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

osteopathy

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Today, HRH the Prince of Wales has his 72th birthday. As every year, I send him my best wishes by dedicating an entire post to a brief, updated summary of his achievements in the area of so-called alternative medicine (SCAM).

EARLY INFLUENCE OF LAURENCE VAN DER POST

Aged 18, Charles went on a journey of ‘spiritual discovery’ into the Kalahari desert. His guide was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to SCAM: virtually every form of SCAM is based on the assumption that some sort of vital force exists. Charles was impressed with van der Post that he made him the godfather of Prince William. After Post’s death, he established an annual lecture in his honour (the lecture series was quickly discontinued after van der Post was discovered to be a fraud).

CHIROPRACTIC and OSTEOPATHY

Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality. To this day, these two SCAM professions are  the only ones regulated by statute in the UK.

THE BRITISH MEDICAL ASSOCIATION

In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating SCAM. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.

Six years later, a second report, entitled ‘Complementary Medicine – New Approaches to Good Practice’, heralded U-turn stating that: “the demand for non-conventional therapies had become so pressing that organised medicine in Britain could no longer ignore its contribution“. At the same time, however, the BMA set in motion a further chapter in the history of SCAM by insisting that it was “unacceptable” to allow the unrestricted practice of non-conventional therapies, irrespective of training or experience.

THE FOUNDATION OF INTEGRATED HEALTH

In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail.

MOSARAF ALI

In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and SCAMs, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have around 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to SCAM.

INTEGRATIVE MEDICINE

In 2001, Charles published an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS. Ever since, Charles has been internationally recognised as one of the world’s most vociferous champions of integrated medicine.

GERSON DIET

In 2004, Charles publicly supported the Gerson diet as a treatment for cancer. Prof Baum, an eminent oncologists, was invited to respond in an open letter to the British Medical Journal: ” …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.”

THE SMALLWOOD REPORT

In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate the alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement.

WORLD HEALTH ORGANISATION

In a 2006 speech, Prince Charles told the World Health Organisation in Geneva that SCAM should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

TRADITIONAL CHINESE MEDICINE (TCM)

In 2007, the People’s Republic of China recorded the visit of Fu Ying, its ambassador in London at the time, to Clarence House, and announced that the Charles had praised TCM. “He hoped that it could be included in the modern medical system . . . and was willing to make a contribution to it.”

HERBAL MEDICINE

In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies.

In the same year, Charles urged the government to protect SCAM because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, medical director of the FIH and Charles’ advisor in SCAM, put it.

UK HEALTH POLITICS

In 2009, the health secretary wrote to the Prince suggesting a meeting on the possibility of a study on integrating SCAM in England’s NHS. The Prince had written to Burnham’s predecessor, Alan Johnson, demanding greater access to SCAM in the NHS alongside conventional medicine. Charles stated that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”.

In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do. I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.

In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of SCAM.

THE COLLEGE OF MEDICINE

In 2009, it was announced that the ‘College of Integrated Medicine’ (the successor of the FIH) was to have a second base in India. In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre. The collaboration was reported to include clinical training to European and Western doctors in Ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.

In 2020, Charles became the patron of the College of Medicine which, by then, had re-christened itself ‘College of Medicine and Integrated Health’. The College chair, Michael Dixon, was quoted stating: ‘This is a great honour and will support us as an organisation committed to taking medicine beyond drugs and procedures. This generous royal endorsement will enable us to be ever more ambitious in our mission to achieve a more compassionate and sustainable health service.”

DUTCHY ORIGINALS DETOX TINCTURE

In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.

ANTIBIOTIC OVERUSE

In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

DUMFRIES HOUSE

In 2017, Charles declared that he will open a centre for SCAM in the recently purchased Dumfries House in Scotland. Currently, the College of Medicine and Integrated Health is offering two-day Foundation Courses at this iconic location. Gabriel Chiu, a US celebrity cosmetic and reconstructive surgeon, and his wife Christine, joined the Prince of Wales as he opened the integrated health and wellbeing centre on the Dumfries House Estate in East Ayrshire in 2019. As he unveiled a plaque, Prince Charles said: “I’m so glad that all of you have been able to get here today, particularly because I could not be more proud to see the opening of this new integrated health centre at Dumfries House. It’s something I’ve been wanting to do for the last 35 years. I’m also so proud of all the team at Dumfries House who built it, an all in-house team.”

HOMEOPATHY

Generations of royals have favoured homeopathy, and allegedly it is because of this influence that homeopathy became part of the NHS in 1948. Homeopathy has also been at the core of Charles’ obsession with SCAM from its beginning. In 2017, ‘Country News’ published an article about our heir to the throne stating that Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

In the same year, it was revealed that UK farmers were being taught how to treat their livestock with homeopathy “by kind permission of His Royal Highness, The Prince Of Wales

In 2019, the Faculty of Homeopathy announced that His Royal Highness The Prince of Wales had accepted to become Patron of the Faculty of Homeopathy. Dr Gary Smyth, President of the Faculty of Homeopathy commented, “As the Faculty celebrates its 175th anniversary this year, it is an enormous honour for us to receive the Patronage of His Royal Highness The Prince of Wales and I am delighted to announce this news today.” Charles’ move amazed observers who saw it as a deliberate protest against the discontinuation of reimbursement of homeopathy by the NHS.

In 2020, Charles fell ill with the corona-virus and happily made a swift recovery. It was widely reported that his recovery was due to homeopathy, a notion denied by Clarence House.

_______________________

Happy Birthday Charles

The objective of this RCT was to compare the effects of

  • spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
  • to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)

on pain and disability in patients with subacromial pain syndrome (SAPS).

Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.

At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.

The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.

The authors of this trial have impressive looking affiliations:

  • American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
  • Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
  • Research Physical Therapy Specialists, Columbia, SC.
  • Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
  • Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
  • Copper Queen Community Hospital, Bisbee, AZ.
  • BenchMark Physical Therapy, Atlanta, GA.
  • Eastside Medical Care Center, El Paso, TX.
  • Department of Physical Therapy, Georgia State University, Atlanta, GA.
  • Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.

If one expected a well-designed study from all this collective expertise, one would have been disappointed.

Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.

The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:

  1. Acupuncture was effective.
  2. Dry needling was effective.
  3. The electrical current was effective.
  4. Mobilisation made things worse.
  5. Exercise made things worse.
  6. one or multiple positive or negative interactions between the therapies.
  7. The drugs in the experimental group were more effective than those taken by controls.
  8. The experimental group adhered to their drug prescriptions better than controls.
  9. Any mixture of the above.

So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:

  • Any researcher who designs a foreseeably nonsensical trial should go back to school.
  • Any ethics committee that passes such a study needs to retire.
  • Any funder who gives money for it wastes scarce resources.
  • Any reviewer who recommends publication needs to learn about trial design.
  • Any editor who publishes such a trial needs to go.

The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.

Manual therapy is a commonly recommended treatment of low back pain (LBP), yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs non-thrust (spinal mobilization) techniques. This study evaluated the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.

This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period. Licensed clinicians (either a doctor of osteopathic medicine or physical therapist), with at least 3 years of clinical experience using manipulative therapies provided all treatments.

Primary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.

A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized.

  • 54 participants were randomized to the spinal manipulation group,
  • 54 to the spinal mobilization group,
  • 54 to the placebo group.

There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, -0.38 to 0.86]; P = .45), spinal manipulation and placebo (-0.03 [95% CI, -0.65 to 0.59]; P = .92), or spinal mobilization and placebo (-0.26 [95% CI, -0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (-1.00 [95% CI, -2.27 to 0.36]; P = .14), spinal manipulation and placebo (-0.07 [95% CI, -1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, -0.41 to 2.29]; P = .17). A comparison of treatment credibility and expectancy ratings across groups was not statistically significant (F2,151 = 1.70, P = .19), indicating that, on average, participants in each group had similar expectations regarding the likely benefit of their assigned treatment.

The authors concluded that in this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.

This is an exceptionally well-reported study. Yet, one might raise a few points of criticism:

  1. The comparison of two active treatments makes this an equivalence study, and much larger sample sizes are required or such trials (this does not mean that the comparisons are not valid, however).
  2. The patients had rather mild symptoms; one could argue that patients with severe pain might respond differently.
  3. Chiropractors could argue that the therapists were not as expert at spinal manipulation as they are; had they employed chiropractic therapists, the results might have been different.
  4. A placebo control group makes more sense, if it allows patients to be blinded; this was not possible in this instance, and a better placebo might have produced different findings.

Despite these limitations, this study certainly is a valuable addition to the evidence. It casts more doubt on spinal manipulation and mobilisation as an effective therapy for LBP and confirms my often-voiced view that these treatments are not the best we can offer to LBP-patients.

 

One of the many issues that needs addressing about chiropractic is its safety. On this blog, we have had dozens of posts and debates on this topic. Today, I want to try and summarise them by providing a fictitious dialogue between a critic and a chiropractor.

Here we go:

Critic (CR): It seems to me that most of the chiros I talk to are convinced that their hallmark therapy, spinal manipulation, is risk-free.

Chiro (CH): Hallmark therapy? Not true! Osteopaths, physios, doctors they all use spinal manipulation.

CR: I know, but name me a profession that employs it more regularly than you chiros.

CH: In any case, it is as good as risk-free; nothing is totally devoid of risk, but chiropractic spinal manipulation (CSMT) is generally very safe, because we are better trained at it than the others.

CR: Do you say that because you believe it or because you know it?

CH: I know it.

CR: That means you have the evidence to prove it?

CH: Yes, of course. Over the years, I have treated over a thousand patients and never heard of any problems.

CR: Without a monitoring system of adverse events that occur after chiropractic spinal manipulation, this is pretty meaningless.

CH: Monitoring systems do not establish causality.

CR: No, but they are a start and can tell you whether there is a problem that requires looking into.

CH: Let me remind you please that the question of safety is foremost an issue for conventional medicine; this is why a monitoring system is useful for drugs. We actually do not need one, because CSMT is safe.

CR: Are you sure?

CH: Yes, V DabbsW J Lauretti have shown this very clearly in their seminal paper comparing drug treatments with chiropractic. 

CR: The much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim. Is there not a better comparison for supporting your point?

CH: Not as far as I know. But you can trust our collective experience: CSMT is safe!

CR: Don’t you think that the issue is too important to rely purely on experience? Your collective experience can be very misleading, you know.

CH: Then tell me why chiros pay only a fraction of the insurance premium compared to doctors.

CR: Yes, that is the argument many chiros love. But it also is a very poor one: doctors treat patients who are often very ill, while chiros treat mostly sore backs. Don’t you think that explains a lot about the difference in insurance premiums?

CH: Perhaps, but if you claim CSMT to be harmful, how about you supporting your claim with evidence?

CR: Sure, the best is to review systematically all prospective studies on the topic; and if you do this, the conclusion is that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

CH: I bet these are studies done by people who are against chiropractic.

CR: No, actually the primary studies were all done by chiropractors.

CH: Minor transient problems! These are merely what we expect; things often need to get worse before they get better.

CR: Imagine that a drug company claims such BS about the side-effects of a new drug.

CH: But that’s different!

CR: In what way?

CH: Big Pharma is only out to make money.

CR: And chiros?

CH: That’s different too.

CR: What about the serious adverse events like vertebrobasilar accidents, disk herniation, and cauda equina syndrome? Are you going to deny they exist?

CH: Some of those serious complications, while rare, are conditions that existed prior to CSMT being performed with the practitioner missing it upon initial examination.

CR: How do you know?

CH: I know this from experience.

CR: I already told you that experience is unreliable.

CH: Then show me the evidence that I am wrong.

CR: No, you have to come up with the evidence; the burden of proof is evidently on your shoulders.

CH: Whatever! As long as there is no good evidence, I cannot accept that serious complications are a real problem.

CR: That’s just fine: you say “as long as there is no good evidence…” and, at the same time, you prevent good evidence from emerging by preventing a decent AE monitoring system.

CH: I always knew that one cannot have a reasonable discussion with you. I consider that I have won this debate; this issue is now closed.

 

On this blog, I have discussed the adverse events (AEs) of spinal manipulative therapy (SMT) with some regularity, and we have seen that ~ 50% of patients who receive SMT from a chiropractor experience some kind of AE. In addition there are many serious complications. In my book, I discuss, apart from the better-known vascular accidents followed by a stroke or death, the following:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture,
  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome.

Considering this long list, we currently have far too little reliable information. A recent publication offers further information on this important topic.

The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them.

A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. The results show that:

  • 97% of the chiropractors believed benign AEs occur.
  • 82% reported their own patients have experienced an AE.
  • 55% of the patients reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness.
  • 61.5% of the chiropractors reported trying a mitigation strategy with their patients.
  • Yet only 21.2% of patients perceived their clinicians had tried any mitigation strategy.
  • Chiropractors perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT.
  • Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage

 

The authors concluded that this is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The question that I have often asked before, and I am bound to ask again after seeing such results, is this:

If there were a drug that causes temporary pain/soreness, headache and stiffness in 55% of all patients (plus an unknown frequency of a long list of serious complications), while being of uncertain benefit, do you think it would still be on the market?

 

My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:

“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago.[1] Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM)[2], and they certainly are relevant to chiropractic.

Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame[3], is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.

I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:

  • How well-established is chiropractic?
  • What treatments do chiropractors use?
  • What conditions do they treat?
  • What claims do they make?
  • Are their assumptions reasonable?
  • Are chiropractic spinal manipulations effective?
  • Are these manipulations safe?
  • Do chiropractors behave professionally and ethically?

Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.

I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.

In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?

This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.

[1] https://pubmed.ncbi.nlm.nih.gov/9820267

[2] https://www.amazon.co.uk/SCAM-So-Called-Alternative-Medicine-Societas/dp/1845409701/ref=pd_rhf_dp_p_img_2?_encoding=UTF8&psc=1&refRID=449PJJDXNTY60Y418S5J

[3] https://www.amazon.co.uk/Text-Book-Philosophy-Chiropractic-Chiropractors-Adjuster/dp/1635617243/ref=sr_1_1?keywords=DD+Palmer&qid=1581002156&sr=8-1

Tasuki is a sort of sash for holding up the sleeves on a kimono. It also retracts the shoulders and keeps the head straight up. By correcting the wearer’s posture, it might even prevent or treat neck pain. The greater the forward head posture, for example, the more frequent are neck problems.  However, there is little clinical evidence to support or refute this hypothesis.

This study was conducted to determine whether Tasuki-style posture supporter improves neck pain compared to waiting-list. It was designed as an individually-randomized, open-label, waiting-list-controlled study. Adults with non-specific chronic neck pain who reported 10 points or more on modified Neck Disability Index (mNDI: range, 0-50; higher points indicate worse condition) were enrolled. Participants were randomly assigned 1:1 to the intervention group or to a waiting-list control group. The primary outcome was the change in mNDI at 1 week.

In total, 50 participants were enrolled. Of these participants, 26 (52%) were randomly assigned to the intervention group and 24 to the waiting-list. Attrition rate was low in both groups (1/50). The mean mNDI change score at 1 week was more favourable for Tasuki than waiting-list (between-group difference, -3.5 points (95% confidence interval (CI), -5.3 to -1.8); P = .0002). More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than with waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)).

The author concluded that this trial suggests that wearing Tasuki might moderately improve neck pain. With its low-cost, low-risk, and easy-to-use nature, Tasuki could be an option for those who suffer from neck pain.

In the previous two posts, we discussed how lamentably weak the evidence for acupuncture and spinal manipulation is regarding the management of pain such as ‘mechanical’ neck pain. Here we have a well-reported study with a poor design (no control for non-specific effects) which seems to suggest that simply wearing a Tasuki is just as effective as acupuncture or spinal manipulation.

What is the lesson from this collective evidence?

Is it that we should forget about acupuncture and spinal manipulation for chronic neck pain?

Perhaps.

Or is it that poor trial designs generate unreliable evidence?

More likely.

Or is it that any treatment, however daft, will generate positive outcomes, if the researchers are sufficiently convinced of its benefit?

Yes, I think so.

___________________

 

PS

If you had chronic neck pain, would you rather have your neck manipulated, needles stuck into your body, or get a Tasuki? (Spoiler: Tasuki is risk-free, the other two treatments are not!)

 

Non-specific chronic neck pain is a common condition. There is hardly a so-called alternative medicine (SCAM) that is not advocated for it. Amongst the most common approaches are manual therapy and therapeutic exercise. But which is more effective?

This study was aimed at answering the question by comparing the effects of manual therapy and therapeutic exercise. The short-term and mid-term effects produced by the two therapies on subjects with non-specific chronic neck pain were studied. The sample was randomized into three groups:

  1. spinal manipulation (n=22),
  2. therapeutic exercise (n=23),
  3. sham treatment (n=20).

The therapists were physiotherapists. Patients were not allowed any other treatments that the ones they were allocated to. Pain quantified by visual analogue scale, the pressure pain threshold, and cervical disability quantified by the Neck Disability Index (NDI) were the outcome measures. They were registered on week 1, week 4, and week 12.

No statistically significant differences were obtained between the experimental groups. Spinal manipulation improved perceived pain quicker than therapeutic exercise. Therapeutic exercise reduced cervical disability quicker than spinal manipulation. Effect size showed medium and large effects for both experimental treatments.

The authors concluded that there are no differences between groups in short and medium terms. Manual therapy achieves a faster reduction in pain perception than therapeutic exercise. Therapeutic exercise reduces disability faster than manual therapy. Clinical improvement could potentially be influenced by central processes.

The paper is poorly written (why do editors accept this?) but it laudably includes detailed descriptions of the three different interventions:

Group 1: Manual therapy

“Manual therapy” protocol was composed of three techniques based on scientific evidence for the treatment of neck pain. This protocol was applied in the three treatment sessions, one per week.

    1. 1.High thoracic manipulation on T4. Patients are positioned supine with their arms crossed in a “V” shape over the chest. The therapist makes contact with the fist at the level of the spinous process of T4 and blocks the patient’s elbows with his chest. Following this, he introduces flexion of the cervical spine until a slight tension is felt in the tissues at the point of contact. Downward and cranial manipulation is applied. If cavitation is not achieved on the first attempt, the therapist repositions the patient and performs a second manipulation. A maximum of two attempts will be allowed in each patient.
    2. 2.Cervical articular mobilization (2 Hz, 2 min × 3 series). The patient is placed on the stretcher in a prone position, placing both hands under his forehead. The therapist makes contact with his two thumbs on the spinous process of the patient’s C2 vertebra and performs grade III posteroanterior impulses at a speed of 2 Hz and for 2 min. There are 3 mobilization intervals with a minute of rest between each one of them [13].
    3. 3.Suboccipital muscle inhibition (3 min). With the patient lying supine, the therapist places both hands under the subject’s head, by contacting their fingers on the lower edge of the occipital bone, and exerts constant and painless pressure in the anterior and cranial direction for 3 min.

Group 2: Therapeutic exercise

“Therapeutic exercise” protocol: this protocol is based on a progression in load composed of different phases: at first, activation and recruitment of deep cervical flexors; secondly, isometric exercise deep and superficial flexors co-contraction, and finally, eccentric recruitment of flexors and extensors. This protocol, as far as we know, has not been studied, but activation of this musculature during similar tasks to those of our protocol has been observed. This protocol was taught to patients in the first session and was performed once a day during the 3 weeks of treatment, 21 sessions in total. It was reinforced by the physiotherapist in each of the three individual sessions.

Week 1: Exercises 1 and 2.

    1. 1.Cranio-cervical flexion (CCF) in a supine position with a towel in the posterior area of the neck (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest).
    2. 2.CCF sitting (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest)

Week 2: Exercises 1, 2, 3, and 4.

    1. 3.Co-contraction of deep and superficial neck flexors in supine decubitus (10 repetitions, 10 s of contraction with 10 s of rest).
    2. 4.Co-contraction of flexors, rotators, and lateral flexors. The patients performed cranio-cervical flexion, while the physiotherapist asked him/her to tilt, rotate, and look towards the same side while he/she opposes a resistance with his/her hand (10 repetitions, 10 s of contraction with 10 s of rest).

Week 3: Exercises 1, 2, 3, 4, 5, and 6.

    1. 5.Eccentric for extensors. With the patient seated, he/she should perform cervical extension. Then, he/she must realize a CCF and finish doing a cervical flexion (10 repetitions).
    2. 6.Eccentric for flexors. The patients, placed in a quadrupedal and neutral neck position, should perform neck flexion; then, they must have done a cranio-cervical flexion and, maintaining that posture, extend the neck and then finally lose the CCF (10 repetitions).

Group 3: Sham treatment

For the “control” protocol, the patients were placed in the supine position, while the physiotherapist placed his hands without therapeutic intention on the patient’s neck for 3 min. The physiotherapist simulated the technique of suboccipital inhibition. Later, with the laser pointer off, patients were contacted without exerting pressure for 10 s. Patients assigned to the control group received treatment 1 or 2 after completing the study.

This study has many strengths and several weaknesses (for instance the small sample sizes). Its results are not surprising. They confirm what I have been pointing out repeatedly, namely that, because exercise is cheaper and has less potential for harm, it is by far a better treatment for chronic neck pain than spinal manipulation.

Pisa syndrome (PS) is a condition in which there is sustained involuntary flexion of the body and head to one side and slight rotation of the trunk so the person appears to lean like the Leaning Tower of Pisa. The PS can occur as a complication of Parkinson’s disease (PD). It can also be an adverse effect of some medications. It is characterized by a trunk lateral flexion higher than 10 degrees which is reversible when lying. The underlying pathophysiological mechanisms responsible for the development of PS are poorly understood. One pathophysiological hypothesis is that PS in PD is caused by an altered verticality perception, due to a somatosensory impairment.

The management of PS remains a challenge. Physiotherapy with early rehabilitation emphasising stretching exercises for the external oblique and paraspinal muscles is usually recommended. Therapy is also needed to improve static, dynamic posture and the control of pain symptoms. Osteopathic Manipulative Treatment (OMT) is also sometimes advocated for PS, but does it work?

The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry. In this single-blinded trial the investigators studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received OMT plus MIRT for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) was also performed.

At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT – 326.00±491.24 mm2, p = 0.01). The experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).

The authors concluded that among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.

The authors entitled their paper ‘Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: A Pilot Randomized Placebo-Controlled Trial’. As a pilot study, it should not test efficacy but explore the feasibility of a definitive trial. The fact the authors report outcome data, indicates to me that this is, in fact, not a pilot study, but a hopelessly underpowered clinical trial. This means that the findings could be due merely to chance alone. And this, in turn, means that the researchers owe it to their patients to conduct a properly powered RCT.

During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).

Here is the abstract of the Tuchin paper:

Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).

Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.

Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.

Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.

The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:

Objective: To identify adverse effects of spinal manipulation.

Design: Systematic review of papers published since 2001.

Setting: Six electronic databases.

Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.

Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.

Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.

In my view, there are several things that are strange here:

  1. Tuchin published his paper 5 years after mine.
  2. He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
  3. Tuchin never contacted me and never alerted me to his publication.
  4. The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
  5. A ‘replication study’ is a study that repeats the methodology of a previous study.
  6. Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.

But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.

As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.

As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.

Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.

But I think there is a more important point to be made here:

Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.

The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care. 

And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation. 

 

 

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