Clinical evaluation and regulation of CAM
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- Ask about use of complementary medicines and advise patients about potential hazards. [√]
- Warn patients that echinacea and royal jelly can precipitate life-threatening anaphylaxis in predisposed individuals with asthma. (IV)
- Encourage a good therapeutic partnership with the patient by approaching the issue in an open, sympathetic manner and avoiding a rigid dismissal of complementary therapy. [√]
- Monitor effects of complementary therapies as for conventional therapies. [√]
- Encourage patients to choose TGA-assessed products in preference to unregulated products and make sure they understand that the Aust L code does not indicate that the product is effective. [√]
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Patients may not mention that they are using complementary therapies for asthma.
A non-judgemental, respectful attitude may encourage patients to discuss their use of complementary therapies. |
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Overall, there is less documented evidence for the effectiveness and safety of complementary therapies than for conventional therapies.
- The majority of published studies have examined the complementary therapy as adjunctive therapies given in addition to patients' usual medical care (usually inhaled corticosteroids).
- Clinical trials of complementary therapies have not always collected safety data (e.g. frequency of exacerbations, deaths), as is routinely done in registration trials of conventional drug therapies.
- Some studies have not recorded lung function outcomes or measures of airway inflammation.
The placebo effect might explain the findings of those trials that have reported improvements in symptoms or reduction in reliever use, but failed to demonstrate lung function improvements. Regardless of the mechanism for observed effects, such a modality may confer clinically significant benefits (e.g. reduction in adrenergic adverse effects resulting from reduced reliever use, reduced response to allergens, reduced mast cell tachyphylaxis).3-5
In Australia, most complementary medicines are regulated by the Therapeutic Goods Administration to ensure that they conform with lists of permitted ingredients, and are manufactured under the same standards as pharmaceuticals.6 Products that have undergone this assessment are indicated on the label by the codes Aust L or Aust R. Most complementary medicines are Aust L coded. Patients should be encouraged to choose TGA-assessed products in preference to unregulated products (e.g. those obtained via the internet), and advised that The Aust L code does not indicate that the product is effective.
Most complementary therapists are not required to be registered with a professional association regulating their practice, so the ‘buyer beware' principle applies.
| Table 1. Some potential adverse effects of CAM |
| CAM modalities |
Potential safety issues |
| Any product |
Interactions between complementary and conventional medicines7
Refer to Australian Drug Reactions Advisory Committee (ADRAC) (www.tga.gov.au/adr/adrac.htm) reports for information about specific products.
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Echinacea
Royal jelly
Willow tree bark extracts (aspirin)
Camomile |
Allergic reactions8-10 |
| Traditional Chinese medicines |
- Mahuang (ephedra) preparations contain ephedrine, associated with headache, nausea, irritability, restlessness, insomnia, tachycardia, hypertension, motor disturbances.11
- Heavy metal contamination12
- Adulteration with conventional pharmaceuticals, e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids12-14
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| Indian Ayurvedic medicines |
- Heavy metal contamination14,15
- Adulteration with conventional pharmaceuticals, e.g. NSAIDs, corticosteroids14
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| Ginkgo biloba |
- Headache, nausea, dizziness, palpitations, allergic skin reactions, bleeding (rarely).8
- Interaction with warfarin.8
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| Vitamin and mineral supplements |
Toxic in high doses 7
Refer to Approved Product Information |
Content Created (Thursday, 16 November 2006)
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