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Development of therapeutics: opportunities within complementary and alternative medicine


Whereas other components of the National Institutes of Health support the discovery and subsequent development of novel chemical entities into drugs, the National Center for Complementary and Alternative Medicine (NCCAM) studies complex natural products that are marketed as dietary supplements. This article contrasts the regulatory framework for dietary supplements and drugs, outlines the challenges of evaluating dietary supplements for safety and clinical effectiveness, and describes the evolving drug model for botanicals.

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Figure 1: Growth of CAM visits.
Figure 2: Artemesia and Cassia plants.
Figure 3: Stages in the development of conventional drugs and CAM products.
Figure 4: Intended use defines the US regulatory classification (example: claims for garlic products).
Figure 5: A hierarchy of evidence.
Figure 6: Regulatory approaches for a botanical product.


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The authors thank I. Scott–Bass, J. Betz, R. Temple, J. Thompson and R. Upton for their critical reading of the manuscript and helpful input. We are especially grateful to J. Tisch for meticulously researching background materials.

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Correspondence to Linda W. Engel.

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Complementary and Alternative Medicine, House of Lords Session 1999–2000

Exploring Opportunities for Collaboration with Industry

Guidance for Industry: Botanical Drug Products

The NCCAM Five-Year Strategic Plan, 2001–2005

The NIH NCCAM web site



Ayurveda is India's traditional system of medicine. Ayurvedic medicine (meaning “science of life”) is a comprehensive system of medicine that places equal emphasis on the body, mind and spirit, and strives to restore the innate harmony of the individual. Some of the primary Ayurvedic treatments include diet, exercise, meditation, herbs, massage, exposure to sunlight and controlled breathing.


The Bayh–Dole Act of 1980 guarantees organizations/investigators the right to patent and retain title to their inventions from research sponsored with government funds. The law was enacted to promote the transfer, commercialization and utilization of federally funded technologies.


A process for monitoring a body function (such as breathing, heart rate and blood pressure), and altering the function through relaxation or imagery.


(CMCs). Extensive, detailed documentation of the drug under study, including its structural formula, animal-testing results and manufacturing information, all of which are required for an investigational new drug (IND) application.


A system of treatment that is based on the relationship between structure (primarily the spine) and function, and how that relationship affects the preservation and restoration of health.


(CRADA). A provision of the Federal Technology Transfer Act of 1986 that permits the directors of government-operated Federal laboratories to enter into cooperative research and development agreements on behalf of such agencies with other Federal agencies, units of state or local government, industrial organizations, public and private foundations, and nonprofit organizations (including universities).


A dietary supplement is a product that: contains one or more ingredients (such as vitamins and minerals, and herbs or botanicals) that is intended to supplement the diet; is intended for human use; is a tablet, capsule, powder or some other form that is “not represented as conventional food [or] for use as a sole item of a meal or diet,”; passes through the alimentary canal; and was not a new drug or biological before being marketed as a dietary supplement or food in this country.


(GMPs). Systems, processes and controls that are used in the manufacture of consumer products, particularly FDA-regulated products, that help to ensure the quality of finished goods.


Plants or plant products that produce or contain chemicals that act on the body.


Individual herbs or mixtures of herbs that are used for therapeutic value.


A Western system of medicine that is based on the principle that 'like cures like', — that is, the same substance that in large doses produces the symptoms of an illness, in very minute doses cures it. Homeopathic physicians believe that the more dilute the remedy, the greater its potency. Therefore, homeopaths use small doses of specially prepared plant extracts and minerals to stimulate the body's defence mechanisms and healing processes in order to treat illness.


A request for authorization from the US Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.


The manipulation of the soft tissues of the body to normalize those tissues.


A self-directed practice for relaxing the body and calming the mind in which the meditator makes a concentrated effort to focus on a single thought in order to still the mind's inclination to mull over the thousands of demands and details of daily life.


A system of treatment that views disease as a manifestation of alterations in the processes by which the body naturally heals itself. It emphasizes health restoration as well as disease treatment. Naturopathic physicians use an array of healing practices, including diet and clinical nutrition; homeopathy; acupuncture; herbal medicine; hydrotherapy (the use of water in a range of temperatures and methods of applications); spinal and soft-tissue manipulation; physical therapies involving electric currents, ultrasound and light therapy; therapeutic counselling; and pharmacology.


Qi (pronounced chi) gong is a component of traditional oriental medicine that combines movement, meditation and the regulation of breathing to enhance the flow of vital energy (qi) in the body, to improve blood circulation and to enhance immune function.


Meaning Universal Life Energy, Reiki is based on the belief that by channelling spiritual energy through the practitioner the spirit is healed, and it in turn heals the physical body.


A special diet therapy that is believed to prevent and/or control illness and/or promote health, such as those proposed by Drs Atkins, Ornish and Pritikin.


Therapeutic touch is derived from the ancient technique of 'laying-on of hands', and is based on the premise that it is the healing force of the therapist that affects the patient's recovery and that healing is promoted when the body's energies are in balance.


Traditional oriental medicine emphasizes the proper balance or disturbances of qi — or vital energy — in health and disease, respectively. Traditional oriental medicine consists of a group of techniques and methods, including acupuncture, herbal medicine, oriental massage and qi gong (a form of energy therapy).

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Engel, L., Straus, S. Development of therapeutics: opportunities within complementary and alternative medicine. Nat Rev Drug Discov 1, 229–237 (2002).

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