‘’Natural health’’ due for a shakeup

The Natural Health Products Bill passed its first reading in Parliament in September. It appears to have wide support across most political parties, and those who follow such things expect it to pass into law next year without significant amendment (www.lawfuel.co.nz/releases/release.asp?NewsID=2763).
The bill proposes regulation of a wide range of alternative health modalities including traditional treatments, herbal and homeopathic remedies, and dietary supplements. Therapies based on manipulating ‘energy flows’ or spinal subluxations are not covered, nor are any ingredients intended for administration to the eye or ear, or by injection. Leaving aside that some of what is covered would be better described as supernatural rather than natural, the new legislation brings a degree of control over a sector which until now has been something of an afterthought in the Dietary Supplements Regulations 1985 or the Medicines Act 1981; these are now considered out of date in any case. It provides for a list of prohibited ingredients, and an open-ended list of ingredients that can be used.

There is plenty about the bill that skeptics would probably support. Natural health products are an industry estimated to turn over about $760 million annually in this country, so they definitely deserve greater oversight. There have been horror stories of, for example, so-called traditional Chinese medicines containing dangerous levels of potent drugs, and more stringent controls on permitted ingredients and labelling should reduce this risk.

But it remains to be seen how the law will work in practice. One issue is that there will be no restrictions on the nature of therapeutic claims that may be made for a product. Sponsors must declare they hold evidence to support the claims made (and supply it if requested), but one wonders how this is supposed to work for homeopathic remedies, which contain little or no trace of any allegedly therapeutic product, and which have consistently failed to be substantiated in properly run trials. What standards of evidence will actually be required? The new Natural Health Products Regulatory Authority may exempt an entire category of products from the requirement to have a product notification (needed before they can be distributed), and it will be interesting to see how this clause is applied.

The bill also requires the Authority to establish an advisory committee of up to eight persons to provide them with expert advice. Each member must have expertise in an area relating to natural health products, so will this committee be stacked with practitioners, who may have rather generous interpretations of the law’s provisions? This story will be something for skeptics to keep a close eye on as it unfolds over the next few years.

Traditional Chinese Medicine and the Health Practitioners Competency Assurance Act

Submission to the Ministry of Health on the matter of the proposal that Traditional Chinese Medicine (TCM) become a regulated profession under the Health Practitioners Competency Assurance Act (HPCAA) 2003.

1. Is TCM a health service, as defined by the HPCA Act?

In the proposal, the applicants have defined TCM:

as an occupation with a clear professional identity and an established body of knowledge with standards of practice, and as a system of primary health care, encompassing a range of therapeutic interventions, including but not limited to, acupuncture and moxibustion, Chinese herbal medicine, remedial massage, diet and exercise, as well as contemporary practice developments….

Statistics New Zealand defines TCM as:

the treatment of imbalances of energy flows through the body by assessing the whole person, and using techniques and methods such as acupuncture, Chinese herbal medicine, massage (tuina), diet, exercise and breathing therapy (quigong).

We consider that Statistics New Zealand provides a better descriptive definition of TCM, as the applicants’ definition focuses on the interventions that are part of TCM rather than defining TCM as a whole. The former definition also tends to be overly broad, with the term “including but not limited to” allowing the definition to be arbitrarily added to and any products and services appended. The alternative health industry is well known for taking a scatter-gun approach to include a vast range of modalities based, it seems, on marketing and consumer wishes, rather than on evidence of efficacy.

As well, some interventions are defined as unique to TCM but are in fact used by many other health practices, such as diet, exercise and massage in providing health care services. In the case of dietary approaches, there already is a health profession adequately covered by the HPCAA of Dieticians, and based on evidence and independent verification.

In many respects either of these definitions appears to meet Primary Criteria, as the practice of TCM does appear to involve the process of assessing and treating the physical or mental health of individuals or groups of individuals. Whether the assessment or treatment is acceptable health practice is another matter, and we maintain that it should not be accepted as such based on current evidence.

Measures to protect the public such as regulation and other applicable consumer protection legislation, particularly in the context of health care, need to be robust and have the trust of the public. It is particularly important to support the process of regulation of health care practice and delivery where appropriate to ensure that people seeking care can be confident that the person they seek care from is qualified and competent to practice safely and that, should they fail to meet identified standards, there is a system in place to deal with this.

There is, however, significant risk in granting the legitimacy of official regulation ahead of adequate evidence of efficacy and a plausible method of action (Secondary criteria: Criterion 2). Such presumption can lead to regulation being ineffective in protecting the public.

An example is where the ability for informed consent is diminished as the person seeking care must make an assessment based on the beliefs of the provider rather than proper assessment of their clinical condition and choice of evidence-based therapies. It is also possible that such a person can receive treatment that is not only ineffective for their condition, but which also has the potential to cause harm.

This has been demonstrated in many of the core practices of TCM such as acupuncture, energy medicines, cupping/moxibustion and the like (example case studies from the media are monitored by WhatsTheHarm.net; others are available via professional medical groups and monitoring organisations).

In such cases, regulation may fail in its aims by creating the situation where it is difficult for a health care consumer to determine the best health care provider to treat them and provide apparent support for situations where care can be inappropriate or even harmful but where the provider is not deemed to be acting outside the regulations that cover their practice. This also tends to go against a growing number of legislative developments worldwide where jurisdictions have determined that it is illegal to make claims about treatments where no evidence exists to support that claim.

TCM uses two major concepts – that of Yin-Yang and Five Elements. Diagnosis involves looking, listening, smelling, asking and touching. It includes acupuncture, which is based the idea that health relates to the flow of the claimed Chi/Qi (life force) through pathways in the body. The goal of needling is to rebalance and unblock Chi, under the belief that such imbalance and blockages cause illness. TCM also involves dietary management by categorising foods into set characteristics of “hot” or “cold” (NB: not actually based on temperature, but on esoteric qualities) and by flavour. Imbalances in such characteristics are believed to be a root cause of illness. As an example, the stomach and spleen are conceptualised as a cauldron, with internal fire transforming the food into energy and blood. Herbal medicine in TCM again involves categorising by temperature and flavour that is considered to influence Yin-Yang energy patterns.

All of these concepts developed long before modern medicine, biology, chemistry and physics, which are evidence-based, cross-cultural bodies of knowledge that exist independently of a practitioner’s or client’s beliefs, supported by independent verification and monitored practice. With TCM, there is no evidence for the existence of concepts such as Yin-Yang or its role in health care.

The highly fluid nature of such beliefs means that there is little correlation between practitioners when diagnosing and treating patients and no correlation with relevant physiological processes in the body. Where the diagnosis may be cited as something like “kidney Qi deficiency”, this has no relationship to any conventional medical diagnosis. Thus while TCM practitioners may appear to be undertaking assessments, diagnosis and treatment using similar-sounding terms and practices to evidence- based medicine, there is no accepted medical body of knowledge or health practice at work.

TCM does not fulfill the criteria of being a health service, but is more in the nature of an applied cultural practice or belief system. Much of its current system, in fact, owes a great deal to the political and social context of China in the 1950s and 60s rather than to the claimed long-established traditional practices. The same can be said for a great deal of its apparent pharmacopoeia, where materials have been added, often on an ad hoc basis, over the past 50 years. There are many reports of the problems that this lack of consistency and independent oversight has caused, ranging from animal welfare issues (eg the use of bear bile or tiger parts) to negative health outcomes from unmonitored and unacceptable production process (eg heavy metal poisoning or inclusion of drugs such as Viagra).

As such, to provide TCM with apparent legitimacy of health regulation would be misleading to those seeking such services, doing a disservice to the general public, particularly if this were used to justify the expenditure of public monies for the provision thereof. The only way in which this could be accepted would be if there were to be established an independent assessment and monitoring body prepared to:

  • Examine all current and proposed practices for both safety and efficacy.
  • Check claims relating to practices, services and products.
  • Provide in-depth, freely accessible advice to allow informed consent on the part of the general public with regard to the relative claims, successes and appropriate applicability of such practices, services and products.

2. Are practitioners of TCM generally agreed on the qualifications required to deliver the health services they provide?

It is typical of such cultural practices that there is a wide, divergent range of beliefs and applications throughout those operating within such a system. This has proved a major problem for much in the way of complementary and alternative health practices where very little agreement has been possible in defining such practices, the nature, role or extent of qualifications required; the responsibilities of those involved etc (New Zealand’s MACCAH group serves as one example of the industry’s lack of capability in this regard).

In the proposal it is noted that currently there are two institutions offering bachelor degrees and diploma and certificate courses in TCM which are the New Zealand School of Acupuncture and Traditional Chinese Medicine and the New Zealand College of Chinese Medicine. These courses are approved by NZQA. The proposal notes not all groups agree on hours required to achieve both theoretical and clinical competence, and that courses need to be a combination of both to define minimum standards for practice and to determine a practitioners fitness to practice.

On checking information provided by these institutions, it is extremely difficult to determine whether there is any agreement between the courses and what teaching they deliver. In addition, while there is some agreement, there are significant differences in schools of thought within TCM with, for example, some acupuncturists working on the basis of 14 meridians, while many support the idea of 12 and with additional concepts such as Yin-Yang some schools may divide this into 2 subcategories while others may divide into 4. This does not provide any confidence that there is any recognised basis for acceptable health care practice or meaningful education related to these practices. Rather than suggesting that these practices are acceptable health care, such disparity indicates that they are based on highly variable cultural beliefs with significant variation from practitioner to practitioner.

The currently provided courses may have some science-based material within the qualification they offer, but it is well known that NZQA determinations are more about processes and quality of delivery than actual content of courses. Mere acceptance in to the NZQA framework says little to nothing about the validity, scholarship, research, safety and the like of approved courses.

This does not engender any confidence in the ability of the industry to define, monitor or regulate its practices. This is exacerbated by those practices being fully embedded in a culturally determined context, rather than in any evidence-based, cross-cultural body of knowledge.

An example may help indicate the problems that this approach causes for any attempt to provide industry-wide regulation for such a non-defined culturally based approach to health.

The New Zealand School of Acupuncture provides the following information on TCM core teaching areas:

Core Teaching Areas in TCM: Traditional Chinese Medicine is a vast area of study with many and varied concepts concerning sickness and health. Of that body of information there are certain core concepts that underpin this system of medicine. Listed below are those concepts that can be taken as the ‘core teachings’ of TCM.

  • Yin-Yang / The Five Phases
  • Zang-fu organ theory
  • Qi-Blood-Body Fluid Inter-relationships
  • Channel Theory
  • Acupoint Classification/Nomenclature
  • Therapeutic Properties the Points
  • Etiology and Pathogenesis
  • The Four Diagnostic Methods
  • Eight Principles Syndromes
  • Qi-Blood-fluids Syndromes
  • Differential Diagnosis
  • Principles of Treatment
  • Treatment Methods
  • Basic Prescription Principles
  • Selection of Points
  • Selection of Herbs and Formulas

While it is not possible here to comment on detailed content, it is clear students are being taught pre-scientific concepts that bear no relationship to the current understanding of the human body, anatomy, physiology, the germ theory of disease etc, etc.

It may be that they would be the first to admit that – and perhaps even claim it as a strong point of differentiation for their practices – but it does mean that there are definite vulnerabilities for their target client market who may not be aware of the lack of evidence for the practices, the cultural context for TCM and the variability of training in potential practitioners.

In another example, which raises concerns regarding the nature of research and teaching within the TCM industry, a University of Salford examination paper (2009) included questions such as:

Q1: Which of the following explain(s) the physiological relationships between qi and blood/xue:

  1. Qi is the source of all material in the body and blood carries the energy.
  2. Blood is the source of all material in the body including Qi.
  3. Qi drives blood moving and blood carries Qi.
  4. Qi flows in the channels and blood is stored in the organs.
  5. Qi produce blood and blood is the mother of Qi.

Q24: In Chinese Medicine, anger is associated with liver and the suppression of of anger causes Liver Qi stagnation. Explain your understanding of the statement in 100 words.

As with other alternative health approaches, proponents of TCM do not question the underlying assumptions of their industry, treating their authorities as having perfect knowledge that does not need testing. In many cases, any external calls for such testing is met with resistance, if not outright hostility. Providing a faux legitimisation of such a authoritarian approach will make the would-be consumer much more vulnerable to negative health outcomes, and with very little in the way of any avenue for protection or redress.

3. Is there a risk of harm to the public from the practice of TCM?

Yes.

There is the risk of physical harm from:

  • The use of unnecessary and inappropriate invasive practices (such as acupuncture).
  • The distribution of unmonitored substances which may contain harmful substances that are not disclosed to the consumer (or even the practitioner if they are supplied by a third party, as is common practice).
  • The tendency for this type of industry to discourage (whether actively or passively) their clientele from seeking conventional medical treatment.

There is the risk of financial harm from:

  • the long-term reliance encouraged by this industry on its products and services; dependency relationships are a common factor in alternative health practices, which raise both financial and ethical issues.
  • the diversion of public monies (whether ACC payments, insurance coverage or outright funding support) into a health industry based on cultural beliefs.

There are many examples of specific examples of actual and potential harm related to core TCM practices. The alternative health industry is well-known for poor record- keeping and a lack of patient redress, but many cases and concerns can be found in publications such as The Journal of Alternative and Complementary Medicine; websites such as Quackwatch.com; health analytics such as the Cochrane Collaboration and so on.

1. Acupuncture Risks:

For a core practice such as acupuncture, there are risks of:

  • Infection due to not using sterile techniques, including not using single use needles and incorrect disposal of used sharps.
  • Tissue damage from bruising and bleeding, forgotten or broken needles and perforation of vital organs such as the lung or heart. The proposal states that “the evidence of risk of harm is largely based on practitioners that are inadequately trained or who have inadequate clinical experience”. While this may be the case for such areas as prevention of infection, this tends to ignore risks inherent in the insertion of needles. The “Code of Safe Practice for Acupuncturists” from the New Zealand Acupuncture Standards Authority (NZASA) states that there are vulnerable points that require skill and care including Zhongfu LU1, Jiangjing GB21 and Dazhu BL11 which are points over lung tissue unprotected by bone or cartilage. This indicates that acupuncturists may insert needles in areas with an increased risk to the patient if it is deemed necessary for treatment. In addition, in case decision 07HDC12714 of the Health and Disability Commissioner, pneumothorax was experienced as a complication of using acupuncture to treat asthma. The acupuncturist was not deemed to have breached the standard of care with the opinion of another acupuncturist being “The following points were selected by [Mr B] in the treatment: BL12, BL13, BL23, BL43, DU4, EX-B1, K13, ST36 and SP6. These points are used to treat Asthma or reinforce body energy…[Mr B’s] acupuncture treatments comply with these standards.” despite the complication occurring.

TCM is claimed to treat many disorders, from acne to vertigo, but with little to no actual proof beyond placebo and marketing testimonials for many such claims. It is a common attribute of the alternative health industry to maximise its clientele and profits by keeping its alleged coverage as broad as possible.

The fact that acupuncture is accepted by ACC is already used to legitimise use of the practice far beyond any clinically accepted areas, with a consequent risk to patient care and waste of public funds.

As an example, acupuncture has been shown to have minimal use in almost all its applications, with only some success in a very limited context (i.e. it may provide some pain relief). Its effects have been replicated using sham acupuncture and other non-invasive techniques, which makes its use ethically questionable, particularly given the cases of infection and other negative outcomes associated with its use.

Acupuncture is widely used for conditions for which there is no evidence that it has any efficacy. Acupuncture additionally may not compare well in outcomes or cost-effectiveness for the patient in comparison with other comparable treatments. Even if there appears to be some efficacy, it can be difficult to assess benefit/risk for the patient. Non-specific effects may apply for pain-related conditions and there may be some benefit to needling in those cases. However, for conditions such as lower back pain simple and cheap interventions like regular pain relief and advice to keep active can achieve the same benefit for the person seeking care without the risks of needling being incurred. Using Chinese diagnosis may also mean a medical condition is not properly diagnosed or treated.

That many studies are of poor quality can make it difficult to determine whether any evidence is reliable. According to Edzard Ernst and Simon Singh (citing the Cochrane Collaboration in “S Singh, E Ernst (2008) Trick or treatment?”” Bantam Books. ISBN 0593061292, 9780593061299), there is no significant benefit from acupuncture for the following conditions: smoking, cocaine dependence, induction of labour, Bell’s palsy, chronic asthma, stroke, breech presentation, depression, carpal tunnel syndrome, irritable bowel, schizophrenia, Rheumatoid Arthritis, insomnia, back pain, lateral elbow pain, shoulder pain, soft tissue shoulder injury, morning sickness, egg collection, glaucoma, vascular dementia, period pain, whiplash. Any perceived benefit appears to be from the placebo effect. Some other conditions have been more optimistically reported, but not stated to be convincing, such as pelvic and back pain in pregnancy, low back pain, headaches, post- operative and chemotherapy induced nausea and vomiting. Later well-designed trials for conditions such as chronic tension headache, migraine prevention, nausea under chemotherapy and post-operative nausea and vomiting using sham acupuncture provide no convincing evidence that real acupuncture is much more effective than sham acupuncture. These finding apply also to any variations of acupuncture, such as laser acupuncture or acupressure.

2. Chinese Herbal Medicine risks:

  • Interactions between herb and drugs, or herb-herb interactions.
  • Failure to assess contraindications of herbs for patients i.e. liquorice root (Glychrriza species) may cause problems for those with high blood pressure, exacerbating the condition.
  • Safety issues such as the possibility of toxicity and liver or kidney damage or allergic reactions. Some herbs may require specific preparation such as boiling before use, which may fail to be communicated and therefore increase the risk of toxicity. It may also fail to be communicated to the patient that they may have an adverse event, and what to do if they have any possible reaction to a herbal medicine they are taking.
  • Contamination or adulteration of products which may cause poisoning or if adulterated with pharmaceuticals, adverse effects or interactions with other medications that may be being taken.
  • Labelling or identification issues that mean an herb may be misidentified.
  • The use of several types of herbs in a mix as made by TCM practitioners can mean dosage varies and increasing numbers of herbs taken in the mixture gives a greater chance of adverse effects.
  • TCM may use rare or threatened species of plants or animal products in preparations.
  • Inappropriate use such as the use of herbal preparations where there is a safer and more effective pharmaceutical option can be risky where evidence is lacking for the safety and efficacy of an herb or herbal preparation. Using Chinese diagnosis may mean a medical condition is not properly diagnosed or treated. Patients may also fail to inform their doctor or abandon current treatment which may lead indirect harm from their condition not being treated properly or at all. It can be very difficult to determine if any particular preparation is safe to use and there may be a lack of information as to whether many herbs are safe for use while pregnant or breastfeeding, in children or with current medication being taken.
  • TCM herbal preparations are used to treat many disorders and while there is a plausible mechanism of action due to active ingredients, the evidence for efficacy may be variable and many trials are poor and have methodological problems. This means that these may be used for conditions for which there is no evidence it may be effective which can be considered an indirect harm as it may delay uptake of effective treatment, interfere with other treatments being used by the patient or make it difficult to assess benefit/risk in using the treatment. This may also not compare well in outcomes or cost-effectivenessfor the patient in comparison with other comparable treatments due to the lack of evidence of efficacy and safety issues. The Cochrane Library in New Zealand has assessed Chinese herbal medicines in conjunction with lifestyle modification for impaired Glucose tolerance or impaired fasting blood glucose (D72D15553B7D8719E901E.d01t04), finding that “The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.” and for idiopathic chronic fatigue and chronic fatigue syndrome finding that “Although studies examining the use of TCM herbal products for chronic fatigue were located, methodologic limitations resulted in the exclusion of all studies. Of note, many of the studies labelled as RCTs and conducted in China did not utilize rigorous randomization procedures. Improvements in methodology in future studies is required for meaningful synthesis of data.” Other Cochrane reviews are in their database and it would be relevant to consider that if regulating, that this is limited to preparations where evidence of efficacy and safety for a condition are present.

3. Tui na:

  • Tui na is a form of massage and can be generally regarded as being safe, however spinal manipulation may cause harm particularly when a practitioner is inadequately trained.
  • There appears to be little evidence for effectiveness in treating any condition, and one study which was a systematic review and meta-analysis of the efficacy of tuina for cervical spondylosis (Wang MY, Tsai PS, Lee PH, Chang WY, Yang CM systematic review and meta-analysis of the efficacy of tuina for cervical spondylosis J Clin Nurs. 2008 Oct;17(19):2531-8.) found that “based on the results of this systematic review, a definitive conclusion regarding the effects of tuina on cervical spondylosis remains to be determined” with the clinical relevance being that “The efficacy of tuina is not supported by parallel-group comparison studies.”

4. Diet:

  • Dietary interventions can be considered generally low risk, however there may be some risk that a proposed diet and restrictions of certain foods could cause harm or inconvenience to the patient. The advice given as it does not follow current human nutritional rationales may conflict with other advice given by health professionals, such as diet recommendations for diabetics.

5. General:

  • Traditional Chinese Medicine may be used inappropriately, as in treating very young children, pregnant or lactating women or the elderly who may have different health needs to the rest of the population and/or for conditions it is not effective for. It is not difficult to find websites that promote its use for children for conditions such as colic, cerebral palsy, new born jaundice, myopia, eczema and epilepsy which have material on them such as “children may avoid disease altogether if introduced to acupuncture at an early age.” This also may indicate that treatments such as acupuncture may be recommended where there is no evidence of needing treatment, increasing risk without benefit to the person. It is important for these groups to be properly assessed, as they may not display symptoms of illness the same or have specific health care needs and it is important that they have appropriate assessment and treatment with minimal delay.
  • Failure to refer on to medical or other care or inform other health professionals appropriately may occur as the practitioner may not recognise the limits of their expertise or may incorrectly think they can treat a diagnosed condition.
  • TCM practitioners may make claims that outstrip the evidence and give advice contrary to other health practitioners such as displaying or giving anti-vaccination advice or giving information that otherwise may deter people from medical care. Many may make an artificial division between so-called “Western” and “Eastern” medicine which does not in fact exist. In one case, an immune system package is offered along with information stating acupuncture is effective for colds and flu and an article stating “The flu shot does not work for babies … the flu shot does not work in children with asthma … adults are also not protected by flu vaccine … for elderly living in nursing homes, flu shots were non-significant for preventing the flu … for elderly living in the community, vaccines were not significantly effective…”. This may discourage people seeking appropriate interventions, particularly in groups vaccines are recommended for.
  • General contraindications such as need for caution or not using acupuncture and other therapies with those with bleeding disorders, pacemakers (use of electroacupuncture), high blood pressure, diabetes and unstable epilepsy.

(Note: with unstable epilepsy the NZASA Code of Safe Practice for Acupuncturists states “care should be taken with needling. If a seizure is triggered then appropriate resuscitation techniques apply including the use of Rhenzong CV26 or/and Yongquan KI 1.” It could be suggested that basic first aid, including keeping the person safe, would be the most appropriate intervention rather than needling a seizuring person.)

4. If so, what are the nature, frequency, severity and potential impact of risks to the public? What is the likelihood of the harm occurring?

According to the 2000 paper by Bensoussan, Myers and Carlton “Risks Associated With the Practice of Traditional Chinese Medicine: An Australian Study” (Bensoussan A, Myers SP, Arch Fam Med. 2000;9:1071-1078) it is extremely difficult to estimate the rate of adverse events for Chinese Herbal Medicines (CHM) as the total exposure to any particular substance is unknown and there is likely to be significant under-reporting.

The study stated:

the most common adverse events reported were severe gastrointestinal symptoms (n=124), fainting and dizziness (n=119), and significant skin reactions (n=110). Serious adverse events reported included central nervous system effects (n=37), hepatotoxicity (n=29), renal toxicity (n=28), and death (n=19). The number of deaths reported is consistent with literature reviews, which cite deaths associated with specific Chinese herbal preparations, notably those containing aconite…

For acupuncture the paper stated:

Medical practitioners used predominantly acupuncture, while non medical practitioners frequently combined acupuncture and CHM…Mean length of full-time TCM practice was 7.7 years. Practitioners reported that more than 3000 adverse events occurred duringtheir practice lifetimes. The most common adverse events reported were fainting during treatment (n=1169), increased pain (n=1069), and nausea/vomiting (n=534). Serious adverse events reported included pneumothorax (n = 64) and convulsions (n=80).” In addition the authors noted “Instances of local and systemic infections have been reported in the literature such as endocarditis, septicemia,hepatitis B, human immunodeficiency virus infection, osteomyelitis,myositis, peritonitis, and pleural empyema, allegedly contractedas a result of acupuncture. Causality had not been confirmed in many of these cases. Numerous reports of trauma-related injuries from acupuncture have been published in the last 15 years, including pneumothorax, spinal cord injuries, auricular chondritis, fatal and nonfatal cardiac tamponade, pseudoaneurysm, deep- vein thrombosis,nerve damage, burns (from moxa), and severe bruising (from cupping). Published reports have also referred to psychiatric changes(such as depression), insomnia, convulsions, hypotension, menstrual disturbance, increased pain, and allergies to certain needle compositions.

The majority of acupuncture practitioners stated that they always used single-use disposable needles (93%) and adhered to government skin penetration guidelines (83%). Of the small number (n=69) who did not always use disposable needles, autoclaving was the preferred method of sterilization (68%). A variety of treatment techniques, many of which fell under the umbrella of acupuncture, were administered to patients. Some of the more traditional techniques such as bleeding, scarring moxibustion, and scraping were used only by non medical practitioners,and carried their own distinct risks. It is unknown how many of the adverse events reported by practitioners could be accounted for by any one technique….Adverse events due to acupuncture accounted for 79% of all adverse events reported. This reflects the substantially larger cohort of practitioners who principally use acupuncture…

The paper stated:

We determined that each practitioner had encountered an average of 1.38 adverse events during each year of equivalent full-timeTCM practice. Hence, approximately 1 adverse event occurred every 8 to 9 months of full-time practice, or for every 633 consultations.

Practitioners were also identified as having prescribed a number of scheduled or restricted substances.

Another paper by White, Hayhoe, Hart and Ernst (White A, Hayhoe S, Hart A and Ernst E, Adverse events following acupuncture: prospective survey of 32000 consultations with doctors and physiotherapists BMJ 323 : 485 doi: 10.1136/bmj.323.7311.485 (Published 1 September 2001)) attempted to ascertain the incidence related to acupuncture treatment finding that:

a total of 2135 minor events was reported, giving an incidence of 671 per 10 000 (42/10 000 to 1013/10 000) consultations. The most common events were bleeding (310 (160 to 590) per 10 000 consultations) and needling pain (110 (49-247) per 10 000 consultations). Aggravation of symptoms occurred in 96 (43-178) per 10 000 consultations; in 70% of these cases, there was a subsequent improvement in the presenting complaint. The highest rates reported by individual acupuncturists, expressed as a percentage of consultations, were 53% for bleeding, 24% for pain, and 11% for aggravation of symptoms. … Doctors and physiotherapists who performed acupuncture reported no serious adverse events and 671 minor adverse events per 10 000 acupuncture consultations. These rates are classified as minimal; however, 14 per 10 000 of these minor events were reported as significant. These event rates are per consultation, and they do not give the risk per individual patient.

The researchers noted that some avoidable adverse events occurred.

Ernst (Ernst E, Acupuncture – a critical analysis Journal of Internal Medicine 2006; 259: 125-137) has also published safety data in an 2005 paper “Acupuncture a critical analysis” stating that:

Acupuncture has occasionally been associated with several serious adverse effects, in particular, trauma to internal organs (e.g. pneumothorax or cardiac tamponade) and infections, such as hepatitis C or HIV. Several large prospective studies have shown that such adverse events are extreme rarities, provided acupuncture is carried out by well trained practitioners. These studies also show that mild, transient adverse effects, e.g. needling pain or bleeding at the site of needling, occur in about 7-11% of all cases. The largest study included 190 924 chronic pain patients. The data revealed 2.4 serious adverse events per 10 000 patients. However, the authors suspect this figure to be distorted through under-reporting. In their series, only 5% of the average death rate in the German population was reported. Assuming therefore that under-reporting of acupuncture-unrelated death (and by implication serious acupuncture-related adverse events) was 95%, the true incidence of serious adverse events after acupuncture could be as high as 48 per 10 000 patients. A recent UK survey suggested that, in 3% of all cases, non- medically qualified acupuncturists interfere with the prescribed medications of their patients, which could therefore constitute an indirect risk of acupuncture. The totality of this evidence nevertheless suggests that acupuncture, as used by well-trained professionals is probably a reasonably safe therapy. Serious adverse effects may be a consequence of poor training and the large number of paramedics exercising the technique.

We are concerned that any move to legitimate TCM as an accepted health practice alongside evidence-based medicine will see a rise in negative patient outcome through encouraging public uptake of inappropriate practices and the use of unmonitored substances.

5. Other than on the basis of risk of harm, is it in the public interest that the profession of TCM be regulated?

The only public interest that it would appear to serve is that of the industry itself. We already have a number of medically dubious practices covered by our regulations, and this legitimisation has been used as a marketing tool by them to justify public funding, expand their clientele base and gain credibility without requiring to provide evidence as to the safety and efficacy of their practices. The public of New Zealand will not be better served by adding to this.

Currently there are a few organisations offering voluntary membership for members of this industry, including the New Zealand Register of Acupuncture Incorporated and the New Zealand Acupuncture Standards Authority Incorporated. Membership in either organisation allows its members to become ACC acupuncture providers. Currently neither has the authority to register an acupuncture practitioner as a health care provider under the HPCA Act.

Regulation also occurs through the practice of TCM being subject to the Code of Health and Disability Services Consumers’ Rights. The Code has ten rights covering being treated with respect and dignity; being given information in a way that is clear; being given quality care and having the right to make a complaint if there is the belief that these rights have been breached in any way. Members of the public have rights to ask any health practitioner what qualifications they have. Members of the public also have the right to contact professional associations to ask what is required of their members, in terms of qualifications, professional development and code of practice. Members of the public can also contact a professional association to ask if a particular practitioner is a member of that association.

The Ministry of Health provides Guidelines for Skin Piercing and local Councils have regulations and licensing processes covering areas such as skin piercing and tattooing which includes acupuncture practice. Local authorities are required to appoint Environmental Health Officers under Section 28 of the Health Act 1956 and under Section 128 have rights of inspection and to execute works under the Act in order to promote and protect the health of the public by ensuring minimum standards of hygiene and health are practised. TCM may also be impacted by provisions in the

Medicines Act and MedSafe guidelines as well as general consumer legislation such as the Fair Trading Act and Consumer Guarantees Act and bodies such as the Advertising Standards Authority.

This current self-regulation regime with external regulations broadly applicable to practicing TCM appear to cover most health and safety issues, but should be strengthened. It would be preferable to see more TCM practitioners comply with general requirements as regards advertising and claims whilst in the process of applying for recognition under the HPCAA.

As stated earlier, there are concerns about granting official legitimacy ahead of there being adequate evidence for TCM. If such is granted, scopes of practice would need to be strictly limited to areas where sufficient evidence is supportive of the treatment being effective and for risks to be managed. Otherwise, regulation may fail in its aims by creating the situation where it is difficult for a health care consumer to determine the best provider and, additionally, the situation where care can be inappropriate or even harmful for the condition, but the provider cannot be deemed to be acting outside the regulations that cover their practice.

Given this, it would be preferable to improve the current self-regulatory regime or look at other means such as accreditation to strengthen the current regulatory environment and ensure compliance with safety guidelines and evidence based practice. Currently, there is encouragement for practitioners of TCM to gain membership with the NZASA or the New Zealand Register of Acupuncture Incorporated to become ACC Acupuncture providers, the majority of treatment provided by TCM practitioners. If the organisations were required to develop and maintain rigorous and open standards of practice under third-party independent scrutiny, this could have the desired effect in maintaining standards within the practice of TCM and protecting the public from harm.

6. Are practising TCM practitioners generally agreed on the standards that

TCM practitioners are expected to meet?

With a disparate workforce consisting of some who are voluntary members of an organisation and others who work independently, it is difficult to ascertain whether there is any agreement between practitioners outside of the general standards set by the current self and external regulatory environment.

It appears that, in some cases, the codes and standards as set out by various bodies may not be fully complied with in such areas as claims in advertising of their services. This suggests that TCM practitioners themselves may hold differing views of these codes and standards of practice or not feel that they are fully applicable to their practice as it is currently. The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA and that this will happen may be an issue for some practitioners that may face a number of changes to how they currently practice.

7. Are practising TCM practitioners generally agreed on the competencies for scopes of practice for TCM?

It is difficult to ascertain whether there is any agreement between practitioners outside of the exceptions of general standards set by any organisation they are members of and the external regulatory environment. The situation appears too fluid to suggest there is general agreement on such. The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA. In the event of regulation some practitioners may not agree with what the competencies should be or any restrictions or limits that may be set on competencies and/or scopes of practice and this may make it difficult to determine appropriate competencies that apply to TCM practitioners.

8. What qualifications are generally held by members of the profession, and what is the degree of uniformity in qualifications across members?

The proposal document states that although the applicants have developed policies on qualifications and scopes of practices this will not necessarily be the same as those put in place in the event the practice of TCM is regulated under the HPCAA.

With a disparate workforce consisting of some that have previously trained in New Zealand qualifying with a Diploma, others that have studied to Degree level, some who have overseas qualifications that may differ in content to New Zealand qualifications as well as others that have done short courses and who may or may not have other health-related qualifications, it is difficult to ascertain what, if any, qualifications may be held by any one TCM practitioner or whether this is uniform over all practitioners. Given that there is this inconsistency it appears that there is a distinct lack of uniformity in what qualifications are generally held by members of the profession.

With regard to all three questions above, one of the defining features of an alternative health practice is the tendency to have very fluid definitions relating to their scope practice, knowledge base, product offerings, application of service etc. It is clear from examining marketing material and listening to those involved in the industry, that apart from the use of TCM as a marketing term, there can be a highly variable provision of services and product. It is clear from examining the various offerings of TCM educational services, that equal variability exists in the training aspects of this industry.

9. Does your organisation accord any standing or status to the profession of TCM, or to those who practise as TCM practitioners?

No, not outside its social context as a cultural and political response to well-being.

For consumer protection, in terms of safety and efficacy as well as informed consent, it is imperative that we assess the benefits and risks of any particular health care practice by:

  • Investigating whether the treatment(s) provided offer therapeutic benefits greater than placebo
  • Determining the safety of the treatments
  • Establishing how it compares in outcomes and cost effectiveness with comparable treatments

It would be generally accepted that we should be cautious about health claims made by one individual practitioner, particularly working in an area which provides little in the way of independent verification of such claims. We should be equally cautious regarding claims of status based on the vested interests of those involved in the industry.

Most other regulated health professions provide comparable levels of evidence- based services and products. The public generally understands the educational level and standards which are required in order to participate as a practitioner. To afford similar mana on TCM practitioners would be misleading and to the detriment of general health outcomes.

NZ Skeptics Call for Building on Solid Science

Building on solid science is the theme for this year’s annual NZ Skeptics conference, an appropriate-enough theme for a meeting being held in Christchurch (26-28 August). “When we’re unsure of things, looking for better understanding of what’s happening …

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Proposed constitutional changes for NZ Skeptics

The following changes to the constitution of the NZ Skeptics have been proposed and will be considered at the Annual General Meeting in Christchurch on Sunday, 28 August 2011. This notice is published in accordance with the society”s rules which require 21 days” written notice of any such change.

Motion 1
That clause 11(a) be rewritten to reflect the current financial year used by the society.
Current: (a) The financial year of the Society shall commence on the first day of April and terminate on the last day of March next following.
Proposed: (a) The financial year of the Society shall commence on the first day of January and terminate on the last day of December next following.
Proposed by: Michelle Coffey
Motion 2
That clauses 11(b), (c) and (d) be rewritten to change from there being a requirement for an annual auditor’s report, to giving the committee responsibility for reviewing financial statements, and asking for them to be audited if it sees fit.
Current:
(b) The Treasurer shall prepare a Statement of Accounts and Balance Sheet as soon as possible after the end of each financial year and such statement and Balance Sheet shall after consideration by the Committee be submitted to the Auditor who shall report thereon in writing.
(c) The Statement of Accounts and Balance Sheet together with the Auditor’s report thereon shall be submitted to the Annual General Meeting next following its preparation and shall be open for discussion thereat. The audited Statement and Balance together with the Chairperson’s report on the year’s activities shall be sent to members with the notice of Annual General Meeting.
(d) An Auditor shall be appointed by each Annual General Meeting or if not so appointed then by the Committee and shall hold office until the termination of the Annual General Meeting next following his or her appointment. The remuneration of the auditor may be fixed by the Committee.
 Proposed:
(b) The Treasurer shall prepare a Statement of Accounts and Balance Sheet as soon as possible after the end of each financial year and such statement and Balance Sheet shall be considered by the Committee. The Statement of Accounts and Balance Sheet may be approved by the Committee or may from time to time as determined by the Committee be subject to submission to the Auditor who shall report thereon in writing.
(c) The Statement of Accounts and Balance Sheet shall be submitted to the Annual General Meeting next following its preparation and shall be open for discussion thereat. The Statement and Balance together with the Chairperson’s report on the year’s activities shall be supplied to members at the Annual General Meeting, along with any Auditor’s report that may be prepared on request of the Committee.
(d) The Auditor shall be appointed at the Annual General Meeting or if not so appointed then by the Committee from time to time as deemed necessary and shall hold office until the termination of the Annual General Meeting next following his or her appointment. The remuneration of the auditor may be fixed by the Committee.
Proposed by: Michelle Coffey

Forum

Homeopathic ‘vaccines’ on sale in New Zealand

The website www.endohealth.co.nz is selling such items as homeopathic immunisation and travel kits . On offer are such remedies as Natrium Muriaticum 200C which, it is claimed, will protect against all types of Malaria and Haemophilus 200 for protection against H I B (this abbreviation is for Haemophilus influenzae type B which causes severe pneumonia and meningitis in infants).

The site’s owners say:

Endo Health Limited provides accessible and experienced health care based on Homoeopathic principles as defined by Dr Samuel Hahnemann in the Sixth edition of The Organon of Medicine. We also manufacture and supply a full range of homoeopathic products, both classical and complexes, in a number of different presentations. We provide Homoeopathic prophylaxis for childhood diseases, and individualised kits for travel to areas where there is risk of exotic diseases, as well as kits to alleviate the medical dangers of travelling by aircraft. We provide information on vaccines used in the prevention of childhood diseases. Unless stated otherwise, all this information is sourced from Medical journals and has been available to all Medical Practitioners and Medical authorities.

One of the homeopaths claims to have been a pharmacist for many years and to be President of the Homoeopathic Association of New Zealand, an organisation which appears to be non-existent.

I’ve been aware for a while that some people have sourced and used these homoeopathic immunisations , so as an individual I’ve sent an email off to Medsafe’s Compliance Unit stating that I believe that these homoeopaths and their website’s sales could be harmful to people, and that the site would likely contravene the Medicines Act as they are making therapeutic claims (as per New Zealand Regulatory Guidelines for Medicines Edition 6.13, March 2011).

They also attempt to circumvent the section 34 provision which allows natural therapists and others to supply after being requested by or on behalf of that person to use his own judgment as to the treatment required . They do this by saying the Medicines Act requires that there must be an exchange of information and this consultation (really an order for the product) may be by email. This would also be likely to be actionable under advertising standards, as they have requirements under their therapeutic product and service codes regarding advertising and therapeutic claims.

Unfortunately I suspect even if this is found to be correct and some action is taken, this will be dealt with by the old slap with a wet bus ticket (probably a cease and desist letter asking for them to remove the claims as to therapeutic purpose and/or asking for the withdrawal of the products), if any of the other examples I’ve seen over the years (eg adulterated supplements) are any guide. I’m not aware of anything happening other than withdrawal of the unsafe product after Medsafe has done testing, even though the product(s) may have been supplied and sold for quite a period of time and would pose a risk to the consumer.

That being said, it may help if other individuals or the society consider taking some action, as well such as contacting relevant agencies to express concern or even sending out a press release addressing the anti-vaccine stance of those in the alt med industry. The consumer is being exploited by sale of homoeopathic vaccines and homoeoprophylaxis products that claim to prevent diseases such as malaria, typhoid and cholera. Consumers could become seriously ill if they come into contact with these diseases and haven’t used proven interventions.

This could be another opportunity to call on homeopaths to do the right thing and come out in support of conventional vaccines and against the practice of homeopathic vaccination . As the Ministry of Health says, There is no evidence that homoeopathic ‘immunisation’ provides any protection against infectious diseases. The UK Faculty of Homoeopathy supports conventional immunisation.

NZ Skeptics Conference 2011

All welcome for two days of learning and laughter covering a diverse range of topics from environmental issues to earthquake predictions, psychic performances to podcasting on critical thinking.

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Moon Man Non-Event Lunch Planned

Members of the New Zealand Skeptics, geologists, earthquake engineers, MP Nick Smith and NewstalkZB morning host Sean Plunket are to gather for a lunch on top of the Port Hills in Christchurch on March 20th, the time when so-called “Moon Man” …

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Another Candle Goes Out….

Denis was a founder member of New Zealand Skeptics, back in 1984 when it was known as the NZ Committee for Scientific Investigation of the Paranormal. For many years he was the face of organised scepticism in New Zealand, fronting up to the media …

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Acupuncture

Acupuncture is one area of alternative treatment which has apparently gained widespread support, but questions remain about whether it actually does any good.

Acupuncture evolved from primitive blood­letting rituals to the insertion of needles into points alleged to lie on lines called meridians. Acupuncture needles can be twirled or electrically stimulated and, in addition, a burning herb can be applied to the acupuncture point (moxibustion). Acupuncture points can also be stimulated with laser light. It is even claimed that the ear contains an inverted foetus pattern (homunculus) which can be used for treating disease in distant organs.

There is no anatomical or physiological basis for the existence of either acupuncture points or meridians. The concept of the auricular homunculus is a scientific absurdity.

There have been extravagant claims made for the success of acupuncture treatment. A common finding is that the most extreme claims of success are made on behalf of the most poorly designed trials. Because acupuncture involves needling of the body, it has been difficult to perform adequate double-blind placebo controlled trials. Nevertheless, careful studies have contradicted many of the claims made by the proponents of acupuncture.

One controlled study showed that electroacupuncture of the ear to treat chronic pain was no more effective than just lightly touching the ear, despite claims of effective treatment for such.

Some have argued that acupuncture analgesia can be explained by suggestion in the same manner as hypnosis. He found no discernible difference in the behaviour of patients whether operated on under acupuncture anaesthesia or hypnosis. This suggests that needles are unnecessary and would also explain the apparent success of laser stimulation of acupuncture points.

Following its evolution from blood-letting, acupuncture points numbered around 365, but the number has increased to over 2,000. Many published charts of the points and meridians do not agree with each other and this lack of specificity would explain the success of random needling. Despite thousands of years of use in China, the Emperor removed acupuncture from the curriculum of the Imperial Medical College because he viewed it as a barrier to the progress of Western medicine.

Since its introduction to the West, acupuncture has undergone many revivals, complete with extravagant claims of disease treatment. In 1822 the editor of a medical journal wrote,

“A little while ago, the town rang with acupuncture, everybody was curing incurable diseases with it; but now not a syllable is said upon the subject.”

The latest revival of acupuncture followed Nixon’s visit to China in 1972. He and his entourage were treated to dramatically staged examples of operations under acupuncture anaesthesia. Reports of these operations were grossly exaggerated and took no account of the published historical evidence of surgery being done in the West without any anaesthetic at all. Professors Geng Xichen and his colleague Tao Naihuang denounced surgical acupuncture as a myth and a hoax.

Acupuncture anaesthesia is not as commonly used for surgery in China as is often claimed. It is not applied to emergency surgery and, when used on carefully screened patients, is often used in conjunction with local anaesthesia or narcotics.

In New Zealand, approximately 14% of doctors practice acupuncture on the basis that 3,500 years of clinical observations by the Chinese are reliable evidence of its efficacy — the same could be said of astrology or the belief in a flat Earth.

Acupuncture has been introduced in such a way that unproven assumptions were made about its effectiveness. Instead of being experimentally evaluated it has become widely used for an absurd range of clinical indications.

A huge scientific literature has arisen in support of acupuncture, such as studies purported to show improvement in asthma symptoms following acupuncture treatment. However, when the studies were repeated by asthma specialists, the claimed improvement could not be duplicated. The acupuncture literature is an example of how people will always find support for what they believe in.

Parsimony refers to the philosophical process of checking whether some new effect or phenomenon can be explained by current knowledge. Acupuncture analgesia can be explained within the paradigm of contemporary conditioning theory. Other theories suggest acupuncture stimulates the production of endorphins, reducing pain. However, this sort of pain relief can be produced by many other types of hyperstimulation, without using needles or requiring meridian points or flows of “chi” vital life force.

When acupuncture is administered by someone who believes in it to someone of a like mind, it is hardly surprising that there is a huge placebo response. One trial claimed dramatic improvements in pain reduction for patients with rheumatoid arthritis when acupuncture points were stimulated by laser. The same improvements were found with the laser switched off!

It has been claimed that the successful treatment of animals with acupuncture proves that acupuncture is not a placebo therapy. The same arguments have been advanced by vets in support of homeopathic treatment. All this demonstrates is that animals, like humans, are subject to spontaneous and unexpected recovery.

Many acupuncture claims are pure fantasy. One paper claimed that a patient with 96% burns, mostly 3rd degree, made an uneventful recovery following treatment with acupuncture. Publication bias means that only positive trials tend to get reported and published. Since the better-designed acupuncture trials consistently report negative findings (i.e. fail to show any benefit from acupuncture) they tend to be under-reported.

Safety is important and acupuncture treatment can cause serious complications such as collapsed lung and various infections, as well as nerve and spinal cord damage. A survey of almost 200 acupuncturists revealed 132 cases of fainting, 26 cases of increased pain, 8 cases of pneumothorax (punctured lung) and 45 other adverse results amongst their patients. A further concern is that non-medically trained acupuncturists are likely to misdiagnose or fail to diagnose serious conditions.

There is little or no evidence to justify the current widespread use of acupuncture. It should not be funded by the health system. Acupuncture needs to be confined to an experimental setting in order to prove its efficacy and indications.

Colloidal Silver

Composed of particles of silver suspended in another medium, such as water, colloidal silver is taken orally, and is claimed to cure at least 650 different conditions, including bacterial, viral and fungal infections, leukaemia, Lyme disease, cancer, malaria, HIV and impaired immune systems.

Three main products

There are three different forms, each with vociferous proponents.

Non-ionic colloidal silver contains metallic silver particles which are said to ionise and become active once ingested.

Ionic colloidal silver claims to be 0.006-0.015 microns in diameter (highly unlikely), and is sold at a concentration of 1×103 – 1×106 ppm. Its small particle size is said to make it capable of crossing cell membranes and accessing viruses. The claimed particle size is unlikely, although people working on nanotechnology do make such particles, but not with medicinal uses in mind. One product claims to contain hydrogen peroxide and deionised water in addition to ionic silver.

Colloidal silver protein is made from a mixture of silver nitrate, sodium hydroxide, gelatine and water. Mild silver protein (19-23% silver) is said to be less ionisable and thus less effective than strong silver protein (7.5-8.5% silver), which is said to be bactericidal. Health food shops may be selling further dilutions of these two forms of colloidal silver protein.

Silver does not occur normally in humans and in its elemental form is not considered to be extremely toxic, though most of its salts are. Colloidal silver products show some antibacterial activity in laboratory tests, but this does not mean they are effective if swallowed. Silver products were used in the past to treat gonorrhea and for infections of the nose and throat, but have been discontinued because they were ineffective and toxic. By 1960, warnings were made that there is no justification for its internal use, either theoretically or practically.

Colloidal silver creams for topical use sometimes contain manuka honey, so any beneficial effects from the silver alone would be hard to prove.

What happens inside?

When swallowed, silver enters the gut. Once there, smaller particles could form a complex with proteins, while larger particles could simply be excreted. Some may enter the blood and any that is systemically absorbed concentrates in the skin, liver, spleen, and adrenals, with lesser deposits in the muscle and brain.

Colloidal silver is said to work by binding to pathogens and thereby causing the body to get rid of them, though there is no way in which it could differentiate between human and pathogenic cells. It is also claimed that, as a foreign body, it activates the immune system and that kills all pathogens. In fact, beneficial CD4 and CD8 cells of the immune system are actually destroyed by colloidal silver. Claims that it is stored in the Kupfer cells of the liver where it increases their action are unlikely, as it is more likely to inactivate or kill such cells.

Colloidal silver is said to be able to pulverise pathogens by Brownian motion, which is characteristic of colloidal silver particles. All this is claimed to happen within six minutes of making contact with the pathogen.

One of the more outlandish claims is that colloidal silver interferes with mitosis, and that one of the daughter cells becomes a stem cell that can migrate within the body and cure anything!

Serious effects

Contrary to what is claimed by proponents, silver does accumulate in the body. Silver salts can cross the blood-brain barrier and accumulate in cells of the brain and spinal cord. Systemic toxicity increases where mucous membranes are disrupted in the gut or on the skin, such as in burns.

Large amounts of absorbed silver accumulate in the skin causing argyria. The first sign of this is a slate-blue/grey pigmentation of the gums. Such discolouration can spread to other skin areas and is irreversible.

A candidate for the US Senate turned his skin blue by taking colloidal silver for about two years as a precaution to there being no antibiotics available after the turn of the millennium. He has been nicknamed “Papa Smurf”, and although the disfigurement is permanent, it is not considered medically serious – he just looks ridiculous. There are over 300 cases of argyria in the medical literature and certainly thousands more which have gone unreported. It is usually self-limiting in that when people’s skin starts to turn grey, they are usually willing to follow advice to stop taking silver products.

When used as eye drops, it turns the white of the eye bluish-grey or brownish-black. Silver nitrate eye drops have been used to kill gonococci bacteria in newborns, and this is often quoted in support of the product. However, these drops were used once, not repeatedly, and have been superceded by antibiotics.

Skin discolouration is the most common side effect, and one which can have a profound psychological effect. Physiological effects are more difficult to assess, due to the relatively small number of cases that have been covered in the medical literature.

There are suggestions that ingestion of silver can have serious medical consequences, such as neurological defects after prolonged use, including problems with walking and reduced senses of taste and smell. There is also the possibility of silver accumulation affecting the developing foetus, causing anomalies in the ear, face and neck. Customers are being duped, purchasing either a useless medication or simply very expensive water. Selling silver products can be lucrative. Albert Barnes invented argyrol, a silver drug used as eye and nose drops in the early 20th century. The fortune he made funded one of the greatest collections of modern art, which is displayed at the Barnes Foundation in Philadelphia.

In Australia in 2000, the Federal Court granted injunctions against a manufacturer of devices to make colloidal silver, banning them from making misleading claims about the benefits of taking these products, and enforcing the payment of refunds to purchasers.