spinal manipulation
This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.
Nine trials with a total of 779 participants were included in the meta-analysis.
- low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
- moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
- low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).
The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.
Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):
- For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
- Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
- It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
- The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
- The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
- In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
- Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
- In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
- In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
- An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED
I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.
It follows that the main conclusion of the authors of the review should be modified:
There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.
Spinal manipulation is usually performed by a therapist (chiropractor, osteopath, physiotherpist, doctor, etc.). But many people do it themselves. Self-manipulation is by no means safer than the treatment by a therapist, it seems. We have previously seen cases where the results were dramatic:
- Spinal epidural haematoma after neck manipulation (edzardernst.com)
- A ‘Self-Chiropractic Spinal Manipulation’ that resulted in death (edzardernst.com)
Now, a further case has been reported. In this paper, American pathologists present a tragic case of fatal vertebral artery dissection that occurred as the result of self-manipulation of the cervical spine.
The decedent was a 40-year-old man with no significant past medical history. He was observed to “crack his neck” while at work. Soon after, he began experiencing neck pain, then developed stroke-like symptoms and became unresponsive. He was transported to a local medical center, where imaging showed bilateral vertebral artery dissection. His neurological status continued to decline, and brain death was pronounced several days later.
An autopsy examination showed evidence of cerebellar and brainstem infarcts, herniation, and diffuse hypoxic-ischemic injury. A posterior neck dissection was performed to expose the vertebral arteries, which showed grossly visible hemorrhage and dilation. There was no evidence of traumatic injury to the bone or soft tissue of the head or neck. Bilateral dissection tracts were readily appreciated on microscopic examination. Death was attributed to self-manipulation of the neck, which in turn led to bilateral vertebral artery dissection, cerebellar and brainstem infarcts, herniation, hypoxic-ischemic injury, and ultimately brain death.
It seems clear to me that only few and spectacular cases of this nature are being published. In other words, the under-reporting of adverse effects of self-manipulation must be close to 100%. It follows that the risk of sel-manipulation is impossible to quantify. I suspect it is substancial. In any case, the precautionary principle compells me to re-issue my warning:
do not allow anybody to manipulate your neck, not even yourself!
This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.
I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.
An article about chiropractic caught my attention. Let me show you its final section which, I think, is relevant to what we often discuss on this blog:
If chiropractic treatment is unscientific, then why do I feel better? Because lots of things alleviate pain. Massage, analgesia and heat – but also a provider who listens, empathises and bothers to examine a patient. Then there is the placebo effect. For centuries, doctors have recognised that different interventions with unclear pathways result in clinical improvement. Among the benefits patients attributed to placebo 100 years ago: “I sleep better; my appetite is improved; my breathing is better; I can walk further without pain in my chest; my nerves are steadier.” Nothing has changed. Pain is a universal assignment; no one has a monopoly on its relief.
The chiropractic industry owes its existence to a ghost. Its founder, David Palmer, wrote in his memoir The Chiropractor that the principles of spinal manipulation were passed on to him during a séance by a doctor who had been dead for half a century. Before this, Palmer was a “magnetic healer”.
Today, chiropractors preside over a multibillion-dollar regulated industry that draws patients for various reasons. Some can’t find or afford a doctor, feel dismissed, or worse, mistreated. Others mistrust the medical establishment and big pharma. Still others want natural healing. But none of these reasons justifies conflating a chiropractor with a doctor. The conflation feels especially hazardous in an environment of health illiteracy, where the mere title of doctor confers upon its bearer strong legitimacy.
Chiropractors don’t have the same training as doctors. They cannot issue prescriptions or order advanced imaging. They do not undergo lifelong peer review or open themselves to monthly morbidity audits.
I know that doctors could do with a dose of humility, but I can’t find any evidence (or the need) for the assertion on one website that chiropractors are “academic overachievers”. Or the ambit claim that most health professionals have no idea how complicated the brain is, but chiropractors do.
Forget doctors, patients deserve more respect.
My friend’s back feels better for now. When it flares, I wonder if she will seek my advice – and I am prepared to hear no. Everyone is entitled to see a chiropractor. But no patient should visit a chiropractor thinking that they are seeing a doctor.
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I would put it more bluntly:
- chiropractors are poorly trained; in particular, they do not learn to question their own, often ridiculous beliefs;
- they are poorly regulated; in the UK, the GCC seems to protect the chiros rather than the public;
- chiropractors regularly disregard essential rules of medical ethics, e.g. informed consent;
- many try to mislead us by pretending they are physicians;
- their hallmark intervention, spinal manipulation, can cause considerable harm;
- it generates hardly any demonstrable benefit for any condition;
- chiropractors also cause considerable harm, e.g. by interfering with real medicine, e.g. vaccinations;
- thus, in general, chiropractors do more harm than good;
- yes, everyone is entitled to see a chiropractor, but before they do, reliable information should be mandatory.
As we have often discussed on this blog, chiropractic spinal manipulations can lead to several complications and can result in vascular injury, including traumatic dissection of the vertebral arteries with often dire consequences – see, for instance, here:
- Chiropractor caused a Vertebral Artery Dissection from a completely unnecessary neck adjustment
- Associations between cervical artery dissection and spinal manipulation
- Chiropractic spinal manipulation is a risk factor for cranio-cervical artery dissection
- Double-sided vertebral artery dissection in a 33-year-old man. The chiropractor is not guilty?
- Vertebral artery dissection in a pregnant woman after cervical spine manipulation
- Chiropractic manipulations are a risk factor for vertebral artery dissections
- Cervical artery dissection and stroke related to chiropractic manipulation
- Vertebral artery dissection after chiropractic manipulation: yet another case
- Pseudoaneurysm of Neck External Carotid Artery Related to Chiropractic Manipulation
- Cervical Arterial Dissections and Association With Cervical Manipulative Therapy
- Chiropractic adjustments are causing more and more strokes in younger adults
- Another case of stroke due to chiropractic
- More about the dangers of chiropractic
- The incidence of severe adverse events after chiropractic spinal manipulative therapy
- Catastrophic injuries after chiropractic treatment
- “As soon as the chiropractor manipulated my neck, everything went black”
This recent paper is a most unusual addition to the list. It is a case report of a 43-year-old woman who was admitted to the emergency department after performing a self-chiropractic spinal manipulation. She experienced headache and vomiting and was unresponsive with severe hypertension at the time of hospital admission. Clinical computerized tomography angiography showed narrowing of the right vertebral artery but was inconclusive for dissection or thrombosis.
The patient died a short while later. At autopsy, subacute dissection of the right vertebral artery was identified along with cerebral edema and herniation. A small peripheral pulmonary thromboembolism in the right lung was also seen. Neuropathology consultation confirmed the presence of diffuse cerebral edema and acute hypoxic-ischemic changes, with multifocal acute subarachnoid and intraparenchymal hemorrhage of the brain and spinal cord.
The authors concluded that this case presents a unique circumstance of a fatal vertebral artery dissection after self-chiropractic manipulation that, to the best of our knowledge, has not been previously described in the medical literature.
The aim of this study was to investigate whether there is a difference in outcome between participants with high compared to low pain self-efficacy (PSE) receiving manual therapy, acupuncture, and electrotherapy.
Participants were stratified into high or low baseline (i) PSE, (ii) shoulder pain and disability index (SPADI), and (iii) did or did not receive the treatment. Whether the effect of treatment differs for people with high compared to low PSE was assessed using the 95% confidence interval of the difference of difference (DoD) at a 5% significance level (p < 0.05).
Treatment was labelled using 3 categories, 2 of which were subcategories of the first
- “Any passive treatment” – any form of manual therapy and/or acupuncture and/or electrotherapy.
- “Any manual therapy” – shoulder or spine joint mobilisations, deep transverse frictions, capsular stretches, trigger point therapy, muscle facilitation, or other techniques listed by the treating physiotherapist.
- “Spinal/shoulder joint mobilisation” – for example, Maitland, Kaltenborn or Mulligan techniques.
To be categorised, treatment must have been delivered by the physiotherapist at least once and may have been delivered in conjunction with other treatments.
Six-month SPADI scores were consistently lower (less pain and disability) for those who did not receive passive treatments compared to those who did (statistically significant less pain and disability in 7 of 24 models). However, DoD was statistically insignificant.
The authors concluded that PSE did not moderate the relationship between treatment and outcome. However, participants who received passive treatment experienced equal or more pain and disability at 6 months compared to those who did not. Results are subject to confounding by indication but do indicate the need for further appropriately designed research.
This analysis suggests that manual therapy, electrotherapy, or acupuncture in addition to advice and exercise offered no improvement in pain or disability at six months, irrespective of PSE. Some patients who receive these treatments experienced more pain and disability at six months compared to those who do not.
I am not aware of compelling evidence that either of these treatments, all of which are often recommended, are effective for shoulder pain, and the results of this new study certainly do not suggest they are. However, as the design of the study was not primarily for this research question, these findings are, of course, merely tentative and need to be investigated further.
Since the introduction of their new Education Standards in March 2023, the General Chiropractic Council (GCC) has been working with chiropractic education providers to support them in implementing the changes to their curricula. Recently, the GCC have stated this:
We expect students to be taught evidence-based practice: integrating individual clinical expertise, the best available evidence from current and credible clinical research, and the values and preferences of patients. Chiropractors are important members of a patient’s healthcare team, and interprofessional approaches enable the best outcomes. Programmes that meet these Standards will teach ethical, professional care and produce competent healthcare professionals who can serve the needs of patients.
These are indeed most encouraging words!
Basically, they are saying that chiropractic education will now have to be solidly based on the principles of evidence-based medicine (EBM) as well as sound medical ethics. Let me spell out what this really means. Chiropractic courses must teach that:
- The current and credible clinical evidence suggesting that spinal manipulations, the hallmark intervention of chiropractors, are effective is weak for back pain and negative or absent for all other conditions.
- The current and credible clinical evidence suggests that spinal manipulations, the hallmark intervention of chiropractors, can cause harm which in many instances is serious.
- The current and credible clinical evidence thus suggests that the risk/benefit balance for spinal manipulations, the hallmark intervention of chiropractors, is not positive.
- Medical ethics require that competent healthcare professionals inform their patients that spinal manipulations, the hallmark intervention of chiropractors, may not generate more good than harm which is the reason why they cannot employ these therapies.
So, the end of chiropractic in the UK is looming!
Unless, of course, the GCC’s words are not really meant to be translated into action. They could be just window dressing and politically correct bullshit. But that’ s really far too far fetched – after all they come from the GENERAL CHIROPRACTIC COUNCIL, known for its excellent track record, e.g.:
- The GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”
- A 5-year strategy for UK chiropractors: not fit for purpose
- Chiro behaving badly… is the GCC fit for purpose?
- The UK General Chiropractic Council: fit for purpose?
- Farcical Chiropractic Council: Chiropractic Patient Satisfaction and Experience
- The General Chiropractic Council “regulates chiropractors to ensure the safety of patients” … well, you could have fooled me!
- Death of a chiropractic patient prompts a reaction by the UK General Chiropractic Council
The risks of chiropractic spinal manipulations (CSMs) feature regularly on my blog, not least because most chiropractors are in denial of this important issue and insist that chiropractic spinal manipulations are safe!!!. I therefore thought it might be a good idea to try and summarize the arguments they often put forward in promoting their dangerously fallacious and quasi-religious belief that CSMs are safe:
- There is not evidence to suggest that CSMs do harm. Such a statement is based on wishful thinking and ignorance motivated by the need of making a living. The evidence shows a different picture.
- There are hundreds of clinical trials that demonstrate the safety of CSMs. This argument is utterly unconvincing for at least two reasons: firstly clinical trials are far too small for identifying rare (but serious) complications; secondly, we know that clinical trials of CSM very often fail to report adverse events.
- Case reports of adverse effects are mere anecdotes and thus not reliable evidence. As there is no post-marketing surveillance system of adverse events after CSMs, case reports are, in fact, the most important and informative source of information we currently have on this subject.
- Case reports of harm by CSMs are invariably incomplete and of poor quality. Case reports are usually published by doctors who often have to rely on incomplete information. It would be up to chiropractors to publish case reports with the full details; yet chiropractors hardly ever do this.
- Case reports cannot establish cause and effect. True, but they do provide important signals which then should be investigated further. It would be up to chiropractors to do this; sadly, this is not what is happening.
- Adverse effects such as arterial dissections or strokes occur spontaneaously. True, but many have an identifiable cause, and it is our duty to find it.
- The forces applied during CSM are small and cannot cause an injury. This might be true under ideal conditions, but in clinical practice the conditions are often not ideal.
- If an arterial dissection occurs nevertheless, it is because there was a pre-existing injury. This argument is largely based on wishful thinking. Even if it were true, it would be foolish to aggravate a pre-existing injury by CSMs.
- Injuries happen only if the contra-indications of CSMs are ignored. This obviously begs the question: what are the contra-indications and how well established are they? The answer is that they are largely based on guess-work and not on systematic research. Thus chiropractors are able to claim that, once an adverse effects has occurred, the incident was due to a disregard of contra-indication and not due to the inherent risks of CSM.
- Only poorly trained chiropractors cause harm. This is evidently untrue, yet the argument provides yet another welcome escape route for those defending CSMs: if something went wrong, it must have been due to the practitioner and not the intervention!
- Chiropractors are an easy target. In my fairly extensive experience in this field, the opposite is true. Chiropractors tend to have multiple excuses and escape routes. As a consequence, they are difficult to pin down.
- Other causes, e.g. car accidents, are much more common causes of vascular injuries. Even if this were true, it does certainly not mean that CSM can be ruled out as the cause of serious harm.
- Patients who experience harm had pre-existing issues. Again, this notion is mostly based on wishful thinking and not based on sound evidence. Yet, it clearly is another popular escape route for chiropractors. And again, it is irresponsible to administer CSM if there is the possibility that pre-existing issues are present.
- The alleged harms of CSMs are merely an obsession for people who don’t really understand chiropractic. That is an old trick of someone trying to defend the indefensible. Chiropractors like to pompously claim that opponents are ignorant and only chiropractors understand the subject area. They use arrogance in an attempt to intimidate or scilence experts who disagree with them.
- Chiropractors do so much more than just CSN. True. They have ‘borrowed’ many modalities from physiotherapy and, by pointing that out, they aim at distracting from the dangers of CSMs. Yet, it is also true that practically every patient who consults a chiropractor will receive a CSM.
- Doctors are just jealous of the success of chiropractors. This fallacy is used when chiropractors run out of proper arguments. Rather than addressing the problem, they try to distract from it by claiming the opponent has ulterior motives.
- Medical treatments cause much more harm than CSM. Chiropractors are keen to mislead us into believing that NSAIDs, for instance, are much more dangerous than CSMs. The notion is largely based on one lousy article and thus not convincing. Even if it were true, it would obviously be no reason to ignore the risks of CSNs.
I am sure my list is far from complete. If you can think of further (pseudo-) arguments, please use the comments section below to let us know.
Chiropractors may have a bad reputation, but that’s all wrong. They are selfless and dedicated to the extend that some of them even offer their services for free! A UK chiropractor, for instance, proundly claims on his website this:
If your spine is not healthy, you are not healthy. Chiropractic care works to help ensure your spine is aligned so that your central nervous system works properly as it controls every single organ, gland, blood vessel and cell in your body. Over the years, Dr Jason (Chiropractor) has seen how chiropractic care goes far beyond pain relief to find the underlying cause of your problem. “I have seen people simply giving up all hope of a life free from pain and illness, then taking an active role in their health and completely turning their own and their families’ quality of life around.”
He also states that:
When complications during delivery led Dr Jason’s (Chiropractor) son Jake to be born via a ventouse birth, his passion for paediatric care was also born. Seeing his son immediately benefit from care inspired him and has led the O’Connor Chiropractic direction to focus on helping Yorkshire families experience wellness. Now, Dr Jason (Chiropractor) has paired a passion for helping children with specialised paediatrics training so he can help children to live life to their full potential.
Children are being offered free spinal checks in Harrogate this weekend.
O’Connor Chiropractic on Station Parade is welcoming visitors for a Christmas party on Saturday (16th December). Families are being invited to attend the family wellness centre for coffee and treats from 7:30am until 12pm. And children are being offered free spinal checks from chiropractor Jason O’Connor alongside an offer for 50% off full assessments.
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The 16th December has long passed, and we all missed the occasion of free spinal checks for our kids.
What a shame!!!
Think of all the subluxations that will now have to remain undiagnosed!
Think of all the Yorkshire families unable to experience wellness now!
Think of all the children unable to live life to their full potential!
PS
To those who are not regulars on my blog, I recommend a few previous posts that put the above into context:
- A chiropractic paper that, in my view, is nothing less than the promotion of child abuse
- Pediatric care by chiropractors borders on child abuse
- Spinal manipulation in children amounts to abuse
- Children are regularly (mis)treated by practitioners who do not have adequate competence to do so
- What are the competencies of a ‘certified paediatric doctor of chiropractic’?
The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:
- education programs that support knowledge and self-care strategies;
- exercise programs;
- some physical therapies, such as spinal manipulative therapy (SMT) and massage;
- psychological therapies, such as cognitive behavioural therapy; and
- medicines, such as non-steroidal anti-inflammatory medicines.
The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:
- lumbar braces, belts and/or supports;
- some physical therapies, such as traction;
- and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.
As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:
Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.
The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.
The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.
Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.
The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.
The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.
The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.
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This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:
WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.
That explains a lot!
It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:
Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.
Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. 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.
Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).
The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.
Why?
Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?
The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.
Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.
