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

chiropractic

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So-called alternative medicine (SCAM) could easily be described as a business that exists mainly because it profits from the flaws of conventional medicine. I know, this is not a good definition, and I don’t want to suggest it as one, but I think it highlights an important aspect of SCAM.

Let me explain.

If we ask ourselves why consumers feel attracted to SCAM, we can identify a range of reasons, and several of them relate to the weaknesses of conventional medicine as it is practised today. For instance:

  1.  People feel the need to have more time with their clinician in order to discuss their problems more fully. This means that their GP does not offer them sufficient time, empathy and compassion they crave.
  2.  Patients are weary of the side-effects of drugs and prefer treatments that are gentle and safe. This shows that they realise that conventional medicine can cause harm and they hope to avoid this risk.
  3.  Patients find it often hard to accept that their symptoms are ‘nothing to worry about’ and does not require any treatment at all. They prefer to hear that the clinician knows exactly what is wrong and can offer a therapy that puts it right.

Conventional medicine and the professionals who administer it have many flaws. Most doctors have such busy schedules that there is little time for building an empathetic therapeutic relationship with their patients. Thus they often palm them off with a prescription and fail to discuss the risks in sufficient detail. Even worse, they sometimes prescribe drugs in situations where none are needed and where a reassuring discussion would be more helpful. It is too easy to excuse such behaviours with work pressures; such flaws are serious and cannot be brushed under the carpet in this way.

Recently, the flawed behaviour of doctors has become the focus of media attention in the form of

  • opioid over-prescribing
  • over-use of anti-biotics.

In both cases, SCAM providers were quick to offer the solution.

  • Acupuncturists and chiropractors claim that their treatments are sensible alternatives to opioids. Yet, there is no good evidence that either acupuncture or chiropractic have analgesic effects that are remotely comparable to those of opioids. They only are seemingly successful in cases where opioids were not needed in the first place.
  • Homeopaths claim that their remedies can easily replace antibiotics. Yet, there is not a jot of evidence that homeopathics have antibiotic activity. They only are seemingly successful in cases where the antibiotic was not needed in the first place.

In both instances, SCAM is trying to profit from the weaknesses of conventional medicine. In both cases, the offered solutions are clearly bogus. Yet, in both cases, scientifically illiterate politicians are seriously considering the alleged solutions. Few seem to be smart enough to take a step backwards and contemplate the only viable solution to these problems. If doctors over-prescribe, they need to be stopped; and the best way to stop them is to give them adequate support, more time with their patients and adequate recognition of the importance of reassuring and talking to patients when they need it.

To put it differently:

The best way to reduce the use of bogus SCAMs is to make conventional medicine less flawed.

Recently, we discussed the findings of a meta-analysis which concluded that walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.

At the time, I commented that

this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.

My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

Now, there is new evidence that seems to confirm what I wrote. An international team of researchers requested individual participant data (IPD) from high-quality randomised clinical trials of patients suffering from persistent low back pain. They conducted descriptive analyses and one-stage IPD meta-analysis. They received IPD for 27 trials with a total of 3514 participants.

For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up.

Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care.

But you cannot dismiss so-called alternative medicine (SCAM), just like that, I hear my chiropractic and other manipulating friends exclaim – at the very minimum, we need direct comparisons of the two approaches!!!

Alright, you convinced me; here you go:

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with chronic low back pain (CLBP). Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review. Only three RCTs met the inclusion criteria. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term. The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Convinced?

No?

But I am!

Exercise is preferable to chiropractic and other manipulating SCAMs because:

  1. It is cheaper.
  2. It is safer.
  3. It is readily available to anyone.
  4. And you don’t have to listen to the bizarre and often dangerous advice many chiros offer their clients.

Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.

Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.

The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.

I have to admit, I have problems with these conclusions.

  1. Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone.  By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life.  This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
  2.  I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.

To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.

FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.

This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.

Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.

MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.

SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.

A total of 182 participants were randomized. The short‐term and long‐term groups demonstrated significant improvements in back disability (ODI score –3.9 [95% confidence interval (95% CI) –5.8, –2.0] versus ODI score –6.3 [95% CI –8.2, –4.4]) and neck disability (NDI score –7.3 [95% CI –9.1, –5.5] versus NDI score –9.0 [95% CI –10.8, –7.2]) after 36 weeks, with no difference between groups (back ODI score 2.4 [95% CI –0.3, 5.1]; neck NDI score 1.7 [95% CI 0.8, 4.2]). The long‐term management group experienced greater improvement in neck pain at week 36, in self‐efficacy at weeks 36 and 52, and in functional ability, and balance.For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.

FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.

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I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.

This survey investigated how many chiropractors in the Canadian province of Alberta promote a theory of subluxation, which health ailments or improvements were linked to subluxation, and whether the subluxation discourse was used to promote chiropractic for particular demographics.

Using the search engine on the Canadian Chiropractic Associations’ website, the researchers made a list of all clinics in Alberta. They then used Google searches to obtain a URL for each clinic with a website, totalling 324 URLs for 369 clinics. They then searched on each website for “subluxation” and performed content analysis on the related content.

One hundred twenty-one clinics’ websites (33%) presented a theory of vertebral subluxation. The ailments and improvements discussed in relation to subluxation were wide-ranging; they included the following:

  • ADHD,
  • allergies,
  • asthma,
  • autism,
  • back pain,
  • bed wetting
  • blood pressure,
  • cold,
  • colitis,
  • constipation,
  • diarrhoea,
  • dizziness,
  • ear infection,
  • epilepsy,
  • fatigue,
  • fever,
  • flu,
  • headache,
  • heart disease,
  • hormonal imbalance,
  • inflammation,
  • learning problems,
  • menstrual cramps,
  • MS,
  • nausea,
  • pain,
  • Parkinson’s disease,
  • problems with hearing,
  • problems with vision,
  • prostate cancer,
  • respiratory disease,
  • sciatica,
  • scoliosis,
  • sleeping problems,
  • spinal decay,
  • sudden infant death syndrome,
  • and many more.

The marketing of chiropractic for children was observed on 8% of the clinic websites.

The researchers concluded that, based on the controversy surrounding vertebral subluxation, the substantial number of clinic websites aligning their practice with vertebral subluxation should cause concern for regulatory bodies.

Why do so many chiropractors cling so tightly to the long obsolete concept of subluxation? The way I see it there are at least three reasons:

  1.  If they abandoned subluxation, they would quickly become physiotherapists, only with a much reduced scope of practice.
  2. Using the subluxation myth avoids the need of the knowledge of any complicated pathophysiology.
  3.  Subluxation is ever so good for business, as it renders chiropractic manipulation a cure all.

D. D. Palmer, the magnetic healer who invented chiropractic about 120 years ago, claimed that a vital energy, which he called the “innate”, controls all body functions. In the presence of “vertebral subluxation,” it cannot work adequately, he postulated. In other words, subluxations block the flow of the innate which, in turn, is the cause of all disease. Palmer therefore developed spinal manipulations to correct such subluxations and de-block the flow of the innate. Palmer defined chiropractic as a system of healing based on the premise that the body requires unobstructed flow through the nervous system of innate intelligence. This effectively makes the adjustment of subluxation a panacea.

To put it simply: subluxation is the carte blanche required for making unlimited bogus claims, while ripping off the public.

 

We have discussed the tragic case of John Lawler before. Today, the Mail carries a long article about it. Here I merely want to summarise the sequence of events and highlight the role of the GCC.

  • In 2017, Mr Lawler, aged 79 at the time, has a history of back problems, including back surgery with metal implants and suffers from pain in his leg.
  • His GP recommends to consult a physiotherapist.
  • As waiting lists are too long, Mr Lawler sees a chiropractor shortly after his 80th birthday who calls herself ‘doctor’ and who he assumes to be a medic specialising in back pain.
  • The chiropractor uses a spinal manipulation of the neck with the drop table.
  • There is no evidence that this treatment is effective for pain in the leg.
  • No informed consent is obtained from the patient.
  • This is acutely painful and brakes the calcified ligaments of Mr Lawler’s upper spine.
  • Mr Lawler is immediately paraplegic.
  • The chiropractor who had no training in resuscitation is panicked tries mouth to mouth.
  • Bending the patient’s neck backwards the chiropractor further compresses his spinal cord.
  • When ambulance arrives, the chiropractor misleads the paramedics telling them nothing about a forceful neck manipulation with the drop and suspecting a stroke.
  • Thus the paramedics do not stabilise the patient’s neck which could have saved his life.
  • Mr Lawler dies the next day in hospital.
  • The chiropractor is arrested immediately by the police but then released on bail.
  • The expert advising the police is a prominent chiropractor.
  • One bail condition is not to practise, pending a hearing by the GCC.
  • The GCC decide not to take any action.
  • The police therefore release the bail conditions and she goes back to practising.
  • The interim suspension hearing of the GCC is being held in September 2017.
  • The deceased’s son wants to attend but is not allowed to be present at the hearing even though such events are normally public.
  • The coroner’s inquest starts in 2019.
  • In November 2019, a coroner rules that Mr Lawler died of respiratory depression.
  • The coroner also calls on the GCC to bring in pre-treatment imaging to protect vulnerable patients.
  • The GCC announce that they will now continue their inquiry to determine whether or not chiropractor will be struck off the register.

The son of the deceased is today quoted stating that the GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”

I sympathise with this statement. On this blog, I have repeatedly voiced my concerns about the GCC – see here, for instance – which I therefore do not need to repeat. My opinion of the GCC is also coloured by a personal experience which I will quickly recount now:

A long time ago (I estimate 10 – 15 years), the GCC invited me to give a lecture and I accepted. I do not remember the exact subject they had given me, but I clearly recall elaborating on the risks of spinal manipulation. This was not too well received. When I had finished, a discussion ensued in which I was accused of not knowing my subject and aggressed for daring to ctiticise chiropractic. I had, of couse, given the lecture assuming they wanted to hear my criticism. In the end, I left with the impression that this assumption was wrong and that they really just wanted to lecture, humiliate and punish me for having been a long-term critic of their trade.

I therefore can fully understand of David Lawler’s opinion about the GCC. To me, they certainly behaved as though their aim was not to protect the public, but to defend chiropractors from criticism.

Yes, chiropractic spinal manipulation shows promise to alleviate symptoms of infant colic! At least, this is the result of an overview of systematic reviews of so-called alternative medicines (SCAMs) for infant colic. Here I focus merely on the part that deals with chiropractic spinal manipulation. The authors of the overview come to this result based mainly on the statement:

Spinal manipulation was assessed in six reviews [22, 23, 25,26,27,28]. Two multiple CAM reviews assessed manipulation but did not pool the results [22, 25]. Both found three trials to be effective [68, 69, 72, 73, or] with the exception of one [71].

And here are the references they cite (all the primary studies are on chiropractic manipulation):

22.Perry R, Hunt K, Ernst E. Nutritional supplements and other complementary medicines for infantile colic: a systematic review. Pediatrics. 2011;127:720–33.

23.Bruyas-Bertholo V, Lachaux A, Dubois J-P, Fourneret P, Letrilliart L. Quels traitements pour les coliques du nourrisson. Presse Med. 2012;41:e404–10.

24.Harb T, Matsuyama M, David M, Hill RJ. Infant colic—what works: a systematic review of interventions for breast-fed infants. J Pediatr Gastroenterol Nutr. 2016;62(5):668–86.

25.Gutiérrez-Castrellón P, Indrio F, Bolio-Galvis A, et al. Efficacy of Lactobacillus reuteri DSM 17938 for infantile colic. Systematic review with network meta-analysis. Medicine. 2017;96(51):e9375.

26.Dobson D, Lucassen PLBJ, Miller JJ, Vlieger AM, Prescott P, Lewith G. Manipulative therapies for infantile colic. Cochrane Database of Systematic Reviews. 2012;(Issue 12. Art. No.: CD004796)

27.Gleberzon BJ, Arts J, Mei A, McManus EL. The use of spinal manipulative therapy for pediatric health conditions: a systematic review of the literature. J Can Chiropr Assoc. 2012;56(2):128–41.

28.Carnes D, Plunkett A, Ellwood J, et al. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open. 2018;8:e019040.

68.Wiberg J, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled trial with a blinded observer. J Manip Physiol Ther. 1999;22(8):517–22.

69.Mercer C. A study to determine the efficacy of chiropractic spinal adjustments as a treatment protocol in the Management of Infantile Colic [thesis]. Durban: Technikon Natal,Durban University; 1999.

70.Mercer C, Nook B. The efficacy of chiropractic spinal adjustments as a treatment protocol in the management of infantile colic. In: Presented at: 5th Biennial Congress of the World Federation of Chiropractic. Auckland; 1999. p. 170-1.

71.Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomized controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001;84(2):138–41.

And here is the relevant part of the overview’s conclusion:

Spinal manipulation shows promise to alleviate symptoms of colic, although concerns remain as positive effects were only demonstrated when crying was measured by unblinded parent assessors.

I have several concerns about this new overview:

  • My comments on the Canes paper are here and do not need repeating.
  • My comments on the Dobson paper (according to the overview authors, it is the best of all the reviews) are also available and need no repeating.
  • Reference 22 is a systematic review I did together with the lead author of the new overview while she was one of my co-workers at Exeter. It is not focussed on spinal manipulation, but on all SCAMs. Here is the relevant passage from our conclusions regarding spinal manipulation: The evidence for … manual therapies does not indicate an effect.

How the review authors could come to the verdict that spinal manipulation shows promise is thus more than a little mysterious. If we consider the following, it gets positively bewildering. Even the most rudimentary of searches on Medline will deliver a 2009 systematic review by myself entitled ‘Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials. It was the first systematic review on the subject but was not included in the new overview.

Why not?

I do not know.

Here are my conclusions from this paper:

Collectively these RCTs fail to demonstrate that chiropractic spinal manipulation is an effective therapy for infant colic. The largest and best reported study failed to show effectiveness (11). Numerous weaknesses of the primary data would prevent firm conclusions, even if the results of all RCTs had been unanimously positive.

And here is what my review stated about the three primary RCTs assessed in all the other review authors:

The trial by Wiberg et al. (10) did not attempt to blind the infants’ parents who acted as the evaluators of the therapeutic success. The paper provides little details about the recruitment process, but it is fair to assume that patients were asked to participate in a trial of spinal manipulation. Thus one might expect a degree of disappointment in parents of the control group whose children did not receive this treatment. This, in turn, could have impacted on the parents’ subjective judgements. In any case, there is no control for placebo effects which can be very different for a physical intervention compared with an oral placebo – dimethicone was administered as a placebo and the authors stress that it is ‘no better than placebo treatment’.

The RCT by Olafsdottir et al. (11) is by far the best-reported study of all the included RCTs. In many ways, it is a replication of Wiberg’s investigation (10) but on a larger scale with twice the sample size. It is the only study where a serious attempt was made to control for the placebo effects of spinal manipulations. For these reasons, its results seem more reliable than those of the other RCTs.

The RCT by Browning and Miller (12) is a comparison of two manual techniques both of which are assumed by the authors to be effective. Thus it is essentially a non-inferiority trial. Yet, it is woefully underpowered for such a design. Even if it had the necessary power, its results would be difficult to interpret because none of the two interventions have been proven to be effective. Thus, one would still be uncertain whether both interventions are similarly ineffective or effective. As it stands, the result simply seems to demonstrate that symptoms of infant colic lessen over time possibly as a result of non-specific therapeutic effects, the natural history of the disease, concomitant treatments, social desirability or a combination of these factors.

So, what should we conclude from all this? I am not sure – except for one thing, of course: I would not call the evidence for chiropractic spinal manipulation promising.

This letter (dated 21 June 2019) to the Safer Care Victoria review team represents a statement by the Australian Medical Association of Victoria on chiropractic for children. As it is highly relevant to many of the discussions we had on this blog, I take the liberty of copying it here in full:

RE: Review of chiropractic spinal care for children under 12 years

The Australian Medical Association (AMA Victoria) appreciates the opportunity to respond to the Safer Care Victoria (SCV) consultation on chiropractic manipulation of children under 12 years.

The AMA is pleased that SCV has decided to review this practice which is manifestly unsafe and unwarranted.

Chiropractic spinal manipulation on children has received recent media attention and prompted community concerns about its safety, appropriateness and the professional duties of those undertaking it.  Most notably, in February this year medical experts and the Victorian Government condemned the controversial practice of infant spine manipulation after footage emerged of a Melbourne chiropractor treating a two-week old baby on the chiropractor’s own site.

Treatment of infants and very young children

We are aware that chiropractors are treating children for problems such as “infantile colic” by manipulative therapies.  There is no credible evidence for this, it is a dangerous practice in itself and it potentially impedes the proper assessment and management of an infant.  Additionally, it preys on often tired parents by the promise of a frequently false unequivocal diagnosis and false “quick fix”. This is plainly unconscionable and dangerous behaviour.

In preparing our response, we engaged with doctors across many specialities who have offered valuable insights into the matters being considered as part of this review.  It is our very firm view that the risk of undertaking spinal manipulation on small infants is of no benefit and is potentially extremely dangerous.  Newborn babies are extremely fragile and AMA Victoria warns that damage done to a baby or infant may not be immediately obvious to parents, and may not manifest until many years later.  This is supported by a study conducted by the American Academy of Pediatrics [1] which found serious adverse events may be associated with paediatric spinal manipulation.1

Another critical issue is that it is very unlikely that parents are providing informed consent to such procedures.  For parents to provide informed consent, they would need to be fully advised of the risks including, for example:

• the diagnosis of “infant colic” is a catch all for a range of symptoms with different aetiologies;

• the potential drastic short and long term consequences of spinal manipulation on their baby;

• there are no scientific safety and efficacy studies undertaken; and

• there is no credible scientific evidence for manipulation.

Chiropractors should also be directing parents to general practitioners for the proper holistic assessment and care of the child and family.

Additionally, infants and very young children cannot provide assent for a procedure for which there is no evidence they require and which may leave them with long term consequences.  Consideration of whether such potentially dangerous therapies, which are not underpinned by a strong evidence-base, should be supported by private health insurance rebates is also warranted.

Treatment of children under 12 years of age

Although there is limited evidence that some musculoskeletal treatments are effective in adults, there is no credible scientific evidence that manipulation, mobilisation or any applied spinal therapy in children under 12 years of age is warranted or safe.

AMA Victoria does not support clinical interventions unless there is scientific evidence that such treatments are useful in treating the illness.  AMA Victoria also supports patients being fully informed on the illness and the risks and benefits to any treatment. When the risks are to be borne by a non-assenting child, the requirement of evidence and consent is especially important.

AMA Victoria strongly advocates that chiropractic (and other health professionals) spinal care for children under 12 years of age is dangerous, unwarranted and must cease immediately.

If you would like to discuss any aspect of our response, please contact Ms Nada Martinovic, Senior Policy Advisor on (03) 9280 8773 or nadam@amavic.com.au.

Yours sincerely

Associate Professor Julian Rait OAM AMA VICTORIA PRESIDENT

1 Sunita, V., et al., Adverse Events Associated with Pediatric Spinal Manipulation: A Systemic Review, Pediatrics, 2007: 119; 275-283.

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I am truly delighted that the AMA Victoria agrees with many points I have tried to make previously (see for instance here, here and here). The statement is unsurpassed in its directness and strength. My congratulations to Prof Raith – very well done!

Let’s hope that professional bodies of other regions and counties will swiftly follow suit with equal clarity.

I have reported previously about the tragic death of John Lawler. Now after the inquest into the events leading to it has concluded, I have the permission to publish the statement of Mr Lawler’s family:

We were devastated to lose John in such tragic and unforeseen circumstances two years ago. A much-loved husband, father and grandfather, he continues to be greatly missed by all of us. Having to re-live the circumstances of his death has been particularly difficult for us but we are grateful to have a clearer picture of the events that led to John’s death. We would like to take this opportunity to thank the coroner’s team, our legal representatives and our wider family and friends for their guidance, empathy and sensitivity throughout this process.

There were several events that went very wrong with John’s chiropractic treatment, before, during, and after the actual manipulation that broke his neck.

Firstly, John thought he was being treated by a medically qualified doctor, when he was not. Furthermore, he had not given informed consent to this treatment.

The chiropractor diagnosed so-called ‘vertebral subluxation complex’ which she aimed to treat by manipulating his neck. We heard this week from medical experts that John had ossified ligaments in his spine, where previously flexible ligaments had turned to bone and become rigid. This condition is not uncommon, and is present in about 10% of those over 50. It would have showed on an X-ray or other imaging technique. The chiropractor did not ask for any images before commencing treatment and was seemingly unaware of the risks of doing a manual manipulation on an elderly patient.

It has become clear that the chiropractor did the manipulation incorrectly, and broke these rigid ligaments during a so-called ‘drop table’ manipulation, causing discs in the cervical spine to rupture and the spinal cord to become crushed. Although these manipulations are done frequently by chiropractors, we have heard that the force applied to his neck by the chiropractor would have had to have been “significant”.

Immediately John reported loss of sensation and paralysis in his arms. At this stage the only safe and appropriate response was to leave him on the treatment bed and await the arrival of the paramedics, and provide an accurate history to the ambulance controller and paramedics. The chiropractor, in fact, manhandled John from the treatment bed into a chair; then tipped his head backwards and gave “mouth to mouth” breaths. She provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport John downstairs to the ambulance without stabilising his neck. If the paramedics had been given the full and accurate story, they would have stabilised his neck in situ and transported him on a scoop stretcher – and he would have subsequently survived.

The General Chiropractic Council decided not to suspend the chiropractor from practicing in September 2017. They heard evidence from the chiropractor that she had “not touched the neck during the appointment” and from an expert chiropractor that it would be “physically impossible” for the treatment provided to cause the injury which followed. We have heard this week that this is incorrect. The family was not allowed to attend or give evidence at that hearing, and we are waiting – now 2 years further on – for the GCC to complete their investigations.

We hope that the publicity surrounding this event will highlight the dangers of chiropractic, especially in the elderly and those with already compromised spines. We would again urge the regulator to take immediate measures to ensure that the profession is properly controlled: that chiropractors are prevented from styling themselves as medical professionals; that patients are fully informed and consent to the risks involved; that imaging is done before certain procedures and on high risk clients; and that the limits of the benefits chiropractic can provide are fully explored.

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Before someone comments pointing out that this is merely a single case which does not amount to evidence, let me remind you of the review of cervical manipulation prepared for the Manitoba Health Professions Advisory Council. Here is the abstract:

Neck manipulation or adjustment is a manual treatment where a vertebral joint in the cervical spine—comprised of the 7 vertebrae C1 to C7—is moved by using high-velocity, low-amplitude (HVLA) thrusts that cannot be resisted by the patient. These HVLA thrusts are applied over an individual, restricted joint beyond its physiological limit of motion but within its anatomical limit. The goal of neck manipulation, referred to throughout this report as cervical spine manipulation (CSM), is to restore optimal motion, function, and/or reduce pain. CSM is occasionally utilized by physiotherapists, massage therapists, naturopaths, osteopaths, and physicians, and is the hallmark treatment of chiropractors; however the use of CSM is controversial. This paper aims to thoroughly synthesize evidence from the academic literature regarding the potential risks and benefits of cervical spine manipulation utilizing a rapid literature review method.

METHODS Individual peer-reviewed articles published between January 1990 and November 2016 concerning the safety and efficacy of cervical spine manipulation were identified through MEDLINE (PubMed), EMBASE, and the Cochrane Library.

KEY FINDINGS

  • A total of 159 references were identified and cited in this review: 86 case reports/ case series, 37 reviews of the literature, 9 randomized controlled trials, 6 surveys/qualitative studies, 5 case-control studies, 2 retrospective studies, 2 prospective studies and 12 others.
  • Serious adverse events following CSM seem to be rare, whereas minor adverse events occur frequently.
  • Minor adverse events can include transient neurological symptoms, increased neck pain or stiffness, headache, tiredness and fatigue, dizziness or imbalance, extremity weakness, ringing in the ears, depression or anxiety, nausea or vomiting, blurred or impaired vision, and confusion or disorientation.
  • Serious adverse events following CSM can include the following: cerebrovascular injury such as cervical artery dissection, ischemic stroke, or transient ischemic attacks; neurological injury such as damage to nerves or spinal cord (including the dura mater); and musculoskeletal injury including injury to cervical vertebral discs (including herniation, protrusion, or prolapse), vertebrae fracture or subluxation (dislocation), spinal edema, or issues with the paravertebral muscles.
  • Rates of incidence of all serious adverse events following CSM range from 1 in 10,000 to 1 in several million cervical spine manipulations, however the literature generally agrees that serious adverse events are likely underreported.
  • The best available estimate of incidence of vertebral artery dissection of occlusion attributable to CSM is approximately 1.3 cases for every 100,000 persons <45 years of age receiving CSM within 1 week of manipulative therapy. The current best incidence estimate for vertebral dissection-caused stroke associated with CSM is 0.97 residents per 100,000.
  • While CSM is used by manual therapists for a large variety of indications including neck, upper back, and shoulder/arm pain, as well as headaches, the evidence seems to support CSM as a treatment of headache and neck pain only. However, whether CSM provides more benefit than spinal mobilization is still contentious.
  • A number of factors may make certain types of patients at higher risk for experiencing an adverse cerebrovascular event after CSM, including vertebral artery abnormalities or insufficiency, atherosclerotic or other vascular disease, hypertension, connective tissue disorders, receiving multiple manipulations in the last 4 weeks, receiving a first CSM treatment, visiting a primary care physician, and younger age. Patients whom have experience prior cervical trauma or neck pain may be at particularly higher risk of experiencing an adverse cerebrovascular event after CSM.

CONCLUSION The current debate around CSM is notably polarized. Many authors stated that the risk of CSM does not outweigh the benefit, while others maintained that CSM is safe—especially in comparison to conventional treatments—and effective for treating certain conditions, particularly neck pain and headache. Because the current state of the literature may not yet be robust enough to inform definitive prohibitory or permissive policies around the application of CSM, an interim approach that balances both perspectives may involve the implementation of a harm-reduction strategy to mitigate potential harms of CSM until the evidence is more concrete. As noted by authors in the literature, approaches might include ensuring manual therapists are providing informed consent before treatment; that patients are provided with resources to aid in early recognition of a serious adverse event; and that regulatory bodies ensure the establishment of consistent definitions of adverse events for effective reporting and surveillance, institute rigorous protocol for identifying high-risk patients, and create detailed guidelines for appropriate application and contraindications of CSM. Most authors indicated that manipulation of the upper cervical spine should be reserved for carefully selected musculoskeletal conditions and that CSM should not be utilized in circumstances where there has not yet been sufficient evidence to establish benefit.

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Just three points which, in my view, sand out most in relation to Mr Lawler’s death:

  1. Mr Lawler had no proven indication (and at least one very important contra-indication)  for neck manipulation.
  2. He did not give infromed consent.
  3. The neck manipulation was not within the limits of the physiological range of motion.

The tragic case of John Lawler who died after being treated by a chiropractor has been discussed on this blog before. Naturally, it generated much discussion which, however, left many questions unanswered. Today, I am able to answer some of them.

  • Mr Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by considerable external force.
  • The pathologist’s report also shows that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
  • This is a common abnormality in elderly patients and limits the range of movement of the neck.
  • There was no adequately informed consent by Mr Lawler.
  • Mr Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
  • There is no reason to assume that the treatment of Mr Lawler’s neck would be effective for his pain located in his leg.
  • The chiropractor used an ‘activator’ which applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.

I have the permission to publish the submissions made to the coroner by the barrister representing the family of Mr Lawler. The barrister’s evidence shows that:

a. The treating chiropractor owed a duty of care to the Deceased, her patient;
b. That duty was breached in that:
i. After the Deceased reported loss of sensation and paralysis in his arms, the only safe and appropriate response was to:
1. Leave him in situ;
2. Await the arrival of the paramedic;
3. Provide an accurate history to the ambulance controller and attending paramedic;
ii. The treating chiropractor, in fact:
1. Manhandled the Deceased from the treatment bed into a sitting position on a chair;
2. Tipped his head backwards and gave “mouth to mouth” breaths;
3. Provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport the Deceased downstairs to the ambulance without stabilising his neck.
c. The risk of death was a reasonably foreseeable consequence of the breach;
d. In the absence of the breach:
iii. The paramedic would have stabilised the neck, in situ, and transported the Deceased on a scoop stretcher;
iv. The deceased would have survived.
e. Having regard to the risk of death involved, the misconduct was grossly negligent so as to be condemned as the serious crime of manslaughter. The decision to intervene as she did, went beyond a very serious mistake or very serious error of judgment having regard to the fact that:
i. She held herself out as a provider of (quasi) medical treatment;
ii. She styled herself as “doctor”, (when she was not entitled to do so);
iii. She intervened without any understanding of the injury she had caused nor any training in how to intervene safely.
___________________________________________________________________________
To put it in blunt layman’s terms, the chiropractor broke Mr Lawler’s neck and, by then moving his head the way she did (she put him into the sitting position and bent his head backwards), may well have caused his death.
Here are five lessons we might learn from this tragic case:
  1. Chiropractors are not medical doctors and should make this perfectly clear to all of their patients.
  2. Elderly patients can have several contra-indications to spinal manipulations. They should therefore think twice before consulting a chiropractor.
  3. A limited range of spinal movement usually is the sign for a chiropractor to intervene. However, this may lead to dramatically bad consequences, if the patient’s para-vertebral ligaments are ossified which happens in about 10% of all elderly individuals.
  4. Chiropractors are by no means exempt from obtaining informed consent. (In the case of Mr Lawler, this would have had to include the information that the neck manipulation carries serious risks and has not shown to work for any type of pain in the leg and might have saved his life, as he then might have refused to accept the treatment.)
  5. Chiropractors are not trained to deal with medical emergencies and must leave that to those healthcare professionals who are fully trained.

The Telegraph published an article entitled ‘Crack or quack: what is the truth about chiropractic treatment?’ and is motivated by the story of Mr Lawler, the 80-year-old former bank manager who died after a chiropractic therapy. Here are 10 short quotes from this article which, in the context of this blog and the previous discussions on the Lawler case, are worthy further comment:

1. … [chiropractic] was established in the late 19th century by D.D. Palmer, an American magnetic healer.
“A lot of people don’t realise it’s a form of alternative medicine with some pretty strange beliefs at heart,” says Michael Marshall, project director at the ‘anti-quack’ charity the Good Thinking Society. “Palmer came to believe he was able to cure deafness through the spine, by adjusting it. The theory behind chiropractic is that all disease and ill health is caused by blockages in the flow of energy through the spine, and by adjusting the spine with these grotesque popping sounds, you can remove blockages, allowing the innate energy to flow freely.” Marshall says this doesn’t really chime with much of what we know about human biology…“There is no reason to believe there’s any possible benefit from twisting vertebra. There is no connection between the spine and conditions such as deafness and measles.”…

Michael Marshall is right, chiropractic was built on sand by Palmer who was little more than a charlatan. The problem with this fact is that today’s chiros have utterly failed to leave Palmer’s heritage behind.

2. According to the British Chiropractic Association (BCA), the industry body, “chiropractors are well placed to deliver high quality evidence-based care for back and neck pain.” …

They would say so, wouldn’t they? The BCA has a long history of problems with knowing what high quality evidence-based care is.

3. But it [chiropractic] isn’t always harmless – as with almost any medical treatment, there are possible side effects. The NHS lists these as aches and pains, stiffness, and tiredness; and then mentions the “risk of more serious problems, such as stroke”….

Considering that 50% of patients suffer adverse effects after chiropractic spinal manipulations, this seems somewhat of an understatement.

4. According to one systematic review, spinal manipulation, “particularly when performed on the upper body, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke.” …

Arterial dissection followed by a stroke probably is the most frequent serious complication. But there are many other risks, as the tragic case of Mr Lawler demonstrates. He had his neck broken by the chiropractor which resulted in paraplegia and death.

5. “There have been virtually hundreds of published cases where neck manipulations have led to vascular accidents, stroke and sometimes death,” says Prof Ernst. “As there is no monitoring system, this is merely the tip of a much bigger iceberg. According to our own UK survey, under-reporting is close to 100 per cent.” …

The call for an effective monitoring system has been loud and clear since many years. It is nothing short of a scandal that chiros have managed to resist it against the best interest of their patients and society at large.

6. Chiropractors are regulated by the General Chiropractic Council (GCC). Marshall says the Good Thinking Society has looked into claims made on chiropractors’ websites, and found that 82 per cent are not compliant with advertising law, for example by saying they can treat colic or by using the misleading term ‘doctor’…

Yes, and that is yet another scandal. It shows how serious chiropractors are about the ‘evidence-based care’ mentioned above.

7. According to GCC guidelines, “if you use the courtesy title ‘doctor’ you must make it clear within the text of any information you put into the public domain that you are not a registered medical practitioner but that you are a ‘Doctor of Chiropractic’.”…

True, and the fact that many chiropractors continue to ignore this demand presenting themselves as doctors and thus misleading the public is the third scandal, in my view.

8. A spokesperson for the BCA said “Chiropractic is a registered primary healthcare profession and a safe form of treatment. In the UK, chiropractors are regulated by law and required to adhere to strict codes of practice, in exactly the same ways as dentists and doctors. Chiropractors are trained to diagnose, treat, manage and prevent disorders of the musculoskeletal system, specialising in neck and back pain.”…

Chiropractors also like to confuse the public by claiming they are primary care physicians. If we understand this term as describing a clinician who is a ‘specialist in Family Medicine, Internal Medicine or Paediatrics who provides definitive care to the undifferentiated patient at the point of first contact, and takes continuing responsibility for providing the patient’s comprehensive care’, we realise that chiropractors fail to fulfil these criteria. The fact that they nevertheless try to mislead the public by calling themselves ‘primary healthcare professionals’ and ‘doctors’ is yet another scandal, in my opinion.

9. The spokesperson said, “medication, routine imaging and invasive surgeries are all commonly used to manage low back pain, despite limited evidence that these methods are effective treatments. Therefore, ensuring there are other options available for patients is paramount.”…

Here the spokesperson misrepresents mainstream medicine to make chiropractic look good. He should know that imaging is used also by chiros for diagnosing back problems (but not for managing them). And he must know that surgery is never used for the type of non-specific back pain that chiros tend to treat. Finally, he should know that exercise is a cheap, safe and effective therapy which is the main conventional option to treat and prevent back pain.

10. According to the European Chiropractors’ Union, “serious harm from chiropractic treatment is extremely rare.”

How do they know, if there is no system to capture cases of adverse effects?

_________________________________________________________

So, what needs to be done? How can we make progress? I think the following five steps would be a good start in the interest of public health:

  1.  Establish an effective monitoring system for adverse effects that is accessible to the public.
  2. Make sure all chiros are sufficiently well trained to know about the contra-indications of spinal manipulation, including those that apply to elderly patients and infants.
  3. Change the GCC from a body defending chiros and their interests to one regulating, controlling and, if necessary, reprimanding chiros.
  4. Make written informed consent compulsory for neck manipulations, and make sure it contains the information that neck manipulations can result in serious harm and are of doubtful efficacy.
  5. Prevent chiros from making therapeutic claims that are not based on sound evidence.

If these measures had been in place, Mr Lawler might still be alive today.

 

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