CHAPTER 22 WESTERN HERBALISM

VICTOR S. SIERPINA, SUSAN M. GERIK, RADHESHYAM. MIRYALA, MARC S. MICOZZI

Plants have been used by humans for food, medicine, clothing, and tools, as well as in religious rites, since before recorded history, more than 60,000 years ago, as evidenced by pollen from plants placed in Neanderthal cave burials found in modern-day Iraq (Solecki et al, 1975). Indeed, the art of herbal medicine probably predates Homo sapiens. Catalogues of remedies in pharmacopoeias date back 5000 years (Inamdar et al, 2008). No continent, island, climate, or geography that is home to human culture lacks a formal tradition of incorporating local flora into daily and ceremonial life as a means of enhancing health and well-being. Prehistoric plant life prepared the earth to be a viable and hospitable habitat for Homo sapiens, and plant ecology continues to help maintain the oceans, continents, and atmosphere today. Only recently have many Western health care providers recognized the number of remedies that had their origin in herbal medicine (Inamdar et al, 2008).

Herbal products have gained increasing popularity in the last decade. When questioned, approximately one fourth of adults reported using an herb to treat a medical illness within the past year (Bent, 2004, 2008). The most common herbs used included ginkgo, garlic, St. John’s wort, soy, kava, echinacea, and saw palmetto (Bent, 2008). The global market for herbal products is over $60 billion annually (Inamdar et al, 2008).

DEFINITIONS

Herbalism is the study and practice of using plant material for food, medicine, and health promotion. This includes not only treatment of disease but also enhancement of quality of life, both physically and spiritually. A fundamental principle of herbalism is to promote preventive care and guided, simple treatment for the general population. An herbalist, or herbal practitioner, is someone who has undertaken specific study and supervised practical training to achieve competence in treating patients. Herbal medicines are recommended by physicians in the practice of integrative medicine and by other practitioners within the pharmacopeia of their traditions (see Chapter 4).

There is also an eclectic practice of herbal medicine in Europe and North America that draws on herbs from many healing traditions and has been called Western herbalism.

An herb can be an angiosperm (i.e., a flowering plant), shrub, tree, moss, lichen, fern, algae, seaweed, or fungus. The herbalist may use the entire plant or just the flowers, fruits, leaves, twigs, bark, roots, rhizomes, seeds, or exudates (e.g., tapped and purified maple syrup), or a combination of parts. Botany defines an herb as a nonwoody, low-growing plant, but herbalists use the entire plant kingdom. In many herbal traditions, nonplants including animal parts (organs, bone, tissue), insects, animal and insect secretions, worm castings, shells, rocks, metals, minerals, and gemstones are used as healing agents. These examples are recorded in ancient and contemporary materiae medicae and formal manuscripts of healing agents with their indications and uses. Egyptian, Chinese, Tibetan, European, American, and other worldwide materiae medicae are important references for herbal practitioners. This chapter addresses only plant herbal agents.

Herbalism may be a misleading term because it implies that a single hidden “root” gives rise to the diverse ways in which all human cultures across the millennia have used plants for food, medicine, and ritual. The use of herbs by the peoples of the Americas, Europe, Africa, the Middle and Far East, the Pacific Islands, and other regions is specific to each society and paradigm. For example, contemporary Western scientists have been restricted until recently by the Western mechanistic premises of biology and physics (see Chapter 1).

Although there is no single, worldwide system of herbalism, all herbal traditions share certain themes (Box 22-1).

BOX 22-1 Common Themes of Herbalism

“Herb” and Other Words

Herb as a word has an ancient pedigree, originating with the Latin word herba, which refers to green crops and grasses and could also mean the same as we mean by herb today (Oxford English Dictionary, or OED). The word entered English through Old French. The English use of “herb” in the sense of a plant whose stem does not become woody and persistent but remains more or less soft and succulent, dying down to the ground (or entirely) after flowering, can be traced to the thirteenth century. In the thirteenth century it was also understood that an “herb” (with variant spellings, e.g., “erbe”) is a plant whose leaves and stems (and sometimes roots) could be used as food or medicine or for scent or flavor.

Herbarium, in the sense of a collection of dried plants, has its origins in the eighteenth century. A source for the association of “herbarium” with the medicinal properties of plants is that the idea for drying plants for study originated with a professor in sixteenth-century Italy who also held a chair in “simples,” in which he studied medicinal and other plants.

Herbalist has shifted meaning. Originally (in the sixteenth century) an “herbalist” was one versed in the knowledge of herbs and plants—a collector of and writer about plants, more what we mean by “botanist” today. Usually, however, “herbalist” is now used to refer to early writers about plants, as well as persons who use alternative medical therapy, although the OED does not mention this.

Herbal meaning a book containing names and descriptions of herbs (or other plants in general) that provides properties and virtues came into use in the early sixteenth century. “Herbal” meaning belonging to, consisting of, or made from herbs has its origins in the early seventeenth century.

Early botanical gardens started in Renaissance Italy. These should properly be called “physic gardens,” because they were used to help educate medical students, that is, to teach people—in this case medical students—about medicinal plants. Physic gardens appeared in England in the sixteenth century, in private hands. The Oxford Physic Garden began in 1621. (The Chelsea Physic Garden was begun in 1673 by the Society of Apothecaries.) The Oxford Physic Garden became the Botanic Garden in 1840, an important and representative change. There was no real difference between a “physic garden” and a “botanic garden,” because botany and the study of the medicinal properties of plants were not distinct fields. William Turner (1510-1568) was a physician, was the author of an herbal, and is considered the father of English botany. For Turner, taxonomy was not separate from pharmacology in the study of plants.

Although the process was gradual, by the nineteenth century the study of plants for their own sake—botany—was a clearly separate field. Pharmacopoeias and botanical atlases grew in importance as the need for herbals waned.

There are clear ways to classify types of gardens. In the 1790s, Dr. Benjamin Rush called for the establishment of a “botanic garden” at the College of Physicians of Philadelphia. In Rush’s time this would have meant a garden to study the properties of plants, in this case, medicinal properties. Rush suggested, however, that the garden could also be a source of medical preparations, as well as a place to grow plants that might be lost as Europeans settled North America. Although it was not the only purpose of Rush’s garden, study was a component, and research lies at the heart of any botanical garden’s purpose. (Botanical gardens are not limited strictly to taxonomy.)

Therefore, medical botany would be the study of the medicinal properties of plants, for example, chemical analysis to find new medically important compounds. A medical botanical garden would be the source of plants for studying their medical properties.

A medicinal herb garden would, in a technical sense, be a place that has examples of plants, from which samples could be taken to make medicinal preparations. Also, the garden would contain only herbaceous plants, not plants with woody stems and branches.

CLASSIFICATIONS OF HERBALISTS

Each cultural or medical system has different types of herbal practitioners, all consistent with its paradigm. However, most paradigms identify professional herbalists, lay herbalists, plant gatherers, and medicine makers. (Professional and lay herbalists often collect their own plants and prepare their own medicines.)

Professional Herbalist

A professional herbalist undergoes formalized training or a long apprenticeship in plant and medical studies or, alternatively, in plant and spiritual or healing studies. This knowledge includes extensive familiarity—often a relationship—with specific plants, which involves their identification, habitat, harvesting criteria, preparation, storage, therapeutic indications, contraindications, and dosing. A professional herbalist is not necessarily the primary healer (Iwu, 1993). A professional herbalist might follow a family tradition or might be selected at a young age as being endowed with the potential for mastering the use of plants as healing aids. In Europe and the United States, this group includes officially trained medical herbalists, clinical herbalists, licensed naturopathic doctors specializing in botanical medicine, licensed acupuncturists with training in Chinese herbal medicine, licensed Ayurvedic doctors, Native American herbalists and shamans, Latin American curanderos, and other lineage-recognized or culturally recognized professional herbalists. The shaman from Madagascar who—although never acknowledged or compensated for his contribution—revealed the usefulness of Caranthas roseus, the periwinkle plant from which vinblastine and vincristine were developed in the West for treatment of certain cancers, exemplifies the spirit and expertise of a professional healer and herbalist. Furthermore, the herbal practitioner’s familiarity with each medicinal plant or herbal formula usually is greater than the medical practitioner’s familiarity with each individual pharmaceutical. This permits the herbalist to select precisely a particular plant or formula for each individual patient. Three different patients with a chief complaint of headache would likely each receive a different herbal prescription. The approach that an herbalist uses to determine which herbs to prescribe is distinct from that used by a conventional Western physician to prescribe a pharmaceutical.

HERBS AND MEDICINAL PLANTS

Physicians in the United States studied and relied on plant drugs as primary medicines through the 1930s until World War II. Until then, medical schools taught basic plant taxonomy and pharmacognosy and medicinal plant therapeutics. The term drug derives from an ancient word for root, and the roots and rhizomes of many medicinal plants continue to provide alkaloids, steroidal saponins, and many active constituents that are clinically useful today. The United States Pharmacopeia listed 636 herbal entries in 1870; only 58 were listed in the 1990 edition (Boyle, 1991). Although some plants were dropped because they were found to be weak or unsafe, the majority of clinically useful plants were replaced with pharmaceuticals, which generated profits from patented drugs and contributed to the standardization and industrialization of medicine.

Characteristics and Composition

In many traditional systems the characteristics of a medicinal plant are emphasized without attention to its composition, because techniques and equipment for plant analysis are relatively new.

Preanalytical, chemical knowledge of medicinal and food plants is derived from direct perception through the five senses; from the herbalist’s attentive, empirical observation of plants’ effects on animals and humans; and, in some traditions, from sacred teachings and “sixth sense” intuition.

More recently, attention is being paid to standardizing the product, that is, to providing a consistent, measured amount of product per unit dose, and one ingredient is selected as the marker, usually the presumed active ingredient. Although research may reveal different or additional active ingredients, for convenience the designated constituent will usually remain the accepted marker. Over the years, more and more sophisticated methods of analysis to detect the marker have been developed, including such techniques as high-performance liquid chromatography and dioxide array detection. Perhaps a disadvantage to identifying, categorizing, and researching molecular constituents from plants is the risk of equating the plant’s therapeutic efficacy to its composition. Analysis is reductionist in paradigm, and data cannot exist beyond the limits of the technology (and available funding to apply it) or the paradigm from which it arises (Cheng et al, 2008).

Food, medicinal, and healing plants may contain digestible fiber (carbohydrates and hemicellulose) and indigestible fiber (cellulose and lignins), nutritives (calories, vitamins, minerals, trace elements, amino acids, essential fatty acids, and water), and inert and active constituents.

When a Western paradigm is followed, plant constituents can be classified according to their morphology, source plant taxonomy, therapeutic (pharmacological) applications, or chemical constituents (Tyler et al, 1988) (Box 22-2).

Physiological Activities

Activities and corresponding indications for the use of plants are, again, paradigm specific (see the sidebar “Influences on Plant Activities and Their Therapeutic Properties”). In the United States alone, opinions vary regarding a particular plant’s full spectrum of physiological action because of the complex nature of plants and their uses.

A sample of some classic herb categories based on plant actions—often associated with identifiable nutritives or active constituents—are adaptogens (balance body systems), anticatarrhals (eliminate mucus), carminatives (antigas), demulcents (reduce inflammation), galactogogues (promote milk production), nervines (reduce stress), and tonics (promote optimal organ function) (Sierpina, 2001).

These examples illustrate a few of the many actions ascribed to herbs viewed from the classic Western paradigm. Often, contemporary research explains the constituents, mechanisms of action, and clinical responses that justify traditional uses. Occasionally, some plants are found to be inactive or ineffective or to contain potential toxins, which results in their discontinuance or necessitates special methods of preparation and dosing. As with most current prescription medications, some strong herbs must be dosed carefully to render them safe and effective.

There are other limitations to the direct association of active constituents with in vivo and clinical medicinal actions. Many times the active compounds remain unidentified, or the physiological response to the medicinal part of the whole plant is distinct from the actions of the individual active constituents (e.g., Valeriana, Echinacea). In addition, ingredients that appear inert are sometimes later found to be active when a more accurate mechanism of action or bioassay associated with the plant’s effects is discovered.

When a nonreductionist paradigm is used, plant composition alone offers an incomplete explanation of the full scope of the properties and actions of food and healing plants. Traditional herbalists, nineteenth-century vitalists (see Chapter 6), naturopathic doctors, and many contemporary medical doctors and practitioners share a belief in a “life force” that is yet to be fully understood. Many herbalists hold that healing energy is inherent to plants; it is this energy, in addition to nutritive or chemical constituents, that promotes healing. Shamans, traditional healers, and alchemists use their skills, knowledge, and power to instill certain plants with special healing properties, in this view.

Herbal Therapeutics

Different cultural paradigms use plants for healing in a manner founded on each paradigm’s premises (Box 22-3).

Herbal medicines can be delivered in many forms. Some plants are best when used fresh but are seldom marketed fresh because they are highly perishable, and improper storage will affect quality. Dried, whole, or chopped herbs can be prepared either as infusions (steeped as tea) or decoctions (simmered over low heat). Typically, flowers, leaves, and powdered herbs are infused (e.g., chamomile or peppermint), whereas fruits, seeds, barks, and roots require decocting (e.g., rose hips, cinnamon bark, licorice root). Many fresh and dried herbs can be tinctured as medicines preserved in alcohol. Some plants are suited to acetracts (vinegar extracts), whereas others are active and well preserved as syrups, glycerites (in vegetable glycerine), or miels (in honey). Powered or freeze-dried herbs are available in bulk and as tablets, troches, pastes, and capsules. Fluid and solid extracts—strong concentrates (four to six times the crude herb strength)—and fresh plant juices preserved in approximately 25% alcohol (as with the fresh plant Echinacea succus) are other forms.

Nonoral delivery forms include herbal pessaries, suppositories, creams, ointments, gels, liniments, oils, distilled waters, washes, enemas, baths, poultices, compresses, moxa, snuffs, steams, and inhaled smokes and aromatics (volatile oils). The predominant plant delivery forms vary among different herbal traditions. Tinctures are widely used in Britain and the United States; tablets of standardized extracts of certain herbs (e.g., Ginkgo biloba) are popular in Germany and the United States; decoctions are common in Tibetan, Chinese, and African traditions; therapeutic oils are used topically and internally in Ayurvedic treatments; and teas, smokes, and compresses are used in the Native American tradition.

Capsules and tablets are the most common delivery system. Gelatin or vegetable-based capsules are filled with powdered dried herbs. Tablets are powdered herbs compressed into a solid pill, often with a variety of inert ingredients as fillers.

Herbs are supplied in a variety of sizes and strengths, so it is important to read the label carefully. The label also usually gives an average suggested dose as a guideline, based on research and clinical use. It is recommend to start at the low end; watch for a response, including unwanted effects; and adjust the dose accordingly.

Safety

Side effects of drugs can be serious or fatal; the worst is death by overdose. According to one report, overdoses are associated with an annual rate of 30.1 deaths per 1 million prescriptions of antidepressants. On the other hand, to quote Norman Farnsworth, PhD, professor of pharmacognosy at the University of Illinois, Chicago, “Based on published reports, side effects or toxic reactions associated with herbal medicines in any form are rare. . . . In fact, of all classes of substances . . . to cause toxicities of sufficient magnitude to be reported in the United States, plants are the least problematic.”

Herbal products are often considered safe because they are “natural” products (Kuruvilla, 2002). Nonetheless, the quality of products may be affected by species differences, seasonal variations, environmental factors, collection methods, transport and storage, manufacturing practices, or contamination with foreign plant material, toxins, heavy metals, or environmental pollutants. One must also remember that any substance that has biological activity has the potential to cause adverse effects. Dangerous and lethal side effects related to direct toxic effects, allergic reactions, effects from contaminants, and interaction with drugs or other herbs have been reported (Chan, 2003; Dobos et al, 2005; Hu et al, 2005; Izzo et al, 2001).

Groups have assembled to look at special circumstances of herb use in the context of dental procedures, in the perioperative period, and with concurrent use of particular prescribed drugs. Some cautions identified through these inquiries include the following: bromelain, cayenne, chamomile, and feverfew interact with aspirin; aloe latex, ephedra, ginseng, and licorice interact with corticosteroids; kava, St. John’s wort, and valerian interact with central nervous system depressants; chamomile, horse chestnut, and fenugreek enhance the risk of bleeding; ginseng can produce hypoglycemia; and ephedra may lead to cardiovascular instability (Abebe, 2002, 2003; Ang-Le et al, 2001; Bent, 2004, 2008; Izzo et al, 2001).

Quality control is essential, with assurance that the product contains ingredients and quantities as labeled, and without such contaminants as bacteria, molds, or pesticides. Selection of plant material based on quality, standardization of methods of preparation, and enforcement of regulations regarding labelling improve the quality and safety of herbal preparations as therapeutic agents.

In traditional medicine systems, herbs are prepared to obtain the most active ingredient for use in the specific preparation discovered to be most effective for the particular herb and tailored to the unique characteristics of the patient (Khalsa, 2007).

In 2004, Europe enacted legislation designed to improve the protection of public health by setting up a registration scheme for manufactured traditional herbal medicines. The evidence of 30 years of traditional use was relied upon to establish a European list of herbal substances that includes indication, strength, dosing recommendations, and route of administration. The list is now being compiled by the Committee on Herbal Medicinal Products at the European Medicines Agency (Routledge, 2008). The European Agency for the Evaluation of Medicinal Products has drafted test procedures and acceptance criteria for herbal drug preparations (Rousseaux et al, 2003).

The Therapeutic Goods Administration in Australia created a Complementary Medicines Evaluation Committee to address the issue of regulation of herbal products (Rousseaux et al, 2003).

In the United States, trade and professional organizations such as the American Herbal Products Association are setting standards including good agricultural practice, good laboratory practice, good supply practice, good manufacturing practice, and standard operating procedures which can help control environmental factors that may contribute to contamination (Chan, 2003; Fong, 2002; Routledge, 2008). Most herbal products are regulated as “dietary supplements.” In 1994 the U.S. Dietary Supplement Health and Education Act (DSHEA) set new guidelines with regard to quality, labeling, packaging, and marketing of supplements. It also sparked a surge of interest in herbal products. DSHEA allows manufacturers to make “statements of nutritional support for conventional vitamins and minerals.” Because herbs are not nutritional in the conventional sense, DSHEA allows manufacturers to make only what are called “structure and function claims,” but no therapeutic or prevention claims. Thus a label can claim that St. John’s wort “optimizes mood,” but it cannot call it a “natural antidepressant,” which would be a therapeutic claim.

The regulatory authority of the U.S. Food and Drug Administration (FDA) over herbs is frequently misrepresented as “absent,” including by the FDA commissioner, according to hearings of the U.S. House of Representatives Committee on Government Reform in 2001. Nonetheless, the health care system must rely on vigilance by the medical profession and voluntary compliance by industry to safeguard patients against adverse reactions. Although legislative efforts are periodically made to alter the regulatory environment, changes are not anticipated in DSHEA, which regulates herbs as dietary supplements, not as drugs. Senator Orrin Hatch (R-Utah), co-chair of the Congressional Caucus on Complementary and Alternative Medicine and Dietary Supplements, has documented the unprecedented involvement of a coalition of citizens and commercial groups in the passage of this bill (Hatch, 2002). It is likely that better information and education of consumers and health professionals will help to achieve what more regulation cannot achieve (see the sidebar “Legislative and Regulatory Environment for Herbal Medicines”).

Further abuses involving herbal products adulterated with therapeutic drugs and contaminants (especially a problem with imports from overseas, particularly China) are a serious safety issue. Many times the adulteration is inadvertent, but sometimes undeclared prescription drugs may be fraudulently added, allegedly for medicinal purposes (Chan, 2003). Consumers, health professionals, and responsible elements of the U.S. natural products industry all suffer when irresponsibly adulterated products are imported from abroad. The National Institutes of Health (NIH) clinical trial investigating the Chinese herbal formulation PC-SPES for prostate cancer was undermined by the unwitting use of adulterated herbs. Some natural products from China have even been contaminated with chloramphenicol (Micozzi, 2007).

Improvements in manufacturing and marketing standards in the natural products industry will be required for effective integrative medical practice (Fong, 2002).

Children

Herbs may often be a treatment of choice for children. Despite lack of modern research, centuries of use have shown many products to be safe when dosed appropriately according to children’s weight, although there is a general bias in medicine against using CAM treatments in children that many may consider “experimental” despite centuries of use.

Although concerns exist about safety, efficacy, and appropriate dosing in the pediatric population, families do offer herbs to their children. A group in Canada interviewed 1804 families who came to an emergency department. They found that 20% of the families used natural health products concurrently with drugs. A quarter of those paired agents had the potential to cause interactions (Goldman et al, 2007).

Another study was conducted at an emergency department at Emory University in Atlanta, Georgia. Over a 3-month period, 142 families with children aged 3 weeks to 18 years were interviewed. Forty-five percent of caregivers reported giving their children herbal products. Of those 45%, 53% had given one type and 27% had given three or more types in the previous year. The most common therapies were aloe, echinacea, and sweet oil. The most dangerous combination reported was ephedra given concomitantly with albuterol for asthma. Seventy-seven percent of the caregivers did not suspect potential side effects. Only two thirds of the families anticipated interactions with other herbal products or with medications (Lanski et al, 2003).

GENERAL CONSIDERATIONS FOR THE USE OF HERBS IN INTEGRATIVE MEDICINE

As health care providers, we have a responsibility to act as informed intermediaries for patients and families seeking information about the use of herbal products. We must consider issues of quality, safety, and efficacy.

The role of herbalism in contemporary Western society is not to serve as a substitute for the pharmaceutical advances of the last decades but to provide access to an ancient paradigm that is less mechanistic and more holistic and humane in scope and that, if responsibly reclaimed and integrated, can greatly benefit future health care worldwide. This is illustrated in the following statement by Paiakan, a contemporary Kayapo Indian leader.

Changes in the practice of medicine are causing a shift to increasing self-care with more benign, less invasive treatments. Patients prefer to take personal control over their health, such as through the use of herbal remedies not only for therapeutic benefit, but also for prevention of disease. Herbal remedies are commonly used by patients with chronic medical conditions such as cancer, liver disease, immunodeficiencies, asthma, and rheumatological disorders (Inamdar et al, 2008). Because of this, it is critical that practicing clinicians (and, in turn, patients) be made aware of the indications, actions, and drug interactions of herbal remedies.

The World Health Organization (WHO) estimates that 80% of the world’s population relies on herbal medicine. Meanwhile, the use of herbs in the United States is expanding rapidly; herbal products are readily found in most pharmacies and supermarkets. From 1990 to 1997, as the use of complementary and alternative (integrative) medicine rose from 34% to 42% of those surveyed, herbal use quadrupled from 3% to 12% (Eisenberg et al, 1998). The growth of complementary and alternative medicine has continued apace in the years since then.

Importantly, these rapid changes have occurred because of popular demand. The public has discovered that natural medicines often provide a safe, effective, and economical alternative, and research is increasingly validating this finding. Many of those who use herbal and high-dose vitamin products fail to tell their physicians. Either they assume that “natural” products are harmless and not worth mentioning, or they fear telling health professionals who may be skeptical about their use. Health professionals, however, are beginning to familiarize themselves with the subject. Aside from some advantages of natural products, herb-drug interactions are a growing concern: almost one in five prescription drug users is also using supplements (Eisenberg et al, 1998).

Reliance on the appropriate use of nutrients and herbs is a critical and fundamental component of many integrative medical practices. Presently in the United States, these natural products are widely available. Unlike for pharmaceuticals, information about the health effects cannot be provided on the product label or with the product as a product insert.

As observed by WHO, herbs are essentially “people’s medicine.” In many parts of the world, traditional systems of herbalism generally make little distinction between food and medicinal plants, and local accessibility of food, spices, and therapeutic herbs generally is assumed in traditional agrarian, nonindustrialized societies. Before the twentieth century, most people everywhere generally had closer personal contact with food and medicinal plants.

A restoration of the personal and symbolic relationship to food and medicine plants could be linked with contemporary scientific knowledge of herbal applications. Appropriate self-care could be encouraged with public education, access to consultation with professional herbalists and physicians, and access to fresh herbs and high-quality, processed herbal medicines when needed. This improved patient involvement in the self-care of the body and its signals might then improve the use of professional medical care.

Many herbalists consider the patient’s direct involvement in his or her own healing and the summoning of the patient’s intellectual, emotional, physical, and spiritual attention to the process as critical. Partly for this reason, and because of traditional herbalism’s emphasis on “right relationship,” social context, and self-responsibility, many herbal practitioners deliberately prescribe elaborate rather than convenient herbal therapies. For example, on returning home to Ghana, a merchant developed an infected leg ulcer. Instead of being supplied an herbal medicine by the herbalist, he was directed to the nearby live plant source (a local tree bark). He collected and prepared the antimicrobial and vulnery poultice and applied it daily until his wound healed. Although self-collection and medicine preparation are generally impractical in the United States, self-involvement in the healing process is possible in many ways and parallels the complex lifestyle changes now routinely recommended to patients with chronic ailments such as cardiovascular disease.

Because of the increasing availability of credible third-party research on the efficacy of herbal and nutritional ingredients, as well as the increasing recognition by the medical profession of the importance of dietary supplementation for optimal health and for the prevention and management of many medical conditions (see Journal of the American Medical Association, July 2002), it is incumbent on practitioners of integrative medicine to maintain a medical standard of information and practice about herbal and nutritional ingredients. One approach to this requirement is to develop and maintain capability for clinic-based or hospital-based formularies of appropriate, effective, and high-quality herbs and nutrients.

The current regulatory environment is coupled with the reality that much of the natural products industry does not operate to medical and scientific standards, that many irresponsible marketing claims are made, and that many medical and scientific professionals are not knowledgeable about the science behind herbal and nutritional medicine. For practitioners new to the medicinal use of herbs, dose selection can be confusing. This volatile mix produces much confusion and misinformation on both sides, documented periodically by such sources as the New England Journal of Medicine. Medical professionals presently are largely on their own in trying to understand the proper indications, ingredients, and dosages for the appropriate scientific use of herbal and nutritional remedies, and consumers can only look to practitioners for guidance.

New information technologies are being brought on line to provide distributors, consumers, and practitioners fair and accurate information about the appropriate use of dietary supplements. The authors do not, however, recommend any one particular website alone nor advise using websites without confirmation by a knowledgeable practitioner.

In any case, to adequately guide patients, it is essential to obtain a complete drug and herbal history from the patient using an open and nonjudgmental approach.

RESEARCH IN FOOD AND MEDICINAL PLANTS

Although there is a relatively extensive contemporary literature on medicinal and healing plants, much of it exists outside the United States and often in languages other than English. In addition, there is little consistency in standard research designs and protocols among various countries.

Currently the National Center for Complementary and Alternative Medicine (NCCAM) is funding the following centers for botanical research: Botanicals Research Center for Age Related Diseases (Indiana), Botanical Research Center: Metabolic Syndrome (Louisiana), Center for Botanical Dietary Supplements Research in Women’s Health (Illinois), Center for Botanical Immunomodulators (New York), Center for Botanical Lipids (North Carolina), and Center for Research on Botanical Dietary Supplements (Iowa). More information regarding this research can be obtained by visiting the NCCAM website and clicking on the links.

The need for more research on food, spice, and medicinal plants is great, especially with regard to their potential use in syndromes and conditions not well recognized or treated by conventional Western medicine. The challenge is to conduct the research in a holistic context. This requires creative funding of research that is unlikely to provide high-profit returns to a single source.

Many medicinal plants eliminated from the United States Pharmacopeia over the years were dropped because contemporary research documentation of their efficacy was lacking, not because they were proved to be ineffective (although some plants proved less useful clinically than newly developed drugs).

Retaining a holistic context in medicinal plant research also involves addressing differences in paradigm. Involving traditional herbalists as research design consultants would protect against inadvertently eliminating a critical element of the paradigm within which the herb is used. In the past, plant collection for research has sometimes proved an environmental threat (habitats, species, or traditional knowledge was lost or threatened). A holistic approach to contemporary plant collection and research must be implemented to conserve the traditional knowledge and ecology of the source plant and to avoid transgression of intellectual property rights, destruction of the plant habitat, or an imbalance of economic or intellectual returns to the source habitat and community.

Simple, well-documented analysis and outcomes-based research of crude and whole plant medicines are needed to determine their greatest potential applications and benefit to human health. Increasing contemporary research on medicinal plants is critical, but the importance of documenting and incorporating the empirical knowledge of healing plants cannot be overemphasized. Information gleaned from research should be linked with empirical knowledge (usually derived from hundreds of years of human use across many generations and ethnic groups), along with contemporary clinical reporting from patients and practitioners on tolerance and efficacy. Then herbal therapeutics and preventive protocols can be better targeted to enhance the health of future generations.

PUBLIC POLICY ISSUES

The modern era has brought many advantages in human health and sanitation, but one potential disadvantage of economic and occupational specialization is the loss of contact with the source of plant medicines. The marketplace has become multileveled, so the consumer usually has no direct or personal relationship with the herb producer. Sometimes, because of costs of production, taxes, and marketing, the packaged herbal product costs 20 times the price of the crude herb. There are undeniable advantages to certain prepackaged or concentrated herbal products, but two disadvantages are accountability and economic access. If the sale of fresh or bulk crude herbs is abandoned in the marketplace for the sale of less perishable and higher-return products, the patient has access to only highly processed products, and the cash-poor patient loses access altogether. This is particularly ironic in the case of medicinal plants; most traditional systems considered healing plants a gift of nature and access to them a basic human right.

State governments have developed a traditional role in regulating medical practice and in supporting medical education. The federal government maintains a unique and critical role in stimulating and supporting medical research, regulating medical products and devices, protecting the public health, and helping build health care infrastructure, and it is now paying approximately one third the costs of health care in America.

Policy makers at the state and federal levels should become more knowledgeable about the needs and opportunities related to integrative medicine. The bipartisan Congressional Caucus on Complementary and Alternative Medicine and Dietary Supplements was organized for this purpose. The Integrative Healthcare Policy Consortium, Policy Institute for Integrative Medicine, and other groups are working with members of the caucus and other elected representatives to broaden and deepen federal support for appropriate analyses and programs in integrative medicine. It is unlikely that the current regulatory legislation governing dietary supplements (DSHEA of 1994, as amended in 1998) will be changed. Although funding for NCCAM has increased commensurate with the multiyear doubling of the overall NIH budget, it is critical that other federal agencies charged with programs related to health resources and services, primary care, health professions training and workforce development, consumer education, health services research, and other areas be brought to bear on the important challenge and opportunity of integrative medicine. Integrative medicine has an important role that requires further articulation in current congressional actions on medical liability insurance reform and the national patient safety and quality assurance initiative. Public support together with private innovation has been the hallmark for medical advancement in the twentieth century and should continue to be the case for integrative medicine in the twenty-first century.

SUMMARY

Herbalism clearly offers potential benefit for the treatment of disease as well as promotion of wellness. Going forward, efforts should focus on more standardization of quality control, development of an official compendia that encompasses the content of the various pharmacopoeias currently available, clear and honest communication and sharing of information, and more inclusive research regarding safety and efficacy in all populations.

image See the Evolve site at http://evolve.elsevier.com/Micozzi/complementary for the Common Herbs for Integrative Care Appendix and Image Collection.

image Chapter References can be found on the Evolve website at http://evolve.elsevier.com/Micozzi/complementary/