MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk

Realgar, a commonly used traditional Chinese medicine, has – according to the teachings of Traditional Chinese Medicine (TCM) – acrid, bitter, warm, and toxic characteristics and is affiliated with the Heart, Liver and Stomach meridians. It is used internally against intestinal parasites and treat sore throats, and is applied externally to treat swelling, abscesses, itching, rashes, and other skin disorders.

Chemically, it is nothing other than arsenic sulphide. Despite its very well-known toxicity, is thought by TCM-practitioners to be safe, and it has been used in TCM under the name ‘Xiong Huang’ for many centuries. TCM-practitioners advise that the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically.

Toxicologists from Taiwan report a case of fatal realgar poisoning after short-term use of a topical realgar-containing herbal medicine.

A 24-year-old man with atopic dermatitis had received 18 days of oral herbal medicine and realgar-containing herbal ointments over whole body from a TCM-practitioner. Seven days later, he started to develop loss of appetite, dizziness, abdominal discomfort, an itching rash and skin scaling. Subsequently he suffered generalized oedema, nausea, vomiting, decreased urine amount, diarrhoea, vesico-oedematous exanthemas, malodorous perspiration, fever, and shortness of breath.

He was taken to hospital on day 19 when the dyspnoea became worse. Toxic epidermal necrolysis complicated with soft tissue infection and sepsis were then diagnosed. The patient died shortly afterwards of septic shock and multiple organ failure. Post-mortem blood arsenic levels were elevated at 1225 μg/L. The analysis of the patient’s herbal remedies yielded a very high concentration of arsenic in three unlabelled realgar-containing ointments (45427, 5512, and 4229 ppm).

The authors of this report concluded that realgar-containing herbal remedy may cause severe cutaneous adverse reactions. The arsenic in realgar can be absorbed systemically from repeated application to non-intact skin and thus should not be extensively used on compromised skin.

The notion that a treatment that ‘has stood the test of time’ must be safe and effective is very wide-spread in alternative medicine. This, we often hear, applies particularly to the external use of traditional remedies – what can be wrong with putting a traditional Chinese herbal cream on the skin?? This case, like so many others, should teach us that this appeal to tradition is a classical and often dangerous fallacy. And the ‘realgar-story’ also suggests that, in TCM, the ‘learning-curve’ is very flat indeed.

Chinese and Ayurvedic remedies are often contaminated with toxic heavy metals. But the bigger danger seems to be that some of these traditional ‘medicines’ contain such toxins because, according to ‘traditional wisdom’, these constituents have curative powers. I think that, until we have compelling evidence that any of these treatments do more good than harm, we should avoid taking them.

One of the most gratifying aspect of my work in Exeter was being able to offer posts to visiting researchers from across the world. Some of these co-workers, after returning to their home countries, became prominent scientists in their own right, and quite a few remained in contact and continued to collaborate with me or with members of my team. In one of these collaborative projects, we wanted to investigate adverse events attributed to traditional medical treatments in the Republic of Korea.

For this purpose, we reviewed adverse events recorded in the Republic of Korea, between 1999 and 2010, by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers’ complaints, were evaluated.

Overall, 9624 records of adverse events were identified. Liver problems after the administration of herbal medicines were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 – mostly infections, cases of pneumothorax and burns – were linked to physical therapies (n = 285) or acupuncture/moxibustion (n = 1104).

We concluded that traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system.

The assumption that alternative treatments are entirely harmless is widespread, not least because it is incessantly promoted via millions of web-site, thousands of books, newspaper articles, VIPs like Prince Charles etc. etc. Consumers are incessantly being told that NATURAL = SAFE. Yet, if we look closely, most alternative treatments are not natural and, as this investigation demonstrates, they are certainly not devoid of risks.

I already see the apologists preparing to comment that, compared to conventional therapies, alternative treatments are very safe. So let me pre-empt this fallacy by pointing out (yet again) that 1) in the absence of adequate surveillance systems, nobody can say how frequent adverse-effects of alternative treatments really are, and that 2) even severe adverse effects can normally be tolerated, if the treatment in question has been shown to be efficacious.

So, instead of commenting on my repeated reports about the risks of alternative medicine, I invite, in fact, I challenge my critics to answer this simple question: For how many alternative therapies is there a well-documented positive risk/benefit balance?

Swiss chiropractors have just published a clinical trial to investigate outcomes of patients with radiculopathy due to cervical disk herniation (CDH). All patients had neck pain and dermatomal arm pain; sensory, motor, or reflex changes corresponding to the involved nerve root and at least one positive orthopaedic test for cervical radiculopathy were included. CDH was confirmed by magnetic resonance imaging. All patients received regular neck manipulations.

Baseline data included two pain numeric rating scales (NRSs), for neck and arm, and the Neck Disability Index (NDI). At two, four and twelve weeks after the initial consultation, patients were contacted by telephone, and the data for NDI, NRSs, and patient’s global impression of change were collected. High-velocity, low-amplitude thrusts were administered by experienced chiropractors. The proportion of patients reporting to feel “better” or “much better” on the patient’s global impression of change scale was calculated. Pre-treatment and post-treatment NRSs and NDIs were analysed.

Fifty patients were included. At two weeks, 55.3% were “improved,” 68.9% at four and 85.7% at twelve weeks. Statistically significant decreases in neck pain, arm pain, and NDI scores were noted at 1 and 3 months compared with baseline scores. 76.2% of all sub-acute/chronic patients were improved at 3 months.

The authors concluded that most patients in this study, including sub-acute/chronic patients, with symptomatic magnetic resonance imaging-confirmed CDH treated with spinal manipulative therapy, reported significant improvement with no adverse events.

In the presence of disc herniation, chiropractic manipulations have been described to cause serious complications. Some experts therefore believe that CDH is a contra-indication for spinal manipulation. The authors of this study imply, however, that it is not – on the contrary, they think it is an effective intervention for CDH.

One does not need to be a sceptic to notice that the basis for this assumption is less than solid. The study had no control group. This means that the observed effect could have been due to:

a placebo response,

the regression towards the mean,

the natural history of the condition,

concomitant treatments,

social desirability,

or other factors which have nothing to do with the chiropractic intervention per se.

And what about the interesting finding that no adverse-effects were noted? Does that mean that the treatment is safe? Sorry, but it most certainly does not! In order to generate reliable results about possibly rare complications, the study would have needed to include not 50 but well over 50 000 patients.

So what does the study really tell us? I have pondered over this question for some time and arrived at the following answer: NOTHING!

Is that a bit harsh? Well, perhaps yes. And I will revise my verdict slightly: the study does tell us something, after all – chiropractors tend to confuse research with the promotion of very doubtful concepts at the expense of their patients. I think, there is a name for this phenomenon: PSEUDO-SCIENCE.

Upper spinal manipulation, the signature-treatment of many chiropractors is by no means free of serious risks. Most chiropractors negate this, but can any reasonable person deny it? Neurosurgeons from New York have just published an interesting case-report in this context:

A 45 year old male with presented to his internist with a two-week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination revealed nothing abnormal, except for a decreased range of motion of the right arm. He referred the patient to a chiropractor who performed plain X-rays which apparently showed “mild spasm” (how anyone can see spasm on an X-ray is beyond me!). No magnetic resonance imaging study was done.

The chiropractor proceeded manipulating the patient’s neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining a magnetic resonance study, the chiropractor manipulated the patient’s neck for a third time.

Thereafter, the patient immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the magnetic resonance scan, the patient remained quadriplegic. There seemed to be very little doubt that the quadriplegia was caused by the chiropractic spinal manipulation.

The authors of this report also argue that a major point of negligence in this case was the failure of both the referring internist and chiropractor to order a magnetic resonance study of the cervical spine prior to the chiropractic manipulations. In his defence, the internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet. Even the quickest of literature searches discloses this assumption to be wrong. The first such case seems to have been published as early as 1957. Since then, numerous similar reports have been documented in the medical literature.

The internist furthermore claimed that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. As we have pointed out repeatedly, this argument is pure speculation; under-reporting of such cases is huge, and therefore exact incidence figures are anybody’s guess.

The patient sued both the internist and the chiropractor, and the total amount of the verdict was $14,596,000.00 the internist’s liability was 5% ($759,181.65).

A cult can be defined not just in a religious context, but also as a” usually nonscientific method or regimen claimed by its originator to have exclusive or exceptional power in curing a particular disease.” After ~20 years of researching this area, I have come to suspect that much of alternative medicine resembles a cult – a bold statement, so I better explain.

One characteristic of a cult is the unquestioning commitment of its members to the bizarre ideas of their iconic leader. This, I think, chimes with several forms alternative medicine. Homeopaths, for instance, very rarely question the implausible doctrines of Hahnemann who, to them, is some sort of a semi-god. Similarly, few chiropractors doubt even the most ridiculous assumptions of their founding father, D D Palmer who, despite of having been a somewhat pathetic figure, is uncritically worshipped. By definition, a cult-leader is idealised and thus not accountable to anyone; he (yes, it is almost invariably a male person) cannot be proven wrong by logic arguments nor by scientific facts. He is quite simply immune to any form of scrutiny. Those who dare to disagree with his dogma are expelled, punished, defamed or all of the above.

Cults tend to brain-wash their members into unconditional submission and belief. Likewise, fanatics of alternative medicine tend to be brain-washed, i.e. systematically misinformed to the extend that reality becomes invisible. They unquestioningly believe in what they have been told, in what they have read in their cult-texts, and in what they have learnt from their cult-peers. The effects of this phenomenon can be dramatic: the powers of discrimination of the cult-member are reduced, critical questions are discouraged, and no amount of evidence can dissuade the cult-member from abandoning even the most indefensible concepts. Internal criticism is thus by definition non-existent.

Like religious cults, many forms of alternative medicine promote an elitist concept. Cult-members become convinced of their superiority, based not on rational considerations but on irrational beliefs. This phenomenon has a range of consequences. It leads to the isolation of the cult-member from the rest of the world. By definition, critics of the cult do not belong to the elite; they are viewed as not being able to comprehend the subtleties of the issues at hand and are thus ignored or not taken seriously. For cult-members, external criticism is thus non-existent or invalid.

Cult-members tend to be on a mission, and so are many enthusiasts of alternative medicine. They use any conceivable means to recruit new converts. For instance, they try to convince family, friends and acquaintances of their belief in their particular alternative therapy at every conceivable occasion. They also try to operate on a political level to popularize their cult. They cherry pick data, often argue emotionally rather than rationally, and ignore all arguments which contradict their belief system.

Cult-members, in their isolation from society, tend to be assume that there is little worthy of their consideration outside the cult. Similarly, enthusiasts of alternative medicine tend to think that their treatment is the only true method of healing. Therapies, concepts and facts which are not cult-approved are systematically defamed. An example is the notion of BIG PHARMA which is employed regularly in alternative medicine. No reasonable person assumes that the pharmaceutical industry smells of roses. However, the exaggerated and systematic denunciation of this industry and its achievements is a characteristic of virtually all branches of alternative medicine. Such behaviour usually tells us more about the accuser than the accused.

There are many other parallels between a  cult and alternative medicine, I am sure. In my view, the most striking one must be the fact that any spark of cognitive dissonance in the cult-victim is being extinguished by highly effective and incessant flow of misinformation which often amounts to a form of brain-washing.

Some people will probably think that I am obsessed with writing about the risk of chiropractic. True, I have published quite a bit on this subject, both in the peer-reviewed literature as well as on this blog – but not because I am obsessed; on this blog, I will re-visit the topic every time a relevant new piece of evidence becomes available because it is indisputably such an important subject. Writing about it might prevent harm.

So far, we know for sure that mild to moderate as well as serious complications, including deaths, do occur after chiropractic spinal manipulations, particularly those of the upper spine.  What we cannot say with absolute certainty is whether they are caused by the treatment or whether they happened coincidentally. Our knowledge in this area relies mostly on case-reports and surveys which, by their very nature, do not allow causal inferences. Therefore chiropractors have, in the past, been able to argue that a causal link remains unproven.

A brand-new blinded parallel group RCT might fill this gap in our knowledge and might reject or establish the notion of causality once and for all. The authors’ objective was to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. They thus conducted the first ever RCT  with the specific aim to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20-85, with spinal pain. Ninety two participants received individualized care consistent with the chiropractors’ usual treatment approach; 91 participants received a sham intervention. Each participant received two treatment sessions.

Completed adverse questionnaires were returned by 94.5% of the participants after the first appointment and 91.3% after the second appointment. Thirty three per cent of the sham group and 42% of the usual care group reported at least one adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), headache (sham 17%; usual care 9%). The relative risk was not significant for either adverse event occurrence (RR = 1.24 95% CI 0.85 to 1.81); occurrence of severe adverse events (RR = 1.9; 95% CI 0.98 to 3.99); adverse event onset (RR = 0.16; 95% CI 0.02 to 1.34); or adverse event duration (RR = 1.13; 95% CI 0.59 to 2.18). No serious adverse events were reported.

The authors concluded that a substantial proportion of adverse events following chiropractic treatment may result from natural history variation and non-specific effects.

If we want to assess causality of effects, we have no better option than to conduct an RCT. It is the study design that can give us certainty, or at least near certainty – that is, if the RCT is rigorous and well-made. So, does this study reject or confirm causality? The disappointing truth is that it does neither.

Adverse events were clearly more frequent with real as compared to sham-treatment. Yet the difference failed to be statistically significant. Why? There are at least two possibilities: either there was no true difference and the numerically different percentages are a mere fluke; or there was a true difference but the sample size was too small to prove it.

My money is on the second option. The number of patients was, in my view, way too small for demonstrating differences in frequencies of adverse effects. This applies to the adverse effects noted, but also, and more importantly, to the ones not noted.

The authors state that no serious adverse effects were observed. With less that 200 patients participating, it would have been most amazing to see a case of arterial dissection or stroke. From all we currently know, such events are quite rare and occur perhaps in one of 10 000 patients or even less often. This means that one would require a trial of several hundred thousand patients to note just a few of such events, and an RCT with several million patients to see a difference between real and sham treatment. It seems likely that such an undertaking will never be affordable.

So, what does this new study tell us? In my view, it is strong evidence to suggest a causal kink between chiropractic treatment and mild to moderate adverse effects. I dose not prove it, but merely suggests it – yet I am fairly sure that chiropractors, once again, will not agree with me.

The vexing question whether the acupuncture needle is as safe as most acupuncturists seem to believe has been raised several times before on this blog. Here is a new case-report by Japanese authors which sheds an interesting light on this issue.

A 62-year-old man was admitted to A+E complaining of dizziness and diaphoresis. He had received an acupuncture treatment in the sub-xyphoid area (lower 2 cm and left 1 cm point from the lower xyphoid process border) only about one hour ago. He had a history of cerebral infarction and atrial fibrillation, and the latter condition was treated with 2 mg warfarin per day. On admission, the acupuncture needle was still sticking in his sub-sternum.

His blood pressure was 80/50 mm Hg, and tachycardia with 110 beats/min was noted. The acupuncture-needle was duly removed, but the patient went into cardiac arrest and had to be resuscitated. Because his international normalized ratio was 1.99, 2 pints of fresh frozen plasma and 5 mg of vitamin K were administered at that stage. A transthoracic echocardiography revealed pericardial effusion with early diastolic collapse of the right ventricle. Emergency pericardiocentesis using a sub-costal approach was performed. After drainage of 500 mL of sanguineous effusion, the patient seemed to stabilize.

Two hours later, the drainage of pericardial effusion amounted to around 1000 mL, and cardiac arrest re-developed. After another resuscitation, an operation was performed under cardiopulmonary bypass (CPB). A median sternotomy allowed visualization of huge hematomas over the right atrium and ventricle. After the hematomas had been evacuated, pulsating blood loss from the marginal branch of the right coronary artery was identified. The vessel had been torn into pieces, and it was ligated which stopped the bleeding. Thereafter, the patient remained hemodynamically stable. Subsequently the patient made an uneventful recovery and, eventually, he was discharged without further complications.

The authors of this case-report conclude as follows: To our best knowledge, this appears to be the first case of an acupuncture-related coronary artery injury. The important causes of this unfortunate adverse event are a lack of anatomic knowledge and an incorrect application of the procedure. It can be avoided that acupuncture leads to cardiac tamponade like most serious complications….every acupuncturist should be aware of the possible and life-threatening adverse events and be adequately trained to prevent them.

In 2011, we published a review of all cases of cardiac tamponade after acupuncture. At the time, we found a total of 26 such incidences. In 14 patients, the complications were fatal. In most reports, there was little doubt about causality. We concluded that cardiac tamponade is a serious, often fatal complication after acupuncture. As it is theoretically avoidable, acupuncturists should be trained to minimize the risk.

Acupuncture-fans will, of course, claim (as before) that it is alarmist to go on about risks of acupuncture or alternative medicine which are so minute that they are dwarfed by those of conventional health care. And I will counter (as before) that it is never the absolute risk that counts, but that it is the risk benefit balance which defines the value of any therapeutic intervention. As long as we have no solid proof that acupuncture is more than a “theatrical placebo“, even a tiny risk weighs heavily and seems unacceptable.

But the true significance of this case-report lies elsewhere, in my view: risks of this nature can and should be avoided. The only way to achieve this aim is to train and educate acupuncturists properly. At present this does not seem to be the case, particularly in Asian countries where acupuncture is most popular. It is up to the acupuncture communities across the globe to get their act together.

Alternative medicine has the image of being gentle and risk-free; it is therefore frequently used for children. German experts have just published an important article on this rather controversial topic.

They performed a systematic synthesis of all Cochrane reviews in paediatrics assessing the efficacy, clinical implications and limitations of alternative medicine use in children. The main outcome variables were: percentage of reviews concluding that a certain intervention provides a benefit, percentage of reviews concluding that a certain intervention should not be performed, and percentage of studies concluding that the current level of evidence is inconclusive. A total of 135 reviews were included – most from the United Kingdom (29), Australia (24) and China (24). Only 5 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26 (19.4%) issued a conditional positive recommendation. The 5 positive recommendations were:

1) Calcium supplements during pregnancy for prevention of hypertension and related conditions

2) Creatinine supplements for treating muscular disorders

3) Zinc supplements for prevention of pneumonia

4) Probiotics for prevention of upper respiratory infections

5) Acupuncture for prevention of post-operative nausea and vomiting

Nine (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased over time. The three most common criticisms of the quality of the primary studies included were: more research needed (82), low methodological quality (57) and small number of study participants (48).

The authors concluded: Given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

As it happens, we published a very similar review two years ago. At the time (and using slightly different inclusion criteria), we identified a total of 17 systematic reviews. They related to acupuncture, chiropractic, herbal medicine, homeopathy, hypnotherapy, massage and yoga. Results were unconvincing for most conditions, but there was some evidence to suggest that acupuncture may be effective for postoperative nausea and vomiting, and that hypnotherapy may be effective in reducing procedure-related pain. Most of the reviews failed to mention the incidence of adverse effects of the alternative treatments in question. Our conclusions were as follows: “Although there is some encouraging evidence for hypnosis, herbal medicine and acupuncture, there is insufficient evidence to suggest that other CAMs are effective for the treatment of childhood conditions. Many of the systematic reviews included in this overview were of low quality, as were the randomised clinical trials within those reviews, further reducing the weight of that evidence. Future research in CAM for children should conform to the reporting standards outlined in the CONSORT and PRISMA guidelines.”

Treating children with unproven or dis-proven therapies is even more problematic than treating adults in this way. The main reason is that children cannot give informed consent. Thus alternative medicine for children can open difficult ethical questions, and sometimes I wonder where the line is between the application of bogus treatments and child-abuse. Examples are parents who opt for homeopathic vaccinations instead of conventional ones, or paediatric cancer patients who are being treated with bogus alternatives such as laetrile.

Why would parents not want the most effective therapy for their children? Why would anyone opt for dubious alternatives? The main reason, I think, must be misinformation. Parents who use alternative medicine are convinced they are effective and safe because they have been misinformed. We only need to google ALTERNATIVE MEDICINE to see for ourselves what utter nonsense and dangerous rubbish is being promoted under this umbrella.

Misinformation is the foremost reason why well-meaning parents (mis-) treat their children with alternative medicine. The results can be disastrous. Misinformation can kill!

A team of Swiss and UK chiropractors just published a survey to determine which management options their colleagues would choose in response to several clinical case scenarios. In order to avoid the accusations of citing out of context, or misreporting the findings in other ways, the wording of the following post is close to the original text of the article.

PART ONE

The clinical scenarios refer to treatments which appear not to be successful, not indicated, possibly harmful or where a patient might be suffering from a treatment-induced complication:

Scenario 1. A patient with non-specific low back pain has not improved at all after 4–6 treatments.

Scenario 2. A patient, who has a simple neck problem with no previous long-term problems, has now improved at least 80% and stayed at this level for a couple of weeks.

Scenario 3. A patient returns from the last treatment with a new distal pain (e.g. sciatica when treated only for localized LBP, or brachialgia when treated only for local neck pain).

Scenario 4. An elderly woman complains about immediate chest pain on inspiration after manual treatment directed to her thoracic spine.

It is worth noting that scenario 4 is the most dramatic but it is by far not the worst case scenario; this would have been the case of a patient who develops signs of a stroke after neck manipulation. It is telling, I think, that this possibility has been excluded in the survey.

The following 9 management options were provided:

• I would re-evaluate the patient with a view to establishing a better diagnosis

• I would send the patient for diagnostic imaging

• I would change my treatment approach and use another technique

• I would send the patient for a second opinion to another healthcare professional but keep on monitoring their condition

• I would try a few times more

• I would encourage the patient to continue the treatment until their spine is subluxation-free

• I would stop treatment and monitor the patient regularly

• I would stop the treatment, apologise and report the event to the chiropractic reporting and learning system

• I would stop the treatment, but tell the patient that s/he is welcome to return if they feel the need

To each of these options, the chiropractors could answer by ticking: ‘never’, ‘unlikely’, ‘likely’ and ‘most likely’.

PART TWO

In a second part of the questionnaire the researchers assessed the chiropractors’ general attitude towards safety issues by seeking the level of agreement on a five-point scale, with the responses ‘strongly disagree’, ‘disagree’, ‘neither agree nor disagree’, ‘agree’ and ‘strongly agree’, with 23 statements relating to six different safety dimensions, as follows:

• Teamwork – helping out, relationships, respect, teamwork-emphasis

• Work pressure – rushing, overwork, staff contingent, patient numbers

• Staff training – in response to new processes, on-the-job, appropriateness of tasks

• Process and standardisation – organisation, procedures, workflow, processes

• Communication openness – ideas for improvement, alternative views, asking questions, voicing disagreement

• Patient tracking/follow-up – reminders, documentation, reports, monitoring

260 Swiss and 1258 UK chiropractors were invited to complete the questionnaire. Responses were received from 76% of the Swiss and from 31% of the UK chiropractors. The dismal response rate for UK chiropractors seems to speak volumes.

The results of this survey indicate that both Swiss and UK chiropractors tend to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a serious complication might have occurred, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. The authors believe that this unlikeliness of safety incident reporting is due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.

In this context, scenario 4 is the most dramatic and therefore the most relevant scenario -but, as noted above, not a worst case scenario. It suggested a rib fracture as a result of chiropractic manipulation, with osteoporosis as a possible risk factor. The authors state that there is a strong argument for such an incident to be reported because patient injury occurred and because reflection on the detailed circumstances of the case, shared with colleagues, might serve to minimise the risk of such an occurrence happening elsewhere. However, incident reporting was found to be an unlikely option and comments revealed that this may be due to a perceived connection of reporting with guilt and error, as has been identified with other healthcare reporting initiatives, or only warranted in extreme cases.

The survey also showed that 33% of UK and 48% of Swiss chiropractors seem to work alone. In the eyes of the authors, this is limiting opportunities for fostering a safety culture through activities such as teamwork.

The authors draw the following conclusions:

• This study prompted chiropractors to reflect on aspects of clinical risk.

• Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by reevaluating their care and changing their approach

• Safety incident reporting to an online system is currently an unlikely course of action, probably due to previously recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting.

• Barriers to the use of safety incident reporting systems need to be addressed in order to encourage wider use of the existing systems.

• A significant proportion of Swiss and UK chiropractors practice in a single-handed environment. We suggest that single-handed practitioners have most to gain from participation in a national safety incident reporting and learning system.

• Female chiropractors appear to be more risk-averse than male chiropractors.

• Positivity towards key aspects of clinic safety indicate a developing safety culture within the Swiss and UK chiropractic professions.

In my view, the findings of this survey are deeply worrying and the interpretation of the authors is not far from an attempt to ‘white-wash’ the results. Like with most investigations of this nature, the results are wide open to selection bias; particularly the dismal UK response rate begs many questions. In all likelihood, reality is much worse than implied by the results of this investigation. And these results clearly show that, even with a fairly dramatic safety incident, chiropractors fail to respond adequately. There is no doubt in my mind: chiropractors put patients at risk.

Ignaz von Peczely (1826-1911), a Hungarian physician, got the idea for iridology (or iris-diagnosis) more than a century ago, after seeing streaks in the iris of a man he was treating for a broken leg, and similar phenomena the iris of an owl whose leg von Peczely had broken many years before. He subsequently became convinced that his method was able to distinguish between healthy organs and those that are overactive, inflamed, or distressed. Iridology became internationally known when US chiropractors began adopting this method in their clinical practice. In the United States, most insurance programs do not cover iridology but, in some European countries, they often do. In Germany, for instance, 80% of the Heilpraktiker (non-medically qualified health practitioners) practice iridology.

Iridologists claim to be able to diagnose the health status of an individual, medical conditions or predispositions to disease through abnormalities of pigmentation in the iris. The popularity of iridology renders it necessary to ask whether this method is valid.

The aim of my systematically review from 1999 was to critically evaluate all available, reliable tests of iridology as a diagnostic tool. Four case control studies were included; these are investigations where iridologists are asked to tell by looking at the iris of individuals whether that person does or does not have a certain condition. The majority of these studies suggested that iridology is not a valid diagnostic method. Back then, I concluded that “the validity of iridology as a diagnostic tool is not supported by scientific evaluations. Patients and therapists should be discouraged from using this method.”

Since the publication of my article, several further studies have emerged:

One German team conducted a study investigating the applicability of iridology as a screening method for colorectal cancer. Digital color slides were obtained from both eyes of 29 patients with histologically diagnosed colorectal cancer and from 29 age- and gender-matched healthy control subjects. The slides were presented in random order to acknowledged iridologists without knowledge of the number of patients in the two categories. The iridologists correctly detected 51.7% and 53.4%, respectively, of the patients’ slides; therefore, the likelihood was statistically no better than chance. Sensitivity was, respectively, 58.6% and 55.2%, and specificity was 44.8% and 51.7%. The authors’ conclusion was blunt: “Iridology had no validity as a diagnostic tool for detecting colorectal cancer in this study.”

A study from South Africa aimed to determine the efficacy of iridology in the identification of moderate to profound sensorineural hearing loss in adolescents. A controlled trial was conducted with an iridologist, blind to the actual hearing status of participants, analysing the irises of participants with and without hearing loss. Fifty hearing impaired and fifty normal hearing subjects, between the ages of 15 and 19 years, controlled for gender, participated in the study. An experienced iridologist analysed the randomised set of participants’ irises. A 70% correct identification of hearing status was obtained with a false negative rate of 41% compared to a 19% false positive rate. The respective sensitivity and specificity rates therefore were 59% and 81%. The authors of this investigation concluded that “iridological analysis of hearing status indicated a statistically significant relationship to actual hearing status (P < 0.05). Although statistically significant sensitivity and specificity rates for identifying hearing loss by iridology were not comparable to those of traditional audiological screening procedures.”

A further German study investigated the value of iridology as a diagnostic tool in detecting some common cancers. One hundred ten subjects were enrolled; 68 subjects had histologically proven cancers of the breast, ovary, uterus, prostate, or colorectum, and 42 were cancer-free controls. All subjects were examined by an experienced practitioner of iridology, who was unaware of their medical details. He was allowed to suggest up to five diagnoses for each subject and his results were then compared with each subject’s medical diagnosis to determine the accuracy of iridology in detecting malignancy. Iridology identified the correct diagnosis in only 3 cases (sensitivity, 0.04). The authors concluded that “iridology was of no value in diagnosing the cancers investigated in this study.”

Based on these results it is impossible, I think, to claim that iridology is a valid or useful diagnostic tool. As there is no anatomical or physiological basis for its assumptions, iridology is not biologically plausible. Furthermore, the available clinical evidence does not support its validity as a diagnostic tool. In other words, iridology is bogus. This statement is in sharp contract to the information consumers receive about the method on uncounted websites, books, articles, etc. One website picked at random provides the following information:

The iris reveals changing conditions of every part and organ of the body. Every organ and part of the body is represented in the iris in a well defined area. In addition, through various marks, signs, and discoloration in the iris, nature reveals inherited weaknesses and strengths.

By means of this art / science, an iridologist (one who studies the coloration and fiber structure of the eye) can tell an individual his/her inherited and acquired tendencies towards health and disease, his current condition in general, and the state of every organ in particular.

Iridology cannot detect a specific disease, but, can tell an individual if they have over or under activity in specific areas of the body. For example, an under-active pancreas might indicate a diabetic condition.

Another source claims:

The underlying platform of iridology is that that eyes act as a ‘window’ to a person’s health & well being. This ‘window’ enables the practitioner to see whether areas or organs within the body are healthy, inflamed or ‘over active’. It also enables them to assess a person’s past/ possible future health problems & consider if the patient has a susceptibility to certain diseases. It is important to understand that iridology is simply a method of diagnosis & analysis.

You may well think that none of this really matters. Who cares whether iridology is bogus or not! I would argue that it does matter. Bogus methods cost money that could be better spent elsewhere. More importantly, false positive and false negative diagnoses generated by bogus diagnostic methods can put lives at risk.

But there is a more general and perhaps more crucial point here: alternative medicine is an area where people far too easily get away with ignoring the published evidence and scientific consensus. In the last two decades, I have seen many alternative modalities getting scientifically dis-proven; not in a single such instance can I remember that the corresponding alternative practitioners and their professional organisations took any notice of this fact, and not once did I notice that their practice had changed.

If research is  systematically ignored, it becomes a useless appendix. More importantly, progress is then stifled to the detriment of all our best interests.

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