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Preface

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ecause of the increasing sophistication of the U.S. health care system, its increasing administrative costs, and the exponentially expanding degree of training and specialization required by the health care practitioners who administer it, health care costs in this country have skyrocketed in the past few decades. Indeed, in 1940, health care absorbed $4 billion, a mere 4 percent of the U.S. gross national product (GNP); by 1992, health care costs had ballooned to more than $800 billion, or almost 14 1 percent of GNP.1 Experts predict these costs will exceed $1 trillion this year.

Despite these expenditures, many Americans currently have little or no access to adequate health care. In fact, 37 million Americans have no health insurance at all; another 22 million have inadequate health care coverage. To increase access to basic health care, individuals and organizations from many sectors of society are now calling for reform of the present health care system. To date, this debate has focused mainly on making the current system less expensive through capping the amount of damages that can be awarded because of medical malpractice, limiting physician and hospital fees, further regulating the pharmaceutical companies, and controlling the misuse of health insurance.

Unfortunately, this debate has failed to take into account the fact that the current health care crisis is primarily a crisis of chronic disease. Today almost 33 million Americans are functionally limited in their daily activities by chronic, debilitating conditions such as arthritis, allergies, pain, hypertension, cancer, depression, cardiovascular disease, and digestive problems. More than 9 million, or almost one-third, of these individuals have limitations so severe that they cannot work, attend school, or maintain a household. The U.S. Public Health Service (PHS) estimates that 70 percent of the current health care budget is spent on the treatment of these individuals; as the

population grows older, such conditions will continue to consume an even larger proportion of national health care expenditures. Furthermore, the worldwide pandemic of acquired immunodeficiency syndrome is threatening to completely overwhelm the health care delivery systems in certain areas of the United States.

While the dominant system of health care in the United States-often called "conventional medicine," or biomedicine is extremely effective for treating infectious diseases and traumatic injuries, it is often ill equipped to handle complex, multifaceted chronic conditions. One reason is that over the years, conventional medicine has increasingly emphasized finding a single "magic bullet" solution for each condition or disease it confronts. The reality is that many chronic conditions are not amenable to such onedimensional solutions.

Rather, such complex conditions require equally multifaceted treatment approaches. Furthermore, it is far less expensive to prevent them from occurring in the first place than to attempt to treat the symptoms and consequences with surgery and expensive drugs, which often offer only shortterm solutions. For example, coronary artery disease affects approximately 7 million Americans and causes about 1.5 million heart attacks and 500,000 deaths a year. Approximately 300,000 coronary artery bypass graft operations are performed in the United States each year at a cost of about $30,000 each, or $9 billion total. Yet coronary artery bypass surgery prevents premature death in only a few patients with the most serious main coronary or multiple-vessel heart disease. On the other hand, heart disease is almost entirely attributable to poor diet (i.e., high fat intake) and unhealthy lifestyle decisions (alcohol consumption and smoking), and thus can be avoided. For those who already have heart disease, an extremely low-fat diet combined with exercise and other therapies may actually start

1Most of the statistics cited in this preface can be found in the publication Healthy People 2000: National Health Promotion and Disease Prevention Objectives, U.S. Department of Health and Human Services (DHHS Pub. No. PHS-91-50212), Washington, DC, 1990. Healthy People 2000 is the latest in a series of reports that have been developed by the U.S. Public Health Service since the early 1970s dealing with issues that affect the health of the Nation.

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unclogging blocked arteries and significantly extend life.

Thus, for health care reform truly to succeed at reducing costs and increasing access, disease prevention must be the ultimate focus of the primary health care system rather than disease treatment. This change in emphasis can be accomplished only by restructuring the current system so that people learn that they are far better off staying healthy than relying on high technology to rescue them from a lifetime of unhealthy living. In addition, to care adequately and costeffectively for those who already have chronic illnesses, health care reform must incorporate multifaceted approaches to the treatment of these patients, approaches that control the symptoms while alleviating the underlying causes.

In 1990, PHS recognized the need to completely revamp the current approach to health and illness when it released a 700-page report called Healthy People 2000. This report enumerated the challenges and goals for improving the Nation's collective health by the year 2000 and challenged the Nation to move beyond merely saving lives. It explained that "the health of a people is measured by more than death rates. Good health comes from reducing unnecessary suffering, illness, and disability. It comes from an improved quality of life. Health is thus measured by citizens' sense of well-being. The health of a Nation is measured by the extent to which the gains are accomplished for all the people." To reach this goal, the report called for "mobilizing the considerable energies and creativity of the Nation in the interest of disease prevention and health promotion" as an economic imperative.

This report was developed in the spirit of Healthy People 2000. Its purpose is to investigate which "alternative" health care options might best be mobilized to help in the fight against the major diseases and conditions that are robbing so many Americans of their quality of life. The individuals who helped write it comprised members of systems of medicine and therapies that emphasize improving quality of life, disease prevention, and treatments for conditions for which conventional medicine has few, if any, answers. Therefore, the popular term alternative has been chosen to describe these medical systems and therapies. Another term for these systems and therapies, which is preferred in Europe, is complementary medicine.

This report establishes a baseline of information on alternative medicine, which may be used to direct future research and policy discussions. Specifically, this report will aid OAM in its mandate to establish an information clearinghouse on alternative medicine so that the public, policymakers, and public health experts can make informed decisions about their health care options. The goal of OAM is to speed the discovery, development, and validation of potent treatments that may be added to the complementary wheel of alternatives currently available to patients and practitioners. Ultimately, it may provide the foundation for the development of a whole new system of medicine, one that incorporates the best of conventional and alternative medicines.

Brian M. Berman, M.D.

David B. Larson, M.D., M.P.H. Cochairs, Editorial Review Board December, 1994

Executive Summary

Introduction

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edicine in the United States evolved from a mix of Native American, East.ern, and European botanical traditions. In the mid-1800s, the medical system called biomedicine began to dominate. Biomedicine was shaped by the observations that bacteria were responsible for producing disease and characteristic pathological damage and that antitoxins and vaccines could improve a person's ability to ward off the effects of pathogens. With this knowledge, biomedical investigators and clinicians began to conquer devastating infections and to perfect effective surgical procedures.

Thus biomedicine became the "conventional," or mainstream, health care system and began setting the standards for the diagnosis and treatment of every facet of illness. Several decades ago, however, consumer trust in conventional medicine began to falter, and many Americans sought alternative treatments outside conventional medicine. Today, alternative medicine constitutes a significant portion of Americans' health care expenditures.

A number of barriers are preventing promising alternative therapies from being investigated and developed. Structural barriers are caused by problems of classification, definition, culture, and language. Regulatory and economic barriers include legal and cost implications of complying with Federal and State regulations. Belief barriers have been caused by constraining ideologies, misconceptions, and myths.

In late 1992, Congress established the Office of Alternative Medicine (OAM) within the Office of the Director, National Institutes of Health (NIH), to facilitate the fair, scientific evaluation of alternative therapies that could improve many people's health and well-being. OAM, as a de facto intermediary between the alternative medical community and the Federal research and regulatory communities, seeks to reduce barriers that may keep promising alternative therapies from coming to light.

Part I of this report examines six fields of alternative medicine: mind-body interventions, bioelectromagnetics applications in medicine, alternative systems of medical practice, manual healing methods, pharmacological and biological treatments, herbal medicine, and diet and nutrition in the prevention and treatment of chronic disease. Part II deals with a number of cross-cutting issues germane to all six fields, including research infrastructure, research databases, research methodologies, the peer review process, and public information activities. The major recommendations from all chapters are included at the end of this executive summary.

Part I, FIELDS OF PRACTICE

Mind-Body Interventions

Most traditional medical systems make use of the interconnectedness of mind and body and the power of each to affect the other. During the past 30 years there has been a growing scientific movement to explore the mind's capacity to affect the body. The clinical aspect of this enterprise is called mind-body medicine. Mind and body are so integrally related that it makes little sense to refer to therapies as having impact just on the mind or the body.

Mind-body interventions often help patients experience and express their illness in new, clearer ways. Distinctions between curing and healing have little place in contemporary medical practice but are important to patients. Perceived meaning has direct consequences to health. The placebo response is one of the most widely known examples of mind-body interactions in contemporary, scientific medicine, yet it is also one of the most undervalued, neglected assets in medical practice. That the placebo response relies heavily on the relationship between doctor and patient says a great deal about the importance of the doctor-patient relationship and the need to provide further medical training on understanding and using this relationship. The therapeutic potential of spirituality as well

as religion also has been neglected in the teaching and practice of medicine.

Interest in the mind's role in the cause and course of cancer has been substantially stimulated by the discovery of the complex interactions between the mind and the neurological and immune systems, the subject of the rapidly expanding discipline of psychoneuroimmunology. The profound differences in the psychological stances taken by people who survive cancer suggest that there is extreme variation both among cultures and within cultures.

Specific mind-body interventions include psychotherapy, support groups, meditation, imagery, hypnosis, biofeedback, yoga, dance therapy, music therapy, art therapy, and prayer and mental healing.

Psychotherapy directly addresses a person's emotional and mental health, which is, in turn, closely interwoven with his or her physical health. It encompasses a wide range of specific treatments from combining medication with discussion, to simply listening to the concerns of a patient, to using more active behavioral and emotive approaches. It also should be understood more generally as the matrix of interaction in which all the helping professions operate. Conventional psychotherapy is conducted primarily by means of psychologic methods such as suggestion, persuasion, psychoanalysis, and reeducation. It can be divided into general categories. All of the therapies can be undertaken either individually or in groups.

Research indicates that psychotherapeutic treatment can hasten a recovery from a medical crisis and is in some cases the best treatment for it. Psychotherapy also appears to be valuable in the treatment of somatic illnesses, in which physical symptoms appear to have no medical cause, are often improved markedly with psychotherapy. In addition, psychotherapy has been shown to speed patients' recovery time from illness. This, in turn, leads to smaller medical bills and fewer return visits to medical practitioners.

Support groups, as the research literature demonstrates, can have a powerful positive effect in a wide variety of physical illnesses, from heart disease to cancer, from asthma to strokes. Indeed, one study found that women with breast cancer who took part in a support group lived an average of 18 months longer (a doubling of the sur

vival time following diagnosis) than those who did not participate. In addition, all the long-term survivors belonged to the therapy group.

Support groups have two other major benefits: (1) they help members form bonds with each other, an experience that may empower the rest of their lives; and (2) they are low cost or even "no cost" (e.g., Alcoholics Anonymous).

Meditation is a self-directed practice for relaxing the body and calming the mind. Most meditative techniques have come to the West from Eastern religious practices, particularly India, China, and Japan, but can be found in all cultures of the world. Until recently, the primary purpose of meditation has been religious, although its health benefits have long been recognized. During the past 15 years, it has been explored as a way of reducing stress on both mind and body. Cardiologists, in particular, often recommend it as a way of reducing high blood pressure.

Some studies have found that regular meditation reduces health care use; increases longevity and quality of life; reduces chronic pain; reduces anxiety; reduces high blood pressure; reduces serum cholesterol level; reduces substance abuse; increases intelligence-related measures; reduces post-traumatic stress syndrome in Vietnam veterans; reduces blood pressure; and lowers blood cortisol levels initially brought on by stress.

Imagery is both a mental process (as in imagining) and a wide variety of procedures used in therapy to encourage changes in attitudes, behavior, or physiological reactions. As a mental process, it is often defined as "any thought representing a sensory quality." It includes, as well as the visual, all the senses-aural, tactile, olfactory, proprioceptive, and kinesthetic.

Imagery has been successfully tested as a strategy for alleviating nausea and vomiting associated with chemotherapy in cancer patients, to relieve stress, and to facilitate weight gain in cancer patients. It has been successfully used and tested for pain control in a variety of settings; as adjunctive therapy for several diseases, including diabetes; and with geriatric patients to enhance immunity.

Imagery is usually combined with other behavioral approaches. It is best known in the treatment of cancer as a means to help patients mobilize their immune systems, but it also is

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