Herbalism

For partial list of herbs with known adverse effects, see List of herbs with known adverse effects.

A number of herbs are thought to be likely to cause adverse effects.[4] Furthermore, “adulteration, inappropriate formulation, or lack of understanding of plant and drug interactions have led to adverse reactions that are sometimes life threatening or lethal[5].” Proper double-blind clinical trials are needed to determine the safety and efficacy of each plant before they can be recommended for medical use.[177] Although many consumers believe that herbal medicines are safe because they are “natural”, herbal medicines and synthetic drugs may interact, causing toxicity to the patient. Herbal remedies can also be dangerously contaminated, and herbal medicines without established efficacy, may unknowingly be used to replace medicines that do have corroborated efficacy.[76]

Standardization of purity and dosage is not mandated in the United States, but even products made to the same specification may differ as a result of biochemical variations within a species of plant.[178] Plants have chemical defense mechanisms against predators that can have adverse or lethal effects on humans. Examples of highly toxic herbs include poison hemlock and nightshade.[179] They are not marketed to the public as herbs, because the risks are well known, partly due to a long and colorful history in Europe, associated with “sorcery”, “magic” and intrigue.[180] Although not frequent, adverse reactions have been reported for herbs in widespread use.[181] On occasion serious untoward outcomes have been linked to herb consumption. A case of major potassium depletion has been attributed to chronic licorice ingestion.[182], and consequently professional herbalists avoid the use of licorice where they recognise that this may be a risk. Black cohosh has been implicated in a case of liver failure.[183] Few studies are available on the safety of herbs for pregnant women[184][185], and one study found that use of complementary and alternative medicines are associated with a 30% lower ongoing pregnancy and live birth rate during fertility treatment[186]. Examples of herbal treatments with likely cause-effect relationships with adverse events include aconite, which is often a legally restricted herb, ayurvedic remedies, broom, chaparral, Chinese herb mixtures, comfrey, herbs containing certain flavonoids, germander, guar gum, liquorice root, and pennyroyal[187]. Examples of herbs where a high degree of confidence of a risk long term adverse effects can be asserted include ginseng, which is unpopular among herbalists for this reason, the endangered herb goldenseal, milk thistle, senna, against which herbalists generally advise and rarely use, aloe vera juice, buckthorn bark and berry, cascara sagrada bark, saw palmetto, valerian, kava, which is banned in the European Union, St. John’s wort, Khat, Betel nut, the restricted herb Ephedra, and Guarana[5].

There is also concern with respect to the numerous well-established interactions of herbs and drugs[5]. In consultation with a physician, usage of herbal remedies should be clarified, as some herbal remedies have the potential to cause adverse drug interactions when used in combination with various prescription and over-the-counter pharmaceuticals, just as a patient should inform a herbalist of their consumption of orthodox prescription and other medication.

For example, dangerously low blood pressure may result from the combination of an herbal remedy that lowers blood pressure together with prescription medicine that has the same effect. Some herbs may amplify the effects of anticoagulants.[188] Certain herbs as well as common fruit interfere with cytochrome P450, an enzyme critical to much drug metabolism.[189]

Name confusion

The common names of herbs (folk taxonomy) may not reflect differences in scientific taxonomy, and the same (or a very similar) common name might group together different plant species with different effects. For example, in 1993 in Belgium, medical doctors created a formula including some Traditional Chinese medicine (TCM) herbs for weight loss. One herb (Stephania tetrandra) was swapped for another (Aristolochia fangchi) whose name in Chinese was extremely similar but which contained higher levels of a renal toxin, aristolochic acid; this mistake resulted in 105 cases of kidney damage.[190][191] Note that neither herb used in a TCM context would be used for weight loss or given for long periods of time. For this reason, Western herbalists use binomial nomenclature in their terminology within the profession.

In Chinese medicine these herbs are used for certain forms of acute arthritis and edema.[192][193][194]

Effectiveness

Running total of the number of research papers listed on PubMed from 1990-2007 containing the word “phytotherapy.”

The gold standard for pharmaceutical testing is repeated, large-scale, randomized, double-blind tests. In 2004 the U.S. National Center for Complementary and Alternative Medicine of the National Institutes of Health began funding clinical trials into the effectiveness of herbal medicine.[195]

Many herbs have shown positive results in-vitro, animal model or small-scale clinical tests[196] but many studies on herbal treatments have also found negative results.[197] The quality of the trials on herbal remedies is highly variable and many trials of herbal treatments have been found to be of poor quality, with many trials lacking an intention to treat analysis or a comment on whether blinding was successful.[198] The few randomized, double-blind tests that receive attention in medical publications are often questioned on methodological grounds or interpretation. Likewise, studies published in peer-reviewed medical journals such as Journal of the American Medical Association receive more consideration than those published in specialized herbal journals.

One study found that non-impact factor alternative medicine journals published more studies with positive results than negative results and that trials finding positive results were of lower quality than trials finding negative results. High impact factor mainstream medical journals, on the other hand, published equal numbers of trials with positive and negative results. In high impact journals, trials finding positive results were also found to have lower quality scores than trials finding negative results.[197] Another study reported that some clinical studies of herbal medicines were not inferior to similar medical studies.[199] However, this study used a matched pair design and excluded all herbal trials that were not controlled, did not use a placebo or did not use random or quasi random assignment.

Herbalists criticize mainstream studies on the grounds that they make insufficient use of historical usage, which has been shown useful in drug discovery and development in the past and present[200]. They maintain that tradition can guide the selection of factors such as optimal dose, species, time of harvesting and target population.[201]

Dosage is in general an outstanding issue for herbal treatments: while most medicines are heavily tested to determine the most effective and safest dosages (especially in relation to things like body weight, drug interactions, etc.), there are fewer varieties of dosages for various herbal treatments on the market.[citation needed] Furthermore, from a conventional pharmacological perspective, herbal medicines taken in whole form cannot generally guarantee a consistent dosage or drug quality, since certain samples may contain more or less of a given active ingredient.

Several methods of standardization may be applied to herbs. One is the ratio of raw materials to solvent. However different specimens of even the same plant species may vary in chemical content. For this reason, thin layer chromatography is sometimes used by growers to assess the content of their products before use. Another method is standardization on a signal chemical.[202]

Standards and quality control

The issue of regulation is an area of continuing controversy in the EU and USA. At one end of the spectrum, some herbalists maintain that traditional remedies have a long history of use, and do not require the level of safety testing as xenobiotics or single ingredients in an artificially concentrated form.[citation needed] On the other hand, others are in favor of legally enforced quality standards, safety testing and prescription by a qualified practitioner.[citation needed] Some professional herbalist organizations have made statements calling for a category of regulation for herbal products.[203] Yet others agree with the need for more quality testing but believe it can be managed through reputation without government intervention.[204] The legal status of herbal ingredients varies by country.

In the EU, herbal medicines are now regulated under the European Directive on Traditional Herbal Medicinal Products.

In the United States, most herbal remedies are regulated as dietary supplements by the Food and Drug Administration.[citation needed] Manufacturers of products falling into this category are not required to prove the safety or efficacy of their product, though the FDA may withdraw a product from sale should it prove harmful.[205][206]

The National Nutritional Foods Association, the industry’s largest trade association, has run a program since 2002, examining the products and factory conditions of member companies, giving them the right to display the GMP (Good Manufacturing Practices) seal of approval on their products.[65]

In the UK, herbal remedies that are bought over the counter are regulated as supplements, as in the US[citation needed]. However, herbal remedies prescribed and dispensed by a qualified “Medical Herbalist“, after a personal consultation, are regulated as medicines.

A Medical Herbalist can prescribe some herbs which are not available over the counter, covered by Schedule III of the Medicines Act[citation needed]. Forthcoming changes to laws regulating herbal products in the UK, are intended to ensure the quality of herbal products used[citation needed].

Some herbs, such as Cannabis, are outright banned in most countries. Since 2004, the sales of ephedra as an dietary supplement is prohibited in the United States by the Food and Drug Administration.[207], and subject to Schedule III restrictions in the United Kingdom.

Danger of extinction

On January 18, 2008, the Botanic Gardens Conservation International (representing botanic gardens in 120 countries) stated that “400 medicinal plants are at risk of extinction, from over-collection and deforestation, threatening the discovery of future cures for disease.” These included Yew trees (the bark is used for cancer drugs, paclitaxel); Hoodia (from Namibia, source of weight loss drugs); half of Magnolias (used as Chinese medicine for 5,000 years to fight cancer, dementia and heart disease); and Autumn crocus (for gout). The group also found that 5 billion people benefit from traditional plant-based medicine for health care[208]. Some herbalists are aware of this problem and substitute least concern species as a result.

See also

References

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