Evidence for complementary medicines: the value of science and traditions


medicines under magnifying glass

Brenda Davy takes a look at the the evidence base for CMs

Complementary medicines have existed for centuries and have provided the basis for many of the formulations of ‘conventional’ medicines that are widely available today.

More commonly referred to as vitamins, minerals and herbal supplements, these medicines have become part of our mainstream healthcare practice in Australia as well as globally.

The evidence for complementary medicines can be either ‘traditional’ or ‘scientific’. Each of these requires rigour and the allowable claims coming out of each type of evidence differs.

Many complementary medicines have a plethora of traditional evidence. This is a well-recognised form of evidence accepted by the Therapeutics Goods Administration and allows specific traditional-use claims to be made.

Traditional evidence for complementary medicines refers to a history of use of at least 75 years (considered to represent three generations of use), although sometimes extends to thousands of years, within a particular traditional medicine paradigm. This could refer to traditional Chinese medicine, Ayurvedic medicine, or Western herbal medicine, amongst others.

Most cultures developed systems to treat their sick and injured, so there are many different paradigms for traditional medicine. Some traditional medicine systems are easier to trace this development, due to the long history of detailed written records, such as found with traditional Chinese medicine.

Others are more difficult to trace, and further work is required to create accurate records to prevent this information from being lost.

Many traditional ingredients have a well-established period of widespread traditional use which is extensively recorded in recognised evidence sources for traditional medicine such as materia medica, monographs and publications from various international regulatory authorities.

The rigour required for traditional evidence is substantial and more about this can be found on the TGA website.

‘Scientific evidence’ also exists for many complementary medicines. Scientific evidence refers to quantifiable data and includes: clinical trials in humans; epidemiological evidence; animal studies; and other evidence of biological activity.

Scientific indications are usually supported with data from relevant scientific evidence, and there are many high quality sources of scientific evidence, including:

  • peer-reviewed original clinical research in well cited journals;
  • systematic reviews of the clinical research relating to particular subject areas;
  • unpublished studies or ‘Propriety research’ (as long as they meet the required criteria); and
  • secondary sources or non-clinical studies.

 

The advantage of referencing peer-reviewed research is that these studies have typically been subjected to rigorous methodological evaluation that ensure that the results are robust and valid.

The methodological design is a key feature for determining the quality of the evidence. If the parameters used in the study are not precise, then the results will be of less value, however a study conducted using accurate measures, well-matched controls, and appropriately adjusting for confounding factors provides far greater confidence in the results (and therefore the evidence and efficacy of the product) than an uncontrolled, or poorly measured study that fails to differentiate between correlation and causation.

The rigour required for scientific evidence is also substantial and more about this can be found on the TGA website.

 

Brenda Davy is the Strategy Manager Complementary Medicines, Australian Self Medication Industry.

Previous Pharmacists urged to check patient inhaler technique
Next Safety tips for pharmacy staff

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.

6 Comments

  1. kingswaycompounding
    20/07/2016

    Thanks Brenda for an excellent article! Thousands of years of evidential use doesn’t seem to hold much sway with various people… hope this clarifies some of the confusion.

    • Ken Harvey
      20/07/2016

      Oh dear! The history of medicine is littered with examples that demonstrate how misleading this fallacy can be. Bloodletting was believed to be effective, was widely practised for at least 3000 years and was highly popular, yet it certainly killed more patients than it ever helped.

      Yes Brenda, the TGA Evidence guidelines do allow “Traditional Evidence”. But they also say, “traditional indications present factual statements of a health benefit relating to a historical record of use within a traditional paradigm. Traditional indications cannot make a scientific claim of efficacy; as such indications require supportive scientific evidence”.

      They go to say, “If you are aware that there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, then it is advisable to include a statement to this effect in any labelling and advertising associated with the medicine, for example: ‘this traditional use is not supported by scientific evidence’. This will ensure that the advertised information relating to your medicine is truthful, valid and not misleading”.

      So why don’t homeopathic medicines such as “Key Sun All Natural Kids range” have such a disclaimer. Over to ASMI for a response please?

      • kingswaycompounding
        21/07/2016

        ah now Ken… bloodletting in the same context at vitamins minerals and herbs????…. what was that you said about ‘misleading this fallacy’. As for scientific evidence may I refer you to an article published in the BMJ 2003…

        Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

        BMJ 2003; 327 doi: http://dx.doi.org/10.1136/bmj…. (Published 18 December 2003)Cite this as: BMJ 2003;327:1459

        A good explanation is found here.
        http://io9.gizmodo.com/can-a-p

  2. kingswaycompounding
    20/07/2016

    ah now Ken… bloodletting in the same context at vitamins minerals and herbs????…. what was that you said about ‘misleading this fallacy’. As for scientific evidence may I refer you to an article published in the BMJ 2003…

    Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

    BMJ 2003; 327 doi: http://dx.doi.org/10.1136/bmj.327.7429.1459 (Published 18 December 2003)Cite this as: BMJ 2003;327:1459

    A good explanation is found here.
    http://io9.gizmodo.com/can-a-parachute-save-your-life-not-according-to-scienc-1556426507

    • Ken Harvey
      22/07/2016

      Ah now Kingswaycompounding…. is the outcome of supplementing large numbers of healthy people with vitamins, minerals and herbs as self-evident as the value of parachutes? “You might think that”, but unlike Francis Urquhart in the “House of Cards” who “couldn’t possibly comment” I refer others to the scientific literature.

  3. Ron
    22/07/2016

    Sad to see that the industry-funded TGA has given in even further to the over-the-top hype of those selling so-called “complementary” medicines. So now as well as AUSTR and AUST L numbers (which seem almost identical to the innocent consumer) we are told that the AUST L can be subdivided into those that have some sort of “evidence”.
    “Traditional” evidence? What a joke. Astrology has been very popular for at least 4000 years, but there’s not a speck of truth in it. In fact there are good reasons to believe that the medicines that DON’T work are in fact MORE likely to be accepted and handed down as “traditional” medicines.
    The TGA should adopt a system that will make the truth easy for consumers to understand. It should ban the commercial sale of all medicines that are not proven safe and effective to the TGA’s satisfaction based on published scientific research.

Leave a reply