Osteopathy:A Question of Evidence (Part 1)

Posted on February 1, 2011

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My past posts on this subject: Cranial Osteopathy:

Whilst waiting for the National Council for Osteopathic Research (NCOR) to complete and publish the results of their ongoing literature/evidence review into Cranial Osteopathy, it is worth looking at what evidence and information is already out there.

I was recently asked (again) in a comment “out of interest, what medical or research credentials do you hold to comment on such a topic? “ and it is worth addressing this before going any further. I’ve been asked this question before and have no problem at all with people asking it. I have no medical background or a background in medical research. I do have experience in gathering and evaluating information and data (not medical) from a variety of sources and looking at what is being said based on that information …… and more importantly what information seems to be missing from that data that would reasonably be required to support the various claims and assumptions being made against it.

The opinions I hold are mine, based on information that is readily available. When I see gaps in that information or something that I feel doesn’t make sense, my usual course of action is to ask those who should know the answer. Sometimes those people seem either reluctant to provide a clear answer or remarkably uninformed!

OK back to the question of evidence …...

Cranial Osteopathy is a form of treatment offered by some, but by no means all osteopaths. There is a definite split in the osteopathic profession about acceptance of these claims and this post will look solely the evidence and claims of these Cranial treatments.

I want to focus on comments coming from within the Osteopathic profession and where possible from within the UK, especially from those in the UK whose job it is to evaluate and regulate these matters!

I want cover a number of areas and it soon became clear that this would be better covered in two sections – Part 1 will cover.The Osteopath

* What is Cranial Osteopathy?

* What claims are being made?

* What evidence is required?

* What evidence is currently out there?

What is Cranial Osteopathy?

I don’t intend to give an in depth description of what Cranial Osteopathy is or isn’t. Far better to let the experts describe their own therapy. The Sutherland Society, a UK organisation whose aim is the promotion of Cranial Osteopathy http://www.cranial.org.uk/page2.html

“It is a gentle yet extremely effective approach and may be used in a wide range of conditions for people of all ages, from birth to old age.“

I do not question that Cranial Osteopathy is ‘gentle‘, but the statement that is is ‘extremely effective‘ for ‘a wide range of conditions‘ is far from proven!

Fundamental to Cranial Osteopathy is a belief in ‘The Cranial Rhythm’

“The Cranial Rhythm: Cranial osteopaths are trained to feel a very subtle, rhythmical shape change that is present in all body tissues. This is called Involuntary Motion or the Cranial Rhythm. The movement is of very small amplitude, therefore it takes practitioners with a very finely developed sense of touch to feel it“

The whole question of the existence of this ‘rhythm’ remains to be proven and is to some extent outside the scope of this post. Recently a Cranial Osteopathy sent me a comment and links to research with the aim of showing that this rhythm exists. Comment

What I will say on this is that:

EVEN IF this Cranial Rhythm could be proven, there is a huge gap between detecting something with medical technology (see Laser Doppler Flow later) and being able to detect it with the bare hands.

EVEN IF this could be detected with bare hands, it is a huge step to prove that it can be manipulated or influenced by the practitioner.

EVEN IF it could be detected and manipulated, this gets us nowhere near proving that it can be used to treat specific medical conditions.

What is needed is some evidence. If you take look at the ‘Research’ page of the Sutherland Society website Research and related articles. It’s remarkably (although perhaps understandably) lacking in information that could support this notion!

What claims are being made?

So now we’ve got a description of what Cranial Osteopathy is, lets take a quick look at some of the treatment claims made. The list is a long one and ranges from minor, non-specific complaints to far more serious conditions, all of which would need evidence to support them! Some of the more common ones are listed below – the wording has been taken direct from UK cranial osteopathy websites.

“Cerebral palsy and other types of brain damage, Learning difficulties, Behaviour problems, ADHD, Recurrent infections, Ear infections, Asthma, Stress, ME, Period Pains and many more”

So perhaps it is best to stick to a few of the more common claims.

I’ll look mainy at Colic but also Asthma, Ear Infections (Glue Ear) and Learning difficulties. These are four very common conditions that can be found on a large number of Cranial Osteopaths websites and advertising literature. So it is these conditions that I have asked NCOR and the General Osteopathic Council (GOsC) for the latest/best quality evidence currently available to support the claims

What evidence is required to support those claims & who sets the required standard?

Different groups (Osteopaths, Skeptics, Scientists and the Public) can interpret evidence in different ways and may be satisfied by different levels and quality of evidence. So we need to establish exactly what level of evidence is needed to support these advertising claims.

I do not simply expect people to accept my views. So perhaps it is best to look at the Osteopaths own Code of Practice. Agreed to by the profession and administered by the GOsC.

122. All advertising must be legal, decent, honest and truthful and must conform to the current guidance, such as the British Code of Advertising Practice.

So what we are looking for is evidence that is of a sufficiently high quality to satisfy the requirments of the Osteopaths Code of Practice and the guidance issued by the ASA/CAP.   This normally means robust, high quality evidence, usually RCT’s.

OK, now we have an overview of what Cranial Osteopathy is, what claims are being made and what sort of evidence is required to support those claims. All based on the views of those within the (cranial) osteopathic profession in the UK.

What evidence is currently out there?

Now we can actually look at what evidence is currently available. I say currently, because new research is always ongoing and being published – And this is a good thing!

But it is important to recognise that current claims can only be supported by current evidence. For obvious reasons we cannot draw conclusions from ongoing research. If the research is ongoing, then it is incomplete and the results and quality of the research have not been verified, people cannot simply assume that new research will support their current views.

Lets start with a report that is perhaps the easiest to cover and has been given wide coverage by the GOsC. The Bronfort Report, or to give it its full title the ‘Effectiveness of manual therapies: the UK evidence report‘, was commissioned by the General Chiropractic Council to help address their own issues surrounding evidence for a variety of claims. The report was not limited to chiropractic but reviewed the evidence for a range of therapies that involve manipulation and mobilisation, including chiropractic, osteopathy and massage. It was this report that initially prompted me to contact the GOsC, back in March 2010. The full report is readily available to read, but perhaps the part most relevant to this post can be found in figure 7, reproduced below.

Bronfort Report table 7 We can see that for osteopathic manipulative therapy, conditions such as Colic, Asthma and Ear Infections (Otitis media) are classed as ‘Inconclusive – Favourable’. To see how this applies we need to look at the definition of this classification of evidence, as listed in figure 1 of the report.

Inconclusive, but favourable evidence:

  • Does not support any public claims regarding effectiveness.
  • Recommend effective alternative if available.
  • Advise patients that this is a treatment option in the absence of an effective alternative.

Apart from the fact that the report states the evidence does not support ANY public claims (websites, printed advertising etc), some may reasonably argue, that as there are no fully effective treatments for colic, it is acceptable to promote Cranial Osteopathy.

So to avoid any confusion it is best to turn to NCOR for a position regarding this report.

Amongst other things (to be covered later), NCOR say:

“The evidence suggests spinal manipulation is ineffective in treating asthma, hypertension, pneumonia, and childhood colic, amongst other conditions. Osteopaths are reminded that they should regularly review their practice leaflets,website content and print advertising to ensure that their publicity complies with the ASA’s requirements, as well as the GOsC’s Code of Practice.”

Additional commentary (not NCOR or GOsC) on this report can be found here. (pdf) Two comments worthy of note are:

The vast majority of osteopaths and chiropractors in the UK are in private practice. This could lead to a concern that unproven treatments are being inappropriately offered for short term commercial gain. Similar concerns might be raised for my medical colleagues who work in private practice. Such unprofessional behaviour should be avoided by all professions.”

For some non-musculoskeletal disorders for which manual treatment has achieved popularity, without evidence of effectiveness being available there is a need for new trials to produce definitive evidence of effectiveness/ineffectiveness of manual therapy. In the meantime, this excellent report gives clear guidance on the disorders for which the use of manual therapy is supported by objective evidence of effectiveness.”

Clearly there is guidance in this report that needs to be considered and the GOsC make frequent references to it. However, rather than supporting the claims of osteopaths, it shows that there is a distinct lack of credible evidence on which to base this treatment.

I’ll leave Bronfort for now, as it has been well covered elsewhere. For more info on the Bronfort report and its limitations, visit Zeno’s Blog – Talking the talk.

Next it is probably best to see what NCOR have to say on the available evidence.

They have previously looked at a large volume of research in this area and found 506 relevant papers.  They did not limit their evidence solely to papers on Cranial Osteopathy, but also included papers on craniosacral, cranial bones, cerebrospinal fluid, cerebrospinal pulse, and cranial impulse plus other search terms that are not listed in the summary of the review, which was published in The Osteopath Dec09/Jan10 (pages 19-21).
‘Osteopathy in the cranial field a brief summary of current evidence”.
Under the section called What literature is available? They state:

A total of 506 relevant papers were examined. The literature looking at OCF covers a wide range of methodological approaches. The largest number of studies can be classified as opinion pieces, largely unreferenced and not published in peer-reviewed journals. A small number of case studies exist, as do editorials and hypotheses. Some clinical trials have been published, including a small number of literature reviews and one systematic review.

The literature available in this area is predominantly viewed as lower-grade evidence in terms of the hierarchy of research.”

OCF = Osteopathy in the Cranial Field.

As NCOR describe these 506 papers as mainly unreferenced, opinion pieces, it is safe to say that they do not reach standards the GOsC Code of Practice requires as evidence.  The NCOR review makes particular reference to a prospective controlled trial by Hayden et al from 2006.  This study was led by a practising UK Osteopath and a researcher associated with the European School of Osteopathy.

The review concludes with the statement that “This well-conducted trial is frequently cited as good quality evidence by many sources” – This is not the same as NCOR saying it is a good quality trial, just that others cite it as such.  It is in fact very easy to find this research quoted on may Cranial Osteopathy websites.

The details NCOR give for this trial were interesting and worth a closer look, after-all it is often cited as good quality, so may be the best evidence there is! An abstract of the report can be found here Hayden et al 2006 and whilst acknowledging that it is a (small) preliminary study and further research is warranted, it does seem to report some quite positive results.

Struggling to obtain a full copy, I asked on Twitter if anybody could help. A full copy was generously supplied by a UK Osteopath and I am grateful for his help in obtaining it.

The report presents a rather positive analysis and I do not intend to argue that these observations were not actually seen (as I wasn’t there!), but looking through the full report there are a couple of comments that do not make it into the abstract that are worth repeating.

The authors acknowledge that there were issues with the methodology of the trial, it was not double blinded and that any impact of the placebo effect could not be assessed and they acknowledge that a number of parents where unhappy that their children were assigned to the control group, so would not receive any treatment. The report states:

“ The unblinded study may have generated additional stress in parents of infants in the control group, resulting in negative effects on the infant; this could possibly explain the apparent skewing of the data at week 2 for the crying and sleeping variables in this group. By contrast, awareness of the treatment group may have positively influenced parental recording of colicky symptoms for infants in the treated group.“

This acknowledges that the results were not independently assessed, but were observations reported by parents whose perception of the success or failure of the treatment could have been subject to bias.

There is also an issue with the nature of the condition being tested, namely colic.

Colic is a self-limiting condition that, whilst upsetting for both parent and child, does not pose any serious threat to health.  It tends to appear around 2-3 weeks and has normally gone by around 3-4 months, even without treatment. Although in some cases it can last longer.
The onset of colic at 2-3 weeks is acknowledged in the report, however it fails to mention any time scale when the symptoms would normally have expected to have cleared.

The 28 children accepted onto the trial were between the ages of 1 and 12 weeks and treatment lasted for 4 weeks.  Clearly any child of 12 weeks old (3 months) undergoing a treatment of 4 weeks would be around 4 months old and of an age where untreated colic may well have cleared up or at least be showing a significant improvement.  The trial was randomised, so we could assume that the impact of this would apply to both control and treatment groups and would cancel itself out.

It is a little confusing that the report states:

“ The small reduction in crying time observed for infants in the control group may have been associated with the normal growth and development of the infant and the natural progressive history of this condition of improvement over time”

If properly randomised wouldn’t this natural progression of the condition and reduction in crying time apply to the treatment group also, yet this is not mentioned. What is stated about the treatment group is:

“The progressive and sustained improvement in crying patterns observed in the treated group may have resulted from a normalization in musculo-skeletal tone, which was possibly achieved by osteopathic manipulation”.

Why is any reduction in crying time in the control group associated with normal development of  child and condition, whilst improvement in the treatment group is ‘possibly’ related to osteopathic manipulation!
A typical example of the positive comments in the report is:

“The results obtained in our study lend support to the thesis that cranial osteopathy can help alleviate the abnormal behavioural symptoms associated with infantile colic.”

Lending support to a thesis, isn’t the same as finding conclusive proof and indeed the authors do not claim proof!

However, this post is not simply about this one study, so I’ll refer out to another report that gives more details, including the positive effects.  ‘crying time’ and ‘sleeping hours’ reported in the control group are covered in this analysis of Osteopathy and colic. Does osteopathy help in infantile colic ?

The conclusions say: “There is level three evidence that cranial osteopathy may decrease the amount of inconsolable crying and increase the amount of sleep in infants with colic.” They define ‘level three’ as:  “Some evidence without a high degree of reliability“.   “Studies where the results are doubtful because the study design does not guarantee that fair comparisons can be made“.

Level 3 clearly falls well below the standards that have been set, so perhaps it is understandable that NCOR themselves don’t actually refer to it as ‘good quality evidence’!

Note: The article refers to both Craniosacral and Cranial Osteopathy treatments. I did ask both NCOR and GOsC how they viewed the differences between the two therapies.
GOsC replied: “With regard to ‘cranial osteopathy’ and ‘craniosacral therapy’, we don’t have a view on the distinction between the practices “

NCOR replied:  “Craniosacral therapy and cranial osteopathy are terms that are used interchangeably in many studies and their definitions within those studies, if available, will be recorded as part of the review.”

Other studies mentioned in the review are, Moran and Gibbons (2001), and Rogers et al (1998) – investigated reliability for palpation of the cranial rhythmic impulse  “but findings were not encouraging”.

Wirth-Patullo et al (1994) and Nelson et al (2006) investigated craniosacral rate measurements and the relationship to subjects’ and examiners’ heart and respiratory measurements, and the rate of the cranial rhythmic impulse respectively. “They found a direct correlation, but it was measured using a technique called Laser Doppler Flow.  As the name suggests, this method uses lasers to measure flow rate. This would not automatically mean that this flow can be detected or directed just using the therapists hands …… however ‘highly trained‘.  Nor does it mention effective treatment of any specific condition.

Finally, they reference a 1999 systematic review (Green et al) you can read the full report for yourself if you wish, but the conclusions, referenced by NCOR, should be enough for most people:

“This systematic review found there is insufficient scientific evidence to recommend craniosacral therapy to patients, practitioners or third party payers for any clinical condition.“

“There is also some evidence (albeit of variable research quality) that there is potential movement at these suture sites in earlier life. Questions remain as to whether such “movement” is detectable by human palpation or whether mobility has any influence on health or disease.”

Note the reference to ‘third party payers’ – it’s not worth the patients, NHS or insurance companies money! and there is also the question of ‘detection, manipulation and influence on health’.
Again this mentions ‘craniosacral’, but  NCOR seem content with incorporating it into Cranial Osteopathy evidence.  This would seem to be a pretty accurate assessment for the overall level of evidence available, including that published since 1999.

It is certainly worth reading the full NCOR article so these comments are not taken out of context, but I can find no sign of any evidence that even approaches the standards required by the ASA/CAP or indeed the GOsC Code of Practice.  If higher quality evidence does currently exist, neither NCOR or GOsC have been willing to refer to it when I have asked them.

I will finish looking at the evidence by having a very quick look at this report from 2006. Cranial Osteopathy – its fate seems clear. It was produced by a U.S. Osteopathy who had (at that time) taught at the same Osteopathic college for 20 years.  You can read the full report for yourself, but I will highlight 2 very revealing comments.

Summary
“Until outcome studies show that these techniques produce a direct and positive clinical effect, they should be dropped from all academic curricula; insurance companies should stop paying for them; and patients should invest their time, money, and health elsewhere.”

Note: Another recommendation that people and companies should not pay for this treatment.
Not all osteopaths support Cranial Osteopathy, but many do and there were  arguments against this report, some of the discussion and comments can be seen here.

The final summary at the bottom of the report is a powerful statement on the validity of the “cranial arts” and the role of scientific evidence in medicine generally.

“After millennia as socially sanctioned, organized magical thinking, medicine has become a powerful service profession. This transition was possible only because scientific inquiry has become integral to almost everything physicians do. Without science, medicine would still involve little more than applying tourniquets, setting bones, and administering placebos. Cranial osteopathy/craniosacral therapy is not a medicine for this century. Perhaps properly controlled outcome studies will show that, though biologically anomalous, these techniques nonetheless produce a direct and positive effect on patient health. Until they do, however, the “cranial” arts should be dropped from all academic curricula; insurance companies should stop paying for them; and patients should invest their time, money, and health in treatments grounded in the extraordinarily successful, science-based biomedical model of the modern era.”

……..Hear, hear!

That pretty well covers the bulk of the research that is readily available or at least of a quality high enough to consider looking at. I do not claim that this is every report published, but I have covered that evidence referenced by NCOR and I have asked NCOR and GOsC if there is any better evidence available – none has been supplied.

There are undoubtedly people who are supporters of Cranial Osteopathy and who will disagree with many of the comments above. It is for this reason that where possible I have concentrated on analysis and commentary from within the Osteopathic profession.

Given all of the above, I certainly do not think that it can be accepted that Cranial Osteopathy is effective in the treatment of any condition and I do not think it is unacceptable to ask questions of those who have a statutory duty to regulate the profession.  Genuinely interested in the for/against views of UK Osteopaths on Cranial Osteopathy.

Part 2 of this post will be out shortly and will cover…..

How common is Cranial Osteopathy

Advertising advice & guidance!

What answers has the GOsC given?

And finally!…….

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Posted in: Osteopathy