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

pain

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A Winnipeg woman is suing her chiropractor, claiming he injured her by tearing an artery during treatment and that she suffered a stroke as a result. The woman had been a patient at Maples Chiropractic in Winnipeg for some time, and she had previously indicated that she did not want the chiropractor treating or adjusting her neck. In May 2023, the patient suffered a right vertebral artery dissection as a result of treatment. “Due to this injury from the treatment, [the plaintiff] suffered a stroke,” says the statement of claim, filed late last month in Court of King’s Bench at Winnipeg.

Maples Chiropractic is claimed to have failed to give the patient immediate care to minimize the effects of her injury. The patient was admitted to hospital at the Health Sciences Centre. The allegations have not been tested in court and statements of defence have not yet been filed. The lawsuit names as defendants the chiropractor, Gilbert Miranda, and his company, Everybody Health Inc., which operates Maples Chiropractic. The lawyer for the plaintiff declined to comment on the case.

The claim states that the patient will need ongoing therapy, psychological treatment and medical attention. It seeks an unspecified amount in damages for the patient’s alleged pain and suffering, loss of income and loss of enjoyment of life. The chiropractor allegedly failed to warn the patient about the risks associated with the chiropractic treatment, “specifically failing to warn her that a stroke could occur from the treatment or from any injury caused by the treatment”. The claim states that the chiropractor was negligent for not obtaining informed consent from the plaintiff about the treatment in general, and specifically for the treatment that allegedly resulted in injury.

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Let me be clear: this case report – like so many similar ones – lacks important details and thus cannot be interpreted properly. Chiropractors will therefore claim – as they did so many times before – that the case does not amount to evidence. They will also pretend that chiropractic manipulations are safe and that there is no sound evidence to prove otherwise. They can make this claim because the chiropractic profession has – since ~120 years! – resisted adopting an adequate monitoring system for registering events like the one above.

And let me be clear again: such claims by chiropractors are based on self-interest and willful ignorance, polite expressions for ‘dishonesty’.

Yes, it’s CAW again!

How best should we celebrate?

  • I could show you how often we had to discuss the harm chiropractic does to patients.
  • I could tell you about the contraproductive advice chiropractors tend to issue to anyone who wants to hear it.
  • I could list the fatalities chiropractic manipulations have caused.
  • I could write about the unethical transgressions many chiropractors commit.
  • I could elaborate on the financial fraud some chiropractors are involved in.
  • I could write about the dishonest cherry-picking that chiropractors like to engage in.

But that would not be nice, and they would say that I have an axe to grind, a chip on my shoulder, that I am incompetent, don’t know what I am writing about, in the pocket of BIG PHARMA, etc.

So, I decided to celebrate the CAW by reporting on a chiropractic success story, a type of article that chiropractors like: a case report of a patient cured by chiropractic treatments.

Chronic low back pain (CLBP) has been the leading cause of disability globally for the past few decades, resulting in decreased quality of life physically and emotionally. This case report is, according to its authors, important in the medical literature to add to studies reporting successful conservative treatment of CLBP and chronic neck pain (CNP). Triage, diagnosis, and understanding of economical and conservative therapeutics can, the authors stress, benefit patients; providers as well as institutions and third party payors benefit from improved outcomes.

A 39-year old male presented with severe CLBP who had experienced no long-term success with prior chiropractic spinal manipulative therapy (SMT). After symptoms began to worsen in spite of receiving SMT, the patient sought treatment for his pain, abnormal spine alignment, and poor sagittal alignment at a local spine facility. History and physical examination demonstrated altered spine and postural alignment including significant forward head posture and reduced cervical and lumbar lordosis and coronal plane abnormalities. Treatment consisted of a multi-modal regimen focused on strengthening postural muscles, specific spine manipulation directed toward abnormal full-spine alignment, and specific Mirror Image traction aiming to improve spine integrity by realigning the spine toward a more normal position. The treatment consisted of 36 treatments over three months. All original tests and outcome measures were repeated following care.

Objective and subjective outcome measures, patient-reported outcomes, and radiographic mensuration demonstrated improvement at the conclusion of treatment and maintained at 1-year follow-up re-examination.

The authors concluded that this is case demonstrates that the CBP orthopedic chiropractic treatment approach may represent an effective method to treat abnormal spinal alignment and posture. This study adds to the literature regarding conservative methods of treating spine pain and spinal disorders.

What, you are NOT impressed?

  • You even claim that the patient’s symptoms worsend despite long-term SMT?
  • You insist that such a case poves nothing and certainly does not justify the conclusion?
  • You point out that one of the authors is a compensated researcher for CBP Non-Profit, Inc., while another one is a compensated consultant and researcher for Chiropractic BioPhysics, NonProfit, Inc. and one is the CEO of Chiropractic BioPhysics® (CBP®)?
  • And you note that this paper was funded by Chiropractic BioPhysics?

Let me tell you this: you are a spoilt sport! We are, after all, in the realm of chiropractic research where things are different. What is normally called promotion florishes here as research, and the rules of science, ethics or even common sense are suspended.

Dysmenorrhea affects 40–80% of women causing discomfort, pain and absenteeism. This study aimed to evaluate the effectiveness of shiatsu massage and abdominal stretching exercises in reducing primary dysmenorrhea among adolescent girls.

A quasi-experimental design with a pre-post test two-group comparison was employed. Sixty-six adolescent girls
with primary dysmenorrhea were purposively selected and divided into two groups: one received shiatsu massage therapy, and the other performed abdominal stretching exercises. Data were analyzed using the Wilcoxon and Mann-Whitney tests with a significance level set at p < 0.05.

The results showed that both interventions significantly reduced menstrual pain (p = 0.000). However, the shiatsu group experienced a greater average pain reduction (2.36 points) compared to the stretching group (1.55 points).

The authors concluded that their results of this study indicate that shiatsu massage therapy demonstrates a greater effectiveness in alleviating primary menstrual pain, commonly referred to as dysmenorrhea, when compared to abdominal stretching exercises, exhibiting a notable difference of 0.8 points in pain reduction between the two interventions.

The authors also offer the following suggestion: This intervention can be used in midwifery and healthcare settings, with Shiatsu materials serving as educational tools for adolescents on dysmenorrhea and reproductive health.

In my recent book, I reviewed the evidence on shiatsu (for references, see the original): It is a (mostly) manual therapy that was popularised by Japanese Tokujiro Namikoshi (1905–2000). It developed out of the Chinese massage therapy, ‘tui na’. The word shiatsu means finger pressure in Japanese; however, a range of devices is also being promoted for shiatsu. In 1940, Tokujiro Namikoshi established the Japan Shiatsu College in Tokyo. He taught many practitioners, some of whom subsequently developed their own version of shiatsu. Shiatsu follows the principles of Traditional Chinese Medicine based on chi, meridians, yin and yang, etc. These are philosophical concepts at best but lack scientific and biological plausibility. The amount of pressure used during treatment can be considerable and therefore, Shiatsu is experienced by some patients as (mildly) painful. Shiatsu is a treatment which includes not just the pressure applied by the therapist at specific points but also awareness of body posture, breathing and exercise. Shiatsu is claimed to stimulate the body’s vital energy. One observational study concluded that “clients receiving shiatsu reported improvements in symptom severity and changes in their health-related behaviour that they attributed to their treatment, suggestive of a role for shiatsu in maintaining and enhancing health.” A similar study observed a wide range of common, immediate and longer term effects. These included effects on initial symptoms, relaxation, sleeping, posture, and experiences of the body. There have been very few controlled clinical trials. One low-quality trial suggested that shiatsu massage seems to be effective in managing agitation in mechanically ventilated patients . A systematic review found no convincing data to suggest that shiatsu is effective for any specific health condition. Even though some patients experience the treatment as painful, Shiatsu is generally considered to be a safe therapy. It is, however, not totally free of risks. One observational study found that 12–22% “of patients reported ‘negative effects’ after shiatsu treatment,” and several case reports have associated Shiatsu also with serious complications (END OF QUOTE).

Because ther are so few studies of shiatsu, every new trial is potentially valuable. The present study, however, is a disappointment in this respect. It did not make the slightest attempt to control for any type of bias. Its findings are thus entirely meaningless. Most likely, they have little or nothing at all to do with the treatments administered but are due to placebo effects, natural history of the condition, selection bias, etc.

My suggestion, therefore, differs dramatically from that of the authors: if you suffer from dysmenorrhea – or, indeed, any other condition – you are well advised to avoid implausible and unproven treatments and opt for one of the many therapies thaat are supported by sound evidence.

 

A popular ‘TikTok creator’ claims that he became bedridden for months after a chiropractic adjustment to his neck left him with a herniated disc, causing him “the worst pain I’ve ever experienced” and the loss of his life savings in medical bills. Tyler Stanton, a Nashville-based ‘content creator’ stated that he’s been recovering from an injury sustained when a chiropractor adjusted his neck.

In a TikTok video Stanton said he’d been working out a lot before his birthday because “I wanted to be in the best shape of my life.” He’d been feeling some tightness in his back, so he went to see a chiropractor. At first, the chiropractor struggled to “get my back to crack,” but finally he was able to do it. Stanton said when they had the same trouble with his neck, “on the second time where he tried to crack my neck, he put a lot of force behind it, and I heard one huge and painful pop,” Stanton explained. “I knew immediately that something was wrong … the whole room was spinning. My equilibrium was just completely f—ked. I was like instantly, like, profusely sweating.”

It took him a half hour of lying down to “be good enough to walk out the door,” but as soon as he got home, he began “violently throwing up, uncontrollably. I can’t see straight.” Stanton says he went promptly to bed even though it was the middle of the day, and when he woke up the next morning moving to turn his phone alarm off caused him “the worst pain I’ve ever experienced in my entire life.” Stanton described it as “static” all over the “entire right side of my body. It was really scary, I had no idea what was happening, but I knew something was really wrong.”

He went to the hospital, where it was determined that the chiropractor had “herniated my C6,” the disc at the base of the neck. Over the next month, he spent a few weeks “on and off” in the hospital, because the “pain was so bad.” He received epidural injections, and “they didn’t even make a dent into the pain. Like, it literally did nothing.”

At this point, his options were surgery — which he said, “I’ve heard so many horror stories about that” — or physical therapy and learning to live with a herniated disc. He chose the second option, explaining he has a “a pharmacy” at home of pain medication. “I ended up just having to go home and lay down for about two more months. It took, like, three months to get my feeling back in my arm.”

He thought of legal action, as the injury “really hurt me financially …  my savings just evaporated … I still deal with pain. I’m still limited on what I can do physically. It just destroyed me mentally, financially, physically — all of it.”

In a later update Stanton said that it’s been hard for him to create content since he herniated his disc. “People asking me why I keep disappearing and why I stopped posting … I didn’t really want to say much about it because one thing I’ve learned over the years being on the internet is that if you have a following, no one cares if you’re sad,” he said. “To be honest with you, I love to come on here and make you guys laugh, but it’s hard to when s—t just ain’t funny.”

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Having treated many patients with herniated discs, I can confirm: it’s not funny!

Having read about many cases of serious complications after chiropractic manipulations, I assume that this one – like so many others – will not enter into the medical literature where sufficient details might be provided to allow a fuller evaluation – doctors are simply too busy to write up the events and findings for publication. The case will also not appear in any system that monitors adverse events, because chiropractors have in their ~120 Years history not been able to establish such a thing. The result will be that this event – as so many like it – will pass virtually undocumented and unnoticed.

And this suits whom exactly?

Yes, it suits the chiros who can continue to falsely claim that, as there are just few records to the contrary,

“our maipulations are entireely safe!”

Yes, this was the (rather sensationalist) headline of a recent article in the Daily Mail that I allegedly wrote. Its unusual genesis might interest some of you.

I was contacted by a journalist who asked for a telephone interview on the subject of chiropractic as well as my recent book. I agreed under the condition that we do this not over the phone but in writing via email. So, he sent me his questions and I supplied the responses; here they are:

 

· What’s the absolute worst case scenario of seeing a chiropractor?

The worst that can happen is that you die. Certain manipulations that chiropractors regularly do can injure an artery that supplies part of the brain. This would then result in a stroke; and a stroke can of course be fatal. This is what happened, for example, to the American model Katie May. She had pinched a nerve in her neck on a photoshoot and consulted a chiropractor who manipulated her neck. This caused a tear to an artery in her upper spine. The result was a massive stroke of which she died a few days later.

· How did you first become interested in the topic?

I learned hands on spinal manipulation as a junior doctor. Later, as the head of the department of Physical Medicine and Rehabilitation at the University of Vienna, we used such techniques routinely. In 1993, I became chair of Complementary Medicine in Exeter, and my task was to scientifically investigate alternative therapies such as chiropractic. Recently, I decided to summarize all our research in a book.

· What did you learn from your research?

In essence, our investigations found that almost all the claims that chiropractors make are unsubstantiated. Their manipulations are not nearly as effective as they claim. More worryingly, they are also not free of risks. About 50% of patients who see a chiropractor suffer from side effects after spinal manipulation. These are usually not severe and disappear after 2 or 3 days. But, in addition, very serious complications like stroke, death, bone fractures, paralysis can also occur. Chiropractors say that these are rare, and I hope they are right, but the truth is that nobody knows because there is no system of monitoring such events. We once asked British neurologists to report cases of neurological complications occurring within 24 hours of cervical spine manipulation over a 12-month period. This unearthed a total of 35 cases. Particularly striking was the fact that none of these cases had previously been reported anywhere. So, the underreporting was exactly 100%. This tells me that, when chiropractors claim there are just a few such incidents, in truth there might be a few hundred or even thousand.

· Is there an especially shocking finding?

What I find particularly unnerving is the way chiropractors regularly disregard medical ethics. Take the issue of informed consent, for example. It means that we all have to fully inform patients about the treatment we plan to give. In the case of chiropractic spinal manipulation, it would need to include that the therapy is of doubtful effectiveness, that other options are more likely to help, and that the treatment carries very frequent minor as well as probably rare major risks. I do understand why chiropractors do often not provide this information – it would chase away most patients and thus impact of their income. At the same time, I feel that chiropractors should not be allowed to violate fundamental principles of medical ethics. This is not in the interest of patients!!!

· Why do you think patients are so keen on chiropractors?

I am not sure that they really are so keen; some are but the vast majority are not. Our own research suggests that, depending on the country, between 7 and 33% of the population see chiropractors. This means that between 93 and 67% have enough sense to avoid chiropractors.

· But what does the evidence actually show about the efficacy of chiropractic?

As it happens our most recent summary has just been published. It concluded that “it is uncertain if chiropractic spinal manipulation is more effective than sham, control, or deep friction massage interventions for patients with headaches” [Is chiropractic spinal manipulation effective for the treatment of cervicogenic, tension-type, or migraine headaches? A systematic review – ScienceDirect]. For other conditions the evidence tends to be even less convincing. The only exception might be chronic low back pain, according to another recent summary [Analgesic effects of non-surgical and non-interventional treatments for low back pain: a systematic review and meta-analysis of placebo-controlled randomised trials | BMJ Evidence-Based Medicine]. But here too, I would argue that other treatments are safer and cheaper.

· Are some chiropractors worse than others?

The profession is divided into 2 groups, the ‘straights’ and the ‘mixers’. The former believe in all the nonsense their founding father, DD Palmer, proclaimed 120 years ago, including that spinal manipulation is the only treatment for virtually all our ailments, and that vaccinations must be avoided at all cost. The mixers have realized that Palmer was a charlatan of the worst kind, focus on musculoskeletal conditions and use treatments borrowed from physiotherapy. Needless to say that the mixers might be bad, but the straights are even worse.

· What can patients do to keep safe?

Avoid chiropractors, go to a library and read my book.

· If you have backpain or joint pain what can you do instead?

There is lots people can do but advice has to be individualized. By far the best is to prevent back pain from happening. Here advice might include more exercise, loosing weight, changing your mattress, avoiding certain things like heavy lifting, etc. If you are acutely suffering, see a physio or a doctor, keep moving and be aware that over 90% of back pain disappears within a few days regardless of what you do.

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I had insisted that I see his edits before this gets published, and a little while later I received the edited version. To my big surprise, the journalist had transformed the interview into an article allegedly authored by me. I told him that I was uncomfortable with this solution, and we agreed that he would make it clear that the article was merely based on an interview with me. I then revised the article in question and the result was the mentioned article published still naming me as its author but with a footnote: “As told in an interview with Ethan Ennals”

Never a dull day when you research so-called alternative medicine!

I has been reported that a man is pleading to steer clear of chiropractors. Last year, Tyler Stanton endured “the worst pain I had ever experienced in my life,” a hospital stay, and the beginning of an ongoing struggle that has left him unable to work. All started immediately after a chiropractor cracked his neck — and something popped.

After adjusting Stanton’s back, the chiropractor moved on to his neck. “It didn’t crack on the first time. On the second time where he tried to crack my neck, he put a lot of force behind it, and I heard one huge and painful pop. I knew immediately that something was wrong.” Stanton recalled that when he tried to sit up, the room began to spin. “My equilibrium was just completely f—ked. I was instantly, profusely sweating.”

After laying on the table for half an hour, Stanton made the short trip back to his home, where he became “violently ill.” Throwing up uncontrollably and unable to see straight, he got into bed, hoping rest would alleviate his symptoms. The following morning, Stanton woke up to “the worst pain I had ever experienced in my life. The entire right side of my body was numb. It was really scary.”

He was taken to the hospital, where he was diagnosed with a herniated disc between the C5 and C6 vertebrae in his neck. Due to the acute pain he was experiencing, he stayed in the hospital for several weeks. “They ended up giving me epidural injections into my spine, and they didn’t even make a dent into the pain,” he said. Ultimately, doctors gave him two choices: spinal fusion therapy or physical therapy to manage his discomfort.

Fearful of the consequences of surgery, Stanton opted for PT. “I had a pharmacy of pain medication to help the nerves be less inflamed so I can get mobility and feeling back into the right side of my body. Essentially, I just had to go home and lay down for about two more months.”

Unable to work, Stanton burned through his savings, and six months into his recovery, he is just beginning to regain sensation in his right arm. “I still deal with pain. I’m still limited in what I can do physically. It just destroyed me. Mentally, financially, physically, all of it.” With limited mobility and mounting medical bills, Stanton is consulting with lawyers and considering legal action. “I kinda feel like I just don’t have another choice because this really just derailed my entire life overnight,” he said.

While proponents say chiropractors help alleviate pain, many doctors describe the field as pseudoscience — and warn that it can actually lead to serious problems. ““There are reports of severe side effects with chiropractic treatment, including blood clot formation, herniated discs, fractures, artery dissection, stroke, paralysis, and death,” explained Gbolahan Okubadejo, MD, a spinal surgeon and the head of The Institute for Comprehensive Spine Care. Dr. Charles R. Wira III, an emergency medicine doctor at Yale Medicine, told the Huffington Post that there’s a known link between chiropractic neck manipulations and major artery tears that can cause strokes. “Thankfully, overall the incidence of neck dissections are small,” he said. “But intentional and aggressive manipulations of the neck merits strong consideration for concern.” Cardiologist Dr. Danielle Belardo said she was “heartbroken” to see a young patient with “dissection of the vertebral artery” following a neck adjustment. “How can we live in a world where it’s legal to perform something with zero evidence for benefit (neck adjustment from a chiro) when there are such incredibly dangerous and life changing risks?” she wrote on Twitter. “[My patient] trusted a licensed healthcare practitioner to provide care that has more benefit than harm. This is a disgrace.”

Stanton hopes his story can serve as a warning for others. “I think it’s important that I share this story because I just don’t want what happened to me to happen to someone else,” he said. “Please don’t go to the chiropractor, OK? If I can do anything with my platform to share the story and save somebody from experiencing what I had to experience, then hopefully, something positive can come out of what I went through. Please hear me when I say this: Please be careful. This is the last thing that you want to experience.”

In a disturbing parallel, a young woman who felt a “crack to her neck” during a gym workout in 2021 died weeks later after going to a chiropractor to treat her neck pain. In 2022, a Georgia woman became paralyzed after a routine neck adjustment ended up rupturing her spinal arteries in several spots. In 2023, an Australian man suffered a stroke after cracking his neck in an ill-advised attempt to cure his chronic back pain.

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None of these are proper case reports in a medical sense, of course. Such publications are relatively rare.

I wonder why.

Could it be related to the fact that many chiropractors are in denial and, as a profession, they still have no adequate monitoring system for adverse event?

Patients with headaches often seek so-called alternative medicine (SCAM), including chiropractic care. Chiropractic spinal manipulation is one of the most commonly used techniques for these patients; however, its effectiveness remains unclear. This systematic review aimed to evaluate the effectiveness of chiropractic spinal manipulation in reducing headache days, episode duration, episode intensity, and medication intake in patients with headaches.

MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to April 2024. PICO search strategy was used to identify randomized controlled trials applying chiropractic spinal manipulations versus sham manipulation, no additional intervention, or other conservative non-pharmacological interventions in patients with headaches. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with Physiotherapy Evidence Database scale, and risk of bias with Cochrane Collaboration tool. Certainty of the evidence was evaluated using GRADE approach.

Eight studies ranging from low to high methodological quality were included. The results were categorized into three subgroups: chiropractic manipulation versus sham, chiropractic manipulation versus control, and chiropractic manipulation versus deep friction massage. Among the five studies comparing chiropractic manipulation to sham, two found a significant reduction in the number of headache days. Of the three studies comparing chiropractic manipulation to another control, one reported a decrease in headache episode duration. No significant differences were observed for any other variable across the subgroups. The certainty of evidence was downgraded to very low.

We concluded that it is uncertain if chiropractic spinal manipulation is more effective than sham, control, or deep friction massage interventions for patients with headaches.

These conclusions might not surprise many readers. Yet, in at least one way, they are quite surprising: the version of the article we submitted to the ‘European Journal of Integrative Medicine’ had a substantially different conclusion; it was as follows:

chiropractic spinal manipulation does not generate benefits for patients suffering from headaches.

What happened?

You may well ask!

The journal wanted us to change our conclusion! Because the main authors of our paper needed, for academic reasons, to publish without any further delay, they agreed to the demand. As far as I remember, such a thing  is unprecedented in my ~50 years of publishing research in medical journals.

PS

It is also the last time I will have any dealings with the European Journal of Integrative Medicine

In a recent post, I mentioned a new report which allegedly claimed that “employing chiropractors in the [English] health service could save £1.5 billion“. Thanks to ‘Blue Wode’, we can now read the original report, and I had a critical look at it. Here are some quotes of crucial passages from the report:

The objective of this analysis was to establish how chiropractors could help to address the unmet need of people with MSK [musculoskeletal] conditions, who are currently absent from work due to these conditions, on NHS MSK physiotherapy waiting lists …

To assess the available evidence on the relative effectiveness of chiropractors, physiotherapists and osteopaths a pragmatic literature review was undertaken. This consisted of a rapid, pragmatic search of existing literature evidence to explore the effectiveness of chiropractic interventions (in terms of productivity/return to work) compared with physiotherapists and/or osteopaths … The strategies were not designed to be ‘comprehensive’ but focused to target records for relevant studies whilst retrieving record numbers that were manageable within the project timescales and available resources…

The results of the analysis are based on the assumption that there are equivalent work-related outcomes associated with MSK physiotherapy and chiropractic care…

1,270 records were retrieved from the database searches and 41 records were sent by the BCA. 101 duplicates were removed, and the remaining 1,210 references were screened for inclusion. 18 studies met the eligibility criteria and were included in data extraction (see Appendix B for the study flow diagram). Included studies had the following study designs: five systematic reviews [29-32] (of which one was only a summary [33]), three non-systematic reviews [34, 35] with one running a meta analysis [36], five randomised controlled trials [37-41], three cohort studies [42-44], and two case series studies [26, 45]…

A pragmatic review of literature found that evidence of the effectiveness of chiropractors in helping people with MSK conditions to get back to work is sparse and poor quality. There is weak evidence to suggest that chiropractors treating MSK conditions would be able to achieve equivalent return-to-work outcomes as physiotherapists. If more robust evidence could be developed, it is feasible that chiropractors could be used to address supply shortages in treatment for MSK conditions. This would require the NHS to consider closely the clinical governance arrangements it would need to put in place to ensure patient safety. It would also need to review the type of treatment and advice that chiropractors were able to provide for people with MSK conditions.

The initial analysis carried out for this study estimated that there are almost 1.6 million people unable to work due to an MSK condition in the UK. Spare capacity in the chiropractic profession indicates that around 114,000 more people per year could be treated by chiropractors. This represents around 7% of the current waiting list. Chiropractors have an average waiting time of 1.5 weeks compared with a minimum of 11 weeks for physiotherapists.

If the spare chiropractor capacity was used to address MSK conditions preventing people from working, then this could improve workforce productivity by reducing the time people are waiting for treatment. Adopting a simple analysis, assuming that all of the spare capacity could be used in the most efficient way, the estimated value of the improvement in productivity is £612 million per year. Using the Markov model to factor in a wider range of potential outcomes provides a more conservative, more robust estimated value of £399 million per year. If minimum rather that median wages are used to value the productivity gain based on an 11 week wait then it would reduce to £258 million.

A range of factors may increase or decrease the potential productivity gains. If the 11-week waiting time for physiotherapists is an under-estimate and the waiting times are 18 or 24 weeks, then the productivity gain would increase to £713 million and £1 billion respectively.

This analysis focused on productivity costs only, but people may also potentially have better health outcomes and lower treatment costs if they are treated more quickly.

Recommendations
Key recommendations emerging from this research are:

  • The NHS should consider commissioning pilot research studies to generate evidence to make the case for the use of chiropractors in providing treatment for people with MSK conditions to allow them to return to work more quickly.
  • The NHS should consider how the potential use of chiropractors to provide treatment and advice for people with MSK conditions can help to address the demand, capacity and financial challenges facing the health and social care system. This would need to be within the constraints of clinical guidelines and governance, to ensure safety and effective outcomes.

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And here are a few critical points:

  • What on earth is a “pragmatic literature review”; was the term invented to disguise tha fact that the review is not systematic and thus is a bonanza in cherry-picking? I had a look at the cited literature and can confirm that any critical assessment of chiropractic has been excluded.
  • “The results of the analysis are based on the assumption that there are equivalent work-related outcomes associated with MSK physiotherapy and chiropractic care.” Are you kidding me? I thought the aim was to “assess the available evidence on the relative effectiveness of chiropractors, physiotherapists and osteopaths”. How can you then assume equivalent outcomes as a basis for conducting the research?
  • “Included studies had the following study designs: five systematic reviews [29-32] (of which one was only a summary [33]), three non-systematic reviews [34, 35] with one running a meta analysis [36], five randomised controlled trials [37-41], three cohort studies [42-44], and two case series studies [26, 45].” So, just 5 RCTs are the basis of the evaluations? What did you do with the dozens of other RCTs in this area? Did they perhaps not fit your conclusions?
  • “If more robust evidence could be developed, it is feasible that chiropractors could be used to address supply shortages in treatment for MSK conditions.” However, I predict that more robust evidence will show the opposite of what you seem to wish!
  • “Ensure patient safety”. Yes, thanks for mentioning safety. The report neglects safety completely. In view of the known risks of chiropractic this seems a serious mistake!
  • “The estimated value of the improvement in productivity is £612 million per year.” From my comments above, it follows that this wild and largely unsubstantiated estimate was guided by little more than wishful thinking.
  • “This analysis focused on productivity costs only, but people may also potentially have better health outcomes and lower treatment costs if they are treated more quickly.” More likely people experience health outcomes that are very similar to those of doing nothing at all. In this case, it would follow that a lot of money might be saved if we scrap MSK treatments altogether.

This report is a transparent and dilettante attempt to push more chiropractic on the NHS, a move that would not improve much and could even put a few patients in wheelchairs.

This “randomized controlled clinical trial” (has anyone ever seen a randomized trial without a control group? – No, therefore, the correct term is “ramdomized clinical trial (RCT)”) aimed to compare the effectiveness of wet cupping therapy (WCT) and Acupuncture in treating migraine patients. It was conducted between 01.03.2022 and 01.10.2023 in a Traditional and Complementary Medicine Center of a tertiary hospital. Patients diagnosed with migraine were included in the study and randomized into three groups.

  • The WCT group received wet cupping 3 times, once a month.
  • The acupuncture group received 10 sessions of acupuncture once a week.
  • The waiting list group served as the control group.

VAS and MIDAS scales were used for all groups at the beginning and the end of the treatment, and the results were compared.

Initially, 168 patients were enrolled. However, there were some dropouts throughout the study period. In the acupuncture group, 11 patients did not attend subsequent sessions, with one dropout occurring due to adverse effects. In the wet cupping (WCT) group, three patients discontinued their participation following the initial treatment. Ultimately, a total of 153 patients were included.

The findings show that all three groups were similar regarding age and sex. Migraine Disability Assessment Scale (MIDAS) and Visual Analogue Scale (VAS) pain scores decreased significantly in both treatment groups after the applications, while they remained similar for the same period in the control group. Additionally, the post-treatment values of MIDAS and VAS in both the WCT and acupuncture groups were significantly lower compared to controls, while they were similar when compared in between.

The authors concluded that both of these applications were found to be similarly effective in improving disability status and pain intensity in patients with migraine.

I beg to differ!

Apart from all other flaws of this trial, it did not control for placebo effects. Both WCT and acupuncture are invasive treatments that are bound to cause sizeable placebo responses. The waiting list control might account for the natural history of the disease and for regression towards the mean, but it is not a method for allowing for placebo effects. In view of this fundamental limitation of the study, its conclusions should be re-written as follows:

Both of these applications were similarly effective in producing sizeable placebo effects which in turn improved disability status and pain intensity in patients with migraine.

For migraine patients, this means that neither of these therapies are likely to be the best available option.

Recently, several papers reported about PP353 as a new ‘wonder drug’ for chronic low back pain (cLBP). The reason is that Persica Pharmaceuticals Limited (Persica) announced positive results of a randomised, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with chronic low back pain (cLBP). PP353 is a specifically formulated combination of linezolid, iohexol and a thermosensitive gel that is injected into the degenerate lumbar disc, delivering prolonged exposure of a high concentration at the site of infection. A 2-dose regime (dosed 4 days apart) is said to eliminate the infection, thus addressing the underlying cause of cLBP which is claimed to be an infection.

Intradiscal administration of 3 mL of PP353 has been reported to be well-tolerated and based on the pharmacokinetics following a single injection, a two-dose regimen of PP353 (150 mg linezolid) on Day 1 and Day 5 ± 1 was selected to explore safety, tolerability, pharmacokinetics, and efficacy in Part B of the Persica 002 study.

The abovementioned efficacy trial enrolled 44 patients who had suffered from cLBP for more than 6 months (mean duration of 5.5 years) and had not been helped by existing non-surgical treatments. They were randomized to receive either PP353 or placebo injected into intervertebral discs. The results of the study demonstrated statistically significant and clinically meaningful results in patients with cLBP. Compared to placebo, the verum led to a 30% reduction of pain after 12 months. The placebo group did not achieve clinically meaningful change from baseline. The PP353 group also reported statistically significant and clinically meaningful reductions in disability with a within-group reduction of 9.4-points (63%) and a between-group reduction of 3.9-points (39%) from placebo in the Full Analysis Set of subjects at 12 months.

The manufacturer claims to provide an alternative, non-opioid, treatment for cLBP patients by replacing the 100-day high-dose oral antibiotics course to treat cLBP with an injectable antibiotic formulation that will achieve high local concentration and adequate duration of exposure in the spine to effect the sterilisation of the infected disc.

Local administration of antibiotic has the potential to elicit a faster response because an effective drug concentration in the infected tissue is immediately achieved. It also significantly reduces the amount of drug required, reducing the likelihood of systemic side effects, especially those associated with perturbation of the gut microbiome.

Intradiscal administration of therapeutics to treat cLBP is an established but mostly ineffective route. Persica believes that an effective treatment must address the underlying cause of disease – the infection. An effective antibacterial therapeutic should reduce the inflammatory stimuli in the intervertebral space and adjacent bone and allow repair over time, leading to a reduction in pain.

During the development of PP353, Persica tested several generic antibiotics in vitro and in vivo to find an antibiotic with the required properties: active against the bacteria identified in disc and herniated tissue samples, little to no resistance in clinical isolates, and the ability to be formulated to provide a depot to extend the duration of exposure.

To enable administration of the antibiotic, Persica developed a unique formulation which delivers the antibiotics to the site of infection and ensures that it remains within the infected area.

_______________________

Sounds good?

Yes, perhaps even a little too good to be true!

Here are some of my concerns:

  1. The manufacturer has, as far as I can see, not published the findings in a peer-reviewed journal and thus wants us to believe the findings without scrutinizing the methodology.
  2. Even if they eventually do publish the study in full, and even if it turns out to be rigorous, one would still want  independent preplications.
  3. There is an undenialble and very substantial financial interest in the matter (anyone who comes out with an effective and safe pill against cLBP, will quickly make billions!), and one might therefore wonder how objective the manufacturer can be about the merits of PP353.
  4. The assumption that many cases of cLBP are caused by a disc infection is a well-known theory, but it remains largely unproven.
  5. As we dicuseed only recently, antibiotics have not been shown to be effective for cLBP.

Clearly, we have to wait and see – but my advice is to take PP353 with a healthy pinch of salt.

 

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