the public that despite clinically insignificant benefits in trials often lasting well under a year, tested against only placebo,  the drugs could be registered  for chronic use even though there were long- proven natural remedies that did as well or better. They (their well-paid researchers, statisticians and often professional spin writers) then produce and pay for publication of  drug  trial reports claimed to be favourable, even though the evidence is weak or in fact adverse. . And the FDA is at least consistent- it still allows American chronic drugs to be thus launched with  only short trials, without head-to-head comparison against proven remedies – but blocks dubious foreign drugs like rimonabant..

Hence in our lifetime we have seen the rise and spectacular  fall – fatal for many patients- of many trumpeted medicines – of  stilbestrol, anabolic steroids, practolol, thalidomide, ticrynafen, barbiturates, antidepressants, fenformin, Vioxx, benzbromarone, troglitazone, cerivastatin, antiarrhythmics, phenfen, and antiplatelet drugs. And the Bush Administration recently forced through legislation immunizing the drug industry against claims for  damages from failed drugs! Mostly me-too drugs whose sole need and purpose was to create profit for industry for a few years before complications force their disappearance. This indeed is the FDA – Drug Industry’s  60  year commercial War Against Humanity (Elaine Feuer)  and compassion, Al Gore’s The Assault on Reason, Naomi Klein’s Disaster Capitalism, Ivan Illich’s Medical Nemesis.

The FDA-Disease Industry (and medical schemes)  then calls this sham  process  EBM, and denies the same recognition to long proven  optimal remedies  eg parenteral human HRT because there is no need, and no sponsor, to do long-term trials on natural remedies long-proven in clinical practice studies. The only “designer” drug – metformin- which is in fact a simple tagged plant extract-  that has ever been subjected to a 20 year trial  was effectively kept  off the USA market until the  trial was nearing completion in the mid-1990s – ie metformin in the UKPDS, which proved to be the only designer drug ever that almost  halves both all mortality and all chronic major degenerative diseases including type 2 diabetes. And still the FDA demanded a 10-000 patient one-year trial  – COSMIC- to prove the safety of metformin- after all, it was a Scottish invention and long-proven European drug, thus not to be trusted because it was not invented in USA. As if the Americans were not of recent European origin.

Similarly, the FDA (and the British)  embargoed/derided  lithium- the gold standard drug against bipolar disease- until 1970, forcing Mogens Schou to do an unethical double-blind withdrawal trial on stabilized patients to prove it’s efficacy – 100% of whom relapsed within 6 months on placebo, and restabilized back on Lithium. .

Hence all drug study and trial reports, especially for  registered drugs – however prestigious the journal and origin- have to be examined carefully to see if they were done without bias/spin to paint the new drug in a rosy light. The Womens’ Health Initiative most certainly was not unbiased despite the close to $1billion cost – it scandalously failed to test Wyeth’s two xenohormones against the gold standard, human estradiol and progesterone. Similarly, the statins for mild-to-moderate hypercholesterolemia  have never been tested head to head against the only drugs that reduce all-cause morbidity and mortality by 1/3 to 1/2- metformin, fish oil, appropriate balanced human hormone replacement, and a blend of effective safe doses of all the beneficial minerals, vitamins and biologicals including some herbs.

Similarly, the Viagra trials were fraudulent- they excluded men with frank hypogonadism (since Viagra will not work without testosterone priming). But Pfizer  and the FDA also colluded to refuse to disclose, publish the testosterone levels of men enrolled in the Viagra trials- when it has been known since the early 1980s that there is a dose-response correlation between erectile function up to a plateau above a serum testosterone of about 4.5ng/ml 16nmol/L -.1982 Salmimies ea. It turns out from other Viagra trials that the serum testosterone of trialists was around 13.5nmol/L.. So most of the men using Viagra/Cialis  did not/do not  need 2 Viagra tabs a week costing hundreds of dollars a month (as the NHS was conned into providing), but a conservative shot of depot testosterone perhaps 160mg every fortnight at a cost of below $5/month- with far more multisystem benefit, and none of the deadly risks (sudden death or stroke or blindness) of Viagra.

The Wiki article on erectile dysfunction dismisses testosterone deficiency as being a rarer cause of erectile dysfunction, but fails to mention the obvious, that partial androgen deficiency ie a serum testosterone below the mid-range -ie average- often responds to adequate depot injection trial of testosterone to elevate the blood level into the mid range of healthy young men (not just the range of elderly men, as is so often done).

Such is the power of fraudulent drug company deceit in collaboration with Regulators.

It is hollow hypocrisy that the UK has now introduced a regulator of alternative practitioners- but neither the USA, UK nor  other governments  have ordered their Medicines Regulators  to drastically restrict many of the scheduled drugs discussed below (and a few risky complementaries like black cohosh and kava) when there are far safer proven  alternatives. Manufacturers and Regulators themselves are certainly not going to do this- not when their  raison d’etre is well-paid screening and registering as many new drugs as possible, not policing old drugs.

PART 1: THERAPY OF COMMON MULTISYSTEMIC DEGENERATIVE DISEASES OF AGING:

1.1 Hypercholesterolemia and statins

1.2 Osteoporosis and Bisphosphonates

1.3 Hypertension and antihypertensives

1.4 Diabetes type 2, Obesity, metformin and other weight-reducing drugs.

1.5 Pain, arthritis and NSAIDs.

1.6 Fish Oil

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS

PART 2: SEX HORMONES see next publication.

1.1 Under hypercholesterolemia wiki says “statins are the most commonly used and effective forms of medication for the treatment of high cholesterol”. But the wiki entries on statins, cardiovascular disease and hypercholesterolemia, and Pubmed, give no evidence to justify statins’ heavily marketed primary use in mild-to-moderate hypercholesterolemia and diabetes, no reference that shows they are as good and safe as the old proven combination of natural evidence-based remedies – vitamins, minerals and biologicals (including appropriate eg non-prescription fish oil, carnitine, CoQ10, arginine, ribose, carnosine,  galega officinalis- metformin, and appropriate sex hormone replacement).

It is metformin and appropriate HRT, not statins, that reduces both cardiovascular and all-cause deaths by at least a third, and meformin that halves the incidence of new diabetes when used preventatively in the adipose with insulin resistance etc. It is metformin, not statins, that merit marketing over the counter:  in sensible use imetformin is totally safe, unlike unregulated poisons like cigarettes, alcohol and  sugar.

None of the vast statin trials show that statins do any good other than lowering CVD risk by a third. So it is a blatant dangerous lie to state as Wiki does that “statins are the most effective medication for treatment of high cholesterol”- this claim certainly does not apply to the universal common mild to moderate hypercholesterolemia MMHC. Familial or secondary severe hypercholesterolemia justifying statins is generally rare; and  the indolent overweight/ diabetics with MMHC have enough problems with diabetic cardiovascular disease, neuromyopathy,  and osteoporosis without the added risk (fatigue; myalgia; hepatorenal; depressive; sexual; skin; respiratory impairment; and cancer associated with severe hypolipidemia) of statins, when metformin and the other antioxidant insulin-sensitizing supplements like appropriate HRT are safe and far more effective across the board – and do not deplete and antagonize  crucial and very expensive CoQ10 as statins do..

1.2 Under bisphosphonates, wiki says “In osteoporosis, alendronate and risedronate are the most popular first-line drugs. If these are ineffective or the patient develops digestive tract problems, intravenous pamidronate may be used. Alternatively, strontium ranelate or teriparatide are used for refractory disease, and the SERM raloxifene is occasionally administered in postmenopausal women instead of bisphosphonates”.

But popular does not mean most effective or safe. Wiki quotes no sources to prove that bisphosphonates- now with a notoriously long list of complications – or the designer drugs mentioned are anywhere near as good and safe for osteoporosis and all diseases of aging as the baker’s dozen of appropriate human HRT, vitamins and minerals. The popularity of bisphosphonates, premarin, statins and SERMs is obviously based simply on heavy marketing.

1.3 ANTIHYPERTENSIVES: the Wiki entries for hypertension, antihypertensives and reserpine are in total conflict – for the obvious main reason that the main entries are written by those sponsored by new-drug companies. On the other hand, Wiki says correctly under Reserpine: “it is one of the few antihypertensive medications that have been shown in randomized controlled trials to reduce mortality… In some countries reserpine is still available as part of combination drugs for the treatment of hypertension, in most cases they contain also a diuretic.”  see Pubmed  for at least a dozen such landmark studies.  It was confirmed as recently as the SHEP(1995) and ALLHAT (2007) trials that combinations containing reserpine are the best for resistant hypertension. And numerous trials up to the 1990s showed that lowdose reserpine plus a lowdose diuretic is as good as any more modern drug for mild-to-moderate hypertension. And trials show that lowdose thiazide diuretic plus a potassium-sparing diuretic eg amiloretic is better than a thiazide alone, and such combination was the only drug regime  associated with halving of dementia in the Cache County study.

It has been established for decades, and we see in hypertension practice every day, that the best results, with zero adverse effects, are with low dose of reserpine eg starting with ½ a reserpine tablet (ie 0.125mg/day) and half an amiloretic tablet (ie 27.5mg/day); usually reducing to ¼ of each tablet daily after a week. In many cases the dose can be reduced to 3 times a week because amiloretic has a gentle action over 24hours, but reserpine over weeks- so (unlike with modern drugs) forgetting the occasional dose does not matter. It’s cardioprotective, bone-protective and antianxiety benefits persist, with neutral effect or benefit on the metabolic and allergic and oedema  problems that abound with modern regimes.

But under Antihypertensives and Hypertension, this optimal regime is barely mentioned to be condemned – because it is old-fashioned, and the most effective therapy for mild to moderate hypertension. But it costs as little as $0.50 a month in eg South Africa, 1/300th of the price of an inferior designer combination like Prexum Plus. So it was removed from state codes in eg UK, Europe and South Africa precisely because it is too cheap and too good, it drastically reduces revenues from modern drugs. This despite the fact that this optimal combination has not been tested as first-line therapy against any modern drug- trials up to the 1990s showed that it was too good, so no drug company dare allow head-to-head trials again. And Regulators and involved politicians simply ignore these hard facts since their massive incomes depend on promoting modern, not old, drugs.

1.4 Antidiabetic and anti-obesity drugs: Wiki correctly says “Metformin is usually the first-line medication used for treatment of type-2 diabetes.” In practice, it is always the first line drug in a new type 2 diabetic since such patients invariably have excessive visceral girth and body fat if not rising BMI (above about 23kg/sqm except in a gymnast/athlete). But Wiki then perpetuates a disinformation myth: “Initial metformin dosing is 500 mg twice daily but can be increased up to 1000 mg twice daily”. This is nonsense, the reason why so many patients drop out of metformin trials and treatment, since perhaps half of us ( especially smaller people) are genetically slow metabolizers of metformin. . Metformin must simply be started at very low dose eg ¼ tablet (125mg/day), and adjusted upwards every day or two to tolerance- avoiding more than reduction in appetite and loosening of stools… with this simple approach, whether for diabetes control or, far more important, for obesity-diabetes and polycystic ovary syndrome prevention , the average tolerated dose is about 2.5 to 3gm a day in split dose (except with the new sustained release tablet). .

Wiki then says “metformin is also available in combination with other oral diabetic medications.”- but this is also dangerous marketing hype, such fixed combinations are to be avoided at all costs  since combination of metformin with any other antidiabetic drug both brings the disastrous risk of hypoglycemia, and neutralizes some of the benefits of  optimal dose metformin combined with optimised diet and lifestyle.  This is the heart of the reason not to delay metformin till diabetes- neurovascular- pancreatic disease is established, by when sometimes irreparable damage – glycation – is common, with irreversible eg kidney, nerve, eye or heart damage.

Wiki correctly states that the French drug  rimonabant was soon abandoned, and never released in the USA. And under Obesity Wiki indicates the adverse effects and lack of longterm safety-efficacy data that confirm why orlistat and sibutramine have no place in overweight-obesity-diabetes prevention and treatment when metformin is by far the best proven. .

1.5 NSAIDS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: The Wiki entry is pretty good except that it ignores the obvious – not only are these drugs poor analgesics, little better than the old paracetamol Tylenol, but they also have major risks- not just gastrointestinal bleeding but also heart and kidney failure, dermatoses and sudden death. Wiki discreetly omits to mention that there are many cheap proven old supplement NSAIDs  that in combination do better without risk (eg MSM methylsulphonomethane; vitamins (B3, B5, C, D); curcumin; cat’s claw, boswelia, bromelain, arnica, fish oil) than the problems of aspirin and the other myriad patent NSAIDS; and that, trauma aside, NSAIDS do nothing for the cause ie the underlying disease.

And there is no evidence whatsoever to support the for-profit rationale for promoting use of the NSAIDS- that they (even ibuprofen) are any better or safer short-term or long-term than judicious appropriate use of paracetamol+-codeine, or natural supplements eg judicious appropriate steroids- whether corticosteroid, secosteroid (vitamin D3) or sex steroid SHRT eg estrogen and testosterone. Detailed referenced reviews the past year on each of these topics are published below.

1.6 FISH OIL: Coyly, the only NSAID that Wiki lists under “other” is omega 3 – which actually reduces all major degenerative diseases and mortality by 20 to 50%…

But Wiki certainly gives full credit to the myriad health  benefits- and lack of adverse effects- of fish oil -EPA+DHA – in appropriate dose.

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS: The older we are, the more likely we are to suffer from multiple chronic diseases, the more likely we are to be recommended different drugs for each disease- especially if we shop around consulting a doctor per disease. In particular, the use of multiple designer and synthetic drugs that interfere with normal metabolism is high risk- and becomes higher in older people who are prone to combined degenerative diseases like osteoporosis, muscle frailty, vascular disease, diabetes, anxiety, depression, arthritis and infections.

Eg there are on Pubmed since 1992 at least 6 reports on serious bisphosphonate – induced dermatoses, and 9 on statin dermatoses. . Statins are notorious for causing insidious myositis- especially with antibiotics; and there are reports of myositis-arthitis with bisphosphonates.   Statins can cause interstitial pneumonitis, fatigue and  weakness; bisphosphonates can contribute to lung problems via reflux, antihypertensive drugs via bronchial irritation. NSAIDs cause gastritis, oedema, hypertension, heart failure. the modern antidiabetics and antihypertensives  can aggravate heart failure. Yet doctors who advise against any HRT and other medicinal supplements frequently prescribe statin, bisphosphonate, NSAIDs, modern antidiabetics, antihypertensives  and periodic antibiotics together. This is criminal, since these drugs are mostly  unnecessary in either mild-to-moderate lipidemia, or osteoporosis, or arthritis, or hypertension, or  type 2 diabetes.

In conclusion, especially as specialists  (except for the old-fashioned increasingly rare general practitioner and the specialist in general internal medicine) tend to be increasingly specialized in one niche organ system or area of medicine ( but not in comprehensive and preventative care) , it is obvious that for serious illness, the patient is advised to study personally the latest illness advances  remedies and problems. But for researching health matters, the public is advised to use the websites of international multidisciplinary expert associations eg ISSAM- the International Society for Aging Males; IMS- the International Menopause Society; and  Medline- Pubmed;

rather than those which are prone to commercial or academic  bias (by local vested/ financial  eg drug/ equipment company/institutional interests) like Wikipedi,   universities, patient support associations,  the FDA/NIH, other National Health Services,  private practice  and craft groups,  or patient’s or lay associations’ reports and advice; especially the mass media which are especially open to marketing hype and sensationalism, and which with publication deadlines and bias to sensationalism, bad or lurid  news,  seldom succeed in tracking down objective unbiased expert opinions.Like Only Disease Pays, Only Bad News Pays.

And once disinformation is published, the media  (unlike Wikipedia) rarely bother to give equal time to  or opportunity for correction of misinformation- eg withdrawing bad information from websites. Which is not to say that old ideas should be deleted from the internet- they should just give the date of last update, and indicate if they are outdated.
Wikipedia health articles should be depended on only if they are certified by international multidisciplinary consensus bodies (of specialists and family practitioners)  like ISSAM and IMS.; or if material facts are referenced to a verifiable expert source. For the reasons stated, neither trials, reviews, metanalyses or “expert opinions” – even on Pubmed- are necessarily reliable evidence.

Detailed reviews of all these topics have been published the past year below on this column.

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REVIEW: MENOPAUSE SYMPTOM CONTROL and the HRT Sex Hormone Replacement vs PLANT REMEDIES DEBATE:

MENOPAUSE SYMPTOM CONTROL and the HRT Sex Hormone Replacement vs PLANT REMEDIES DEBATE:

see http://www.imsociety.org/.

We are constantly exhorted to use commercial plant menopause/ andropause antiaging hormone alternatives like soy and black cohosh. The fight for a share of this billion-dollar patent market continues around bewildered aging men, women, healthcare professionals, and purveyors of supplements.

But -owing to the increasing shortage of fish, the overabundance of corn and decreasing grazing space, and the profit imperative – our western diet is now so stuffed with inflammatory omega6 (eg GLA gammalinoleic acid) that the average western diet omega6:omega3 ratio has risen from 6:1 to 20:1 – chickens are no longer fed fish-meal nor livestock on grass as they were when we were children; they are now fed on maize. And fast foods for gullible humans are now loaded with cornstarch.
so we should discourage any omega6 supplements ie plant oils except as salad dressing; but we all need at least 2g if not 4g fishoil a day.

West of Aden, we are not marketing to, caring for, long-lived small slim fish-and brown-rice eating Asians who till the fields all day- quite the opposite. So it is very relevant.
One sees few small Asian women in practice at the southern tip of Africa or north and west, as opposed to East or the Pacific rim. .

Most oil-bearing plants contain some plant estrogens. a patient brought this to my attention angrily after discovering that even flaxseed oil has them, they apparently grew her fibroid. Flax seed is better- only 40% oil, and balanced by the huge benefit of the fibre, lignans.

Soy is most certainly a major source of non-marine omega: per 100g soy – Linoleic Acid (LA-omega6) 9%. Alpha-Linolenic Acid (ALA Omega3) 1.6% ALA is not the marine eicosapentanoic acid EPA+DHA docosahexanoic acid required by human brains and membranes- in infants and sick/ aging humans, our conversion of omega6 GLA – and even ALA – to EPA+DHA -ie marine oil- is far too little for our needs.
So soy provides the opposite of the needed fish oil omega3 (which is 30% in good fish oil).

There is no apparent problem about soya (or eg pueraria) as part of a balanced diet – especially in small women who are largely vegetarians, and especially Asians. And soy is not the ideal fibre source!!!

We surely do not need plant oil extracts as a supplementary panacea when fish oil alone does far better, almost halves all disease and deaths without any adverse effects, and when appropriate HRT, metformin/galega officinalis, and appropriate combined other micronutrients, each reduce all disease and deaths by about 1/3.

Our audience and target is largely postmenopausal Afro/White women in a hugely polluted and stressed ie estrogenic -high cortisol-fat environment.

The problem is vigorous POSTMENOPAUSAL soy/other plant oil supplements- which provide excess phytoestrogens AND omega6 in overweight “westerners”- afro/hispanic/white.

The evidence is worrying that environmental estrogenics (including soya) long term in the West increase the problems of cancer let alone fattening.

It’s the usual story- as with black cohosh, for any commendation of a product,
1. there must be both evidence of benefit (which there is for soy, but not BC),
2. and evidence of need ie there must not be far cheaper safer products that do the job better;
3. and no evidence of harm.

So if there is no evidence of benefit, why recommend :
black cohosh – like red clover, it has no proven medicinal menopause benefit, but it (like kava) can unpredictably albeit rarely kill- black box warnings have been issued by most first world authorities,
or
soy or any plantoil supplement when these may stimulate breast , endometrial and prostate cancer, and aggravate omega6- mediated inflammation, and there is far better specific therapy in appropriate balanced HRT and fish oil? (palm oil MCT and sunflower oil supplement maybe better than soy, if not as good as fish oil.);
or
aspartamate when there are natural plant-derived insulin-sensitizing intense sweeteners like stevia ,
and when aspartamate is a slowly accumulating neuro-excitotoxin, carcinogen and cardiotoxin?

Surprisingly, search under Randomized Controlled Trials RCTs on Medline finds only 3 references for “Menopause symptom relief “, and 1 on “menopause herbs”- these favour estradiol plus androgen or lowdose estradiol + progestin over estrogen or placebo alone; .and estrogen over herbs including black cohosh. Under search for RCTs of black cohosh for menopause symptoms, the great majority of patients show no benefit of BC over placebo at any BC dose . We are all well aware that only drug companies can afford to pay for major drug trials- but only modern designer drugs are patentable, and only blockbuster patents are profitable- so drug companies (and therefore researchers that do research – clinicians, universities etc)- cannot afford to fund independent trials of natural alternatives, and especially not allow comparison of modern synthetics against obviously beneficial but unpatentable natural supplements.

The European, Uk , Canadian, Australian, New Zealand , Japan and Singapore authorities and now the US Pharmacopoeia- have all issued warnings against black cohosh BC. RSA remains the only (?ex-) “1st world” country where “authorities ” – MCC, HPCSA and Health24 – still ignore the issue of potential fatality. The University of Cape Town Medicines Information Centre issued a solitary warning in September 2006. The Health Products Association of South Africa still (January 2008) refuses to withdraw its Endorsement of black cohosh on it’s website, despite the evidence against it.

So why promote BC or soya concentrates for any menopause therapy? Since the greatest common voluntary killers- sugar, alcohol, tobacco, motorcars, weapons, non-steroidal anti-inflammatory drugs- are freely available to adults, there is no reason to restrict sales of lesser potential hazards like xenohormones. But it is immoral to promote them (sugar, cigarettes, black cohosh, horse hormones, soya supplements), when there is no good evidence of need let alone benefit, and there is evidence of potential lethal harm in conventional usage.

The Wikipedia Menopause review puts it in perspective:
Treatment of symptoms (Appropriate conservative ) “hormone therapy provides the best relief.” While the prognosis from advanced memory or vascular deterioration or hip fracture is poor, appropriate physiological “hormone therapy from menopause is amongst the best prevention/ treatment for osteoporosis”; vascular disease; insulin resistance and type 2 diabetes; depression and memory loss.
“GABA” and 5HTP and their patent derivatives are ” second only to HRT in relief of menopause symptoms.”
“Complementary and alternative therapies Medical non-hormone treatments provide less than complete relief, and each has side effects. There are claims that soy isoflavones are beneficial concerning menopause. Other remedies that have proven no better than a placebo at treating hot flashes and other menopause symptoms include red clover isoflavone extracts and black cohosh. Black cohosh has potentially serious side-effects such as the stimulation of breast cancer, therefore prolonged administration is not recommended in any case.”
http://en.wikipedia.org/wiki/Soybean debunks many of the claimed benefits of soy supplements.

The 2007 Review of the world expert menopause body, the International Menopause Society, says it all on ALTERNATIVE TREATMENTS: at http://www.imsociety.org/pdf_files/ims_recommendations/ims_updated_recommendations_on_postmenopausal_hormone_therapy_27_02_07.pdf
“The efficacy and safety of complementary alternative medicines have not been demonstrated and further studies are required.”
Bodies promoting alternative therapies are not qualified to judge, let alone endorse products for treatment of symptoms that affect most older women, when well-proven remedies without any significant risks are well established. ”
“There are no medical or scientific reasons to recommend unregistered bio-identical hormones.” The only proven and approved safe long-term treatment post menopause is appropriate registered HRT; and as alternative, GABApentin for hot flash relief.
Intensive post-menopause experience with appropriate HRT (even horse hormone HT) for almost 60 yrs has shown only benefit – and trials for up to 10 years (WHI; Oulu) the same.

The SAMS Review of Menopause therapy notes: No therapy for menopausal symptoms should be initiated without proper clinical assessment including breast and pelvic examination http://www.samenopausesociety.co.za/asp/pdf/SAMS%20Statement2006.pdf.;
and condemns black cohosh: http://www.samenopausesociety.co.za/asp/content.asp?ContentID=27

Thus, given the risks in middle-aged women, it is quite clear that no-one except a registered appropriately trained health professional may recommend therapy for menopause symptoms – which affect the majority of women at the most critical time of their lives, when they should if anything be starting (after appropriate clinical examination ) on appropriate HRT (for which there are rarely absolute permanent contra-indications), and when any menopause therapy requires that they be assessed clinically before any such therapy, and then regularly on it. Hot flashes are not always due to hormone imbalance- which is why placebo has such strong effect, and Gabapentin/5HTP more so..

Insulin resistance, overweight and obesity have become the greatest midlife risks in the affluent. So it is worth noting that while appropriate HRT, fish oil and hundreds of other natural supplements lower insulin resistance, fish oil is apparently better than olive oil, which is in turn better than sunflower and soy oils as regards insulin sensitization.

Finally, Professor Fred Naftolin of the IMS comments January 31, 2008 as follows
” This is an immensely complex area and cannot be disposed of with a few platitudes.
All agents that interact with ERs estrogen receptors – like phytoestrogens – are SERMS. This means that in isolation they have a specific profile of agonistic action, but have an antagonistic profile in the presence of other SERMS. Further, this may both tissue and subject-specific.
In short, the patient is on her own when she begins to experiment with these agents. This is true when using pharmaceutical compounds, but at least they will have been more widely tested using standardized paradigms.”

(Professor Fred Naftolin retired a few years ago from Chairmanship of Obs & Gyne at Yale, was then Prof of Biology there for a few years then “retired” to his present research position at New York University with the Nachtigalls.
He is a chairman of the scientific committee of the International Menopause Society. He has 444 citations on Pubmed since 1966, 55 papers as first author, and 10 books to his name.. He is a very modest man, arguably one of the greatest living authorities on women’s health, reproduction and biology, a born teacher, and a supreme diplomat in the chair under fire – as when colleagues raged around him over the Women’s Health Initiative debacle at the Vienna workshop in December 2003. Thus, to paraphrase Kipling, he could keep his head when all around us, the self-styled Regulators of Europe, UK and USA were losing theirs and damning gold-standard appropriate HRT.)

READ THE LITERATURE:

This April 2008 fulltext report in the latest MJAustralia is the latest published case of specific-type fatal iiver failure attributable solely to BC:
http://www.mja.com.au/public/issues/188_07_070408/cho11166_fm.html

Black cohosh: a cause of abnormal postmenopausal liver function tests The health scares restricting the use of hormone replacement therapy have made women tend to opt for ‘natural’ remedies that are generally perceived as safe. Unfortunately, there is lack of definite opinion on the safety of herbal remedies. Black cohosh is commonly used for postmenopausal symptoms. We present two cases of liver toxicity related to this and recommend close monitoring of women on this herbal preparation. D. Joy ea, UK. Climacteric, 2008:11: 84 – 88

Can the combination of flaxseed and its lignans with soy and its isoflavones reduce the growth stimulatory effect of soy and its isoflavones on established breast cancer? Consumption of phytoestrogen (PE)-rich foods (i. e., soy and flaxseed (FS)) is increasing because of their suggested health benefits. However, recent studies raise concern over the safety of soy and its isoflavones, particularly genistein (GEN), for postmenopausal breast cancer (BC), due to their potential stimulatory effects on human breast tissue and on the growth of existing tumors in rodents.(Power KA, Thompson LU. University of Toronto, Canada.Mol Nutr Food Res. 2007 J51:845-56. )

Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study. Long-term treatment (up to 5 years) with soy phytoestrogens was associated with an increased occurrence of endometrial hyperplasia. These findings call into question the long-term safety of phytoestrogens with regard to the endometrium. Unfer V et al, Obstetrics and Gynecology Centre, Rome, Italy. Fertil Steril. 2004;82:145-8,

Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia..In men with prostate cancer, relatively minor side effects of chronic soy isoflavone treatment were observed including some estrogenic effects (breast changes, increased frequency of hot flashes). Serum dehydroepiandrosterone was decreased by 31.7%. (Fischer L et al University of North Carolina Nutr Cancer. 2004;48:160-70)

Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood.
women fed soy formula as infants reported slightly longer duration of menstrual bleeding with no difference in severity of menstrual flow. They also reported greater discomfort with menstruation. Infant exposure to soy formula does not appear to lead to different general health or reproductive outcomes than exposure to cow milk formula. (Strom BL et al University of Pennsylvania, JAMA. 2001;286:807-14).

Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment. Group Trial. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. The soy product did not alleviate hot flashes in breast cancer survivors. Quella SK, et al: Mayo Clinic Rochester, USA. J Clin Oncol. 2000 ;18:1068-74.)

.Effect of the interaction between the fatty acid binding protein 2 gene Ala54Thr polymorphism and dietary fatty acids on peripheral insulin sensitivity: a cross-sectional study.Morcillo S, Rojo-Martínez G,ea, Hospital Universitario Carlos Haya , Málaga, Spain. Am J Clin Nutr. 2007 Oct;86(4):1232-7 : Anthropometric measurements were obtained for 1226 persons aged 18-65 y selected randomly from the municipal census of Pizarra, Spain. An oral-glucose-tolerance test was given to 1020 of these persons. Samples of the cooking oil being used were taken from the kitchens of a random subset of 538 persons. RESULTS: Persons who consumed sunflower oil and who also had the Thr54 variant had higher insulin resistance than did those who consumed olive oil (P = 0.01).

Soybean oil treatment impairs glucose-stimulated insulin secretion and changes fatty acid composition of normal and diabetic islets.Nunes E, ea . Institute of Physiology, Coimbra, Portugal. Acta Diabetol. 2007 ;44:121-30. We observed that soybean-treated Wistar rats present insulin resistance and defective islet insulin secretion when compared with untreated Wistar rats. The decrease in insulin secretion occurred at all concentrations of glucose and arginine tested. Concerning diabetic animals, we observed that soybean-treated diabetic rats, when compared with untreated GK rats, present an increase in plasma non-fasting free fatty acids, an exacerbation of islet insulin secretion impairment in all conditions tested and a significant decrease in the monounsaturated palmitoleic acid. Altogether our results show that SO treatment results in a decrease of insulin secretion and alterations on fatty acid composition in normal and diabetic islets. Furthermore, the impairment of insulin secretion, islet erucic acid and fasting plasma insulin levels are similar in treated normal and untreated diabetic rats, suggesting that SO could have a deleterious effect on beta-cell function and insulin sensitivity.

Oleic acid from cooking oils is associated with lower insulin resistance in the general population (Pizarra study).
Soriguer F, ea Hospital Universitario Carlos Haya, Malaga, Spain.
Eur J Endocrinol. 2004;150:33-9.
AIM: To evaluate the relation between type of dietary fatty acid and degree of insulin resistance. Anthropometrical data were measured in 538 subjects, aged 18-65 Years, selected randomly from the municipal census of Pizarra (Spain). An oral glucose tolerance test (OGTT) was given to all subjects and measurements were made of glycemia, insulinemia and the proportion of fatty acids in plasma phospholipids Samples of cooking oil being used were obtained from the kitchens. RESULTS: Insulin resistance was significantly less in people who used olive oil compared with those who used sunflower oil or a mixture. Statistical significance remained in the group of people with normal OGTT after adjusting for obesity. In the whole sample, IR correlated negatively with the concentration of oleic acid (r=-0.11; P=0.02) and positively with that of linoleic acid (r=0.10; P=0.02) from the cooking oil. In subjects with normal OGTT, IR correlated negatively with oleic acid from cooking oil (r=-0.17; P=0.004) and from plasma phospholipids (r=-0.11; P=0.01) and positively with the concentration of linoleic acid in cooking oil (r=0.18; P=0.004) and plasma phospholipids (r=0.12; P=0.005). The risk (OR) of having raised IR was significantly lower in people who consumed olive oil, either alone (OR=0.50) or mixed (OR=0.52) compared with those who consumed only sunflower oil.