Edzard Ernst

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

Today, several UK dailies report about a review of osteopathy just published in BMJ-online. The aim of this paper was to summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. The authors conducted an overview of systematic reviews (SRs) and meta-analyses (MAs). SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included.

The literature searches revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs covered a wide range of conditions including

  • acute and chronic non-specific low back pain (NSLBP, four SRs),
  • chronic non-specific neck pain (CNSNP, one SR),
  • chronic non-cancer pain (CNCP, one SR),
  • paediatric (one SR),
  • neurological (primary headache, one SR),
  • irritable bowel syndrome (IBS, one SR).

Although with different effect sizes and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving the functional status in acute/chronic NSLBP, CNSNP and CNCP. Due
to the small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headaches and IBS. No adverse events were reported in most SRs. The methodological quality of the included SRs was rated low or critically low.

The authors concluded that based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.

This paper raises several questions. Here a just the two that bothered me most:

  1. If the authors had truly wanted to evaluate the SAFETY of OMT (as they state in the abstract), they would have needed to look beyond SRs, MAs or RCTs. We know – and the authors of the overview confirm this – that clinical trials of so-called alternative medicine (SCAM) often fail to mention adverse effects. This means that, in order to obtain a more realistic picture, we need to look at case reports, case series and other observational studies. It also means that the positive message about safety generated here is most likely misleading.
  2. The authors (the lead author is an osteopath) might have noticed that most – if not all – of the positive SRs were published by osteopaths. Their assessments might thus have been less than objective. The authors did not include one of our SRs (because it fell outside their inclusion period). Yet, I do believe that it is one of the few reviews of OMT for musculoskeletal problems that was not done by osteopaths. Therefore, it is worth showing you its abstract here:

The objective of this systematic review was to assess the effectiveness of osteopathy as a treatment option for musculoskeletal pain. Six databases were searched from their inception to August 2010. Only randomized clinical trials (RCTs) were considered if they tested osteopathic manipulation/mobilization against any control intervention or no therapy in human with any musculoskeletal pain in any anatomical location, and if they assessed pain as an outcome measure. The selection of studies, data extraction, and validation were performed independently by two reviewers. Studies of chiropractic manipulations were excluded. Sixteen RCTs met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale (max = 5). Five RCTs suggested that osteopathy compared to various control interventions leads to a significantly stronger reduction of musculoskeletal pain. Eleven RCTs indicated that osteopathy compared to controls generates no change in musculoskeletal pain. Collectively, these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

It was published 11 years ago. But I have so far not seen compelling evidence that would make me change our conclusion. As I state in the newspapers:

OSTEOPATHY SHOULD BE TAKEN WITH A SIZABLE PINCH OF SALT.

 

 

Spinal cord injury after manual manipulation of the cervical spine is rare and has never been described as resulting from a patient performing a self-manual manipulation on his own cervical spine. This seems to be the first well-documented case of this association.

A healthy 29-year-old man developed Brown-Sequard syndrome immediately after performing a manipulation on his own cervical spine. Brown-Sequard syndrome is characterized by a lesion in the spinal cord which results in weakness or paralysis (hemiparaplegia) on one side of the body and a loss of sensation (hemianesthesia) on the opposite side.

Imaging showed large disc herniations at the levels of C4-C5 and C5-C6 with severe cord compression. The patient underwent emergent surgical decompression. He was discharged to an acute rehabilitation hospital, where he made a full functional recovery by postoperative day 8.

The authors concluded that this case highlights the benefit of swift surgical intervention followed by intensive inpatient rehab. It also serves as a warning for those who perform self-cervical manipulation.

I would add that the case also serves as a warning for those who are considering having cervical manipulation from a chiropractor. Such cases have been reported regularly. Here are three of them:

A spinal epidural hematoma is an extremely rare complication of cervical spine manipulation therapy (CSMT). The authors present the case of an adult woman, otherwise in good health, who developed Brown-Séquard syndrome after CSMT. Decompressive surgery performed within 8 hours after the onset of symptoms allowed for complete recovery of the patient’s preoperative neurological deficit. The unique feature of this case was the magnetic resonance image showing increased signal intensity in the paraspinal musculature consistent with a contusion, which probably formed after SMT. The pertinent literature is also reviewed.

Another case was reported of increased signal in the left hemicord at the C4 level on T2-weighted MR images after chiropractic manipulation, consistent with a contusion. The patient displayed clinical features of Brown-Séquard syndrome, which stabilized with immobilization and steroids. Follow-up imaging showed decreased cord swelling with persistent increased signal. After physical therapy, the patient regained strength on the left side, with residual decreased sensation of pain involving the right arm.

A further case was presented in which such a lesion developed after chiropractic manipulation of the neck. The patient presented with a Brown-Séquard syndrome, which has only rarely been reported in association with cervical epidural hematoma. The correct diagnosis was obtained by computed tomographic scanning. Surgical evacuation of the hematoma was followed by full recovery.

Brown-Séquard syndrome after spinal manipulation seems to be a rare event. Yet, nobody can provide reliable incidence figures because there is no post-marketing surveillance in this area.

THE END?

No, it is the start of the ‘HOMEOPATHY AWARENESS WEEK 2022′!

But, running a quick search for new evidence, I came across an abstract that seems like signaling the end of homeopathy. Here it is in its full beauty:

Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV.

Methods: In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires – all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen’s d) were calculated on the intention-to-treat sample.

Results: Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. Sulphur (17.5%), Natrum muriaticum (15.1%), Calcarea phosphorica (14.3%), Pulsatilla nigricans (10.3%), and Antimonium crudum (7.1%) were the most frequently prescribed medicines; Pulsatilla nigricansTuberculinum bovinum and Natrum muriaticum were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.

Conclusion: There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV. 

And why do I suggest that this signals the end of anything?

Two reasons:

  1. It is a negative study of homeopathy from India, and by Jove, there are not many of those (mind you, the authors did try their best to squeeze in a glimpse of positivity, but I shall ignore this for their benefit [I particularly liked the sentence: “Pulsatilla nigricans, Tuberculinum bovinum and Natrum muriaticum were the most effective of those used” which is remarkable considering that the inter-group results – the only ones that matter in a controlled trial –  were negative).
  2. It was published in the journal ‘HOMEOPATHY‘, the flagship publication of homeopathy.

I reckon that, if this journal (remember, its editor, the late Peter Fisher, fired me from the ed-board because of my criticism of the history of homeopathy) runs out of positive papers and starts publishing negative trials, it must be close to the end.

This study explored the curative effects of remote home management combined with ‘Feng’s spinal manipulation’ on the treatment of elderly patients with lumbar disc herniation (LDH). (LDH is understood by the investigators to be a condition where lumbar disc degeneration or trauma causes the nucleus pulposus and annulus fibrosus to protrude towards the spinal canal and to constrict the spinal cord or nerve root.)

The clinical data of 100 patients with LDH were retrospectively reviewed. The 100 patients were equally divided into a routine treatment group and an interventional group according to the order of admission. The routine treatment group received conventional rehabilitation training, and the interventional group received remote home management combined with Feng’s spinal manipulation. The Oswestry disability index (ODI) and straight leg raising test were adopted for the assessment of the degrees of dysfunction and straight leg raising angles of the two groups after intervention. The curative effects of the two rehabilitation programs were evaluated.

Compared TO the routine treatment group, the interventional group had a remarkably higher excellent and good rate (P < 0.05), a significantly lower average ODI score after intervention (P < 0.001), notably higher straight leg raising angle, surface AEMG (average electromyogram) during stretching and tenderness threshold after intervention (P < 0.001), markedly lower muscular tension, surface AEMG during buckling, and flexion-extension relaxation ratio (FRR; (P < 0.001)), and much higher quality of life scores after intervention (P < 0.001).

The authors concluded that remote home management combined with Feng’s spinal manipulation, as a reliable method to improve the quality of life and the back muscular strength of the elderly patients with LDH, can substantially increase the straight leg raising angle and reduce the degree of dysfunction. Further study is conducive to establishing a better solution for the patients with LDH.

The authors state that “Feng’s spinal manipulation adopts spinal fixed-point rotation reduction to correct the vertebral displacement, and its curative effects have been confirmed in the treatment of sequestered LDH.” This is an odd statement: firstly, there is no vertebral displacement in LDH; secondly, if the treatment had been confirmed to be curative, why conduct this study?

Chart of Feng’s Spinal Manipulative Therapy (FSM). See the difference among the spinal manipulation (SMA), spinal mobilization (SMO) and sham spinal manipulation (SSM).

Moreover, I don’t quite understand how the authors conducted a retrospective chart review and equally divide the 100 patients into two groups treated differently. What I do understand, however, is this:

  1. a retrospective review does not lend itself to conclusions about the effectiveness of any therapy;
  2. no type of spinal manipulation can hope to cure a lumbar disc degeneration or trauma that causes a herniation of the nucleus pulposus and annulus fibrosus.

Thus, I recommend we take this study with a sizable pinch of salt.

The Anglo-European College of Chiropractic (AECC) has been promoting pediatric chiropractic for some time, and I have posted about the subject before  (see, for instance, here). Now the AECC has gone one decisive step further. On the website, the AECC announced an MSc ‘Musculoskeletal Paediatric Health‘:

The MSc Musculoskeletal Paediatric Health degree is designed to develop your knowledge and skills in the safe and competent care of children of all ages. Our part-time, distance-based course blends live online classes with ready to use resources through our virtual learning environment. In addition, you will have the opportunity to observe in the AECC University College clinical services at our Bournemouth campus. The course covers topics in paediatric musculoskeletal practice with specific units on paediatric development, paediatric musculoskeletal examination, paediatric musculoskeletal interventions, and paediatric musculoskeletal management. You will address issues such as risk factors and public health, including breastfeeding, supine sleep in infancy, physical activity in children and conditions affecting the musculoskeletal health of children from birth. The paediatric specific topics are completed by other optional units such as professional development, evidence-based practice, and leadership and inter-professional collaboration. In the dissertation unit you will conduct a study relevant to musculoskeletal paediatric health.

Your learning will happen through a mix of live and recorded lectures, access to online reading materials, and access to the literature through our learning services. You will also engage with the contents taught through guided activities with your peers and staff. Clinical paediatric experience is recommended to fully engage with the course. For students with limited access to a suitable clinical environment to support their studies, or for student who wants to add to their clinical experience, we are able to offer a limited number of opportunities to observe and work alongside our clinical educators within the AECC University College clinical services. Assessments are tailor made to each unit and may include a variety of methods such as critical reviews, reflective accounts, portfolios and in the last year a research dissertation.

___________________________

The AECC emphasizes its commitment to being a leading higher education institution in healthcare disciplines, nationally and internationally recognised for quality and excellence. Therefore, it seems only fair to have another look at the science behind pediatric chiropractic. Specifically, is there any good science to show that would justify a Master of Science in ‘Musculoskeletal Paediatric Health’?

So, let’s have a look and see whether there are any good review articles supporting such a degree. Here is what I found with several Medline searches (date of the review on chiropractic for any pediatric conditions, followed by its conclusion + link [so that the reader can look up the evidence]):

2008

I am unable to find convincing evidence for any of the above-named conditions. 

2009

Previous research has shown that professional chiropractic organisations ‘make claims for the clinical art of chiropractic that are not currently available scientific evidence…’. The claim to effectively treat otitis seems to
be one of them. It is time now, I think, that chiropractors either produce the evidence or abandon the claim.

2009

The … evidence is neither complete nor, in my view, “substantial.”

2010

Although the major reason for pediatric patients to attend a chiropractor is spinal pain, no adequate studies have been performed in this area. It is time for the chiropractic profession to take responsibility and systematically investigate the efficiency of joint manipulation of problems relating to the developing musculoskeletal system.

2018

Some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

What seems to emerge is rather disappointing:

  1. There are no really new reviews.
  2. Most of the existing reviews are not on musculoskeletal conditions.
  3. All of the reviews cast considerable doubt on the notion that chiropractors should go anywhere near children.

But perhaps I was too ambitious. Perhaps there are some new rigorous clinical trials of chiropractic for musculoskeletal conditions. A few further searches found this (again year and conclusion):

2019

We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.

2018

Adding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment-if any-for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.

I might have missed one or two trials because I only conducted rather ‘rough and ready’ searches, but even if I did: would this amount to convincing evidence? Would it be good science?

No! and No!

So, why does the AECC offer a Master of Science in ‘Musculoskeletal Paediatric Health’?

Search me!

It wouldn’t have something to do with the notion that it is good for business?

Or perhaps they just want to give science a bad name?

Anyone who has been following this blog will have noticed that we have our very own ‘resident chiro’ who comments every single time I post about spinal manipulation/chiropractic/back pain. He uses (mostly?) the pseudonym ‘DC’. Recently, DC explained why he is such an avid poster of comments:

” I read and occasionally comment on this blog for two main reasons. 1. In my opinion Ernst doesn’t do a balance reporting on the papers his shares regarding spinal manipulation and chiropractic. Thus, I offer additional insight, a more balanced perspective for the readers. 2. There are a couple of skeptics who occasionally post that do a good job of analyzing papers or topics and they do so in a respectful manner. I enjoy reading their comments. I will add a third. 3. Ernst, from what I can tell, doesn’t censor people just because they have a different view.”

So, DC aims at offering additional insights and a more balanced perspective. That would certainly be laudable and welcome. Yet, over the years, I have gained a somewhat different impression. Almost invariably, my posts on the named subjects cast doubt on the notion that chiropractic generates more good than harm. This, of course, cannot be to the liking of chiropractors, who therefore try to undermine me and my arguments. In a way, that is fair enough.

DC, however, seems to have long pursued a very specific and slightly different strategy. He systematically attempts to distract from the evidence and arguments I present. He does that by throwing in the odd red herring or by deviating from the subject in some other way. Thus he hopes, I assume, to distract from the point that chiropractic fails to generate more good than harm. In other words, DC is a tireless (and often tiresome) fighter for the chiropractic cause and reputation.

To check whether my impression is correct, I went through the last 10 blogs on spinal manipulation/ chiropractic/ back pain. Here are my findings (first the title of and link to the blog in question, followed by one of DC’s originals distractions)

No 1

Chiropractic: “a safe form of treatment”? (edzardernst.com)

“It appears conventional medicine has a greater number of AE. This is not surprising.”
correct!
real doctors treat really sick patients

So the probability of an AE increases based upon how sick a patient is? Is there research that supports that?

No 2

Malpractice Litigation Involving Chiropractic Spinal Manipulation (edzardernst.com)

It would be interesting to know more about these 38 cases that weren’t included since that’s almost half of the 86 cases. What percentage of those cases involved SMT by a non chiropractor?

“Query of the VerdictSearch online legal database for “chiropractor” OR “chiropractic” OR “spinal manipulation” within the 22,566 listed cases classified as “medical malpractice” yielded 86 cases. Of these, 48 cases met the inclusion criteria by featuring a chiropractic practitioner as the primary defendant.”

No 3

Lumbar disc herniation treated with SCAM: 10-year results of an observational study (edzardernst.com)

there are three basic types of disc herniation

contained herniation
non-contained herniation
sequestered herniation

Some add a forth which are:

disc protrusion
prolapsed disc
disc extrusion
sequestered disc

where the first two are considered incomplete (contained) and the last two are called complete (non-contained) but they are all classified as a disc herniation.

You’re welcome

No 4

Multidisciplinary versus chiropractic care for low back pain (edzardernst.com)

Elaborate on what you think was my mistake regarding clinical significance.

No 5

Which treatments are best for acute and subacute mechanical non-specific low back pain? A systematic review with network meta-analysis (edzardernst.com)

An evidence based approach has three legs. If you wish to focus on the research leg, what does the research reveal regarding maintenance care and LBP? Have you even looked into it?

No 6

Meditation for Chronic Low Back Pain Management? (edzardernst.com)

CRITERIA in assessing the credibility of subgroup analysis.

https://www.nature.com/articles/s41433-022-01948-0/tables/1

No 7

Acute Subdural Hemorrhage Following Cervical Chiropractic Manipulation (edzardernst.com)

sigh, my use of the word require was pointing out that different problems require different solutions.

You confuse a lack of concern with my critical analysis of what some use as evidence of serious harm.

I have only used one other identifier on this blog. Some objected to my use of the word Dr in that identifier so I changed it to DC as it wasn’t worth my time to argue with them (which of course DC still refers to Doctor but it seemed to appease them).

In healthcare and particularly in manual therapy we look at increasing comfort and function because most come to us because…wait for it…a loss of comfort and function.

Yes, there is the potential to cause harm, I have never said otherwise. Most case reports suggest that serious harm is due to an improper history and exam (although other reasons may exist such as improper technique). Thus, most cases appear to be preventable with a proper history, exam and technique. That, is a different problem that, yes, requires a different solution.

So yes, spinal manipulation isn’t “required” anymore than physical therapy, NSAIDs, etc for most cases. The question is: does the intervention increase comfort and function over doing nothing and is that justified due the potential risk of harm….benefit vs risk.

Now, i shall excuse my self to prepare for a research presentation that deals with a possible new contraindication to cSMT (because I have a lack of concern, right?)

No 8

Double-sided vertebral artery dissection in a 33-year-old man. The chiropractor is not guilty? (edzardernst.com)

Hmmm, let’s change that a bit…

The best approach is to consider the totality of the available evidence. By doing this, one cannot exclude the possibility that NSAIDs and opioids cause serious adverse effects. If that is so, we must abide by the precautionary principle which tells us to use other treatments that seem safer and at least as effective.

So based upon the totality of the available evidence, which is safer and at least as effective: cervical spinal manipulation vs NSAIDs/opioids?

No 9

Chiropractic spinal manipulation is not safe! (edzardernst.com)

getting the patient to sign something describing the risks. This is apparently something chiropractors don’t do before a neck manipulation.

Apparently?

No 10

Vertebral artery dissection in a pregnant woman after cervical spine manipulation (edzardernst.com)

Most case reports fail on one of two criteria, sometimes both.

1. No clear record of why the patient sought chiropractic care (symptoms that may indicate a VAD in progress or not)

2. Eliminating any other possible causes of the VAD especially in the week prior to SMT.

I would have to search but I recall a case report of a woman presenting for maintenance care (no head or neck symptoms at the time) and after cSMT was dx with a VAD. Asymptomatic VADs are very rare thus there is a high probability that cSMT induced the VAD in that case, IMO.

Although not published I had a dialogue with a MD where a patient underwent a MRI, had cSMT the next day and developed new symptoms thus another MRI was shortly done and was dx with a VAD. I encouraged her to publish the case but apparently she did not.

There was a paper published that looked at the quality of these case reports, most are poor.

__________________________________

I might be mistaken but DC systematically tries to distract from the fact that chiropractic does not generate more good than harm and that there is a continuous flow of evidence suggesting it does, in fact, the exact opposite. He (I presume he is male) might not even do this consciously in which case it would suggest to me that he is full of quasi-religious zeal and unable to think critically about his own profession and creeds.

Reviewing the material above, I also realized that, by engaging with DC (and other zealots of this type), it is I who often gives him the opportunity to play his game. Therefore, I will from now on try harder to stick to my own rules that say:

  • Comments must be on-topic.
  • I will not post comments which are overtly nonsensical.
  • I will not normally enter into discussions with people who do not disclose their full identity.

 

A press release informs us that the World Health Organization (WHO) and the Government of India recently signed an agreement to establish the ‘WHO Global Centre for Traditional Medicine’. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from the Government of India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of people and the planet.

“For many millions of people around the world, traditional medicine is the first port of call to treat many diseases,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”

The term traditional medicine describes the total sum of the knowledge, skills and practices indigenous and different cultures have used over time to maintain health and prevent, diagnose and treat physical and mental illness. Its reach encompasses ancient practices such as acupuncture, ayurvedic medicine and herbal mixtures as well as modern medicines.

“It is heartening to learn about the signing of the Host Country Agreement for the establishment of Global Centre for Traditional Medicine (GCTM). The agreement between Ministry of Ayush and World Health Organization (WHO) to establish the WHO-GCTM at Jamnagar, Gujarat, is a commendable initiative,” said Narendra Modi, Prime Minister of India. “Through various initiatives, our government has been tireless in its endeavour to make preventive and curative healthcare, affordable and accessible to all. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”

The new WHO centre will concentrate on building a solid evidence base for policies and standards on traditional medicine practices and products and help countries integrate it as appropriate into their health systems and regulate its quality and safety for optimal and sustainable impact.

The new centre focuses on four main strategic areas: evidence and learning; data and analytics; sustainability and equity; and innovation and technology to optimize the contribution of traditional medicine to global health and sustainable development.

The onsite launch of the new WHO global centre for traditional medicine in Jamnagar, Gujarat, India will take place on April 21, 2022.

__________________________

Of course, one must wait and see who will direct the unit and what work the new centre produces. But I cannot help feeling a little anxious. The press release is full of hot air and platitudes and the track record of the Indian Ministry of Ayush is quite frankly abominable. Here are a few of my previous posts that, I think, justify this statement:

 

WATCH THIS SPACE!

This randomized, double-blind, two-armed, parallel, single-center, placebo-controlled study investigated the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.

Participants aged > 18 years, with influenza-like symptoms and a positive COVID test were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.

The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.

Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between the two groups (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.

The authors concluded that the results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.

Homeopaths will probably claim that the trial was negative because homeopathic treatments must be individualized (true only for one school of homeopathy). More rational thinkers might point out that the study was woefully underpowered and therefore the positive trends seen in some of the subgroups are nothing other than background noise. Others again might notice that, due to the small sample size, the randomization was not successful in generating comparable groups: the placebo group was older, had more pre-existing conditions, and took more conventional medication than the homeopathy group. And they might point out that these differences could easily explain some of the findings.

Whichever way we turn it, the bottom line is simple:

Homeopathy is ineffective for COVID infections.

Today is the start of chiropractic awareness week 2022. On this occasion the BCA states most categorically: First and foremost, chiropractic is a statutorily regulated healthcare profession, supported by evidence, which offers a safe form of treatment for patients with a range of conditions.  Here I am tempted to cite my friend Simon Singh:

THEY HAPPILY PROMOTE BOGUS TREATMENTS

I am, of course, particularly impressed by the BCA’s assurance of safety. In my view, the safety issue needs to be addressed more urgently than any other in the realm of chiropractic. So, to make a meaningful contribution to the current chiropractic awareness week, I conducted a few Medline searches to identify all publications of 2022 on chiropractic/spinal manipulation risks.

This is what I found:

paper No 1

Objective: Patients can be at risk of carotid artery dissection and ischemic stroke after cervical chiropractic manipulation. However, such risks are rarely reported and raising awareness can increase the safety of chiropractic manipulations.

Case report: We present two middle-aged patients with carotid artery dissection leading to ischemic stroke after receiving chiropractic manipulation in Foshan, Guangdong Province, China. Both patients had new-onset pain in their necks after receiving chiropractic manipulations. Excess physical force during chiropractic manipulation may present a risk to patients. Patient was administered with recombinant tissue plasminogen activator after radiological diagnoses. They were prescribed 100 mg and clopidogrel 75 mg daily for 3 months as dual antiplatelet therapy. There were no complications over the follow-up period.

Conclusion: These cases suggest that dissection of the carotid artery can occur as the result of chiropractic manipulations. Patients should be diagnosed and treated early to achieve positive outcomes. The safety of chiropractic manipulations should be increased by raising awareness about the potential risks.

paper No 2

Spontaneous intracranial hypotension (SIH) still remains an underdiagnosed etiology of new-onset headache. Important risk factors include chiropractic manipulation (CM). We present a case of a 36-year-old Filipino woman who presented with severe bifrontal and postural headache associated with dizziness, vomiting, and doubling of vision. A cranial computed tomography scan was done which showed an acute subdural hematoma (SDH) at the interhemispheric area. Pain medications were given which afforded minimal relief. On history, the headaches occurred 2 weeks after cervical CM. Cranial and cervical magnetic resonance imaging revealed findings supportive of intracranial hypotension and neck trauma, respectively. The patient improved with conservative management. We found 12 articles on SIH and CM after a systematic review of literature. Eleven patients (90.9%) initially presented with orthostatic headache. Eight patients (66.7%) were initially treated conservatively but only 5 (62.5%) had complete recovery. Recovery was achieved within 14 days from start of supportive therapy. Among the 3 patients who failed conservative treatment, 2 underwent non-directed epidural blood patch and one required neurosurgical intervention. This report highlights that a thorough history is warranted in patients with new onset headache. A history of CM must be actively sought. The limited evidence from the case reports showed that patients with SIH and SDH but with normal neurologic examination and minor spinal pathology can be managed conservatively for less than 2 weeks. This review showed that conservative treatment in a closely monitored environment may be an appropriate first line treatment.

paper No 3

Introduction: Cranio-cervical artery dissection (CeAD) is a common cause of cerebrovascular events in young subjects with no clear treatment strategy established. We evaluated the incidence of major adverse cardiovascular events (MACE) in CeAD patients treated with and without stent placement.

Methods: COMParative effectiveness of treatment options in cervical Artery diSSection (COMPASS) is a single high-volume center observational, retrospective longitudinal registry that enrolled consecutive CeAD patients over a 2-year period. Patients were ≥ 18 years of age with confirmed extra- or intracranial CeAD on imaging. Enrolled participants were followed for 1 year evaluating MACE as the primary endpoint.

Results: One-hundred ten patients were enrolled (age 53 ± 15.9, 56% Caucasian, and 50% male, BMI 28.9 ± 9.2). Grade I, II, III, and IV blunt vascular injury was noted in 16%, 33%, 19%, and 32%, respectively. Predisposing factors were noted in the majority (78%), including sneezing, carrying heavy load, chiropractic manipulation. Stent was placed in 10 (10%) subjects (extracranial carotid n = 9; intracranial carotid n = 1; extracranial vertebral n = 1) at the physician’s discretion along with medical management. Reasons for stent placement were early development of high-grade stenosis or expanding pseudoaneurysm. Stented patients experienced no procedural or in-hospital complications and no MACE between discharge and 1 year follow up. CeAD patients treated with medical management only had 14% MACE at 1 year.

Conclusion: In this single high-volume center cohort of CeAD patients, stenting was found to be beneficial, particularly with development of high-grade stenosis or expanding pseudoaneurysm. These results warrant confirmation by a randomized clinical trial.

paper No 4

Background: Manipulation and mobilisation for low back pain are presented in an evidence-based manner with regard to mechanisms of action, indications, efficacy, cost-effectiveness ratio, user criteria and adverse effects. Terms such as non-specific or specific are replaced by the introduction of “entities” related to possible different low back pain forms.

Efficacy: MM is effective for acute and chronic low back pain in terms of pain relief, recovery of function and relapse prevention. It is equally effective but less risky compared to other recommended therapies. MM can be used alone in acute cases and not only in the case of chronic low back pain where it is always and necessarily part of a multimodal therapy programme, especially in combination with activating measures. The users of MM should exclusively be physician specialists trained according to the criteria of the German Medical Association (Bundesärztekammer) with an additional competence in manual medicine or appropriately trained certified therapists. The application of MM follows all rules of Good Clinical Practice.

Adverse effects: Significant adverse effects of MM for low back pain are reported in the international literature with a frequency of 1 per 50,000 to 1 per 3.7 million applications, i.e. MM for low back pain is practically risk-free and safe if performed according to the rules of the European Training Requirements of the UEMS.

paper No 5

Studies have reported that mild adverse events (AEs) are common after manual therapy and that there is a risk of serious injury. We aimed to assess the safety of Chuna manipulation therapy (CMT), a traditional manual Korean therapy, by analysing AEs in patients who underwent this treatment. Patients who received at least one session of CMT between December 2009 and March 2019 at 14 Korean medicine hospitals were included. Electronic patient charts and internal audit data obtained from situation report logs were retrospectively analysed. All data were reviewed by two researchers. The inter-rater agreement was assessed using the Cohen’s kappa coefficient, and reliability analysis among hospitals was assessed using Cronbach’s Alpha coefficient. In total, 2,682,258 CMT procedures were performed in 289,953 patients during the study period. There were 50 AEs, including worsened pain (n = 29), rib fracture (n = 11), falls during treatment (n = 6), chest pain (n = 2), dizziness (n = 1), and unpleasant feeling (n = 1). The incidence of mild to moderate AEs was 1.83 (95% confidence interval [CI] 1.36-2.39) per 100,000 treatment sessions, and that of severe AEs was 0.04 (95% CI 0.00-0.16) per 100,000 treatment sessions. Thus, AEs of any level of severity were very rare after CMT. Moreover, there were no instances of carotid artery dissection or spinal cord injury, which are the most severe AEs associated with manual therapy in other countries.

_______________________________

This is not too bad after all!

Five papers are clearly better than nothing.

What conclusions might be drawn from my mini-review?

I think it might be safe to say:

  1. There is not much but at least some research going on in this area.
  2. The risks of chiropractic/spinal manipulation are real and are being recognized.
  3. BUT NOT BY CHIROPRACTORS! The most remarkable feature of the 5 papers, I think, is that none originates from a chiropractic team.

Thus, allow me to make a suggestion to chiropractors worldwide: Instead of continuing with HAPPILY PROMOTING BOGUS TREATMENTS, what about using the ‘chiropractic awareness week’ to raise awareness of the urgent necessity to research the safety of your treatments?

This paper is an evaluation of the relationship between chiropractic spinal manipulation and medical malpractice. The legal database VerdictSearch was queried using the terms “chiropractor” OR “spinal manipulation” under the classification of “Medical Malpractice” between 1988 and 2018. Cases with chiropractors as defendants were identified. Relevant medicolegal characteristics were obtained, including legal outcome (plaintiff/defense verdict, settlement), payment amount, nature of plaintiff claim, and type and location of the alleged injury.

Forty-eight cases involving chiropractic management in the US were reported. Of these, 93.8% (n = 45) featured allegations involving spinal manipulation. The defense (practitioner) was victorious in 70.8% (n = 34) of cases, with a plaintiff (patient) victory in 20.8% (n = 10) (mean payment $658,487 ± $697,045) and settlement in 8.3% (n = 4) (mean payment $596,667 ± $402,534).

Over-aggressive manipulation was the most frequent allegation (33.3%; 16 cases). A majority of cases alleged neurological injury of the spine as the reason for litigation (66.7%, 32 cases) with 87.5% (28/32) requiring surgery. C5-C6 disc herniation was the most frequently alleged injury (32.4%, 11/34, 83.3% requiring surgery) followed by C6-C7 herniation (26.5%, 9/34, 88.9% requiring surgery). Claims also alleged 7 cases of stroke (14.6%) and 2 rib fractures (4.2%) from manipulation therapy.

The authors concluded that litigation claims following chiropractic care predominately alleged neurological injury with consequent surgical management. Plaintiffs primarily alleged overaggressive treatment, though a majority of trials ended in defensive verdicts. Ongoing analysis of malpractice provides a unique lens through which to view this complicated topic.

The fact that the majority of trials ended in defensive verdicts does not surprise me. I once served as an expert witness in a trial against a UK chiropractor. Therefore, I know how difficult it is to demonstrate that the chiropractic intervention – and not anything else – caused the problem. Even cases that seem medically clear-cut, often allow reasonable doubt vis a vis the law.

Apologists will be quick and keen to point out that, in the US, there are many more successful cases brought against real doctors (healthcare professionals who have studied medicine). They are, of course, correct. But, at the same time, they miss the point. Real doctors treat real diseases where the outcomes are sadly often not as hoped. Litigation is then common, particularly in a litigious society like the US. Chiropractors predominantly treat symptoms like back troubles that are essentially benign. To create a fair comparison of litigations against doctors and chiros, one would therefore need to account for the type and severity of the conditions. Such a comparison has – to the best of my knowledge – not been done.

What has been done, however – and I did previously report about it – are comparisons between chiros, osteos, and physios (which seems to be a more level playing field). They show that complaints against chiros top the bill.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives

Categories