This page was last updated on 12th July 2010.
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What's the harm in herbal remedies?Reports of people harmed by herbal remedies. Herbal Medicine"Just because something is natural does NOT mean that it is harmless." An overview of herbology: the use of herbs as medicine. (UK-Skeptics) Information Resource: About Herbs, Botanicals and Other ProductsEvidence-based information on herbs, botanicals, vitamins, and other supplements. Provides objective information for oncologists and healthcare professionals, including a clinical summary for each agent and details about constituents, adverse effects, interactions, and potential benefits or problems. A consumer version of each monograph is also available to help deal with the often confusing claims made for over-the-counter products and regimens. (Memorial Sloan-Kettering Cancer Center) Herbal medicinesWhat you need to know as a consumer. UK Medicines and Healthcare products Regulatory Agency (MHRA) Buying and using herbal medicinesAdvice 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) Report on the 'Safety of herbal medicinal products'Useful safety information for anyone using herbal medicines and anyone operating in the herbal medicines sector, including manufacturers, herbal practitioners, suppliers and retailers. UK Medicines and Healthcare products Regulatory Agency (MHRA) [pdf] Herbal Supplement Sellers Dispense Dangerous Advice, False Claims“Undercover US government employees received consistently false information when shopping for supplements, and analyses show most supplements contain trace amounts of contaminants.” Scientific American (28th May 2010) Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice28-page testimony before the Special Committee on Aging, United States Government Accountability Office - Statement of Gregory D. Kutz, Managing Director Forensic Audits and Special Investigations. (26th May 2010) [pdf] Herbal Medicines a Mystery to Most Doctors"Physicians don't know much more about complementary and alternative medicine than their patients do, according to a new survey. Most healthcare professionals who answered an online survey of Drug and Therapeutic Bulletin subscribers said their profession was just as poorly informed about herbal medicines (75.5%) as the general public (86.3%). And almost half of respondents rated their own knowledge about herbal medicines as "quite" or "very" poor (36.2% and 10.4%, respectively). Even more worrying, journal editor Ike Iheanacho, MBBS, said in a podcast released in conjunction with the survey, was that medical professionals exhibited a lack of interest in even asking whether patients were taking herbal compounds. More than half of respondents said they never or only occasionally (8.6% and 46.6%, respectively) ask when reviewing patients' medications whether they are taking herbal medicines.” MedPage Today (7th April 2010) Ginkgo biloba – No Effect“….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) Totally Hypothetical Remedy? — MHRA introduce certification mark for herbal remedies"According to the Medicines and Healthcare Regulatory Agency (MHRA), this indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC. There have been 92 applications since the scheme began in March 06. The most important line is this one: Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product. So, as I wrote before with homeopathy, as long as the seller can demonstrate safety of the product and a history of use for the particular therapeutic indication, then it can receive the THR stamp and be sold legitimately, despite there being no investigation into whether it works or not…On a positive note, any product with this mark on it will single it out clearly and obviously to me as snakeoil - if it were a *real* medicine that, you know, actually had some effect, then it would be marketed as such and would have some evidence to back it up. So, perhaps we should look at this stamp as a victory for evidence-based medicine, as it singles out products without any provable efficacy for all to see." Thinking Is Dangerous blogspot (23rd October 2009) Warning Over Unlicensed 'Herbal Valium'“The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people of the dangers of taking unlicensed herbal medicines containing aconite. Aconite has recently been portrayed in the media as 'herbal valium', however, it is actually an extremely poisonous plant that is toxic to the heart. It is also known as monkshood and herbal products containing this ingredient could be fatal or cause serious illness if consumed…MHRA Head of Herbal Policy, Richard Woodfield, said it was vital people did not confuse herbal medicines and omeopathic ones. "Registered homeopathic products that contain aconite are considered acceptably safe as the active ingredient, aconite, is sufficiently diluted," he said. "Herbal medicines are made from plants and so can have a very significant effect on the body. In certain cases, such as with aconite, the medicine can be extremely potent. "This is a classic case where 'natural' does not mean 'safe'."” Medical News Today (5th October 2009) Commercial deception: undeclared drugs in herbs and other dietary supplements"…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) FDA Warns Consumers to Stop Using Hydroxycut ProductsThe 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) Informing the Public Responsibly About Herbal Medicine"The current popularity requires reliable information in this sector to minimize harm and maximize benefit. Currently there are only very few such sources of information aimed at the lay public. Instead, we have a plethora of seriously misleading texts. In the interest of public health, we need reliable, unbiased, and easily accessible information." E. Ernst, Journal of Dietary Supplements (March 2009) Complementary and Alternative Medicines for the treatment of rheumatoid arthritis, osteoarthritis and fibromyalgia"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] Interactions between herbal medicines and prescribed drugs: an updated systematic reviewThe concomitant use of herbal medicines and pharmacotherapy is wide spread. This review of the literature determines the possible interactions between seven popular herbal medicines (ginkgo, St John's wort, ginseng, garlic, echinacea, saw palmetto and kava) and conventional drugs. Izzo AA, Ernst E. Drugs (2009) Limitations of 'Evidence-Based Indications' for Herbs"Most clinical trials that support the efficacy of herbals are financed by their manufacturers. Critical reviews of the quality of those clinical trials reveal serious limitations, including small sample size, short study duration, and lack of allocation concealment or double-blinding. In addition, most of these studies fail to disclose the source of funding and the identity of those who analyzed the data. Despite these shortcomings, many reviews conclude that the clinical trial data are inconclusive but "promising." Evaluation of therapeutic agents also requires an assessment of risks. Data on the toxicity of herbals are very limited because adverse events are evaluated only by patient self-reports and because clinical trials lack monitoring of hepatic or renal function." (The reliability of the Natural Standard as a source of evidence-based indications is also questioned.) Donald M. Marcus, MD , Baylor College of Medicine, Houston, Texas, and Arthur P. Grollman, MD, State University of New York at Stony Brook (Mayo Clinic Proceedings, November 2007) The trouble with herbals"…..there are structural problems in the way that herbalists work: they have failed to collectivise, so they do not work together on research, but rather as independent commercial traders. They tend not to move into university settings, where the culture of critical self-appraisal might infect them. And where alternative therapists do move into universities, they wall themselves off from the most valuable influences. They don't rub shoulders with colleagues from other disciplines, who could share ideas with them. The alternative medicine courses I have approached have flatly refused to tell me the most basic things, like what they teach and how. It's because of this culture, not funding, that the "research" on herbal remedies is inadequate. Huge numbers of "trials" are produced, at great expense, but they are inept, they are not fair tests, they have inadequate blinding and randomisation, positive results alone are cherry-picked, and worse." Ben Goldacre, MD, Bad Science (October 2007) Herbal medicines fail test"A paper published in the Postgraduate Medical Journal, October 2007, has been reported widely. In the same issue there was a commentary by Edzard Ernst. They show the astonishingly poor evidence that herbal treatments work, despite the fact that they have been around for thousands of years." Article by Professor David Colquhoun, Dept. of Pharmacology, University College London (DC's Improbable Science, October 2007) [See the study linked to below] A systematic review of randomised clinical trials of individualised herbal medicine in any indicationConclusion: 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) Herbal remedies may alter laboratory testsReport in Focus on Alternative and Complementary Medicine [FACT] (September 2006) BBC2 series on Alternative Medicine (herbalism)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] Euro-court backs vitamin restrictions"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) Herbal remedies are not risk freeAn article looking at the risks to children posed by herbal medicine and other CAM therapies. Edzard Ernst, The Guardian (14th June 2005) Prescribing herbal medications appropriately"Safety issues related to herbal medicine are complex: possible toxicity of herbal constituents, presence of contaminants or adulterants, and potential interactions between herbs and prescription drugs." A critical look at the efficacy, safety, quality and cost issues involved in the prescribing of herbal medicines. Edzard Ernst, Md,PhD, FRCP, FRCPEd, The Journal of Family Practice (December 2004) Shedding the light"A third of us have tried herbal medicine, yet few have more than a vague idea about what it actually is." Edzard Ernst, The Guardian (17th August 2004) Medicine Man"Traditionally a herbal remedy was taken on its own. It was certainly not combined with the drugs we use today. Therefore, herb-drug interactions are an important consideration. The lesson we should learn form all this is one of caution and common sense. Natural is not necessarily safe and a long history of use is a far cry from providing guarantees." Edzard Ernst, The Guardian (13th July 2004) Are people who use 'natural drugs' aware of their potentially harmful side effects and reporting to family physician?"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 Serious adverse effects of unconventional therapies for children and adolescents: a systematic review of recent evidence"Most of the adverse events were associated with herbal medications." European Journal of Paediatrics (February 2003) Internet Marketing of Herbal ProductsConsumers may be misled by vendors' claims that herbal products can treat, prevent, diagnose, or cure specific diseases, despite regulations prohibiting such statements. The Journal of the American Medical Association (2003) Variations in product choices of frequently purchased herbs: caveat emptorThis study demonstrates that health providers and consumers need to closely examine label ingredients of presumably the same or similar herbal products. Archives of Internal Medicine (2003) Interactions between herbal medicines and prescribed drugs: a systematic reviewConcludes that interactions between herbal medicines and synthetic drugs exsit and can have serious clinical consequences. Drugs (2001) Systematic reviews of complementary therapies — an annotated bibliography. Part 2: Herbal medicineConcludes that systematic reviews are available on a broad range of herbal perparations prescribed for defined conditions. There is very little evidence on the effectiveness of herbalism as practised by specialist herbalists who combine herbs and use unconventional diagnosis. BMC Complementary and Alternative Medicine (2001) Herbal Health Products — What You Should KnowAmerican Family Physician (1999) Herbs that can cure you — or kill youArticle by Professor Edzard Ernst, The Independent (10th November 1998) Herbs as Medicines"When a patient asks for advice regarding the use of a particular herb, how should a physician respond? Similarly, how does a physician determine if a patient's symptoms are caused by a "remedy"? This review attempts to answer these questions by investigating pertinent definitions, the history of herbs in medicine, epidemiology and prevalence of herbal use, and relevant psychosocial issues." Lisa Corbin Winslow, MD; David J. Kroll, PhD , Archives of Internal Medicine, 1998;158:2192-2199. Herbal MedicineIncludes origins, safety, effectiveness, green issues and profit. SkepticWiki (The Encyclopaedia of Science and Critical Thinking) Side Effects, Interactions and Warnings About Vitamins and SupplementsNOTE: This link has been included as it is relevant to consumer health safety issues regarding supplements. It should not be confused with Herbal Medicine. |

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