It is impossible to estimate the rate of adverse effects for CHM from case reports and case series alone, since the total exposure to a particular medicinal substance is unknown. Chan et al (1992) undertook a prospective study of hospital admissions over an 8-month period in Hong Kong42. Adverse effects from CHM accounted for 0.2% of admissions (3 patients in 1701 admissions), and from western pharmaceuticals, 4.4%. This study only measured severe adverse effects and the lack of data on the relative usage of CHM and western medicine makes this comparison difficult to interpret.

The same investigators collected cases of CHM poisoning over a 4-year period from hospital admissions, previous reports and/or enquiries to their Drug and Poisons information centre41. They identified 33 cases of poisoning, including 20 with aconite poisoning from Chuan Wu or Cao Wu and 5 with anticholinergic poisoning. Other severe reactions included angioneurotic oedema from Da Zao (jujube date) and hypokalemic paralysis from Gan Cao (liquorice root).

There is currently insufficent data to fully quantify the risks presented by Chinese herbal medicine. Obtaining this data should be considered a research priority.

The TCM Workforce Survey findings reported in Section 4.10 provide some limited quantification of these events.

4.8 Risks associated with acupuncture

As with CHM, adverse effects of acupuncture can be divided into predictable reactions (type A) and bizarre reactions (type B).

Predictable (Type A) reactions include:

• local and systemic infection transferred via unsterile needles;
• local trauma due to the needle and its location; and
• responses by the patient, which include fainting, nausea and vomiting.

Bizarre or unpredictable (Type B) reactions include:

• allergic reactions to the material in the needle;
• depression;
• insomnia;
• convulsions;
• hypotension;
• menstrual disturbance; and
• increased pain.

4.8.1 Predictable Reactions to Acupuncture

4.8.1.1 Local/Systemic Infection

A number of reports of infections have appeared in the literature, including local infections at the site of needling, but the adverse effects of greatest concern are those systemic infections allegedly contracted as a result of acupuncture. These include:

• endocarditis 83-86;
• septicaemia 87,88;
• hepatitis B 89-91;
• HIV 92;
• osteomyelitis 93;
• myositis 93;
• peritonitis 93; and
• pleuraempyema 93;.

The Australian TCM Workforce Survey showed that 93% of the profession are currently using disposable needles. While common sense suggests that the shift towards disposable needles should reduce risk, there is no published data to confirm this in Australia.

4.8.1.2 Trauma

Numerous reports of trauma-related injuries from acupuncture have appeared in the literature particularly over the last 15 years, including:

• pneumothorax (single and bilateral) 94-100;
• spinal cord injuries 101-104;
• factitial panniculitis 105;
• auricular chondritis 106, 107;
• fatal and non-fatal cardiac tamponade 108, 109;
• pseudoaneurysm 110;
• deep vein thrombosis 111;
• nerve damage 112,113;
• burns (moxa) 93; and
• severe bruising (cupping) 114.

4.8.2 Unpredictable Reactions to Acupuncture

Metal needles are generally made from stainless steel. Allergies have been shown to occur to certain needle compositions, for example those including chromium and nickel 115-117, although no reports of this kind have appeared in the last 10 years. Other unusual reactions reported include psychiatric changes such as depression, insomnia, convulsions, hypotension, menstrual disturbance and increased pain 89,93.

4.8.3 Australian Cases

Adverse effects from acupuncture that have been the subject of coronial or legal examination in Australia include:

• a patient in NSW in 1984 who is believed to have stopped taking his western medications after visiting an acupuncturist118. The patient later died of status asthmaticus;
• a 34 year woman in Perth in 1995 who died of scepticaemia arising from necrotising fascitis after receiving acupuncture for neck pain119. The case implied that the acupuncture had introduced infection from the skin into deeper tissues, and the Coroner found that this occurred despite correct sterile technique;
• an acupuncturist in Sydney in 1990 used over 70 cups at one time on a patient114, resulting in blistering and reddening over a large proportion of the patient's back; and
• a patient in Sydney in 1986 who had an acupuncture needle with its top removed became lodged in a muscle of her back120. Several operations were needed to remove it, and she suffered a significant amount of pain and depression.

Other Australian cases reported have included pneumothorax, broken needle travelling to the peritoneal cavity, and severe exacerbations of asthma.

4.9 Quantification of Adverse Effects of Acupuncture

Case reports do not allow estimation of the risk associated with acupuncture since the total exposure is not known and there is likely to be under-reporting.

Norheim and Fonnebo (1996) conducted a survey of Norwegian doctors and acupuncturists93. Out of the 1466 doctors and 311 `traditional' acupuncturists approached, 1135 (77%) doctors and 197 (68%) acupuncturists responded. The most frequently reported adverse effect was fainting during treatment (142 reports). There were 33 reports of pneumothorax, 68 of local skin infections, 2 of endocarditis and 1 of hepatitis B. The study suggested that acupuncturists were more likely to report reactions such as fainting, nausea, vomiting and increased pain, whereas doctors were likely to report reactions such as pneumothorax and local skin infections. A table of findings is attached as Appendix 13. Norheim and Fonnebo93 have estimated that:

• more than 2,400 patients have experienced an acupuncture-related adverse effect in Norway; and
• the adverse effects occur at a rate of 0.21 per year of practice, giving a rate of 1 event for each 4-5 years of practice. This analysis however, only uses the reports from acupuncturists that responded divided by equivalent full-time years of practice.

The figures quoted could be an underestimate, due to potential biases within the design of this study:

• The acupuncturists were taken from the Yellow Pages. This may represent a selection bias as these practitioners may be more `reputable' and not representative of the profession as a whole.
• The non-respondents in the study could be more likely to have `questionable' practices and be hesitant to participate.

4.10 Australian Workforce Survey Data on Adverse Events in CHM and Acupuncture

4.10.1 Chinese Herbal Medicine

Question 61 of the Workforce Survey asked:

Have you ever in your practice caused any significant adverse effect in a patient due to the consumption or application of Chinese herbal medicine? Please identify the adverse reaction and the number of times you estimate it to have occurred in all your years of practice.

The total responses to this question are given in Table 4.9. The data relates only to the three States surveyed (Victoria, New South Wales and Queensland), and not all adverse events reported will have occurred in Australia.

The adverse events which are reported have occurred during the practice lifetime of the respondents. Mean length of full-time practice was 7.7 years. Adverse event rates are presented in Section 4.11. In the final row of Table 4.9 the raw numbers of adverse events are extrapolated for the whole TCM workforce, based on response rates to the survey: calculations and assumptions behind these figures are found in Chapter Five.

The most common adverse events reported are severe gastrointestinal symptoms (n=124), fainting and dizziness (n=119) and significant skin reactions (n=110). Serious adverse events reported include CNS effects (n=37), hepatotoxicity (n=29), renal toxicity (n=28) and death (n=19). The number of deaths reported is consistent with the literature review which cites deaths both in Australia and overseas associated with specific Chinese herbal preparations, notably those containing aconite.

The difference in the number of Chinese herbal medicine adverse events reported by medical (n=9) and non-medical practitioners (n=334) reflects the low number of medical practitioners who identify themselves as using CHM (see Chapter Five).

Data from practitioners currrently working in Australia who have extensive overseas TCM experience may confound these figures in relation to adverse events in Australia because a number of the adverse events they recorded may have occurred overseas. It has been suggested that TCM practised in China and other Asian countries carries greater risks. Table 4.10 list the adverse events in CHM identified by members of the Australian workforce with one year or less overseas experience. Removal of the data from practitioners with more than one year overseas experience does reduce the number of adverse events. A substantial number still remain which are presumed to have occurred in Australia.

Question 60 of the Workforce Survey asked practitioners whether they prescribe any of a range of specified Chinese herbs either in raw form or proprietary Chinese medicines, including a number of scheduled or restricted substances. These substances and their frequency of usage are identified in Table 4.11. It is clear from this data that a number of scheduled substances (including aconite) are still used relatively widely by Chinese herbalists. This reflects either a lack of awareness by practitioners of the restrictions or a lack of willingnesss to abide by them.

Table 4.9. Adverse events in CHM identified by the Australian workforce (n=1,074) which have occurred during their practice lifetime.
Figures are given as total numbers.

* Includes mild gastrointesintal symptoms, hot flushing and weakness.

** Based on the response rates of 43% for non-medical practitioners and 18% (number in brackets adjusted to 26%) for medical practitioners.

Table 4.10: Adverse events in CHM identified by members of the Australian workforce with one year or less overseas experience (n=864). Figures are given as total numbers.

* Based on the response rates of 43% for non-medical practitioners and 18% (adjusted to 26%) for medical practitioners.

Table 4.11: Selected scheduled and restricted herbs prescribed for oral use by TCM practitioners

Table 4.11:Selected scheduled and resticted herbs prescribed for oral use by TCM practitioners

4.10.2 Acupuncture

Question 58 of the Workforce Survey asked:

Have you ever in your practice caused any significant adverse effect in a patient due to acupuncture? Please identify the adverse reaction and the number of times you estimate it to have occurred in all your years of practice (exclude point bleeding and small haematomas).

The total responses to this question are given in Tables 4.12. This data relates only to the three States surveyed (Victoria, New South Wales and Queensland).

The most common adverse events reported were fainting during treatment (n=1155), increased pain (n=1059) and nausea/vomiting (n=515). Serious adverse events reported included pneu mothorax (n=64) and convulsions (n=80). As with CHM, the proportion of time worked by practitioners in other countries may confound the accuracy of these figures.

Table 4.13 lists the adverse events in acupuncture identified by members of the Australian workforce with one year or less overseas experience. Removal of the data from practitioners with more than one year overseas experience does not alter the number of adverse events substantially.

The majority of acupuncture practitioners stated that they always use single-use disposable needles (92.5%) and adhere to their State skin penetration guidelines (82.6%). 17.4% however, stated they do not use the skin penetration guidelines. Of the small number who did not always use disposable needles, autoclaving was the preferred method of sterilisation (68.3%).

Table 4.12. Adverse events in acupuncture identified by the Australian workforce (n=1,074) which have occurred during their practice lifetime. Figures are given as total numbers.

* Includes headaches, diarrhea, sweating, dizziness, severe asthma, and feeling unwell.

** Based on the response rates of 43% for non-medical practitioners and 18% (adjusted to 26%) for medical practitioners.

Table 4.13: Adverse events in acupuncture identified by the Australian workforce with one year or less overseas experience (n=864). Figures are given as total numbers.

* Based on the response rates of 43% for non-medical practitioners and 18% (adjusted to 26%) for medical practitioners.

4.11 Adverse Event Rates Associated with the Practice of TCM in Victoria, New South Wales and Queensland

The findings for Chinese herbal medicine and acupuncture need to be combined to provide overall rates for adverse events in the practice of TCM.

Two parameters have been defined using other components of the Workforce Survey to provide a measure of quantification. These are:

• adverse events per year of full-time practice, and
• adverse events per number of patient consultations.

The adverse events per year of full-time practice is calculated for each practitioner responding to the TCM Workforce Survey. Total adverse events reported by a practitioner (Q58+Q61) are divided by the practitioner's equivalent full-time years of practice (Q100). The mean rate of adverse events per year of full-time practice can then be calculated. This takes into account the rate for each individual practitioner. In comparison, the Norwegian study93 calculated the total number of adverse events and divided it by the total number of years of practice, making no allowance for the variation in events rates between practitioners.

The adverse events per number of patient consultations is less robust. It is derived for each practitioner by dividing the total adverse events reported by that practitioner (Q58+Q61) by an estimation of total consultations for that same practitioner. Total consultations are calculated by multiplying average consultations per week (Q10) by 48 weeks per year by equivalent full-time years of practice (Q100). This calculation assumes that the number of patients practitioners are currently seeing has remained static throughout their practice lifetime. The mean rate of adverse events per number of patient consultations can then be calculated. This figure can only be used as a crude measure of the frequency of adverse events.

Tables 4.14 and 4.15 give figures for these two parameters for the whole of the workforce. Both acupuncture and Chinese herbal incidents are included.

The number of adverse events per year of full time practice is 1.5 for the total TCM workforce. The data suggests that a full-time TCM practitioner will experience one adverse event each eight months of full-time practice. This figure includes adverse events related to both CHM and acupuncture; however, adverse events due to acupuncture accounted for 79% of all adverse events reported. This reflects the substantially larger cohort of practitoners who principally use acupuncture (585) in contrast to those who principally use CHM (32).

Table 4.14: Adverse events per year of full-time TCM practice for medical(320) and non-medical(520) TCM practitioners.

Table 4.15: Adverse events per consultation and consultations per adverse event for TCM practitioners (n=758)

A Wilcoxon rank sum test for non-parametric data shows there is a significant difference between the adverse event rate per year of full-time TCM practice for medical and non-medical practitioners (P<0.0001). Medical practitioners report a higher rate of adverse incidents. This may reflect shorter TCM training programs (see Table 4.16) or an increased willingness to report adverse events. However, there is no evidence to support the latter.

There are 4.2 adverse events for each 1,000 consultations provided by the TCM workforce. This figure is based on the responses to the Workforce Survey of 758 practitioners and, as mentioned above, is presumed to be less robust because of the additional assumptions required to calculate this figure.

The number of adverse events reported were compared to the length of TCM training undertaken by the practitioner (Table 4.16). It appears from these findings that shorter periods of training in TCM (less than one year) carry an adverse event rate double that of practitioners who have studied for four years or more.

Table 4.16: Adverse event rate by length of TCM training (undergraduate plus postgraduate)

A Wilcoxon rank sum test for non-parametric data shows a significant difference between the annual adverse event rates between practitioners with 0-12 months of TCM education and those with 37-60 months (P<0.005), suggesting that length of TCM education is a modifier of adverse events. If this is the case, then increasing or improving TCM education will lower adverse events. This supports concerns expressed by associations representing TCM practitioners that the education provided by short courses is inadequate for safe practice.

The overall number of adverse events recorded is substantial. The Workforce Survey suggests that TCM practitioners will experience a number of adverse events during their practice life-time. Further research is needed to provide a more accurate assessment of these risks, and minimising the risks should be a priority of both government and the TCM profession.

4.12 Comparison of the Risks Related to TCM with Other Health Care Occupations

Comparing risks posed by TCM and by western medicine is difficult, requiring actual numbers of treatments and adverse events. The only reported comparison is on hospital admissions in Hong Kong, and this lacks data on the relative usage of TCM and western medicine. Dartnell et al recently reported that 5.7% of Australian hospital admissions were drug related121. If one presumes that only 1% of the actual Australian adverse events to TCM have been reported, then the number of cases currently on record over the past 20 years multiplied by 100 would not reach the number of adverse events due to pharmaceutical drugs in one year of medical practice. It is highly unlikely that the practice of TCM poses as great a risk to public safety as the practice of western medicine.

Reviews on spinal manipulation by chiropractors and osteopaths stress the infrequency of adverse events compared to the number of manipulations performed throughout the world on a single day122. One review of cases of cerobrovascular `catastrophes' related to spinal manipulation found 78 significant incidents from 1934 to 1992123. This excludes anecdotal reports and those cases where there was complete recovery, near complete recovery, or unknown outcome. As with TCM, it is likely that a number of factors contribute to under-reporting, but without actual numbers of adverse events for either profession or numbers of treatments per year, comparisons are difficult. Assessment of the published data alone would suggest that TCM poses a more significant risk to public safety than the practice of spinal manipulation by chiropractors and osteopaths. One contributing factor is the potential for one batch of Chinese medicine to cause the same adverse effect in a large number of consumers; for example, the 70 cases of renal failure due to one slimming preparation in Belgium47,50.

Hence, whilst it is unlikely that the practice of TCM poses as great a risk to public safety as the practice of medicine, the practice of TCM may pose greater risks to the public than some other regulated health care practices.

4. 13 Risks to Endangered Species by the Practice of TCM

The traditional Chinese materia medica includes preparations made from animal products, some from parts of endangered animals. The use of rhinocerus horn, tiger bone and deer musk have contributed to the reduction of numbers in these species to critical levels124.

In Australia, the Wildlife Protection (Regulation of Exports and Imports) Act 1982 controls the export and import of wildlife and wildlife products, and fulfils Australia's legislative requirement as a signatory to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). Appendix I of the CITES lists species threatened with extinction which are or may be threatened by trade.

The Australian Chinese Medicine Education and Research Council (ACMERC) have a clear policy that `condemns the use of endangered species of both animals and plants and is actively promoting the use of appropriate substitutes'. Most professional associations representing TCM practitioners are in general agreement with this policy.

A report on the trade in endangered species in Australia and New Zealand was released by TRAFFIC Oceania in May 1995. A number of specific recommendations regarding amendments to current Australian legislation made in the TRAFFIC report are endorsed by this report, including:

• making it an offence to sell specimens or products of CITES Appendix I species for therapeutic purposes, irrespective of whether or not the product or specimen was legally imported; and
• any product or specimen which appears, from accompanying documentation, labelling or packaging to be part or derivative of a CITES-listed species, to be treated as containing that species.

If occupational regulation of the TCM profession is to occur, this report recommends that:

• TCM practitioners trading in, prescribing or providing medicines or raw products containing CITES Appendix I-listed species should be penalised under the legislative act providing for occupational regulation.

A more complete discussion regarding the risks to endangered species by the practice of TCM is outlined in Appendix 14.

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83. Lee RJE, McIlwain JC. Subacute bacterial endocarditis following ear acupuncture. International Journal of Cardiology 1985;7:62-3.

84. Scheel O, Sundsfjord A, Lunde P, Anderson BM. Endocarditis after acupuncture and injection - treatment by a natural healer. JAMA 1992;267(1):56.

85. Spelman DW, Weinman A, Spicer WJ. Endocarditis following skin procedures. Journal of Infection 1993;26(2):185-9.

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87. Izatt E, Fairman M. Staphylococcal septicemia with disseminated intravascular coagulation associated with acupuncture needles. Postgraduate Medical Journal 1977;53:285-6.

88. Peirick MG. Fatal staphylococcal septicaemia following acupuncture. Rhode Island Medical Journal 1982;65(6):251-3.

89. Acupuncture. Canberra. National Health and Medical Research Council. 1989;79.

90. Dominguez A, Milicua JM, Larraona JL, Barcena R, Fernanadez Rodriguez CM, Gil Grande LA. Viral Hepatitis B transmitted by acupuncture. Medicina Clinica 1985;84(8):317-9.

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92. Vittecoq D, Mettetal JF, Rouzioux C, Bach JF, Bouchon JP. Acute HIV infection after acupuncture treatments. The New England Journal of Medicine 1989;320(4):250-1.

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95. Goldberg I. Pneumothorax associated with acupuncture. Medical Journal of Australia 1973;941-2.

96. Lewis-Driver DJ. Pneumothorax associated with acupuncture. Medical Journal of Australia 1973;296-7.

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98. Ritter HG, Tarala R. Pneumothorax after acupuncture. Medical Journal of Australia 1978;602-3.

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Chapter 4: Risks Associated with the Practice of TCM

Summary of Findings

• Risks to the public may arise from the clinical judgement of the TCM practitioners. These may be either risks of commission or omission. These types of risks exist in all health care practices.
• Cases of adverse events related to commission and omission were reported to the researchers, however none have been investigated with the rigour required to prove causality.
• Risks may also be directly related to the consumption of Chinese herbal medicines or to the effects of acupuncture.

Risks Associated with Chinese Herbal Medicine (CHM)

• Like western medicines, CHM may produce both predictable and unpredictable effects. Cases were identified in each of the areas discussed below.
• Predictable effects may include direct toxicity, toxicity related to overdose of a preparation, and interaction with western pharmaceuticals. Unpredictable effects may include allergic and anaphylactic reactions to herbal medications, and idiosyncratic reactions.
• There are many well-documented herbs such as Aconitum known to cause toxic reactions. Particular toxic substances are restricted by current legislation. However, a number of less toxic substances are available to practitioners for use in prescriptions.
• Risks may also be associated with the inappropriate handling or manufacture of CHM, for example:
• • misidentification
  • lack of standardisation
  • substitution of one herb for another
  • contamination of the herbal preparations
  • adulteration with western pharmaceuticals.
• Interpretation of the literature on adverse events in CHM can be complicated by several factors including the correct identification of the plant material and the nomenclature used in Chinese herbal medicine.
• Where substitution of one herb for another has occurred in a CHM preparation, it has made attributing adverse effects to a particular herb difficult.
• No examples of contamination of Chinese herbal medicines were noted in Australia. Cases of contamination with heavy metals have been reported overseas.
• Whilst poorly reported to date, Chinese herbal medicines have significant potential to interact with western pharmaceuticals.
• There are several reports in the literature regarding the intentional adulteration of Chinese herbal medicines with western pharmaceuticals. Adulteration has made it more difficult to attribute efficacy to CHM as well as leading to severe adverse effects.
• It is impossible to estimate the rate of adverse effects for CHM from case reports and case series alone, since the total exposure to a particular medicinal substance is unknown. There is currently insufficent data to fully quantify the risks presented by Chinese herbal medicine.

Risks of Acupuncture

• Acupuncture can lead to both predictable and unpredictable effects. Cases were identified in each of these categories.
• Predictable reactions may include cross-infection with blood-borne infective agents (notably hepatitis), trauma such as pneumothorax and localised bleeding, and physiological responses such as fainting, nausea and vomiting. Unpredictable reactions may include metal allergy, convulsions and mood disturbance.
• The most serious and prevalent adverse effects related to acupuncture are trauma and local and systemic infection.
• Local trauma and significant predictable adverse reactions, such as pneumothorax, may be minimised by appropriate training.
• There are only limited reports that systematically review the risks associated with acupuncture.

Australian Data

• The number of adverse events associated with TCM recorded in Australia is substantial and the types of events reported are not trivial. The TCM Workforce Survey data suggests that TCM practitioners will experience one adverse event every eight months of full-time practice, with 4.2 adverse events for every 1,000 consultations.
• A significant difference was found between the adverse event rate for practitioners graduating from long TCM education programs and those from short programs. The length of TCM education may be an important modifier of adverse events.
• There appears to be significant under-reporting to government agencies of adverse effects of CHM and acupuncture, possibly due in part TCM practitioners' lack of awareness of avenues for such reporting.
• Further research needs to be undertaken to provide a more accurate assessment of these risks. The minimising of the risks should be a priority of both government and the TCM profession.

Comparison of TCM to Other Health Care Occupations

• It is unlikely that the practice of TCM poses as great a risk to public safety as the practice of medicine.
• As compared with western medicines, Chinese herbal medicine causes fewer severe reactions leading to hospital admissions.
• The practice of TCM appears to pose greater risks to the public than some regulated health care practices such as chiropractic and osteopathy.

Risks to Endangered Species

• The TCM profession in general opposes the use of endangered species within Chinese medical practice.

Chapter 4: Risks Associated with the Practice of TCM

Recommendations

• That a review of TCM education be undertaken, based on the finding that the length of education is a modifier of adverse events. This should aim to establish a minimum standard of TCM education for safe practice.
• That TCM education institutions revisit their course content and ensure adequate training is available to minimise the specific adverse events identified and to promote the ability of practitioners to deal with these adverse events.
• That TCM professional associations in conjunction with relevant government agencies identify and promote a centralised location for reporting and recording of adverse events related to TCM practice. This may be State Drug Information Services, ADRAC, State health care complaints units, or another agency. It needs to be responsive to aspects of the TCM profession, such as its cultural mix. The agency's existence should be widely communicated within the TCM profession.
• That TCM professional associations and educational institutions work to engender a consciousness amongst the profession of the need to report adverse events related to TCM practice.
• That national funding bodies such as the National Health and Medical Research Council allocate funding for research into TCM in areas such as the quantification of adverse events in both acupuncture and Chinese herbal medicine, and the interactions between Chinese herbal medicines and western pharmaceutical drugs.
• That Commonwealth and State Health Departments fund the translation into English of the current Chinese language scientific literature pertaining to adverse events of Chinese herbal medicines and interactions between CHM and western pharmaceuticals.
• That protocols for managing adverse events related to Chinese medicines be reviewed, and developed where necessary, for use in Australian hospitals; and that this review be undertaken by recognised toxicologists.
• That in the formation of any legislative Act providing for occupational regulation of TCM practitioners, consideration be given to the need for appropriate penalties for practitioners trading in, prescribing or providing Chinese medicines or raw products containing CITES Appendix I-listed endangered species.