Risks of Herbs and Supplements Finally Getting Some Attention

Some of the most popular forms of alternative medicine are the myriad herbs and “dietary supplements” (a faux category created by the 1994 Dietary Supplement Health and Education [DSHEA] act to allow marketing of unproven drugs without regulatory oversight). These nostrums are potentially more useful than outright quackery like homeopathy or “energy medicine” because they contain actual physiologically active chemicals. Unfortunately, that means these are also the most likely for of CAM to cause direct harm.

There have been numerous examples of this kind of harm in the past. Kidney failure caused aristolochic acid in traditional Chinese medicines, lead poisoning from contaminated Ayurvedic and Chinese preparations, and deaths from ephedra-containing supplements such as ma huang are among the most dramatic and well-publicized examples. Below is an extensive list of references regarding these and other such examples.

Despite this, the perception that such preparations are “safe and natural” still seems widespread, and it seems difficult to disabuse people of this notion. However, I am encouraged by a number of recent indications that the risks associated with untested and unregulated supplement use may be getting more attention. I recently wrote about an article looking at the association of herbal therapy with poorer compliance and quality of life in asthma patients.

Another article on the subject that recently caught my attention was entitled Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem?, published in eCAM. The article is essentially a series of anecdotes, so of course it proves nothing about the overall impact of herbal remedies. However, the theme that emerges from the cases reported strikes me as key to understanding the risks of such treatments. The cases almost all involved people who took herbal preparations for more psychological than medical or rational reasons. They generally took a variety of supplements, often with no systematic dosing or schedule or even any understanding of what they were taking or what the intended effects or possible side effects were. This is only possible because these people accepted the baseless notion that somehow because they were “natural” these preparations could be expected to have beneficial effects without any risk, any dose/response relationship, or any of the usual limitations know to affect pharmaceuticals.

Ironically, the people discussed in the article also commonly reported turning to herbs and supplements because of fears of the side effects of conventional medical therapies. This is similar to the attitude reported in the study of asthma patients. Clearly, any therapy that has measurable effects is going to be tinkering with a complex and massively interconnected system, and this makes it highly likely that unanticipated or undesirable effects will occur as well. In scientific medicine, it is understood that all therapeutic decisions require a cost/benefit analysis, and that while it is appropriate to avoid unnecessary interventions that might do more harm than good, there are clearly many circumstances in which the risks of a treatment are far outweighed by the potential benefit. CAM advocates and users seem to have the notion that these rules only apply to conventional medicine, and they tend to have an exaggerated awareness of risks while taking the benefits for granted. They then fall prey to the irrational and demonstrably false notion that CAM therapies are exempt from the rules of pharmacology and physiology that constrain scientific medicine and that they can somehow get something for nothing–benefits without risk. This is a dangerous notion which must be debunked so that the true potential of herbal medicines can be developed in a rational and scientific way and unnecessary risks be avoided.

Finally, the cases illustrate the sense many CAM users have of not being in control of their medical care when dealing with conventional, scientific medicine. Being able to change their diet, take supplements or herbal remedies guided by their own internal sense of how they are responding, and so on gives them a feeling of having some control over their bodies and their care. This is a challenging psychological issue. Scientific medicine has rightly moved away from the paternalistic model and acknowledges that patients have the ultimate right to make decisions about their own care. However, it is also an undeniable fact that health care have factual knowledge and a overall perspective that make their assessments and decisions about specific interventions generally more reliable than those of lay people with a personal and intense emotional investment in their or their pets health.

Somehow, scientific medical providers need to do a better job of dealing with the psychological aspects of disease in their patients or, in the veterinary domain, their patients’ owners. We must understand and manage the normal psychological factors that lead people into use of unproven or bogus therapies while maintaining a solidly scientific and evidence-based standard for the medicine we employ. And we must do all of this within the limitations of time and resources under which we operate. A significant challenge indeed.

Another article I ran across recently that bears of the dangers of herbal medicine use is A review of the potential forensic significance of traditional herbal medicines in the Journal of Forensic Sciences (Byard RW. 2010:55(1);89-92). This is a nice summary of some of the specific dangers of unregulated and unscientifically used herbal preparations, including direct toxicity, heavy metal poising, adulteration with toxins, interaction effects of multiple active compounds taken together, and interactions with conventional medicines. These risks are exacerbated by the facts that many users of herbal remedies don’t tell their doctors what they are taking (or they may not know themselves), most doctors know little about the possible risks of such remedies, and there is no meaningful regulatory control over the preparation or marketing of these products.

On this last point, a revision to DSHEA has been proposed in the Senate by Tom McCain (R-AZ) and Byron Dorgan (R-ND). While not perfect, this bill would improve the FDA’s ability to monitor dietary supplements and other currently under-regulated supplements and to force removal of these from sale if there is evidence of harm. Given the power of the supplement lobby and their biggest legislative boosters, Tom Harkin (D-IA) and Orin hatch (R-UT), and the general anti-regulation mood of the country, I am not overly optimistic this will become law, but I am encouraged at least that mainstream political figures are at least willing to talk about the inadequacy of consumer protections in the area of herbs and supplements, and this alone may raise awareness of this underappreciated risk.
Coon JT, Ernst E. Panax ginseng: A Systematic Review of Adverse Effects and Drug Interactions. Drug Saf 2002;25(5):323-44 Drug Saf 2002;25(5):323-44

Cupp MJ  Herbal remedies: adverse effects and drug interactions. Am Fam Physician 1999 Mar 1;59(5):1239-45

Debelle FD, Vanherweghem JL, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int. 2008 Jul;74(2):158-69. Epub 2008 Apr 16.

Emery DP, Corban JG  Camphor toxicity. J Paediatr Child Health 1999 Feb;35(1):105-6

Ernst E Adverse effects of herbal drugs in dermatology. Br J Dermatol 2000 Nov;143(5):923-

Fugh-Berman A Herb-drug interactions. Lancet 2000 Jan 8;355(9198):134-8

Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol. 1997 Apr;37(4):344-50

Lai MN, Lai JN, Chen PC, Tseng WL, Chen YY, Hwang JS, Wang JD. Increased risks of chronic kidney disease associated with prescribed Chinese herbal products suspected to contain aristolochic acid. Nephrology (Carlton). 2009 Apr;14(2):227-34.

Lawrence JD.  Potentiation of warfarin by dong quai. Page RL 2nd, Pharmacotherapy 1999 Jul;19(7):870-6

Means C.  Selected herbal hazards. Vet Clin North Am Small Anim Pract 2002 Mar;32(2):367-82

Norred CL, Finlayson CA Hemorrhage after the preoperative use of complementary and alternative medicines. AANA J 2000 Jun;68(3):217-20

O’Connor A, Horsley CA. Yates, KM “Herbal Ecstasy”: a case series of adverse reactions.  N Z Med J 2000 Jul 28;113(1114):315-7

Pittler MH. Ernst, E Risks associated with herbal medicinal products. Wien Med Wochenschr 2002;152(7-8):183-9

Poppenga RH. Risks associated with the use of herbs and other dietary supplements. Vet Clin North Am Equine Pract. 2001 Dec;17(3):455-77, vi-vii

Pies R  Adverse neuropsychiatric reactions to herbal and over-the-counter “antidepressants”. J Clin Psychiatry 2000 Nov;61(11):815-20

Prakash S, Hernandez GT, Dujaili I, Bhalla V. Lead poisoning from an Ayurvedic herbal medicine in a patient with chronic kidney disease. Nat Rev Nephrol. 2009 May;5(5):297-300.

Raman P, Patino LC, Nair MG. Evaluation of metal and microbial contamination in botanical supplements. J Agric Food Chem. 2004 Dec 29;52(26):7822-7

Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noll G  Acute heart transplant rejection due to Saint John’s wort. Lancet 2000 Feb 12;355(9203):548-9

Saper RB, Phillips RS, Sehgal A, Khouri N, Davis RB, Paquin J, Thuppil V, Kales SN. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA. 2008 Aug 27;300(8):915-23.

Shad JA, Chinn CG, Brann OS Acute hepatitis after ingestion of herbs. South Med J 1999 Nov;92(11):1095-7

Smolinske SC J Am Med Womens Assoc 1999 Fall;54(4):191-2 Dietary supplement-drug interactions.

Yang HY, Wang JD, Lo TC, Chen PC. Increased mortality risk for cancers of the kidney and other urinary organs among Chinese herbalists. J Epidemiol. 2009;19(1):17-23. Epub 2009 Jan 22.

Zhang SY, Robertson D. A study of tea tree oil ototoxicity. Audiol Neurootol 2000 Mar-Apr;5(2):64-8

Kidney failure from aristolochia in TCM herbals preparations.

Lead, mercury and arsenic in herbal preparations.

Lead in TCM preparations.

Lead in ayurvedic preparations.

Lead in herbal preparations.

Tea Tree Oil Can be toxic to cats.

Toxic metals in Brazilian herbal preparations.

Contamination of herbal products with undisclosed pharmaceuticals.Widespread contamination of supplements with undisclosed toxins and parmaceuticals

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10 Responses to Risks of Herbs and Supplements Finally Getting Some Attention

  1. Pingback: Chinese Herbs and Fertility | Ginseng Blog

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  3. David Stanworth says:

    At 73 years of age, I find my overall energy decreasing (particularly sexual energy) and survived a heart attack 6 years ago (since passed fit – if I so wished – to pilot a 747 or drive a HGV). My doctor suggested taking Garlic.
    My local Chinese herbalist suggested taking a BAI HE DI HUANG capsule once a week
    (ingrediants – Bulbus Lilii 36%, Radix Rehmanniae Praeparata 32%, Semen Cuscutae
    15%, Radix Morindae Officinalis 17%). I took one capsule with dramatic effects after 2 hours (strong erection, an alert mind, an overall feeling of wellbeing, including feeling randy). I felt like a teenager again, the erection came and went according to visual or other stimulus and the total effect of the capsule lasting around 10 days. My GP could
    offer nothing similar, and if he could he said he would have a queue a mile long every day outside his surgery.
    Your comments please.

  4. skeptvet says:

    First point is that no one knows what is in these things, despite the label. Here is a similar TCM product recalled in the UK for containing Viagra and other prescription drugs:

    Dangerously high levels of undeclared pharmaceuticals have been discovered in a supposed ‘Herbal Viagra’ being sold in many Traditional Chinese Medicine (TCM) stores in the United Kingdom.

    The product ‘Jia Yi Jian’ was recently seized by the Medicines and Healthcare products Regulatory Agency (MHRA) and claimed to contain only herbal ingredients.

    However, laboratory analysis revealed the unlicensed product contained up to four times the level of pharmaceuticals found in legally prescribed medicinal products licensed for the treatment of obesity and erectile dysfunction.

    Manufactured by Hu Nan Aimin Pharmaceuticals Ltd, the undeclared ingredients could cause serious side effects including significant heart and blood pressure problems as well as adversely reacting with other prescription drugs such as those for blood pressure, heart disease and some antidepressants.

    Richard Woodfield, MHRA Group Manager for Herbal Medicines, said people should consult their GP or a health care professional before taking herbal medication particularly for serious medical conditions such as obesity or erectile dysfunction.

    “This product, adulterated with large and uncontrolled amounts of pharmaceutical substances, presents a clear risk to consumers.

    There is continuing evidence that some so-called ‘herbal’ products on the UK and international markets are nothing of the kind.

    Often, such marketing claims about the supposed natural ingredients in these unlicensed products are simply an attempt to divert the consumer’s attention away from very low manufacturing and ethical standards.

    The MHRA has issued warnings previously about adulterated products supplied by some TCM outlets, but the problem is by no means limited to that sector.

    The safest method to obtain medication is to see a health care professional and have a proper diagnosis, especially as sometimes conditions such as erectile dysfunction can be the symptom of something more serious.”

    The MHRA advise anyone using this product to stop taking it immediately and consult their GP or a healthcare professional.

    There are many other such cases, so you are truly playing Russian (or Chinese) Roulette with your health. There’s no doubt these products contain biologically active chemical compounds. The issue is whether the stuff in them is safe and effective, and without systematic testing and monitoring nobody knows. You are, of course, free to gamble with your health, and you may be lucky and feel great or you may be unlucky and end up poisoned by the herbs themselves or contaminants in them. Either way, it doesn’t really prove anything in general about this kind of treatment.

  5. David Stanworth says:

    I very much welcome your comments – it is clear that I have tried a product which comes within your description of being a Herbal “Viagra”. There is a general misconception that the word “Herbal” implies “Harmless” which may not always be the case. However, the product I tried did carry a warning “Be cautious in use if the person has high blood pressure or heart disease, please consult doctor before taking.” I should have consulted my GP, and although I enjoyed the one experience, it will not be repeated without concrete evidence of its safety (including a blessing from my GP).
    Thanks.

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  7. MAC says:

    I used a similar product and its content contains the following (see below).I researched every single ingredient and I found all those are herbal ingredient which you can buy seperatly. I gave the capsule to a medical student to analyze and see if there is any chemical content in it, he could not find any chemical content. I am taking this and I feel 20 years younger. Of course there is risk if it contains chemical compounds, the content I use is purely herbal. I take no responsibility to recommend this to anyone, but I feel great.

    Bai He Di Huang

    1. Bulbus Lilii 36%
    ??
    Radix Rehmanniae Praeparata 32%

    ?? ???
    Semen Cuscutae 15%
    ???
    4. Radix Morindae Officinalis 17%

    ???

  8. skeptvet says:

    Sorry, but herbs ARE chemical compounds. If there is nothing in it at all, it won’t o anything. If it has active ingredients that affect your health, then it has risks as well as benefits. What you are saying makes no sense.

  9. MAC says:

    chemical means – manufactured by combination of chemical compounds. Those ingredient are produce in nature and by God’s creation not human. You seem what I mean.

    Has anybody analyses the above ingredient that I list above?

    MAC

  10. dogowner says:

    There are still going to be chemicals in it if it’s herbal, and just because it’s produced in nature doesn’t mean it’s safe. Any botanist will tell you that compounds produced by plants are often there to make them less likely to be eaten, not to help the things that will eat them. Unfortunately some of these things will be obvious (for example the poisonous effects of foxglove) and some will only become apparent when studied.

    Aristolochia was a very widely-used herb, most of the people taking it thought it was fairly safe, and then when it was studied (and after some cases where a lot of people got sick) suddenly it was discovered that it wasn’t so safe after all. http://www.sciencebasedmedicine.org/herbal-medicine-and-aristolochic-acid-nephropathy/

    Same thing happened with other ‘remedies’ like ma huang.

    There is still risk if it’s herbal. Plants which have a medicinal effect do so because they contain ‘drugs’- chemicals which have an effect on the body.
    http://dictionary.reference.com/browse/drug

    If it has an effect, it’s probably going to have side-effects. This is because the body uses lots of different receptors in different places which respond to the same things.

    A quick google of the ingredients you mentioned shows that they appear to be generally regarded as safe, but not necessarily to have been particularly well studied. Have you any data on their safety, or are you taking the chance? No problem if you are, so long as you recognise that it is a gamble.

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