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It was actually the only thing that helpe dme lose 30 lbs. A very interesting debate. If under the age of 40 and from pretty much any colledge you probably suffer a serious taint problem. At the time of the presentation, Herbalife was already a well-known name on Wall Street. There is a word that describes distributors who go around making fantastic unverifiable snakeoil wonder-cure claims about Monavie — and that word is A-HOLE. In one of nine follow-up communications to the accountants, Ackman noted:
Make Money. Make a Difference.
Her liver tests gradually improved within the following few months. Case 2 A year-old woman presented to our hospital with a 1-mo history of diffuse abdominal pain, mild nausea, and painless jaundice. She denied any past medical or surgical history, family history of liver disease, or any alcohol or illicit substance abuse. She admitted that she had been taking Herbalife dietary supplements for the past 3-mo in an attempt to lose weight.
The patient was afebrile with normal vital signs on presentation. Her physical exam was noticeable for bilateral scleral icterus and generalized jaundice.
Her abdominal exam revealed a non-tender, non-distended abdomen with no stigmata of liver disease. All other laboratory values, including amylase, lipase, and INR, were within normal limits.
Given these lab abnormalities, the patient was admitted to the hospital for further work-up. Serum ceruloplasmin, ferritin, iron studies, and immunoglobulins were all within normal range.
A computerized tomography CT scan of the abdomen and pelvis with intravenous IV contrast showed multiple low-density lesions in the liver measuring up to 8-mm. However, her liver biopsy specimens also showed evidence of bridging fibrosis, which suggest some degree of chronic liver disease but with drug-induced injury in addition. Liver biopsy was performed and showed periportal bridging fibrosis, ductal metaplasia, cholestasis, moderate intralobular lymphocytic infiltration, and troxis necrosis and apoptosis consistent with drug-induced hepatitis on top chronic liver disease.
The patient was treated supportively with fluids and nutrition. The only laboratory value to increase was the patient's serum TB, which was at The patient did not develop encephalopathy, hypoglycemia, or any other complications.
The patient was followed for several months, throughout which her symptoms continued to improve. At her 2-mo follow-up, the patient's icterus and jaundice had resolved completely. Case 3 A year-old previously healthy woman presented with a 3-wk history of painless jaundice and pruritus. She denied any family history of liver disease, or any alcohol or illicit substance abuse.
She had not been taking any new prescribed medications. On further questioning about over-the-counter supplements she divulged a 4-mo history of consuming various Herbalife weight loss products in the form of shakes, teas and pills.
On general inspection she had scleral icterus and jaundice, with evidence of excoriations. A 2-cm palpable liver edge could be appreciated, that was tender to touch. There were no other signs of chronic liver disease. An ultrasound showed borderline hepatomegaly of cm. A liver biopsy revealed acute hepatitis characterized by hepatocellular injury, with periportal fibrosis, cholestasis, ductal metaplasia and diffuse intralobular and periportal troxis necrosis consistent with a drug-induced etiology.
Acute liver injury induced by over the counter weight-loss herbal supplement Hydroxycut and Herbalife products have been reported previously[ 3 - 6 , 8 - 11 ]. These case reports were limited by the fact that liver biopsies were performed in only a few patients, confirming clinical suspicions histologically. In terms of our patients, all three had liver biopsy performed and all showed some common morphological features including diffuse lymphocytic infiltration of sinusoids and portal tracts, ductal metaplasia and toxic necrosis.
Some variations of morphological features could be explained by predominance of intrinsic or idiosyncratic mechanisms of hepatic injury, individual patient response to the affecting drug and duration of injury. No hyaline globules were identified in any of the three cases.
The absence of histological findings and the fact that our patients had no history of chronic obstructive pulmonary disease excluded diagnosis of alphaantitripsin deficiency in all three cases.
Prussian blue and copper stains did not reveal excessive iron or copper depositions in the hepatocytes and Kupffer cells. Only one previous case of Hydroxycut-induced acute liver injury had reported findings on liver biopsy.
Although the most likely explanation for the mechanism of liver injury caused by these herbal products is idiosyncratic reaction, one of the ingredients in Hydroxycut, green tea extract Camellia sinensis , has been linked with acute liver injury in other over the counter weight-loss herbal supplements[ 12 - 20 ]. In fact, the weight-loss herbal supplement Exolise Arkophama, Carros, France , which also contained C. Furthermore, several cases of hepatotoxicity were associated with another herbal weight-loss supplement, Cuur Scandinavian Clinical Nutrition, Sweden , which also contains the ethanolic dry extract of green tea C.
Rechallenging patients with the same product led to hepatotoxicity, confirming the role of C. However, there have been cases of liver failure caused by green tea extract C. The liver biopsy obtained in our patient who took Hydroxycut showed multi-lobular necrosis consistent with acute toxic necrosis and fulminant hepatitis.
These findings are similar to the findings in patients with liver injury associated with green tea extract C. The exact mechanism of hepatotoxicity induced by Hydroxycut is unknown. However, as this product contains green tea extract C. Prior investigation into the mechanism of hepatotoxicity by green tea extract was inconclusive[ 21 ].
Others have hypothesized that a possible allergic reaction to the green tea extract, contamination during the production of the extract or a metabolic idiosyncrasy are possible mechanisms of liver injury in these patients[ 16 ].
Both of our patients took several Herbalife weight-loss herbal products concurrently, similar to most of the previously reported cases of hepatotoxicity due to Herbalife products[ 8 - 11 ]. Therefore, it is difficult to identify the exact ingredient or mechanism that causes the liver injury, as in the previously documented cases[ 8 - 11 ].
In a previously reported case, one investigator was able to isolate contamination with Bacillus subtilis , in which the bacterial supernatant caused dose-dependent increase of LDH leakage in HepG2 cells[ 8 ]. Although not commonly known as a human pathogen, B. Investigators have also suggested that another explanation for hepatotoxicity due to Herbalife products could be secondary to locally restricted contamination with chemicals such as softeners, preservatives, flavor enhancers, pesticides, or heavy metals either intentionally added during the production process or contained in the unrefined raw herb extracts[ 24 ].
This contamination hypothesis could also explain the different patterns of pathology seen on liver biopsy specimens previously observed in patients with hepatotoxicity from Herbalife products as both predominantly cholestatic injury pattern and acute hepatitis pattern have been reported[ 8 - 11 ].
Our patients had findings consistent with acute hepatitis due to drug-induced liver injury on their liver biopsy specimens.
Due to the obesity epidemic, the usage of weight-loss herbal supplements has flourished. Green tea extract is one of the key components in many of the over-the-counter weight-loss herbal supplements. Although significant liver injury induced by herbal supplements taken for weight loss purposes is a rare event, we cannot ignore the fact that there have been multiple reported cases in the medical literature of hepatotoxicity associated with weight-loss herbal supplements including Hydroxycut and Herbalife products.
Even though our patients successfully recovered from the adverse reactions, we must bear in mind that the hospitalization and medical care of these patients were associated with significant cost and healthcare resource utilization, while there is no evidence that herbal supplements can help with weight-loss[ 26 ]. We must also consider the impact on patients with underlying chronic liver disease, in whom herbal weight loss medications could cause worsening in their synthetic function and even fulminant failure.
In May of , the US Food and Drug Administration warned consumers to immediately stop using Hydroxycut products, citing linkage to liver damage in one patient who died due to liver failure[ 27 ]. However, Hydroxycut products are currently still available in many parts of the world.
Likewise, Herbalife products are widely available globally. Furthermore, our cases once again demonstrated the importance of questioning patients regarding the usage of herbal or nutritional supplements at the time of evaluation. Sforza 28, Milano , Italy. Recent trends in use of herbal and other natural products. Two patients with acute liver injury associated with use of the herbal weight-loss supplement hydroxycut. Acute liver injury associated with the herbal supplement hydroxycut in a soldier deployed to Iraq.
Shim M, Saab S. Severe hepatotoxicity due to Hydroxycut: Severe hepatotoxicity following ingestion of Herbalife nutritional supplements contaminated with Bacillus subtilis. Association between consumption of Herbalife nutritional supplements and acute hepatotoxicity.
Herbal does not mean innocuous: Hepatotoxicity associated with the consumption of herbal slimming products. Med Clin Barc ; Hepatotoxicity associated with supplements containing Chinese green tea Camellia sinensis Ann Intern Med. Fulminant hepatitis during self-medication with hydroalcoholic extract of green tea. Eur J Gastroenterol Hepatol. Green tea extracts and acute liver failure: Bjornsson E, Olsson R.
Serious adverse liver reactions associated with herbal weight-loss supplements. Acute liver failure induced by green tea extracts: Acute hepatitis due to Exolise, a Camellia sinensis dried ethanolic extract [letter] Med Clin Barc ; Acute hepatitis associated with Camellia thea and Orthosiphon stamineus ingestion [letter] Gastroenterol Hepatol. Hepatotoxicity associated with green tea extracts [electronic letter].
Toxicity of green tea extracts and their constituents in rat hepatocytes in primary culture. Bacillus cereus and other Bacillus species. Bacillus subtilis as a cause of cholangitis in polycystic kidney and liver disease. N Engl J Med. Slimming at all costs: Supplemental products used for weight loss. J Am Pharm Assoc ; Published online February This article has been cited by other articles in PMC.
Aloe has been widely used in phytomedicine. Phytomedicine describes aloe as a herb which has anti-inflammatory, anti-proliferative, anti-aging effects. In recent years several cases of aloe-induced hepatotoxicity were reported. But its pharmacokinetics and toxicity are poorly described in the literature. Here we report three cases with aloe-induced toxic hepatitis. A yr-old woman, a yr-old woman and a yr-old woman were admitted to the hospital for acute hepatitis.
They had taken aloe preparation for months. Their clinical manifestation, laboratory findings and histologic findings met diagnostic criteria RUCAM scale of toxic hepatitis. Upon discontinuation of the oral aloe preparations, liver enzymes returned to normal level. Aloe should be considered as a causative agent in hepatotoxicity.
The demand for dietary supplements has continually increased in recent years as the concept of 'well being' widely spread in Korea. The market value for dietary supplements in Korea was approximately billion won million USD in year 1 , and personal spending was approximately , won USD per year in 2.
One of the leading products in Korea's dietary supplements market is aloe. Aloe has been purported to have positive effects on wound healing, recovery from burn injury, cell growth, and immune modulation. However, cases of aloe-induced toxic hepatitis have been reported since We report 3 cases of aloe-induced toxic hepatitis in Korea. Case 1 A yr-old female patient with a 2 month history of dyspepsia was presented to our department.
Past medical history and family history did not reveal any significant disease. She also used drugs for arthralgia intermittently for several years.
She did not take any alcohol. She had taken aloe tablets containing mg of an extract of Aloe arborescens and On admission, the patient's physical examination was normal. Preparation of aloe which the patient had taken. A Container bottle and tablets. B Packs of aloe extract. Anti-HBs IgG was positive. Autoimmune markers were all negative.
Abdominal ultrasonography showed reduced echogenicity of liver. Dilatation of intra- or extrahepatic bile ducts was absent. Liver biopsy revealed moderate portal infiltrates consisting of eosinophilis, neutrophils, and monocytes. There were inflammatory cell infiltration and acidophil body on the hepatic lobule. There was no bile stasis Fig. Histopathological findings of the liver. Aloe tablets was immediately discontinued.
ALT as well as total bilirubin gradually returned to normal level over several weeks Fig. Upon discontinuation of the oral aloe preparation, liver enzymes returned to normal level. Case 2 A yr-old female patient was presented to our department with a week history of fatigue. The patient did not take any alcohol or durgs.
She had taken aloe powder containing mg of an extract of Aloe vera Fig. Physical examination revealed jaundice on her sclera. She was the sales person of the aloe product she was taking. Abdominal ultrasonography was normal. Liver biopsy revealed severe portal and lobular infiltrates consisting of neutrophils and monocytes.
There were several acidophilic bodies and ballooning cell change in hepatic lobule. There were bile-stasis and bile stained Kupffer cells Fig. Aloe extract was immediately discontinued. We explained to her about the aloe-induced hepatotoxity and advised not to take it anymore. However, the patient started taking the same aloe extract again 1 month after her discharge from the hospital.
Since a hepatitis recurred after re-challenge of aloe extract, we could confirm her diagnosis as aloe-induced toxic hepatitis. The type of liver injury was determined as 'hepatocellular' since R ratio was After re-challenge arrow , liver enzymes go up again. Six months later, the patient was presented to our department with a 2 week history of jaundice.
We recommended admission, but she refused to be admitted and she never visited our hospital again. Case 3 A yr-old female patient was presented to our department with a 3 month history of epigastric discomfort. The patient did not take any alcohol or drugs. She had taken aloe extracts Fig. On admission, the patient's physical examination was normal except mild tenderness on epigastric area.
Autoimmune markers were negative. Abdominal ultrasonography showed increased echogenicity of liver. After 4 days, she visited our department for follow-up. The major driving force for the growth of the dietary supplements market is the perception that 'they are safe because they are natural'. However, the recently reported cases of hepatotoxicity induced by natural substances 8 indicate that natural substances may not be entirely safe.
There are about species of aloe. Among them, particularly aloe vera has been used in phytomedicine. There have been positive reports on aloe vera as anti-inflammatory, anticancer, analgesic, anti-aging as well as liver protective. But, clinical effectiveness of aloe vera was not sufficiently defined because there were no large and randomized studies 9. In , Korea's National Institute of Safety Research conducted an experiment on the efficacy and toxicity of aloe There was no difference of natural killer cell activity between the aloe vera gel treated and control animals.
To observe the toxicity of aloe gel, rats were given the high dose aloe orally. Any adverse effects were not detected in hematological test, serum biochemistry, and histopathological examination. There are no specific tests or diagnostic criteria for herbinduced hepatic injury. Careful history taking, laboratory finding, and histopathology are used to diagnose it. The best way to determine causing agent is re-challenging.
But it is not ethical and not applicable. Since patients usually do not regard dietary supplements as 'real' medicine, they may fail to mention it when physicians query medication history. Physicians should keep in mind that dietary supplements can be the cause of hepatotoxicity when querying medication history, and should educate the lay public.
There are three types of acute liver injury by drug or herb Our cases are characterized as hepatocellular; there is a predominant initial elevation of the ALT level. There are two proposed pathogeneses of drug induced liver disease It is more likely that an idiosyncratic immunological mechanism hypersensitivity is responsible for the cases. A role for hypersensitivity is further supported by the presence of eosinophilic granulocytes in the periportal fields seen in the biopsy.
Hypersensitivity to aloe has been described in humans 14 , and the patch test or allergic skin test showed positive results Herb induced liver injury is an important problem in clinical setting, because it can be an etiology of undiagnosed acute hepatitis. However, there are few available data about the incidence and clinical manifestation of dietary supplements such as aloe.
Our cases emphasize that physicians should consider various dietary supplements as causative agents for hepatotoxicity. Food and Drug Statistical Yearbook. Korea Food and Drug Administration. Aug, [accessed 0ct 27]. The survey for the actual condition of drug medication and development of health care cost associated with toxic liver injury in Korean: Acute hepatitis induced by an aloe vera preparation: Aloe vera-induced acute toxic hepatitis in a healthy young man.
Eur J Intern Med. Oral aloe vera-induced hepatitis. Criteria of drug-induced liver disorders. Report of an international consensus meeting. Vogler BK, Ernst E. Br J Gen Pract. Studies of the effectiveness and toxicity of aloe vera gel. The report of National Institute of Safety Research.
Clinical features and diagnosis of drug induced liver injury. Pathologic features of toxic and drug induced liver injury. A case of hypersensitivity associated with oral aloe agent. J Asthma Allergy Clin Immunol. Herbalife, Liver, Hepatotoxicity, Weight loss products, Dietary supplements. Case 1 involved a patient who did not consume Herbalife products, while Cases 2 and 3 each reportedly consumed various Herbalife products.
Herbalife fundamentally disagrees with the conclusions made by the authors with regard to any cause and effect relationship related to the intake of Herbalife products. First, Herbalife is not a single product and no unique suspect product or ingredient has been implicated in this paper amongst the reported cases. In addition, the authors arbitrarily compared cases involving the use of a single product Hydroxycut with patients who consumed a group of totally unrelated products produced by the company Herbalife.
To bundle a brand of products such as Herbalife with another company that sells different products simply because they are all dietary supplements is not valid. Finally, there are specific considerations, in regard to the two patients who consumed Herbalife products, that would render many of the observations and conclusions discussed by the authors as speculative and unsubstantiated.
The specific and factual points supporting these views are further detailed below. Case 2 describes a year-old female who developed symptoms of abdominal pain, mild nausea, and painless jaundice 1 mo prior to presenting at the hospital[ 1 ].
Several pertinent negatives were disclosed by the authors, including autoimmune markers and viral serology. According to the authors, the patient did not report any pre-existing medical conditions for which the onset had preceded the use of Herbalife products. This opinion contradicts repeated statements by the authors that acute liver injury in each case report was due to the use of herbal weight loss products.
In addition, the etiology of the pre-existing condition was not identified by the authors, and there was no discussion regarding the role of the condition in the acute onset of her symptoms.
Furthermore, the dosage and frequency at which this patient consumed Herbalife products is unknown. In the absence of the aforementioned data, the exclusion of possible differential diagnoses is not well-supported.
Case 3 describes a year-old female who developed symptoms of painless jaundice and pruritus 3 wk prior to presenting at the hospital[ 1 ]. The authors further stated that the patient had not been prescribed any new medications, which implies that she may have been taking other agents concomitantly.
However, information regarding the use of concomitant medications, or the conditions for which she may have been receiving treatment, was not disclosed. In addition to the absence of the aforementioned pertinent patient data, there are various refutable facts that remain in regard to the comments and conclusions made by the authors. In their WJH article, the authors concluded that it was difficult to isolate a single ingredient or mechanism associated with acute liver injury for either patient consuming Herbalife products[ 1 ].
In an effort to discuss potential causative agents for the reported conditions in these patients, the authors extraneously reference previously published case reports involving Herbalife products, including those of two consumers who reportedly developed hepatotoxicity following exposure to Bacillus subtilis B.
In review of this reference, it has been noted that there were various critical deficiencies in the scientific methodology used to isolate B. Neither patient reported symptoms consistent with classical B. Furthermore, the investigators did not enumerate the levels of B. This was a crucial step missing in the reported investigation as all previous documented reports find that high levels of the organism must be consumed to cause illness.
Herbalife products, consumed by the patients described in the WJH article, to date show no evidence of B. This bacterium is actually ubiquitous in nature and generally recognized as safe with a history of safe use in food, and is considered to be safe for the production of enzymes or ingredients for use in food[ 3 ].
There have been reported cases of B. Therefore, it is highly unlikely that B. The WJH authors also suggest intentional or incidental contamination of Herbalife ingredients and identify various potential sources, including unrefined raw herbal extracts, heavy metals, pesticides, and additives[ 1 ]. However, some of the additives mentioned as potential contaminants by the authors e. In addition, authors also reference an article from that reviews possible contamination sources inherent to herbal remedies marketed without proper quality control measures in place[ 5 ].
Herbalife is not specifically implicated in the referenced article, yet the authors imply that Herbalife product contamination and lack of quality control contributed to the liver injury. Herbalife has rigorous processes in place concerning quality control, including extensive safety reviews based on existing literature for product ingredients, testing to confirm that labeled ingredients are present in finished goods, and to assure all tested ingredients meet product specifications on an ongoing basis.
In addition to complying with cGMP regulations, Herbalife acts in accordance with other generally recognized industry standards or requirements by sourcing and testing raw materials to further ensure that the final product complies with specifications for identity, purity, potency and contaminants. The authors also try to implicate the Camellia sinensis C. The most important safety consideration for green tea is the extraction method. The historical data supporting the safety of green tea is based on the consumption of an aqueous extract over thousands of years, specifically, the typical three cups per day that are commonly consumed in Asian countries.
Aqueous extracts of green tea are quite different from solvent extractions, which are commonly used to concentrate select fractions of green tea, such as EGCG or caffeine. Again, the WJH authors have not considered the clinical significance of potential differences in raw material processing amongst manufacturers, controls for contamination and identification of raw materials, and the implication of these differences when reviewing published case reports of liver injury.
In addition, the authors state that Herbalife has refused to provide detailed analyses of ingredients and formulations, although no attempt was made by these authors to contact Herbalife to obtain further information regarding Herbalife products or ingredients.
Herbalife has, to date, remained compliant with all formal regulatory requests and requirements for product information. The authors state that significant liver injury induced by herbal supplements is a rare event[ 1 ]. This statement is true as approximately 20 to 50 percent of all cases presenting as hepatotoxicity are cryptogenic leading to the incidental association of liver disease with a group of products in the absence of specific evidence[ 5 ].
While this disease is the most common cause of drug withdrawal during post-marketing surveillance, it is an uncommon cause of liver disease. The background incidence of hepatotoxicity in populations is clearly comparable to the reported incidence of immunoallergic and individualistic reactions to allergens in foods, supplements, or the environment.
While the spectrum of liver diseases may well have changed since when this survey was done, idiopathic liver disease remains a significant percentage of all cases. Therefore, it is particularly important in making such associations to have incontrovertible evidence such as is often available for prescription drugs where, under controlled conditions, a cause-effect relationship can be established.
Finally, the authors also state that existing case reports of dietary supplement-induced hepatotoxicity include patients with pre-existing liver disease and that weight loss supplements could worsen such conditions in these patients. In conclusion, the reference to Herbalife products as contaminated and generally comparable to all dietary supplements or weight loss products is not scientifically supported.
Further information regarding patient histories, concomitant medications and other compounds, dechallenge results, and product specifications and usage is indicated to assess fully the association of Herbalife products in the WJH case reports.
Acute liver injury induced by weight-loss herbal supplements. The occurrence of new hepatic disorders in a defined population. Christopher Pascale Posted on Dec 21, Herbalife is a publicly traded company based out of Los Angeles, California. Since it has allowed people the opportunity to become independent sales reps with the opportunity to lead others to do the same in the form of multi-level marketing, or network marketing. Like any large organization with several decades of experience, there are some controversies behind this one.
Along with these legal matters are much more pressing health concerns. Several medical resources have found that Herbalife products may actually cause hepatitis. What is Hepatitis and How is it Caused? Hepatitis can be characterized as an inflammation of the liver. One visible symptom is jaundice, and less visible ones are lack of appetite and a feeling of overall discomfort.
Hepatitis is typically caused by a virus, but it can also be caused by toxins when taken regularly, such as alcohol or an infection that is already present.
The question on many people's minds regarding Herbalife products would be, how could these products be linked to infecting those who take them? The answer is in the ingredients. There has to be something toxic in some or all of the products released by the company, but it is hard to know which ones because the FDA does not regulate herbal supplements the same way it does medicine. This is why athletes find out via heart attack that ephedrine is not so great, and how health conscious people discover that they may be poisoning themselves the hard way, as reported in a article published in The Journal of Hepatology titled " Herbal Does not Mean Innocuous.
This is because some people go on the attack against networking companies because they think they are dangerous or terrible, and some governments are anti-capitalistic , so they would be against a company like Herbalife because they do not want their people to have too much freedom and control.
In , 12 patients in Israeli hospitals with severe liver problems had one thing in common. They were taking an Herbalife supplement that aided digestion.
When their liver enzymes normalized, they resumed their normal regimen of the product and were sick again. The article noted from the European Journal of Hepatology had several sources, one of which was medical professionals from Switzerland. If you need detailed definitions of the products included in a particular report then please email info euromonitor. Retail selling price, i. MSP is the manufacturer selling price, i. Off-trade sales represent total sales through the following channels: NBO stands for National brand owner, i.
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