Herbal preparations and phytomedicinals are increasingly being used by the public as self-selected OTC products for therapeutic or preventative purposes.
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Herbal preparations and phytomedicinals are increasingly being used by the public as self-selected OTC products for therapeutic or preventative purposes. Sales of herbal remedies in the U.S. reached nearly $2.5 billion in 1966.1 Sales of herbal products in pharmacies increased by 24% while still representing only a small percentage of the total herbal market. Increased public interest in herbal therapy is riding the wave of an increased health consciousness of the "baby boomer" generation. Baby boomers are aware that conventional drugs, although extremely successful in controlling many disorders, have not cured all diseases, especially cancer, cardiovascular and neurodegenerative diseases. Also, emphasis has shifted more toward disease prevention than treatment. For these and other reasons, more Americans are turning to so-called "unconventional medicine." This complementary or alternative approach to traditional or conventional therapy often includes the use of herbs or phytomedicinals. One recent survey revealed that the frequency of use of unconventional therapy in the United States was far higher than previously reported.2 One in three respondents reported using at least one unconventional therapy in the past year.
Herbal medicine is as old as the human race and has historically been nurtured by shamans, wise-women and healers. A tremendous amount of empirical information has accumulated to form a nebulous system of "herbal medicine." Two of the most extensively developed are traditional Chinese medicine and the Indian system of Ayurvedic medicine. The recent popularity of herbal remedies is often associated with high hopes and expectations by consumers. These expectations can be fueled by unrealistic claims and advertisements from the herbal manufacturers. Stroll down the aisles of most pharmacies and health food stores and you’ll find an herbal remedy for almost any woe. FDA regulations have forced herbal medications to be sold as "dietary supplements" without backing or guidance from the FDA. As a result, consumers are exposed to the manufacturer’s promotional literature, which is designed to advertise and sell the product more than to educate.
Consumers taking a particular herbal remedy to improve their health may experience any of the following outcomes: improved health with no side effects, no change, some symptom improvement but with noticeable side effects, or noticeable worsening. The majority of books, courses, websites and professional training programs in natural health care do not provide specific guidance on what to do when a supplement or herb fails to act as desired. This treatment failure is often explained by incorrect diagnoses. Therefore, the herbal remedy selected—as a result of this incorrect diagnosis—would not be effective. Health care providers with specific training in the therapeutic use of herbal remedies are needed to serve as a knowledgeable resource for other health care professionals. Therefore, the need to educate the public as well as pharmacists and other health care professionals on the risks and benefits of the expanding herbal remedy market is becoming more urgent.
FDA Regulations: An Update
As a result of the passage of the Dietary Supplement Health and Education Act (DSHE) in 1994, herbs and phytomedicinals can be sold in this country as "dietary supplements" provided that no therapeutic or health claims appear on the label. In addition, a statement must appear on the label noting that the product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. Most herbal remedies sold as dietary supplements are placed in Category II or III by FDA panels on OTC drugs. This means that the FDA has not received sufficient data to allow the remedies to be classified as Category I: safe and effective drugs. Sufficient data involving expensive basic research and clinical trials would require a prospective manufacturer to spend hundreds of millions of dollars on a nonpatentable product. There would be no economic incentive for a manufacturer to make this investment. In Germany, suggested by some as a good model for the U.S. to follow, a less stringent system is in place to evaluate herbal safety and efficacy. Information contained in the German Federal Health Agency appointed Commission E monographs stipulates that herbal products sold in Germany must be proven safe and have "reasonable proof" of effectiveness before they can be marketed. The basis for reasonable evidence comes not only from controlled clinical trials and basic research, but also from health practitioner experience in using herbal remedies and any other supportive evidence that gives an overall indication of an herb’s risk to benefit ratio.
The result of U.S. FDA legislation has been to allow the expanding sales of herbal remedies without the benefit of FDA guidance to consumers. Advocacy literature based upon exaggerated, unsubstantiated claims and testimonials has flooded the marketplace. The literature is often placed near the display of the herbal product, and is thus available to the purchaser. It is not classified by the FDA as labeling or advertising. The FDA seems to be saying simply, "buyer beware." However, a few companies in this expanding industry offer high standards of quality in the products and information they distribute.
President Clinton has appointed a new commission as a part of implementing the DSHE Act of 1994. Composed of leaders in the field of herbal medicine, the commisssion is charged with amassing information in order to create a better legal definition of dietary supplements. The new definition should better distinguish dietary supplements from foods and drugs for regulatory purposes. The commission’s goal is to reform labeling laws and provide more informative dietary supplement labels for the public. The final report of this Commission on Dietary Supplement Labels will become available later this year. In addition, as part of implementation of provisions of the DSHE Act, steps are under way to reassess the current good manufacturing practice (GMP) regulations for dietary supplements.
Quality Control and Standardization
Since the FDA does not regulate quality control measures for herbal products, the consumer must rely on the integrity of the manufacturer. This situation makes it prudent for the consumer to be aware of and observe several precautions. Many herbal products are mislabeled and/or contain different plants than those indicated on the label. This often results from an initial misidentification of the herb in the field, a mistake then passed on to the unknowing manufacturer. Especially in the case of expensive herbs, less expensive "substitutes" often adulterate an herbal preparation. Part of the confusion comes from the continued use of common plant names instead of the correct Latin binomial. Often a distinct species is referred to by many different common names. Equally confusing is when several different species have the same or a similar common name.
Standardization is another important issue. Although this seems to be a logical solution, it is not an easy one. Which constituent among the sometimes hundreds present in a given herbal preparation should be standardized? This is particularly relevant in the case of those herbs where the active ingredients are not identical or in those where several components work together to produce the desired effect. Standardizing to a key component in a given preparation would likely improve uniformity and consistency among products. Without FDA guidelines and enforced standardization, consumers can’t be certain that sufficient active ingredients are present in a product to have at least a chance at being therapeutically useful. Some examples illustrate the point. Feverfew contains parthenolide, believed to be the active component responsible for its anti-migraine activity. The Drug Regulatory Agency in Canada requires a feverfew product to contain at least 0.2% parthenolide to be considered therapeutically effective. A recent study in the U.S. revealed that many products containing feverfew had no detectable levels of this active component.3
Another key issue concerns consistency of active ingredients. A recent Consumer Reports study found that levels of "ginsenosides," the supposed active ingredient in ginseng, varied greatly among 10 different product brands.4 Another study revealed that 60% of the 54 ginseng products tested contained far less than known therapeutically effective levels of ginseng, with 20% containing none at all.5 Without standardizing to a known reference component in an herbal preparation, wide variations will occur from batch to batch and between manufacturers. This could result from variation in plant-growing conditions, as well as from differences in extraction procedures and stability of the active components. Storage conditions and product shelf life are also important considerations.
Potential Dangers of Self-Treatment
A large proportion of the public believes that herbal remedies are harmless and always achieve the desired effect. It should be noted that herbal remedies function as a drug similar in many ways to OTC and prescription drugs. Differences include methods of derivation, formulation of dosage forms and typical presence of multiple active ingredients.
The effectiveness of a given herbal preparation or drug strongly depends on its proper usage and the correct diagnosis of the patient. A potential danger arises from self-diagnosis and treatment since herbal preparations are easily available and many patients are restricted only by cost rather than the need for a professional opinion. TABLE 2 provides a listing of a few notable examples of herbs that could be dangerous without proper counseling and supervision from someone who is knowledgeable in herbal therapy.
Table 1.
Herbs Considered Unsafe*
Name Source Uses Comments
Chaparral
(Larrea tridentata) Leaves Skin disorders, anticancer, relieves pain Large doses and/or prolonged use can cause liver damage
Ephedra/
(Ma-Huang)
(Ephedra sinica) Stems Decongestant, allergies, depression, obesity Should not be used in case of heart disease, diabetes, high blood pressure. Not to be used with MAO inhibitors
Hydrangea
(Hydrangea arborescens) Roots Diuretic, kidney and prostate disorders Leaves contain cyanide (do not consume)
Poke root
(Phytolacca decantra) Roots Chronic rheumatism, possible anticancer (breast) Overdose can cause vomiting, purging, may be fatal in children
Sassafras
(Sassafras albidum) Root, bark Rheumatic pain, antiseptic Contains safrole; carcinogen, can cause liver damage
Yohimbine
(Corynanthe yohimbe) Bark Increases libido, weight loss Can cause high blood pressure, anxiety, should not be used in kidney disease or psychological disorders
* Based on References 7-11
A Pharmacist’s Herbal Education
Most information concerning the safety and efficacy of herbal remedies is in the form of exaggerated promotional literature from the manufacturer instead of scientific literature based upon good basic and clinical research. Consumers need a pharmacist’s knowledge in helping them select the best quality products and counsel in how to use them. Consumers need help with assessing risks-to-benefits associated with a given herbal remedy. Are today’s pharmacists prepared to give this advice? Unfortunately, few pharmacy or medical schools offer any training opportunities in the area of herbal medicine. Indeed the traditional "Pharmacognosy" courses have all but disappeared from most U.S. pharmacy schools. Therefore, a situation has developed where consumer interest in alternative herbal therapy is expanding rapidly and today’s newly trained pharmacists lack the knowledge to be able to effectively advise the public. This is in striking contrast to the situation in Germany, where herbal medicine is much more developed and respected. German pharmacy and medical students undergo rigorous training and German physicians prescribe herbal remedies almost as often as traditional drugs. Fortunately this trend may be changing. Recently several schools of pharmacy—Northeast Louisiana,6 Midwestern and Campbell Universities—have initiated elective courses in herbal remedies to bridge this knowledge gap.
Table 2.
Herbs Considered Moderately Unsafe*
Name Source Uses Comments
Bearberry, Uva-ursi
(Arctostaphylos uva-ursi) Leaves Bladder, kidney infection, diabetes Do not use in acute inflammation or during pregnancy or for prostate disorders
Black/Blue Cohosh
(Cimicifuga racemosa)
(Caulophyllum thalictroides) Roots Heart and circulatory disorders, menstrual cramps, nervous disorders Should not be used during pregnancy and for chronic disease
Boneset
(Eupatorium perfoliatum) Flower, roots Anti-inflammatory, laxative, reduces fever Long-term/large doses is toxic
Comfrey
(Symphytum officinale) Roots, leaves Healing wounds, bruises ulcers, psoriasis May cause liver damage, should not be used during pregnancy
Juniper
(Juniperus communis) Berry Digestive disorders, antiseptic in cystitis Prolonged use in kidney disease and during pregnancy should be avoided
Licorice
(Glycyrrhiza glabra) Roots Expectorant, ulcers, promotes adrenal gland function Should not be used in case of diabetes, pregnancy, heart disease, high blood pressure
Lobelia
(Lobelia inflata) Flowers, seeds, leaves Asthma, bronchitis, cough suppressant Nicotine-like effect, use only for short-term use and less than 50 mg
Wormwood
(Artemisia absinthium) Leaves Sedative, reduces fever, expels worms Long-term use and use during pregnancy should be avoided
* Based on references 7-11
Evidence of greater awareness in the medical community is the current popularity of Dr. Andrew Weil, a holistic physician at the University of Arizona School of Medicine. Various courses in this medical school focus upon alternative medicine, mind-body interactions, and the use of herbal remedies.
In addition to the introduction of herbal remedies into some pharmacy curriculums, several continuing education (CE) programs have been offered. The Association of Natural Medicine Pharmacists (ANMP) offered a CE program in herbal medicine at the 1997 annual APhA conference in Los Angeles with plans to offer other programs in the future. The American Botanical Council and the Texas Pharmacy Foundation sponsored an accredited home study CE program on "phytomedicinals." Other state pharmacy programs are likely to follow in the near future. Since 1995, the Gaia Herbal Research Institute has organized a spring symposium on herbal medicine, called Medicines from the Earth, Exploring Nature’s Pharmacy, providing CE credit for both nurses and pharmacists.
Summary
Medicinal plants are considerable in number and are economically important. They contain active constituents that are very effective in the treatment of many diseases. As the number of plants used in herbal remedies grows, plants are also being rediscovered by pharmaceutical, cosmetic and food industries.
Consumer interest in alternative health treatments is expanding and reflects the desire for knowledge and counsel in the use of the many herbal remedies available on pharmacy shelves. To meet this increasing need, it seems prudent to bolster the pharmacist’s education and training in this important area. In subsequent articles, we will present and discuss currently available evidence based upon clinical and basic research studies for the therapeutic use of some of the most commonly encountered herbal preparations, such as garlic, gingko and echinacea.
Useful Resources
The American Botanical Council’s publications Herbal Gram and Herbs for Health and the Association of Natural Medicine Pharmacists quarterly publication The Source are both excellent resources for factual information on herbal medicines. Also the Herb Research Foundation serves as a clearinghouse for scientific information on herbs used in medicines and food. A comprehensive monograph, A Modern Herbal—The Medicinal, Culinary, Cosmetic and Economic Properties, Cultivation and Folklore of Herbs, Grasses, Fungi Shrubs and Trees with all Their Modern Scientific Uses, by Mrs. M. Grieve, in two volumes contains a wealth of information from the past with recipes. Therapeutic Herbalism by David Hoffmann is a holistic approach with strong pharmacology and therapeutics. The Honest Herbal—A Sensible Guide to the Use of Herbs and Related Remedies and Herbs of Choice—The Therapeutic Use of Phytomedicinals, both by Dr.Varro Tyler, are good resources for herb therapy information. Recently, the English translation of the German Commission E herbal monographs has become available through the American Botanical Council. These monographs, which form the scientific basis of the German herbal practice, are considered by many to be the best available information on herbal remedies. The Office of Alternative Medicine, a newly formed NIH branch, funds research in alternative therapies, including herbal therapies.
According to web.campbell.