FDA acknowledges Traditional Chinese Medicine(TCM) belonging to whole medical systems

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Whole Medical System

http://www.fda.gov/cber/gdlns/altmed.pdf

E. What Are whole Medical Systems?

NCCAM describes whole medical systems as involving complete systems of theory and practice that have evolved independently from or parallel to allopathic (conventional) medicine.?  These may reflect individual cultural systems, such as traditional Chinese medicine and Ayurvedic medicine. Some elements common to whole medical systems are a belief that the body has the power to heal itself, and that healing may involve techniques that use the mind, body, and spirit.

 

Introduction

http://nccam.nih.gov/health/backgrounds/wholemed.htm

Whole medical systems involve complete systems of theory and practice that have evolved independently from or parallel to allopathic (conventional) medicine. Many are traditional systems of medicine that are practiced by individual cultures throughout the world. Major Eastern whole medical systems include Traditional Chinese Medicine--A

whole medical system that originated in China.  It is based on the concept that disease results from disruption in the flow of qi and imbalance in the forces of yin and yang. Practices such as herbs, meditation, massage, and acupuncture seek to aid healing by restoring the yin-yang balance and the flow of qi. .....

 

 

Traditional Chinese Medicine

TCM is a complete system of healing that dates back to 200 B.C. in written form. Korea, Japan, and Vietnam have all developed their own unique versions of traditional medicine based on practices originating in China. In the TCM view, the body is a delicate balance of two opposing and inseparable forces: yin and yang The concept of two opposing yet complementary forces described in traditional Chinese medicine. Yin represents cold, slow, or passive aspects of the person, while yang represents hot, excited, or active aspects. A major theory is that health is achieved through balancing yin and yang and disease is caused by an imbalance leading to a blockage in the flow of qi.. Yin represents the cold, slow, or passive principle, while yang represents the hot, excited, or active principle. Among the major assumptions in TCM are that health is achieved by maintaining the body in a "balanced state" and that disease is due to an internal imbalance of yin and yang. This imbalance leads to blockage in the flow of qi In traditional Chinese medicine, the vital energy or life force proposed to regulate a person's spiritual, emotional, mental, and physical health and to be influenced by the opposing forces of yin and yang. (or vital energy) and of blood along pathways known as meridians. TCM practitioners typically use herbs, acupuncture A family of procedures that originated in traditional Chinese medicine. Acupuncture is the stimulation of specific points on the body by a variety of techniques, including the insertion of thin metal needles though the skin. It is intended to remove blockages in the flow of qi and restore and maintain health., and massage Pressing, rubbing, and moving muscles and other soft tissues of the body, primarily by using the hands and fingers. The aim is to increase the flow of blood and oxygen to the massaged area. to help unblock qi and blood in patients in an attempt to bring the body back into harmony and wellness.

Treatments in TCM are typically tailored to the subtle patterns of disharmony in each patient and are based on an individualized diagnosis. The diagnostic tools differ from those of conventional medicine Medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals such as physical therapists, psychologists, and registered nurses.. There are three main therapeutic modalities:

  1. Acupuncture and moxibustionIn traditional Chinese medicine, the use of heat from burning the herb moxa on or near the skin at an acupuncture point. Intended to stimulate the flow of qi and restore health. (moxibustion is the application of heat from the burning of the herb A plant or part of a plant used for its flavor, scent, or potential therapeutic properties. Includes flowers, leaves, bark, fruit, seeds, stems, and roots. moxa at the acupuncture point)
  2. Chinese Materia Medica (the catalogue of natural products used in TCM)
  3. Massage and manipulation

Although TCM proposes that natural products catalogued in Chinese Materia Medica or acupuncture can be used alone to treat virtually any illness, quite often they are used together and sometimes in combination with other modalities (e.g., massage, moxibustion, diet changes, or exercise).

The scientific evidence on selected modalities from TCM is discussed below.

Acupuncture
The report from a Consensus Development Conference on Acupuncture held at the National Institutes of Health (NIH) in 1997 states that acupuncture is being "widely" practiced--by thousands of acupuncturists, physicians, dentists, and other practitioners--for relief or prevention of pain and for various other health conditions.1 In terms of the evidence at that time, acupuncture was considered to have potential clinical value for nausea/vomiting and dental pain, and limited evidence suggested its potential in the treatment of other pain disorders, paralysis and numbness, movement disorders, depression, insomnia, breathlessness, and asthma.

Preclinical studies have documented acupuncture's effects, but they have not been able to fully explain how acupuncture works within the framework of the Western system of medicine.

It is proposed that acupuncture produces its effects by the conduction of electromagnetic signals at a greater-than-normal rate, thus aiding the activity of pain-killing biochemicals, such as endorphins and immune system cells at specific sites in the body. In addition, studies have shown that acupuncture may alter brain chemistry by changing the release of neurotransmitters and neurohormones and affecting the parts of the central nervous system related to sensation and involuntary body functions, such as immune reactions and processes whereby a person's blood pressure, blood flow, and body temperature are regulated.2,3

Chinese Materia Medica
Chinese Materia Medica is a standard reference book of information on medicinal substances that are used in Chinese herbal medicine.4 Herbs or botanicals usually contain dozens of bioactive compounds. Many factors--such as geographic location, harvest season, post-harvest processing, and storage--could have a significant impact on the concentration of bioactive compounds. In many cases, it is not clear which of these compounds underlie an herb's medical use. Moreover, multiple herbs are usually used in combinations called formulas in TCM, which makes the standardization of herbal preparations very difficult. Further complicating research on TCM herbs, herbal compositions and the quantity of individual herbs in a classic formula are usually adjusted in TCM practice according to individualized diagnoses.

In the past decades, major efforts have been made to study the effects and effectiveness of single herbs and of combinations of herbs used in classic TCM formulas. The following are examples of such work:

  • Artemisia annua. Ancient Chinese physicians identified that this herb controls fevers. In the 1970s, scientists extracted the chemical artemisinin from Artemisia annua. Artemisinin is the starting material for the semi-synthetic artemisinins that are proven to treat malaria and are widely used.5

     
  • Tripterygium wilfordii Hook F (Chinese Thunder God vine). Thunder God vine has been used in TCM for the treatment of autoimmune and inflammatory diseases. The first small randomized, placebo-controlled trial of a Thunder God vine extract in the United States showed a significant dose-dependent response in patients with rheumatoid arthritis.6 In larger, uncontrolled studies, however, renal, cardiac, hematopoietic, and reproductive toxicities of Thunder God vine extracts have been observed.