MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk/benefit

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Myelopathy is defined as any neurologic deficit related to the spinal cord. When due to trauma, it is known as (acute) spinal cord injury. When caused by inflammatory, it is known as myelitis. Disease that is vascular in nature is known as vascular myelopathy.

The symptoms of myelopathy include:

  • Pain in the neck, arm, leg or lower back
  • Muscle weakness
  • Difficulty with fine motor skills, such as writing or buttoning a shirt
  • Difficulty walking
  • Loss of urinary or bowel control
  • Issues with balance and coordination

The causes of myelopathy include:

  • Tumours that put pressure on the spinal cord
  • Bone spurs
  • A dislocation fracture
  • Autoimmune diseases like multiple sclerosis
  • Congenital abnormality
  • A traumatic injury

This review presents a series of cases with cervical spine injury and myelopathy following therapeutic manipulation of the neck, and examines their clinical course and neurological outcome.

Its authors conducted a search for patients who developed neurological symptoms due to cervical spinal cord injury following neck SMT in the database of a spinal unit in a tertiary hospital between the years 2008 and 2018. Patients with vertebral artery dissections were excluded. Patients were assessed for the clinical course and deterioration, type of manipulation used and subsequent management.

A total of four patients were identified, two men and two women, aged between 32 and 66 years. In three patients neurological deterioration appeared after chiropractic adjustment and in one patient after tuina therapy. The patients had experienced symptoms within one day to one week after neck manipulation. The four patients had signs of:

  1. central cord syndrome,
  2. spastic quadriparesis,
  3. spastic quadriparesis,
  4. radiculopathy and myelomalacia.

Three patients were managed with anterior cervical discectomy and fusion while one patient declined surgical treatment.

The authors note that their data cannot determine whether the spinal cord dysfunction was caused my the spinal manipulations or were pre-existing problems which were aggravated by the treatments. They recommend that assessment for subjective and objective evidence of cervical myelopathy should be performed prior to cervical manipulation, and suspected myelopathic patients should be sent for further workup by a specialist familiar with cervical myelopathy, such as a neurologist, a neurosurgeon or orthopaedic surgeon who specializes in spinal surgery. They also state that manipulation therapy remains an important and generally safe treatment modality for a variety of cervical complaints. Their review, the authors stress, does not intend to discard the role of spinal manipulation as a significant part in the management of patients with neck related symptoms, rather it is meant to draw attention to the need for careful clinical and imaging investigation before treatment. This recommendation might be medically justified, yet one could argue that it is less than practical.

This paper from Israel is interesting in that it discloses possible complications of cervical manipulation. It confirms that chiropractors are most frequently implicated and that – as in our survey – under-reporting is exactly 100% (none of the cases identified by the retrospective chart review had been previously reported).

In light of this, some of the affirmations of the authors are bizarre. In particular, I ask myself how they can claim that cervical manipulation is a ‘generally safe’ treatment. With under-reporting at such high levels, the only thing one can say with certainty is that serious complications do happen and nobody can be sure how frequently they occur.

It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).

Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”

But is this always interpretation correct?

I seriously doubt it.

Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.

Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).

This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”

When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?

The answer is YES and NO.

YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?

NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.

So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.

I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.

I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!

The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.

Some people seem to think that all so-called alternative medicine (SCAM) is ineffective, harmful or both. And some believe that I am hell-bent to make sure that this message gets out there. I recommend that these guys read my latest book or this 2008 article (sadly now out-dated) and find those (admittedly few) SCAMs that demonstrably generate more good than harm.

The truth, as far as this blog is concerned, is that I am constantly on the lookout to review research that shows or suggests that a therapy is effective or a diagnostic technique is valid (if you see such a paper that is sound and new, please let me know). And yesterday, I have been lucky:

This paper has just been presented at the ESC Congress in Paris.

Its authors are: A Pandey (1), N Huq (1), M Chapman (1), A Fongang (1), P Poirier (2)

(1) Cambridge Cardiac Care Centre – Cambridge – Canada

(2) Université Laval, Faculté de Pharmacie – Laval – Canada

Here is the abstract in full:

Introduction: Regular physical activity may modulate the inflammatory process and be cardio-protective. Yoga is a form of exercise that may have cardiovascular benefits. The effects of yoga on global cardiovascular risk have not been adequately described. The purpose of this study is to determine whether the addition of yoga to a regular exercise regimen reduces global cardiovascular risk.
Methods: Sixty consecutive individuals with essential hypertension were recruited in a lifestyle intervention program. All individuals with known hypertensive end organ damage, known cardiovascular diseases, as well as those taking medications/supplements that affected blood pressure, blood sugar, cholesterol or vascular inflammation were excluded. Participants were randomized to either a yoga group or similar duration stretching control group. Participants, over the 3-month intervention regimen, performed 15 minutes of either yoga or stretching in addition to 30 minutes of aerobic exercises thrice weekly. Blood pressure, cholesterol levels and hs-CRP were measured, and Reynold’s Global Cardiovascular Risk Score was calculated at baseline and at the end of the 3-month intervention program.
Results: At screening, there were no statistically significant differences between the groups in any measured parameters or the 10-year risk of a cardiovascular event as measured by the Reynolds Risk Score. (8.2 vs. 9.0%; yoga vs. control group) After the 3-month intervention period, there was a statistically significantly greater decrease in the Reynold’s Risk Score in the yoga vs. the control group. (7.0 vs. 8.4%, p=0.003, relative reduction 13.2 vs. 6.5%, p<0.0001)
Conclusions: In patients with essential hypertension on no medications and with no known end organ damage, the practice of yoga incorporated into a 3-month exercise intervention program was associated with significant greater improvement in the Reynold’s Risk of a 10-year cardiovascular event, when compared to the control stretching group. If these results are validated in more diverse populations over a longer duration of follow up, yoga may represent an important addition to traditional cardiovascular disease prevention programs.

Yes, this study was small, too small to draw far-reaching conclusions. And no, we don’t know what precisely ‘yoga’ entailed (we need to wait for the full publication to get this information plus all the other details needed to evaluate the study properly). Yet, this is surely promising: yoga has few adverse effects, is liked by many consumers, and could potentially help millions to reduce their cardiovascular risk. What is more, there is at least some encouraging previous evidence.

But what I like most about this abstract is the fact that the authors are sufficiently cautious in their conclusions and even state ‘if these results are validated…’

SCAM-researchers, please take note!

Dr Alice Hodkinson is a GP in Cambridge, England. She says of herself that she is interested in supporting people to make informed choices about their own health, reduce the burden of illness and lighten the load of medication on patients and the country’s National Health Service. She is studying medical ethics and law at King’s College London.

Even though we live in the same town, I don’t know Dr Hodkinson personally and never met her. My only contact with her is the one depicted here: on Twitter I had posted my recent article entitled ‘A new, comprehensive review: HOMEOPATHY = PLACEBO THERAPY‘. This prompted the following exchange:
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Alice @HodkinsonAlice

At the very least homeopathy and placebos don’t cause harm that medicines do.
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Edzard Ernst @EdzardErnst

have you heard of something called ‘risk/benefit balance’?
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Alice @HodkinsonAlice

Which is precisely where homeopathy wins over toxins I prescribe as medication.
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Edzard Ernst @EdzardErnst

oh really? I do worry about the students you teach
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Alice @HodkinsonAlice

I worry about the over-use of toxins that harm. Lots of ppl get much better when meds are stopped. They come back from the dead and live much happier. Lots of evidence for this.
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Edzard Ernst @EdzardErnst

” Lots of ppl get much better when meds are stopped.” surely this is a sign that they never needed them; in other words, it is the mistake of the GP who did the prescription
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Alice @HodkinsonAlice

It’s a sign meds’ aren’t reviewed and they do harm. Water doesn’t harm, unless in excess. Promoting water as a cure might be harmful, yet there are sooooo many conditions where medicine has no answers, and for these, homeopathy comes up trumps.
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Edzard Ernst @EdzardErnst

I am sooooooo pleased you are not my GP!
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Alice @HodkinsonAlice

I’m bored. Go poison yourself on prescribed medication!
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END OF EXCHANGE

I don’t know why this shocks me more than any of the often much more disagreeable disputes I have with other proponents of homeopathy on Twitter or on this blog. Perhaps it is because it occurred with a person who is a doctor like myself, or because it happened with a complete stranger, or because it was with someone who is, for all I know, an entirely reasonable clinician in other medical matters, or because Dr Hodkinson is studying medical ethics? I really don’t know.

Or perhaps nobody have ever told me to poison myself?

The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.

Here I take the liberty of citing a short excerpt from this paper:

CLAIMS:

Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.

Claims should not assume that interventions are safe, effective or certain.

  • Interventions can cause harm as well as benefits.
  • Large, dramatic effects are rare.
  • We can rarely, if ever, be certain about the effects of interventions.

Seemingly logical assumptions are not a sufficient basis for claims.

  • Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
  • An outcome may be associated with an intervention but not caused by it.
  • More data are not necessarily better data.
  • The results of one study considered in isolation can be misleading.
  • Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
  • Interventions that are new or technologically impressive might not be better than available alternatives.
  • Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.

Trust in a source alone is not a sufficient basis for believing a claim.

  • Competing interests can result in misleading claims.
  • Personal experiences or anecdotes alone are an unreliable basis for most claims.
  • Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
  • Peer review and publication by a journal do not guarantee that comparisons have been fair.

COMPARISONS:

Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).

Comparisons of interventions should be fair.

  • Comparison groups and conditions should be as similar as possible.
  • Indirect comparisons of interventions across different studies can be misleading.
  • The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
  • Outcomes should be assessed in the same way in the groups or conditions being compared.
  • Outcomes should be assessed using methods that have been shown to be reliable.
  • It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
  • When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.

Syntheses of studies should be reliable.

  • Reviews of studies comparing interventions should use systematic methods.
  • Failure to consider unpublished results of fair comparisons can bias estimates of effects.
  • Comparisons of interventions might be sensitive to underlying assumptions.

Descriptions should reflect the size of effects and the risk of being misled by chance.

  • Verbal descriptions of the size of effects alone can be misleading.
  • Small studies might be misleading.
  • Confidence intervals should be reported for estimates of effects.
  • Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
  • Lack of evidence for a difference is not the same as evidence of no difference.

CHOICES:

What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.

Problems, goals and options should be defined.

  • The problem should be diagnosed or described correctly.
  • The goals and options should be acceptable and feasible.

Available evidence should be relevant.

  • Attention should focus on important, not surrogate, outcomes of interventions.
  • There should not be important differences between the people in studies and those to whom the study results will be applied.
  • The interventions compared should be similar to those of interest.
  • The circumstances in which the interventions were compared should be similar to those of interest.

Expected pros should outweigh cons.

  • Weigh the benefits and savings against the harm and costs of acting or not.
  • Consider how these are valued, their certainty and how they are distributed.
  • Important uncertainties about the effects of interventions should be reduced by further fair comparisons.

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END OF QUOTE

I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.

An article in the ‘Chronicle of Chiropractic’ defends the currently much debated chiropractic care for children. It is authored by ‘ChiroFuture‘, a Risk Purchasing Group founded by chiropractors. Here is the unabridged article (the references were added by me and refer to my comments below):

The chiropractic care of children has been the subject of increased media attention and scrutiny following decisions by chiropractic regulatory boards in Europe, Australia and Canada. These decisions were not based on science, research or data but rather a purposeful misrepresentation of the concept of evidence informed practice (1) and its application coupled with compelled speech.

As with the chiropractic care of adults, an evidence informed perspective (2) respects the needs and wants of parents for the care of their child, the published research evidence and the clinical expertise of chiropractors in the care of children.

ChiroFutures Malpractice Program does not base its malpractice insurance rates on the age of the patients a chiropractor sees.  In fact, we are not aware of any actuarial data showing an increase in adverse events from the tens of millions of pediatric chiropractic visits per year (3). The vast majority of claims or incidents alleging chiropractic negligence involve adult patients (4).

What chiropractors do is minimally invasive and typically nothing else but their hands are used to gently ease any obstruction to the functioning of the patient’s nervous system (5). Since the nervous system controls and coordinates all functions of the body it is important to be sure it is functioning as best it can with no obstructions and no matter the disease afflicting the patient.

State and provincial laws, federal governments, international, national and state chiropractic organizations and chiropractic educational institutions all support the role and responsibility of chiropractors in the management of children’s health (6). The rationale for chiropractic care of children is supported by published protocols that are safe, efficacious, and valid (7). The scientific literature is sufficiently supportive of the usefulness of these protocols in regard to the chiropractic care of children (8).

Those contending that there is no evidence supporting the safety and efficacy of the chiropractic care of children demonstrate a complete disregard for the evidence and scientific facts related to the chiropractic care of children (9).

ChiroFutures encourages and supports a shared decision making process between doctors (10) and patients regarding health needs. As a part of that process, patients have a right to be informed about the state of their health as well as the risks, benefits and alternatives related to care. Any restriction on that dialogue or compelled statements inconsistent with the doctrine of informed consent present a threat to public health (11).

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Here are my comments:

  1. Why ‘evidence informed’ and not evidence-based’? The term ‘evidence informed’ is popular with SCAM practitioners. Barratt and Hodson noted, “The evidence-informed practitioner carefully considers what research evidence tells them in the context of a particular child, family or service, and then weighs this up alongside knowledge drawn from professional experience and the views of service users to inform decisions about the way forward.”  This seems to imply that the two terms are synonymous. However, in reality they are not.
  2. Does that mean that ‘evidence-informed’ is defined as the practice wanted by patients, regardless of the evidence?
  3. There is no post-marketing surveillance in chiropractic. Therefore we do not have reliable data on adverse events.
  4. That might be true but it is unclear what it tells us. It might simply mean that chiropractors treat more adults than children.
  5. There is no good evidence to show that the function of the nervous system can be enhanced by manual therapy.
  6. Provincial laws and federal governments might tolerate but I don’t think they ‘support’ the role and responsibility of chiropractors. That chiropractic organisations support it surprises nobody.
  7. This sentence does not make sense to me. The facts, however, are clear: there is no sound rational for chiropractic manipulations and they are neither efficacious nor totally safe for children.
  8. The scientific evidence does not show that chiropractic care is effective for any paediatric condition.
  9. I think the complete disregard is shown not by critics but by the authors of these lines.
  10. Calling chiropractors ‘doctors’ gives the impression they have  been to medical school and is therefore misleading the public.
  11. The threat to public health are those chiropractors who advise parents not to immunise their children.

Perhaps ChiroFuture need to brush up on their knowledge of the evidence. Chiropractic has no place in the healthcare of children. Parents should be warned!

As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:

In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Of course, not all SCAM professions focus on children. The following, however, treat children regularly:

  • acupuncturists
  • anthroposophical doctors
  • chiropractors
  • craniosacral therapists
  • energy healers
  • herbalists
  • homeopaths
  • naturopaths
  • osteopaths

I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.

Cupping is a so-called alternative medicine (SCAM) that has existed in several ancient cultures. It recently became popular when US Olympic athletes displayed cupping marks on their bodies, and it was claimed that cupping is used for enhancing their physical performance. There are two distinct forms: dry and wet cupping.

Wet cupping involves scarring the skin with a sharp instrument and then applying a cup with a vacuum to suck blood from the wound. It can thus be seen (and was traditionally used) as a form of blood-letting. Wet cupping is being recommended by enthusiasts for a wide range of conditions. But does it work?

This study compared the effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping or conventional treatment. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional treatment group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively.
The results show that there was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups. Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits. The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly superior compared to the conventional treatment group. The final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01).

The authors concluded that wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.

Perhaps the authors were joking? In any case, their conclusions cannot be taken seriously. Why? There are several reasons, but the most obvious ones are:

  1. There was no adequate control of the presumably substantial placebo effects of wet cupping.
  2. The control group received a treatment that is known to be ineffective or even detrimental.

For people with acute low back pain, advice to rest in bed is less effective than advice to stay active. Thus comparing wet cupping to a control group treated with bed rest is bound to generate a false-positive outcome for wet cupping.

My final point is perhaps the most important: wet cupping can lead to serious complication, and I therefore do not recommend it to anyone – other than masochists, perhaps.

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

Treating children is an important income stream for chiropractors and osteopaths. There is plenty of evidence to suspect that their spinal manipulations generate more harm than good; on this blog, we have discussed this problem more often than I care to remember (see for instance here, here, here, here and here). Yet, osteopaths and chiropractors carry on misleading parents to abuse their children with ineffective and dangerous spinal manipulations. A new and thorough assessment of the evidence seems to confirm this suspicion.

This systematic review evaluated the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness.

Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. The results showed that:

  • Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis.
  • Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.

The authors concluded that due to very low quality of the evidence, the effectiveness of gentle, low-velocity mobilizations in infants and HVLA manipulations in children and/or adolescents is uncertain. Assessments of intermediate outcomes are lacking in current pediatric SMT research. Therefore, the relationship between specific treatment and its effect on the hypothesized spinal dysfunction remains unclear. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique. Although scarcely reported, HVLA manipulations in infants and young children could lead to severe harms. Severe harms were likely to be associated with unexamined or missed underlying medical pathology. Nevertheless, there is a need for high quality research to increase certainty about effectiveness and safety of specific SMT techniques in infants, children and adolescents. We encourage conduction of controlled studies that focus on the effectiveness of specific SMT techniques on spinal dysfunction, instead of concluding about SMT as a general treatment approach. Large observational studies could be conducted to monitor the course of complaints/symptoms in children and to gain a greater understanding of potential harms.

The situation regarding spinal manipulation for children might be summarised as follows:

  1. Spinal manipulations are not demonstrably effective for paediatric conditions.
  2. They can cause serious direct and indirect harm.
  3. Chiropractors and osteopaths are not usually competent to treat children.
  4. They nevertheless treat children regularly.

In my view, this is unethical and can amount to child abuse.

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