Alternative Systems of Medical Practice

Jennifer Jacobs, M.D.--Cochair

John C. Reed, M.D.--Cochair

Michael Balick, Ph.D.

Steven Birch

Gerald Bodeker, Ed.D.

Carola Burroughs

Carlo Calabrese, N.D., M.P.H.

Edward Chapman, M.D.

Deepak Chopra, M.D.

Effie Chow, Ph.D.

Patricia Culliton, M.A., Dipl.Ac.

Robert Duggan

Peter Hindebergh, M.D.

Tori Hudson, N.D.

Ted Kaptchuk

Fredi Kronenberg, Ph.D.

Nancy Lonsdorf, M.D.

Robert S. McCaleb

Kevin McNamee, D.C., L.Ac.

Paul Ortega

CONTRIBUTING AUTHORS

John C. Reed, M.D., Lead Author

Background

Claire Cassidy, Ph.D.

John C. Reed, M.D.

Traditional Oriental Medicine

Effie Chow, Ph.D.

Steven Birch

John C. Reed, M.D.

Acupuncture

John C. Reed, M.D.

Ayurvedic Medicine

Nancy Lonsdorf, M.D.

Homeopathic Medicine

Jennifer Jacobs, M.D.

Brian Berman, M.D.

Anthroposophically Extended Medicine

Paul Scharff, M.D.

Naturopathic Medicine

Tori Hudson, N.D.

Environmental Medicine

Charles Moss, M.D.

Community-Based Health Care Practices

Claire Cassidy, Ph.D.

Rayna Green, Ph.D.

Clara Sue Kidwell, Ph.D.

Pat Locke

Background

In the United States many people think of mainstream biomedicine as the world's standard health care system, assuming it is used by most people most of the time._ Actually, careful estimates reveal that worldwide only 10 to 30 percent of human health care is delivered by the conventional, biomedically oriented health care system. The remaining 70 to 90 percent of health care sought out by people includes everything from self-care according to folk principles to care rendered in an organized health care system based on an alternative tradition of practice (Dean, 1981; Hufford, 1992).

Such strikingly high usage of alternative health care systems also is reflected in a number of recent surveys. For example, a nationwide telephone survey of 1,539 people, conducted in 1990, indicated that up to one in three Americans used alternative therapies (Eisenberg et al., 1993). Another telephone survey conducted in 1992 in the States of Maryland and Pennsylvania reported that someone in 33 percent of 1,165 households consulted chiropractors, 25 percent, massage therapists; and 16 percent, spiritual healers (Kirby, 1992). One biomedical clinic survey of 660 cancer patients showed that 54 percent used alternative medical care along with conventional care, and 8 percent used strictly alternative care (Cassileth et al., 1984). In addition, a survey of 628 cancer patients found the utilization rate of folk treatments for cancer to be 70 percent (Hufford, 1992). Finally, an acupuncture clinic survey of 180 general-care patients showed that 70 percent sought other alternative professional or community-based health care in addition to biomedical and acupuncture care (Cassidy, 1994).

Given the immense political and economic investment this country has made in its "mainstream" medicine, these statistics are quite surprising. However, to better understand why alternative systems of medicine not only survive but thrive, it is worthwhile to first examine how people typically go about choosing their health care.

Studies show that most people go through a "hierarchy of resort" when seeking health care assistance (Romanuicci-Ross, 1969). That is, when ill, they usually begin by trying simple home remedies, often consulting friends and family about what to do. Only if the condition persists and worsens do people typically seek help from health care specialists.

The hierarchy of health care specialists includes the popular, community-based, and professionalized (Hufford, 1988; Kleinman, 1980). All are similar in that they aim to help people stay or get well and use manipulation (from laying on of hands to surgery), chemical substances (foods and drugs), or psychospiritual approaches (e.g., talking, suggesting, praying, drumming) as therapeutic techniques. They differ, however, in factors such as how much training they require of practitioners, how intensely they scrutinize and theorize about their own methods, how widely their practice is spread, and to whom they primarily aim their care.

Popular health care is what most people practice and receive at home, such as drinking hot honey and lemonade to relieve a sore throat. People get information about popular health care primarily from family or friends; it can be centuries old or relatively new to that family or social circle. People also learn about popular medicine from magazines, television, and other informal sources. In the United States, popular medicine often uses the words but not necessarily the underlying thinking of biomedicine.

Community-based health care refers to the nonprofessionalized yet specialized health care practices of both rural and urban people. The term community-based is used to avoid the stereotypes associated with the terms folk and tribal. Information in such systems is commonly passed on orally (through workshops, apprenticeships, and so on) and through informal and popular media sources. Some community-based practices have ancient roots (such as rootwork among African-Americans, powwowing among European-Americans, curanderismo among Hispanic-Americans, and religious pilgrimage and psychic healing traditions), while others have developed relatively recently, such as the various 12-step programs (e.g., Alcoholics Anonymous), popular weight loss programs, and various health and natural foods dietary practices. In contrast to popular and professionalized systems, these community-based systems characteristically focus on community health care or on the individual as part of the community. They also usually fuse concepts of medicine and religion or spirituality in such a way that all care is explained as being influenced by a "higher power."

Professionalized health care is characteristically urban and complexly organized. It is the most intellectualized and formalized type of health care. Certain of these have been called the "Great Tradition" medical care systems. Examples of such professionalized health care systems include conventional Western biomedicine, Asian-Indian Ayurveda, traditional oriental medicine, and traditional Persian medicine (Unani), all of which have evolved over time within major urban cultures. Other systems such as chiropractic medicine, osteopathic medicine, anthroposophically extended medicine, environmental medicine, and homeopathic medicine have been the result of the formalization and expansion of the teachings of a specific creative founder within the Western rational and intellectual culture. Each of these major formal systems of medical practice has the following general characteristics: (1) a theory of health and disease; (2) an educational scheme to teach its concepts; (3) a delivery system involving practitioners who usually practice in offices, clinics, or hospitals; (4) a material support system to produce its medicines and therapeutic devices; (5) a legal and economic mandate to regulate its practice; (6) a set of cultural expectations on the role of the medical system; and (7) a means to confer "professional" status on the approved providers.

Two major types of illnesses are recognized in most of these systems, though one or the other is usually emphasized: the naturalistic illness (which results from an accident, infection, intoxication, malformation, aging, environmental stress, etc.) and the personalistic illness (which is the result of malfunction in relationships between people). A third category of illness is increasingly proposed: the energetic illness, which is the result of abnormalities in the flow of subtle energies.

Studies show that people are quite astute at knowing what sorts of conditions to take to what sorts of practitioners. The practitioners at the top of the hierarchy, those that are the most "socially foreign" (i.e., hard to reach from the point of view of the patient), are consulted last and usually only when the condition is unresponsive, very serious, or chronically debilitating. For example, rural Mexicans go to the curandero or curandera for "folk" illnesses, to the nun or nurse for mild biomedical conditions, and to the biomedical physician for the most serious conditions (Young, 1981). Likewise, in urban America many people consult a registered nurse, pharmacist, or health food salesperson before taking their concerns to the medical doctor. One-third of the users of unconventional therapy are estimated to use it for "nonserious" conditions, health promotion, or disease prevention. However, in the case of more serious health problems, the medical doctor is not the most socially foreign type of practitioner in the United States, because M.D.s and D.O.s (doctors of osteopathy) are abundant. People consulting alternative practitioners for an identified health problem are much more likely to have first consulted a medical doctor (Eisenberg et al., 1993). This point suggests that many of the alternative practitioners are rendering care to people with conditions either unresponsive to or unsatisfactorily treated by standard biomedical care.

Of the types of health care listed above, only the professionalized practitioners have received much, if any, scientific study regarding the causes of illness and the explanations and results of treatment. Indeed, community-based practices have been virtually ignored by conventional medicine on the assumption that these superstitious ways are dying out. On the other hand, popular and community-based systems have been studied primarily by social scientists, historians, and folklorists. These researchers, though not primarily concerned with clinical results or health outcomes, have provided most of the clinical material currently available. Health educators have made use of such studies in designing culturally sensitive outreach programs (see the "Diet and Nutrition" chapter).

In recent years, the professionalized biomedical health care system has initiated a number of programs in an attempt to influence popular health practices on the basis of sound epidemiological concerns, addressing such issues as smoking and health, diet and cardiovascular disease, sexual behavior and human immunodeficiency virus (HIV), and healthy childbirth practices. The comparative clinical effectiveness of indigenous community-based health care practices remains, however, a fruitful field for further research.

The remainder of this chapter comprises three major sections, the first of which describes several examples of professionalized alternative health care systems. The following section focuses on community-based practices. Except for the epidemiological issues addressed in the "Diet and Nutrition" chapter, popular practices are not discussed in this document, because the emphasis is on health care delivered by the community of alternative medicine practitioners rather than by laypeople. The last major section addresses the barriers, key issues, and overall priorities for research in alternative systems of medical practice.

Professionalized Health Systems

This section includes discussions of representative health systems whose practitioner base and standards of practice are such that outcomes research may lead to generalizable conclusions applicable to the improvement of the Nation's health care delivery system. These systems are

* traditional oriental medicine,

* acupuncture,

* Ayurvedic medicine,

* homeopathic medicine,

* anthroposophically extended medicine,

* naturopathic medicine, and

* environmental medicine.

Traditional oriental medicine and Ayurvedic medicine are professionalized health systems that are enjoying popularity beyond the ethnic Asian community and are building practitioner bases, educational systems, and popular awareness in North America. Likewise, acupuncture, both as a treatment method and as a formal professional medical system, has an established formal educational base, extensive legal sanction for a variety of practitioners, and a broad base of public support and acceptance in the United States.

Homeopathic medicine has maintained a sound educational base for both professional practitioner training and popular self-help support and has the only officially established "alternative" drug production system regulated by the Food and Drug Administration (FDA). Naturopathy has a base in two formally accredited naturopathic medical schools in the United States and legal recognition of practitioners in a number of States. Anthroposophically extended medicine, while limited in availability in the United States, has a track record of thoughtful research and drug development in Europe that exemplifies the possibilities for "scientific alternatives" in our own health care system. Environmental medicine is a modern specialty area within biomedicine that has developed in ecological theory of health and disease.

Discussion of these professionalized systems is intended as an overview only. The serious student or researcher will find an extensive global database for future research. Each of the following subsections ends with a discussion of current research issues and recommendations for future research.

Traditional Oriental Medicine

Overview. Traditional oriental medicine is a sophisticated set of many systematic techniques and methods. Many of these methods are widely known in the United States, including acupuncture, herbal medicines, acupressure, qigong, and oriental massage techniques. Traditional oriental medicine is rooted in Chinese culture and has spread, with variations, throughout other Asian countries, particularly Japan, Korea, and Vietnam. As a professionalized health system, it has a range of applications from health promotion to the treatment of illness.

The fundamental concepts of oriental medicine are embedded in the philosophical and metaphysical worldviews of Taoism, Confucianism, and Buddhism, which began evolving and spreading throughout East Asia 2,500 years ago. Whereas the religions and philosophies of the Western world developed around the theme of separation of mind, body, and spirit, the Eastern philosophies undergirding oriental medicine consider the whole person and nature to be systematically interrelated.

Chinese medicine developed concurrently with Chinese culture out of its shamanic, tribal origins in the pre-Christian era. By the beginning of the Han Dynasty (200 B.C.E.) the Chinese had acquired and documented formidable medical experience. The first mention of the Shen Nung pharmacopoeia dates from the first century A.D. (Unschuld, 1986). Anatomic dissections and surgeries were practiced during the earlier eras, although in later centuries the Confucian belief in the sacredness of the human body prevented further developments in surgery and anatomic research. The early Chinese State distinguished various sorts of doctors, including medical physicians, surgeons, dietitians, veterinary surgeons, and community-based health officers. By the close of the Han era (220 A.D.), the Chinese had a clear idea of preventive medicine and first aid, knew pathology and dietetics, and had devised breathing practices to promote longevity. After Buddhist influences were assimilated, particularly a tolerance for judging medical practices by their results and not by their theories, the characteristic qualities and components of Chinese medicine had developed by 500 A.D. These qualities and components were expanded during periods of cultural intellectual growth that paralleled the Middle Ages and the Renaissance in Western Europe (Unschuld, 1985).

During the colonial periods of encounter with Western culture, the systems of oriental medicine became fragmented. As Western medical science followed the spread of Western social and political power throughout East Asia, some traditional methods were relegated to folk and quasi-religious practitioners. However, since 1949, traditional Chinese medicine has enjoyed a Government-sponsored renaissance in the People's Republic of China (PRC) (Hiller and Jewel, 1983; Unschuld, 1992). Today, both traditional-and Western-oriented medical training, research, and institutional practice are available throughout mainland China (Quinn, 1972). In addition, traditional practices survive in various degrees in other East Asian countries (Sonoda, 1988).

The most striking characteristic of oriental medicine is its emphasis on diagnosing disturbances of qi (pronounced "chee"), or vital energy, in health and disease (Unschuld, 1985; Wiseman et al., 1985). There are many aspects of healthy balance and function in oriental medicine, and these aspects are described qualitatively or metaphorically as "disharmonies" among forms of vital energy. The concept of yin and yang harmony is a basic description of the interaction between the active and passive, stimulating and nurturing, masculine and feminine, and "heavenly" and "earthly" qualities that characterize living things. Imbalances of yin and yang can manifest within the functions of internal organs in their generation of metabolic energy, can propagate along energetically active channels represented on the body as the acupuncture meridians, and can undergo transformations of expression according to the system of "five phases." Each phase of energy has a characteristic quality of material expression represented by the elemental natures of fire, earth, metal, water, and wood. The Chinese systematically incorporated into their theories new discoveries of environmental and infectious influences on healthy qi and incorporated the emotional, psychological, and personality aspects of illness into the five-phase system.

Diagnosis in oriental medicine involves the classical procedures of observation, listening, questioning, and palpation, including feeling the quality of the pulses and the sensitivity of various body parts. The well-trained physician is taught to use all procedures together in evaluating the patient and to search for details of habit, lifestyle, nutritional indulgence, and specific mediating circumstances. Physical and emotional aspects of health are assumed to be interrelated; for example, fullness of the lungs is said to produce dreams of sorrow and weeping. A range of traditional therapies is prescribed to correct physical symptoms, restore energetic balance, and redirect and normalize the patient's qi.

The professionalization of oriental medicine has taken diverse paths in both East Asia and the United States. Currently, the model in the PRC, which was established after the 1949 revolution, involves the organized training of practitioners in schools of traditional Chinese medicine. The curriculum of these schools includes acupuncture, oriental massage, herbal medicine, and pharmacology, though the theoretical style of making a diagnosis and designing a treatment plan is the one traditionally associated with herbal medicine (Flaws, 1993). The graduates of these colleges are generally certified in one of the four specialty areas at a training level roughly equivalent to that of the Western bachelor's degree (Flaws, 1993). In contrast, in Japan there is a distinct profession of acupuncture, and the herbs used in traditional herbal medicine products (kampo) are prescribed by medically trained physicians or pharmacists (Birch, 1993).

In the United States the professional practitioner base for oriental medicine is organized around acupuncture and oriental massage. There are about 6,500 acupuncturist practitioners in the United States. The American Oriental Body Work Therapy Association has approximately 1,600 members representing practitioners of tuina, shiatsu, and related techniques (Flaws, 1993). Many American schools of acupuncture are evolving into "colleges of oriental medicine" by adding courses in oriental massage, herbal medicine, and dietary interventions. They are also offering diplomas and master's or doctor's degrees in oriental medicine. Although graduates of these programs are exposed to herbal medicine pharmacology, only the States of California and Nevada include a specific section evaluating knowledge of herbal medicine in the state acupuncturist licensing examination. The legal sanctioning of oriental medical practice is most extensive in New Mexico, where the acupuncturists have established an exclusive profession of oriental medicine. Their legal scope of practice is currently similar to that of primary care M.D.s and D.O.s, and their State statute restricts other licensed New Mexico health professionals' ability to advertise or bill for oriental medicine or acupuncture services (New Mexico Association of Acupuncture and Oriental Medicine, 1993).

As with any new profession in the United States, the issues of appropriate formal training, State-by-State legal scope of practice, official title and privileges of practitioners, and professional monopoly on health practices are currently controversial, even among the community of oriental medicine advocates. Furthermore, the position of oriental medicine practices and practitioners within the broader U.S. health care system continues to be a subject of heated political, economic, and intellectual debate (Birch, 1993; Flaws, 1993; National Council Against Health Fraud, 1991; New Mexico Association of Acupuncture and Oriental Medicine, 1993).

The treatment modalities most associated with traditional oriental medicine and used regularly by practitioners include acupuncture, moxibustion, acupressure, remedial massage, cupping, qigong, herbal medicine, and nutritional and dietary interventions. These are discussed below. Acupressure, massage, and qigong are also discussed in the "Manual Healing Methods" chapter.

Acupuncture. It is important to remember that acupuncture was but one branch among several therapies. It involves the direct manipulation of the network of energetic meridians, which are believed to connect not only with the surface or structural body parts but also to influence the deeper internal organs. The needle is inserted at appropriately chosen energetic points to disperse or activate the qi by a variety of technical manipulations. Western-style research showing that acupuncture could relieve pain and cause surgical analgesia through the release of pain-inhibiting chemicals (endorphins) in the nervous system led to the first theories of how acupuncture might work in terms of a biomedical science model (Han, 1987). This model does not, however, account for the many different ways acupuncture is used clinically to improve or correct ailing body functions. Because acupuncture has attracted major interest in the United States, an expanded section on acupuncture is included in this chapter.

Moxibustion. Moxibustion using Artemisia vulgaris (a plant of the composite, or daisy, family) evolved in early times in northern China. In this cold, mountainous region, the effect of heating the body on the energetically active points was a logical development. Moxibustion is thought to have preceded the use of needles. The crushed leaves, or moxa, of vulgaris may be used in loose or cigar form. In theory, the burning from the moxa releases a radiant heat that penetrates deeply and is used to affect the balance and flow of qi.

Acupressure. The energy points and channels can be treated with direct physical pressure by the fingertips or hands of the therapist. Simple points may be used for first aid or symptomatic relief or entire systems of manual therapy (e.g., shiatsu, jin shin jyutsu) may be used to effect the overall well-being of the body.

Remedial massage. The techniques of remedial massage (an-mo and tuina) are described in medical texts of the Han period. Later, in the Tang dynasty, massage was taught in special institutes. An-mo tonifies the system using pressing and rubbing hand motions, while tuina soothes and sedates using thrusting and rolling hand motions. Both systems employ a complex series of hand movements called the eight kua on specific body areas to produce the desired effects.

Cupping. Cupping is a technique of applying suction over selected points or zones in the body. A vacuum is created by warming the air in a jar of bamboo or glass and overturning it onto the body to disperse areas of local congestion. This therapy is used in the treatment of arthritis, bronchitis, and sprains, among other ailments.

Qigong. Qigong is the art and science of using breath, movement, and meditation to cleanse, strengthen, and circulate the vital life energy and blood._ Three basic principles are observed in the performance of the exercises: relaxation and repose; association of breathing with attention; and the interaction of movement and rest. Tai chi and other practices of oriental physical culture emphasize maintaining internal and external balance while encountering one's environment. Certain of the qigong exercises, particularly the gou lin form, have been used for immune stimulation and self-help in cancer patients (Sancier, 1991, 1993). These personal practices are the "internal" qigong type. Certain qigong "masters" are considered to be "energetic healers," who via "external" qigong use some of their own energy to strengthen the vitality of others who have ailments.

Herbal medicine. There is a complex series of practices regarding the preparation and administering of herbs in Chinese medicine (Unschuld, 1986). The traditional materia medica in China included approximately 3,200 herbs and 300 mineral and animal extracts (Bensky and Gamble, 1986). Herbal prescriptions cover the entire range of medical ailments, including pain, hormone disturbances, breathing disorders, infections, and chronic debilitating illnesses. Medications are classified according to their energetic qualities (e.g., heating, cooling, moisturizing, drying) and prescribed for their action on corresponding organ dysfunction, energy disorders, disturbed internal energy, blockage of the meridians, or seasonal physical demands. One unique aspect of traditional prescribing is the use of complex mixtures containing many ingredients. Such prescriptions are systemically compounded to have several effects: to principally affect the disease or disharmony, to balance out any potential side effects of the principal therapy, and to direct the therapy to a specific area or a physical process in the body. (See the "Herbal Medicine" chapter for details on specific Chinese herbs and how they are used).

Nutrition and dietetics. Dietary interventions are also individualized on the basis of the physical characteristics of both the patient's constitution and the patient's illness disturbance. Foods are characterized according to their energetic qualities (e.g., tonifying, dispersing, heating, cooling, moistening, drying). Emphasis is given to eating in harmony with seasonal shifts and life activities.

Research base. Although extensive research has been done in China through the institutions of traditional Chinese medicine, much of this clinical research has been empirical, that is, reports of observed results of various treatments. Many of these reports have been difficult to translate into Western languages and into the standard formulas or analysis typical for Western biomedical research. Because of the interest in applying acupuncture for pain and for chronic conditions, much research has focused on these two areas. However, clinical practice experience in the Asian countries suggests there is a role for complementary use of traditional therapies with a myriad of modern Western "scientific" medical interventions (Sun, 1988; Unschuld, 1992; Wong et al., 1991).

Only in the past quarter-century have biomedical scientists in China been characterizing and identifying the active agents in much of the traditional medical formulary (Hsu et al., 1982, 1985). However, extensive research has been published detailing the pharmacology and toxicity of many traditional oriental herbs (Bensky and Gamble, 1986; Hsu et al., 1982, 1985; Ng et al., 1991). How many clinical trials of traditional oriental herbal medicine have been conducted and what extent and validity the findings have are unclear. Few references to published studies appear in the databases available in the West. Although some individual studies appear quite promising, only preliminary conclusions can be drawn about the field until more complete literature searches are conducted. (See the "Herbal Medicine" chapter for a more complete discussion of the status of herbal medicine research in China.)

Tsutani conducted an extensive search to find the number of clinical trials of herbal medicine in China (Tsutani, 1993). Of 148 studies retrieved from computerized databases, 39 were double blind, used random allocation, or were randomized controlled clinical trials. He conducted a combined computerized and manual search of the Japanese literature and retrieved references to 59 controlled studies on the use of kampo (Japanese traditional herbal medicine). An additional unpublished search by Birch of computer-indexed herbal medicine studies published in the period 1978-92 located 23 studies in English and 44 in other languages (Chinese 37, Japanese 5, German 1, French 1). In general, the methodological quality of these studies was poor, and they had multiple study design problems, including poor experimental design, lack of randomization, unclear entry criteria and end points, and lack of consideration of the traditional uses of the herbs (Birch, 1993).

Research in the medical effects of qigong has been a subject of interest in the PRC in recent years and was the topic of six international conferences between 1986 and 1991. Patients who practice internal qigong exercises combining meditation and gentle body movement were shown to have better results in therapy for hypertension, cancer, and coronary artery disease (Sancier, 1991, 1993). Qigong exercise also was shown to affect the blood chemistry of individuals practicing it. In addition, studies on external qigong have included measurements of the effect of qi emitted by master practitioners on cell cultures, germination rate of seeds, and electroencephalographic measurements of human recipients (Sancier and Hu, 1991).

Measurements of emissions from external qigong practitioners suggested that infrasonic energy was present in frequency ranges from 8 to 12.5 hertz (lower than the human ear can hear) and in intensities measurably different than background-noise level (Sancier and Hu, 1991). These suggestive findings parallel certain studies done in the West on mind-body interactions and nonlocal or "energetic" healing. (See the "Manual Healing Methods" and "Mind-Body Interventions" chapters.) Unfortunately, these Chinese studies are available only in abstract or conference proceedings formats in English. It is not known whether the complete papers are published in the Chinese literature with supporting data that would allow a methodological evaluation of the quality of the studies.

Future research opportunities. Although many diseases may be helped by the modalities of traditional oriental medicine, documenting its benefit in conditions of greatest concern to the United States should have research priority: cancer, acquired immune deficiency syndrome (AIDS), cardiovascular diseases, neuromuscular disabilities, chronic fatigue syndrome, psychosomatic problems, alcohol and drug addictions, and chronic pain.

Clinical research into the nondrug modalities of traditional oriental medicine includes opportunities for investigating manual healing therapies, bioelectricity and magnetic physical interventions, and the use of body-mind interactions for health purposes. Issues and criteria for such future research are discussed in other chapters of this report.

The use of traditional oriental herbal medicines and formulas in China and Japan has been studied for therapeutic value in the following areas: chronic hepatitis; rheumatoid arthritis; hypertension; atopic eczema; various immunologic disorders, including AIDS; and certain cancers (Hirayama et al., 1989; Sheehan and Atherton, 1992; Smith, 1987; Sun, 1988; Tao et al., 1989; Wong et al., 1991; Xu et al., 1989; Zhao et al., 1993). It would be useful to repeat these studies in the United States using high-quality research criteria. Research into the application of traditional oriental products could be roughly organized in three levels: first, publication of appropriate safety studies; second, pharmacological studies characterizing the contents, action, and components of single herbs and herbal formulas; and third, controlled clinical trials for specified conditions. The expense of this research endeavor can be lessened if World Health Organization proposals (see the "Herbal Medicine" chapter and app. C) allowing the documentation of traditional use are adopted by U.S. regulatory authorities (McCaleb, 1993). Given the large-scale use of over-the-counter herbal products as "food supplements" in the U.S. market, studies involving postmarketing surveillance of the use, clinical results, and complications of currently available products also would be appropriate (Ng et al., 1991).

Examples of creative basic research would include viewing the pH balance of body fluids as a representation of yin-yang balance, noting changes in organ and tissue receptor sites following treatment with herbal preparations, and investigating various neurological responses to massage and acupressure interventions. There is a major opportunity for cataloging and translating research done in China, Japan, and Korea in order to stimulate further development of the field in the United States.

Outcomes research can also address the application of traditional oriental medicine as a system. Such research would involve comparing (a) the overall health improvement and cost of care of a population working with a program of mixed interventions prescribed by practitioners of traditional oriental medicines with (b) the health indices of a control group using conventional care.

Acupuncture

Overview. Acupuncture involves stimulating specific anatomic points in the body for therapeutic purposes. Puncturing the skin with a needle is the usual method of application, but practitioners may also use heat, pressure, friction, suction, or impulses of electromagnetic energy to stimulate the points. Acupuncture was an evolving part of the medical practices of the Chinese people and is described in two surviving historical texts: the well-known medical treatise Huang Ti Nei Ching Su WLn (The Yellow Emperor's Classic of Internal Medicine), and Shi Ji (Book of History), both dating to the period 200-100 B.C.E.

Over the centuries, acupuncture spread throughout the medical practices of the Asiatic peoples around the Pacific Rim. However, it has been practiced as a medical art in Western Europe for several hundred years, having been brought home by the traders, diplomats, and missionary priests who encountered it during their travels in the Orient. By the late 19th century, acupuncture was known and used on the east coast of the United States. Sir William Osler's American medical textbook, which was first published in 1892 and was updated periodically through 1947, recommended acupuncture for treating lumbago or lower back pain (Lytle, 1993). Acupuncture also reached the United States on the west coast as an ethnic practice among Asian immigrants in the 19th and 20th centuries.

George Soulie de Morant, a French diplomat in China at the turn of the century, became an accomplished acupuncturist. On his return to France he began systematically introducing the full range of acupuncture to the French and European medical community. He published significant texts in 1934, 1939, 1941, and 1955 that represent a landmark effort to expand Western biomedical explanations of the physiology of health and disease to include the classical and empirical observations of Chinese acupuncture. His influence did much to establish acupuncture as an accepted clinical art in Europe (Zmiewski, 1994).

In the past 40 years acupuncture has become a well-known and reasonably available treatment in both developed and developing countries. Since the reopening of relations between the United States and the PRC, acupuncture has attracted increased attention from the American public and governmental agencies (Chen, 1973). With the emergence of traditional Chinese medicine as an organized system of practice in the PRC, formal training programs in acupuncture and oriental medicine have expanded throughout the world. Schools and training programs of acupuncture in the United States incorporate varying degrees of traditional Chinese medicine as well as European acupuncture approaches and elements of the traditional and modern practice traditions from Japan, Korea, and Vietnam.

Because the traditional view of health and illness in oriental medicine is related to a proper balance of qi, or energy, in the body, acupuncture is used to regulate or correct the flow of qi to restore health. Acupuncture treatment points are chosen on the basis of diagnosis of a medical problem by history and physical exam using one or more models of how the body operates in health and disease. The model, or "tradition," that is used to guide treatment may vary according to the cultural background and education of the practitioner as well as the nature of the patient's problem. Acupuncture prescriptions can be simple or sophisticated. A series of 10 or more treatments is usually prescribed for a chronic illness or physical rehabilitation. On the other hand, one to four treatments may suffice for minor injuries, a self-limited illness, or a seasonal "tune up."

Modern theories of acupuncture are based on laboratory research conducted in the past 40 years. Acupuncture points have been found to have certain electrical properties, and stimulation of these points has been shown to alter the chemical neurotransmitters in the body. Many of the therapeutic effects of acupuncture can be clearly related to the mechanism of neurotransmitter release via peripheral nerve stimulation. This mechanism is associated with changes in the balance of the natural physiological chemicals in the body, which can be used for a therapeutic effect (Pomeranz, 1986). Other therapeutic effects may be related to mechanical stimulation or alteration of the natural electrical currents or electromagnetic fields in the body.

Although the physiological effects of acupuncture stimulation in experimental animals have been well documented, the use of acupuncture treatments for clinical illness in humans has remained controversial within much of the mainstream medical community in the United States. Some controversy comes from the "foreignness" of traditional Chinese interpretations of medical illness, and some may be due to an unfamiliarity with the existing global research base. In 1973 the commissioner of the FDA announced that devices used in acupuncture, including the specialized needles, electrical stimulators, and associated paraphernalia, would be considered investigational on the basis of the perception at that time that "the safety and effectiveness of acupuncture devices [had] not yet been established by adequate scientific studies to support the many and varied uses for which such devices are being promoted including uses for analgesia and anesthesia" (Lytle, 1993). This designation is still official FDA policy.

In the subsequent 20 years, however, acupuncture has become an increasingly established health care practice in the United States. Furthermore, there are currently more than 40 schools and colleges of acupuncture and oriental medicine in the United States, 20 of which are either approved or in candidacy status with the National Accreditation Commission for Schools and Colleges of Acupuncture and Oriental Medicine. There are licensure or registration statutes in 28 States for the practitioner graduates of these programs. There are an estimated 6,500 acupuncturist practitioners in the United States, of whom 3,300 have taken the examination of the National Commission for the Certification of Acupuncturists. In addition to these practitioners, naturopathic and chiropractic physicians also can legally incorporate acupuncture in their practice in a limited number of States.

Besides the "alternative" medical practitioners who are trained in acupuncture, an estimated 3,000 conventionally trained physicians (M.D.s and D.O.s) have taken courses to incorporate acupuncture as a treatment modality in their medical practices. Such courses have been affiliated with the UCLA School of Medicine, the New York University School of Medicine and Dentistry, and St. Louis University Medical School (Helms, 1993). Proficiency certification examination for physician acupuncturists has been offered for a number of years in Canada by the Acupuncture Foundation of Canada, and similar examinations are currently in development in the United States, Australia, and New Zealand (Williams, 1994). The gradual acceptance of acupuncture therapeutics based on clinical practice experience in American medicine is reflected by the incorporation of descriptions of this discipline into most current textbooks of physical medicine and pain management (Chapman and Gunn, 1990; Lee and Liao, 1990). Moreover, a recent review estimated that patient visits for acupuncture to physician and nonphysician practitioners are occurring at a rate of 9 to 12 million per year in the United States (Lytle, 1993). Thus, the continued FDA "experimental" designation, which is echoed by the reference committee of the American Medical Association (AMA), is considered by many to be obsolete in the face of the large-scale use of acupuncture by legally sanctioned practitioners in the United States as well as in many other countries' health care systems.

Research base. Acupuncture is one of the most thoroughly researched and documented of the so-called alternative medical practices. A series of controlled studies on the treatment of a variety of conditions has shown compelling, though not statistically conclusive, evidence for the efficacy of acupuncture. These conditions are osteoarthritis (Dickens and Lewith, 1989), chemotherapy-induced nausea (J. Dundee et al., 1989), asthma (Fung and Chow, 1986), back pain (Gunn and Milbrandt, 1980), painful menstrual cycles (Helms, 1987), bladder instability (Phillip et al., 1988), and migraine headaches (Vincent, 1990). Moreover, in spite of the unenviable challenge of serving as the "alternative" therapy of "last resort," acupuncture studies have shown positive results in managing chronic pain (Patel et al., 1989) and drug addiction (Bullock et al., 1989; Smith, 1988), two areas where conventional Western medicine has generally failed. Indeed, the criminal justice systems in New York City and Portland, OR, have mandated acupuncture as part of their detoxification and probation programs for drug abusers.

In addition, basic science research in animal models suggests that neurological pathways are the mechanism by which acupuncture relieves pain (Pomeranz, 1986). There also is work showing acupuncture effects in treating veterinary medical problems, such as bacteria-induced diarrhea in pigs (Hwang and Jenkins, 1988). A broad range of applications in human medicine also has been explored.

The risk and safety issues in acupuncture also have been thoroughly investigated (Lytle, 1993). In a recent review of 3,255 acupuncture citations in the world scientific literature, the conditions of study in 365 Western and 344 Chinese clinical research papers were tabulated (American Foundation of Medical Acupuncture, 1993). The number of studies per topic was as follows: surgical applications, 77; pain (chronic and acute pain of all types), 222; neurological disorders, 62; organic illness (e.g., heart, lungs), 200; women's reproductive disorders, 43; mental illness, 29; addiction therapy, 54; and acupuncture treatment complications, 11. The diversity of clinical applications and supporting basic physiology studies points to acupuncture having a therapeutic effect that exceeds a purely placebo or culturally dependent action.

Acupuncture research involves tailoring the study design and question to one of several levels of clinical investigation. At the most basic level, one can study the effect of stimulating a specific acupuncture point on a specific physiological response. For example, Dundee and colleagues conducted a series of investigations involving more than 500 patients for a 5-year period, evaluating the effect on nausea of stimulating the acupuncture point PC-6 (neiguan). These studies involved manual needling, electrical stimulation on the needle, acupressure, and noninvasive electrical stimulation. Control groups included patients with no treatment as well as patients who were needled at a sham point (a point unrelated to the accepted treatment meridian). The patients being investigated were undergoing minor gynecologic operations under general anesthesia. Results of the active acupuncture treatments showed better response than was shown by controls or by those who received sham acupuncture treatments. Indeed, needle acupuncture gave slightly better results than the then-standard antinausea drugs (R. Dundee et al., 1989).

Moreover, the effect of acupuncture in the treatment of specific clinical conditions has been measured. For example, Helms (1987) studied 43 women suffering from dysmenorrhea (painful menstrual periods); the patients were divided into four groups: real acupuncture, sham acupuncture, standard controls (no intervention), and visitation controls (visits to the treating physician). The patients were free to take their previously used pain medications during the 3-month treatment period and a followup period. Ninety-one percent of the real acupuncture treatment group showed improvement, whereas only 36 percent of the sham acupuncture group showed improvement. Only 18 percent of the standard control group and 10 percent of the visitation control group showed improvement. In addition, there was a 41-percent decrease in use of pain medication in the real acupuncture group, versus no change in the others (Helms, 1987). Furthermore, the improvement noted in the real acupuncture treatment group persisted beyond the end of the active treatment period.

Although acupuncture effects on pain problems can be considered purely subjective phenomena, acupuncture treatments also can be studied in terms of their effect on altering patient behavior and use of medical care. Bullock et al. (1989) studied 80 severe alcoholics through the Hennipen County, MN, alcohol detoxification program. These patients all had a history of repeated hospital admissions for alcoholism, or were severe recidivists. They were divided into two groups, a treatment group receiving acupuncture at specific ear acupuncture points and a control group treated with sham acupuncture points on the ear. The patients were treated for 45 days from the date of their last acute alcoholism hospital admission.

Six months after the treatment program the control (sham) group had nearly twice as many drinking episodes and admissions to detox centers as the treatment groups (Bullock et al., 1989). These types of results have caught the attention of public agencies and criminal justice systems across the country who are concerned with the cost of managing the social impact of people with severe drug abuse behavior.

Promising early evidence suggests that acupuncture can be cost-effective in conventional medical practice settings as well. In France, for example, statistics from the insurance syndicate show that physicians whose practice is at least 50 percent acupuncture cost the system considerably less for laboratory examinations, hospitalizations, and medication prescriptions than their non-acupuncture-practicing colleagues (Helms, 1993). In the United States, a pilot study on followup of chronic pain patients receiving acupuncture in a managed-care setting demonstrated a reduction of clinic visits, physical therapy visits, telephone consultations, and prescription costs in the 6 months following a short course of acupuncture therapy (Erickson, 1992).

In Denmark a study was made involving the 58 patients on a county health system's waiting list for elective knee replacement surgery. Forty-eight of these patients were considered candidates for a controlled trial of acupuncture therapy, and two-thirds (32) participated in the study. The subgroup treated with acupuncture initially showed improvement in both objective and subjective measures of knee function and a 50-percent reduction in nonsteroidal anti-inflammatory drug (NSAID) use after six treatments when this group was compared with its own baseline findings and with the untreated subgroup. The untreated patients were then treated with acupuncture and also showed improvement. Five of these were called for their elective surgery, and the remaining 17 continued in long-term followup for 49 weeks with monthly acupuncture treatments for maintenance. At the 1-year followup point, NSAID use in the group as a whole was still 20 percent less than the baseline measurements, and 22 percent (seven) of the study group had responded so well that they no longer desired knee replacement surgery. These seven patients constituted 12 percent of the original elective surgery waiting list (Christensen et al., 1992). Taken as a whole, these results suggest that wider use of acupuncture in the United States might reduce health care costs significantly as well as improve outcomes of selected conditions.

Future research opportunities. Basic research is needed to examine the effects of acupuncture beyond the pain management field. This extended basic research in acupuncture should address the broad range of clinically observed effects of acupuncture treatments, including improved physical health, improved emotional stability and cognitive functioning, and overall improvement in quality of life. State-of-the-art techniques for monitoring and detecting changes in body physiology (e.g., electroencephalography, brain mapping, single-photon emission tomography scans, positron emission tomography scans, and electromyographic mapping) could be used. Such techniques are useful in evaluating medical conditions in which patients do not show gross changes in standard biochemical measures.

Basic research in the bioelectromagnetic effect of acupuncture on the physical and energetic phenomena of the human body might present another modern correlation to the traditional concept of qi. (See the "Bioelectromagnetics Applications in Medicine" and "Manual Healing Methods" chapters.) The alterations by acupuncture of the neuropeptide chemicals involved in the digestive and immune responses also could be studied. This biochemical research would parallel the existing studies on pain relief with acupuncture. Another promising area is research into disorders of the autonomic nervous system and their alteration or correction by acupuncture.

Acupuncture's traditionally reported effects on improving the well-being of the whole person should be investigated using established psychological and behavioral health measures as well as standardized measurements of health status and quality of life. Since acupuncture is a procedural therapy involving an intentional interaction between the practitioner and the patient, acupuncture research is an appropriate area in which to investigate the interpersonal and transpersonal aspects of mind-body healing. (See the "Mind-Body Interventions" chapter.)

Acupuncture research in clinical medicine is entering a challenging period. With a broad base of research and practice supporting the safety and promising results of acupuncture in many clinical conditions, studies now need to be done to firmly establish the efficacy of acupuncture in comparison with other medical interventions for relevant health problems. There are three appropriate questions for clinical studies of acupuncture: (1) Is acupuncture efficacious for the condition under study in comparison with conventional or other alternative treatments? (2) Is acupuncture more than a placebo intervention for the specific conditions being studied? (3) Is the mechanism of acupuncture more than that of a nonspecific irritant stimulation? That is, does it matter where you stick the needle? These levels of research, done as controlled clinical trials, are necessary to answer treatment efficacy questions that are equivalent to those being studied in Phase III drug treatment trials. These initial studies should assist in correcting the "experimental" designations imposed by the FDA and the AMA on the practice of acupuncture.

Key issues. Because of the entrenched skepticism in American medicine regarding acupuncture, an extremely high standard of biostatistical and clinical expertise will be required for these acupuncture clinical trials. Unfortunately, as an operator-dependent procedure--a type of procedure that has individualized treatment protocols--acupuncture can be studied in a full-scale, blinded, randomized, placebo-controlled fashion in only a limited number of clinical conditions. Suggested areas for such placebo-controlled acupuncture research studies include treatment of acute low back pain, chronic osteoarthritis of the knee, cancer chemotherapy-induced nausea and vomiting, and pain related to dental procedures. Issues for which existing studies have been criticized, such as sample bias, inadequate statistical power, lack of appropriate controls, practitioner incompetence, and inappropriate treatment design, must be addressed to ensure that the data generated in new clinical trials are of the highest possible quality (ter Riet et al., 1990).

Furthermore, the drug model of biomedical research is appropriate for only a limited range of acupuncture investigations. For most clinical applications, acupuncture research trials will have to compare clinical effectiveness, that is, compare the outcome of courses of acupuncture treatment with clinical outcomes in non-acupuncture-treated or conventionally treated patients. (See the "Research Methodologies" chapter.) The priority areas for these acupuncture research studies should be based on considerations of public health importance, the inadequacy of current treatment methods owing to excessive side effects or cost, and the existing promising data in the global acupuncture research base. Attention to specificity of the diagnostic, therapeutic, and outcome criteria is necessary to allow compelling conclusions to be drawn about the effectiveness of acupuncture in disorders such as chronic headaches, urinary system dysfunction, respiratory disorders, allergies, neurological and orthopedic problems, and substance abuse problems.

Since acupuncture treatments for many of these health problems are individually designed and directed at improving the function of the whole person, specific research methods must be involved that will not only document alterations in a specific disease process but also validate the improved quality-of-life outcomes reported by patients who have been treated by experienced acupuncture practitioners.

Ayurvedic Medicine

Overview. Ayurveda is the traditional, natural system of medicine of India, which has been practiced for more than 5,000 years. Ayurveda provides an integrated approach to the prevention and treatment of illness through lifestyle interventions and a wide range of natural therapies. The term Ayurveda has its origins in the Sanskrit roots ayus, which means "life," and veda, which means "knowledge."

Ayurvedic theory states that all imbalance and disease in the body begin with imbalance or stress in the awareness, or consciousness, of the individual. This mental stress leads to unhealthy lifestyles, which further promote ill health. Therefore, mental techniques such as meditation are considered essential to the promotion of healing and to prevention.

Ayurveda describes all physical manifestations of disease as due to the imbalance of three basic physiological principles in the body, called doshas, which are believed to govern all bodily functions. Evaluation of these three doshas--vata, pitta, and kapha--is accomplished primarily by feeling the patient's pulse at the radial artery, which is a detailed and systematic technique called nadi vigyan. This evaluation determines the types of herbs prescribed, and it guides the physician in the application of all other ayurvedic therapies.

Specific lifestyle interventions are a major preventive and therapeutic approach in Ayurveda as well. Each patient is prescribed an individualized dietary, eating, sleeping, and exercise program depending on his or her constitutional type and the nature of the underlying dosha imbalance at the source of the illness. The Ayurvedic practitioner uses a variety of precise body postures, all derived from the age-old discipline of yoga; breathing exercises; and meditative techniques. These postures are used to create an individualized self-care program to improve both physical health and personal consciousness. In addition, herbal preparations are added to the patient's diet for preventive and rejuvenative purposes as well as for the treatment of specific disorders.

In addition to mental factors, lifestyle, and dosha imbalance, Ayurveda identifies a fourth major factor in disease: the accumulation of metabolic byproducts and toxins in the body tissues. Ayurvedic physical therapy, called panchakarma, consists of physical applications, including herbalized oil massage, herbalized heat treatments, and elimination therapies (e.g., therapies to improve bowel movements), which promote internal cleansing and removal of such toxic metabolic wastes. Certain of the agents used in panchakarma therapy are proposed to have free-radical scavenging, or antioxidant, effects (Fields et al., 1990). Free radicals are naturally occurring atoms or molecules that are highly reactive with anything they come into contact with. A recently developed theory suggests that free radicals play important roles in causing a wide range of degenerative and chronic disorders, including cancer and aging. Thus, substances with antioxidant properties may be effective in preventing, or even treating, myriad conditions. (See the "Diet and Nutrition" chapter for more information on free radicals and antioxidants.)

Ayurveda emphasizes the interdependence of the health of the individual and the quality of societal life. Therefore, measures to ensure the collective health of society, such as pollution control, community hygiene, the collective practice of meditation programs, and appropriate living conditions, are supported.

There are currently approximately 10 Ayurveda clinics in North America, including one hospital-based clinic, which together have served an estimated 25,000 patients since 1985 (Lonsdorf, 1993). More than 200 physicians have received training as Ayurvedic practitioners through the American Association of Ayurvedic Medicine, have received continuing medical education credit for Ayurvedic training programs, and have incorporated Ayurveda into their clinical practices as an adjunct to modern medicine (Lonsdorf, 1993). A modern revitalization of Ayurveda now being practiced in the United States and internationally is known as Maharishi Ayurveda. This approach utilizes a full range of physical and mental therapies from the Ayurvedic tradition.

In India, Ayurvedic practitioners receive State-recognized and-institutionalized training along with their physician counterparts in the Indian state-supported systems for conventional Western biomedicine and homeopathic medicine. A number of these Indian-trained Ayurvedic physicians practice or teach Ayurveda in the United States.

Research base. There have been extensive studies of the physiological effects of meditative techniques and yoga postures in both the Indian medical literature and the Western psychological literature (Funderburk, 1977; Murphy, 1992a; Murphy and Donovan, 1988). For example, students in hatha yoga classes showed improvement in fitness measures, including flexibility, strength, equilibrium, and stamina (Jharote, 1973).

In addition, effects of yogic postures and breathing on finger blood flow showed consistent changes with various breathing practices, changes that were more pronounced in trained yogic practitioners (Gopal et al., 1973). Changes in endocrine hormone measurements also have been associated with certain Ayurvedic practices (Glaser et al., 1992; Udupa et al., 1971). Measurement of metabolic rate, oxygen exchange, lung capacity, and red and white blood cell counts have been found to be associated with general yogic training and in some cases with specific asanas (posture) (Gopal et al., 1974). Similar basic research on meditative practices has led to the development in Western medicine of biofeedback and relaxation training (see the "Mind-Body Interventions" chapter).

Yogic and meditative practices also have been studied as specific interventions for disease states such as asthma and hypertension (Bhole, 1967; Patel, 1973). A recent pilot study performed in Holland followed a group of patients who used a combination of Ayurvedic therapies. The study documented improvements with Ayurvedic therapies in 79 percent of patients who were studied for a 3-month treatment period with a number of chronic disease conditions, including rheumatoid arthritis, asthma, chronic bronchitis, eczema, psoriasis, hypertension, constipation, headaches, chronic sinusitis, and non-insulin-dependent diabetes mellitus (Janssen, 1989).

In addition, published studies have documented reductions in cardiovascular disease risk factors, including blood pressure, cholesterol, and reaction to stress, in individuals practicing Ayurvedic methods (Schneider et al., 1992) and have shown improvement in overall health care utilization measures among meditators (Orme-Johnson, 1988).

The "technology" of meditative practices has been subjected to studies showing physiological changes of heart rate, blood pressure, brain cortex activity, metabolism, respiration, muscle tension, lactate level, skin resistance, salivation, and pain and stress responses (improvement), and both negative and positive behavioral effects (Murphy, 1992a).

Further laboratory and clinical studies on Ayurvedic herbal preparations and other therapies have shown them to have a wide range of potentially beneficial effects for the prevention and treatment of certain cancers, including breast, lung, and colon cancers (Sharma et al., 1990). They have also been shown effective in the treatment of mental health (Alexander et al., 1989b) and infectious disease (Thyagarajan et al., 1988), in health promotion (Schneider et al., 1990), and in treatment of aging (Alexander et al., 1989a; Glaser et al., 1992). Mechanisms underlying these effects are believed to include free-radical scavenging effects (Fields et al., 1990), immune system modulation, brain neurotransmitter modulation, and hormonal effects (Glaser et al., 1992). The National Cancer Institute (NCI) has included Ayurvedic compounds on its list of potential chemopreventive agents and has recently funded a series of in vitro studies on the cancer-preventive properties of two Ayurvedic herbal compounds, maharadis amrit kalash 4 and 5 (MAK-4 and MAK-5). In preliminary studies, NCI researchers have demonstrated that MAK-4 and MAK-5 significantly inhibited cancer cell growth in both human tumor and rat tracheal epithelial cell systems (Arnold et al., 1991).

Future research opportunities and priorities. Because of the potential of ayurvedic therapies for treating conditions for which modern medicine has few, if any, effective treatments, this area is a fertile one for research opportunities. For example, when NCI researchers began testing MAK-4 and MAK-5 for effects against tumor cell growth, they also found that similar compounds such as ferulic acid, catechin, bioflavonoids, retinoic acid (vitamin A), ascorbyl palmitate, and glycyrrhetinic acid also showed chemopreventive activity (Arnold et al., 1991).

Known scientific data on the intrinsic rhythms and laterality (right side vs. left side) patterns in the autonomic nervous system can provide a model for understanding how stress disrupts healthy physical function. Certain meditative and yogic practices have been proposed as noninvasive "technologies" to self-regulate the neural matrices that couple mind and metabolism in the body (Shannahoff-Khalsa, 1991). Translation of the traditional concepts of yogic medicine into the language of modern medicine could stimulate creative research in the neurophysiology of stress and adaptation.

The following are the research opportunities as well as the priorities for investigations in this area of alternative medicine:

1. Performing a critical review of world literature to identify potentially useful Ayurvedic therapies for various conditions.

2. Conducting long-term health care utilization and cost effectiveness studies on individuals who use Ayurvedic therapies, lifestyle programs, and meditation regularly for prevention.

3. Studying the effectiveness of Ayurvedic therapies and lifestyle for the prevention and treatment of diseases such as cardiovascular disease, cancer, AIDS, osteoporosis, autoimmune disorders, Alzheimer's, and aging.

4. Assessing the cost and treatment effectiveness of Ayurvedic therapies in the treatment of specific functional or chronic disorders such as chronic fatigue syndrome, premenstrual syndrome, chronic pain, functional bowel and digestive problems, insomnia, allergies, and neuromuscular disorders.

5. Identifying the mechanisms underlying therapeutic effects of herbal therapies, diet, Ayurvedic physical therapies such as panchakarma, meditation, yogic practices, and other treatment modalities.

6. Studying the effects of the collective practice of meditation on community health indices and health care costs in cities, the Nation, and other social groups.

Homeopathic Medicine

Overview.

The term homeopathy is derived from the Greek words homeo (similar) and pathos (suffering from disease). The first basic principles of homeopathy were formulated by the German physician Samuel Hahnemann in the late 1700s. Curious about why quinine could cure malaria, Hahnemann ingested quinine bark and experienced alternating bouts of chills, fever, and weakness, the classic symptoms of malaria. From this experience he derived the principle of similars, or "like cures like": that is, a substance that can cause certain symptoms when given to a healthy person can cure those same symptoms in someone who is sick.

Hahnemann spent the rest of his life extensively testing, or "proving," many common herbal and medicinal substances to find out what symptoms they could cause. He also began treating sick people, prescribing the medicine that most closely matched the symptoms of their illness. The information from this experimentation has been carefully recorded and makes up the homeopathic materia medica, a listing of medicines and their indications for use. According to the Homeopathic Pharmacopoeia of the United States, homeopathic medicines, or remedies, are made from naturally occurring plant, animal, and mineral substances.

By the end of the 19th century, homeopathy was widely practiced in the United States, when there were 22 homeopathic medical schools, more than 100 homeopathic hospitals, and an estimated 15 percent of physicians practicing homeopathy. The practice of homeopathy (along with other types of alternative medicine) declined dramatically in the United States following the publication of the Flexner Report in 1910, which established guidelines for the funding of medical schools. These guidelines favored AMA-approved institutions and virtually crippled competing schools of medicine. In the past 15 years, however, there has been a resurgence of interest in homeopathy in this country. It is estimated that approximately 3,000 physicians and other health care practitioners currently use homeopathy, and a recent survey showed that 1 percent of the general population, or approximately 2.5 million people, had sought help from a homeopathic doctor in 1990 (Eisenberg et al., 1993).

Those who are licensed to practice homeopathy in the United States vary according to state-by-state "scope of practice" guidelines, but they include M.D.s, D.O.s, dentists, naturopaths (N.D.s), chiropractors, veterinarians, acupuncturists, nurse practitioners, and physician assistants. Three states now have specific licensing boards for homeopathic physicians: Arizona, Connecticut, and Nevada. Specialty certification diplomas for those prescribing homeopathic drugs are established through national boards of examination for M.D.s/D.O.s and N.D.s. Self-help as well as professional training courses in homeopathy are offered through the National Center for Homeopathy (NCH) in Alexandria, Virginia. NCH serves as an umbrella organization for consumer support of homeopathy as well as a focus for coordination among an increasing number of organizations and specialty societies offering lay and professional training programs in homeopathy.

Homeopathic medicine also is currently widely practiced worldwide, especially in Europe, Latin America, and Asia. In France, 32 percent of family physicians use homeopathy, while 42 percent of British physicians refer patients to homeopaths (Bouchayer, 1990; Wharton and Lewith, 1986). In India, homeopathy is practiced in the national health service, and there are more than 100 homeopathic medical colleges and more than 100,000 homeopathic physicians (Kishore, 1983).

In the United States today, the homeopathic drug market has grown to become a multimillion-dollar industry; a significant increase has occurred in the importation and domestic marketing of homeopathic drugs. Homeopathic remedies are recognized and regulated by the FDA and are manufactured by established pharmaceutical companies under strict guidelines established by the Homeopathic Pharmacopoeia of the United States. Products that are offered for the treatment of serious conditions must be dispensed under the care of a licensed practitioner. Other products offered for the use of self-limiting conditions such as colds and allergies may be marketed as over-the-counter drugs.

Homeopathy is used to treat both acute and chronic health problems as well as for health prevention and promotion in healthy people. Homeopathic medicines are prescribed on the basis of a wide constellation of physical, emotional, and mental symptoms. The one remedy that most closely fits all of the symptoms of a given individual is called the similimum for that person. Thus, homeopathic treatment is individualized, and two or more people with the same diagnosis may be given different medicines, depending on the specific symptoms of illness in each person. A person with a sore throat, for instance, may need one of six or seven common remedies for sore throats, depending on whether the pain is worse on the right or left side, what time of day it is worse, what the person's mood is, and his or her body temperature, thirst, and appetite (Jouanny, 1980).

Hahnemann also discovered that if the homeopathic remedies were "potentized" by diluting them in a water-alcohol solution and then shaking, side effects could be diminished. He found that after the medicines were potentized to high dilutions, there was still a medicinal effect, and side effects were minimal. Some homeopathic medicines are diluted to concentrations as low as 10-30 to 10-20,000. This particular aspect of homeopathic theory and practice has caused many modern scientists to reject homeopathic medicine outright. Critics of homeopathy contend that such extreme dilutions of the medicines are beyond the point at which any molecules of the medicine can theoretically still be found in the solution (When to believe..., 1988).

On the other hand, scientists who accept the validity of homeopathic theory suggest several theories to explain how highly diluted homeopathic medicines may act. Using recent developments in quantum physics, they have proposed that electromagnetic energy may exist in the medicines and interact with the body on some level (Delinick, 1991). Researchers in physical chemistry have proposed the "memory of water" theory, whereby the structure of the water-alcohol solution is altered by the medicine during the process of dilution and retains this structure even after none of the actual substance remains (Davenas et al., 1988).

Recent research accomplishments. Basic science research in homeopathy has primarily involved investigations into the chemical and biological activity of highly diluted substances. The most thought-provoking research has involved observation of the physiological responses of living systems to homeopathically potentized solutions. For example, in the 1920s a German researcher conducted a series of studies spanning 12 years in which he showed periodic variations in the growth patterns of plants that had been exposed to a series of homeopathic dilutions of metallic salts (Kolisko, 1932). With the focus of modern biological laboratory research on cellular and organ function, homeopathic studies have more recently been conducted in this area. Such laboratory studies have shown positive effects of homeopathically prepared microdoses on mouse white blood cells (Davenas et al., 1987), arsenic excretion in the rat (Cazin et al., 1987), bleeding time with aspirin (Doutremepuich et al., 1987), and degranulation of human basophils--blood cells that mediate allergic reactions--(Davenas et al., 1988; Poitevin et al., 1988).

Furthermore, recent clinical trials in Europe have suggested a positive effect of homeopathic medicines on such conditions as allergic rhinitis (Reilly et al., 1986), fibrositis (Fisher et al., 1989), and influenza (Ferley et al., 1989), while an earlier study showed no apparent effect in the treatment of osteoarthritis by a homeopathic medicine (Shipley et al., 1983). The British Medical Journal published a meta-analysis in 1992 of homeopathic clinical trials, which found that 15 of 22 well-designed studies showed positive results. This study concluded that more methodologically rigorous trials should be done to address the question of efficacy of homeopathic treatment (Kleijnen et al., 1991). A recent double-blind study comparing homeopathic treatment with placebo in the treatment of acute childhood diarrhea found a statistically significant improvement in the group receiving the homeopathic treatment (Jacobs et al., 1993).

Homeopathic research study design has used different methodologies depending on the question being asked. One of the earliest studies of homeopathy in a peer-reviewed conventional medical journal asked the question, "Is the homeopathic medical system taken as a whole more effective or less detrimental than another treatment or placebo in the condition studied?" In this study, which focused on rheumatoid arthritis, 195 patients who had previously been treated with nonsteroidal anti-inflammatory drugs were allocated to placebo treatment or active treatment. The active-treatment population then was divided between aspirin and a homeopathic medication. The homeopathic doctors were allowed to prescribe any medication at whatever interval, frequency, or potency they considered appropriate.

The trial was conducted for a year, and by the end of the year almost 43 percent of the homeopathic treatment group had stopped other treatments and were judged to have improved since the beginning of the study. Another 24 percent of the homeopathic group improved, but they continued on their conventional medications. In contrast, only 15 percent of the aspirin group were maintained and improved on the treatment. The entire placebo group had dropped out within 6 weeks.

This study, however, was criticized on some methodological grounds--principally that the homeopathic prescribers were more committed to the treatment and the patients were easily able to determine who was in the placebo group (Gibson et al., 1978). Subsequently, the same researchers conducted another trial of this type, in which a specific disease was subjected to homeopathic treatment by any one of a number of clinically indicated homeopathic medications. This time, a placebo-controlled, double-blind study showed that the improvements among the homeopathically treated patients were statistically more significant than those of the placebo group (Gibson et al., 1980).

A second type of homeopathic study has been used to ask a more specific question, namely, Is a particular homeopathic medication more effective than another treatment or placebo for a particular disease? Fisher and colleagues (1989) asked this question in a study of primary fibromyalgia, a type of inflammation; patients who met recognized diagnostic criteria for fibromyalgia were further stratified as patients for whom a particular homeopathic medicine, rhus toxicodendron 6C, was homeopathically indicated. Patients with the active treatment were better on all variables, and a number of their tender points were reduced by 25 percent at the end of 4 weeks of active treatment in comparison with controls.

In a similar study, Reilly and colleagues (1986) used homeopathic medications with hay fever patients to address the issue of whether homeopathic medications are in fact placebos. The researchers directly treated matched groups of approximately 70 patients with a homeopathic medication made from mixed grass pollens at the dilution of one part in 1060. This was done to address the assertion that a potency lacking in any of the original substances could act as more than a placebo. Patients took one tablet twice daily of either placebo or the test drug and were free to use a standard antihistamine at any time during the 5-week study. Only the homeopathically treated group showed a clear reduction in symptoms, and in comparison with the placebo-treated group, twice as many of the homeopathically treated patients had discontinued their antihistamines. This study also demonstrated that even a simple study design requires careful analysis of potential confounding variables, including the clinical observations that some homeopathically treated patients experience temporary aggravation of their symptoms before achieving a sustained improvement.

A third type of study simply looks at comparative utilization figures for homeopathic practitioners in a health care system with or without attention to the comparative clinical outcomes. For example, in France, research on cost-effectiveness has shown that the annual cost to the social security system for a homeopathic physician is 54 percent lower than the cost for a conventional physician. Moreover, the same study found that the price of the average homeopathic medicine is one-third that of standard drugs (CNAM, 1991).

Research opportunities. Research into the basic science areas of quantum physics, physical chemistry, and biochemistry may determine whether a homeopathic medicine's mechanism of action can be elucidated. Existing studies of the effects of the succussion process on the physical-energetic nature of medicinal dilutions should be repeated and extended (Smith and Boericke, 1967). Moreover, modern-day herbal, biological, or pharmaceutically synthesized agents should be subjected to homeopathic "provings." This scientific documentation of effects and side effects in healthy people would enable new homeopathic drug development.

Evaluating the clinical efficacy of homeopathy using randomized, double-blind clinical trials for the treatment of acute problems such as diarrhea, otitis media, and postoperative pain as well as for chronic illnesses is a fertile area for research. Existing studies should be repeated with different investigators, giving attention to rigorous methodology. Special emphasis should be given to research in areas where modern medicine does not have an established, satisfactory solution, such as arthritis, AIDS, asthma, headaches, and inflammatory bowel disease.

More clinical research also needs to be directed toward analyzing and improving the accuracy of the clinical data in the homeopathic literature, much of which is currently at least a century old. Indeed, homeopaths in Great Britain are currently establishing a system using a modern, computerized medical database and standardized subjective and objective outcome measures to analyze the outcomes of patients treated with various homeopathic medications (van Haseln and Fisher, 1990). This sort of study will help homeopathic clinicians to investigate the differential efficacy of various homeopathic medications and allow for an updating of the prescribing criteria for various medications in the homeopathic materia medica.

In addition to clinical trials on conditions with specific diagnoses, studies also need to be done to evaluate the possible benefits of long-term treatment with the system of homeopathic medicine. Since proponents of this discipline claim that homeopathy improves overall physical and mental health, health status indicators should be used to evaluate changes in health in patients treated this way for several months or years.

Recent surveys in the United States found that most homeopathic patients seek care for chronic illnesses (Jacobs and Crothers, 1991) and that homeopathic physicians spend twice as much time with their patients, order half as many laboratory tests and procedures, and prescribe fewer drugs (Jacobs, 1992). Since treatment of chronic illness accounts for a large proportion of health care expenditures in the United States, the cost-effectiveness of homeopathic medicine should be investigated by comparing homeopathy with conventional treatments for specific chronic illnesses such as recurrent childhood ear infections, allergies, arthritis, headaches, depression, and asthma. Clinical outcomes should be measured as well as such factors as utilization of health services, number of missed days of work or school, patient satisfaction, and overall cost of health care. This research will help determine whether incorporating homeopathy into the national health care scheme would significantly reduce health care costs.

Anthroposophically Extended Medicine

Overview. The foundations of anthroposophically extended medicine were laid down by the Austrian philosopher and spiritual scientist Rudolf Steiner, Ph.D. (1861-1925). Steiner's "anthroposophy" (anthropos [human]; sophia [wisdom]) proposed a philosophical or spiritual-scientific model of human individuality. He took rigorous precision and methodologies of scientific empiricism and extended them into the spiritual domain, into what he called the "supersensible world," the domain underlying all human life, thought, and physical well-being. Steiner's theories were applied to agriculture (biodynamics), education (Waldorf Schools), and social theories (threefold social order) as well as art, painting, sculpture, dance (eurythmy), architecture, music, and speech (e.g., for performance, education, and therapeutics).

In the 1920s Ita Wegman, M.D. (a Dutch physician, 1876-1943), and Steiner coauthored a foundational work for physicians seeking to broaden their medical practice according to these anthroposophical principles (Steiner and Wegman, 1925). Steiner's intention was to outline a "rationally exact medical mode of thinking" as part of his larger, lifelong program of approaching issues of spiritual knowledge as a scientist. He gave an extended series of lectures and training courses for physicians, nurses, social workers, and pastoral counselors. This effort to extend therapeutics through the anthroposophical paradigm was based on Steiner's 34 years of work with the scientific method and encompassed therapeutic efforts based on botany, anatomy, natural sciences, and the dynamics of healing. Steiner and his physician followers attempted to reorient medical therapeutics so that they would encompass the spiritual depths of human existence. "Medicine will be broadened by a spiritual conception of man to an art of healing or else it will remain a souless technology that removes only symptoms. Through the concrete inclusion of the spirit and soul of man, a humanization of medicine is possible" (Wolff, undated).

As an extension of Western medicine, anthroposophical medicine builds on three preexisting movements and therapeutics. The first is natural medicine or naturopathy, which involves the use of material substances in nondegraded, non-chemically separated forms. Naturopathy, established in Europe in the early 19th century, is now practiced in an increasing number of States in the United States (see below). The second foundation is homeopathy, introduced by the German physician Samuel Hahnemann in the 18th century (see the "Homeopathic Medicine" section). The third foundation for anthroposophical medicine is modern scientific medicine itself. Steiner insisted that anthroposophically extended medicine be practiced only on the foundation of a Western medical training and credentials, and thus only M.D.s could become anthroposophical physicians.

Estimates of the number of M.D.s who mainly or exclusively practice anthroposophical medicine range from 1,000 to 6,000 worldwide with between 30 and 100 such physicians in the United States (Ministry of Science and Technology, Federal Republic of Germany, 1992; Scharff, 1993). Most practitioners are concentrated in Switzerland, Germany, Sweden, and Holland, and there are more than a dozen hospitals and clinics in Europe specializing in anthroposophically extended medicine. The Witten-Herdecke Medical School, established in 1983 near Dortmund, Germany, teaches anthroposophical medicine and grants M.D. degrees. Efforts are under way to formally certify physicians with anthroposophical training, and the Board of the American College of Anthroposophically Extended Medicine has been established in the United States (Scharff, 1993).

Hundreds of uniquely formulated medications are used in anthroposophical practice. Some are prepared by a multiple dilution and succussion (potentization) process, which is similar to that used in standard homeopathic pharmaceuticals. About 85 percent of the remedies are such potentized preparations, and the remaining 15 percent are similar to other botanical or traditional herbal medicines. All the basic substances go through a standardized pharmaceutical process and are made into remedies according to the official pharmacopoeia of the country of manufacture. The preparation of medications seeks to match the "archetypal forces" in plants, animals, and minerals with disease processes in humans and, through this correspondence, to stimulate healing.

Two major pharmaceutical firms prepare anthroposophical medications for physicians around the world: Waleda and Wala, which are both located in Europe with subsidiaries in many countries, including the United States. Use of these products is not limited exclusively to anthroposophical medicine specialists. In the United States approximately 300 physicians regularly order anthroposophical pharmaceuticals, while in Germany up to 15,000 physicians prescribe these products, mainly preparations of the mistletoe plant for treatment of cancers (Ministry of Science and Technology, Federal Republic of Germany, 1992).

Today, anthroposophical physicians augment conventional science by including new scientific approaches to the living processes of nature, the soul, and the human spirit. One model for approaching this task is to identify three different interdependent aspects of a human's body-mind processes. First, the "sense-nerve" system, which includes the nervous system and the brain organization that support the mind and the thinking process. Second, there is the "rhythmic" system, which includes physical processes of a rhythmic or periodic nature (e.g., the pulse, breathing, intestinal rhythms) and supports the emotional or feeling processes. Third is the "metabolic-limb" system, which includes digestion, elimination, energetic metabolism, and the voluntary movement processes. This third system supports the aspects of human behavior that express the will.

This threefold model gives the physician a diagnostic scheme for understanding an illness as a deviation from the harmonious internal balance of the functions of the bodily self and the spiritual self. In this approach, a person's physical, human makeup is seen as continually interacting with the soul or spiritual nature of that person. This anthroposophical model is used by practitioners as a creative entry for therapeutic insight into what are now recognized as the processes of mind-body interactions in health and disease.

Research base. Much of the research in the field of anthroposophically extended medicine has been connected with attempts to understand the nature of disease, assess it qualitatively, and understand how the essential properties of the objects under investigation could be applied in therapy. For instance, Steiner suggested that mistletoe might have a role in cancer therapy. It was observed that mistletoe had unusual biological properties as a relatively undifferentiated plant as well as a tendency to show regular rhythmic changes in both a seasonal and a lunar cycle. From this observation came an extensive series of studies in Europe on iscador, iscucin, abnoba, vysorel, and helixor, cancer remedies made from mistletoe. This work suggests that these mistletoe remedies can stimulate the body's immunological defense systems and act as chemostatic agents to prevent further growth of tumors. Mistletoe extracts have been analyzed for their chemical fractions, which include lectins, polysaccharides, and proteins. A review of 36 controlled clinical trials using mistletoe in cancer therapy showed six as statistically significant, having results pointing to a life-extending effect (Keine, 1989). (See the "Pharmacological and Biological Treatments" chapter and the "Research Methodologies" chapter for further information on mistletoe research.)

In recent years, collaboration between anthroposophical scientists and established university-based researchers has led to improvement in the quality and mutual acceptability of "unconventional" anthroposophical research in Germany. Of particular note is the work done by Professor G. Hildebrandt and his colleagues at the University of Marburg. In the past 30 years they have contributed more than 500 papers to the world's scientific literature, placing particular emphasis on the chronobiology (biorhythms) of body physiology in stress, disease, and therapy (Hildebrandt and Hensel, 1982; Hildebrandt, 1986). An example of the application of this line of research is shown by the work of von Laue and Henn, who reported studies of the time rhythms of cancer patients and tumor growths and how these abnormal rhythmic functions in cancer could be altered with mistletoe therapy (von Laue and Henn, 1991).

The qualitative and analytical aspects of anthroposophical research are further illustrated in the psychosomatic field by the work of Fischer and Grosshans with colitis patients at Herdecke Hospital. They conducted a structured interview with 60 patients admitted with ulcerative colitis or Crohn's disease (inflammations of the bowel) for a 2-year period and found that in addition to the well-known physical characteristics of these two diseases, the patients displayed other characteristic behaviors, including distinct underlying mood tendencies, communication styles, self-perceptions, and typical attitudinal relationships to past and future events. These psychological responses differentiated the Crohn's disease and ulcerative colitis patients along a pattern that could be interpreted as a parallel to the clinical symptoms (Fischer and Grosshans, 1992).

Cost and effectiveness issues in health care delivery are important in European countries as well as the United States. In Germany, von Hauff and Praetorius, an economist and a political scientist, conducted a pilot study (1990) on the performance structure of alternative medical practices. They used a nonrandom poll of established practitioners of conventional, homeopathic, or anthroposophical practices and were able to qualitatively analyze the practices under consideration as well as show quantitative differences in health care utilization. They found that the patients being treated by homeopathic and anthroposophical practitioners claimed 30 percent to 50 percent fewer illness days, respectively, than patients being treated by conventional practitioners. Furthermore, the homeopathic and anthroposophical practices had fewer referrals for hospitalization, fewer referrals to specialists, and fewer laboratory tests.

Research opportunities. Anthroposophical physicians approach issues of medical research by stressing basic methodological issues. For instance, the current dominant model of medical practice based on classical physics is seen as inadequate for understanding the laws of living organisms. This criticism extends to clinical research, where anthroposophical principles emphasize the overall therapeutic strategies being studied and not the isolated effect of specific chemical medicines. A truly scientific research agenda, according to the anthroposophical approach, must match the study methods and questions posed with the subject under investigation. In other words, inorganic systems require one type of science, living organic systems require another, psychological processes another, and intellectual-spiritual activities yet another. Although a single rational scientific method may be valid throughout these various domains of human endeavor, the specific nature of the scientific approach must be different and appropriate to the context of each domain. A recent poll in Germany of anthroposophical physicians identified this methodological issue as the major problem for future medical research (Ministry of Science and Technology, Federal Republic of Germany, 1992).

Particular areas of recommended research for anthroposophical medicine include the following:

* Establishing comprehensive valid criteria for assessing quality-of-life outcomes in therapy trials.

* Conducting comparison trials of isolated active ingredients versus extracts from the whole plant.

* Comparing a single-therapy approach to a combination-therapy approach (e.g., medical treatment, diet, and curative eurythmy artistic therapies for groups of patients with given clinical conditions).

* Documenting the effect of the use of anthroposophical remedies from a chronobiological perspective.

* Prospectively evaluating the effect of using anthroposophical methods for early detection and correction of tendencies toward illness before they manifest as serious pathology requiring expensive medical interventions.

Naturopathic Medicine

Overview. As a distinct American health care profession, naturopathic medicine is almost 100 years old. It was founded as a formal health care system at the turn of the century by a variety of medical practitioners from various natural therapeutic disciplines. By the early 1900s there were more than 20 naturopathic medical schools, and naturopathic physicians, called "eclectic" physicians at the time, were licensed in most of the States. After the Flexner Report in 1910 and the rise in belief that pharmaceutical drugs could eliminate all disease, the practice of naturopathic medicine experienced a dramatic decline. It has experienced a resurgence in the past two decades, however, as a health-conscious public began to seek natural therapies delivered by professionals skilled in these modalities.

Today, there are more than 1,000 licensed naturopathic doctors (N.D.s) in the United States. Currently, there are two accredited U.S. naturopathic medical schools: the National College of Naturopathic Medicine (NCNM) in Portland, OR, and Bastyr College of Natural Sciences in Seattle, WA, which graduate approximately 50 physicians each per year. A third naturopathic medical school, Southwest College of Naturo-pathic Medicine in Scottsdale, AZ, began classes in September 1993. Seven U.S. States and four Canadian provinces grant licenses to practice naturopathic medicine. In addition, a number of other States have legal statutes that allow the practice of naturopathic medicine within a specific context. The American Association of Naturopathic Physicians publishes the Journal of Naturopathic Medicine, which includes articles on original research, research reviews, and news and review articles relating to naturopathic medicine.

As it is practiced today, naturopathic medicine integrates traditional natural therapeutics--including botanical medicine, clinical nutrition, homeopathy, acupuncture, traditional oriental medicine, hydrotherapy, and naturopathic manipulative therapy--with modern scientific medical diagnostic science and standards of care. Naturopathic physicians are trained in anatomy, cell biology, nutrition, physiology, pathology, neurosciences, histology, pharmacology, biostatistics, epidemiology, public health, and other conventional medical disciplines, and they receive specialized training in the alternative medicine disciplines. They integrate this knowledge into a cohesive medical practice and tailor their approaches to the needs of an individual patient according to these eight primary principles:

1. Recognition of the inherent healing ability of the body.

2. Identification and treatment of the cause of diseases rather than mere elimination or suppression of symptoms.

3. Use of therapies that do no harm.

4. The doctor's primary role as teacher.

5. Establishment and maintenance of optimal health and balance.

6. Treatment of the whole person.

7. Prevention of disease through a healthy lifestyle and control of risk factors.

8. Therapeutic use of nutrition to promote health and to combat chronic and degenerative diseases.

Research base. Medical research on naturo-pathic practice is based on the empirical documentation of treatments with case history observations, medical records, and summaries of practitioners' clinical experiences. Naturopathic physicians have conducted scientific research in natural medicines in China, Germany, India, France, and England as well as U.S. research in clinical nutrition.

The two current accredited naturopathic medical schools have active research departments. For example, NCNM participated in a 10-year nationwide study of the cervical cap as a method of birth control. Study conclusions were submitted to the FDA (National College of Naturopathic Medicine Clinical Faculty, 1991). Naturopathic researchers also have investigated the pharmacology and physiological effects of nutritional and natural therapeutic agents (Barrie et al., 1987a, 1987b; Mittman, 1990). Digestive tract stresses and their treatment with natural methods also have been a focus of study (Blair et al., 1991; Collins and Mittman, 1990; Thom, 1992), and naturopathic physicians have been active in the investigation of new homeopathic remedies (Brown and Lange, 1992).

Naturopathic medical researchers have shown a particular interest in the natural treatment of women's health problems. One series of clinical research studies evaluated a naturo-pathic treatment protocol for women with cervical dysplasia (abnormal Pap smears). All subjects received oral nutritional and botanical supplementation, local topical cleansings, and suppositories made from herbal and nutritional agents (Hudson, 1991). Eight distinct naturopathic protocols were used depending on the severity of the abnormal Pap smears. Treatment included topical applications of Bromelia, Calendula, zinc chloride, and Sanguinaria. Additional home treatments included vaginal suppositories with myrrh, Echinacea, Usnea, Hydrastis, Althaea, geranium, and yarrow. The patients also used vitamin A suppositories, vitamin C, beta-carotene, folic acid, selenium, and Lomatium systemically as well as a botanical formula including (a) Trifolium, (b) Taraxacum, (c) Glycyrrhiza and Hydrastis, or (d) Thuja plus Echinacea and Ligustrum (Hudson, 1993b).

Of the 43 women in the study, 38 returned to normal Pap smears and normal tissue biopsy. Three had partial improvement, two showed no change, and none progressed toward more advanced disease states during treatment (Hudson, 1993a). It was suggested that partial use of these protocols might also benefit the long-term outcome in patients undergoing conventional treatment of cervical dysplasia including cryosurgery, conization, or loop electrosurgical excision procedures.

The most recently completed naturopathic study in women's health tested the clinical and endocrine effects of a botanical formula as an alternative to estrogen replacement therapy. Results of this study suggest a clinically significant benefit (measured as reduction in the total number of menopausal symptoms) in 100 percent of the women versus 17 percent in the placebo group (Hudson and Standish, 1993).

Future research opportunities. The following areas in the field of naturopathy offer the best opportunities for yielding significant research results:

* Clinical trials on naturopathic botanical formulas as an alternative to hormone replacement therapy.

* Effects of individual herbs on specific disease, for example, Glycyrrhiza for peptic ulcer disease, Crataegus for hypertension, Echinacea as an antiviral, Ulmus fulva for irritable bowel, and Taraxacum as a diuretic.

* Evaluations of the postsurgical outcomes of patients who have used naturopathic medicine to accelerate healing and improve their recovery.

* Evaluations of naturopathic protocols for treatment of hyperlipidemia, cervical dysplasia, otitis media, diabetes, and hypertension.

* Clinical trials on the outcome of breast cancer patients who use naturopathic medicine with their conventional therapy versus patients who use only conventional treatment.

* Facilitation of research into ethnomedicines by documenting oral traditions and studying them in the context of their cultures--for example, hydrotherapy and European traditions, native plants of developing countries and their local use by native healers, and traditional diets of native peoples.

* Clinical trials to evaluate the effectiveness of combination naturopathic medical protocols and rigorous evaluation of single-agent botanical medicines and naturopathic modalities in the treatment of HIV and AIDS.

Environmental Medicine

Overview. Environmental medicine is an alternative system of medical practice based on the science of assessing the impact of environmental factors on health. It is the result of continuing study of the interfaces among chemicals, foods, and inhalants in the environment and the biological function of the individual.

Environmental medicine traces its roots to the practice of allergy treatment. In the 1940s Theron Randolph, the founding father of environmental medicine, identified a wide range of medical problems he believed were caused by food allergies. Working with the techniques developed by Herbert Rinkel, Randolph identified multiple symptoms due to a variety of common foods such as corn, wheat, milk, and eggs--symptoms previously unrecognized as caused by food exposure. Using Rinkel's method of unmasking food allergies by avoiding the suspect food for at least 4 days before challenging, Randolph was able to identify food-related triggers for symptoms such as arthritis, asthma, depression and anxiety, enuresis, colitis, fatigue, hyperactivity, and others (Randolph, 1962).

In the 1950s Randolph noted that in small amounts, chemicals such as natural gas, industrial solvents, pesticides, car exhaust, and formaldehyde were also responsible for significant and previously unrecognized health problems (Randolph, 1962). It was noted that certain individuals were more sensitive to these minute exposures and that illness could be triggered in such hypersensitive individuals by amounts of chemicals that most people could tolerate without apparent symptoms.

Many of the findings of Randolph and others were originally identified through the use of environmental control units (strictly controlled environments in hospitals). In these settings, patients' allergies and sensitivities were unmasked through fasting and complete avoidance of incitant chemicals. When foods or chemicals were introduced in a systematic fashion, cause and effect could be identified. Today there are several environmental control units in the United States and a Canadian Government-sponsored unit in Nova Scotia, Canada.

Through careful and detailed environmentally focused clinical observations of thousands of patients, Randolph and others developed a new model and associated clinical principles that helped explain and treat many of the complex problems seen in medical practice today. By assessing the interaction between the individual's internal state and exposure to external factors, the physician may understand the cause of an illness. This type of medical practice goes beyond traditional medical concepts because it emphasizes the effects of food and chemicals in health.

The problems treated by environmental medicine include both diagnosis of problems that are traditionally considered allergic problems--asthma, hay fever, allergic rhinoconjunctivitis, eczema, and anaphylactic food allergies mediated by immunoglobulin E (IgE) antibody as well as other factors--and other diagnoses for which the underlying immunological aspects are not yet understood: arthritis, colitis, depression, fatigue, attention deficit disorder, cardiovascular disease, migraine and other headaches, urinary tract disorders, and other functional illnesses.

Of particular importance is the recognition of the effects of chemicals in the home and workplace, such as in the "sick building syndrome." With the changing environment found in workplaces and homes as well as outdoors, the incidence of environmentally triggered illness has increased. Chemically induced environmental illness is already affecting 4 million to 5 million Americans, and it is estimated that no more than 5 percent have been identified and treated. If patients with problems stemming from environmental exposure are not seen by a physician knowledgeable in environmental illness, they are often misdiagnosed or told they have psychiatric problems or hypochondriases (Randolph and Moss, 1980; Rea and Mitchell, 1982).

In 1965, Randolph and his colleagues founded the Society for Clinical Ecology to further explore the connection between the environment and illness. Today, courses organized by the American Academy of Environmental Medicine are available for training in the techniques and principles of this field. This organization, the successor to the Society for Clinical Ecology, has annual scientific meetings to further research and education. It publishes the peer-reviewed journal Environmental Medicine (formerly Clinical Ecology).

Today, environmental medicine is a medical specialty practiced by more than 3,000 physicians worldwide, most of them in the United States, Canada, and Great Britain. Many of these clinicians and researchers are members of one of the following professional medical organizations: the American Academy of Environmental Medicine, the Pan American Allergy Society, or the American Academy of Otolaryngologic Allergy. More than 50 percent of the members in the American Academy of Environmental Medicine are board certified in one or more of 19 medical specialties. The binding factor in these diverse physicians' backgrounds is an expanded view of health and illness, including an emphasis on the role the environment plays in a wide variety of medical disorders. This view of health and illness allows environmental medicine to be considered as an "alternative system" of medical practices developed from within the Western heritage of biomedical science.

Principles of environmental medicine. Many complex problems in medicine are called idiopathic: there is no readily apparent cause for the illness. The conventional medical model holds that similar illnesses have the same cause in all patients and should be treated similarly. This is not the case in the paradigm of environmental medicine.

Environmental medicine recognizes that illness in the individual can be caused by a broad range of inciting substances, including foods; chemicals found in the home and workplace; chemicals in air, water, and food; and inhalant materials, including pollens, molds, dust, dust mites, and danders. Individual susceptibility to these exposures can vary widely. The response to these exposures over time is specific to each person's own level of susceptibility and can manifest differently from person to person. Therefore, the specific symptoms and illnesses developed depend on all these factors, and environmental medicine attempts to answer the question why a particular patient has a particular symptom at a particular time.

One key to understanding the diagnosis in environmental medicine is a detailed chronological history. The emphasis of this history is on environmentally focused events and stressors over time. A thorough medical history and a physical examination are also needed. The detail of the home and work environment is explored to identify possible incitants.

The factors contributing to the sensitivity of the patient are related to genetics, nutritional status, effectiveness of detoxification pathways, and total allergic and chemical load at the time. Biochemical individuality determines the adequacy of nutritional stores and influences the ability to operate the detoxification pathways effectively and thus contributes to the individual's degree of sensitivity. Other factors that can induce immune system dysfunction, such as emotional stress, may have a major impact on the outcome of an exposure to a chemical toxin, a food exposure, or an inhalant contact.

The onset of illness coincides with the person's inability to continue coping with the total allergic load. This onset can occur either with a large acute exposure or with low-level, gradual exposures. The total allergic load is defined as the total level of exposure to substances that the person can be sensitive to, and it varies significantly over time. The total allergic load is often the determining factor in maintaining health (homeostasis) versus falling ill.

Environmental medicine practitioners believe that large amounts of toxic substances affect all those exposed, but minute amounts affect only those who are susceptible to the material. This fact explains the varied response to a material such as formaldehyde; 10 percent of the population is highly sensitive to small amounts of this poison and 90 percent is not. Thus, a susceptible person may get sick from a small workplace exposure, while others who are not susceptible suffer no ill effects. This situation often leads to missing a diagnosis while ignoring the patient's individual susceptibility. Indeed, many patients and physicians are unaware of the effects of chemical exposures as a contributing factor in illnesses. As a result, patients are often labeled "hypochondriacs" or told their illness is psychosomatic ("all in their mind") (Choffres, 1987; Davis, 1985; Saifer and Saifer, 1987).

Another concept that can help to explain the course of events in environmental illnesses is adaptation. Adaptation is the process by which the body attempts to maintain homeostasis. There are four distinct phases of adaptation: preadapted-nonadapted (alarm), adapted (masked), maladapted, and exhausted-nonadapted. The first three stages occur sequentially and if left uninterrupted can lead to the exhausted stage, or the onset of disease.

An example of adaptation phenomena is a sensitivity to wheat. At first exposure, wheat might cause symptoms such as fatigue (preadapted phase). After further exposure, the homeostatic mechanism creates an adapted state with no reactions. On further and frequent exposure, however, overt symptoms can occur (maladapted phase); for example, headaches to wheat may be labeled migraine and treated with medication. Eventually, with continued exposure, more serious symptoms can occur (exhausted phase). If the person stops being exposed to the food for at least 4 days and challenging (deadaptation) then causes the symptoms to reappear, cause and effect have been observed clearly. This sequence can also be seen with low-level chemical exposures.

Another observed phenomenon in environmental medicine is the spreading phenomenon. There are two aspects: (1) new onset of acute or chronic susceptibility to previously tolerated substances, and (2) spreading of susceptibility to new target organs. These events can occur with a single large exposure to a chemical that damages particular biological mechanisms and causes sensitivity to occur to other chemicals in addition to the primary incitant substance. This phenomenon is frequently seen with solvent or pesticide exposure causing a person to become a "universal reactor" to many other chemicals.

The type of symptoms experienced in the reaction to an offending substance (food, chemical, or inhalant) is not specific to the substance but is determined by a combination of factors specific to the person. In contrast, all individuals exposed to a highly toxic chemical have similar symptoms (e.g., respiratory symptoms from exposure to formaldehyde). Symptoms of sensitivity to small levels of exposure can affect many target organs; widespread central nervous system effects such as fatigue, depression, anxiety, or poor memory and concentration may occur and can differ from person to person. This observation often makes the cause of these problems extremely difficult to identify and underlines the need for the multifactorial approach, which is the basis of environmental medicine.

The final pattern described in environmental medicine is labeled the switch phenomenon. In this situation, symptoms change and can affect different organ systems; symptoms may range from psychological (e.g., anxiety) to asthma, fatigue, and hyperactivity. This movement of symptoms was described by Randolph as bipolar and bi-phasic responses of the biological mechanism ranging from stimulatory phases (+1 to +4) to withdrawal phases (-1 to - 4). It is possible to range from stimulation to withdrawal in the course of the illness (Randolph, 1976).

Diagnostic and treatment techniques. Several aspects of the assessment and treatment approaches employed in environmental medicine are unique to this specialty. The key to proper treatment is an accurate environmental history. With a broader view of the connection between environment and illness, many illnesses that are attributed to other causes by traditional medicine are assessed in terms of environmental aspects.

The environmental history details the chronology of the symptoms as well as the current form of the illness. Using the chronological history and the assessment of the detailed circumstances of the symptoms can lead to a greater understanding of the etiology. There is a search for a history of adverse reactions to specific environmental substances, including biological inhalants, foods, and chemicals. A detailed description of the home, the workplace, and the effects of season, activity, and other environmental factors is necessary. A thorough understanding of the pathophysiology of the dysfunctioning systems is also required. The effects of total allergic load, the spreading phenomenon, the switch phenomenon, and biochemical individuality need to be recognized so that the etiology of the illness can be assessed.

The physical examination and laboratory assessment look for evidence of nutritional deficiencies, organ system dysfunction, and disorders of detoxification systems. Blood tests might include standard assessments such as chemistry panels, blood counts, and hormonal function tests. In addition, tests that further assess immune function are required, such as lymphocyte subset panels, immunoglobulin levels, autoantibody screens, viral and chemical antibody panels, and in vitro assessment of allergy to foods, inhalants, and chemicals. Furthermore, assessment of nutritional status is often included, involving in vitro analysis of minerals and vitamins through enzyme system activation, as well as serum, plasma, leukocyte, or erythrocyte levels. Levels of toxic chemicals and minerals may be measured in serum or other biological markers.

In-office testing for allergies and hypersensitivity is often the most important aspect of assessing a patient with environmental illness. The techniques employed include serial end-point titration, provocative neutralization, and bronchoprovocation. These techniques test a wide range of antigens including bacteria, foods, chemicals, and inhalants such as dust, mites, pollens, and molds. The antigen sources are the same ones used in traditional allergy testing, but these techniques can more effectively assess the non-IgE sensitivity reaction (King, 1989; McGovern, 1981; Miller, 1972; Morris, 1981; Rinkel, 1963). Although the validity of these techniques is controversial, a significant number of studies support these approaches (Brostoff, 1988; Gerdes, 1993; King, 1981).

Provocative testing is in essence a quantitative bioassay. Individual skin tests with progressively weaker blinded dilutions of extract can reproduce many of the patient's symptoms. Subjective and objective monitoring can show changes in heart rate, blood pressure, nasal patency, respiratory function, cognitive function, and handwriting during and after single allergy tests.

When complex patients cannot be evaluated as outpatients, inpatient environmental control units are available in several locations in the United States and Canada. In these settings, the patients are in hospital rooms that are environmentally controlled and are free of all common chemical exposures. They are fasted on water until all symptoms disappear. At this point, they are challenged with foods by mouth and with chemicals in inhalant booths. The symptomatic response to these substances can help clarify the cause of the illness.

Treatment approaches to these complex problems require a full understanding of the nature of environmentally induced illness. Immunotherapy based on the results of the in vivo allergy testing techniques can be used to reduce the sensitivity to these antigens through a variety of mechanisms, including modulation by T-suppressor cells and altering the ratio of antibody to antigen, which affects the formation of immune complexes and histamine release (Rapp, 1986).

Educating the patient is critical in environmental medicine. A thorough understanding of the factors contributing to illness must be emphasized for long-term improvement to occur. Emphasis is placed on environmental controls in the home and workplace to reduce exposure to inhalants as well as chemicals. Where possible, the patient is informed about alternatives to using chemicals such as pesticides in the home and the workplace.

Dietary management is based on avoidance of food antigens and on the 4-day rotary diversified diet. With the rotary diet and avoidance of repetitive food exposures, it is possible to reduce sensitivity to foods and hasten recovery from food allergies. Nutritional supplements are p