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

osteopathy

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Osteopathy is hugely popular in France. Despite the fact that osteopathy has never been conclusively shown to generate more good than harm, French osteopaths have somehow managed to get a reputation as trustworthy, evidence-based healthcare practitioners. They tend to treat musculoskeletal and many other issues. Visceral manipulation is oddly popular amongst French osteopaths. Now the trust of the French in osteopathy seems to have received a serious setback.

‘LE PARISIEN‘ has just published an article about the alleged sexual misconduct of one of the most prominent French osteopaths and director of one of the foremost schools of osteopathy in France. Here are some excerpts from the article that I translated for readers who don’t speak French:

The public prosecutor’s office of Grasse (Alpes-Maritimes) has opened a judicial investigation against Marc Bozzetto, the director and founder of the school of osteopathy in Valbonne, accused of rape and sexual assault.

In total, “four victims are targeted by the introductory indictment,” said the prosecutor’s office, stating that Marc Bozzetto had already been placed in police custody since the beginning of the proceedings. The daily paper ‘Nice-Matin’ has listed six complaints and published the testimony of a seventh alleged victim.

This victim claims to have been sexually assaulted in 2013, alleging that, during a professional appointment, Bozzetto had massaged her breasts and her intimate area. “He told me that everything went through my vagina and clitoris, that I had to spread my legs and let the energy flow through my clitoris. That I had to learn how to give myself pleasure on my own,” she told Nice-Matin. The newspaper also recorded the testimonies of a former employee, a top-level sportswoman, an employee from the world of culture, and a former student.

“I take note that a judicial inquiry is open. To date, he has neither been summoned nor indicted,” said Karine Benadava, the Parisian lawyer of the 80-year-old Bozzetto. Her client had already responded following initial accusations from students: “This is a normal feeling for women, but if all the women who work on the pelvis complain, you can’t get away with it and you have to stop working as a pelvic osteopath,” replied Bozzetto. In another interview, he had declared himself “furious” and unable to understand the reaction of these two students.

The school of osteopathy trains about 300 students each five years and presents itself as the first holistic osteopathy campus in France.

______________________________

Such stories of sexual misconduct of practitioners of so-called alternative medicine (SCAM) are sadly no rarety, particularly those working in the area of manual therapy. They remind me of a case against a Devon SCAM practitioner in which I served as an expert witness many years ago. Numerous women gave witness that he ended up having his fingers in their vagina during therapy. He did not deny the fact but tried to defend himself by claiming that he was merely massaging lymph-nodes in this area. It was my task to elaborate on the plausibility of this claim. The SCAM practitioner in question was eventually sentenced to two years in prison.

It stands to reason that SCAM practitioners working in the pelvic area are at particularly high risk of going atray. The above case might be a good occasion to have a public debate in France and ask: IS VISCERAL OSTEOPATHY EVIDENCE-BASED? The answer is very clearly NO! Surely, this is a message worth noting in view of the current popularity of this ridiculous, costly, and dangerous charlatanry.

And how does one minimize the risk of sexual misconduct of SCAM professionals? The most obvious answer would be, by proper education during their training. In the case mentioned above, this might have been a problem: if the director is into sexual misconduct, what can you expect of the rest of the school? In many other cases, the problem is even greater: many SCAM practitioners have had no training at all, or no training in healthcare ethics to speak of.

 

I was criticised for not referencing this article in a recent post on adverse effects of spinal manipulation. In fact the commentator wrote: Shame on you Prof. Ernst. You get an “E” for effort and I hope you can do better next time. The paper was published in a third-class journal, but I will nevertheless quote the ‘key messages’ from this paper, because they are in many ways remarkable.

  • Adverse events from manual therapy are few, mild, and transient. Common AEs include local tenderness, tiredness, and headache. Other moderate and severe adverse events (AEs) are rare, while serious AEs are very rare.
  • Serious AEs can include spinal cord injuries with severe neurological consequences and cervical artery dissection (CAD), but the rarity of such events makes the provision of epidemiological evidence challenging.
  • Sports-related practice is often time sensitive; thus, the manual therapist needs to be aware of common and rare AEs specifically associated with spinal manipulative therapy (SMT) to fully evaluate the risk-benefit ratio.

The author of this paper is Aleksander Chaibi, PT, DC, PhD who holds several positions in the Norwegian Chiropractors’ Association, and currently holds a position as an expert advisor in the field of biomedical brain research for the Brain Foundation of the Netherlands. I feel that he might benefit from reading some more critical texts on the subject. In fact, I recommend my own 2020 book. Here are a few passages dealing with the safety of SMT:

Relatively minor AEs after SMT are extremely common. Our own systematic review of 2002 found that they occur in approximately half of all patients receiving SMT. A more recent study of 771 Finish patients having chiropractic SMT showed an even higher rate; AEs were reported in 81% of women and 66% of men, and a total of 178 AEs were rated as moderate to severe. Two further studies reported that such AEs occur in 61% and 30% of patients. Local or radiating pain, headache, and tiredness are the most frequent adverse effects…

A 2017 systematic review identified the characteristics of AEs occurring after cervical spinal manipulation or cervical mobilization. A total of 227 cases were found; 66% of them had been treated by chiropractors. Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%, and 46% had immediate onset symptoms. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AEs using standardized terminology…

In 2005, I published a systematic review of ophthalmic AEs after SMT. At the time, there were 14 published case reports. Clinical symptoms and signs included:

  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome…

Vascular accidents are the most frequent serious AEs after chiropractic SMT, but they are certainly not the only complications that have been reported. Other AEs include:

  • 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…

In 2010, I reviewed all the reports of deaths after chiropractic treatments published in the medical literature. My article covered 26 fatalities but it is important to stress that many more might have remained unpublished. The cause usually was a vascular accident involving the dissection of a vertebral artery (see above). The review also makes the following important points:

  • … numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.
  • Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.
  • This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.

Another review summarised published cases of injuries associated with cervical manipulation in China. A total of 156 cases were found. They included the following problems:

  • syncope (45 cases),
  • mild spinal cord injury or compression (34 cases),
  • nerve root injury (24 cases),
  • ineffective treatment/symptom increased (11 cases),
  • cervical spine fracture (11 cases),
  • dislocation or semi-luxation (6 cases),
  • soft tissue injury (3 cases),
  • serious accident (22 cases) including paralysis, deaths and cerebrovascular accidents.

Manipulation including rotation was involved in 42% of all cases. In total, 5 patients died…

To sum up … chiropractic SMT can cause a wide range of very serious complications which occasionally can even be fatal. As there is no AE reporting system of such events, we nobody can be sure how frequently they occur.

[references from my text can be found in the book]

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.

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