MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

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We all hope that serious complications after chiropractic care are rare. However, this does not mean they are unimportant. Multi-vessel cervical dissection with cortical sparing is an exceptional event in clinical practice. Such a case has just been described as a result of chiropractic upper spinal manipulation.

Neurologists from Qatar published a case report of a 55-year-old man who presented with acute-onset neck pain associated with sudden onset right-sided hemiparesis and dysphasia after chiropractic manipulation for chronic neck pain.

Magnetic resonance imaging revealed bilateral internal carotid artery dissection and left extracranial vertebral artery dissection with bilateral anterior cerebral artery territory infarctions and large cortical-sparing left middle cerebral artery infarction. This suggests the presence of functionally patent and interconnecting leptomeningeal anastomoses between cerebral arteries, which may provide sufficient blood flow to salvage penumbral regions when a supplying artery is occluded.

The authors concluded that chiropractic cervical manipulation can result in catastrophic vascular lesions preventable if these practices are limited to highly specialized personnel under very specific situations.

Chiropractors will claim that they are highly specialised and that such events must be true rarities. Others might even deny a causal relationship altogether. Others again would claim that, relative to conventional treatments, chiropractic manipulations are extremely safe. You only need to search my blog using the search-term ‘chiropractic’ to find that there are considerable doubts about these assumptions:

  • Many chiropractors are not well trained and seem mostly in the business of making a tidy profit.
  • Some seem to have forgotten most of the factual knowledge they may have learnt at chiro-college.
  • There is no effective monitoring scheme to adequately record serious side-effects of chiropractic care.
  • Therefore the incidence figures of such catastrophic events are currently still anyone’s guess.
  • Publications by chiropractic interest groups seemingly denying this point are all fatally flawed.
  • It is not far-fetched to fear that under-reporting of serious complications is huge.
  • The reliable evidence fails to demonstrate that neck manipulations generate more good than harm.
  • Until sound evidence is available, the precautionary principle leads most critical thinkers to conclude that neck manipulations have no place in routine health care.

A 2016 article set out to define the minimum core competencies expected from a certified paediatric doctor of chiropractic using a Delphi consensus process. The initial set of seed statements and sub-statements was modelled on competency documents used by organizations that oversee chiropractic and medical education. The statements were then distributed to the Delphi panel, reaching consensus when 80% of the panelists approved each segment. The panel consisted of 23 specialists in chiropractic paediatrics from across the spectrum of the chiropractic profession. Sixty-one percent of panellists had postgraduate paediatric certifications or degrees, 39% had additional graduate degrees, and 74% were faculty at a chiropractic institution and/or in a postgraduate paediatrics program. The panel was initially given 10 statements with related sub-statements formulated by the study’s steering committee. On all 3 rounds of the Delphi process the panelists reached consensus; however, multiple rounds occurred to incorporate the valuable qualitative feedback received.

The results of this process reveal that the Certified Paediatric Doctor of Chiropractic requires 8 sets of skills. (S)he will …

1) Possess a working knowledge and understanding of the anatomy, physiology, neurology, psychology, and developmental stages of a child. a) Recognize known effects of the prenatal environment, length of the pregnancy, and birth process on the child’s health. b) Identify and evaluate the stages of growth and evolution of systems from birth to adulthood. c) Appraise the clinical implications of developmental stages in health and disease, including gross and fine motor, language/communication, and cognitive, social, and emotional skills. d) Recognize normal from abnormal in these areas. e) Possess an understanding of the nutritional needs of various stages of childhood.

2) Recognize common and unusual health conditions of childhood. a) Identify and differentiate clinical features of common physical and mental paediatric conditions. b) Identify and differentiate evidence-based health care options for these conditions. c) Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population.

3) Be able to perform an age-appropriate evaluation of the paediatric patient. a) Take a comprehensive history, using appropriate communication skills to address both child and parent/ guardian. b) Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. c) When indicated, utilize age-appropriate laboratory, imaging, and other diagnostic studies and consultations, according to best practice guidelines. d) Appropriately apply and adapt these skills to the paediatric special needs population. e) Be able to obtain and comprehend all relevant external health records.

4) Formulate differential diagnoses based on the history, examination, and diagnostic studies.

5) Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. a) Use the scientific literature to inform the management plan. b) Adequately document the patient encounter and management plan. c) Communicate management plan clearly (written, oral, and nonverbal cues) with both the child and the child’s parent/guardian. d) Communicate appropriately and clearly with other professionals in the referral and co-management of patients.

6) Deliver skilful, competent, and safe chiropractic care, modified for the paediatric population, including but not limited to: a) Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. b) Physical therapy modalities. c) Postural and rehabilitative exercises. d) Nutrition advice and supplementation. e) Lifestyle and public health advice. f) Adapt the delivery of chiropractic care for the paediatric special needs population.

7) Integrate and collaborate with other health care providers in the care of the paediatric patient. a) Recognize the role of various health care providers in paediatric care. b) Utilize professional inter-referral protocols. c) Interact clearly and professionally as needed with health care professionals and others involved in the care of each patient. d) Clearly explain the role of chiropractic care to professionals, parents, and children.

8) Function as a primary contact, portal of entry practitioner who will. a) Be proficient in paediatric first aid and basic emergency procedures. b) Identify and report suspected child abuse.

9) Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients and professional practice. a) Monitor and properly reports of effects/adverse events. b) Recognize cultural individuality and respect the child’s and family’s wishes regarding health care decisions. c) Engage in lifelong learning to maintain and improve professional knowledge and skills. d) Contribute when possible to the knowledge base of the profession by participating in research. e) Represent and support the specialty of paediatrics within the profession and to the broader healthcare and lay communities.

I find this remarkable in many ways. Let us just consider a few items from the above list of competencies:

Identify and differentiate evidence-based health care options… such options would clearly not include chiropractic manipulations.

Identify and differentiate clinical features and evidence-based health care options for the paediatric special needs population… as above. Why is there no mention of immunisations anywhere?

Perform age-appropriate and case-specific physical, orthopaedic, neurological, and developmental examination protocols. If that is a competency requirement, patients should really see the appropriate medical specialists rather than a chiropractor.

Establish a plan of management for each child, including treatment, referral to, and/or co-management with other health care professionals. The treatment plan is either evidence-based or it includes chiropractic manipulations.

Deliver skilful, competent, and safe chiropractic care… Aren’t there contradictions in terms here?

Manual therapy and instrument-assisted techniques including manipulation/adjustment, mobilization, and soft tissue therapies to address articulations and/or soft tissues. Where is the evidence that these treatments are effective for paediatric conditions, and which conditions would these be?

Clearly explain the role of chiropractic care to professionals, parents, and children. As chiropractic is not evidence-based in paediatrics, the role is extremely limited or nil.

Function as a primary contact, portal of entry practitioner… This seems to me as a recipe for disaster.

Demonstrate and utilize high professional and ethical standards in all aspects of the care of paediatric patients… This would include obtaining informed consent which, in turn, needs to include telling the parents that chiropractic is neither safe nor effective and that better therapeutic options are available. Moreover, would it not be ethical to make clear that a paediatric ‘doctor’ of chiropractic is a very far cry from a real paediatrician?

So, what should the competencies of a chiropractor really be when it comes to treating paediatric conditions? In my view, they are much simpler than outlined by the authors of this new article: I SEE NO REASON WHATSOEVER WHY CHIROPRACTORS SHOULD TREAT CHILDREN!

The following short passage originates from the abstract of an article that I published in 1998; it is entitled TOWARDS A RISK BENEFIT EVALUATION OF PLACEBOS: the benefits of placebos are often not clearly defined. Generally speaking, the potential for benefit is considerable. The risks are similarly ill defined. Both direct and indirect risks are conceivable. On balance, the risk-benefit relation for placebo could be favourable. Under certain conditions, the clinical use of placebos might therefore be a realistic option. In the final analysis, however, our knowledge for a conclusive risk-benefit evaluation of placebo is incomplete.

Today, I would phrase my conclusion differently: the benefits of placebo therapy are uncertain, while its risks can be considerable. Therefore the use of placebos in clinical routine is rarely justified.

What brought about this change in my attitude?

Lots of things, is the answer; 18 years are a long time in research, and today we know much more about placebo. In my field of inquiry, alternative medicine, we know for instance that, because the mechanisms by which placebos operate are now better understood, some alt med enthusiasts are claiming that placebo effects are real and therefore justify the use of all sorts of placebo treatments, from homeopathy to faith healing. They say that these ineffective (i.e. no better than placebo) therapies are not really ineffective because they help many patients via the well-documented placebo response.

If you are of this opinion, please read the excellent article David Gorski recently published on this issue. Here I want to re-visit my question from above: WHAT DO WE KNOW ABOUT THE RISKS BENEFIT BALANCE OF PLACEBO?

The benefits of placebo can seem impressive on first glance: after receiving placebos, patients can feel better, have less symptoms, need less medication and improve their quality of life. Who would be against any of these outcomes, particularly considering that placebos are usually inexpensive and readily available everywhere?

However, before we get too enthusiastic about the benefits of placebos, we need to consider that they are unreliable. Nobody can predict who will respond to placebo and who won’t. Despite intensive research, it has not been possible to identify placebo-responders as a distinct group of individuals from non-responders. The usefulness of placebos in clinical routine is therefore quite limited. Furthermore, placebo effects are normally only of short duration. Therefore they are not suited for any long-term therapy.

Crucially, placebos almost never effect a cure. They may improve subjective symptoms, but they do not normally cure the disease or remove its causes. A placebo therapy will reduce pain, for instance, and thus it can ease the suffering. If a back pain is caused by a tumour, however, a placebo will not diminish its size or improve the prognosis.

The notion that placebos might cause harm seems paradoxical at first glance. A placebo pill contains no active ingredient – how can it then be harmful? As I have stressed so often before, ANY INEFFECTIVE TREATMENT BECOMES LIFE-THREATENING, IF IT IS USED AS A REPLACEMENT FOR AN EFFECTIVE THERAPY OF A SERIOUS DISEASE. And this warning also applies to placebos, of course.

Seen from this perspective, the much-praised symptomatic relief brought about by a placebo therapy can become a very mixed blessing indeed.

Let’s take the above example of the patient who has back pain. He receives a placebo and subsequently his agony becomes more bearable. Because this approach seems to work, he sticks with it for several month. Eventually the analgesic effect of the placebo wears off and the pain gets too strong to bear. Our patient finally consults a responsible doctor who diagnoses a bone cancer as the cause of his pain. The oncologist who is subsequently consulted regrets that the patient’s prolonged placebo therapy has seriously diminished his chances to cure the cancer.

This may look like an extreme example, but I don’t think it is. Exchange the term ‘placebo’ with almost any alternative treatment, or replace ‘back pain’ and ‘cancer’ with virtually any other conditions, and you will see that such events cannot be rare.

In most instances, placebos may seem helpful but, in fact, they offer little more than the illusion of a cure. They very rarely alter the natural history of a disease and usually achieve little more than a slight, short-term improvement of symptoms. In any case, they are an almost inevitable companion to any well-administered effective treatment. Prescribing pure placebos in clinical routine is therefore not responsible; in most instances, it amounts to fraud.

While some chiropractors now do admit that upper neck manipulations can cause severe problems, many of them simply continue to ignore this fact. It is therefore important, I think, to keep alerting both consumers and chiropractors to the risks of spinal manipulations. In this context, a new article seems relevant.

Danish doctors reported a critical case of bilateral vertebral artery dissection (VAD) causing embolic occlusion of the basilar artery (BA) in a patient whose symptoms started after chiropractic Spinal manipulative therapy (cSMT). The patient, a 37-year-old woman, presented with acute onset of neurological symptoms immediately following cSMT in a chiropractic facility. Acute magnetic resonance imaging (MRI) showed ischemic lesions in the right cerebellar hemisphere and occlusion of the cranial part of the BA. Angiography demonstrated bilateral VADs. Symptoms remitted after endovascular therapy, which included dilatation of the left vertebral artery (VA) and extraction of thrombus from the BA. After 6 months, the patient still had minor sensory and cognitive deficits.

The authors concluded that, in severe cases, VAD may be complicated by BA thrombosis, and this case highlights the importance of a fast diagnostic approach and advanced intravascular procedure to obtain good long-term neurological outcome. Furthermore, this case underlines the need to suspect VAD in patients presenting with neurological symptoms following cSMT.

I can already hear the excuses of the chiropractic fraternity:

  • this is just a case report,
  • the risk is very rare,
  • some investigations even deny any risk at all,
  • the risk of many conventional treatments is far greater.
However, these excuses are lame for a number of reasons:
  • as there are no functioning monitoring systems, nobody can tell with certainty how big the risk truly is,
  • the precautionary principle in health care compels us to take even the slightest of suspicions of harm seriously,
  • the risk/benefit principle compels us to ask whether the demonstrable benefits of neck manipulations outweigh its suspected risks.

The last point is perhaps the most important: AS FAR AS I CAN SEE, THERE IS NO INDICATION FOR NECK MANIPULATIONS FOR WHICH THE BENEFIT IS SUFFICIENTLY CERTAIN TO JUSTIFY ANY SUCH RISKS.

Chiropractors and osteopaths have long tried to convince us that spinal manipulation and mobilisation are the best we can do when suffering from neck pain. But is this claim based on good evidence?

This recent update of a Cochrane review was aimed at assessing the effects of manipulation or mobilisation alone compared with those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up, and when appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes.

Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). They also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies.

Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain were included in this assessment.

Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). The authors calculated pooled risk ratios (RRs) and standardised mean differences (SMDs).

Fifty-one trials with a total of 2920 participants could be included. The findings are diverse. Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up. Cervical manipulation versus another active treatment: For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up. Thoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality). Thoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain. Mobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control. Mobilisation versus another active treatment: For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality).

Confused? So am I!

In my view, these analyses show that the quality of most studies is wanting and the evidence is weak – much weaker than chiropractors and osteopaths try to make us believe. It seems to me that no truly effective treatments for neck pain have been discovered and that therefore manipulation/mobilisation techniques are as good or as bad as most other options.

In such a situation, it might be prudent to first investigate the causes of neck pain in greater detail  and subsequently determine the optimal therapies for each of them. Neck pain is a SYMPTOM, not a disease! And it is always best to treat the cause of a symptom rather than pretending we know the cause as chiropractors and osteopaths often do.

The authors of the Cochrane review seem to agree with this view at least to some extent. They conclude that although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.

The call for further research is, of course, of no help for patients who are suffering from neck pain today. What would I recommend to them?

My advice is to be cautious:

  • Consult your doctor and try to get a detailed diagnosis.
  • See a physiotherapist and ask to be shown exercises aimed at reducing the pain and preventing future episodes.
  • Do these exercises regularly, even when you have no pain.
  • Make sure you do whatever else might be needed in terms of life-style changes (ergonomic work place, correct sleeping arrangements, etc.).
  • If you are keen on seeing an alternative practitioner for manual therapy, consult a osteopath rather than a chiropractor; the former tend to employ techniques which are less risky than the latter.
  • Avoid both chiropractors and long-term medication for neck pain.

We could have expected it, couldn’t we? With so much homeopathy in the press lately, Dr Dixon (we have seen him on this blog before, for instance here, here and here) had to comment. His article in yesterday’s NURSING IN PRACTICE is far too perfect to abbreviate it; I just have to cite it in full (only the reference numbers are mine and refer to my comments below).

HERE WE GO

Should homeopathy be blacklisted in general practice?

I have not prescribed them myself but I know of many GPs and patients who find homeopathic preparations helpful, especially in clinical areas where there is no satisfactory conventional treatment [1]. They are cheap and entirely safe [2], which cannot always be said of conventional treatment [3]. Is the concern about cost? That is implausible as GP prescriptions cost a mere £100,000 per annum, approximately £10 per UK General Practice but effectively less as some patients will be paying for them and they may reduce other prescriptions or medical costs [4]. Is it about evidence? [5] Possibly, and that is because the necessary pragmatic trials on comparative cost effectiveness have never been done [6]. Homeopathy thus joins the frequently quoted 25% of general practice activity that has an insufficient evidence base… So, why not do the research rather than single out homeopathy for blacklisting [7]? Apparently, because it irritates a powerful fraternity of “scientists” [8] with a narrow biomedical perspective on health and healing, who feel the need to impose their atheism [9] on others. They seem opposed to “patient-centred medicine” which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them [10]. Led by the World Health Organization, many countries are examining the appropriate role of complementary and traditional medicine (CAM). Indian Prime Minister Modi has created the first minister for medicine in this area (called AYUSH with the “H” standing for homeopathy). Australia, whose government and medical deans (unlike the UK ) are not intimidated by this breed of scientific fundamentalism, has invested money in research, regulated its herbal [11] practitioners and created important trade links with China in this area [12]. Meanwhile the UK invests 0% of its research budget on CAM and appears to have a closed mind [13]. General practice is at its best a subtle and complex blend of science and art combined in a heady mixture, which recognises personal belief and perspective and respects differences [14]. Blacklisting homeopathy would be the thin edge of the wedge. It would be a mean-minded act of outside interference by many who do not treat patients themselves, denying patient choice and signifying a new age of intolerance and interference [15]. It is a threat to the autonomy of general practice that should concern every GP and patient whatever their views on homeopathy [16].

About the Author

Mike Dixon

Chairman of the NHS Alliance and a GP

Mike Dixon, chairman of the NHS Alliance and a GP at College Surgery in Cullompton, Devon and a Royal College of General Practitioners presidential candidate.

END OF QUOTE AND BEGINNING OF MY DELIBERATELY BRIEF COMMENTS

  1. Whenever this argument comes up, people fail to cite an example. Are they afraid that we would point out what can be done for such a patient other than prescribing placebos?
  2. Actually, they are extremely expensive considering that they are just lactose or water. And the claim that homeopathy is safe merely displays an embarrassing lack of knowledge; see the many posts on this blog that deal with this issue.
  3. Classical ‘tu quoque’ fallacy; display of the ignorance of the risk/benefit concept for judging the value of medical interventions.
  4. Display of ignorance regarding the actual evidence, see here, for instance.
  5. Yes, it’s the evidence but also it’s the biological implausibility and the fact that disregarding it undermines rationality in general.
  6. Pure ignorance again, see my point 4.
  7. Are ~ 300 clinical trials and about 100 systematic reviews not enough? How much more money needs to be wasted?
  8. It seems that Dixon has a problem with science and those who pursue it to improve future health care for the benefit of patients.
  9. Does Dixon admit that homeopathy is a religion?
  10. Patient-centred medicine which factors in the mindset, culture, history, wishes and hopes of each patient, and a wider concept of science that might take account of them – does Dixon not know that all good medicine fits this description, but homeopathy certainly does not?
  11. Every one with an IQ above 50 knows by now that herbal is not homeopathic; is Dixon the exception?
  12. What about the Australian report which concluded that “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.”
  13. This is simply not true, and Dixon should know it.
  14. No reason to include disproven nonsense like homeopathy.
  15. Intolerance is on Dixon’s side, I think. Improving health care by abandoning disproven therapies in favour of evidence-based treatments is no interference, it’s progress.
  16. This can only be true, if we misunderstand autonomy as arbitrariness without rules, checks, ethics and controls. Good general practice has, like all medicine, be in the best interest of patients. An obsolete, expensive, unsafe, ineffective and implausible treatment is clearly not.

Hurray, I can hear the Champagne corks popping: this month is ‘National Chiropractic Months’ in the USA – a whole month! This has depleted my stock of the delicious fizz already in the first three days.

Now that my bottles are empty (is there a chiropractic cure for a hang-over?), I must find other ways to celebrate. How about a more sober look at what has been published in the medical literature on chiropractic during the last few days?

A quick look into Medline identifies several articles of interest. The very first one is a case-report:

Spinal epidural hematoma (SEH) occurring after chiropractic spinal manipulation therapy (CSMT) is a rare clinical phenomenon. Our case is unique because the patient had an undiagnosed cervical spinal arteriovenous malformation (AVM) discovered on pathological analysis of the evacuated hematoma. Although the spinal manipulation likely contributed to the rupture of the AVM, there was no radiographic evidence of the use of excessive force, which was seen in another reported case. As such, patients with a known AVM who have not undergone surgical intervention should be cautioned against symptomatic treatment with CSMT, even if performed properly. Regardless of etiology, SEH is a surgical emergency and its favorable neurological recovery correlates inversely with time to surgical evacuation.

This is important, I think, in more than one way. Many chiropractors simply deny that their manipulations cause serious complications of this nature. Yet such cases are being reported with depressing regularity. Other chiropractors claim that excessive force is necessary to cause the damage. This paper seems to refute this notion quite well, I think.

But let’s not be inelegant and dwell on this unpleasant subject; it might upset chiros during their month of celebration.

The next article fresh from the press is a survey – chiropractors are very fond of this research tool, it seems. It produced a lot of intensely boring data – except for one item that caught my eye: the authors found that ‘virtually all Danish chiropractors working in the primary sector made use of manipulation as one of their treatment modalities.’

Why is that interesting? Whenever I point out that there is no good evidence that chiropractic manipulations generate more good than harm, chiropractors tend to point out that they do so much more than that. Manipulations are not administered to all their patients, they say. This survey is a reminder (there is plenty more evidence on this issue) of the fact that the argument is not very convincing.

Another survey which has just been published in time for the ‘celebratory month’ is worth mentioning. It reports the responses of patients to questions about chiropractic by providing the ‘positive angle’, e.g.: ‘Most (61.4%) respondents believed that chiropractic care was effective at treating neck and back pain…’ Just for the fun of it, I thought it might be worth doing the opposite: 39% did not believe that chiropractic care was effective at treating neck and back pain… If we use this approach, the new survey also indicates that about half of the respondents did not think chiropractors were trustworthy, and 86% have not consulted a chiropractor within the last year.

Oh, so sorry – I did not mean to spoil the celebrations! Better move on then!

A third survey assessed the attitudes of Canadian obstetricians towards chiropractic. Overall, 70% of respondents did not hold a positive views toward chiropractic, 74% did not agree that chiropractic had a role in treatment of non-musculoskeletal conditions, 60% did not refer at least some patients for chiropractic care each year, and comments of the obstetricians revealed concerns regarding safety of spinal manipulation and variability among chiropractors.

And now I better let you get on with your well-deserved celebrations and look for another bottle!

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Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.

The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.

Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.

Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.

Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.

The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.

The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.

These are odd conclusions, in my view, and I think I ought to add a few points:

  • As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
  • Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
  • The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
  • As the authors mention, it is  hardly ever the chiropractor who reports a serious complication when it occurs.
  • In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
  • Therefore their true rate is anyone’s guess.
  • As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
  • Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
  • Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.

And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.

Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:

  • Respect for autonomy – patients must have the right to refuse or choose their treatments.
  • Beneficence – researchers and clinicians must act in the best interest of the patient.
  • Non-maleficence – the expected benefits of interventions must outweigh their risks.
  • Justice – the distribution of health resources must be fair.
  • Respect for persons – patients must be treated with dignity.
  • Truthfulness and honesty – informed consent is an essential element in research and clinical practice.

While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?

After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.

  1. Nonsensical research projects
  2. Lack of informed consent

NONSENSICAL RESEARCH PROJECTS

At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.

But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.

I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.

INFORMED CONSENT

Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.

In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.

But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:

  • you will receive either a homeopathic remedy or a placebo,
  • the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
  • this means that you will receive either a homeopathic or a conventional placebo,
  • neither of these can possibly help your condition,
  • the study can therefore not advance our knowledge in any way,
  • during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.

If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.

I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.

CONCLUSION

There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.

Discussions about the dietary supplements are often far too general to be truly useful, in my view. For a meaningful debate, we need to define what supplement we are talking about and make clear what condition it is used for. A recent paper meets these criteria well and is therefore worth a mention.

The review was aimed at addressing the controversy regarding the optimal intake, and the role of calcium supplements in the treatment and prevention of osteoporosis. The authors demonstrate that most studies on the subject show little evidence of a relationship between calcium intake and bone density, or the rate of bone loss. Re-analysis of data from the placebo group from the Auckland Calcium Study demonstrates no relationship between dietary calcium intake and rate of bone loss over 5 years in healthy older women with intakes varying from <400 to >1500 mg per day .

The authors argue that supplements are therefore not needed within this range of intakes to compensate for a demonstrable dietary deficiency, but might be acting as weak anti-resorptive agents via effects on parathyroid hormone and calcitonin. Consistent with this, supplements do acutely reduce bone resorption and produce small short-term effects on bone density, without evidence of a cumulative density benefit. As a result, anti-fracture efficacy remains unproven, with no evidence to support hip fracture prevention (other than in a cohort with severe vitamin D deficiency) and total fracture numbers are reduced by 0-10%, depending on which meta-analysis is considered. Five recent large studies have failed to demonstrate fracture prevention in their primary analyses.

These facts, the authors argue, must be balanced against the possible harm. The risks of regularly taking calcium supplements include an increase in gastrointestinal side effects (including a doubling of hospital admissions for these problems), a 17% increase in renal calculi and a 20-40% increase in risk of myocardial infarction. Each of these adverse events alone neutralizes any possible benefit in fracture prevention.

The authors draw the following detailed conclusions: “Concern regarding the safety of calcium supplements has led to recommendations that dietary calcium should be the primary source, and supplements reserved only for those who are unable to achieve an adequate dietary intake. The current recommendations for intakes of 1000–1200 mg day−1 are not firmly based on evidence. The longitudinal bone densitometry studies reviewed here, together with the new data included in this review relating to total body calcium, suggest that intakes in women consuming only half these quantities are satisfactory and thus, they do not require additional supplementation. The continuing preoccupation with calcium nutrition has its origin in a period when calcium balance was the only technique available to assess dietary or other therapeutic effects on bone health. We now have persuasive evidence from direct measurements of changes in bone density that calcium balance does not reflect bone balance. Bone balance is determined by the relative activities of bone formation and bone resorption, both of which are cellular processes. The mineralization of newly formed bone utilizes calcium as a substrate, but there is no suggestion that provision of excess substrate has any positive effect on either bone formation or subsequent mineralization.

Based on the evidence reviewed here, it seems sensible to maintain calcium intakes in the region of 500–1000 mg day−1 in older individuals at risk of osteoporosis, but there seems to be little need for calcium supplements except in individuals with major malabsorption problems or substantial abnormalities of calcium metabolism. Because of their formulation, costs and probable safety issues, calcium supplements should be regarded as pharmaceutical agents rather than as part of a standard diet. As such, they do not meet the standard cost–benefit criteria for pharmaceutical use and are not cost-effective. If an individual’s fracture risk is sufficient to require pharmaceutical intervention, then safer and more effective measures are available which have been subjected to rigorous clinical trials and careful cost–benefit analyses. Calcium supplements have very little role to play in the prevention or treatment of osteoporosis.”

Clear and useful words indeed! I wish there were more articles like this in the never-ending discussion about the complex subject of dietary supplements.

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