The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004

Non-representative surveys in many countries have suggested that there is a high use of complementary and alternative medicine (CAM). CAMs include herbal medicines, traditional medicines (Ayurvedic or Chinese), vitamin, mineral and nutritional supplements, homeopathic medicines and aromatherapy products. CAM practices include a diverse group of therapies such as herbal medicine, chiropractic, osteopathy, naturopathy, homeopathy and acupuncture. In the United States, about a third of adults aged 18 years or older use CAMs.1

In Australia, we previously conducted two representative population surveys in South Australia examining the use and cost of CAMs, using the South Australian Health Omnibus Surveys. We found that, between 1995 and 2000, there had been an increase in the use of CAMs and over-the-counter medicines.2,3

In 2004, we conducted a third representative population survey in South Australia, surveying the trend in CAM use since the Pan Pharmaceutical crisis (in which a substantial quantity of CAM products was removed from retail stores) and asking further questions about the public’s beliefs concerning the CAMs and their quality of life.

Data were collected via the South Australian Health Omnibus Survey conducted in March–April 2004. The Health Omnibus Survey is a large representative population survey that has been undertaken annually in South Australia since 1990 using a clustered, multistage, systematic, random, self-weighting area sample. Weighting ensures that every household has the same probability of being selected. This approach has been used consistently from the inception of the survey and involves sampling people aged 15 years and over living in metropolitan Adelaide and major country towns with a population exceeding 1000.4 South Australia has a slightly older population on average than other Australian states, but otherwise the population is generally similar to Australian demographic data.

The survey data were weighted to the 2002 Australian Bureau of Statistics Estimated Residential Population data by sex, 5-year age groups and geographic area so that the findings apply to the demographic profile of South Australia. To estimate reliability, 10% of the respondents were resurveyed.

Age, sex, marital status, education, employment status, area of residence, country of birth, and household income level were recorded.

The respondents were given the following definition:

They were asked whether they had used any complementary or alternative medicines or health products over the past year, with seven main types listed on a prompt card with samples of each type (herbal medicines, vitamins, mineral supplements, Chinese medicines, homeopathic medicines, soy products, aromatherapy oils, other or none). Excluded were calcium, iron or vitamins prescribed by a medical practitioner. The respondents were asked to estimate, to the nearest dollar, the monthly cost of these products.

A prompt card was used to seek the main reasons for the use of these medicines, with the categories general health; blood or circulation; bladder or kidneys; muscles, bones or joints; lungs or sinuses; immune system; nerves or stress; stomach and bowels; prostate; PMS/menopause; skin; other; and don’t know.

Respondents were asked if their medical practitioner knew about the complementary medicines being taken and whether they used these medicines on the same day that they took conventional medicines.

They were also asked if they had visited any of the following therapists listed on a prompt card in the last year: herbal therapist/herbalist; naturopath/natural therapist; aromatherapist; homeopath; acupuncturist; iridologist; osteopath; chiropractor; reflexologist; other; none; and don’t know. The approximate total yearly cost of these therapists (not including the cost of any medicine they prescribed or sold) was asked.

Respondents were asked if any children in their household were ever given CAM medicines or therapies with the following options: no children in household; children but alternative medicine and therapies not used; yes — non-prescribed vitamins; yes — other alternative medicines/products; yes — therapists listed on the above prompt card; other alternative therapists; and don’t know.

Respondents were asked: “Do you think that complementary or alternative medicines are independently tested by a government agency such as the Therapeutic Goods Administration before being sold?” and “What do you think they are tested for?”. Possible answers were quality/safety/side effects; efficacy/strength/effect; that they do what they claim to do; other; and don’t know.

Similar questions, but not all, had been asked using the same method in surveys of the same population in 1993 and 2000.2,3 Where possible, the answers to the same questions were compared between surveys.

The data were analysed using SPSS version 12.0 (SPSS Inc, Chicago, Ill, USA) and Epi Info version 6.04 (Centers for Disease Control and Prevention, Atlanta, Ga, USA). All cost data were adjusted using the consumer price index.

The South Australian Health Omnibus Advisory Committee independently vetted all questions in the survey and gave its ethical approval.

Although there were no significant changes in the numbers of respondents who use CAMs since 2000, in 2004 there was a significant increase in the number of women compared with men using herbal medicines. As confirmed in multivariate analyses in our previous surveys, the greatest users of CAMs are better-educated, higher income, women in the 25–44 years age group living in a metropolitan area. Self-prescribed vitamins were the most used products, followed by herbal medicines. Most respondents had no specific medical reason for using CAMs, but believed they would help their general health. Younger respondents were more li-able to believe that CAMs helped their immune system and older respondents used them more often for chronic disabilities such as joint pains or circulation problems. Women often try herbal medicines around their menopause.5 For the first time, we asked about children’s use of CAMs — almost a third of respondents with children had administered CAMs to their children.

In 2004, the overall extrapolated expenditure in Australia on complementary medicines from our data decreased to $1.31 billion from $1.67 billion in 2000. However, as there was little change in the numbers using CAMs and as, in general, there was little change in the cost of the commonly used products, it is likely that CAM users are now using fewer CAMs per person than in 2000.

This decline in the market could be contributed to consumer response to the adverse publicity in the media surrounding CAMs in 2003 during the Pan Pharmaceutical crisis. In 2003, the TGA had serious concerns about the content and quality control of products manufactured by Pan Pharmaceuticals. After an audit prompted by a range of hospitalisations and other serious adverse events to an over-the-counter non-CAM product manufactured by the company, the TGA suspended the company’s licence to manufacture, and required the recall of 1600 products — mostly CAMs. It has been estimated that this company manufactured about 40% of CAMs on the Australian market. The suspension of its licence resulted in a substantial quantity of CAMs being removed from retail outlets, which may have interrupted or reduced respondents’ use of CAMs.

A similar effect was seen in the use of menopausal hormone replacement therapies in 2002 when media reported, and often exaggerated, the risks of long-term therapy with one regimen.6 Hormone therapy use dropped to a third of its prior use, but has since returned to two-thirds of the levels of use recorded before 2002. Thus, the media appears to have a great influence on decision-making regarding both conventional and complementary medication.

In contrast to the decline in use of CAMs, there has been a steady increase in use of CAM therapists by the South Australian public over the past 10 years. Chiropractors, followed by naturopaths, were the most frequently visited. The profile of the most common user was a woman, between the ages of 35 and 44 years, living in the country, with a higher than average income level. There was a wide range of expenditure on CAM therapists but, again, overall average costs since 2000 had decreased (by 20%), suggesting a lower frequency of attendance.

It is of continuing concern that about half of CAM users ingested them on the same day as conventional medicines and that more than half (53.2%) did not tell the doctor prescribing conventional medicines that they were also taking CAMs. This is a critical issue that needs to be addressed to ensure that the use of CAMs by the community is consistent with the National Strategy for Quality Use of Medicines. Interactions between some CAMs and some prescribed medicines have been frequently described.7,8 Yet, lay beliefs are that most CAMs are safe.3 This is in contrast to increasing reports of adverse effects from CAMs9,10 and other problems seen predominantly overseas, such as contamination, adulteration, substitution, variable dosage, dubious quality control and inappropriate labelling.10,11 Doctors need to directly ask about the use of CAMs in a non-judgmental manner to better ascertain the risks of drug interactions and potential side effects from CAMs.

Giving children medicines that have not been tested in children is another important quality use of medicines concern. In households we surveyed where there were children under the age of 15 years, a third of these children had been administered CAMs. Other surveys have reported use of CAM therapies during pregnancy and in our last survey only 36.2% of respondents thought that CAMs were not safe during pregnancy.3 Although few CAMs have been shown to be teratogenic, most have not been sufficiently tested to rule out adverse fetal effects and CAMs should not be used during pregnancy.

Users of CAMs had a lower quality of life in all of the physical and psychological domains of the SF36 questionnaire except physical functioning. However, these results should be interpreted with caution as this was a cross-sectional study and longitudinal quality-of-life scores are not available from before self-medication with CAMs began. In some cases the public, particularly older respondents, are using CAMs because of chronic health problems and thus they may have had low quality-of-life scores before starting medication. Also, surveys are open to recall bias and potential bias if non-respondents differ from the respondents. However, response rates were high in all three of our surveys and on retesting 10% of respondents the answers remained consistent.

It has been argued that the rising use of CAMs does not change the rules for informed consent.12 If a physician or CAM therapist advocates or prescribes CAMs then it is their legal duty to warn the patient of:

• the material hazards,

• possible complications that could occur,

• reasonable alternatives, and

• the effects of non-treatment.

Prescribers must also have a thorough knowledge of the patient’s medical history, pertinent family history, current medications and risk of pregnancy. This responsibility is incumbent even on those who advise on CAMs at the point of sale; however, most CAMs are not sold with general product information to alert the consumer to possible risks. Further, the scientific evidence that underpins the role of CAMs for the broad range of conditions for which they are used is far from complete. The quality of the evidence for specific CAM medicines or interventions for specific medical conditions ranges from first class to nonexistent.13-17 Even in areas where a substantive amount of work has been undertaken, the research suffers from a lack of methodological rigour.

The Chairman of the Australian Health Ethics Committee, National Health and Medical Research Council, has argued the ethics of promoting products or therapies that may only have a placebo effect.18 Those who practise or recommend CAM have ethical responsibilities to inform patients when the therapy is unproven as well as of any potential risks. Patients offered CAM interventions must not be denied access to standard proven therapies. Equally, as the evidence base for CAM increases, any CAM medicine or intervention with appropriate evidence should be seen as a reasonable alternative to a conventional medical approach.

Our results clearly showed that half the population thought that CAMs were independently tested by the TGA before being allowed to be sold. Currently, the TGA has limited capacity (as the nature of TGA funding requires full cost recovery) and audits less than 1% of CAMs on the market. Most CAMs are “Listed” (L classification) by the TGA on the Australian Register of Therapeutic Goods (their stated contents and safe manufacture have been accepted without audit and without proof of efficacy) and can be sold and advertised with “low level” claims. In contrast, “Registered” (R classification) medicines have been assessed for quality, safety and efficacy.

The Expert Committee on Complementary Medicines in the Australian Health System, set up by the Australian Government after the Pan Pharmaceutical crisis, recommended an increase in the random and targeted assessment of the indications and claims held by sponsors of CAMs.19 The committee made 49 major recommendations for improved regulation of complementary medicines in Australia. In 2005, the Australian Government accepted all but one of these recommendations and is now implementing the process. These changes will strengthen the regulatory framework for CAMs and CAM therapists in Australia.

4 Extrapolated cost of CAMs and CAM therapists in Australia