The other side of the coin: safety of complementary and alternative medicine

The rising use of complementary and alternative medicine (CAM) by the Australian public raises the critical issue of safety. The primary concern for healthcare consumers is generally the potential benefits of the products or services they are considering. Safety, the other side of the coin, is assumed and seldom questioned. The general belief is that because these products or services are “natural” they are safe. The concept that “naturalness” is a guarantee of harmlessness is obviously both simplistic and untrue. Yet, an Australian survey of 3027 people in 2000 showed that 90% of users of CAM (especially the elderly) considered the products safe, compared with 65% of non-users.1 The widespread availability of complementary medicines through health food stores and supermarkets, and the infrequency of litigation against CAM practitioners, has been suggested as evidence of safety.2 However, these cannot be considered as appropriate measures of safety, and more appropriate measures are gradually emerging in the scientific literature.

It is important to realise that any therapy has the potential to cause harm, and that any pharmacologically active product is likely to have adverse effects. The critical issue in assessing any therapy is its risk to benefit. In conventional medicine, this can be often underpinned by hard data, with exact figures outlining the number of individuals experiencing an adverse event versus the number of people achieving a benefit. However, until more CAM therapies and products are rigorously assessed, clinicians should have a schema for considering safety issues.

The Commonwealth Therapeutic Goods Act 1989 defines complementary medicines (Section 52F) as therapeutic goods consisting wholly or principally of one or more active ingredients, each of which has a clearly established identity and either a traditional use or any other use prescribed in the regulations.3 The designated active ingredients are listed in Schedule 14 of the Act (Box 1).

Adverse reactions to CAM products may be either intrinsic or extrinsic.4 Intrinsic reactions are directly related to the active medicine itself and consist of either predictable (Type A) reactions owing to their pharmacological effects, or idiosyncratic (Type B) reactions that are not predicted by their pharmacology (eg, anaphylaxis).5 Extrinsic reactions are not related to the product itself, but result from failure of good handling and manufacturing procedures.

In cooperation with state and territory governments, the TGA is responsible for the regulatory arrangements for complementary medicines. The TGA has developed a risk-management framework which differentiates low-risk and high-risk medicines. This is based on community expectations that therapeutic products will be safe, effective and of good quality, and industry expectations that regulation should be the minimum necessary, appropriate and commensurate with the assessed risk of the products and consistent with international practice.18 Low-risk medicines, which include most complementary medicines, are listed on the Australian Register of Therapeutic Goods (ARTG) and have been assessed by the TGA for quality and safety. They are not assessed for efficacy, but their sponsors must hold the evidence for any claims made, and these need to be consistent with the guidelines for the types and levels of claims for therapeutic goods.19 High-risk medicines, which include over-the-counter pharmaceuticals and prescription drugs, are registered on the ARTG and are assessed for quality, safety and efficacy. The recent Expert Committee on Complementary Medicines in the Health System found that:

• the current single regulatory framework for medicines in Australia is appropriate for complementary medicines; and

• the current two-tier, risk-based regulatory system should be maintained, with some enhancements.18

One enhancement recommended by the committee is that the TGA should increase random and targeted auditing of sponsors of complementary medicines to ensure that evidence for efficacy is held for any claim made for a specific product. This is expected to result in more meaningful marketing claims substantiated by appropriate evidence.

Risks associated with the practice of CAM can be either risks of commission or risks of omission.12 Examples of risks of commission include:

• removal of appropriate medical therapy (which can lead to loss of the benefit of that therapy, increased morbidity and, in some cases, death);

• incorrect prescribing (poor prescribing, failure to observe contraindications, inappropriate dosage, inappropriate duration of therapy, failure to avoid known interactions with pharmaceutical drugs); and

• negligent practice (eg, use of non-sterile acupuncture needles).

Risks of omission include

• misdiagnosis (failure to detect underlying abnormality which can allow a disease to progress);

• failure to refer (often associated with misdiagnosis, but also occurs when practitioners are unaware of the limitations of their discipline); and

• failure to explain precautions (which may equate to failure to obtain informed consent, but can also have direct and serious consequences for a patient unaware of any risks).

During the review of Chinese traditional medicine conducted for the Victorian, New South Wales and Queensland state health departments, most medical practitioners consulted provided examples from their clinical practice of adverse events resulting from acts of commission or omission by CAM practitioners.12 To date, no study of this has been reported in the medical literature.

There is a small but growing body of evidence supporting the safety of CAM practices. Most of the research to date has been in the fields of acupuncture and spinal manipulation. A systematic review of prospective studies on the safety of acupuncture identified nine surveys.20 While the results were not uniform, they indicated that minor adverse events were common (eg, needle pain, 1%–45%; tiredness, 2%–41%; and bleeding, 0.03%–38%). The serious adverse event of pneumothorax was rare, occurring only twice in about 250 000 treatments. A large United Kingdom study reported after this systematic review described the adverse events following acupuncture in a prospective survey of 32 000 consultations with medical doctors and physiotherapists.21 There were no serious adverse events and 2135 minor events, giving an incidence of 671 per 10 000 consultations, or 6.71%. The most common adverse events were bleeding (3.1%) and needle pain (1.1%). Aggravation of symptoms occurred in 0.96%, but subsequently improved in 70% of cases. While these total figures are low, they show that the highest adverse event rates for individual acupuncturists (as a percentage of their consultations) were 53% for bleeding, 24% for pain and 11% for aggravation of symptoms. While there may be a number of explanations for the wide range in rates of adverse events, a potential causative factor is educational standards relating to the practice of CAM. A retrospective Australian study of adverse events in Chinese medicine,22 primarily acupuncture, found that adverse event rates for practitioners with 0–12 months of CAM education were significantly higher than for those with 37–60 months’ education. In 2000, the Victorian government passed the Chinese Medicine Registration Act, which established a minimum educational standard for practitioners of Chinese medicine, including acupuncturists. Similar legislation by other states is yet to follow, but was recommended by the recent expert committee.18 Outside of chiropractic and osteopathy, other CAM practices remain unregulated and the capacity to set and enforce education and practice standards is problematic.

Reviews on spinal manipulation by chiropractors and osteopaths emphasise the infrequency of adverse events from spinal manipulations compared with the number of such manipulations performed throughout the world on a single day.23,24 However, under-reporting is likely to significantly distort the evidence, and large, rigorous studies of cervical spinal manipulation are needed to accurately define the risks.24

Any discussion about the safety of CAM needs to consider wider public safety issues and levels of acceptable risk. There are 7.2 million cases of food poisoning in Australia each year; in 2002, 103 people were hospitalised and two died of food poisoning.25 Moreover, 5.7% of hospital admissions in Australia are related to pharmaceutical drugs.26 Yet, risks from food and conventional medicine are seen as acceptable public risks. It has been estimated that, if the number of cases of adverse events recorded as resulting from Chinese medicine over the past 20 years were multiplied by 100, the number of adverse events would still not be comparable to those related to pharmaceutical drugs in one year of medical practice.12 Discussions about the safety of CAM need to be contextualised and not seen as a means of devaluing widely used health products and practices.

There is no doubt that both CAM products and practices have real risks associated with their use in the community, but, overall, these are most likely minimal.12 A priority for research is to rigorously define these risks so that their potential impact on public health can be assessed. It is probable that the data will point towards specific products or practices that need to be modified or ceased to bring them into line with community expectations of acceptable risk. In addition, occupational regulation of CAM practitioners will minimise practice risks by restricting practice to individuals with acceptable educational qualifications and by enforcing appropriate practice standards. Furthermore, effective education of both the public and CAM practitioners will be the key to minimising risks and maximising safety.