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

cranial osteopathy

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.

As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:

In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Of course, not all SCAM professions focus on children. The following, however, treat children regularly:

  • acupuncturists
  • anthroposophical doctors
  • chiropractors
  • craniosacral therapists
  • energy healers
  • herbalists
  • homeopaths
  • naturopaths
  • osteopaths

I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.

Cranio-sacral therapy is firstly implausible, and secondly it lacks evidence of effectiveness (see for instance here, here, here and here). Yet, some researchers are nevertheless not deterred to test it in clinical trials. While this fact alone might be seen as embarrassing, the study below is a particular and personal embarrassment to me, in fact, I am shocked by it and write these lines with considerable regret.

Why? Bear with me, I will explain later.

The purpose of this trial was to evaluate the effectiveness of osteopathic manipulative treatment and osteopathy in the cranial field in temporomandibular disorders. Forty female subjects with temporomandibular disorders lasting at least three months were included. At enrollment, subjects were randomly assigned into two groups: (1) osteopathic manipulative treatment group (n=20) and (2) osteopathy in the cranial field [craniosacral therapy for you and me] group (n=20). Examinations were performed at baseline (E0) and at the end of the last treatment (E1), and consisted of subjective pain intensity with the Visual Analog Scale, Helkimo Index and SF-36 Health Survey. Subjects had five treatments, once a week. 36 subjects completed the study.

Patients in both groups showed significant reduction in Visual Analog Scale score (osteopathic manipulative treatment group: p = 0.001; osteopathy in the cranial field group: p< 0.001), Helkimo Index (osteopathic manipulative treatment group: p = 0.02; osteopathy in the cranial field group: p = 0.003) and a significant improvement in the SF-36 Health Survey – subscale “Bodily Pain” (osteopathic manipulative treatment group: p = 0.04; osteopathy in the cranial field group: p = 0.007) after five treatments (E1). All subjects (n = 36) also showed significant improvements in the above named parameters after five treatments (E1): Visual Analog Scale score (p< 0.001), Helkimo Index (p< 0.001), SF-36 Health Survey – subscale “Bodily Pain” (p = 0.001). The differences between the two groups were not statistically significant for any of the three endpoints.

The authors concluded that both therapeutic modalities had similar clinical results. The findings of this pilot trial support the use of osteopathic manipulative treatment and osteopathy in the cranial field as an effective treatment modality in patients with temporomandibular disorders. The positive results in both treatment groups should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field and support the importance of an interdisciplinary collaboration in patients with temporomandibular disorders. Implications for rehabilitation Temporomandibular disorders are the second most prevalent musculoskeletal condition with a negative impact on physical and psychological factors. There are a variety of options to treat temporomandibular disorders. This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life after osteopathic manipulative treatment and osteopathy in the cranial field. Our findings support the use of osteopathic manipulative treatment and osteopathy in the cranial field and should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field in patients with temporomandibular disorders. Rehabilitation experts should consider osteopathic manipulative treatment and osteopathy in the cranial field as a beneficial treatment option for temporomandibular disorders.

This study has so many flaws that I don’t know where to begin. Here are some of the more obvious ones:

  • There is, as already mentioned, no rationale for this study. I can see no reason why craniosacral therapy should work for the condition. Without such a rationale, the study should never even have been conceived.
  • Technically,  this RCTs an equivalence study comparing one therapy against another. As such it needs to be much larger to generate a meaningful result and it also would require a different statistical approach.
  • The authors mislabelled their trial a ‘pilot study’. However, a pilot study “is a preliminary small-scale study that researchers conduct in order to help them decide how best to conduct a large-scale research project. Using a pilot study, a researcher can identify or refine a research question, figure out what methods are best for pursuing it, and estimate how much time and resources will be necessary to complete the larger version, among other things.” It is not normally a study suited for evaluating the effectiveness of a therapy.
  • Any trial that compares one therapy of unknown effectiveness to another of unknown effectiveness is a complete and utter nonsense. Equivalent studies can only ever make sense, if one of the two treatments is of proven effectiveness – think of it as a mathematical equation: one equation with two unknowns is unsolvable.
  • Controlled studies such as RCTs are for comparing the outcomes of two or more groups, and only between-group differences are meaningful results of such trials.
  • The ‘positive results’ which the authors mention in their conclusions are meaningless because they are based on such within-group changes and nobody can know what caused them: the natural history of the condition, regression towards the mean, placebo-effects, or other non-specific effects – take your pick.
  • The conclusions are a bonanza of nonsensical platitudes and misleading claims which do not follow from the data.

As regular readers of this blog will doubtlessly have noticed, I have seen plenty of similarly flawed pseudo-research before – so, why does this paper upset me so much? The reason is personal, I am afraid: even though I do not know any of the authors in person, I know their institution more than well. The study comes from the Department of Physical Medicine and Rehabilitation, Medical University of Vienna, Austria. I was head of this department before I left in 1993 to take up the Exeter post. And I had hoped that, even after 25 years, a bit of the spirit, attitude, knowhow, critical thinking and scientific rigor – all of which I tried so hard to implant in my Viennese department at the time – would have survived.

Perhaps I was wrong.

Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.

This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.

A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.

The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.

[Legend to figure above: Percentage of alternative medicine clinic websites advertising at least one of diagnosis, treatment or efficacy for allergy/sensitivity or asthma. Presenting the data in this way demonstrates that the Canadian naturopath, homeopath and acupuncturist websites studied have >50% rates of making at least one health-related claim for both allergy/sensitivity and asthma.]

The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.

In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…

Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”

This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.

Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.

We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore  much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.

We must insist that regulators protect us from such quackery and prevent the serious harm it can do.

Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.

This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.

There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).

The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.

The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:

  • better education of general practitioners,
  • tightening of healthcare budgets,
  • recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
  • the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
  • the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
  • a more general realisation that these therapies can cause very serious harm,
  • a mixture of the above factors.

Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.

Recently, the UK Advertising Standards Authority (ASA) together with the UK General Osteopathic Council (GOsC) have sent new guidance to over 4,800 UK osteopaths on the GOsC register.  The guidance covers marketing claims for pregnant women, children and babies. It also provides examples of what kind of claims can, and can’t, be made for these patient groups.

Regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions only if they hold convincing evidence.  Claims for treating conditions specific to pregnant women, children and babies  are not supported by the evidence available to date.

The new ASA guidance is intended to help osteopaths talk about the healthcare they provide in a way that complies with the Advertising Codes and to protect consumers from being misled. It provides some basic principles and many examples of claims that are, and aren’t, acceptable. The ASA hopes it will provide greater clarity to osteopaths on how to advertise osteopathic care for pregnant women, children and babies responsibly.

Specifically, the guidance points out that “osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies, provided they are qualified to do so.  Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.”

Examples of claims previously made by UK osteopaths which are “unlikely to be acceptable” include:

  • Osteopaths often work with lactation consultations where babies are having difficulty feeding. 
  • Osteopaths are qualified to advise and treat patients across the full breadth of primary care practice.
  • Osteopaths often work with crying, unsettled babies.
  • Birth is a stressful process for babies.
  • Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help.
  • If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help.
  • Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains.
  • Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull.
  • Midwives often recommend an osteopathic check-up for babies after birth.
  • Osteopathy can help with breast soreness or mastitis after birth.
  • If your baby is having difficulty breastfeeding, osteopathy might be able to help.
  • Many pregnant women experience pain in the pelvic girdle area.  Osteopaths offer safe, gentle manipulation and stretches.
  • Many pregnant women find osteopathy relieves common symptoms such as nausea and heartburn.
  • Use of osteopathy can limit perineum or pelvic floor trauma.
  • If your baby suffers from constipation then osteopathy could help.
  • Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health.
  • In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established.
  • Cranial osteopathy releases stresses and strains in the skull and throughout the body.
  • Osteopaths can feel involuntary motion and mechanisms within the body.
  • Cranial osteopathy aims to reduce restrictions in movement.

Elsewhere in the ASA announcement, we find the statement that “The effectiveness of osteopathy for treating some conditions is underpinned by robust evidence”. The two examples provided are rheumatic pain and joint pain. I have to say I was mystified by this. I am not aware of robust evidence for these two indications. Perhaps someone could help me out here and provide some references?

The only condition for which there is enough encouraging evidence is, as far, as I know low back pain – and even here I would not call the evidence ‘robust’. Am I mistaken? If you think so, please supply the evidence with links to the references.

But, in general, the new guidance is certainly a step in the right direction. Now we have to wait and see whether osteopaths change their advertising and behaviour accordingly and what happens to those who don’t.

WATCH THIS SPACE

Cranio-sacral therapy has been a subject on this blog before, for instance here, here and here. The authors of this single-blind, randomized trial explain in the introduction of their paper that “cranio-sacral therapy is an alternative and complementary therapy based on the theory that restricted movement at the cranial sutures of the skull negatively affect rhythmic impulses conveyed through the cerebral spinal fluid from the cranium to the sacrum. Restriction within the cranio-sacral system can affect its components: the brain, spinal cord, and protective membranes. The brain is said to produce involuntary, rhythmic movements within the skull. This movement involves dilation and contraction of the ventricles of the brain,  which produce the circulation of the cerebral spinal fluid. The theory states that this fluctuation mechanism causes reciprocal tension within the membranes, transmitting motion to the cranial bones and the sacrum. Cranio-sacral therapy and cranial osteopathic manual therapy originate from the observations made by William G. Sutherland, who said that the bones of the human skeleton have mobility. These techniques are based mainly on the study of anatomic and physiologic mechanisms in the skull and their relation to the body as a whole, which includes a system of diagnostic and therapeutic techniques aimed at treatment and prevention of diseases. These techniques are  based on the so-called primary respiratory movement, which is manifested in the mobility of the cranial bones, sacrum,  dura, central nervous system, and cerebrospinal fluid. The main difference between the two therapies is that cranial osteopathy, in addition to a phase that works in the direction of the lesion (called the functional phase), also uses a phase that worsens the injury, which is called structural phase.”

With this study, the researchers wanted to evaluate the effects of cranio-sacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. Sixty-four patients with chronic non-specific low back pain were assigned to an experimental group receiving 10 sessions of craniosacral therapy, or to the control group receiving 10 sessions of classic massage. Craniosacral therapy took 50 minutes and was conducted as follows: With pelvic diaphragm release, palms are placed in transverse position on the superior aspect of the pubic bone, under  the L5–S1 sacrum, and finger pads are placed on spinal processes.  With respiratory diaphragm release, palms are placed transverse under T12/L1 so that the spine lies along the start of fingers and the border of palm, and the anterior hand is placed on the breastbone. For thoracic inlet release, the thumb and index finger are placed on the opposite sides of the clavicle, with the posterior hand/palm of the hand cupping C7/T1. For the hyoid release, the thumb and index finger are placed on the hyoid, with the index finger on the occiput and the cupping finger pads on the cervical vertebrae. With the sacral technique for stabilizing L5/sacrum, the fingers contact the sulcus and the palm of the hand is in contact with the distal part of the sacral bone. The non-dominant hand of the therapist rested over the pelvis, with one hand on one iliac crest and the elbow/forearm of the other side over the other iliac crest. For CV-4 still point induction, thenar pads are placed under the occipital protuberance, avoiding mastoid sutures.  Classic massage protocol was compounded by the following sequence techniques of soft tissue massage on the  low back: effleurage, petrissage, friction, and kneading. The maneuvers are performed with surface pressure, followed by deep pressure and ending with surface pressure again. The techniques took 30 minutes.

Disability (Roland Morris Disability Questionnaire RMQ, and Oswestry Disability Index) was the primary endpoint. Other outcome measures included the pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical analyses of interstitial fluid. All outcomes were measured at baseline, after treatment, and one-month follow-up.

No statistically significant differences were seen between groups for the main outcome of the study, the RMQ. However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p ≤ 0.008), hemoglobin oxygen saturation (p ≤ 0.028), and systolic blood pressure (p ≤ 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage.

The authors concluded that 10 sessions of cranio-sacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain.

Given the results of this study, the conclusion is surprising. The primary outcome measure failed to show an inter-group difference; in other words, the results of this RCT were essentially negative. To use secondary endpoints – most of which are irrelevant for the study’s aim – in order to draw a positive conclusion seems odd, if not misleading. These positive findings are most likely due to the lack of patient-blinding or to the 200 min longer attention received by the verum patients. They are thus next to meaningless.

In my view, this publication is yet another example of an attempt to turn a negative into a positive result. This phenomenon seems embarrassingly frequent in alternative medicine. It goes without saying that it is not just misleading but also dishonest and unethical.

In my last post, I made a fairly bold statement without any evidence to support it: “[this] demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.”

I felt that my statement was supported by so many websites that it was almost self-evident. But, as it happens, I was alerted today to another website that provides impressive first had evidence of what I meant:

“The purpose of this site is to provide the public with information about Craniosacral Therapy

Craniosacral therapists recognise health as an active principle. This health is the expression of life – an inherent ordering force, a natural internal intelligence. Craniosacral Therapy is a subtle and profound healing form which assists this natural bodily intelligence.

It is clear that a living human organism is immensely complex and requires an enormous amount of internal organisation. Craniosacral Therapy helps nurture these internal ordering principles. It helps increase physical vitality and well-being, not only effecting structural change, but also having much wider implications e.g. improving interpersonal relationships, managing life more appropriately etc…

The work can address issues in whatever way the client wishes; physical aches and pains, acute and chronic disease, emotional or psychological disturbances, or simply developing well-being, health and vitality.

Craniosacral Therapy is so gentle that it is suitable for babies, children, and the elderly, as well as adults; and also in fragile or acutely painful conditions. As a whole-body therapy, treatment may aid almost every condition, raising the vitality and enabling the body’s own self-healing process to be utilised.”

I find this text rather typical and very revealing: the authors first make several bland statements which are little more that politically correct platitudes. Eventually, they try to tell us what their therapy is good for: it is suitable for babies adults and the elderly. In other words, it is for everyone!

And what is so truly brilliant, it can be used to treat acute and chronic conditions. In other words, it is effective for every disease afflicting mankind!

Once you have realised it, the strategy of such ‘position statements’ (or whatever they might call it) is all too obvious: behind a smokescreen of empty platitudes, quackery is being promoted for profit. The phraseology used is such that there can be little concrete objections in legal or regulatory terms. All the therapeutic claims are general, cleverly hidden and operate merely by implication.

Quackery? Yes, absolutely!

Craniosacral therapy has not been proven to be effective for anything and, as a therapy, it is therefore not ‘suitable’ for anyone. To me, this is almost the definition of quackery.

According to the ‘General Osteopathic Council’ (GOC), osteopathy is a primary care profession, focusing on the diagnosis, treatment, prevention and rehabilitation of musculoskeletal disorders, and the effects of these conditions on patients’ general health.

Using many of the diagnostic procedures applied in conventional medical assessment, osteopaths seek to restore the optimal functioning of the body, where possible without the use of drugs or surgery. Osteopathy is based on the principle that the body has the ability to heal, and osteopathic care focuses on strengthening the musculoskeletal systems to treat existing conditions and to prevent illness. 

Osteopaths’ patient-centred approach to health and well-being means they consider symptoms in the context of the patient’s full medical history, as well as their lifestyle and personal circumstances. This holistic approach ensures that all treatment is tailored to the individual patient.

On a good day, such definitions make me smile; on a bad day, they make me angry. I can think of quite a few professions which would fit this definition just as well or better than osteopathy. What are we supposed to think about a profession that is not even able to provide an adequate definition of itself?

Perhaps I try a different angle: what conditions do osteopaths treat? The GOC informs us that commonly treated conditions include back and neck pain, postural problems, sporting injuries, muscle and joint deterioration, restricted mobility and occupational ill-health.

This statement seems not much better than the previous one. What on earth is ‘muscle and joint deterioration’? It is not a condition that I find in any medical dictionary or textbook. Can anyone think of a broader term than ‘occupational ill health’? This could be anything from tennis elbow to allergies or depression. Do osteopaths treat all of those?

One gets the impression that osteopaths and their GOC are deliberately vague – perhaps because this would diminish the risk of being held to account on any specific issue?

The more one looks into the subject of osteopathy, the more confused one gets. The profession goes back to Andrew Still ((August 6, 1828 – December 12, 1917) Palmer, the founder of chiropractic is said to have been one of Still’s pupils and seems to have ‘borrowed’ most of his concepts from him – even though he always denied this) who defined osteopathy as a science which consists of such exact exhaustive and verifiable knowledge of the structure and functions of the human mechanism, anatomy and physiology & psychology including the chemistry and physics of its known elements as is made discernable certain organic laws and resources within the body itself by which nature under scientific treatment peculiar to osteopathic practice apart from all ordinary methods of extraneous, artificial & medicinal stimulation and in harmonious accord with its own mechanical principles, molecular activities and metabolic processes may recover from displacements, derangements, disorganizations and consequent diseases and regain its normal equilibrium of form and function in health and strength.

This and many other of his statements seem to indicate that the art of using language for obfuscation has a long tradition in osteopathy and goes back directly to its founding father.

What makes the subject of osteopathy particularly confusing is not just the oddity that, in conventional medicine, the term means ‘disease of the bone’ (which renders any literature searches in this area a nightmare) but also the fact that, in different countries, osteopaths are entirely different professionals. In the US, osteopathy has long been fully absorbed by mainstream medicine and there is hardly any difference between MDs and ODs. In the UK, osteopaths are alternative practitioners regulated by statute but are, compared to chiropractors, of minor importance. In Germany, osteopaths are not regulated and fairly ‘low key’, while in France, they are numerous and like to see themselves as primary care physicians.

And what about the evidence base of osteopathy? Well, that’s even more confusing, in my view. Evidence for which treatment? As US osteopaths might use any therapy from drugs to surgery, it could get rather complicated. So let’s just focus on the manual treatment as used by osteopaths outside the US.

Anyone who attempts to critically evaluate the published trial evidence in this area will be struck by at least two phenomena:

  1. the wide range of conditions treated with osteopathic manual therapy (OMT)
  2. the fact that there are several groups of researchers that produce one positive result after the next.

The best example is probably the exceedingly productive research team of J. C. Licciardone from the Osteopathic Research Center, University of North Texas. Here are a few conclusions from their clinical studies:

  1. The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.
  2. The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.
  3. Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.
  4. Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.
  5. The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.
  6. Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.
  7. The only consistent finding in this study was an association between type 2 diabetes mellitus and tissue changes at T11-L2 on the right side. Potential explanations for this finding include reflex viscerosomatic changes directly related to the progression of type 2 diabetes mellitus, a spurious association attributable to confounding visceral diseases, or a chance observation unrelated to type 2 diabetes mellitus. Larger prospective studies are needed to better study osteopathic palpatory findings in type 2 diabetes mellitus.
  8. OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Based on this brief review of the evidence origination from one of the most active research team, one could be forgiven to think that osteopathy is a panacea. But such an assumption is, of course, nonsensical; a more reasonable conclusion might be the following: osteopathy is one of the most confusing and confused subject under the already confused umbrella of alternative medicine.

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