Policy & Strategic Projects Division >> Complementary Therapies/Traditional Chinese Medicine >> Newsletter

Newsletter Number 2, November 1996

This is the second in a series of newsletters on the review of Traditional Chinese Medicine in Victoria. The first newsletter, issued in February 1996, outlined the purpose of the review and the process. This second newsletter gives a progress report on the Victorian Review of TCM, and provides a summary of the main findings of the Interim Report from the research project conducted by University of Western Sydney (UWS Macarthur) and Southern Cross University.

Launch of Research Report on TCM

The final report on the research project on Traditional Chinese Medicine is to be launched by the Victorian Minister for Health on Monday 18th November 1996. The purpose of the research is to identify:

• the risks and benefits associated with the practice of TCM,
• the nature of the TCM work force; and
• the need, if any, for legislative regulation of TCM practice.

Copies of the report are available for sale from:

The Faculty Manager
Faculty of Health
University of Western Sydney Macarthur
PO Box 555
Campbelltown NSW 2560
Australia
Phone: (046) 203 347
Fax: (046) 254 252
Email: j.slater@uws.edu.au

TCM Research Review

Interim Report Findings

The interim report submitted to the Department provided a summary of progress to date in three areas:

• risks and benefits associated with acupuncture and Chinese herbal medicine;
• existing regulations covering TCM in Australia and other countries; and
• a list of key stakeholders concerned with the practice of TCM in Australia.

Below are excerpts from the Executive Summary of the Interim Report.

The findings on Chinese herbal medicine

The evaluation of pharmacological research on Chinese herbal medicine indicates that research in this field has followed similar lines of inquiry and used similar schema to western research in pharmacognosy. In general, the areas investigated were:

• classification and differentiation of medicinal plants;
• identification and characterisation of plant constituents;
• investigation of the activities of the plant and its constituents;
• elucidation of mechanisms of action; and
• pharmacokinetic and toxicological studies.

In relation to clinical trials for Chinese herbal medicine, the researchers concluded that judgment of its effectiveness, based on the sample of literature examined, must be suspended pending further blinded studies.

Two areas of concern raised in the report are:

• direct toxicity, causing either predictable or unpredictable adverse reactions; and
• Problems with Good Manufacturing Practice, including substitution of materials used in Chinese herbal medicine, adulteration with western pharmaceuticals and contamination with heavy metals/toxins;
• Avoidance of predictable
• Adverse reactions to
• Chinese herbal
• medicine relies on
• adequate and appropriate
• education of practitioners.

Mechanisms for minimising the risk of potentially toxic agents and increasing emphasis on Good Manufacturing Practice will be further investigated for the final report.

The findings on acupuncture

The majority of acupuncture research focuses on the use of acupuncture for pain management. However, following review of both clinical trials and experimental research, the researchers conclude there are good quality studies which support acupuncture as a treatment for a variety of disorders, not only the alleviation of pain. In relation to the experimental research, the conclusions are:

• physiological changes do occur as a result of needling and are distinguishable from stress and placebo;
• current neurophysiological knowledge can be used to explain at least some immediate acupuncture effects, but there are no accurate and reliable means of predicting physiological responses to treatment;
• while there exists a considerable amount of research, it has limitations when extrapolated from animal to human subjects; and
• no neurophysiological explanation so far has been capable of explaining many of the conclusions reached in the clinical studies.

The report identifies a number of risks following a literature search and interviews with government officials. The researchers applied to TCM a categorisation of adverse reaction assessment used in western medicine. Predictable adverse reactions from acupuncture include:

• local and systemic infection transferred via unsterile needles;
• local trauma due to the needle and its location;
• allergic reactions to the material in the needle.

Unpredictable reactions include depression, insomnia, convulsions, hypotension, menstrual disturbance and increased pain. The report states that local and systemic infections arising from acupuncture can be minimised by the use of disposable needles or appropriate sterilising procedures. Local trauma and significant predictable adverse reactions, such as pneumothorax, may be minimised by appropriate training, which would include an extensive review of the adverse reactions to acupuncture and the contraindications and restrictions of needling certain anatomical sites.

Regulatory frameworks

An overview of regulations which relate to the practice of TCM in selected overseas countries and in Australia has been prepared. Overseas trends indicate that increasing numbers of jurisdictions, including Hong Kong, Singapore and the United States are moving to license TCM practitioners in additional to the various forms of indirect regulation of skin penetration, infection control and access to therapeutic substances that may apply.

While the policy of both the State and Federal Governments is to support self-regulation by occupational groups, it is the view of the researchers that some form of direct occupational regulation may be required in order to minimise the risks to the public. Analysis of the interrelationship between risk and regulation will be included in the final report.

What Happens Next?

Registration of practitioners is a power that rests with each State Government. Information on risks and benefits associated with the practice of TCM and the adequacy of the existing regulatory framework to protect public health will inform Australian Health Ministers Advisory Council (AHMAC) decisions on whether to recommend to State Health Ministers registration of TCM practitioners and regulation of herbal preparations. Each State Health Minister may then consider options for formulation of policy on regulation of practitioners and herbal preparations.

The Victorian State Government and Federal Government policy is to support wherever possible, self regulation by occupational groups. However, a number of factors have been identified in relation to TCM practice which contribute to increasing public health risks. At the launch of the Research Report, the Victorian Minister for Health will announce the next stage of the Review of TCM in Victoria. This may include involvement of the profession in the development of a policy on regulation of TCM.

Further information is available from Ms Anne-Louise Carlton, Project Manager, Health Care Evaluation Section, Public Health Division, Department of Human Services on (03) 9616 8524, Fax: (03) 9616 8524, or E-mail address: anne-louise.carlton@dhs.vic.gov.au