MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk

In 2010, I have reviewed the deaths which have been reported after chiropractic treatments. My article suggested that 26 fatalities had been published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery. Whenever I write about the risks of spinal manipulation, chiropractors say that I am irresponsible and alarmist. Yet I believe I am merely doing my duty in alerting health care professionals and the public to the possibility that this intervention is associated with harm and that caution is therefore recommended.

Fortunately, I am not alone, as a new report from China shows.This review summarised published cases of injuries associated with cervical manipulation in China, and to describe the risks and benefits of the therapy.

A total of 156 cases met the inclusion criteria. They included the following problems: syncope = 45 cases , mild spinal cord injury or compression = 34 cases, nerve root injury = 24 cases, ineffective treatment or symptom increased = 11 cases ; cervical spine fracture = 11 cases, dislocation or semiluxation = 6 cases, soft tissue injury = 3 cases, serious accident = 22 cases including paralysis, death and cerebrovascular accident. Manipulation including rotation was involved in 42.00%, 63 cases). 5 patients died.

The authors conclude that “it is imperative for practitioners to complete the patients’ management and assessment before manipulation. That the practitioners conduct a detailed physical examination and make a correct diagnosis would be a pivot method of avoiding accidents. Excluding contraindications and potential risks, standardizing evaluation criteria and practitioners’ qualification, increasing safety awareness and risk assessment and strengthening the monitoring of the accidents could decrease the incidence of accidents” (I do apologize for the authors’ poor English).

It is probable that someone will now calculate that the risk of harm is minute. Chinese traditional healers seem to use spinal manipulation fairly regularly, so the incidence of complications would be one in several millions.

Such calculations are frequently made by chiropractors in an attempt to define the incidence rates of risks associated with chiropractic in the West. They look convincing but, in fact, they are complete nonsense.

The reason is that under-reporting can be huge. Clinical trials of chiropractic often omit any mention of adverse effects (thus violating publication ethics) and, in our case-series, under-reporting was precisely 100% (none of the cases we discovered had been recorded anywhere). This means that these estimates are entirely worthless.

I sincerely hope that the risk turns out to be extremely low – but without a functioning reporting system for such events, we might as well read tea-leaves.

I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!

There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.

The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.

Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.

We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.

These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive.

To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.

We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.

If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!

Daniels and Vogel recently published an article entitled “Consent in osteopathy: A cross sectional survey of patients’ information and process preferences” (INTERNATIONAL JOURNAL OF OSTEOPATHIC MEDICINE 2012, 15:3, p.92-102). It addresses an important yet woefully under-researched area.

I find most laudable that two osteopaths conduct research into medical ethics; but the questions still are, does the article tell us anything worth knowing and is it sufficiently rigorous and critical? As the journal does not seem to be available on Medline, I cannot provide a link. I therefore take the liberty of quoting the most important bits from directly the abstract here.

Objective: To explore and describe patients’ preferences of consent procedures in a sample of UK osteopathic patients.

Methods: A cross sectional survey using a new questionnaire was performed incorporating paper and web-based versions of the instruments. 500 copies were made available, (n = 200) to patients attending the British School of Osteopathy (BSO) clinic, and (n = 300) for patients attending 30 randomly sampled osteopaths in practice. Quantitative data were analysed descriptively to assess patient preferences; non-parametric analyses were performed to test for preference difference between patients using demographic characteristics.

Results: 124 completed questionnaires were returned from the BSO sample representing a 41% response rate. None were received from patients attending practices outside of the BSO clinic. The majority (98%) of patient respondents thought that having information about rare yet potentially severe risks of treatment was important. Patients’ preferred to have this information presented during the initial consultation (72%); communication method favoured was verbal (90%). 99% would like the opportunity to ask questions about risks, and all respondents (100%) consider being informed about their current diagnosis as important.

Conclusion: Patients endorse the importance of information exchange as part of the consent process. Verbal communication is very important and is the favoured method for both receiving information and giving consent. Further research is required to test the validity of these results in practice samples

The 0% response-rate in patients from non-BSO practices is, of course, remarkable and not without irony. In my view, it highlights better than anything else the fact that informed consent rarely appears on the osteopathic radar screen. In a way, this increases the praise we should give the two authors for tackling the issue.

The central question of the survey is whether patients want to know about the risks of osteopathy. This is more than a little bizarre: informed consent is not an option, it is a legal, moral and ethical obligation. It seems therefore odd to ask the question “do you want to learn about the risks which you are about to be exposed to?”

Even odder is, I think, the second question “when do you want to receive this information?” It goes without saying that informed consent has to happen before the intervention! This is what, common sense tells us, the law dictates and ethical codes prescribe.

There is general agreement amongst health care professionals and ethicist that verbal consent does suffice in most therapeutic situations, that patients must have the opportunity to ask questions, and that informed consent also extends to diagnostic issues. So, the questions referring to these issues are also a bit strange or naive, in my view.

The article might be revealing mostly by what it does not address rather than by what it tells us. It would be really valuable to know the percentage of osteopaths who abide by the legal, moral and ethical imperative of informed consent in their daily practice. To the best of my knowledge, this information is not available [if anyone has such information, please let me know and provide the reference]. Assuming that it is similar to the percentage of UK chiropractors who obtain informed consent, it might be seriously wanting: only 45% of them routinely obtain informed consent from their patients.

Another issue that, in my view, would be relevant to clarify is the nature of the information provided by osteopaths to patients, other than that of serious risks associated with spinal manipulation/mobilisation. Do they tell their patients about the evidence suggesting that osteopathy does (not) work for the condition at hand? Do they elaborate on non-osteopathic treatments for that disease? I fear that the answers to these questions might well be negative.

Imagine a patient being told that there is no good evidence for effectiveness of osteopathy, that the possibility of some harm exists, and that other interventions might actually do more good than harm than what the osteopath has to offer. How likely is it that this patient would agree to receiving osteopathic treatment?

For most alternative practitioners, including osteopaths, informed consent and most other important ethical issues have so far remained highly uncomfortable areas. This may have a good and simple reason: they have the potential to become real and serious threats to their current practice and business. I suspect this is why there is so very little awareness of and research into the ethics of alternative medicine: “best not to wake sleeping lions”, seems to be the general attitude.

The survey by Daniels and Vogel, even though it touches upon an important topic, avoids the truly pertinent questions. It therefore looks to me a bit like a fig leaf shamefully hiding an area of potential embarrassment.

And where do we go from here? I predict that the current strategy of alternative practitioners to ignore and violate medical ethics as much as possible will not be tolerated for much longer. Double standards in health care cannot and should not survive. The sooner we begin addressing some of these uncomfortable questions with rigorous research, the better – perhaps not for the practitioner but certainly for the patient.

“Don’t take this therapy lightly. Multiple sclerosis, colitis, lupus, rheumatoid arthritis, cancer, hepatitis, hyperactivity, pancreatic insufficiency, psoriasis, eczema, diabetes, herpes, mononucleosis, adrenal failure, allergies and so many other ailments have been relieved through use of this therapy. After you overcome your initial gag response (I know I had one), you will realize that something big is going on, and if you are searching for health, this is an area to investigate. There are numerous reports and double blind studies which go back to the turn of the century supporting the efficacy of using urine for health”. This quote refers to a treatment that I, and probably most readers of this blog, find truly amazing – even in the realm of alternative medicine, we do not often come across a therapy as bizarre as this one: urine therapy.

Urine therapy enthusiasts claim that your own urine administered either externally, internally or both, has a long history of use, that most medical cultures have usefully employed it, that many VIPs swear by it, that it can cure almost all diseases and that it can save lives. What was new to me is the claim that it is supported by numerous double-blind studies.

Such trials would, of course, be entirely feasible; all you need to do is to give one group of patients the experimental treatment, while the other takes a placebo. Recruitment might be a bit of a problem, and the ethics committee might raise one or two eyebrows but, in theory, it certainly seems doable. So where are the “numerous” studies?

A quick, rough and ready Medline-Search found several unfortunate authors with the last name of “URINE”, yet no clinical trials of urine therapy emerged. A little more time-consuming search through my books on alternative medicine revealed nothing that remotely resembled evidence. At this point, I arrived at the conclusion that the clinical trials are either non-existent or extremely well hidden. Further searches of the proponents’ literature, websites etc made me settle for the former explanation.

All this could be entirely irrelevant, perhaps slightly amusing, would it not reveal a pattern which is so painfully common in alternative medicine: anyone can claim anything without fear of any type of retribution, gullible consumers are attracted through the exotic flair, VIP-promotion, long history of use etc. and follow in droves [yes, amazingly, urine therapy seems to have plenty of followers]; consequently, lives are put at risk whenever someone starts truly believing the bogus, irresponsible claims that are being made. 

I do apologise for the rudeness of my words but I really do think THEY ARE TAKING THE PISS! 

Even though I have not yet posted a single article on this subject, it already proved to be a most controversial subject in the comments section. A new analysis of the evidence has just been published, and, in view of the news  just out of a Royal Charter for the UK College of Chiropractors, it is time to dedicate some real attention to this important issue.

The analysis comes in the form of a systematic review authored by an international team of chiropractors (we should not fear therefore that the authors have an “anti-chiro bias”). Their declared aim was “to determine whether conclusive evidence of a strong association [between neck manipulation and vascular accidents] exists”. The authors make it clear that they only considered case-control studies and omitted all other articles.

They found 4 such publications all of which had methodological limitations. Two studies were of  acceptable quality, and one of these studies seemed to show an association between neck manipulation and stroke, while the other one did not. The authors’ conclusion is ambivalent: “Conclusive evidence is lacking for a strong association between neck manipulation and stroke, but it is also lacking for no association”.

The 4 case-control studies, their strength and weaknesses are, of course, well-known and have been discussed several times before. It was also known that the totality of these data fail to provide a clear picture. I would therefore argue that, in such a situation, we need to include further evidence in an attempt to advance the discussion.

Generally speaking, whenever we assess therapeutic safety, we must not ignore case-reports. One might be next to meaningless but collectively they can provide strong indicators of risk. In drug research, for instance, they send invaluable signals about potential problems and many drugs have been withdrawn from the market purely on the basis of case-reports. If we include case-reports in an analysis of the risks of neck manipulations, the evidence generated by the existing case-control studies appears in a very different light. There are virtually hundreds of cases where neck manipulations have seriously injured patients, and many have suffered permanent neurological deficits or worse. Whenever causation is validated by experts who are not chiropractors and thus not burdened with a professional bias, investigators find that most of the criteria for a causal relationship are fulfilled.

While the omission of case-reports in the new review is regrettable, I find many of the staements of the authors helpful and commendable, particularly considering that they are chiropractors. They seem to be aware that, when there is genuine uncertainty, we ought to err on the safe side [the precautionary principle]. Crucially, they comment on the practical implications of our existing knowledge: “Considering this uncertainty, informed consent is warranted for cervical spinal manipulative therapy that advises patients of a possible increase in the risk of a rare form of stroke…” A little later, in their discussion they write: “As the possibility of an association between cervical spinal manipulative therapy and vascular accidents cannot be ruled out, practitioners of cervical spinal manipulative therapy are obliged to take all reasonable steps that aim to minimise the potential risk of stroke. There is evidence that cervical rotation places greater stresses on vertebral arteries than other movements such as lateral flexion, and so it would seem wise to avoid techniques that involve full rotation of the head.”

At this point it is, I think, important to note that UK chiropractors tend not to obtain informed consent from their patients. This is, of course, a grave breach of medical ethics. It becomes even graver, when we consider that the GCC seems to do nothing about it, even though it has been known for many years.

Is this profession really worthy of a Royal Charter? This and the other question raised here require some serious consideration and discussion which, no doubt, will follow this short post.

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