| Regulatory status
Canada: Approved active ingredient in a few Schedule OTC Traditional herbal medicines (e.g. Gallexier®) and some homeopathic medicines, requiring pre-marketing authorization. Food in absence of claims. U.K.: Not entered in the General Sale List. Food.
U.S.: Dietary supplement. Food in absence of claims. Turmeric (§182.10), its essential oil, oleoresin and/or natural extractives (§182.20) are Generally Recognized as Safe (GRAS). Authentication: Macroscopic and microscopic, according to DAC. See also PPRC and API. |
Dr. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson
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 There is the potential for interactions with food, alcohol, other herbs and also disease states, and it has been suggested that treatment with herbal medicines should be discontinued in patients who are due to undergo surgery. These issues illustrate once more the need for healthcare professionals, and especially pharmacists, to be knowledgeable about HMPs. |
Josef A. Brinckmann and Michael P. Lindenmaier
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 Approved active ingredient in a few Schedule OTC Traditional herbal medicines and some homeopathic medicines, both requiring premarketing authorization. U.K.: Herbal medicine in the General Sale List, Table A (internal or external use) of Schedule 1 (requires full Product License).
U.S.: Dietary supplement. Also an active ingredient in some OTC stimulant laxative drug products (§ 310.545(12)(iv)) though not recognized as safe and effective. Specific cautionary label statements are required for products containing stimulant laxative ingredients. |
Richard Leviton
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 Worldwide, sales of herbal medicines (called phytomedicines outside the U.S.) are equally booming, estimated at $12.4 billion for Europe, Japan, Asia, and North America. In Europe, sales of herbal medicines are allocated according to these categories: cardiovascular, 27.2%; digestive, 14.4%; respiratory, 15.3%, tonics, 14.4%; sedative, 9.3%; and others. In Germany, for example, one-third of all nonprescription drugs are herbal and Ginkgo biloba (as a circulatory agent) leads the pack with annual sales of $280 million, followed by horse chestnut (for the blood) with $103 million. |
Heather Boon, BScPhm, PhD and Michael Smith, BPharm, MRPharmS, ND
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 Also, critical and objective evidence regarding the use of herbal medicines in certain scenarios such as pregnancy is lacking. Most information in this area comes from anecdotal and historical sources, the importance of which has yet to be investigated.30
Worthless Procedures
The final category is the delivery of worthless procedures for financial or other gains on the part of the practitioner.12 Unfortunately, as the popularity of 'natural' medicine increases, so does the opportunity for misrepresentation of its use. |
| Legislation
We also consulted the laws governing the manufacture and the sale of herbal medicines in Canada and the United States of America. Here is a summary of those regulations designed to ensure safety in using medicinal herbs.
Canada
In Canada, all botanical medicines are regulated by the Federal Government. The regulations for Natural Health Products (NHPs) have recently undergone extensive modification, with new regulations taking force in January 2004. |
| Herbal Teas:
Decoctions and Infusions A time-honored method of taking herbal medicines is in the form of a tea. There are primarily two kinds: decoctions and infusions. A decoction is normally reserved for fibrous plant material such as stems, bark, roots and rhizomes. It is made by boiling the plant material until it is reduced to a specific volume. Steeping the more delicate plant parts (flowers, leaves) in either hot or cold water makes an infusion. The temperature of the water will influence the constituent(s) extracted. |
David Hoffman, FNIMH, AHG
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 The mere use of herbal medicines does not make a treatment holistic. In fact, using an herbal tincture as a natural alternative to a prescription medication relegates the herb to the status of an organic drug delivery system! What makes herbs part of holistic treatment is the context within which the herbs are prescribed and used.
There is at least one clear conclusion that can be drawn from the concept that holistic medicine treats the whole person and not the disease. |
| Handmade Herbal Medicines: Recipes for Potions, Elixirs, and Salves. Loveland, CO: Interweave Press, 1998. Keville K, Green M. Aromatherapy: A Complete Guide to the
Healing Art. Freedom, CA: Crossing Press, 1995. Kloss J. Back to Eden, mass market revised edition. Twin Lakes,
WI: Lotus Press, 1989. List PH, Schmidt PC. Phytopharmaceutical Technology. Boca
Raton, FL: CRC Press, 1989. Osol A, ed. Remington's Pharmaceutical Sciences, 15th edition.
Easton, PA: Mack, 1975. Pizzorno JE, Murray MT. The Textbook of Natural Medicine.
Edinburgh: Churchill Livingstone, 1999. |
Dr. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson
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| The demand for herbal medicines has continued to grow and, in the USA, annual retail sales were estimated to be US$4 billion in 1998 (Barnes et al 2002).
Newspapers, magazines and television programmes continued to extol the virtues of medicinal herbs, often uncritically, and many 'coffee table' books and articles were written. In the UK, pharmacists asked the Royal Pharmaceutical Society of Great Britain to produce more factual information on medicinal herbs, particularly as to their constituents, pharmacology, clinical trials and safety. |
Mark Blumenthal
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 The Complete German Commission E Monographs—Therapeutic Guide to herbal medicines. Austin, TX: American Botanical Council; Boston: Integrative Medicine Communication; 1998: 88.
Blumenthal M, Goldberg A, Brinckmann J. (eds.) Herbal Medicine: Expanded Commission E Monographs. Newton, MA: Integrative Medicine Communications; 2000: 16-21.
Bomser J, Madhavi DL, Singletary K, Smith MA. In vitro anticancer activity of fruit extracts from Vaccinium species. Planta Med 1996;62:212-6. Bone K, Morgan M. Bilberry: the vision herb. MediHerb Prof Rev 1997;59:1-4. Boniface R, Robert AM. |
Andrew Pengelly
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 This can also lead to problems in compounding herbal medicines since there is a tendency to cause precipitates in some cases. For the same reason it is not considered wise to drink tea with meals; however, herb teas are generally low in tannins (Blake 1993).
Flavonoids
These compounds occur as yellow and white plant pigments (Latin flavus = yellow). Rutin was discovered in rue (Ruta graveolens) in 1842—it later became known as vitamin P (permeability factor).
Chemistry
Flavonoids occur both in the free state and as glycosides. |
Gary Null
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| Sadava and colleagues at City of Hope Medical Center in California studied the pharmacology, cell biology, and molecular biology of a particular type of lung cancer called small-cell lung carcinoma by observing these cancer cells treated with four extracts of Chinese herbal medicines that are in common use in alternative cancer therapies. They found that Chinese herbal medicine extracts OLEN, SPES and PC-SPES kill lung cancer cells but not normal cells in a way that is similar to conventional chemotherapeutic drugs but without the side effects. |
Mark Blumenthal
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| The Complete German Commission E Monographs—Therapeutic Guide to herbal medicines. Austin, TX: American Botanical Council; Boston: Integrative Medicine Communication; 1998.
Blumenthal M, Goldberg A, Brinckmann J. (eds.) Herbal Medicine: Expanded
Commission E Monographs. Newton, MA: Integrative Medicine Communications; 2000:22-7.
Boblitz N, Liske E, Wiistenberg P. Black Cohosh-Efficacy, Effect and Safety of Cimicifuga racemosa in Gynecology. Deutsche Apotheker Zeitung (DAZ) 2000; 24:107-114.
Boon H, Smith M. The Botanical Pharmacy: The Pharmacology of 47 Common Herbs. |
Dr. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson
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| HORMONAL IMBALANCE IN WOMEN
Although the phytoestrogens can be considered to affect hormone activity, there are other herbal medicines that are considered to have the capacity to regulate hormone levels without necessarily being oestrogenic. They are thought to be safe in women who have suffered breast cancer but should be used only under medical supervision in this case. Their mechanism of action is generally not known.
Black cohosh, Cimicifuga racemosa Nutt.
The plant and the drug
Black cohosh (syn. Actaea racemosa L. |
Andrew Pengelly
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| Synergy: interactions within herbal medicines', The
European Phytojournal 2: 1-7, .
2
PHENOLS
Simple phenols
Phenols are one of the largest groups of secondary plant constituents. They are aromatic alcohols since the hydroxyl group is always attached to a benzene ring.
Like all alcohols the names of phenols always end in the letters 'ol'. In addition the ring system may bear other substitutes, especially methyl groups.
Simple phenols consist of an aromatic ring in which a hydrogen is replaced by a hydroxyl group. Their distribution is widespread among all classes of plants. |
| My belief is that the structures give us an important insight into the way herbal medicines act, and are a way of rationalising many of the traditional applications that have been passed down over the centuries. The structures also give us valuable information into the potential for adverse reactions and interactions with pharmaceutical drugs.
In this new edition I have not departed from the original philosophy—to describe the structures as a means of explaining a herb's activity in a way that benefits the practice of medical herbalism. |
| The primary application of this concept is in the traditional methods of combining herbal medicines in formulas; however, in recent times it has also been applied using the combined effects of active constituents within the same herb.
A review of herbal synergism is outside the scope of this text. However, for readers who would like to pursue the topic there is literature available and attempts are being made to qualify and quantify the processes involved (e.g. Duke and Bogenschutz-Godwin 1999; Williamson 2001).
References
Black, N. |
| This genetic variability (polymorphism) has been interpreted as a protective mechanism for identification of bitter poisons; however, it can also lead to rejection of healthy foods such as grapefruit and salad greens by many people, and the familiar problem of non-compliance with herbal medicines!
Table 5.2 is a list of herbal bitter constituents along with known bitterness indices, calculated from the maximum dilutions of constituents at which bitterness is still detectable (Wagner et al. 1984).
Table 5. |
Mark Blumenthal
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| The Complete Guide to herbal medicines.
Springhouse(PA):Springhouse Corporation; 2000. p. 113-4. General Sale List (GSL). Statutory Instrument 1994 No. 2410: The Medicines
(Products Other than Veterinary Drugs). London, UK: Her Majesty's Stationery
Office (HMSO); 1994. GSL. See: General Sale List.
Health Canada. Drug Product Database (DPD) Product Information. Ottawa, Ontario:
Health Canada Therapeutic Products Programme; 2001. Hilepo J, Bellucci A, Mossey R. Acute renal failure caused by cat's claw herbal remedy in a patient with systemic lupus erythematosus [letter]. Nephron 1997;77:36l. |
Dr. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson
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| In recognition of the need for a new regulatory framework for herbal medicines, a European Union (EU) directive has been proposed which aims to establish a harmonized legislative framework for authorizing the marketing of traditional herbal medicinal products. It will require member states to set up a simplified registration procedure, based on quality and safety and relying on evidence of traditional use to support efficacy for traditional herbal medicinal products, which could not otherwise fulfil medicines licensing criteria. |
| The new directive is not a route to licensing for POMs or for traditional herbal medicines that could be licensed by the conventional route. As it stands, the proposed directive would accommodate ethnic medicines that have been used in the UK (or any other member state) for at least 15 years (the directive may provide for some flexibility on this). The European Commission has adopted formal proposals for the directive and, in April 2003, produced a revised draft after consideration of amendments proposed by the European Parliament. |
Mark Blumenthal
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| Rotblatt MD. Herbal medicines: a practical guide to safety and quality assurance.
Western Journal of Medicine. Sept 1999;171:172-175. Rotblatt M, Ziment I. Evidence-Based Herbal Medicine. Philadelphia (PA): Hanley &
Belfus, Inc.; 2002.
Rubin P. Herbal dietary supplements and foods: product liability analysis for a "failure to warn" of herb/drug interactions and guidelines to develop appropriate Warnings. HerbalGram 2002;55:56-59,71.
Schulz V, Hansel R, Tyler VE. Rational Phytohterapy: A Physician's Guide to Herbal Medicine. New York (NY): Springer Verlag; 2001.
Soller, RW. |
Dr. Michael Heinrich, Joanne Barnes, Simon Gibbons and Elizabeth M. Williamson
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| STANDARD REFERENCES CONSULTED FOR THE PREPARATION OF MONOGRAPHS
Barnes J, Phillipson JD, Anderson LA 2002 herbal medicines.
Pharmaceutical Press. London British National Formulary. British Medical Association and the
Royal Pharmaceutical Society London (published biannually) Eschrich W 1983 Pulver-Atlas der Drogen des Deutschen
Arzneibuches. Gustav Fischer Verlag. Stuttgart Evans WC 2002 Trease and Evans's pharmacognosy, 15th edn.
WB Saunders, London Haensel R, Sticher O, Steinegger E 1999 Pharmakognosie-
Phytopharmazie. 6th edn. |
Andrew Pengelly
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| While few would disagree with that proposition, there are many who persist in referring to herbal medicines (along with other 'alternative remedies') as unproven and therefore of little or no clinical value. Increasingly, the public—and particularly the medical establishment—are demanding herbalists and other complementary therapists provide scientific evidence for the efficacy and safety of their practices. |
Michael Tierra
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 Herbal medicines have been a large part of all medical systems over the millennia, but they have been put to a very hard test by the severe conditions of a developing world. The greatest assault on health has come from the unsanitary conditions of city life and from bad diet. The unequal distribution of foods leaves some individuals without adequate nutrients while giving others deadly dietary excesses, especially in the form of highly processed foods. Where practiced, improved sanitation and proper diet have done more for health than any medicine that has ever been used. |
Alan Keith Tillotson, Ph.D., A.H.G., D.Ay.
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 If you are taking cardiac glycoside medicines you must avoid these herbal medicines.
There are also some reports that the commonly used herb hawthorn berry (Crataegus species) may increase the action of digitalis, but I have not seen any adverse reports at this time. Dr. Weiss reports in his textbook Herbal Medicine that "a heart no longer giving an adequate response to digitalis or strophanthin becomes reactive again after intercurrent Crataegus therapy. |
Michael T. Murray, N.D., Joseph E. Pizzorno, N.D.
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 Therapeutic Considerations
The primary therapeutic goal from a natural medicine perspective involves supporting the alcoholic with better nutrition, counseling, and psychological support and specific herbal medicines to deal with any alcohol-related health problem (e.g., liver damage).
QUICK REVIEW
• Genetic factors play a big role in the cause of alcoholism.
• All active alcoholics display signs of injury to the liver.
• Hypoglycemia aggravates the mental and emotional problems of the alcoholic.
• Zinc is one of the key nutrients involved in the breakdown of alcohol. |
| Examples of supplementary measures include medication; surgery; nutritional supplements; herbal medicines; physical therapies such as chiropractic care, massage, and other bodywork; acupuncture; homeopathy; glandular therapy; and any other treatment designed to support or improve health. We will divide supplementary measures into two categories: essential and adjunctive.
An example of an essential supplementary measure is the use of insulin in the treatment of insulin-dependent diabetes. |
Alan Keith Tillotson, Ph.D., A.H.G., D.Ay.
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| Although many effective methods of making herbal medicines have worked fine in the past, the important test of identifying an individual marker must be performed for quality assurance. Knowing how to determine which constituents to look for as markers is a hotly debated issue, and methods vary from company to company.
One obvious drawback is the existing practice of "spiking"—adding some of the marker substance before testing to create the illusion of a healthy batch of plants or medicines. |
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