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

cranial osteopathy

This study described osteopathic practise activity, scope of practice and the osteopathic patient profile in order to understand the role osteopathy plays within the United Kingdom’s (UK) health system a decade after the authors’ previous survey.

The researchers used a retrospective questionnaire survey design to ask about osteopathic practice and audit patient case notes. All UK-registered osteopaths were invited to participate in the survey. The survey was conducted using a web-based system. Each participating osteopath was asked about themselves, and their practice and asked to randomly select and extract data from up to 8 random new patient health records during 2018. All patient-related data were anonymized.

The survey response rate was 500 osteopaths (9.4% of the profession) who provided information about 395 patients and 2,215 consultations. Most osteopaths were:

  • self-employed (81.1%; 344/424 responses),
  • working alone either exclusively or often (63.9%; 237/371),
  • able to offer 48.6% of patients an appointment within 3 days (184/379).

Patient ages ranged from 1 month to 96 years (mean 44.7 years, Std Dev. 21.5), of these 58.4% (227/389) were female. Infants <1 years old represented 4.8% (18/379) of patients. The majority of patients presented with musculoskeletal complaints (81.0%; 306/378) followed by pediatric conditions (5%). Persistent complaints (present for more than 12 weeks before the appointment) were the most common (67.9%; 256/377) and 41.7% (156/374) of patients had co-existing medical conditions.

The most common treatment approaches used at the first appointment were:

  • soft-tissue techniques (73.9%; 292/395),
  • articulatory techniques (69.4%; 274/395),
  • high-velocity low-amplitude thrust (34.4%; 136/395),
  • cranial techniques (23%).

The mean number of treatments per patient was 7 (mode 4). Osteopaths’ referral to other healthcare practitioners amounted to:

  • GPs 29%
  • Other complementary therapists 21%
  • Other osteopaths 18%

The authors concluded that osteopaths predominantly provide care of musculoskeletal conditions, typically in private practice. To better understand the role of osteopathy in UK health service delivery, the profession needs to do more research with patients in order to understand their needs and their expected outcomes of care, and for this to inform osteopathic practice and education.

What can we conclude from a survey that has a 9% response rate?

Nothing!

If I ignore this fact, do I find anything of interest here?

Not a lot!

Perhaps just three points:

  1. Osteopaths use high-velocity low-amplitude thrusts, the type of manipulation that has most frequently been associated with serious complications, too frequently.
  2. They also employ cranial osteopathy, which is probably the least plausible technique in their repertoire, too often.
  3. They refer patients too frequently to other SCAM practitioners and too rarely to GPs.

To come back to the question asked in the title of this post: What do UK osteopaths do? My answer is

ALMOST NOTHING THAT MIGHT BE USEFUL.

This study aimed to evaluate the number of craniosacral therapy sessions that can be helpful to obtain a resolution of the symptoms of infantile colic and to observe if there are any differences in the evolution obtained by the groups that received a different number of Craniosacral Therapy sessions at 24 days of treatment, compared with the control group which did not received any treatment.

Fifty-eight infants with colic were randomized into two groups:

  • 29 babies in the control group received no treatment;
  • babies in the experimental group received 1-3 sessions of craniosacral therapy (CST) until symptoms were resolved.

Evaluations were performed until day 24 of the study. Crying hours served as the primary outcome measure. The secondary outcome measures were the hours of sleep and the severity, measured by an Infantile Colic Severity Questionnaire (ICSQ).

Statistically significant differences were observed in favor of the experimental group compared to the control group on day 24 in all outcome measures:

  • crying hours (mean difference = 2.94, at 95 %CI = 2.30-3.58; p < 0.001);
  • hours of sleep (mean difference = 2.80; at 95 %CI = – 3.85 to – 1.73; p < 0.001);
  • colic severity (mean difference = 17.24; at 95 %CI = 14.42-20.05; p < 0.001).

Also, the differences between the groups ≤ 2 CST sessions (n = 19), 3 CST sessions (n = 10), and control (n = 25) were statistically significant on day 24 of the treatment for crying, sleep and colic severity outcomes (p < 0.001).

The authors concluded that babies with infantile colic may obtain a complete resolution of symptoms on day 24 by receiving 2 or 3 CST sessions compared to the control group, which did not receive any treatment.

Why do SCAM researchers so often have no problem leaving the control group of patients in clinical trials without any treatment at all, while shying away from administering a placebo? Is it because they enjoy being the laughingstock of the science community? Probably not.

I suspect the reason might be that often they know that their treatments are placebos and that their trials would otherwise generate negative findings. Whatever the reasons, this new study demonstrates three things many of us already knew:

  1. Colic in babies always resolves on its own but can be helped by a placebo response (e.g. via the non-blinded parents), by holding the infant, and by paying attention to the child.
  2. Flawed trials lend themselves to drawing the wrong conclusions.
  3. Craniosacral therapy is not biologically plausible and most likely not effective beyond placebo.

I recently came across the ‘Sutherland Cranial College of Osteopathy’.

Sutherland Cranial College of Osteopathy?

Really?

I know what osteopathy is but what exactly is a ‘cranial college’?

Perhaps they mean ‘Sutherland College of Cranial Osteopathy’?

Anyway, they explain on their website that:

Cranial Osteopathy uses the same osteopathic principles that were described by Andrew Taylor Still, the founder of Osteopathy. Cranial osteopaths develop a very highly developed sense of palpation that enables them to feel subtle movements and imbalances in body tissues and to very gently support the body to release and re-balance itself. Treatment is so gentle that often patients are quite unaware that anything is happening. But the results of this subtle treatment can be dramatic, and it can benefit whole body health.

Sounds good?

I am sure you are now keen to become an expert in cranial osteopathy. The good news is that the college offers a course where this can be achieved in just 2 days! Here are the details:

This will be a spacious exploration of the nervous system.  Neurological dysfunction and conditions feature greatly in our clinical work and this is especially the case in paediatric practice. The focus of this course is how to approach the nervous system in a fundamental way with reference to both current and historical ideas of neurological function.  The following areas will be considered: 

    1. Attaining stillness and grounding during palpation of the nervous system. It is within stillness that potency resides and when the treatment happens. The placement of attention.  
    2. The pineal and its relationship to the tent, the pineal shift.
    3. The relations of the clivus and the central importance of the SBS, How do we assess and treat compression?
    4. The electromagnetic field and potency.
    5. The suspension of the cord within the spinal canal, the cervical and lumbar expansions.
    6. Listening posts for the central autonomic network.
Hawkwood College accommodation

Please be aware that accommodation at Hawkwood will be in shared rooms (single sex). Some single rooms are available on a first-come-first-served basis and will carry a supplement. Requesting a single room is not a guarantee that one will be provided.

£390.00 – £490.00

29 – 30 APRIL 2023 STROUD, UK
This will be a spacious exploration of the nervous system. Neurological dysfunction and conditions feature greatly in our clinical work and this is especially the case in pediatric practice.

_________________________

You see, not even expensive!

Go for it!!!

Oh, I see, you want to know what evidence there is that cranial osteopathy does more good than harm?

Right! Here is what I wrote in my recent book about it:

Craniosacral therapy (or craniosacral osteopathy) is a manual treatment developed by the US osteopath William Sutherland (1873–1953) and further refined by the US osteopath John Upledger (1932–2012) in the 1970s. The treatment consists of gentle touch and palpation of the synarthrodial joints of the skull and sacrum. Practitioners believe that these joints allow enough movement to regulate the pulsation of the cerebrospinal fluid which, in turn, improves what they call ‘primary respiration’. The notion of ‘primary respiration’ is based on the following 5 assumptions:

  • inherent motility of the central nervous system
  • fluctuation of the cerebrospinal fluid
  • mobility of the intracranial and intraspinal dural membranes
  • mobility of the cranial bones
  • involuntary motion of the sacral bones.

A further assumption is that palpation of the cranium can detect a rhythmic movement of the cranial bones. Gentle pressure is used by the therapist to manipulate the cranial bones to achieve a therapeutic result. The degree of mobility and compliance of the cranial bones is minimal, and therefore, most of these assumptions lack plausibility.

The therapeutic claims made for craniosacral therapy are not supported by sound evidence. A systematic review of all 6 trials of craniosacral therapy concluded that “the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.” Some studies seem to indicate otherwise, but they are of lamentable methodological quality and thus not reliable.

Being such a gentle treatment, craniosacral therapy is particularly popular for infants. But here too, the evidence fails to show effectiveness. A study concluded that “healthy preterm infants undergoing an intervention with craniosacral therapy showed no significant changes in general movements compared to preterm infants without intervention.”

The costs for craniosacral therapy are usually modest but, if the treatment is employed regularly, they can be substantial.

______________________________

As the college states “often patients are quite unaware that anything is happening”. Is it because nothing is happening? According to the evidence, the answer is YES.

So, on second thought, maybe you give the above course a miss?

Osteopathic tradition in the cranial field (OCF) postulates that the primary respiratory mechanism (PRM) relies on the anatomical links between the occiput and sacrum. Few studies investigated this relationship with inconsistent results. No studies investigated the occiput-sacrum connection from a neurophysiological perspective.

This study aims to determine whether the sacral technique (ST), compared to the compression of the fourth ventricle (CV4) technique, can affect brain alpha-band power (AABP) as an indicator of a neurophysiological connection between the occiput and sacrum.

Healthy students, 22-30 years old for men and 20-30 years old for women, were enrolled in the study and randomized into eight intervention groups. Each group received a combination of active techniques (CV4 or ST) and the corresponding sham techniques (sham compression of the fourth ventricle [sCV4] or sham sacral technique [sST] ), organized in two experimental sessions divided by a 4 h washout period. AABP was continuously recorded by electroencephalogram (EEG) of the occipital area in the first 10 min of resting state, during each intervention (active technique time) and after 10 min (post-active technique time), for a total of approximately 50 min per session. Analysis was carried out utilizing a repeated-measure ANOVA within the linear general model framework, consisting of a within-subject factor of time and a within-subject factor of treatment (CV4/ST).

Forty healthy volunteers (mean age ± SD, 23.73±1.43 years; range, 21-26 years; 16 male and 24 female) were enrolled in the study and completed the study protocol. ANOVA revealed a time × treatment interaction effect statistically significant (F=791.4; p<0.001). A particularly high increase in mean AABP magnitude was recorded during the 10 min post-CV4, compared to both the CV4 and post-sCV4 application (p<0.001). During all the times analyzed for ST and sST application, no statistically significant differences were registered with respect to the resting state.

The authors concluded that the ST does not produce immediate changes on occipital AABP brain activity. CV4, as previous evidence supported, generates immediate effects, suggesting that a different biological basis for OCF therapy’s connection between the head and sacrum should be explored.

Why on earth should a different biological mechanism be explored? Why not conclude that OCF and its assumptions are pure nonsense?

The answer to these questions is not difficult to find: the authors are from the ‘Istituto Superiore di Osteopatia, Milan, Italy’! One can understand that, at this institution, people are unlikely to agree with my conclusion that OCF is based on absurd concepts and does not merit further research.

The objective of this systematic review was to assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Different databases were screened up to 20 August 2020. Randomised clinical trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:

  • SM/chiropractic (7 studies, 567 participants).
  • Osteopathy (5 trials, 645 participants).
  • Kinesiology (1 trial, 58 participants).
  • Articular mobilisations (6 trials, 445 participants).
  • Muscular release (5 trials, 304 participants).

Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.

The authors of the review also provide this further comment:

Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.

Rubinstein et al  compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.

If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple:

NO!

These days, I live in France (some of my time) and I am often baffled by the number of osteopaths and the high level of acceptance of osteopathy in this country. The public seems to believe everything osteopaths claim and even most doctors have long given up to object to the idiocies they proclaim.

The website of the Institute of Osteopathy in Renne is but one of many examples. The Institute informed us as follows (my translation):

In addition to back pain, the osteopath can act on functional disorders of the digestive, neurological, cardiovascular systems or conditions related to ear, nose and throat. Osteopaths can promote recovery in athletes, relieve migraines, musculoskeletal disorders such as tendonitis, or treat sleep disorders. Less known for its preventive aspect, osteopathy also helps maintain good health. It can be effective even when everything is going well because it will prevent the appearance of pain. Osteopathy is, in fact, a manual medicine that allows the rebalancing of the major systems of the body, whatever the age of the patient and his problems. The osteopath looks for the root cause of your complaint in order to develop a curative and preventive treatment.

Who are osteopathic consultations for?

Osteopathic consultations at the Institute of Osteopathy of Rennes-Bretagne are intended for the following types of patients and pathologies

BABY / CHILD

GERD (gastric reflux), plagiocephaly (cranial deformities), recurrent ENT disorders (sinusitis, ear infections…), digestive, sleep and behavioural disorders, motor delay, following a difficult birth…

ADULT

Prevention, comfort treatment of osteoarthritis, musculoskeletal pain, functional abdominal pain, digestive disorders, headaches, dizziness, postural deficiency, facial pains…

PREGNANT WOMAN

Musculoskeletal pain (lumbago, back pain), digestive disorders, preparation for childbirth, post-partum check-up.

COMPANY

Prevention and treatment of MSDs (musculoskeletal disorders) linked to workstation ergonomics, stress, pain due to repetitive movements, poor posture at work, etc.

ADOLESCENT

Scoliosis, prevention of certain pathologies linked to growth, fatigue, stress, follow-up of orthodontic treatment.

SPORTSMAN

Musculoskeletal pain, tendonitis, osteopathic preparation for competition, osteopathic assessment according to the sport practised, repetitive injury.

In case you are not familiar with the evidence for osteopathy, let me tell you that as good as none of the many claims made in the above text is supported by anything that even resembles sound evidence.

So, how can we explain that, in France, osteopathy is allowed to thrive in a virtually evidence-free space?

In France, osteopathy started developing in the 1950s. In 2002, osteopathy received legislative recognition in France, and today, it is booming; between 2016 and 2018, 3589 osteopaths were trained in France. Osteopaths can be DO doctors, DO physiotherapists, DO nurses, DO midwives, DO chiropodists, or even DO dentists.

Thus, in 2018, and out of a total of 29,612 professionals practising osteopathy, there were 17,897 osteopaths DO and 11,715 DO health professionals. The number of professionals using the title of osteopath has roughly tripled in 8 years (11608 in 2010 for 29612 in 2018). There are currently around 30 osteopathic schools in France. About 3 out of 5 French people now consult osteopaths.

But this does not answer my question why, in France, osteopathy is allowed to thrive in a virtually evidence-free space! To be honest, I do not know its answer.

Perhaps someone else does?

If so, please enlighten me.

 

 

The aims of this bibliometric analysis are to describe the characteristics of articles published on the efficacy of osteopathic interventions and to provide an overall portrait of their impacts in the scientific literature. A bibliometric analysis approach was used. Articles were identified with searches using a combination of relevant MeSH terms and indexing keywords about osteopathy and research designs in MEDLINE and CINAHL databases. The following indicators were extracted: country of the primary author, year of publication, journals, impact factor of the journal, number of citations, research design, participants’ age group, system/body part addressed, primary outcome, indexing keywords and types of techniques.

A total of 389 articles met the inclusion criteria. The number of empirical studies doubled every 5 years, with the United States, Italy, Spain, and the United Kingdom being the most productive countries. Twenty-three articles were cited over 100 times. Articles were published in 103 different indexed journals, but more than half (53.7%) of articles were published in one of three osteopathy-focused readership journals. Randomized control trials (n = 145; 37.3%) and case reports (n = 142; 36.5%) were the most common research designs. A total of 187 (48.1%) studies examined the effects of osteopathic interventions using a combination of techniques that belonged to two or all of the classic fields of osteopathic interventions (musculoskeletal, cranial, and visceral).

The authors concluded that this bibliometric analysis shows that publications about efficacy of osteopathy are relatively recent and have increased at a rapid pace over the last three decades. More than half of these publications are published in three osteopathic journals targeting a limited, disciplinary-focused readership. Our results highlight important needs for large efficacy and effectiveness trials, as well as study designs to further understanding of the mechanisms of action of the techniques being investigated. Finally, this bibliometric analysis can assist to identify osteopathy techniques and populations where further clinical research is required.

What the authors fail to state is that their analysis discloses osteopathy to be an area of utter unimportance. Less than 400 studies in 52 years is a dismal result. The fact that they were mostly published in journals of no impact makes it even worse. Twenty-three articles were cited more than 100 times; this is dismal! To put it in perspective, I have ~250 articles that were cited more than 100 times. Does that suggest that my work has made about 10 times more impact than the entire field of osteopathy?

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

Guest post by Richard Rawlins

Ever since its inception, Homeopathy has struggled to establish principled medical ethics amongst its practitioners. For sure, Samuel Hahnemann was good doctor who achieved much by denying his patients the bleeding, emetics, expectorants, laxatives and poly-pharmacy conventional at the turn of the nineteenth century. But he then lost his way in spiritism and vitalism, devised a system of care which could not, and did not, provide any benefit beyond placebo responses, and inveigled many colleagues to share his delusion. Many derided him.

As medicine in all developed countries became better regulated, so the associated ethics became better focussed. “First do no harm” is common to all systems, but in the UK, the four ‘A’s of avoiding adultery with a patient, alcohol whilst in a clinical situation, advertising, and association formed the next domain. ‘Association’ meant having a professional medical relationship with anyone not also a GMC registrant. Times, and standards have changed, but quackery, charlatanism and health care fraud has always been unethical. The problem for society has been the GMC’s reluctance to take any action against its registrants who lack integrity, promote quackery, or seek to defraud. The general response has been “we only act on complaints by a patient, health authority or fellow registrant – and complaints have to be specific.”

So it is that about 400 registrants of the GMC continue practising homeopathy with impunity. Sir Simon Stevens has now all but banned homeopathy from the NHS, but a medically qualified practitioner, in the private sector can do as they please, no matter how vulnerable and gullible the patient.

Doctors are of course required to obtain fully informed consent to treatment, and that should mean advising patients that homeopathic remedies are but placebos. Many patients so treated will declare they “feel better” and are content – but in practice, no explanation is offered to patients attending homeopaths. A classic charlatonnade (a charade promulgated by a charlatan).

But perhaps the vicissitudes of Covid-19 is exposing the hypocrisy of the GMC’s position, and might yet enable some redress for patients seeking redress for unethical medically qualified homeopathic attention.

The Guardian and Sunday Times of 22nd March 2020 reported that Dr Mark Ali allegedly made £1.7M profit in one week from selling kits to test for COVID -19.

“The GMC said no doctor should try to ‘profit from the fear and uncertainly caused by the pandemic…We would be concerned to learn that doctors are exploiting patient’s vulnerability or lack of medical knowledge, in order to profit from fear and uncertainty…’ “

The rationale for that fear is surely irrelevant – any health practice which takes advantage of the patient’s vulnerability or lack of medical knowledge is unethical. Simple.

“We also expect doctors… not to offer or recommend tests that are unproven, clinically unverified or otherwise unreliable.”

This is in the context of the serious issues of SARS-CoV-2 (the name of the corona virus which causes the illness COVID-19) – but it is helpful that the GMC’s ethical principles have been clearly stated.

May we take it the GMC will be equally as stringent with their registrants (doctors) who take advantage of the patient’s vulnerability or lack of medical knowledge, and recommend tests such as homeopathic provings “that are unproven, clinically unverified or otherwise unreliable.”?

And if not, why not?

All homeopathic remedy prescriptions are ‘tests’: “Take this, see how you go, I’ll adjust if needed…”. The German word pruefung used by Hahnemann (meaning ‘testing’ or ‘examination’) has been translated into English as ‘proving’. But the word for ‘to prove’ is beweisen, and that is not the word Hahnemann used. The use of ‘proving’ in English implies merit which is not deserved. All part of the delusion.

Clearly, any doctor who recommends homeopathic remedies, but does not explain the conventional view of the remedy, lacks integrity and is unethical – by definition. If the doctor is GMC registered (which a ‘doctor’ does not have to be – e.g., dentists are not) – they should be subject to sanction by the GMC. The GMC should do its duty to protect the public, and not wait for a crisis to stir them into action.

Sadly, if practitioners are not GMC registered, caveat emptor.

I have been sceptical about Craniosacral Therapy (CST) several times (see for instance here, here and here). Now, a new paper might change all this:

The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.

Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.

Compared to treatment as usual, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
  • disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).

Compared to manual/non-manual sham, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
  • disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;

Compared to active manual treatments, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
  • disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .

At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:

  1. The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
  2. Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
  3. The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
  4. This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
  5. One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
  6. The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
  7. Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.

Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.

So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

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