MD, PhD, FMedSci, FSB, FRCP, FRCPEd

chiropractic

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Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.

But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the

  • Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
  • Department of Planning, Policy and Design, University of California, Irvine,
  • VA Puget Sound Health Care System, Tacoma,
  • New York Chiropractic College, Seneca Falls,
  • Logan University College of Chiropractic, Chesterfield,
  • University of Western States, Portland.

Its purpose was to evaluate the effectiveness of conservative non-drug, non-surgical interventions, either alone or in combination, for conditions of the shoulder. The review was conducted from March 2016 to November 2016 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and was registered with PROSPERO. Eligibility criteria included randomized controlled trials (RCTs), systematic reviews, or meta-analyses studying adult patients with a shoulder diagnosis. Interventions qualified if they did not involve prescription medication or surgical procedures, although these could be used in the comparison group or groups. At least 2 independent reviewers assessed the quality of each study using the Scottish Intercollegiate Guidelines Network checklists. Shoulder conditions addressed were

  • shoulder impingement syndrome (SIS),
  • rotator cuff-associated disorders (RCs),
  • adhesive capsulitis (AC),
  • nonspecific shoulder pain.

Twenty-five systematic reviews and 44 RCTs met inclusion criteria. Low- to moderate-quality evidence supported the use of manual therapies for all 4 shoulder conditions. Exercise, particularly combined with physical therapy protocols, was beneficial for SIS and AC. For SIS, moderate evidence supported several passive modalities. For RC, physical therapy protocols were found beneficial but not superior to surgery in the long term. Moderate evidence supported extracorporeal shockwave therapy for calcific tendinitis RC. Low-level laser was the only modality for which there was moderate evidence supporting its use for all 4 conditions.

The authors concluded that the findings of this literature review may help inform practitioners who use conservative methods (eg, doctors of chiropractic, physical therapists, and other manual therapists) regarding the levels of evidence for modalities used for common shoulder conditions.

This review has so many defects that it would be boring to list them here.

The PRISMA guidelines  – I happen to be a co-author – state, for instance, that the abstract (the above text is from the abstract) should provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. It is obvious that the review authors have omitted several of these items.

And that is just the abstract!  There is much, much more to criticise in this paper.

The most striking deficit, in my view, is the useless conclusion: the one from the abstract (the part of the paper that will be read most widely) could have been written before the review had even been started. It is therefore not based on the data presented. Crucially it does not match the stated aim of this review (“to evaluate the effectiveness of conservative…interventions”).

But why? Why did the authors bother to follow PRISMA? Why did they formulate this bizarre conclusion in their abstract? Why did they do a review in the first place?

I fear, the answers might be embarrassingly simple:

  • They only pretended to follow PRISMA guidelines because that gives their review a veneer of respectability.
  • They formulated the conclusions because otherwise they would have needed to state that the evidence for manual therapy is less than convincing.
  • They conducted the review to promote chiropractic, and when the data were not as they had hoped for, they just back-paddled in an attempt to hide the truth as much as possible.

If this were an isolated case, I would not have bothered to mention it. But sadly, in the realm of chiropractic (and alternative medicine in general) we currently witness a plethora of rubbish reviews (published by rubbish journals). To the naïve observer, they might look rigorous and therefore they will be taken seriously. The end-effect of this pollution of the literature with rubbish is that we get a false-positive impression about the validity of the treatments in question. Consequently, we will see a host of wrong decisions on all levels of healthcare.

The big question is: HOW DO WE PROTECT OURSELVES FROM THIS DANGEROUS TREND?

I only see one solution: completely disregard certain journals that have been identified to regularly publish nonsense. Sadly, the wider medical community is far from having arrived at this point. As far as I can see, the problem has not even been identified yet as a serious issue that needs addressing. For the foreseeable future, we will probably have to live with this type of pollution of our medical literature.

Since more than 20 years, I have been writing about the risks of alternative therapies. One of my first papers on this issue was published in 1995 and focussed on acupuncture. Here is its abstract:

The use of acupuncture is widespread. The procedure is often claimed to be totally, or at least reasonably, safe. The published evidence regarding its potential risks is reviewed. The repeated and/or inappropriate use of an acupuncture needle carries the risk of infections. Amongst others, AIDS and hepatitis have been transmitted. Acupuncture needles may also traumatise tissues and organs. Pneumothorax is the most frequent complication caused in this way. Finally, needles may break and fragments can be dislodged into distant organs. A serious and more general concern related to the safety of acupuncture is the competence of the therapist, whether or not medically qualified. The “philosophy” of acupuncture is not in line with orthodox diagnostic skills; therefore acupuncturists can be dangerously unconcerned with diagnostic categories. Thus indirect risks might add significantly to the direct risks of acupuncture. It is concluded that the true risk of acupuncture cannot be estimated. Whatever its extent, it could and probably should be lowered by enforcing educational and clinical standards.

My reason for banging on about the potential harms (direct and indirect risks) of alternative medicine is fairly obvious: I want to alert healthcare professionals and consumers to the fact that these treatments may not be as harmless as they are usually advertised to be. Yet, I have often be called an alarmist fear-monger. In my view, nothing could be further from the truth.

Thinking about fear-mongering, I began to ask myself whether those who regularly accuse me are the ones guilty of the deed. Are alternative practitioners fear-mongers? Surely not all of them, but some clearly are. Here are a few of the strategies they use for their fear-mongering.

NON-EXISTING DIAGNOSES

Perhaps the most obvious way to instil fear into people is to tell them that they are affected by a disease or condition they do not have. Many alternative practitioners do exactly that!

  • A chiropractor might tell you that you have a subluxation in your spine.
  • A naturopath would inform you that your body is full of toxins.
  • An acupuncturist will tell you that your life energy is blocked.
  • A homeopath might warn you that your vital force is too low.

These diagnoses have one thing in common: they do not exist. They are figments of the therapist’s imagination. And they have another thing in common: the abnormalities need to be corrected, and – surprise, surprise – the very therapy that the practitioner specialises in happens to be just the ticket for that purpose.

  • The chiropractor will tell you that a simple spinal adjustment will solve the problem.
  • The naturopath will inform you that a bit of detox will eliminate the toxins.
  • The acupuncturist will tell you that his needles will de-block your chi.
  • The homeopath will persuade you that he can find the exact remedy to revive your vital force.

And there we have the third thing these diagnoses have in common: they are all treatable, will all result in a nice bill, and will all improve the cash-flow of the therapist.

MEDICALIZING TRIVIALITIES

But often, it is not even necessary for an alternative therapist to completely invent a diagnosis. Patients usually consult an alternative practitioner with some sort of symptom – frequently with what one might call a medical triviality that does not need any treatment at all but can be dealt with differently, for instance, by issuing some life-style advice or just simple re-assurance that nothing major is amiss. But for the fear-monger, this is not enough. He feels the need to administer his therapy, and for that purpose he needs to medicalize trivialities :

  • A low mood thus becomes a clinical depression.
  • A sore back is turned into a nasty lumbago.
  • A tummy upset morphs into a dangerous gastritis.
  • Abdominal unrest is diagnosed to be a leaky gut syndrome.
  • A food aversion turns into a food intolerance, etc., etc.

The common denominator is again the fact that fear is instilled into the patient. And again, a useless therapy is administered, if at all possible in the form of a lengthy series of treatments. This, of course, generates significant benefit – not therapeutic, but financial!

DEMONIZING CONVENTIONAL MEDICINE

But there is always the risk that the patient is wiser than expected. She might be so scared learning of her condition that she decides to see her doctor. That would mean a loss of income which has to be avoided! The trick to achieve this is usually not difficult: conventional healthcare professionals must be demonized.

  • They are not treating the root cause of the problem.
  • They are in the pocket of BIG PHARMA.
  • They prescribe medicines with terrible side-effects.
  • They have no idea about holism.
  • They never have enough time to listen, etc., etc.

I know, some of these criticisms are not entirely incorrect (for instance, many conventional medicines do have serious side-effects but, as I try to point out ad nauseam, we need to consider their risk/benefit balance). But that is hardly the point here; the point is to scare the patient off conventional medicine. Only a person who is convinced that the ‘medical mafia’ is out to get her, will prove to be a loyal customer of all things alternative.

DISEASE PREVENTION

And a loyal customer is someone who comes not just once or twice but regularly, ideally from cradle to grave. The way to achieve this ultimate stimulus of the practitioners cash flow is to convince the patient that she needs regular treatments, even when she feels perfectly alright. The magic word here is PREVENTION! The masters here are the chiropractors, I guess; they promote what they call ‘maintenance care’, i.e. the regular treatment of healthy individuals to keep their spines subluxation-free. It goes without saying that maintenance care is a money-making scam.

The strategy requires two little lies, but that’s forgivable considering the good cause, boosting the income of the practitioner:

  1. Conventional doctors don’t do prevention.
  2. The alternative treatment is an effective preventative.

The first statement can be shown to be an obvious lie. All we know about effective disease prevention today comes from conventional medicine and science; nothing originates from the realm of alternative medicine. Remarkably, the most efficacious preventative measure of all times, immunisation, is frequently defamed and neglected by alternative practitioners.

The second statement is a necessary lie; how else would a patient agree to pay regularly for the practitioner’s services? I am not aware of any alternative therapy that can effectively prevent any disease.

CONCLUSIONS

  • Some alternative practitioners regularly instil fear into consumers.
  • Several strategies are being used for this purpose.
  • They have the aim of maximising the therapists’ income.
  • Fear-mongering is unethical and despicable.
  • Pointing out that a certain therapy might fail to generate more good than harm is not fear-mongering.

Today is ‘World Bedwetting Day’!

No, don’t laugh; the event is initiated and supported by the World Bedwetting Day Steering Committee, which consists of the International Children’s Continence Society (ICCS) and the European Society for Paediatric Urology (ESPU) along with professional groups across the globe (see website for details).

A good day to remember that the British Chiropractic Association once sued my friend Simon Singh because he had disclosed that they were happily claiming that chiropractic was an effective therapy for bedwetting (and a few other childhood problems). An equally good day to remind ourselves that most alternative therapies are highly effective for this condition. At least this is what practitioners will tell you. For instance:

“Stop, stop! This blog is about evidence!!!” I hear you shout impatiently.

Alright, here is a full and unabbreviated list of all alternative therapies that have been scientifically proven to work for bedwetting:

 

HAPPY BEDWETTING DAY EVERYBODY!

The Rubicon Group (TRG) is a collaboration of chiropractic educational institutions, emerging educational efforts and interested parties. The seven institutional members include Barcelona College of Chiropractic (Barcelona, Spain); the Chiropraktik Akademie (Dresden, Germany); Life Chiropractic College West (San Francisco, California, USA); Life University (Atlanta, Georgia, USA); McTimoney College of Chiropractic (Abingdon, Oxfordshire, UK); New Zealand College of Chiropractic (Auckland, New Zealand); and Sherman College of Chiropractic (Spartanburg, South Carolina, USA).

TRG has issued the following statement:

Definition and Position Statement on the Chiropractic Subluxation

The term ‘subluxation’ has been used by the chiropractic profession for over a century.1, 2 It is an important element of chiropractic practice, embedded in legislation and regulation, and its clinical implications have been, and continue to be, scientifically explored.2, 3
The term subluxation, as used by chiropractors, is a researchable concept that is important to health and health care delivery.1, 2, 4 The need to properly define this entity has been widely recognized as a high priority within the profession, as evidenced by the number of groups and organizations who have offered definitions of subluxation.1, 2, 5-10

Many of the past definitions do not provide a testable definition of chiropractic subluxation.11 

Some do not reflect the current research that supports a neurologically-centered model of subluxation. 2 The Rubicon Group (TRG) has utilized the current available scientific evidence to define the chiropractic subluxation. Contemporary neurophysiological language and concepts, based on current scientific publications on the topic, have been used. As this definition is subject to ongoing scientific exploration that is likely to lead to new findings and understandings, modifications may be anticipated. However, this definition reflects what is currently known, and it is congruent with current neurophysiological scientific understanding.

“We currently define a chiropractic subluxation as a self-perpetuating, central segmental motor control problem that involves a joint, such as a vertebral motion segment, that is not moving appropriately, resulting in ongoing maladaptive neural plastic changes that interfere with the central nervous system’s ability to self-regulate, self-organize, adapt, repair and heal.”

(The Rubicon Group, May 2017.)

There are three key elements, namely:

A chiropractic subluxation often relates to the spine and its connecting structures. 1 Chiropractic subluxation assessment generally involves evaluating the pathophysiological consequences of the central segmental motor control problem; 4, 12 these may include pain, asymmetry, biomechanical or postural changes (such as changes in relative range of intervertebral motion), changes in tissue temperature, texture and/or tone, and other findings that can be identified using special tests. 12 Once identified, subluxations are corrected using a variety of techniques including high velocity low amplitude chiropractic adjustments, instrument assisted adjustments, and lower force manual techniques and approaches.13

A growing body of scientific evidence has demonstrated that spinal function impacts central neural function in multiple ways,3, 4, 14-19 and that improving spinal function has an impact on clinical outcomes.20-24 Scientists have known for several decades that neurons continuously adapt in structure and function in response to our ever-changing environment.25-27 This ability to adapt is known as ‘neural plasticity’,27 and it is now well understood that the central nervous system can reorganize in response to altered input.28-35 Examples of increased sensory input that can lead to neural plastic changes include repetitive muscular activity 29, 36-41, such as typing or playing the piano, or repeated tactile sensory input such as occurs with blind Braille readers.42 Similar central nervous system change or reorganization may take place due to a decrease in behavior or activity.+ 32, 43-49 Thus the concept, that alterations in paraspinal muscle function due to abnormal spinal movement patterns are capable of changing central neural function, is totally congruent with current neuroscience understanding, as well as current scientific findings.3, 4, 14-19
[references can be found in the original]

MY COMMENT:

Subluxation is not so much a ‘self-perpetuating motor control problem’ as a self-perpetuating money-maker for chiropractors, it seems to me. The history of the use of this term shows that chiropractors have changed its meaning each time they were unable to deny its nonsensicality. To throw subluxation over board is not an option because chiropractic is at its hear a subluxation cult.

Yet, we have repeatedly been told that chiropractors have all but given up the concept of ‘subluxation’. This is clearly not the case. The above statement of TRG speaks for itself, and so does a recent study showing that “the majority of [North American chiropractic] students would like to see an emphasis on correction of vertebral subluxation”. It is the correction of the non-existent subluxation that stimulates the cash flow of chiropractors, a fact known even to the novices of the cult.

The new definition, it seems to me, is little more than self-serving nonsense. Wikipedia – I know, it’s not always the most reliable source, but in this case it is miles better that TRG – has this to say about subluxation: “In chiropractic, vertebral subluxation is a supposed misalignment of the spinal column leading to a set of signs and symptoms sometimes termed vertebral subluxation complex. It has no biomedical basis and is categorized as pseudoscientific by leading authorities. Traditionally, the “specific focus of chiropractic practice” is the chiropractic subluxation and historical chiropractic practice assumes that a vertebral subluxation or spinal joint dysfunction interferes with the body’s function and its innate intelligence, as promulgated by D. D. Palmer, the inventor of chiropractic.”

Wikipedia furthermore mentions that “in 2015, 8 internationally accredited chiropractic colleges: AECC, WIOC, IFEC-Paris, IFEC-Toulouse, USD-Odense, UZ-Zurich, UJ-Johannesburg and Durban University of Technology made an open statement which included: “The teaching of the vertebral subluxation complex as a vitalistic construct that claims that it is the cause of disease is unsupported by evidence. Its inclusion in a modern chiropractic curriculum in anything other than an historic context is therefore inappropriate and unnecessary”.”

Subluxation currently divides the chiropractic profession as we have seen here, for instance. But it is certainly not a concept that most chiropractors have been wise enough to declare obsolete.

I am sure you always wanted to know what animal chiropractic is all about!

This website explains it quite well:

START OF QUOTES

…Animal chiropractic (veterinary spinal manipulative therapy) focuses on the preservation and health/wellness of the neuro-musculo-skeletal system. Chiropractic is the science that is centered around the relationship between the spine and the nervous system. The spine is your body’s foundation and the nervous system, including your brain, spinal cord and nerves, controls your entire body. They must work together harmoniously to improve one’s general health and their ability heal. If the systems are not functioning to their highest potential you may experience changes in digestion, heart and lung function, reproduction and most evidently musculature. When adjacent joints are in an abnormal position, called a subluxation, the nervous system and all that it controls will be negatively impacted. If these subluxations are not corrected, they can result in prolonged inappropriate stimulation of nerves. This could result in reduced function internally, musculo-skeletal dysfunction and pain.

Spinal manipulation is the art of restoring full and pain free range of motion to joints and can greatly benefit an animal after they have experienced subluxations. The veterinarian will use their hands to palpate joints both statically and in motion. By doing this, they can determine where the animal is experiencing decreased motion or misaligned joints. Once identified, an adjustment can be performed. An adjustment or spinal manipulation is a gentle, specific, quick and low force thrust that will be applied at an angle specific to the different areas of motion in the spine and extremities. Only a certified animal chiropractor will understand the complexity involved in adjustments and can best assess if an animal can benefit from chiropractic care.

Many animals can benefit from this alternative therapy. If you notice that your animal has a particularly sensitive spot somewhere on their body, is walking or trotting differently and or not performing to the same ability they have previously, they may be a candidate for a chiropractic assessment. However, an animal does not need to be sick or injured to benefit from chiropractic care. Animals in good health or ones used for sporting activities are also prime candidates for chiropractic care. By maintaining your pet’s proper spinal alignment and mobility they will attain optimal function of muscles, nerves and tissues that support the joints. When the body can move freely your pet will experience improved mobility, stance and flexibility, which can evolve into improved agility, endurance and overall performance. Finally, many people have never considered that chiropractic care can also benefit their animal by boosting their immune response. It can aid in providing a healthier metabolism and a vibrant nervous system which all facilitate your animal’s natural ability to heal themselves from within. Chiropractic care can enhance the quality of your pet’s life ensuring many active and healthy years to come.

…during veterinary school I began the process of researching how to become an animal chiropractor or veterinary spinal manipulative therapist. As I researched further, I noticed that this specialized profession has grown. It became apparent that one should be certified by either the College of Animal Chiropractors or American Veterinary Chiropractic Association to practice on animals…  It was surprising to find out that there are only four programs in the USA and Canada that are approved by both organizations. The courses consisted of over 200 hours of intensive study and hands on learning followed by certification testing…

END OF QUOTE

Yes, I did shorten the quote a bit but, rest assured, I did not cut out a single word about the efficacy of animal chiropractic. Even if I had wanted to, I couldn’t: there is no mention of it in the article.

I wonder why!

Looking into Medline, I found several reports related to the subject:

  • One study suggested an association between chiropractic findings in the lumbar vertebrae and urinary incontinence and retention in dogs.
  • A case report highlighted the potential benefits of combining traditional medical management with chiropractic treatment and physical therapy techniques for management of severe acute-onset torticollis in a giraffe.
  • A review explained that there is limited evidence supporting the effectiveness of spinal mobilization and manipulation in animals.
  • An observational study suggested that chiropractic manipulations elicit slight but significant changes in thoracolumbar and pelvic kinematics.
  • A comparative study measured the spinal mechanical nociceptive thresholds in 38 horses, and showed that they increased by 27, 12 and 8% in the chiropractic, massage and phenylbutazone groups, respectively.

… and that was basically it. Not a single study to suggest that chiropractic is effective for specific conditions of animals.

Frustrated, I went on the site of the ‘College of Animal Chiropractic’; surely there I would find the evidence I was looking for. They offer lots of platitudes and this largely nonsensical statement:

“When a joint become restricted in its range of motion(hypomobile or ‘locked-up’), through trauma, repetitive injury, degenerative changes, or structural stresses, the surrounding tissues are affected. This, in turn, further affects the joints ability to move freely and sensitive structures are activated causing the area to be sensitive or painful. Nerves are the communication links between all tissues in the body to the brain and spinal cord; when joint dysfunction is present, messages to other areas are also affected, which can lead to pain, weakness, reduced function, and compensatory changes. Animal chiropractic focuses on the restoration of movement and the promotion of heath by restoring normal joint mechanics and soft-tissue function, thus, normalizing neurological patterns that facilitate healing . The main tool an animal chiropractor uses to restore joint motion is called an “adjustment”, or veterinary spinal manipulation. This gentle, specialized, manual skill, involves the application of a quick, low-force maneuver that is directed to a specific area of a joint at a specific angle. A certified animal chiropractor understands these joint angles intimately and can best asses if an animal can benefit from chiropractic care, and, is the only professional who is qualified to adjust your pet.”

But no evidence!

By now I was desperate. My last hope was the ‘American Veterinary Chiropractic Association’. All I found there, however, was this: the “American Veterinary Chiropractic Association (AVCA) is a professional membership group promoting animal chiropractic to professionals and the public, and acting as the certifying agency for doctors who have undergone post-graduate animal chiropractic training.”

Not a jot of evidence!

The assumption that animal chiropractic is effective seems to rely on the evidence from human studies…

… and we all know how solid that body of evidence is!

My conclusion from all this: chiropractors treating animals and those treating humans have one important characteristic in common.

THEY HAPPILY PROMOTE BOGUS TREATMENTS.

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

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!

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