Dr Ken Harvey writes:

Two important research reports on the complementary medicines information needs of Australian consumers and health professionals are now available from the National Prescribing Service (NPS).

In my view, the NPS research highlights the gap between the widespread and increasing use of complementary medicines and the limited evidence available to justify much of this use.

It also shows a major disconnect between the consumer perception of complementary medicines as “natural” and “risk-free” and the reality that these medicines contain pharmacologically active substances that can cause adverse effects, albeit less frequently with conventional medicines.

In addition, the use of complementary medicines for indications in which they lack efficacy can have a significant adverse effect on consumers hip pockets (or purses) and, more importantly, can delay or prevent the use of more evidence-based therapy.

Only about 40% of GPs and community pharmacists surveyed felt confident discussing complementary medicines with patients. Many GPs and pharmacists were not aware of the side effects of some commonly used complementary medicines and their potential interactions with conventional medicines. In addition, they did not always discuss the use of complementary medicines with their patients and were often unaware of complementary medicines use by their patients.

The solution proposed by the NPS (given its limited brief) was better education of health professionals and consumers about complementary medicines. This required an independent and reliable source of
information about complementary medicines, to be made available to both consumers and health professionals.

The final NPS report (due in January 2009) will suggest possible sources of such information. This might include obtaining a n Australian licence to an internationally recognised database such as the U.S. “Natural Medicines Comprehensive Database” or the “Natural Standard Professional Database”.

However, information about generic complementary medicines has major limitations compared to that about conventional medicines because of the current “two-tiered” Australian regulatory system. Unlike conventional (registered) medicines, complementary (listed) medicines are not evaluated for efficacy or therapeutic equivalence. [1]

Sponsors currently perpetuate the misconception that all complementary medicines containing the same ingredients are equally effective. The reality is that complementary medicines, especially herbal medicines, are complex products with numerous biologically active components. This means that evidence of benefits (and risks) are specific to the product tested and cannot necessarily be extrapolated.

The “generic” concept which is valid for conventional medicines, for example the interchangeability of paracetamol containing products, is invalid for CM. This means that a prescription for “St John’s wort” for example, is not reliable as St John’s wort is not one substance.

In addition, meta-analyses and systematic reviews of a “substance”, for example a herb, or glucosamine, are easily misinterpreted because the products made from that “substance” can be so different that any conclusions drawn can only be applied to the specific products trialled. [2]

Because of this, the U.S. “Natural Medicines Database” NMBER system provides specific brand name products that have been studied in clinical trials with a unique effectiveness rating based on the evidence specific
to that product. In addition, independent testing of product quality by the U.S. Pharmacopoeia (who provide a USP trademark) also contributes to the NMBER rating.

In short, to be useful, we would need to augment any database of generic information about complementary medicines with specific information about whether or not products on the Australian market were identical
(or bio/phyto/equivalent to) products proven in clinical trials. This is what the opt-in, independent evaluation system suggested by Choice and others would provide. [2]

In addition, as well as increasing access to good information about complementary medicines, there is also a need to decrease the inaccurate, misleading and unbalanced information currently being promulgated and preferably limiting the listing of products that lack evidence of efficacy. In short, better information needs to be supported by regulatory reform. [3]

• Dr Ken Harvey is Adjunct Senior Research Fellow, School of Public Health, La Trobe University
http://www.medreach.com.au

References

1. Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: Regulation of complementary medicines in Australia. Med J Aust 2008; 188: 21–25. Available at: http://www.mja.com.au/public/issues/188_01_070108/har10522_fm.html

2. Pollard NA || Santoro A || Kotsirilos V || Masters CS || Harvey KJ, Korczak VS, Marron LJ and Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines
in Australia [letters]. Med J Aust 2008; 189 (1): 50-53.
Available at: http://www.mja.com.au/public/issues/189_01_070708/letters_070708_fm-2.html

3. Harvey KJ. Controlling complementary medicine claims [Editorial] Aust Prescr 2008; 31(6): 142-143. Available at: http://www.australianprescriber.com/magazine/31/6/142/3/

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