MD, PhD, FMedSci, FSB, FRCP, FRCPEd

risk/benefit

The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.

The  aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?

A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.

It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.

Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.

In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”

END OF QUOTE

As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:

  1. We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
  2. None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
  3. It seems more than questionable whether the benefits of SMT outweigh its risks.

CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:

  • Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
  • Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
  • Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.

A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”

The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.

The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.

A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.

The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.”  Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.

All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.

MY COMMENT:

This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.

Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.

Charlotte Leboeuf-Yde, DC,MPH,PhD, is professor in Clinical Biomechanics at the University of Southern Denmark and works at the French-European Institute of Chiropractic in Paris. She is a chiropractor with extensive research experience, for example, she was one of the first chiropractors to have studied adverse reactions of spinal manipulation.

Charlotte certainly knows a thing or two about adverse effects of spinal manipulation, and I have always found her work interesting. Therefore, I was delighted to find a recent blog post where she discussed the Cassidy study of 2008 and two opposed views on the validity of this much-discussed paper.

One team (Paulus &Thaler) argued, Charlotte explained, that the Cassidy case-control study is faulty, because vertebro-basilar stroke in general was not separated from stroke specifically caused by vertebral artery dissections, the presumed culprit in cervical spinal manipulation. According to Paulus & Thaler, this would potentially result in a dilution of ‘real’ manipulative-related strokes among all other causes of stroke that are much more common. They argue that the Cassidy-analyses therefore were polluted by this misclassification, whereas the other team (Murphy et al) vehemently disagrees.

The final word is clearly not yet pronounced on this issue, Charlotte concluded, and both teams agree that research has to address various methodological challenges to obtain a trustable answer. Nevertheless, without an international collaboration involving prospective cases this seems an almost impossible task, particularly in view of the rarity of the condition; problems in capturing all cases (going from the reversible to the permanent injuries); the likely large anatomical and physiological variations between individuals; and the daunting task of obtaining relevant and precise descriptions of treatments from a multitude of practitioners.

In the meantime, Charlotte concluded, “practitioners and patients have to make a decision, similarly to judging risk in other walks of life, such as, should I take the plane or stay at home?”

I have always thought highly of Charlotte’s work, however, her conclusion made me doubt whether my high opinion of her reasoning was justified.

Should I take the plane or stay at home?

This question is not remotely similar to the question “should I have chiropractic upper neck manipulation or not?”

Here are a the two main reasons why:

  • Taking the plane of demonstrably effective in transporting you from A to B, while neck manipulation is not demonstrably effective for anything.
  • If you want to go from A to B [assuming B is far way], you need to fly. If you have neck pain or other symptoms, you can employ plenty of therapies other than neck manipulations.

Charlotte Leboeuf-Yde, DC,MPH,PhD, may be a professor in Clinical Biomechanics etc., etc., however, logical and critical thinking do not seem to be her forte.

So, how should we deal with the risks of chiropractic neck manipulations? I think, we should deal with them as responsible healthcare professionals deal with any other suspected therapeutic risks: we must ask whether the known risks of the treatment outweigh the known benefits (as they do with spinal manipulation). If that is so, we have an ethical, legal and moral duty not to employ the therapy in question in routine care. At the same time, we must focus or research efforts on producing full clarity about the open questions. It’s called the precautionary principle!

The world of homeopathy is getting very excited: HOMEOPATHY AWARENESS WEEK is approaching (it’s starting 10 April). An ideal occasion, I think, for making a celebratory offer to all homeopaths:

I am suggesting to give a free lecture on any homeopathy-related subject of your choosing. This, I hope, might increase homeopaths’ awareness of the science, research and evidence for or against homeopathy.

Which professional organisation could possibly say no to such a generous offer?

None with an interest in evidence, surely!

Homeopathy has been the number one subject on this blog from its very beginnings. It regularly attracts lively discussions, and I am confident that I could generate an even better dialogue, if you let me present the evidence. I think I am almost uniquely qualified to give such a lecture, not least because I have the following types of expertise:

  • I have given about 800 lectures on alternative medicine and therefore know what to do,
  • I have a sound knowledge of evidence-based medicine,
  • I possess the ability to tell good from poor science,
  • I have experience as a patient treated by a homeopath,
  • I have research experience in homeopathy (clinical trials, systematic reviews, etc.),
  • I have published many scientific papers on the subject,
  • I possess many years of clinical experience,
  • I have been trained in homeopathy and used it as a clinician,
  • I can think critically,
  • I regularly review the emerging literature,
  • finally, I have recently published a book entitled HOMEOPATHY, THE UNDILUTED FACTS.

The specifics of my offer are as follows:

  • I will give a 45-min lecture to your organisation.
  • I will then answer questions for up to 30 min.
  • This can be scheduled at a location and a time of day that suits you.
  • I will not charge a lecture fee.
  • You will cover my travel cost from my home in Suffolk to your venue.
  • Depending on the location of the venue and timing of the lecture, I might need to stay overnight and would hope you can foot the bill for that.
  • There will be no other costs involved.
  • My offer is limited to a time-window during which I plan to be in the UK. The best time for me would be July and August.

 

I am convinced that we all might profit from such lectures:

  • You might learn about science, the evidence, the need for thinking critically, etc.
  • And I might learn a bit more about the views and concerns of homeopaths.

Therefore, I hope that my offer will find plenty of takers. If you are interested, please contact me via this blog.

Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.

The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.

A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.

The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!

The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”

To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:

  1. It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
  2. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
  3. These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.

I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”

In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.

So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”

Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!

Perhaps you can agree with this statement then:

As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).

The anti-vaccination attitudes of alternative practitioners such as chiropractors, homeopaths and naturopaths are well documented and have been commented upon repeatedly here. But most of these clinicians are non-doctors; they have not been anywhere near a medical school, and one might therefore almost excuse them for their ignorance and uneducated stance towards immunisations. As many real physicians have recently taken to practicing alternative therapies under the banner of ‘integrated medicine’, one may well ask: what do these doctors think about vaccinations?

This study tried to answer the question by evaluating the attitudes and practices regarding vaccination of members of the American Board of Integrative and Holistic Medicine (ABIHM). Prospective participants were 1419 diplomats of the ABIHM. The survey assessed members’ (1) use of and confidence in the vaccination recommendations of the Centers for Disease Control and Prevention (CDC) and of medical-specialty associations, (2) confidence in the manufacturing safety of vaccines and in manufacturer’s surveillance of adverse events, and (3) attitudes toward vaccination mandates. The questionnaire included 33 items, with 5 open-ended questions that provided a space for comments.

The survey was completed by 290 of 1419 diplomats (20%). Its findings showed a diversity of opinions in many vaccination issues. Integrative medicine physicians were less likely to administer vaccinations than physicians in traditional allopathic medicine. Among the 44% who provide vaccinations, 35% used alternative schedules regularly. Integrative medicine physicians showed a greater support of vaccination choice, were less concerned about maintaining herd immunity, and were less supportive of school, day care, and employment mandates. Toxic chemical and viral contaminants were of greater concern to a higher percentage of integrative medicine physicians. Integrative medicine physicians were also more likely to accept a connection between vaccinations and both autism and other chronic diseases. Overall, there was dissatisfaction with the Vaccine Adverse Event Reporting System as well as the vaccination recommendations of the CDC and their primary specialty.

The authors concluded that significant variations in the vaccination attitudes and practices of integrative medicine physicians. This survey provides benchmark data for future surveys of this growing specialty and other practitioners. It is important for public health leaders and the vaccination industry to be aware that integrative medicine physicians have vaccination attitudes and practices that differ from the guidelines of the CDC and the Advisory Council on Immunization Practices.

Now we know!

Physicians practicing integrative medicine (the 80% who did not respond to the survey were most likely even worse) not only use and promote much quackery, they also tend to endanger public health by their bizarre, irrational and irresponsible attitudes towards vaccination.

From bad to worse!

Yes, I am afraid it is Dana Ullman again!

On the last post, he commented: “If you actually think that homeopathic medicines will KILL people, then, we all must assume that you think that conventional medicines create MASS MURDERS.”

In my view, this is a sad comment indeed. It reveals that a homeopath who has, after all, been in the business for decades has really very little idea about what makes an intervention a potentially good or a bad treatment.

Is it its efficacy?

No!

Is it its safety?

No!

IT IS THE RATIO OF THE TWO!!!

For the Ullmans of this world, I provide two very simple examples:

  1. One could prevent a common cold effectively with interferon. Why don’t we do this routinely? Because the benefit would not out-weigh its harm.
  2. We all know that chemotherapy can have terrible adverse effects. Why do we nevertheless use it for cancer? Because the benefits of saving a life out-weigh all the significant harm chemotherapy might do.

The conclusion is simple: to be useful, a therapy must demonstrably generate more good than harm. If there is no effectiveness, the risk/benefit balance can never be positive, even if the risks are relatively small. But risk/benefit balance can still be favourable, even if the therapy causes considerable harm.

This hardly is rocket science, is it? But the Ullmans of this world do refuse to get it, and that is sad, in my view. This ignorance is the basis for the fundamentally misguided advice they issue to their patients day in, day out.

What is more, the Ullmans of this world stubbornly deny that anyone can do significant harm with homeopathic remedies; they evidently think that homeopathy cannot kill patients. Yet they are evidently wrong.

Whenever the simple rules of risk/benefit are ignored, even apparently harmless treatments, like highly diluted homeopathic remedies, can – and sadly will – kill patients.

I suspect that the Ullmans of this world are still in closed-minded denial about this point. Let me therefore quote a few of my own posts where cases of ‘death by homeopathy’ have been mentioned:

I fear that the Ullmans of this world will still not be convinced. Perhaps a look at this website might do the trick? No, probably not – changing one’s mind vis a vis facts requires intelligence. They will carry on claiming that, in comparison, “conventional medicines creates MASS MURDERS”.

And this is where we go full circle and I start again explaining about the balance of risk and benefit…

GIVE ME STRENGTH!!!

According to our friend Dana Ullman, “homeopathy has had a long tradition within Russia. Even though it was not officially recognized during the Communist regime, it was tolerated. And perhaps in part because it did not receive governmental sanction, the Russian people developed a trust in homeopathy. Due to the fact that homeopathic physicians worked outside of governmental medicine, homeopathy was a part of Russia’s “new economy”. People had to pay for homeopathic care, rather than receive it for free.

Homeopathy is still the minority practice. I was told that there are approximately one million medical doctors in Russia and its surrounding republics, with 15,000 medical doctors who use homeopathic medicines regularly, and about 3,000 medical doctors who specialize in classical homeopathy.”

But the ‘free ride’ of homeopathy seems to come to an end. We have seen this happening, for instance in the US, UK, Australia, and Germany. And now it is happening also in Russia:

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

The move forms part of a growing backlash against homeopathy in Russia. Last month, students at the First Moscow State Medical University filed a petition to ban homeopathic principles from being taught in medical schools. Russia’s Federal Customs Service also introduced new rules in November 2016, forcing manufacturers to prove the effectiveness of any homeopathic products that they wish to sell.

To this, I have little to add; perhaps just this: ABOUT TIME TOO!

We have repeatedly discussed the risks of chiropractic spinal manipulation (see, for instance here, here and here). Some chiropractors seem to believe that using a hand-held manipulator, called ‘activator’, better controls the forces used on the spine and therefore is safer. This recent paper raises doubts on this hypothesis.

A neurosurgeon from Florida published the case-report of a 75-year-old active woman who presented to a local hospital emergency room with a 3-day history of the acute onset of severe left temporal headache, initially self-treated with non-steroidals, to which they were resistant. Additional complaints included some vague right eye blurring of vision and a mild speech disturbance. Her primary-care physician had ordered an outpatient MRI, which was interpreted as showing a small sub-acute left posterior temporal lobe haemorrhage. He then referred her to the emergency room where she was categorized as a “stroke alert” and evaluated according to the hospital “stroke-alert” protocol.

There was no prior history of migraine, but some mild treated hypertension. The patient subsequently gave a history of chronic neck and back pain, but no headache, for which she had intermittently received chiropractic adjustments. Her current problem started after an activator treatment to the base of the left side at the junction of the skull with the upper cervical spine. She became concerned enough a few days later, because of the persistence of unremitting headache, to contact her primary-care physician. The patient was not taking any anticoagulants or antiplatelet agents and had a relatively unremarkable past medical and surgical history. Although she did not have a formal visual field examination or an ophthalmology consultation, she was found to have an incomplete right homonymous hemi-anopsia on clinical exam by the neurologist.

Based on MRI characteristics, the haemorrhage was determined to be primarily subarachnoid and displacing but not involving any brain parenchyma, and without any extra-axial component. After a 4-day hospitalization for evaluation and observation, the patient was discharged, neurologically improved in terms of visual and speech symptoms as well as headache complaints, to outpatient follow-up. She has remained well with resolution of imaging abnormalities and no reoccurrence of symptoms.

The authors explain how difficult it is to prove specific causation in such cases. It is frequently inferred by epidemiological reasoning or evidence. While there are other potential causes of the haemorrhage that occurred in this case, none is as or more likely than the activator stimulus. In support of the activator as the cause of the haemorrhage, the symptoms began almost immediately after the activator treatment (a temporal relationship), the area to which the activator was applied is almost directly superficial to the area of haemorrhage (a spatial relationship), the anatomic location of this haemorrhage is statistically unusual for any underlying and/or preexisting conditions, including stroke. The MRI confirmed that there was no infarction underlying the area of haemorrhage. The MRA disclosed no dissections or vascular lesions present. The only mechanisms left are trauma or cryptic vascular lesion that ruptured, obliterated itself, and occurred coincident to the activator stimulus. Although Activator stimulus is not high energy, it nonetheless was targeted to the cervico-occipital junction, an area where neural tissue is among the most vulnerable and least protected and closest to the skin (as opposed to the lower cervical or any of the thoracic or lumbar spine). There are many articles that make reference to minor or trivial head injury as a likely cause of intracranial haemorrhage.

The author concluded that he was unable to find a single documented case in which a brain hemorrhage in any location was reported from activator treatment. As such, this case appears to represent the first well-documented and reported brain hemorrhage plausibly a consequence of activator treatment. In the absence of any relevant information in the chiropractic or medical literature regarding cerebral hemorrhage as a consequence of activator treatment, this case should be instructive to the clinician who is faced with a diagnostic dilemma and should not forget to inquire about activator treatment as a potential cause of this complication. Our case had a benign course, but we do not rule out a more serious or potentially dangerous clinical course or adverse outcome. This is of heightened concern in the elderly and/or those with treatment-induced coagulopathy or platelet inhibition.

In light of all of the difficulties inherent in linking chiropractic treatments, including activator treatments, with serious neurological events, it is very possible that intracranial hemorrhage is far more frequent than reported. Several articles comment on the likelihood that complications of this type are almost certainly underreported. Most of the incidents mentioned in case series or surveys had never been previously reported. Neurologists, neurosurgeons, and chiropractors should be more vigilant both in the application and evaluation of these methods in all patients who report new neurologic-type symptoms following a manipulation (including an activator application) to the occiput or the cranio-cervical junction.

I think that case-report speaks for itself.

Chiropractors will, of course, argue (yet again) that:

  • conventional treatments cause much more harm,
  • spinal manipulation is highly effective,
  • such complications are extreme rarities,
  • the risk/benefit profile of spinal manipulation is positive,
  • some studies have failed to show a risk of spinal manipulation,
  • case-reports cannot establish causality.

We have rehearsed these arguments ad nauseam on this blog. The bottom line is well-expressed in the above conclusions: it is very possible that intracranial hemorrhage is far more frequent than reported. And that obviously applies to all other types of complications after chiropractic treatments.

At a recent conference in Montréal (October 2016), the WFC (World Federation of Chiropractic) and the ACC (Association of Chiropractic Colleges) reached a consensus on education. Consequently, recommendations were produced that offer 12 key ‘take away messages’. I take the liberty of reproducing these statements entitled ‘Training Tomorrow’s Spine Care Experts’ (the square brackets were inserted by me and refer to brief comments I made below).

START OF QUOTE

1. Chiropractic educational institutions have a  responsibility to equip students with the skills and  attributes necessary to become future spinal health care experts. This includes a commitment to astute diagnostic ability, a comprehensive knowledge of spine-related disorders [1], appreciation for the contributions of other health professionals and a commitment to collaborative, patient-centered and evidence-informed care [2].

2. Technological advances [3] provide an opportunity for the chiropractic profession to enhance, evolve and standardize core education and practice. This is relevant to the teaching of chiropractic skills, sharing of learning resources and assessment of performance. Emerging technologies that support the development of clinically-competent practitioners should be embedded within chiropractic programs.

3. The teaching and learning of specialized manual assessment and treatment skills should remain a key distinguishing element of chiropractic curricula.

4. Surveys of the public have a demonstrated a desire for consistency in the provision of chiropractic services. Such consistency need not compromise the identities of individual institutions but will cultivate public trust and cultural authority [4].

5. Globally consistent educational and practice standards will facilitate international portability [5] and promote greater health equity in the delivery of spine care.

6. Chiropractic programs should espouse innovation and leadership in the context of ethical [6], sustainable business [7] practices.

7. Chiropractic educational curricula should reflect current evidence [8] and high quality guidelines [9], and be subjected to regular review to ensure that students are prepared to work in collaborative health care environments.

8. The training of tomorrow’ s spine care experts should incorporate current best practices in education.

9. Interdisciplinary collaboration and strategic partnerships present opportunities to position chiropractors as leaders [10] and integral team players in global spine care.

10. Chiropractic educational institutions should champion the integration of evidence informed clinical practice [11], including clinical practice guidelines, in order to optimize patient outcomes. This will in turn foster principles of lifelong learning and willingness to adapt practice methods in the light of emerging evidence [12].

11. Students, faculty, staff and administrators must all contribute to a learning environment that fosters cultural diversity, critical thinking [13], academic responsibility and scholarly activity.

12. Resources should be dedicated to embed and promote educational research activity in all chiropractic institutions.

END OF QUOTE

And here are my brief comments:

[1] Some chiropractors believe that all or most human conditions are ‘spine-related disorders’. We would need a clear statement here whether the WFC/ACC do support or reject this notion and what conditions we are actually talking about.

[2] ‘Evidence-informed’??? I have come across this term before; it is used more and more by quacks of all types. It is clearly not synonymous with ‘evidence-based’, but aims at providing a veneer of respectability by creation an association with EBM. In concrete terms, asthma, for instance, might, in the eyes of some chiropractors, be an evidence-informed indication for chiropractic. In other words, ‘evidence-informed’ is merely a card blanch for promoting all sorts of nonsense.

[3] It would be good to know which technical advances they are thinking of.

[4] Public trust is best cultivated by demonstrating that chiropractic is doing more good than harm; by itself, this point sounds a bit like PR for maximising income. Sorry, I am not sure what they mean by ‘cultural authority’ – chiropractic as a cult?

[5] ‘International portability’ – nice term, but what does it mean?

[6] I get the impression that many chiropractors do not know what is meant by the term ‘ethics’.

[7] But they certainly know much about business!

[8] That is, I think, the most relevant statement in the entire text – see below.

[9] Like those by NICE which no longer recommend chiropractic for back pain? No? They are not ‘high quality’? I see, only those that recommend chiropractic fulfil this criterion!

[10] Chiropractors as leaders? Really? With their (largely ineffective) manipulations as the main contribution to the field? You have to be a chiropractor to find this realistic, I guess.

[11] Again ‘evidence-informed’ instead of ‘evidence-based’ – who are they trying to kid?

[12] The evidence that has been emerging since many years is that chiropractic manipulations fail to generate more good than harm.

[13] In the past, I got the impression that critical thinking and chiropractic are a bit like fire and water.

MY CONCLUSION FROM ALL THIS

What we have here is, in my view, little more than a mixture between politically correct drivel and wishful thinking. If chiropractors truly want chiropractic educational curricula to “reflect current evidence”, they need to teach the following main tenets:

  • Chiropractic manipulations have not been shown to be effective for any of the conditions they are currently used for.
  • Other forms of treatment are invariably preferable.
  • Subluxation, as defined by chiropractors, is a myth.
  • Spine-related disorders, as taught in many chiropractic colleges, are a myth.
  • ‘Evidence-informed’ is a term that has no meaning; the proper word is ‘evidence-based’ – and evidence-based chiropractic is a contradiction in terms.

Finally, chiropractors need to be aware of the fact that any curriculum for future clinicians must include the core elements of critical assessment and medical ethics. The two combined would automatically discontinue the worst excesses of chiropractic abuse, such as the promotion of bogus claims or the financial exploitation of the public.

But, of course, none of this is ever going to happen! Why? Because it would mean teaching students that they need to find a different profession. And this is why I feel that statements like the above are politically correct drivel which can serve only one purpose: to distract everyone from the fundamental problems in that profession.

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