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EDITORIALS:
E Ernst
Herbal medicines put into context
BMJ 2003; 327: 881-882 [Full text]
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Rapid Responses published:

[Read Rapid Response] Herbal medicines put into context: Indian experience on using herbal medicines in AIDS therapy.
Dr. Sarman Singh   (17 October 2003)
[Read Rapid Response] Allow me to provide some context.
Steven L. Zeitzew   (18 October 2003)
[Read Rapid Response] Half full - or half empty?
David W. Ramey   (18 October 2003)
[Read Rapid Response] The Thomas Gospel correlation
Ned Hoke   (20 October 2003)
[Read Rapid Response] Human Research and Statistics
Alice M. Wahl, M.A. in Health Education   (20 October 2003)
[Read Rapid Response] More on herbal medicine contextualism
Sarita M Von Afehlt   (23 October 2003)
[Read Rapid Response] There is no dicotomy
Felicity Reynolds   (29 October 2003)
[Read Rapid Response] Herbs & Anesthesia
Carol L. Norred, CRNA PhDc   (4 November 2003)
[Read Rapid Response] HERBAL MEDICINES ARE NOT WITHOUT ADVERSE EFFECT
M.A.ALEEM -, KALAVATHY PONNERIVAN   (13 December 2003)
[Read Rapid Response] WHO should take initiative on vitamin S?
Gareth P Morgan   (16 March 2004)

Herbal medicines put into context: Indian experience on using herbal medicines in AIDS therapy. 17 October 2003
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Dr. Sarman Singh,
Professor of Clinical Microbiology
All India Institute of Medical Sciences, New Delhi-110029 (India)

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Re: Herbal medicines put into context: Indian experience on using herbal medicines in AIDS therapy.

To The Editor,

Excellent review by Ernst on Herbal medicines, published in the BMJ (18 October, page 881). He has very successfully conveyed his views in right context. It is true that herbal medicines (known as Ayurvedic medicines in India) also have side effects but as Ernst correctly mentions that number of patients experiencing these side effects are so minimal that benefits of using these medicines clearly outweigh the harms associated. The Ayurvedic system of treatment in India is one of the oldest in the world. However, lately the modern medicine overpowered the ancient system. Recently, Indian government has taken a serious view to revamp this poor friendly treatment system. India is rich source of indigenous herbs and these are easily available to local folks at cheapest cost, albeit used irrationally several times. However, the biggest reason why this pathy could not be so popular, because not much evidence based scientific studies were carried out and these medicines were used only as a traditions, rather than well researched system of medication. Nevertheless, now several scientists in India have started working on these drugs. We also carried out a preliminary study on polyherbal medication in HIV infected patients to potentiate the immune system of these patients.

Thirty seven confirmed HIV positive persons were recruited in this study. Their written consent was obtained. Their baseline haematological, biochemical and serological parameters were recorded and those with severe organ damage and opportunistic infection were excluded from this study. Patients with CD4+ cell counts of less than 100/ml were also not included. All patients were treated with a polyherbal Ayurvedic formulation of herbal medicines (Immu-21®). Two gelatine capsules were given twice daily with liquid just before or after the meals. Each capsule contained Tinospora cordifolia 100 mg, Withania somnifera 100 mg, Ocinum sanctum 100mg and Emblica officinalis 100 mg. The patients on Ayurvedic medicine were counselled and given free choice (in the consent form) to stop Ayurvedic medicine and start the anti-retroviral drugs at any stage of the study. Thirty other patients who were only on antiretroviral therapy comprising of 300 mg AZT + 150 mg 3TC bid were included in the control group. After every 3 months repeat CD3+, CD4+ and CD8+ counts and other biochemical parameters were done on all patients. Patients were followed upto 2 years.

Of the 37 patients on Ayurvedic medicine, 25 were males and 12 females. The patients aged as young as 7 years and as old as 51 years with mean age of 31.89 + 11.1 yr. The age of control group was also ranged 15-55 yrs with mean age of 33.5 + 9.2 yr. During the follow-up period of 2 years, 6 patients (16.2%) died and 7 (19.0%) lost the follow- up after 6 months and another 6 after 12 months for reasons other than the side effects of Ayurvedic medication. Thus, 18 patients successfully completed the two years drug trial In control group 3 (10%) patients died but 9 (30%) patients lost the follow because they could not afford the cost of treatment, as most of the newly HIV infected patients in India are below poverty line.2 The average basal CD4+ cell count at -3 months (before the institution of treatment) was 331.6/ml which declined @ 6.5/ml /month and reached 311.9/ml when the treatment was initiated (0 day). All except two patients treated with herbal medicine showed increase in their CD4+ as well as CD8+ cell counts. After first three months the decline stopped and after 6 months of treatment the mean CD4+ cell count rose to 407.6/ml. After one year CD4+ cell count was 473.4/ml. The maximum increase recorded was from 120/ml to 528 /ml CD4+ in a male patient and from 287/ml to 930/ml in a female patient after 2 years. However, no viricidal effect ( viral load monitoring done only in 5 patients) was observed in Ayurvedic treatment group, neither it was aimed. In cases of anti-retroviral treatment group, the rise in CD4+ cell count was less significant but sharp. In this group the mean CD4+ cell counts rose from 110 /ml CD4+ to 320 /ml CD4+. The number of side effects were significantly more in antiretroviral treatment group than study group. The control group had nausea, vomiting and rash in 10% cases while only 2 (5%) of the 37 patients treated with herbal medication had skin rash which subsided on breaking the treatment for two weeks. The treatment could again be started uneventfully. This pilot study indicated a great potential in the Indian herbal preparation to keep the immune system balanced and check the deterioration in the health of HIV infected persons.3 It was proposed that if combination of Ayurvedic medication with antiretroviral therapy is given to HIV infected patients, the results will be far more impressive.

Sarman Singh, MD

Head, Division of Clinical Microbiology, Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi-110029 (India). Email: sarman_singh@yahoo.com

References

1. Ernst E. Herbal medicines put into context. BMJ 2003;327:881-882

2. Singh S. AIDS Care in India. AIDS Reader 1997; 7: 100-106.

3. Singh S, Kumari Veena, Singhal S, Singh N. An Indian herbal immunomodulator: Highly effective in the treatment of HIV/AIDS. Proceedings of 6th International Conference on AIDS in Asia Pacific, Melbourne, Australia., October, 2001. Abstract [WePo 1254].

Competing interests: None declared

Allow me to provide some context. 18 October 2003
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Steven L. Zeitzew,
Chief, Orthopaedic Surgery
West Los Angeles Veterans Administration Healthcare Center CA, USA,90073

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Re: Allow me to provide some context.

I don’t agree that weak evidence of risk justifies use of herbals based on weak evidence of efficacy. The known risks of pharmaceuticals were not put into the context of risks vs. benefits, and I therefore found the discussion of risk alone to be misleading. I believe that products and services offered in the health marketplace be both safe and effective. If only safety were required, any product or service that would not harm our patients could be hawked to the gullible. Victims of disease do not demand quack treatments because they want to exercise their rights, but because they have been deceived into thinking that they offer hope.

Though popular herbal medicines have not been well studied, the author fails to suggest that they meet a standard of having evidence of safety and efficacy prior to marketing as is required of pharmaceuticals. The author incorrectly argues that dearth of evidence for risk and drug interactions is evidence of safety when it in fact represents a lack of evidence to adequately address that issue. The author makes the assumption that herbal remedies are safe until it is proved otherwise, when they haven’t been sufficiently studied by those who profit from their sale, yet he strongly criticizes pharmaceutical drugs on the basis that there are reported risks though the pharmaceuticals have been studied, been shown safe and been shown effective.

For many of the indications used to recommend common herbal drugs there is an evidence-based medical treatment available of established safety and efficacy. By not putting herbal medicines into the context of evidence-based treatment of patients the author misses the opportunity to provide an evidence-based perspective on the herbal medicines he discussed.

There was no mention of the widely reported problems with potency, purity, accurate labeling, adulterations, and contaminations of current herbal medicines. The assessment of risk must be seen in the context of the risk of what is actually being marketed rather than the risk of what the labels claim is being marketed.

One additional problem with giving these unproved treatments approval, is that it gives more credibility than is justified to their purveyors who often are unable to diagnose serious conditions, try to persuade patients to forgo adequate science based treatment to serious conditions, or are advocates of other complementary remedies and alternative practices that is either known to be harmful, or is simply of unproved efficacy. The risk of our complacency about unproved treatments must be put in the context of the risk of doing business where these products are marketed and with those who market them.

Folk remedy subjected to objective scientific scrutiny has led to numerous useful medical treatments in the past, and will likely continue to do so. It is this scrutiny that forms the foundation of modern scientific evidence based medicine. In fact it was May 20, 1747 that James Lind while serving as the senior surgeon on the HMS Salisbury initiated the first prospective, controlled clinical experiment. He showed that oranges and lemons prevented scurvy (at a time when more sailors died from scurvy than from wounds, infectious diseases, and all other causes combined).

On the other hand, supplements not subjected to scientific scrutiny have later proved harmful. Millions of people were taking beta-carotene supplements before proper randomized clinical trials were finally conducted to see if the hoped for cancer prevention in fact existed. The studies show that either these supplements didn't prevent cancer or perhaps actually increase the risk of lung cancer. Millions were spending their money on a remedy that at best was ineffective.

I recommend that the advice and treatments we offer our patients be based on scientific evidence of safety and efficacy, and that we await such evidence before making our recommendations. As a physician I can not in good conscience recommend that a patient take a substance or undergo a procedure either known to be ineffective or of uncertain efficacy and risk.

Competing interests: None declared

Half full - or half empty? 18 October 2003
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David W. Ramey,
veterinary surgeon (equine), private practice
Glendale, CA USA 91221

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Re: Half full - or half empty?

Sirs -

No one should have any dispute with the idea that pharmacologically active substances may come from plants. Many of these substances appear to be produced as a defense mechanism for the plants. For example, one important subset of "natural" chemicals includes plant toxins that appear to protect plants against fungi, insects and animal predators. Thousands of such compounds are known, and individual species may contain a few dozen toxins, including numerous carcinogens and mutagens. (1)

Popular herbalism (with its slogan of "botanicals are safer") appears to have abandoned most of the obvious pharmacologically active herbs to the pharmaceutical industry, since their therapeutic window is so narrow and misuse can be deadly. Those that remain in more common use are likely to have neither the therapeutic potency nor the toxicity profile of botanicals such as foxglove (from which digitalis was derived). (2) As such, they are also likely to be safer - if there are no significant effects, it is also less likely that there will be significant side effects.

Still, some therapeutic diamonds may yet be discovered in the rough. If discovered, they should be tested. However, it is neither sufficient nor accurate to lament the putative lack of available funds as a reason for the lack of testing of herbal remedies. The "success" of alternative medicine is routinely crowed in surveys by proponents - some estimates have expenditures exceeding the money spent on conventional health care. If that's true, where's the money going? It should not be up to "public funds" and "researchers" to look into the claims made by a for-profit industry. The obligation to provide proof of claims - most especially in the medical field, where people can be harmed by false claims - clearly falls on the claimant.

Crude plant preparations may be good medicine. To find out purveyors of plant products have a moral and ethical obligation to demonstrate 1) that their products are effective and 2) that the products are accurately labelled for content and free of adulterants. They should be required to do so before selling them to an enthusiastic and scientifically-naive public.

David Ramey, DVM

(1) Ames, BN, Profet, M, Gold, LS. Dietary Pesticides (99.99% all natural). Proc Natl Acad Sci 1990; 87: 7777 - 7781.

(2) Eisenberg, DM, Kaptchuk, TJ. The Herbal History of Digitalis: Lessons for Alternative Medicine (Response). JAMA, 2000; 283: 884.

Competing interests: None declared

The Thomas Gospel correlation 20 October 2003
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Ned Hoke,
private pay provider
California USA

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Re: The Thomas Gospel correlation

The house of purist science in modern method would have us believe responsible physicians are obligated to limit their therapeutics to tools proven and endorsed within the halls modern method. Those are simple standards of practice guild rules. From that basic posture all discussion is filtered. To prove herbalism helps billions is as simple as looking out the door. Now that door has found it's way closer and closer to the hallowed halls of modern method and is a central commercial player in everyday healthcare. To peer out that door, fingers closing the nose, and make vague consessionary and cautionary commentary continues to ignore the primal authenticity of patient experiences and the real ecological basis of healing.

Thomas teachings have had the same difficulty. The institution of the church was disinclined to accept that individuals could find their way to God without the intercession of the institution of the (professional) church. Modern medicine doesn't seem to want us to know of the very many ways in which we don't need them and/or are wise to avoid them to avoid greater weakness and distress. Herbalists are part of medicine, good bad and indifferent. It's time modern medicine saw and made peace with the bigger picture that is functionally ecumenical.

Competing interests: I am a licensed oriental physician (OMD) which is inclusive of significant herbal medicines

Human Research and Statistics 20 October 2003
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Alice M. Wahl, M.A. in Health Education,
President
The Wahls, 20904

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Re: Human Research and Statistics

Scientific results are based upon the calculation of average figures based upon statistical presumptions which in turn are based upon results obtained from calculating "widgets" i.e. things that are completely identical. Human beings are not; even identical twins may develop phenomic differences due to different in utero experiences.

How many practicing (or even research) physicians understand the implications of the statistical curve showing "average" results? How many consider that the patient they are prescribing for may be on the tips of that curve (or even an outlyer) rather than on the top of the curve? For it will be only those at least within the range of average who might be assumed to respond in the predicted way. How many practicing physicians schedule follow-up appointments in order to monitor effects of the standard amounts of medications that they prescribe for their patients? So how do they know where their current patient lies on that statistical curve?

Even in the development of that "average" how often is the physiognomy of the researched participants taken into account? How old are they? What do they eat, i.e. put into the systems being analyzed? How close to ideal weight are they? The first is usually (at least loosely) taken into consideration with those too old or too young being eliminated from that consideration. But how often are the criteria for participant selection really closely analyzed?

Furthermore, statistical calculations were developed to be used on widgets. The adjustments that are made to take into account human differences are theoretically applied. These adjustments can be semi- validly applied to very large numbers of human beings (a thousand or more). Thus the "facts" derived from all genetically derived subjects are "adjustable" due to their non-widget formulation. How many practicing phycisians understand this?

Statistics derived from human research can often be questioned simply on the basis of research design. Very often human research is designed for statistical calculation needs as determined by a statistician--not a mind trained to understand the human dynamics being researched. They might not even be measuring what needs to be measured. Yet the published research results almost (and possibly always) never give enough information for a statistically inclined analysis of the results; one is told to find this out from the researcher himself. The researcher himself may or may not divulge this information, information that is totally vital to analysis of the published results. Have all the "peers" had enough statistical background to thoroughly analyze those results if, indeed, they are able or inclined to do so?

So even without using the theoretically derived statistical adjustments that are applied to research data derived from human beings, there are valid arguments available for use to make practicing physicians exercise extreme caution when prescribing drugs to individuals--rather than dishing them up like the best home-made stew.

Yet, many herbs have thousands of practical use/ monitoring behind their use. The Chinese civilization is that old; it is/was a "civilization." Like us, they are humans; they are not dumb. Also, it has been my own experience that American physicians discount statistical results published in European journals showing an equal ethnocentrism, an ethnocentrism that has huge chinks in its armor--as I've pointed out above.

Competing interests: None declared

More on herbal medicine contextualism 23 October 2003
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Sarita M Von Afehlt,
Pharmacist and Student
Wellington, New Zealand

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Re: More on herbal medicine contextualism

I am currently studying herbal medicines, thus was interested but disappointed to read E Ernst’s editorial, which I believe has a number of deficiencies. Firstly, the manner in which herbal medicines are marketed leads consumers to believe that these products are safe because they are natural. This in itself creates a barrier to objective causality assessment and recognition that a herbal medicine may be the cause of an otherwise unexplained adverse reaction. In turn, this is one reason for the paucity of data regarding harmful outcomes of herbal medicine use. It is also worth noting that most adverse reaction reporting schemes are set up to receive reports only from health professionals and only for allopathic medicines.

Secondly, health professionals (and consumers) should not only consider the safety and efficacy of herbal medicines, but also their quality. In many countries, including New Zealand, there is inadequate regulatory oversight meaning there is no or minimal quality control of the ingredients, how they are processed, or how the finished product is labelled with respect to therapeutic claims and listed ingredients. Consequently, the quality of finished products containing herbal medicines is not always able to be determined.

Additionally, both herbal remedies and allopathic medicines contain pharmacologically active compounds, therefore each has the same potential to cause harmful effects. Drug receptors in the body are unable to distinguish between molecules obtained from plants and those synthetically produced in laboratories. On this basis, it is unrealistic to assume that herbal medicines might be safer than allopathic medicines, particularly when citing absence of reported adverse events as evidence of their safety.

Furthermore, evidence of traditional use of herbal medicines is not considered reliable because it does not necessarily establish safety. Historical use may detect acute toxicity, but not harmful effects that are inconspicuous, uncommon or tardive in onset. For example, carcinogenicity and hepatotoxicity due to herbal medicine use is easily overlooked or the causal association not made.

Lastly, I would also point out that while the cost of most crude material for herbal medicines is low, the glossily-packaged end products sold in health food stores and pharmacies are often quite expensive.

Competing interests: (potential): I am employed in the area of pharmacovigilance by Medsafe, the New Zealand medicine regulatory authority.

There is no dicotomy 29 October 2003
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Felicity Reynolds,
emeritus professor of obstetric anaesthesia
St Thomas' Hospital, London SE1 7EH

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Re: There is no dicotomy

Dr Ernst asks: "do the risks of herbal benefits outweigh their potential for harm?" Small misprint (editorial error?) here, but we understand what it means! But to say that although "they are not devoid of risk, they could still be safer than synthetic drugs" is to suggest a false dicotomy.

Medicine, a profession that until recently could not clearly be distinguished from quackery and was certainly not evidence based, has always made use of "natural" and herbal remedies, but in many cases these were replaced by sythetic substitutes because they had a higher therapeutic ratio. Extract of poppy capsule relieves pain and dyspnoea, foxglove steadies the heart, deadly nightshade speeds it and dilates the pupil, willow bark has an anti-inflammatory effect and in low dose wards off stroke, the periwinkle has anti-cancer properties. Extract of coca leaf provided the first local anaesthetic, but was soon replaced by safer synthetic substitutes. There are many other examples of art improving on nature. Where there are true benefits to be had from so-called natural remedies, medicine will, I would hope, always make use of them.

Competing interests: None declared

Herbs & Anesthesia 4 November 2003
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Carol L. Norred, CRNA PhDc,
University of Colorado Health Sciences Center
Denver, Colorado

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Re: Herbs & Anesthesia

The popularity of herbal medicines in a postmodern highly technological era, appeals to a public image of health and wholeness that is lacking in conventional healthcare. A postmodern poststructural response to the positivistic reasoning, control and dominance of western medicine that often denigrates the holistic movement could result in a lack of public confidence in conventional medicine as an authoritarian source of information. Dominant values in health care policy may be perceived as paternalistic, patriarchal and out-of-touch with the transformative philosophical paradigms accepted by holistic caring practitioners.

Nursing embraces both empirical scientific perspectives as well as acausal paradigms that encompass the holistic view of humanness to pragmatically guide interventions that are derived from them. The disparity of conceptual frameworks that theoretically predict herb-drug interactions may create confusion in defining the clinical significance for anesthesiologists or nurse anesthetists in attempts to prevent surgical patient safety risks.

Some herb-drug interactions may have therapeutic effects for surgical patients, such as augmenting antibiotic action or anti-inflammatory effects, or reduction of drug side effects or chemotherapy toxicities. Although some herbal medicines may be therapeutic for surgical patients, the paucity of extant research on botanical-anesthetic drug interactions and very few clinical trials of herbs for surgical patients confound the potential benefits versus true risks of herbs consumed prior to anesthesia.

Guidelines to discontinue preoperative herbal medicines from professional organizations such as the American Society of Anesthesiologists or American Association of Nurse Anesthetists may be difficult to impose because anesthesia providers lack education about botanical medicines. Perioperative nurses, nurse anesthetists as well as anesthesiologists are encouraged to become educated about potential herb- drug interactions for surgical patients. However, the clinical implications and proper management of patients consuming preoperative herbs may be considered important to discern but difficult to incorporate into an anesthetic plan based upon existing knowledge.

Competing interests: None declared

HERBAL MEDICINES ARE NOT WITHOUT ADVERSE EFFECT 13 December 2003
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M.A.ALEEM -,
Assistant Professor of Neurology
Dept of Neuromedicine KAPV Medical College and AGM Govt hospital Tichy-6200017.TamilNadu India,
KALAVATHY PONNERIVAN

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Re: HERBAL MEDICINES ARE NOT WITHOUT ADVERSE EFFECT

EDITOR - The editorial by Ernst on herbal medicines put into context1 was heartening. Herbal medicines are the most widely used one in India. According to an all India Ethno-botanical survey conducted by Indian Ministry of Environment [1985-1990], the tribal communities alone have a knowledge of the use of over 9000 species of plants of which the single major use catagories is tratitional medicine for which over 7500 species are used. The general public has a more positive view about herbal medicine because they are precieved as being natural and safe. In India some area of Tamil Nadu and Kerala have reported over 2000 plants and other resources are used for health care at the house hold level.

Recently many reports have shown that the plant medicines can also have mild to severe adverse health effects. Aristolochia and kava kava are proved to have nephro and hepatotoxicity2. St.Jhon’s wort is proved to have the potential of interaction with various other medicines and which may led to serious adverse effects such as graft rejection and failure to suppress HIV3. Ginko biloba extract have a variety of adverse effects which include headache, diarrohea, vomiting, and hemorhage due to ginkgolids a component of this extract4. Other commenly used herbal medicines that are thought to affect blood clotting include garlic, ginger, ginseng extracts5.

In India many plant medicines used by the traditional healers are not safe. In one of my study about iatrogenic seizures a 26 years old female had treatment for bronchial asthma from a traditional healer with indigenous plant extract probably containing Xanthine alkaloids developed generalized tonic clonic seizures6.

So it is important to realise that the plant medicines contain biologically active ingradiants which may cause adverse effects or they may interact with other conventional drugs.

M.A.ALEEM. Assitant Professor of Neurology, Dept of Neuromedicine KAPV Govt Medical College and AGM. Hospital, Trichy 620017. TAMIL NADU, INDIA. E-Mail: drmaaleem@hotmail.com

KALAVATHY PONNERIVAN, Professor of Biochemistry & DEAN KAPV. Govt Medical College and AGM Hospital, Trichy 620017. TAMIL NADU, INDIA.

Competing Intersts: None declared.

1. Ernst E.Herbal medicines put into context. BMJ 2003;327:381-2.

2. Barnes J, Quality efficacy and safety of Complementary medicines; fashions, facts and future. Part II: effiecncy and safety Br. J clin pharmacol 2003; 55:331-40

3. Ioannides C pharmacokinetic interactions Between herbal remedies and medicinal drugs, Xenobiotica 2002; 32:451-78

4. koltai M, Hosford D, Guinot P et al. platelet activating factors [PAF]. A review of its effects anatagonists and possible future clinical implications (part 1) Drugs 1991;42:9-29

5. Ang Lee MK.Moss J.Yuan C.S. Herbal medicines and perioperative care JAMA 2001; 286:208-16

6. Aleem.M.A Iatrogenic seizures a clinical study from southern india. J Neurol Sci 2001; 187(suppl):s411;

Competing interests: None declared

WHO should take initiative on vitamin S? 16 March 2004
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Gareth P Morgan,
Public Health Practitioner
National Public Health Service for Wales, 36 Orchard Street, Swansea, UK. SA1 5AQ.

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Re: WHO should take initiative on vitamin S?

Salicylate (and related compounds) is produced by fruits, vegetables and other flora as a defence mechanism against disease and damage. It has been suggested that salicylate has hormonal-type functions in flora (1) and in humans it has a range of properties including anti-oxidant and anti -inflammatory effects.(2)

People consume salicylate in several ways, most obviously through the diet by eating fresh fruits and vegetables.(2) It has already been shown (perhaps unsurprisingly) that soups made from organic vegetables contain the highest levels of salicylate. In addition, the widely used medicine aspirin (acetylsalicylate) is metabolised to form salicylate and perhaps some frequently consumed beverages such as red wine and milk are also sources of small amounts of salicylate.(3,4) Herbal medicines are also likely to be a source of salicylate hence my response to the editorial by Ernst (BMJ October 18th 2003).

Some people are salicylate sensitive and experience allergic responses when exposed to it. For most of the population, however, a large evidence base links the regular and long-term consumption of salicylate containing items to health benefits. The health benefits take the form of reduced risks of certain age-related chronic illnesses (notably cardiovascular disease and some common cancers) and all-cause mortality.(5-9) The fact that the evidence base is derived from different studies on different populations using different methods is a strength that reasonably excludes bias, chance and confounding as explanations. In short, therefore, the evidence base shows beyond reasonable doubt that the regular and long-term consumption of salicylate containing items causes health benefits for most of the population.

I accept that the explanations for the causal relationship are multiple and in some cases either not fully understood or controversial. However, I believe that it is safe ground to suggest that salicylate contributes in part to the observed health benefits. The suggestion also has the advantage that it is biologically plausible and even if the contribution to an individual person is a small one, the benefits to the population will large (‘prevention paradox’ principle). It therefore follows that for most people, salicylate deficiency is a deleterious state of health to be avoided if possible.

I have published a well-received paper setting out a case for classifying salicylate as vitamin S.(10) For the reasons presented in my paper, either salicylate should be classified as vitamin S or the whole vitamin literature should be revised and rewritten. I doubt that the latter will happen so for the remainder of the paper, I believe that it is legitimate to refer to salicylate as vitamin S.

The vitamin S concept has far reaching public health implications, particularly for socio-economically deprived communities that typically have high rates of age-related chronic illnesses and premature death. People living in such communities usually have diets that contain little fresh fruits and vegetables and they will be at risk of vitamin S deficiency and the health risks associated with it. Increasing the long- term intake of fresh fruits and vegetables in such communities is difficult but efforts to do so, such as the ‘5-A-Day’ programme, are to be encouraged.

Another possible approach to counteract salicylate deficiency would be the appropriately and non-coercively targeted use of low-dose aspirin (75-150 mg per day). I make two qualifications to this possibility. Firstly, aspirin must only be used when benefit exceeds risk. This qualification excludes a significant number of individuals from taking aspirin including those with certain medical conditions such as gastrointestinal problems or asthma. Secondly, aspirin use is a complement and certainly not a competitor to other interventions that improve health. This qualification means that appropriately targeted low- dose aspirin must be integrated with locally sensitive health improvement strategies.

The potential use of aspirin as a public health weapon to reduce disease is a departure from the use of it in clinical situations. With my two qualifications in mind, should low-dose aspirin programmes be appropriately targeted to deprived communities under the banner of vitamin S supplementation? I have confidence that such programmes would yield substantial public health benefits and at the very least there should be a wide-ranging debate on the question. In any debate, potential adverse effects of such programmes also need to be considered. These include differential aspirin use increasing health inequalities, inappropriate use of this easily available and inexpensive medicine and an increased level of aspirin-related adverse effects. The latter has obvious implications for legal action against health organisations, especially given the litigation culture prevalent today.

The vitamin S content of herbal medicines may be important in explaining some of their beneficial effects. Natural products containing vitamin S, such as willow bark, have been used for thousands of years. It is perhaps time for a re-evaluation of the health promoting promoting properties of vitamin S containing natural products.

Consider yet another approach to vitamin S supplementation. It is a fact of life that people consume a lot of processed foods and beverages. Manufacturers could develop a wide range of processed products that have an element of ’fresh organic’ in them. Products fortified with vitamin S would be nutriceuticals and the amount of it added would be shown in the ‘Nutritional Information’ on the label. The fortification approach might possibly be used as part of an advertising strategy i.e. ‘’eat our product because it contains vitamin S’’. It might even be possible to persuade ‘fast food’ organisations to incorporate low levels of vitamin S into their products.

The bottom line is that vitamin S supplementation programmes have an enormous public health potential.(11,12) They may reduce the burden of certain chronic illnesses in the ageing population and therefore also save healthcare resources that can be put to alternative use. UNICEF has called for efforts to eradicate vitamin deficiency but make no mention of vitamin S.(13) In extension of the UNICEF position, I therefore call for broad based activities on vitamin S to be started as a matter of urgency and look to bodies such as World Health Organisation (WHO) to take initiative.

Acknowledgement:

Part of this response is based upon emails from Dr Mike Walker, WV Development Consultants, Tasmania.

References

1. Pierpoint W.S. The natural history of salicylic acid. Interdisciplinary Science Reviews 1997; 22(1):45-52.

2. Morgan G. Should aspirin be used to counteract salicylate deficiency? Pharmacology and Toxicology 2003; 93:153-155.

3. Muller C.J., Fugelsang K.C. Take two glasses of wine and see me in the morning. Lancet 1994; 343:1428-1429.

4. Levy G. Clinical pharmacokinetics of aspirin. Pediatrics 1978; 65(5):867-72.

5. Morgan G. The public health potential of aspirin. Seminar in Oncology. Bristol University, February 10th 2004.

6. http://www.iarc.fr/epic/ (accessed March 1st 2004)

7. http://www.bhf.org.uk/hearthealth (accessed March 1st 2004)

8. Goldfinger T.M. Beyond the French paradox : the impact of moderate beverage alcohol and wine in the prevention of cardiovascular disease. Cardiol Clin 2003; 21(3):447-57.

9. Elwood P. Milk, coronary disease and mortality. J Epidemiol Community Health 2001; 55:375.

10. Morgan G. An aspirin a day. New Scientist 2004; Feb. 7th:36-39.

11. Morgan G. Vitamin S supplementation in pregnancy (http://bmj.bmjjournals.com/cgi/eletters/327/7424/0-h#50034)

12. Morgan G. The ‘polypill’ from age 55 or low-dose aspirin with a bedtime drink from age 50? (http://bmj.bmjjournals.com/cgi/eletters/328/7434/289-b#49296)

13. Zarocostas J. UNICEF calls for efforts to eradicate vitamin deficiency. Lancet 2004; 363:378.

Competing interests: Secretary of the Welsh Aspirin Group