The key objective of this report is to determine whether the practice of TCM poses a significant risk of harm to public health and safety, in order to assess the need for occupational regulation. This chapter identifies the health risks associated with TCM as practised in Australia with specific reference to acupuncture and Chinese herbal medicine.
Risks to the public from TCM may be divided into two major categories:
- risks associated with the clinical judgement of the TCM practitioner; and
- risks related directly to the consumption of Chinese herbal medicines or the effects of acupuncture needling.
The chapter analyses reports in the literature on adverse effects of TCM, supplemented by reports made to Australian authorities or recorded on databases of adverse events, and data on adverse events obtained from the Australian TCM Workforce Survey.
The following resources were searched to locate TCM adverse effects:
- Biomedical databases: Medline® (1981-1996), EmBase® Drugs and Pharmacology (1981-1996) and Current Contents® (1983-1996) were searched using the strategy outlined in Appendix 11. Only articles in English available in Australia were reviewed. Emphasis was given to articles where the assignment of causality could be well established.
- Bibliography searches: Where possible the bibliographies of relevant articles were searched and the original references obtained.
- Newspapers: Newspapers in Australia and overseas were searched via the Newcastle Regional library online and CD-ROM databases.
- Litigation search, coroners' reports, court records: Only a limited number of cases were located. These are described in detail in the report. The litigation search strategy is described in Appendix 11.
- Adverse Drug Reaction Advisory Committee (ADRAC): The ADRAC database does not have a specific term for TCM. The database was searched for all cases of adverse reactions to herbal medications, and the implicated agents were reviewed to determine if they were Chinese herbal medicine.
- Drug Information Services (DIS): The major drug information service in each capital city was contacted for information on questions that they had been asked regarding TCM. Only the Sydney Drug Information Service had records of questions relating to Chinese medicines. These are reported below.
- State Health Care Complaint Agencies: Agencies in Victoria, Queensland, New South Wales, South Australia and Western Australia were approached.
- International sources: The Chinese Medicinal Materials Research Centre in Hong Kong, the Medical Toxicology Unit at Guys Hospital in London and the NAPRALERT (NAtural PRoducts ALERT) database were contacted.
- Professional Associations: TCM professional associations were approached.
Two questions of the Workforce Survey (Appendix 15) requested information on adverse events: question 58 was on acupuncture and question 61 on Chinese herbal medicine. The questions listed common and adverse effects related to these two practices. Practitioners were asked to indicate the number of times particular adverse reactions had occurred during their TCM practice, and years in practice, to enable quantification of the adverse events per full-time year of TCM practice.
4.3 Reporting and Monitoring of Adverse Effects
4.3.1 Australia
Complaints about Chinese herbal products are directed to both State and Commonwealth agencies, which each have some legislative responsibility for therapeutic goods1.
TCM practitioners fall under State jurisdiction, and complaints related to practitioners may be directed to State authorities.
There is currently no distinct and formal reporting system for adverse effects of Chinese herbal medicine (CHM).
4.3.1.1 Adverse Drug Reactions Advisory Committee (ADRAC)
ADRAC monitors adverse drug reactions to western pharmaceuticals and functions as an advisory committee under the Therapeutic Goods Regulations2. Over the last 20 years, it has received over 100 reports of adverse reactions to `herbal medicines'3, not necessarily CHM. The most serious were two deaths attributed to royal jelly (out of 17 reported reactions)3. Suggestions by ADRAC that this may be a signifcant underestimate of the number of adverse reactions to CHM in Australia are confirmed by the findings of the TCM Workforce Survey (see Chapter 5). Factors leading to under-reporting could include:
- a perception that ADRAC is only interested in drugs and not herbal products;
- no clear mechanism communicated and available for reporting by non-medical practitioners;
- reluctance by non-medical practitioners to report effects because of fear of litigation or admitting some failure in their practice; and
- lack of knowledge by practitioners of ADRAC and its reporting mechanisms.
4.3.1.2 Drug Information Services
Drug and poison information services provide an avenue for the detection and/or reporting of adverse effects of western pharmaceuticals. In Australia there is an established network of State and regional drug information services at major teaching hospitals. These services cover the needs of general practitioners, community pharmacists and other health care professionals.
State drug information services in New South Wales, Queensland, Victoria and the Australian Capital Territory have received few reports of adverse events due to CHM. New South Wales and Queensland report many enquiries regarding western herbal medicines, but New South Wales identified only three relating to CHM, while Queensland could not easily distinguish CHM from other herbal medicines4,5. The Victorian centre received no formal reports of adverse events to CHM6. Relevant reports received by all States have been included in Table 4.3.
There are problems with the recording of CHM adverse effects. CHM is poorly indexed on most in-house databases7, with reports generally indexed under herbal drugs only, although the impression of Drug Information staff is, nevertheless, that only a few enquiries are related to CHM4,7. TCM practitioners may perceive that services which focus on drug information are not the logical place to make enquiries and reports.
4.3.1.3 State Health Care Complaint Agencies
A survey of agencies in Victoria, New South Wales, Queensland, Western Australia and South Australia indicates that complaints primarily relate to practitioners, rather than individual products.
- Since 1987, the New South Wales Health Care Complaints Commission had received 10 complaints about naturopaths and 14 about acupuncturists out of a total of 20,0008. These complaints have included sexual assault (3), incorrect treatment (4) and gross mismanagement (3).
- The Victorian Health Services Commissioner identified 5 complaints related to the behaviour of practitioners.
- No cases were identified by Queensland, South Australia and Western Australia.
4.3.2 Overseas
Several overseas countries have developed methods to monitor adverse effects of CHM:
- Hong Kong: The Chinese Medicinal Material Research Centre (CMMRC) based at the Chinese University of Hong Kong has developed a computerised database of the toxicology and adverse effects of Chinese food and Chinese medicines9.
- United States: The Food and Drug Authority (FDA) introduced MEDWatch, a voluntary reporting system10 that uses a single form to report adverse effects to a medication or device11. Reports may be phoned or faxed on a toll-free number. MEDWatch seeks reports on medications (drugs and biologics), medicinal devices, special nutritional products (dietary supplements, medicinal foods and infant formulas) and other products regulated by the FDA.
- United Kingdom: The Medical Toxicology Unit based at the Guy's & St Thomas' Hospital Trust, London has combined with the Royal Botanic Gardens, Kew to develop methods to monitor adverse effects of traditional medicines12,13. The collaboration is establishing a reference collection of herbs to allow correct identification and authentication of CHM.
- United Kingdom: The National Poisons Unit in London has recently published summary statistics from their database of adverse effects13. The data was collected retrospectively from enquiries to the National Poisons Information Service from January 1983 to March 1989, and prospectively in 1991. It is unclear what degree of follow-up was undertaken to identify the products involved. There were 5,536 enquiries relating to vitamins, minerals, amino acids, fish oils, evening primrose oil, kelp, yeast, herbal preparations, royal jelly and slimming preparations. Of these, 656 (12%) were symptomatic at the time of the call. A total of 1,070 enquiries related herb extracts, royal jelly, pollen, enzyme preparations and hormonal and glandular products, of which 270 (25%) were symptomatic, suggesting that this body of products is more likely to generate symptomatic adverse effects than the overall family of traditional medicines. The paper reports one adverse effect with a Chinese herbal product used for eczema that resulted in acute fatal liver failure14.
In addition the University of Illinois at Chicago has developed a significant bibliographic database on natural products, which includes references on toxicology. The NAPRALERT (NAtural PRoducts ALERT) database includes information on the pharmacology, biological activity, taxonomic distribution, ethno-medicine and chemistry of plant, microbial and animal (including marine) extracts. The database contains more that 100,000 records dating from 1650.
A schema for the classification of risks identified in the practice of TCM is given in Table 4.1. The follow sections expand upon these categories in detail.
4.5 Risks Associated with the Clinical Judgement of the TCM Practitioner
Risks of commission and omission are inherent in the practice of any health care occupation, including western medicine. Many sources have raised concerns regarding these risks in relation to TCM.
Table 4.1 Schema for the classification of risks identified in the practice of TCM
| Category of Risk | Major Risks | Principal Types |
| Clinical Judgement of theTCM Practitioner | Commission | Removal of therapy Incorrect prescribing |
| Omission | Misdiagnosis Failure to refer Failure to explain precautions |
|
| Chinese Herbal Medicines | Predictable toxicity (Type A reactions) |
Direct Overdosage Interaction between Chinese herbal medicines Interaction with pharmaceuticals |
| Unpredictable reactions (Type B reactions) |
Allergy/anaphylaxis Idiosyncratic reactions |
|
| Failure of good handling and manufacture of CHM |
Misidentification Lack of standardisation Contamination Substitution Adulteration |
|
| Acupuncture | Predictable reactions (Type A reactions) |
Cross-infection Trauma Physiological responses |
| Unpredictable reactions | Metal allergy Idiosyncratic reactions |
4.5.1 Risks of Commission
Risks of commission relate to direct and inappropriate acts undertaken by a practitioner during treatment. They include:
Examples include recommending that an epileptic cease taking anti-epileptic medication, or a post-thyroidectomy patient cease taking thyroid replacement hormone. This can lead to:
- Loss of the potential benefit of the therapy.
- Increased morbidity.
- Loss of life.
4.5.1.2 Incorrect Prescribing
Examples and associated risks include:
- poor prescribing: prescribing of preparations that are inappropriate for the patient's condition;
- failure to observe contraindications: for example, Glychrriza species (licquorice root) in individuals with hypertension can result in a significant exacerbation of the condition due to its mineralocorticoid-like action15;
- inappropriate dosage: some preparations are well tolerated at certain dosages (the `therapeutic window'), but can induce toxicity at higher dosages. For example, the herb Ma Huang (Ephedra), which contains ephedrine, can be used as a bronchodilator in the management of asthma, but at higher doses has amphetamine-like properties that can cause nervousness, tachycardia, hypertension, seziures and psychosis16;
- inappropriate duration of therapy: for example, a number of Chinese herbal formulas used in the treatment of chronic skin conditions have been associated with hepatitis17,18, with the adverse effects related to duration of exposure. Safe use of these herbs over prolonged periods requires monitoring of liver function;
- failure to avoid known interactions with pharmaceuticals.
4.5.2 Risks of Omission
Risks of omission arise when TCM practitioners have inadequate skills or are unaware of the limits of their practice. They include:
- misdiagnosis;
- failure to refer on where appropriate; and
- failure to explain precautions associated with a particular substance.
4.5.2.1 Misdiagnosis
Failure to detect significant underlying pathology can increase morbidity by allowing the disease process to progress, and this may influence survival in conditions such as atypical myocardial infarction or cancer. This concern was raised in the 1989 National Health and Medical Research Council (NH&MRC) Working Party on Acupuncture19. Misdiagnosis is often associated with failure to refer a patient to an appropriate health care practitioner, and may be further compounded by incorrect prescribing.
The NH&MRC Working Party on Acupuncture noted that failure to detect underlying pathology was a more important but less quantified risk than other types of risk associated with the practice of acupuncture by non-medically trained practitioners19.
4.5.2.2 Failure to Refer
Failure to refer a patient on to a medical practitioner or other appropriate health care practitioner in cases of need is often associated with misdiagnosis. It may occur where a practitioner fails to recognise the limits of their clinical practice. In such a case, diagnosis may be correct but it is falsely assumed that the treatment will be effective.
Clinical decisions regarding patient management need to be taken in the context of the wider Australian health care community. In provincial China, where hospital facilities may not be readily available, it may be appropriate to treat a correctly diagnosed case of acute appendicitis with Chinese herbal medicine and/or acupuncture. Even if the practitioner in question had treated cases of acute appendicitis successfully in China, it would be inappropriate to do so in Australia. This is due to the significant risks associated with a ruptured appendix and the ready availability of hospital facilities and effective conventional treatment (surgery and intravenous antibiotics).
4.5.2.3 Failure to Explain Precautions
Certain herbal preparations require specific methods of preparation to reduce their toxicity. For example Aconitum carmichaelia contains aconite, an alkaloid that activates sodium channels. The alkaloids are rendered less toxic when the herb is soaked in water and boiled for a specified time20,21. Failure to specify these requirements clearly can result in severe toxic reactions including cardiovascular collapse and cardiac arrhythmias22-24. The therapeutic window of these herbs is very narrow. In Australia they have been included in Schedule 4 of the Standard for Uniform Sceduling of Drugs and Poisions (SUSDP) and can only be prescribed by registered medical practitioners, dentists or veterinarians and dispensed by registered pharmacists.
Failure to disclose known potential adverse effects of the treatment may equate to failure to obtain informed consent.
4.5.3 Approaches to Reducing Risk Related to Poor Clinical Judgement
Most medical practitioners consulted in the course of this report cited examples from their clinical practice of adverse events resulting from acts of commission or omission by non-medically trained therapists in complementary medicine. Despite the anecdotal nature of these cases, the high frequency of reporting indicates that the risks may be significant. None of the cases has been investigated with the rigour required to prove causality. No cases of commission or omission were identified in the English language medical literature or the litigation review. A prospective study is required to estimate the breadth of the problem.
The Australian Medical Acupuncture Society in their submission to the Australian Health Ministers' Advisory Committee (AHMAC) regarding the registration of TCM practitioners recommends that registration be considered when nationally standardised education is established for non-medically trained practitioners (summary of AMAS submission is included as Appendix 21). The underlying assumption is that risks of commission and omission are related to educational standards of practitioners. This applies equally to the level of education in the western medical sciences and TCM.
Some argue that only medically qualified individuals should practice TCM; however educational models exist in other health care occupations that provide standards for basic and clinical sciences for individuals to practise in relative safety without the requirement for a qualification in western medicine. Appropriate educational programs for a number of health occupations exist within Australian universities.
Some jurisdictions have legislated to minimise these risks. In Alberta, Canada, legislation prohibits practitioners from advising a patient to discontinue any treatment prescribed by a physician or dentist. The British Medical Association recommends that non-conventional therapists not alter the instructions or prescriptions given by a patient's medical practitioner without prior consultation and agreement with that doctor25.
It is important to acknowledge that, ultimately, the choice of medication and treatment is a decision made by the patient. Should the patient choose to seek an alternative to a western pharmaceutical treatment, it is their right to do so.
