Abstract

Men have been using herbal medicines for thousands of years. The advantages of this type of
therapeutics include good availability, local cultural aspects, individual preferences, the
increasing demand for natural and organic products, and the already validated synergistic effects
of herbal medicines. However, ethically, the scope and limits of these drugs need to be
established not only by ethnopharmacological evidences but also by scientific investigations,
which confirm the therapeutic effects. With this study, we propose to discuss the possible
advantages of using herbal medicines instead of purified compounds, the truth and myths about
herbal medicines, drug discovery, and the implications for medical education and health care.

All natural" -- it's on the labels of a growing number of foods, cosmetics, cleaning products, and
over-the-counter remedies. This is, in part, what makes herbal medicine so popular. But does
natural always mean safe?

Herbal medicine is the use of plants as medicine. Typically taken by mouth or applied to the
skin, medicinal herbs can come in several forms, such as ointments, oils, capsules, tablets, and
teas.

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Though many people may use them as medicine, herbal supplements are not regulated by the
FDA like prescription and over-the-counter drugs are. For this reason, some potentially
dangerous herbs may be available in stores, online, and even in local coffee shops. You take
them at your own risk. Before taking any herb, be sure to research it and talk to your health care
providers -- doctors, pharmacists, and anyone else who's involved in your medical care.

Risky Herbs

"Some people think herbal supplements really work but that they are harmless," but if it acts like
a drug in the body, then it can also have a negative effect, says Adriane Fugh-Berman, MD, an
expert on medicinal herbs and dietary supplements and a professor at Georgetown University
School of Medicine.

"Most herbs we use in the U.S. are pretty benign," Fugh-Berman says, "but some are dangerous
and others are if not taken correctly."
Anything that works like a drug is going to have some risks, says Cydney McQueen, PharmD, a
professor at the University of Missouri-Kansas City School of Pharmacy.

For herbs that pose major risks, the most common risks are liver and kidney damage and drug
interactions.

Here are examples of herbs that carry risks you may not know about. This is not a complete list
of every potentially risky herb or other supplement; it simply shows that some very risky
substances are available to anyone over the counter. So again, be sure to talk to your health care
providers before taking any herbs.

St. John's Wort

St. John's wort (Hypericum perforatum) can ease mild to moderate depression, says Andrew
Weil, MD, who is the founder and director of the Arizona Center for Integrative Medicine at the
University of Arizona. But there is not enough evidence that it helps with major depression.

Besides, depression isn't something to treat without help. "It's not the common cold. If someone
wants to use St. John's wort for depression, they still must be managed by a health care
provider," McQueen tells WebMD.

Here's one major reason why: drug interactions. St. John's wort can make many other drugs less
effective. There have been cases of unintended pregnancies in women taking St. John's wort and
birth control pills and cases of organ rejection in those taking St John's wort with anti-rejection
drugs after a transplant.

"If you are taking any prescription drug and are interested in trying a course of St. John's wort for
mild to moderate depression, first discuss possible interactions with your doctor or pharmacist,"
says Weil, whose line of dietary supplements includes a product containing St. John's wort.

Just how safe are herbal medicines?

While many of us believe that "herbal" is synonymous with

"safe", herbal remedies can in fact be deadly, says Tammy
Cohen.
St. John's Wort is a popular herbal remedy for depression Photo: GETTY

By Tammy Cohen

7:00AM GMT 02 Nov 2009

Comment

Herbal remedies made from plant leaves, bark, berries, flowers, and roots have been used to heal
illnesses, diseases, and psychological disorders for centuries. Today, with the ease of the internet,
you can self-diagnose, order next day delivery, and even learn how to make your own. Last year
three million Britons took herbal remedies to treat everything from fever to joint pain.

But renewed debate about the safety of these remedies was sparked last week following the news
of an EU crackdown on herbalists and Chinese medicine practitioners who operate unregulated
at present. Under the new law, from 2011 sales of all herbal remedies except for a small number
of products for minor ailments will also be banned. Regulators warn that many of us believe that
"herbal" is synonymous with "safe", whereas herbal remedies can be deadly.

"Research we conducted last year found a significant proportion of people believed 'herbal'
means 'benign'," says Richard Woodfield, Head of Herbal Policy at the Medicines and Health
care products Regulatory Agency (MHRA). "That means people are more liable to self-medicate,
and to neglect to inform their doctors, even though there's a risk that the herbal remedy will react
with any prescription drugs. They're also more vulnerable to fraudulent, even criminal operators
who put products out which are heavily adulterated with dangerous pharmaceuticals."

The actress Sophie Winkleman is reported to have taken aconite, or monkshood, found in some
'herbal Valium' last month to calm her nerves prior to her wedding to Freddie Windsor.
The plant while relatively harmless in licensed homeopathic remedies in which it is rigorously
diluted, can be extremely dangerous, in herbal remedies, even lethal.

"If you were to buy aconite root, which is banned from licensed herbal products in the UK, but
can still be found in products bought over the internet, and make yourself a herbal tea with it,
you'd be dead within five minutes," says Dr Linda Anderson, Pharmaceutical Assessor of the
MHRA.

Last year, scientists at Boston University found that a fifth of Ayurvedic medicines popular
traditional Indian herbal remedies bought over the internet contained dangerous levels of lead,
mercury or arsenic, which could cause stomach pains, vomiting or liver problems.

Earlier this year, herbal arthritis remedies came under scrutiny when looked at as part of the
Arthritis Research Campaign's (ARC) study of complementary therapies. "Not only did we find
that in two-thirds of cases, there was no evidence they actually worked, but one Chinese remedy
used to combat rheumatoid arthritis Thunder god vine was also reported to be extremely
poisonous if not extracted properly," says ARC spokeswoman Jane Tadman.

Menopause remedies also came under fire after a study reported in the Drugs and Therapeutics
Bulletin, a journal that reviews medical treatment, found no evidence they actually worked.
Gynaecologist Heather Curry of the British Menopause Society says: "Our feeling is that there
isn't enough scientific evidence either on effectiveness or safety." A German study last year
found the "herbal antidepressant" St Johns wort to be as effective as standard antidepressants
such as Prozac.

However, side effects such as dry mouth, dizziness and stomach pains have been widely reported
and it interacts strongly with some prescription drugs such as Warfarin and oral contraceptives.
And in April, an MHRA investigation into Jia Ji Jian, sometimes marketed as 'herbal Viagra',
revealed it contained up to four times the level of pharmaceuticals found in legally prescribed
anti-obesity and anti-erectile dysfunction medicinal products, which can cause serious side
effects including heart and blood pressure problems. As a herbal remedy it should not contain
any pharmaceuticals at all.

"Drug interaction is a big area of concern," says Professor Edzard Ermst, professor of
Complementary Medicine at Exeter University. "Herbal medicines may have been around for
thousands of years, but the new synthetic drugs haven't and how they interact is still uncharted
territory."

The MHRA believes regulating the herbal medicine industry is the best way to limit abuses and
ensure consumers are aware of potential dangers. All herbal medicines sold over the counter in
the UK should according to the law be licensed. The MHRA assesses them on safety, quality and
patient information. By 2011 a new scheme, which is currently being rolled out, will be in place.

"Check for products which have the THR (Traditional Herbal Register) or Product Licence (PL)
number on the label," advises Richard Woodfield.
Many herbal practitioners want even further regulation."We want to be registered," says Dee
Atkinson, spokesperson for the National Institute of Medical Herbalists and herself a qualified
medical herbalist. "Herbs are not harmless, they are drugs, just as pharmaceuticals are drugs and
as such they should be prescribed by a qualified, registered practitioner.

"As a rule of thumb, I'd say that for any conditions or problems you'd normally go to a chemist
for, you can visit a shop that sells over-the-counter herbal medicines, but anything beyond that
you should be seeing a qualified, and we'd like to see registered, professional. Never order
anything off the internet unless it's from a UK-based, recognised herbal company."

Richard Woodfield of the MHRA agrees. "Avoid unlicensed herbal remedies, particularly those
sold on the internet and steer clear of anything claiming to be "100% safe" or "safe because it's
natural". Like any other drugs, herbs can have side effects. Look for the THR or PL standard on
the label and consult with your doctor if taking any prescription medicine."

MHRA information line: 020 7084 2000; www.mhra.gov.uk

The quality and safety of traditional traditional Chinese medicines

George Q. Li, Co-ordinator, Colin C. Duke, Senior Lecturer, and Basil D. Roufogalis, Professor of
Pharmaceutical Chemistry, Herbal Medicines Research and Education Centre, University of Sydney,
Sydney

Summary

Modern chemical and pharmacological research has greatly contributed to our understanding of Chinese
medicine. The quality of Chinese medicines may be controlled by understanding their pharmacognosy
and applying pharmaceutical methods. Chinese medicines may have intrinsic toxicity. They can also be
contaminated and adulterated. Interactions with prescription drugs are also possible. Regulation,
backed by education and research, is needed to improve the quality and quality use of traditional
Chinese medicines.

Key words: complementary medicines, herbal preparations, pharmacognosy.

Aust Prescr 2003;26:128-30

Introduction

Traditional Chinese medicine is a medical system based on theory, pathology, diagnosis, treatment and
herbal pharmacology principles that differ from those of orthodox medicine or Western naturopathy.
The practice of traditional Chinese medicine has developed from knowledge accumulated through
clinical observation and treatment over several millennia. Traditional Chinese medicine has an
established history in Australia and has expanded rapidly in recent years. Chinese medicines now
account for 3.2% of the total use of complementary medicines.1 The Chinese Medicine Registration Act
was approved by the Victorian Parliament in 2000, to regulate the qualifications of traditional Chinese
medicine practitioners and dispensers to encourage the safe use of traditional Chinese medicines in
Victoria.

In parallel with the growth of Chinese medicine, serious issues have been raised about its quality and
safety in Western countries. Chinese medicines have been contaminated with toxic heavy metals and
adulterated with prescription drugs.2There is therefore a need for quality assurance of Chinese
medicines in Australia.

Active principles and therapeutic effects of Chinese medicines

Modern research has revealed that many Chinese herbs act through one or more pharmacological
mechanisms. Many active components have been isolated from herbs used in Chinese medicine and
some are used in modern pharmaceutical drugs. They include ephedrine for hypotension (from ephedra
(Ephedra sinica Stapf)), artemisinin for malaria (from Chinese wormwood (Artemisia annua L.)), and
berberine, an antibacterial component (from Chinese goldthread (Coptis chinensis Franch)). Active
components have been defined in many other Chinese herbs, for example anthraquinone glycosides in
rhubarb (Rheum officinale Baill), and gingerols in ginger (Zingiber officinale Rosc).

The chemistry of herbal medicines is the foundation of their pharmacology. It is also important for the
manufacture and quality assurance of herbal preparations. For example, aconite (Aconitum carmichaeli
Debx.) is an 'internal warming, hot and pungent herb' and is used to restore Yang deficiency in heart
failure. Its cardiotonic active substance has been isolated and identified as higenamine, a beta
adrenergic agonist with an isoquinoline structure related to catecholamines. The active components
responsible for analgesic and toxic effects are aconitine, mesaconitine and other diterpene esters, which
are largely hydrolysed during processing and boiling. The toxicity of aconite is well understood in
traditional Chinese medicine and the herb is only listable at very low concentrations in Australia. Red
sage (Salvia miltiorrhiza Bunge) is a herb that is said to 'promote blood circulation and remove blood
stasis'. It purportedly dilates the coronary arteries and increases the peripheral circulation so it has been
used to treat angina pectoris. However, for most Chinese medicines the active components responsible
for their pharmacological activities and clinical applications are not well defined.

The level of clinical evidence to support Chinese medicine does not generally meet the internationally
accepted standards of clinical trials of new drugs. Many preclinical and clinical studies carried out in
China have been published in the Chinese literature, but the results are not readily available to Western
communities.

Quality control from agriculture to fingerprinting

As for pharmaceutical products herbal medicines require professional and government control to ensure
their quality, safety and efficacy. The Chinese pharmacopoeia (2000)3 contains monographs and
standards of materia medica and patent preparations. Australia relies mainly on imported herbal
materials and has not developed a herbal pharmacopoeia.

The quality of a herbal medicine refers to the intrinsic properties of the herb, that is, the amount and
range of medicinally useful or active constituents present. The correct identification of a plant with
reference to its accepted scientific name(s) is a primary step in the quality assurance process, as a single
common name may often refer to different plant species, with potentially dangerous consequences.
Other factors influencing the quality of herbal medicines are:

agriculture

harvesting

processing

good manufacturing practice.

Chinese herbal medicines are usually used as a decoction of a mixture of herbal materials defined in a
formula, which therefore contains hundreds of components. The clinical application of Chinese
medicines is related to the multiple chemical components and not a single component. A
pharmaceutical approach to testing for the content of a single component may therefore not reflect the
quality, safety and efficacy of a herbal preparation. Methods of chromatographic fingerprinting, such as
high-performance thin layer chromatography and high-performance liquid chromatography, are being
developed to define the profiles and variations between herbal medicines.

Safety and regulation of traditional Chinese medicines

The issues associated with the safety and quality of Chinese herbal medicines include toxic herbs,
contamination with heavy metals, microbial organisms, and other contaminants, and deliberate
combination or adulteration with pharmaceutical drugs. Chinese herbal products in Australia are
regulated by the Therapeutic Goods Administration (TGA) and need to meet quality and safety
standards (see comment).

The importation and dispensing of raw herbs are not effectively regulated or closely monitored by the
TGA. At present, raw herbs can be imported and dispensed legally over the counter without registration
with the TGA. These herbs may not meet the standards for herbal products.

Toxic herbs

Some herbs or minerals are known to be toxic and, when appropriate, need to be used with care under
the supervision of highly qualified practitioners. Aconite poisonings have occurred repeatedly overseas
and in Australia. Aconite (Aconitum carmichaeli Debx., Aconitum kusnezoffii Reichb.) contains aconitine,
a cardiotoxin and neurotoxin causing arrhythmia and ventricular fibrillation. Thornapple (Datura metel
L.) and black henbane (Hyoscyamus niger L.) contain hyoscyamine, an antimuscarinic alkaloid. Other
toxic herbs requiring special regulation include nux vomica (Strychnos nux-vomica L.) which contains
strychnine, Chinese arum (Arisaema erubescens (Wall.) Schott), and tri-leaved pinellia (Pinellia ternata
(Thunb.) Breit).

Some species of plants with similar Chinese names differ in their indication and toxicity and cannot be
used interchangeably. Guang fang ji (Aristolochia fangchi) and han fang ji (Stephania tetrandra) have
similar names and clinical indications in traditional Chinese medicine, but Aristolochia fangchi contains
the highly toxic aristolochic acids. Aristolochia fangchi has been found to cause renal failure and
urothelial carcinoma. The nephropathy is characterised by extensive interstitial fibrosis leading to a
severe atrophy of the proximal tubules.4, 5
Contamination or adulteration

Chinese herbal products have been found to contain heavy metals, such as mercury and arsenic, and
non-prescription or even prescription drugs such as paracetamol, indomethacin, chlorpheniramine,
aminopyrine, caffeine and hydrocortisone. The unapproved presence of these substances may have
originated from mineral components, contamination or adulteration.2Currently quality monitoring relies
on TGA post-marketing surveillance. Extra resources would be required to carry out routine surveys of
the quality of Chinese herbal products in the Australian market to detect drug contamination or
adulteration.

Drug-herb interactions

The combination of pharmaceutical drugs and Chinese herbal medicines is a common practice in China
and must be considered when patients are using preparations obtained outside Australia. Similarly,
patients in Australia may use Chinese medicines together with pharmaceutical drugs without informing
their medical practitioners. The potential for drug-herb interactions remains to be investigated.

Regulation of herbal dispensers/pharmacists

Herbal medicines are usually dispensed by the practitioner who prescribes them, even though it is not
accepted Australian practice for practitioners to have both prescribing and dispensing functions. It
seems reasonable that dispensers should have sufficient training in the theory and properties of herbal
medicines, equivalent to that found in pharmacy in Australia and traditional Chinese medicine pharmacy
in China, in order for them to dispense herbal medicines safely according to best practice. This would
require training in the pharmaceutical aspects of herbal medicines.

Recommendation

Best practice for Chinese medicines in Australia requires understanding both the traditional Chinese
medicine system and modern orthodox medicine. There is a need to establish a quality testing system
for raw herbs and their preparations and herbal products. This would detect any mislabelling or
misidentification and the presence of undeclared components. Herbs with toxicities equivalent to
prescription pharmaceutical drugs require a regulatory control system, such as a special schedule to
enable registered practitioners to prescribe them under appropriate monitoring. Herbal dispensers
should have an adequate qualification for dispensing, which includes knowledge of Chinese medicine
and modern pharmaceuticals.

Medical practitioners and pharmacists should have sufficient knowledge of traditional Chinese medicine
and herbal medicines to allow them to discuss issues and give advice to patients, and to identify and
manage drug-herb interactions. Education programs such as short courses on modern Chinese medicine
or exposure to the subject in the undergraduate curriculum may be of benefit to healthcare
practitioners.