The Frog said: Chinese Medicine Counter !Ar 10 Obstacles of the development of TCM
Tradition Chinese Medicine Practice basically divides into three disciples:
Use of medication, including herbs, minerals, and animals, according to some orthodox formularies or some folk formula
Acupuncture °w¨b
Practice and use of "Qi" Éa(The internal flowing "Air"), and many small branches

The use of Traditional Chinese Medication according the Chinese medical theory is the mainstream among Chinese people, because it is traditional, relatively cheap, lack of side effects and claim to be able to treat many type of disease which the western medical approach cannot deal with effectively.

TCM is now getting more attention.  Because of the realization of limitation of western approach, people are seeking alternative approach to boost up the body against ageing, cancer, AIDS, and various immune diseases. TCM has fitted comfortably in these disease category by aiming to stimulate the body's support mechanism to enable it to heal itself.

After several successful clinical trial, e.g. St. John's Wort for the depression, Combination of Chinese herbs for Eczema, the use of TCM as an alternative approach is gaining ground among the West. Drug Trader are seeking opportunity to import TCM into the West as either health food product, or better as medicine to fill in the market.

The extent of TCM's world-wide significance was highlighted by the Chief Executive's Commission on innovation and Technology, and in his second Policy Address of October 1998 Tung Chee-hwa announced that Hong Kong needed to position itself to be a world centre for the development of health food and pharmaceuticals based on Chinese medicine. Besides, the new legislation to govern the practice, use and trading of Chinese medicine will soon be in place as the introduction of the Chinese Medicine Bill is scheduled for the first quarter of 1999.

However, after years of effort of integrating the TCM into the Western market, the impact is not that great. TCM reamins as a way to provide the lead compounds, but nothing more. Many obstacles, both internal and external, have to be overcome before the acceptance of TCM by the Westerner can be materialised.


Here are the summery of some of the major obstacles:

TCM
Internal Factors

1. Practising Theory

Disease causing theory are very different from the Western medicine's.
  • Concern with the harmony of the body, rather than disease causing agent
  • No specific target, by strengthen the body to combat the disease

  • The theory are based on the philosophical Chinese theory which may give an impression of unscientific reasoning.
    The terms for describing the theory are unfamiliar and difficult to understand by westerner.
    he terms used are rather unspecified and hard to do outcome measurement.
    Use combination of herbs rather than a single ingredient
    Poor understanding of general anatomy, microbiology and pharmacology

    2. Formulary
    No genuine orthodox documentation or formularies are established, practitioners tend to add "own" or folk remedy in addition to the traditional formula.
    Use in a combination of herbs, particular formula and dosage are according to the need of a particular patient. i.e. Standard dosage regimen are difficult to be established.
    Most of the effects of single herbs (or a single chemical component of such a herb) were never established
    Some of the special formularies are considered to be private and trade secret, unobtainable to the outsider.
    Special home made production are lengthy and troublesome.
    The decoction are often unpalatable to be drunk
    No standard method of naming ingredients: Scientific Latin names, common names and latinised pharmaceutical names , Chinese translated names are all used.
    Same name of the formula but with different types of herbs contained and/or with different strength.
    Most chinese proprietary medicines are not provided with sufficient information about the ingredient, strength, number of herbs, expire, dose instructions. Errors can be easily found in the number contained herbs, and in the strength.

    3. Quality Control
    The quality ( The component of active ingredients) of the raw material and product  may vary dramatically due to different species, cultivation method, region of plant, grow season, maturation, post treatment, storage, manufacturing techniques, combination of herbs and dosage form.
    Easy target of fungi and pest attack
    Need to obtain information of "marker" chemical in standardization process
    Herbs are easy misidentified.
    Adulterated or counterfeited TCM raw materials are not uncommon
    Reliable sources of raw material are hard to obtained.
    QC control are not emphasized in traditional practice; and modern instrumental method are expensive and not many standard practise are set up.
    Microbiological and heavy metal contamination are very often
    Many of the modern dosage form, such as pills, tablets, sachets, capsules, may not be as effective as the decoction that is done traditionally.


    4. Patent Protection
    Natural products are not eligible to obtain patent protection. Many "Me-Too" products would be pushed into the market once a particular herb has been  proved with a therapeutical value. Investor is reluctant to invest in clinical trail, promotion and formulation development.


    5. Mechanism of Action
    The mode of action cannot be described in modern scientific terms. And the active component of a formula is not determined.
    Delayed action and outcome is hard to measure.
    Holistic approach, action cannot be easily measured in individual organ or parameter.


    External Factors
    6. The Practitioners
    Traditional practitioners are commonly lack of modern anatomical and pharmacological knowledge.
    Not many with good English, not easy to communicate with other medical professionals
    There are many branch of practise and no unified standard is established within the profession.
    Not as rich and as organized as the Western counterparts.
    Experience and case based practice

    7. Environmental Protection
    Some of the raw material, especially those from the animal origin ,such as sea horse*, tiger bone, are classified as endangered species and protected by the Environmental Protection Regulation.
    *Sea horse is currently NOT protected under the law in Hong Kong and the Convention on International Trade in Endangered Species in Wild Fauna and Flora.

    8. Approval Regulation
    Due to report of toxicity after consumption of some TCM, many western countries has started to set up agent to control TCM import and sale. If the TCM want to sell with a medicinal claim, the TCM have to pass through strict assessment like the single ingredient entity. The financial burden of conducting clinical trail without patent protection  is so vast that the asian investors are hesitated to forward.
    TCM claims are often cases based, large scale Western style clinical trials of TCM in western world are required.


    9.Evidences
    No firm evidence that the TCM can dramatically control the medical condition which western approach failed. The TCM approach may be comparatively slower the disease progression and fewer side effect.
    Only several successful well constructed TCM clinical trial were done, more extensive evidence need to be obtained.
    The reasoning of  "5 Thousand Years of Practise must be truth!" doesn't scientific sound.
    Research publications of TCM are often published in Chinese or in Asian journals

    10. Politics
    After the Cold War ended, China becomes the major imaginary enemy of the West. Anything from the East would received strict scrutiny, especially those source is from the East.
    Western medical practitioner would not easy to share some of their "meal" resource.
    Most Insurance only covers and recognizes Western medical practise, the spending in TCM cannot be claimed back. The "leave letter" can only be signed by "registered medical practitioner", that excluding the TCM practitioners!
    Some reports of adulterated, counterfeited, poorly produced TCM were serious damaged the trust to TCM.
     



    Further Reading:
    1. Follow-up of adult patients with atopic eczema treated with Chinese herbal therapy for 1 year. M P Sheen et.al., Clinical and Experimental Dermatology 1995;20: 136-140.
    2. Usage and adverse effects of Chinese herbal medicine. Thomas Y K Chan, Julian A J H Critchley, Human & Experimental Toxicology, 1996, 15: 5-12.
    3. Chinese medicine enters a new era. Hong Kong Industrialist 1999; 2: 10-14.


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    last updated: 24/05/1999
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