Tag Archives: black cohosh

UPDATE 2014 ON LACK OF LIVER DAMAGE FROM HERBALIFE, BLACK COHOSH and KAVA

neil.burman@gmail.com

1/1/2014  again, its comforting that no new evidence of hepatotoxicity of genuine black ohosh; or kava; or (USA-grade) Herbalife  products have been reported  the  past two years.

Teschke ea from Germany make the important point that herbaltoxicity is  likely due to the “kava paradox”,  that no toxicity is reported  with  ancient time-tested herbal remedies used appropriately by tradition in their fresh natural state and their countries of origin eg Pacifi islands; ,

but that adverse events occur with commerial eg alcohol-extracted and often preserved and old  preparations, and in untested combinations with other substances especially statins,  ethanol, and unknown viruses. .

The Herbalife company has just had to publish again  an update rebuttal of bad papers wrongly implicating and accusing Herbalife.  Their summary says:

World J Hepatol. 2013 Oct 27;5(10):601-2..              A correction of misinformation regarding Herbalife. Appelhans K, Najeeullah R, Frankos V. Herbalife International of America Inc, Torrance, CA     The authors of the subject article by Senadhi et al from Indiana State University  have misrepresented the safety and regulatory status of Herbalife‘s products. While we are very concerned with the unwarranted and unfavorable publicity that the inaccuracies listed could generate for Herbalife, we would welcome any inquiries that these authors may have to better clarify our commitment to the safety and quality of our products as has been demonstrated in part by our ability to establish positive relationships with regulatory authorities worldwide through continued cooperation and compliance. This letter clarifies the misinformation presented about Herbalife in the subject article

16 March 2012   it is comforting to note that there have been no new reports the past year of toxicity from these products.

In fact  some lab work seems to favour black cohosh for cancer prevention;

Anticancer Res. 2012 Jan;32(1):21-30.   Chemopreventive potential of black cohosh on breast cancer in Sprague-Dawley rats. Einbond LS, Soffritti M, Degli Esposti D, Tibaldi E, Lauriola M, Bua L, He K, Genovese G, Su T, Huggins L, Wang X, Roller M, Wu HA.  Columbia University, HHSC-1518, 701 W. 168th Street, New York, NY 10032, USA. lseinbond@gmail.com     This study examines the chemopreventive potential and action of the herb black cohosh on Sprague-Dawley rats. CONCLUSION:Our results suggest that black cohosh may have chemopreventive potential for mammary cancer.
while Herbalife has published objective rebuttals of toxicity from Herbalife other than in isolated countries where irregular ingredients were used in local manufacture:
World J Hepatol. 2011 Oct 27;3(10):275-7. Revisiting acute liver injury associated with herbalife products.  Appelhans K, Smith C, Bejar E, Henig YS  Herbalife International of America Inc., Torrance, CA 90502, United States.   In the November 27, 2010 issue of the World Journal of Hepatology (WJH), three case reports were published which involved patients who had consumed various dietary supplements and conventional foods generally marketed as weight loss products. The reference to Herbalife products as contaminated and generally comparable to all dietary supplements or weight loss products is not scientifically supported. The authors provided an insufficient amount of information regarding patient histories, concomitant medications and other compounds, dechallenge results, and product specifications and usage. This information is necessary to fully assess the association of Herbalife products in the WJH case reports. Therefore, the article does not objectively support a causal relationship between the reported cases of liver injury and Herbalife products or ingredients.
Pharmacoepidemiol Drug Saf. 2012 Mar;21(3):333-4. doi: 10.1002/pds.3203. Misconceptions regarding the association between Herbalife products and liver-related case reports in Spain.
Appelhans K, Frankos V, Shao A.  Source  Product Compliance and Safety, Herbalife International of America, Inc, Torrance, CA, USA.

2 Feb 2011

Since June 2010 there have been no new cases of toxicity from Black Cohosh, herbalife or kava reported on Pubmed.

BLACK COHOSH: BEGGING THE QUESTION OF INDICATION- NEED.

The new literature analysis Suspected black cohosh hepatotoxicity: no evidence by meta-analysis of randomized controlled clinical trials for isopropanolic black cohosh extract  by Naser et al from Yale , and Germany(the main producer of black cohosh BC products)- begs the question.

As this colunm has previously reviewd about BC,  women have died from or needed liver transplants after taking it.. Hence most Authorities have Black Box warning requirements Recurrences of liver reaction have been reported on rechallenge. These scattered cases can be argued away on metanalysis, but they cannot be ignored. One death or acute liver failure is unacceptable when BC is never an essential drug without other safe options.

Another study also published now (Wang ea from the FDA Centre for Drug Evaluation ) http://www.ncbi.nlm.nih.gov/pubmed/20920542 contradicts the German metanalysis with more basic toxicological data: “Computational analysis of positively predicted constituents showed … specifically, protocatechuic acid from black cohosh… predicted positive for liver toxicity endpoints also confirmed with literature findings”

Black cohosh is not physiological hormone replacement, BC is recommended by its proponents solely for menopause symptoms (it has no other benefits) for up to 6 months.

So why risk, use black cohosh at all?

Appropriate balanced hormone replacement – preferably human hormones, not xenohormones ie hormones not found in the healthy women, and not by swallowing it- is indicated permanently in all women .

As previouslly pointed out in this column, the International Menopause Society has summed it up in putting approriate HRT as the main agent(s) for menopause symptoms as well as  for its permanent multisuystem benefits;  and the human hormone gamma-aminobutyric acid GABA as the only alternative that is both safe and cleearly proven better than placebo for improving both hot flashes and sleep, anxiety. Used appropriately and with sensible monitoring and dose titration, all such hormone balance has no longterm risks.

MDICOLEGAL LIABILITY: under the new Conumae Protection Act CPA in South Africa, the pendulum has gone ridiculously too far. irrespective of the onus on manufacturers and promoters of any product, the onus is on the end-prescriber, end-dispenser to warn consumers of potential risks,  and any consumer claim for consequent damages is legally against only the final and retail supplier.

So no supplier of black cohosh is protected against consequent liability unless he gets a signed waiver from the purchaser after the recorded warning about its potential toxicity.

16 June 2010

there are no new adverse toxicity reports on Hebalife, black cohosh or kava  so far in 2010 .

Both Herbalife,  and black cohosh products, remain marketed and in demand  in South SAfrica.

There are  no new serious adverse reports or concerns published  on Pubmed or Google about Herbalife products in 2009.

On Pubmed there were 2 new cases of liver and coagulation problems associated with black cohosh in mid2009, from a Germanic and an Italian institute; and 14 hepatitis cases associated with kava ingestion confirmed  from around the world .

4 Jan 2009

This review  is not about benefit of black cohosh (independent trials show none for menopause symptoms) or Herbalife (trials support that Herbalife is indeed a weight loss aid), or kava (it is a confirmed anxiolytic analgesic euphoriant); but about toxicity potential however rare – considering that none of these  products can make any claim to being a necessity.

Contamination aside, there are no new  relevant reports  on Herbalife the past two months on Pubmed,

but indeed  4 new reports on black cohosh; and one on kava.

Lessons for black cohosh and Herbalife may be learnt from kava. Kava-kava was hastily banned  eg  in Europe and South Africa early this decade owing to reputed association with hepatotoxic deaths. But on careful study these toxicity claims appear to be uncertain.

The claimed benefits of kava are analgesic, euphoriant and relaxant, without addiction potential. The four trials of Kava (between 1991 and 2003, in Italy and Germany) confirmed that kava has anxiolytic benefits in the menopause syndrome.) . The hepatotoxicity (not reported from the source – Polynesia – unless taken by alcoholics) was reported largely from western countries, where commercially sold  kava extract was apparently differently extracted, and from the aerial leftovers of the kava; whereas in Polynesia it is extracted only from the root. A recent website from the NIH shows it is not banned there, but expresses much caution.

A careful analysis of kava hepatotoxicity by Teschke ea in Germany last month again finds little evidence of toxicity if kava is taken from a reputable manufacturer  at prescribed dose and for short duration  – as applies equally to alcohol, and most drugs.

Herbalife

An objective  NICUS  Nutritional Institute of University of Stellenbosch Report critical of  Herbalife is quoted verbatim in the Summer 2008  Newsletter of the Association of Dieticians of SA. NICUS- a world authority in Nutrition – confirms it stands by this report. It could thus be taken as a directive (to condemn Herbalife)- to dieticians for whose professional advice some patients wrongly substitute diet supplements;  where these modalities- careful  professional diet advice and counselling, and supplements-  are actually complementary..

But there does not appear to be any  more  evidence to condemn Herbalife than there was a year ago. As far as Pubmed and Google reveals,  the reports  [to date end of 2008 on Pubmed) of adverse effects  were from 4 discrete European regions [ Iceland; Switzerland; Spain & Israel) , apparently wth locally formulated Herbalife, not the USA main factory product, leading to assumption of a local production fault. There appear to have been 2 cases of liver failure in some 33 affected patients, in one of whom liver transplant became necessary but the patient died.. .

One cannot condemn all  babyfood because some is deliberately adulterated with melamine by ruthless Chinese sham factories. Commercial babyfood is arguably a necessity for many.

We await an updated rebuttal from Herbalife in the new year- but there does not seem to be anything for them to add to their rebuttal of last year..There has been no published evidence to justify update on Herbalife during 2008.

The accusation (by one patient, and a  convicted fraudster, Minkow) of a claimed lead-contaminated  Herbalife batch  in California   has, strangely, generated no updates for months now- but on the wiki herbalife update , it says “In August 2008, Minkow retracted all accusations against Herbalife and removed any mention of the company from his Web site.[30]” – there is no report of whether Herbalife bought his silence or not , which is a pity- see also. ;   but see also heavy flak against Minkow , suggesting that his whole campaign was a successful bear scam  to profit from Herbalife shares.

The  current  Wiki Herbalife  review also quotes a new trial validating benefit for weightloss. Caveat Emptor.

It may be asked why a Nutritional authority like NICUS:  warns  against Herbalife but not against the potentially fatal black cohosh. New independent analyses are both for and against them:

ie

Black Cohosh:

Analyses of case reports from Univ Florida (Palacio 2009) and Italy (Borrelli 2008)  recommend caution about black cohosh for humans in view of adverse case reports; while a German analysis (Teschke 2008) exonerates black cohosh in every single case till then.

A trial from USA (Davis 2008) found that “black cohosh significantly increased the incidence of lung metastases in tumor-bearing mice compared with mice fed the isoflavone-free control diet”.

Clearly the valid divergence of opinion comes down to complex statistics of probability.

Black cohosh has been associated with severe liver failure and  transplantation in a number of women on a number of continents, for which reason the local Health Products Association, like all responsible authorities , finally agreed and issued recommendations that Black Cohosh label must be black-boxed- there is no justification for it’s sale as a useful product, unlike the role than can be argued for food substitute powders.

So why should anyone use black cohosh for menopause symptoms (when it’s benefit seems to be largely placebo, with grave doubt about safety) , when there are proven safe symptom relievers eg GABA (no adverse reports); or lowdose balanced appropriate parenteral human sex hormones (no adverse reports, and have numerous longterm multisystem benefits- which neither black cohosh nor GABA can claim..).

This review  is not about benefit, but safety. Regulators remain silent about drastically curtailing sale of the most lethal substances in widespread unregulated (and unnecessary)  use- paracetamol, other nonsteroidal anti-inflammatories, statins for uncomplicated  mild-to-moderate lipidemia, alcohol, tobacco and sugar, and pollution of everything by industrial adulteration with synthetic (often estrogenic) endocrine disruptors and virtually all fast foods with cornstarch and/or sugar.

The hysterical approval of diethylstilbestrol  DES by the FDA by 1950, and for a massive  1950 maternity trial  against all evidence (even though it’s toxicity was recognized by 1953,  it’s sale anywhaere was finally banned only 20 years later) continues to torment the original myriads of  guineapig women, their children and now grandchildren. These scandals are dictated by individual opportunist, corporate and governmental greed, and indifference to medical evidence and prevention.

The analogy for black cohosh, kava  and Herbalife  is perhaps:

#the ~20year delays before the FDA would licence the lifesaving lithium salt, and metformin, in USA;

#the ~5year hysteria over HRT after the Women’s Health Initiative – when the over-estimated risks of inapproriate use of  OHT in elderly women were stupidly and harmfully (for thousands of women) extrapolated to young women and other  HRT preparations;

and

#the melamine- baby milk formula catastrophe – the problem for the latter was exclusively some contaminated  babyfood batches made in China especially for the lucrative export market. .

The jury can thus be considered as still out on both black cohosh, kava  and Herbalife,  until manufacturers of commercial  products (not traditional preparations of  eg kava and black cohosh taken by residents who grow these)  can produce evidence, confirm  that the risk was limited  to specific batches of the commercial product  and adherence to accepted recommendations, and not due to other possible risk factors.

LIVER DAMAGE IN EUROPE ASSOCIATED WITH HERBALIFE USE:

4 Sept 2007 Review
The following reports below of HerbaLife-associated liver failure appear on Medline – from Spain, then Israel and Switzerland.
:The July 2007 reports of the two dozen Herbalife-associated hepatitis cases from Israel & Switzerland reveal that liver problems occurred after about 5 months on the products; and that relapse occurred in about 20% on rechallenge with Herbalife ie in this percentage the association is proven.

Herbalife results for weight control have been reported as good. The only problem is historical according to the current Wikipedia entry: “Some of the original Herbalife weight loss products contained the active ingredient Ma Huang or Sida cordifolia, two herbs containing ephedrine alkaloids.

Adverse reactions involving the company’s Thermojetics original green tablets were recorded by the U.S. Food and Drug Administration and Herbalife subsequently stopped using ephedrine in its products in the face of rising insurance premiums.[3][4] The U.S. FDA banned supplements containing ephedra in 2004.[5]“

It is possible that the case reports below are unrelated to Herbalife itself , or that in those countries ephedra-containing Herbalife was still in use at the time, or that potentially hazardous herbs etc were added locally.

From Yahoo.com, there is an authoritative rebuttal from Iceland dated February 2007.

A score of drugs and herbs can cause liver damage, topical ones – albeit rarely- include mushrooms; black cohosh and kava – see a recent list.

Drugs like ticrynafen, methyldopa and cerivastatin were discarded among other reasons because of liver problems, which are among many reasons why necessary sex hormone contraception and replacement should rather not use designer patent ie synthetic drugs, and especially not by mouth (hepatic first pass effect).

So it is always difficult to blame a single product, as the ongoing debate about black cohosh shows – which many “first world” regulators have “black boxed” ie added a compulsory warning to black cohosh warnings.

As with black cohosh, with a rare adverse event report, users of such products must weigh up for themselves.

As they say, since Herbalife tends to be custom-made in each country, with numerous ingredients (some undisclosed), it is so far impossible to incriminate whether the cause was local product corruption, or some appreoved component, of which the known possible culprits are ephedra and camelia.

Other known hepatotoxic herbs like black cohosh, kava and mushrooms were not mentioned. A few of the patients had viral hepatitis. Only 7 cases had also taken other known potential liver sensitizers – some synthetic sex hormones (4), aspirin (3), statin (1) and hydrochlorothiazide(1), of which 2 cases had positive recurrence of hepatitis on rechallenge with Herbalife.

UCT Medicines Information Centre is unaware of any such problems locally, and can recollect only perhaps 2 queries about Herbalife in some 23 years. Clarification is awaited from Herbalife headquarters.

From Swiss data the estimated incidence was below 2 cases per million Herbalife users, but both studies were based only on hospital records.

Considering the severe global problem of hepatitis from other causes (due to alcohol; obesity/diabetes (steatohepatitis, sulphonylureas, glitazones); numerous infections; carbon tetrachloride; synthetic sex hormones (oral contraception and postmenopausal hormone therapy) , mushrooms, antibiotics and antivirals, , autoimmune disease, antiepileptics, nifedipine, amitryptiline, allopurinol, nonsteroidal anti-inflammatories including aspirin and paracetamol , black cohosh, kava, antifungals and paracetamol), and that the rare adverse association of herbalife with liver damage may well have been limited only to Herbalife products made in those three “European” countries at that time, there is clearly no cause for alarm about Herbalife – just awareness.

The urgent problem of endemic liver disease is rather the avoidance of infections and potentially hazardous antimicrobials; mushrooms; carbon tetrachloride, alcohol excess; sale pf paracetamol without inclusion of protective vitamins and N-acetyl cysteine; and avoidance of potential hepatotoxins which are rarely if ever justified considering their risks, and safe effective alternatives available for eg statins, sulphonylureeas, glitazones, black cohosh, kava, non-steroidal anti-inflammatories; oral sex hormones; and sulphonylureas.

The centuries-proven plant galega officinalis (extract) metformin after 85years of modern use remains the only drug proven in longterm use to both reduce liver damage, lipidemia, thrombosis, adiposity and insulin resistance, and thus almost halve the incidence of new diabetes, hypertension/vascular disease, cancer and thus all-cause premature medical mortality.

Thus appropriate general use of metformin with long-proven vitamins, minerals, biologicals, safe herbs, fish oil and systemic human sex hormones – combined with prudent lifestyle and largely natural fresh foodstuffs- – does away with most of the well-known potential hepatitis drug risks listed above.

In defence of free market enterprise and choices, those who choose convenience safe proven food substitutes or other complementary products as part of an acceptable balanced regime advocated by suppliers like Herbalife do well, they should just be sure of the ingredients and supplier; and they should report and discuss what they use with some knowledgable up-to-date healthcare provider.

Response from Herbalife

04.09.07
Herbalife’s South Africa CEO responds reassuringly:

Good day,
Herewith a statement from Herbalife in response to the issues raised by yourself earlier in the week:

While we are aware of reports of abnormal liver function blood tests such as those reported by Dr. Oneta, our extensive consultation with internationally recognised liver experts has led repeatedly to the conclusion that these associations in time cannot be linked to any Herbalife product.

These small numbers of reports are anecdotal and millions of satisfied customers all over the world have been using our products for more than 27 years. All Herbalife products are formulated and manufactured in accordance with strict standards overseen by the Herbalife Scientific Advisory Board, which is chaired by David Heber, M.D., Ph.D., F.A.C.P., F.A.C.N. Quality control is overseen by our Scientific Affairs Group, chaired by Y. Steve Henig PhD and made up of an international panel of experts in nutrition and botanical dietary supplements.

Herbalife products, which are now sold in 65 countries, are formulated, registered and labelled in accordance with the regulatory requirements in every market where sold. All Herbalife products are safe to consume as directed.

Many consumers who choose to use Herbalife weight-management products for weight loss are overweight, some significantly so. Pre-existing medical conditions such as obesity and diabetes can be associated with non-alcoholic fatty liver disease, a disorder that may return certain types of abnormal blood test results. These test results, therefore, may have nothing to do with any herbal supplement, but rather are the result of a pre-existing medical condition. In addition, it is possible for an individual to have an allergic reaction to our products, the same way one might to any food product; for example, strawberries or shellfish. Herbalife supports the recommendation that consumers visiting their doctors for medical treatment inform them of any supplements they may be taking.

As a socially responsible company, we operate an adverse event reporting procedure that deals with the small number of queries we have from doctors and consumers and we operate an open dialogue policy with the medical community. All adverse event reports are investigated thoroughly in consultation with the consumer and the physician (if they are available) to fully understand the facts. None have resulted in the compulsory withdrawal of any product, ever. In the United States, Herbalife actively lobbied Congress to pass legislation mandating the submission of all dietary supplement and over-the-counter drug serious adverse events to the Food & Drug Administration. That new law takes effect December 22, 2007.”

REFS:

J Hepatol. 2007 Oct;47(4):521-526. Herbal does not mean innocuous: Ten cases of severe hepatotoxicity associated with dietary supplements from Herbalife((R)) products. Schoepfer AM, ea.University Hospital Bern, Switzerland.
METHODS: To determine the prevalence and outcome of hepatotoxicity due to Herbalife((R)) products. A questionnaire was sent to all public Swiss hospitals. Reported cases were subjected to causality assessment using the CIOMS criteria. RESULTS: Twelve cases of toxic hepatitis implicating Herbalife((R)) preparations (1998-2004) were retrieved, 10 sufficiently documented to permit causality analysis. Median age of patients was 51 years (range 30-69) and latency to onset was 5 months (0.5-144). Liver biopsy (7/10) showed hepatic necrosis, marked lymphocytic/eosinophilic infiltration and cholestasis in five patients. One patient with fulminant liver failure was successfully transplanted; the explant showed giant cell hepatitis.     Causality assessment of adverse drug reaction was classified as certain in two, probable in seven and possible in one case(s), respectively. CONCLUSIONS: We present a case series of toxic hepatitis implicating Herbalife((R)) products. Liver toxicity may be severe. A more detailed declaration of components and pro-active role of regulatory agencies would be desirable.

J Hepatol. 2007 Oct;47(4):514-520. Association between consumption of Herbalife((R)) nutritional supplements and acute hepatotoxicity. Elinav E, ea -Hebrew University Medical Center, Israel.
: In 2004, identification of four index cases of acute hepatitis associated with Herbalife((R)) intake led to a ministry of health investigation in all Israeli hospitals. Twelve patients with acute idiopathic liver injury in association with consumption of Herbalife((R)) products were investigated.
RESULTS: Eleven of the patients were females, aged 49.5+/-13.4 y. One patient had stage I primary biliary cirrhosis and another had hepatitis B. Acute liver injury was diagnosed after 11.9+/-11.1 months of initiation of Herbalife((R)) consumption. Liver biopsies demonstrated active hepatitis, portal inflammation rich with eosinophils, ductular reaction and parenchymal inflammation with peri-central accentuation.
. CONCLUSIONS: An association between intake of Herbalife((R)) products and acute hepatitis was identified in Israel. We call for prospective evaluation of Herbalife((R)) products for possible hepatotoxicity.

Med Clin (Barc). 2007 Feb 17;128(6):238-9.
[Hepatotoxicity associated with the consumption of herbal slimming products] Duque JM,ea. [Article in Spanish] Letter

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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.