Monday, November 5, 2012

USE OF HERBAL SUPPLEMENT IN CHRONIC KIDNEY DISEASE

 Use of Herbal Supplements in 

Chronic Kidney Disease

    As a chronic kidney disease (CKD) patient, you may have considered the use of herbal products to assist you with various health concerns. This fact sheet will give you some information to enable you to make decisions regarding your use of herbs.

Use of herbal supplements may be unsafe for CKD patients, since your body is not able to clear waste products like a healthy person. There are some facts about herbs that every CKD patient should know:
  • Very few herbs have been studied in CKD patients. What may be safe for healthy persons may not be safe for someone with CKD, and in fact, could be dangerous. Therefore, you need to be very cautious about your use of these products.
  • The government does not regulate herbal supplements, so the exact content of these products is unknown.
  • Without regulation, there are no requirements for testing, so the purity, safety and effectiveness of the products are unknown.
  • Herbal preparations are subject to contamination (may contain toxic heavy metals such as lead or mercury).
  • Products may contain minerals harmful to CKD patients, for example: potassium.
Some herbs that may serve as diuretics may also cause “kidney irritation” or damage. These include bucha leaves and juniper berries. Uva Ursi and parsley capsules may have negative side effects as well.

Many herbs can interact with prescription drugs. A few examples are St. Johns Wort, echinacea, ginkgo, garlic, ginseng, ginger, and blue cohosh. Transplant patients are especially at risk, as any interaction between herbs and medications could potentially put them at risk for rejection or losing the kidney. It is important to ask your doctor and/or pharmacist about any herbs or medicines you want to take to avoid potential problems.

Herbs that may be toxic to the kidneys
Artemisia absinthium (wormwood plant) Periwinkle
Autumn crocus Sassafras
Chuifong tuokuwan (Black Pearl) Tung shueh
Horse chestnut Vandelia cordifolia


Herbs that may be harmful in chronic kidney disease
Alfalfa Buckthorn Ginger Nettle Vervain
Aloe Capsicum Ginseng Noni juice
Bayberry Cascara Horsetail Panax
Blue Cohosh Coltsfoot Licorice Rhubarb
Broom Dandelion Mate Senna


Herbs known to be unsafe for all people
Chapparal Pennyroyal
Comfrey Pokeroot
Ephedra (Ma Huang) Sassafras
Lobelia Senna
Mandrake Yohimbe

These lists are not necessarily complete. More information regarding the use of herbs will become available over time. You are encouraged to proceed with caution with all herbal preparations and use them only under the direction of your medical team.
With all of these cautions, perhaps you are wondering if use of any herbs is a good idea. The use of common herbs, in normal amounts, when cooking is just fine and typically recommended to enhance the flavor of foods on a low-sodium diet.
So, before you take any herbal supplement, we recommend:
  • Checking with your doctor, dietitian, pharmacist and/or product manufacturer regarding safety, dosage, duration of use, interactions with prescription drugs, etc.
  • Use only standardized herbal extracts made by reputable companies.
  • Never take more than the recommended dosage, or longer than recommended.
  • Do not use herbal remedies for serious illness.
  • Do not use herbs if considering pregnancy.
Remember … natural does not mean safe, especially for CKD patients. Be smart and ask questions before using any herbal products.
The following references can provide additional information regarding the use of herbal supplements:
PDR for Herbal Medicines . Gruenwald J, Bendler T, Jaenicke C, eds. Montvale NJ: Medical Economics Company, Inc., 2000
The Honest Herbal . Tyler V. Pharmaceutical Products Press, New York, 1999
More than 20 million Americans—one in nine adults—have chronic kidney disease, and most don't even know it. More than 20 million others are at increased risk. The National Kidney Foundation, a major voluntary health organization, seeks to prevent kidney and urinary tract diseases, improve the health and well-being of individuals and families affected by these diseases, and increase the availability of all organs for transplantation. Through its 50 affiliates nationwide, the foundation conducts programs in research, professional education, patient and community services, public education and organ donation. The work of the National Kidney Foundation is funded by public donations.
The National Kidney Foundation would like to thank the
Council on Renal Nutrition for the development of this fact sheet.


==================================

About Chronic Kidney Disease

Chronic kidney disease (CKD) is a condition characterized by a gradual loss of kidney function over time. To read more about kidney function, see How Your Kidneys Work. CKD is also known as chronic renal disease.

What is chronic kidney disease (CKD)?

Chronic kidney disease includes conditions that damage your kidneys and decrease their ability to keep you healthy by doing the jobs listed. If kidney disease gets worse, wastes can build to high levels in your blood and make you feel sick. You may develop complications like high blood pressure, anemia (low blood count), weak bones, poor nutritional health and nerve damage. Also, kidney disease increases your risk of having heart and blood vessel disease. These problems may happen slowly over a long period of time. Chronic kidney disease may be caused by diabetes, high blood pressure and other disorders. Early detection and treatment can often keep chronic kidney disease from getting worse. When kidney disease progresses, it may eventually lead to kidney failure, which requires dialysis or a kidney transplant to maintain life.

The Facts About Chronic Kidney Disease (CKD)

  • 26 million American adults have CKD and millions of others are at increased risk.
  • Early detection can help prevent the progression of kidney disease to kidney failure.
  • Heart disease is the major cause of death for all people with CKD.
  • Glomerular filtration rate (GFR) is the best estimate of kidney function.
  • Hypertension causes CKD and CKD causes hypertension.
  • Persistent proteinuria (protein in the urine) means CKD is present.
  • High risk groups include those with diabetes, hypertension and family history of kidney disease.
  • African Americans, Hispanics, Pacific Islanders, Native Americans and Seniors are at increased risk.
  • Three simple tests can detect CKD: blood pressure, urine albumin and serum creatinine.

What causes CKD?

The two main causes of chronic kidney disease are diabetes and high blood pressure, which are responsible for up to two-thirds of the cases. Diabetes happens when your blood sugar is too high, causing damage to many organs in your body, including the kidneys and heart, as well as blood vessels, nerves and eyes. High blood pressure, or hypertension, occurs when the pressure of your blood against the walls of your blood vessels increases. If uncontrolled, or poorly controlled, high blood pressure can be a leading cause of heart attacks, strokes and chronic kidney disease. Also, chronic kidney disease can cause high blood pressure.
Other conditions that affect the kidneys are:
  • Glomerulonephritis, a group of diseases that cause inflammation and damage to the kidney's filtering units. These disorders are the third most common type of kidney disease.
  • Inherited diseases, such as polycystic kidney disease, which causes large cysts to form in the kidneys and damage the surrounding tissue.
  • Malformations that occur as a baby develops in its mother's womb. For example, a narrowing may occur that prevents normal outflow of urine and causes urine to flow back up to the kidney. This causes infections and may damage the kidneys.
  • Lupus and other diseases that affect the body's immune system.
  • Obstructions caused by problems like kidney stones, tumors or an enlarged prostate gland in men.
  • Repeated urinary infections.

What are the symptoms of CKD?

Most people may not have any severe symptoms until their kidney disease is advanced. However, you may notice that you:
  • feel more tired and have less energy
  • have trouble concentrating
  • have a poor appetite
  • have trouble sleeping
  • have muscle cramping at night
  • have swollen feet and ankles
  • have puffiness around your eyes, especially in the morning
  • have dry, itchy skin
  • need to urinate more often, especially at night.
Anyone can get chronic kidney disease at any age. However, some people are more likely than others to develop kidney disease. You may have an increased risk for kidney disease if you:
  • have diabetes
  • have high blood pressure
  • have a family history of chronic kidney disease
  • are older
  • belong to a population group that has a high rate of diabetes or high blood pressure, such as African Americans, Hispanic Americans, Asian, Pacific Islanders, and American Indians.

Learn more About Glomerular Filtration Rate (GFR)

GFR—glomerular filtration rate is the best test to measure your level of kidney function and determine your stage of kidney disease. Your doctor can calculate it from the results of your blood creatinine test, your age, race, gender and other factors.
The earlier kidney disease is detected, the better the chance of slowing or stopping its progression.

What happens if my test results show I may have chronic kidney disease?

Your doctor will want to pinpoint your diagnosis and check your kidney function to help plan your treatment. The doctor may do the following:
  • Calculate your Glomerular Filtration Rate (GFR), which is the best way to tell how much kidney function you have. You do not need to have another test to know your GFR. Your doctor can calculate it from your blood creatinine, your age, race, gender and other factors. Your GFR tells your doctor your stage of kidney disease and helps the doctor plan your treatment.
  • Perform an ultrasound or CT scan to get a picture of your kidneys and urinary tract. This tells your doctor whether your kidneys are too large or too small, whether you have a problem like a kidney stone or tumor and whether there are any problems in the structure of your kidneys and urinary tract.
  • Perform a kidney biopsy, which is done in some cases to check for a specific type of kidney disease, see how much kidney damage has occurred and help plan treatment. To do a biopsy, the doctor removes small pieces of kidney tissue and looks at them under a microscope.
Your doctor may also ask you to see a kidney specialist who will consult on your case and help manage your care.,FOR MORE DETIAL http://herbalife-sideeffects.blogspot.in/

Sunday, November 4, 2012

UPDATE ON LIVER DAMAGE FROM HERBALIFE, BLACK COHOSH and KAVA
Posted on March 17, 2012 | 4 Comments   
neil.burman@gmail.com



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