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Due diligence in practice: or, do you know what your patients are taking?

As naturopaths and herbalists we have an honourable role: we help people recover from illness and injury, and to restore and maintain their health. We supply supplements and herbal products as fundamental factors in treatment.

It is obvious to any of us, as herbalists, that what goes into the mouth has significant effects on health. So, it follows that we need to know not only what a patient eats and drinks, and understand the herbs, nutrients, etc. we intend to prescribe; but also what other medications, supplements, and topical products patients may be using. Some may be beneficial, others neutral; but some are potentially harmful.

So:

1. Do you ask patients to list everything they are taking? Research with medical practitioners clearly shows that most patients don't offer this information unless asked; and that many don't consider supplements as medicines, therefore they don't need to be discussed. (1) This is more common with older patients. It can be very useful to ask every new patient to bring a list of everything they take, or even bring in the actual products, to the appointment.

2. Do you check all the products and their potential for problems?

This does take time; most often it becomes homework in preparation for the next appointment.

3. Do you check where the product came from?

Australian manufacturing regulations are very strict. Other countries do not always have the same manufacturing standards, so products sourced overseas are not necessarily what they seem. Examples:

a) Asian "herbal medicines" purchased over the internet. Many so-called herbal products contain undeclared prescription drugs or, worse, analogues which are not tested for safety in humans. These are most often sold for weight-loss or sexual enhancement. (2)

b) Herbal and nutritional products from the USA.

i. Product labels often lack crucial information, such as plant part, dry herb equivalent or extract ratio, making it impossible to estimate potency.

ii. Manufacturing standards are not always followed. In some cases, ingredient mixing is inefficient, with doses ranging from subtherapeutic to directly toxic. (3)

iii. In many cases, expensive ingredients are replaced with cheap substitutes. This is now such a widespread problem that the AHPA issues weekly newsletters detailing newly discovered adulteration issues. (4)

iv. Sports foods can contain novel ingredients of dubious safety. Occasionally, serious reactions occur, including liver failure. (5)

4. Do you check whether the product has an AUST L number to show that it is listed with the TGA?

a) The TGA's stringent controls mean that AUST L products are safer and more reliable than most natural products.

b) The label of an unlisted product is no guarantee of its contents.

c) Be aware of remedies sourced from backyard producers, e.g. those selling their products through weekend markets and local internet sites. Often the producers are unfamiliar with food regulations, TGA requirements, or potential risks of the "miracle" formula they are selling. As well there are frequently disclaimers that there is excessive and unfair regulation or corporate conspiracy which prevents people buying these products over the counter. Examples include Black Salve and Cansema. (6,7)

Let's look at a current example: colloidal silver. Colloidal silver, also known as silver nanoparticles, is a very effective disinfectant and antiseptic used in operating theatres, on surgical devices, in wound dressings and as a preservative. However, over recent decades it has been promoted to consumers for oral use.

What is the problem with this?

1. Silver is a heavy metal. With higher doses or prolonged use, it can accumulate in organs and under the skin, a condition called argyria (roughly translated as silver sickness). Symptoms include:

* Bluish-grey discolouration of the skin and mucosa, usually permanent

* Deposition of silver compounds in eye structures

* Interference with copper metabolism

* Kidney damage

* Liver damage

* Rarely, cardiac and neurological damage.

While silver is far less toxic than lead or mercury, it does have potential to do harm. Nanosilver is absorbed through the skin to some extent, and there are reported cases of occupational exposure causing argyria.

There are 11 reports in the TGA database (9) of adverse reactions where the oral use of colloidal silver is suspected (with good reason); internationally, there are over 30 scientific reports discussing nanosilver or colloidal silver toxicity in animals and humans. These can be accessed via the TOXNET database. (9) To quote from several reports:
   Recently, there appears to be an increase in the
   practice of colloidal silver ingestion given the
   popularity and easy availability of alternative
   medicines and dietary supplements containing
   various silver-containing compounds. (10)

   The ingestion of colloidal silver appears to be
   an increasing practice among patients using
   alternative health practices. All silver-containing
   products including colloidal silver should be
   labelled with a clear warning to prevent argyria,
   especially in alternative health practices. (11)

   Argyria is a rare cause of cutaneous discolouration
   caused by silver deposition. We report a case
   of dramatic and diffuse argyria secondary to
   ingestion of colloidal silver protein over a 1-year
   period. Stained electron microscopy with spectral
   analysis was used to confirm the clinical diagnosis.
   Silver-protein complexes are deposited in the skin
   and reduced to inert silver salts by sunlight in a
   process similar to that harnessed in photography.

   Our patient had obtained the silver for consumption
   via mail order. It had been advertised as a cure for
   a variety of diseases. Colloidal silver protein is
   commercially available as a 'food supplement',
   hence circumventing the strict controls placed on
   medicines. (12)


According to a report prepared for Food Standards Australia New Zealand: (13)
   Since the 1990s, colloidal silver has been
   marketed as an alternative medicine, however its
   effectiveness for such uses has not been proven.
   After chronic medical or occupational overexposure
   to silver, argyria (a permanent grey or
   blue grey discolouration of the skin and other
   organs) is the most common finding.

   There is currently insufficient data to confidently
   determine if Ag-NPs in food may present a
   toxicological hazard to humans at the dietary
   exposure levels so far estimated. Apart from there
   being no dietary chronic studies, neurobehavioral
   studies are not available. The latter is an important
   data gap given silver, from either Ag-NPs or
   soluble silver, has a long residence time in the
   brain. Similarly, research investigations with
   Ag-NPs showing potential for sperm abnormalities
   and delay of puberty onset need consideration.
   Toxicological data for reproductive impacts of
   Ag-NPs are not available.


Therefore, although colloidal silver or nanosilver is not highly toxic, it does carry risk.

2. Silver is not listable with the TGA except as a homoeopathic ingredient. (14) Therefore, colloidal silver preparations may not be produced under Good Manufacturing Practice (GMP) conditions. This means that there is no guarantee of:

a) the dose of silver;

b) the form of silver;

c) whether any silver is present at all;

d) what else may be in the product.

In other words, the potency, toxicity and safety of any particular colloidal silver product are simply unknown.

3. Similarly, devices for generating colloidal silver solutions at home or sold over the internet, are not registered with the TGA. Once again there is no way for an ordinary consumer to know whether these devices work as advertised, whether they produce the claimed concentrations of silver particles, or whether the resulting solutions are effective or safe.

4. Silver is a potent and non-selective antimicrobial.

While it is a valuable broad-spectrum antiseptic and disinfectant, when used internally, silver will destroy beneficial as well as harmful microbes in the digestive tract. Loss of the delicate Lactobacillus and Bifidobacterium species, among others, is likely to produce imbalance of the gut flora, with obvious health consequences.

5. It is not necessary to turn to a heavy metal for internal antimicrobial activity. Thyme, sage, garlic, myrhh are just a few of many safer alternative treatments which herbalists are ideally placed to offer.

In conclusion:

Silver can be very useful for surface disinfection and as a topical antiseptic--with appropriate safeguards. But it is my firm belief that, as health professionals with a duty of care, and having regard to the Hippocratic instruction to "first do no harm", it is our duty to advocate as strongly as possible against internal use of silver compounds.

Contact information:

Ruth Kendon

The Haven Natural Therapies

PO Box 878, Willoughby, NSW 2068

Email: kendon@haventherapies.com

Phone: 61 (2) 9405 6768

Mobile: 61 414 623 397

References

(1.) https://wwwncbi.nlm.nih.gov/pubmed/21917864

(2.) http://wwwtga.gov.au/alert/france-t253-capsules; http://wwwtga.gov.au/alert/dragon-power-capsules ; http://wwwtga.gov.au/alert/slim-vie-slimming-capsules

(3.) https://wwwncbi.nlm.nih.gov/pubmed/21917864

(4.) Kumar SP. Adulteration and substitution in endangered ASU medicinal plants of India: a review. Int J Med Arom Plants. March 2014;4(1):56-73.

(5.) https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-11-222

(6.) https://wwwtga.gov.au/community-qa/black-salve-red-salve-andcansema

(7.) http://wwwblacksalveaustralia.com/

(8.) http://apps.tga.gov.au/PROD/DAEN/daen-entry.aspx

(9.) https://toxnet.nlm.nih.gov/

(10.) J Drugs Dermatol. 2015, Jul; 14(7):760-1.

(11.) Am J Ind Med. 2009, Mar; 52(3):246-50.

(12.) Clin Exp Dermatol. 2003, May; 28(3):254-6.

(13.) Drew R, Hagen T, 2016. Potential Health Risks Associated with Nanotechnologies in Existing Food Additives.

(14.) https://wwwebs.tga.gov.au/
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Title Annotation:Commentary
Author:Kendon, Ruth
Publication:Australian Journal of Herbal Medicine
Article Type:Report
Date:Jun 1, 2017
Words:1529
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