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CAM Laboratory Tests Fail Two Important Criteria

By Bruce Campbell

A study of 11 common laboratory tests ordered by complementary medicine practitioners finds that they lack clinical validity and utility.

Alternative practitioners often claim that their treatments have been verified and are as reliable as conventionally evaluated medical procedures, but how good are the claims? As with much else in health, it pays to look behind the assertions that complementary and alternative treatments pass the scientific test expected of medicine in Australia.

Alternative practitioners such as naturopaths often use laboratory testing as part of their practice. These may be blood tests using venepuncture samples or dried blood spots, or they may use samples of urine, saliva and, for genetic tests, mouth swabs or hair roots.

Two British colleagues and I have recently reviewed the evidence for 11 commonly used non-genetic tests: live blood cell analysis, eukocytotoxic tests, food intolerance using IgG antibody testing, hair analysis for trace elements and minerals, antioxidant status, urine kryptopyrrole, mitochondrial function tests using neutrophil ATP profiling, Candida testing, post-chelator challenge heavy metal testing, secretory IgA, and adrenal stress profile.

We found that testing methodologies range from the crude, such as live blood cell analysis by microscopy, to the highly sophisticated, including hair trace element analysis by inductively-coupled mass spectrometry. We also examined regulation of this type of testing in the UK, US and Australia.

There are four primary criteria commonly used to evaluate laboratory tests:

  1. analytic validity – does the test accurately and reliably measure the substance of interest?
  2. clinical validity – does the test detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease?
  3. clinical utility – is there a likelihood that the results of testing will lead to an improved outcome for the person or the broader population?
  4. ethical, legal and social implications of the test – how is it promoted, how are reasons for testing explained to the person, what is the cost-effectiveness, and what is the potential for false diagnoses and unnecessary treatment?

We looked to see if there was evidence that these tests could meet the criteria of clinical validity and clinical utility but could not find evidence that any of these 11 tests would meet both criteria. In many cases it appears that use of these tests could lead to false or misleading diagnoses.

There are several potentially harmful consequences of such diagnoses. They may lead to unnecessary and, in rare cases, dangerous treatments, harm if a real diagnosis is missed, unnecessary out-of-pocket expenses for the person involved, nutritional harm to children given spurious advice about food sensitivities, and extra expense to the mainstream healthcare system if people seek further advice and investigation from their GP.

It is worth considering why complementary and alternative medicine (CAM) is so popular in countries with good healthcare and education systems. There is abundant evidence that health literacy in Australia, the US and UK is still poor. Most consumers don’t have the ability to critically evaluate the hyped claims of CAM practitioners, and regulation of CAM advertising claims is very weak.

While it’s clear that some people turn to CAM practitioners because they’re dissatisfied with what conventional medicine has been able to offer them, studies have shown that most CAM users are not dissatisfied with conventional medicine but simply want to broaden the range of options open to them, and may feel that both conventional medicine and CAM are on an equal footing.

Regulation of this type of testing in Australia is done by the Therapeutic Goods Administration (TGA). However, the TGA’s Medical Devices Essential Principles Checklist (https://bit.ly/2lij65q) does not adequately address clinical validity and clinical utility.

Since mid-2017 laboratories using in-house-developed laboratory tests were required to be accredited with the National Association of Testing Authorities (NATA). However, all but one of the tests we evaluated are available from Australian laboratories today.

There is a gap between the roles of the TGA and NATA. TGA does not inspect laboratories, so it doesn’t know what they are doing. NATA does inspect laboratories but only inspects the tests that the lab wants NATA-accredited. Thus, in theory, labs could be using in-house-developed tests that should be NATA-accredited but the TGA will never find out about it.

Clearly, regulation of this area is inadequate at present.


Dr Bruce Campbell is a retired pathologist and pathology representative for Friends of Science in Medicine.