What alternative health

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"While drugs in the U.S. must undergo extensive testing and monitoring to ensure their safety and efficacy, supplements come under much weaker regulation. In a perspective article in The New England Journal of Medicine, Dr. Pieter A. Cohen criticizes the current deficiencies in the regulation of the supplement industry. He argues that a new guidance proposal by the FDA makes important steps toward enhancing supplement safety — but it still doesn’t go far enough."  Health Facts and Fears (26th January 2012)

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“The long-awaited government decision concerning statutory regulation of herbalists, traditional Chinese medicine (TCM) and acupuncture came out today. It is not good news. They have opted for statutory regulation by the Health Professions Council (HPC)…The vast majority of herbalists, traditional Chinese medicine (TCM) and acupuncture has no good evidence that it works. In the case of some herbal medicines and acupuncture, there is good evidence that they don’t work. Yet the HPC has, as one of its criteria, that aspiring to be regulated by them requires "practise based on evidence of efficacy". The Department of Health seems to have quietly forgotten about this criterion. It cannot possibly be met. The HPC has already expressed its willingness to go along with this two-faced approach. Another mistake made by the Department of Health regards the value of ‘training’…Spending three years training people to learn things that are not true, safeguards nobody. On the contrary, it endangers the public. Training in nonsense is obviously a nonsense.” Professor David Colquhoun, DC Science blog (16th February 2011)

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Conclusion: Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any indication. Because of the high potential for adverse events and negative herb–herb and herb–drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended. R Guo , P H Canter , E Ernst, Postgraduate Medical Journal 2007;83:633-637 (October 2007)

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"In conclusion, although the use of natural drugs is extensive, patients' knowledge of their potential adverse effects is poor. A public educational campaign, with inclusion of the need to report such usage to the family physician, should be implemented, and questions on the use of complementary medicine/natural drugs should be incorporated as an integral part of the history taking by primary care physicians." Giveon SM, Liberman N, Klang S, Kahan E., Patient Educ Couns. 2004 Apr;53(1):5-11

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A critical review of part three of the BBC2 series 'Alternative Medicine: The Evidence' which looked at herbalism. By David Colquhoun, FRS, A. J. Clark Professor of Pharmacology at University College London, (8th February 2006) [Includes the current evidence on Sutherlandia and St John's Wort]

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Conclusions: "Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products." David K Raynor, Rebecca Dickinson, Peter Knapp, Andrew F Long and Donald Nicolson, BMC Medicine (9th August 2011)

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Advice on buying and using herbal medicines. Includes related information on buying medicines over the internet, marketing authorisations, patient reporting of adverse drug reactions, 'Herbal Safety News', and the side effects of medicines. UK Medicines and Healthcare products Regulatory Agency (MHRA)

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“Cancer patients risk shortening their lives by taking herbal remedies and supplements which stop their conventional treatment working properly, Scottish doctors have warned. Some common complementary therapies, such as St John's Wort or special ‘anti-cancer diets’, can increase or decrease the amount of chemotherapy drugs circulating in the body.” The Scotsman (25th July 2010)

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"…adulterating commercial herbal products with prescription drugs is so common that the US FDA is keeping a running tally of actions against companies selling supplements containing "undeclared drugs": the polite regulatory term for deceptive doping of a useless product with a real drug…Most concerning is when these adulterants might interact with other medications a patient is taking …to dope supplement products with effective drugs is to admit that one is selling garbage: a deceptive practice to prey upon those who choose to seek out "alternative" medical approaches and keep them coming back….This practice also makes one wonder how many anecdotal cases of "success" with herbal products could be attributed to adulteration with prescription drugs. For this reason, I recommend that grant reviewers and journal editors insist that any dietary supplement used in a clinical trial be subjected to extensive chemical analysis as a condition of funding or publication, respectively, including screening for pharmaceutical compounds capable of exerting the therapeutic effect under investigation." Article by David J Kroll, Science Based Medicine (14th April 2009)

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"This January 2009 report from the Arthritis Research Campaign (UK) must be interpreted carefully. In Part 1, it lists and evaluates 40 products that have been studied in randomized, controlled trials (RCT). The ratings they assign range from 1-5. I take exception to the rating system because a rating of "1" really means there is *zero* evidence of effectiveness, and a rating of "3" (which may *look* okay) really means there is little evidence of effectiveness. Of the 40 products, 36 are rated "3" or below. Only four have good evidence for effectiveness in RCTs. It is not enough to cite an RCT, such a study must be large-enough to be believable — minimally, 100 subjects, preferably 200 (a "Phase 3" clinical trial would have 2,000 subjects). Moreover the study should not have too many subjects who drop out. The ARC relies on studies that fail one, or both, of those criteria and are, thus, dubious (some are marked as such). In Part 2, the ARC study lists another 36 products that are offered to treat arthritis that have not been subjected to any reliable study. Properly considered, the ARC study, in aggregate, cautions one that there are 72 products offered for relief of arthritis with little, or no, evidence of effectiveness. Seen that way, it is a useful warning. Of the total number (76) of products examined in Parts 1 and 2, 70% are herbal." Review summary by Joe Magrath, Ph.D. (27th February 2009) [pdf]

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CONCLUSIONS: “Collectively these data suggest that there are reasons for concerns with regards to the quality of HMPs. Adulteration and contamination of HMPs can cause serious adverse effects. More stringent quality control and its enforcement seem to be necessary to avoid health risks.” Posadzki P, Watson L, Ernst E. Eur J Clin Pharmacol. (29th July 2012)

Blog post on the above overview: Contamination and adulteration of herbal remedies

"There are, of course, several reasons why supposedly "natural" herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated. The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects. Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen. We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc. These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive." Edzard Ernst (12th January 2013)

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“In the current issue of the Annals of Internal Medicine there is a new study of Echinacea for the treatment of cold symptoms: Echinacea for Treating the Common Cold, A Randomized Trial. I won’t hold out the punchline – the study was completely negative. But let’s put the results of this study into the context of the history of echinacea and the clinical evidence…..The prior plausibility for echinacea as a cold remedy is very low, but not zero. As an herbal product it can feasibly have biological activity. The claim that it “boosts the immune system” is not credible, as such a phenomenon is not generally accepted. Basic science research essentially finds that the immune system is activated by echinacea, but this has not been distinguished from a non-specific immune response to a foreign substance. In other words, stimulating the immune system non-specifically (I can do this by punching you in the arm) and “boosting” the immune system so that it functions more effectively against an infection, are not the same thing. Leaping to the latter conclusion is not justified by the evidence.” Steven Novella, MD, Science Based Medicine (22nd December 2010)

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“The use of cheaper materials in drug and supplement products came to light with melamine used to artificially boost apparent protein content in pet food and infant formula products in China. In 2009, the Council for Responsible Nutrition released a statement on the problem of economically-motivated adulteration in the supplement industry. While the new Good Manufacturing Practice guidelines for the industry were intended to address this issue, the current USDA analytical paper tells us that more stringent enforcement of the rules is necessary.” David J Kroll, Science Based Medicine (2nd September 2011)

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"British herbal medicine retailers suffered a fresh blow yesterday when a European court upheld new rules restricting what they can sell." The European Court of Justice has upheld new rules on the sale of vitamin and mineral supplements. The new Food Supplements Directive, which comes into force on 1st August 2005, will ban around 200 supplements from sale. StaffNurse.com (18th July 2005)

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The FDA has ordered a recall of all Hydroxycut products, because of liver toxicity. Hydroxycut is a widely advertised product that is marketed as a rapid weight loss dietary product. US Food and Drug Adminstration News (1st May 2009)

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“….published in JAMA this week are the results of the largest and longest trial to date of Gingko biloba for the improvement of cognitive function and to treat, prevent, or reduce the effects of Alzheimers disease or other dementia. The results of the study are completely negative…These results call into question the practice in many countries of allowing pharmacological agents like G biloba to be marketed as supplements with health claims prior to being adequately studied. The European and US markets for G biloba are in the hundreds of millions of dollars per year. It will be interesting to see what happens following this study…The study did find that G biloba was generally safe. However, it should be noted that G biloba, although sold in the US as a supplement, should be considered a drug. It does have an anti-platelet blood-thinning effect and should not be taken prior to surgery. However, because many people think of herbs as supplements and not drugs, patients rarely disclose their supplements to their doctors, and doctors fail to take a supplement history. Safety is therefore still an issue.” Steven Novella, MD, Science Based Medicine (30th December 2009)

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“The majority of the herbal medicinal products evaluated in systematic reviews were not associated with drug interactions with serious consequences. However, the poor quality and the scarcity of the primary data prevent firm conclusions.” Posadzki P, Watson L, Ernst E. British Journal of Clinical Pharmacology (June 2012)

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Includes origins, safety, effectiveness, green issues and profit. SkepticWiki (The Encyclopaedia of Science and Critical Thinking)