Just a quick update on osteopathy & evidence (or lack of):
In earlier discussions with the GOsC, they agreed that there were areas where the guidance issued by the GOsC could be more focused, particularly when it comes to website claims being made by some sections of the Osteopathic profession.
Osteopathy: More words, Some actions, No evidence!
“Notwithstanding the points above, your observations regarding osteopathic websites indicate that the GOsC must be more targeted in our guidance to practitioners.”
Today the GOsC issued updated guidance to its members, reinforcing the requirement to ensure that osteopaths literature should comply with the ASA CAP guidelines.
GOsC e-Bulletin: Effectiveness of manual therapies
Importantly they have made clear, unambiguous statements about the need for treatment claims to be based on high quality evidence. There can be no doubt as to the message being sent to osteopaths
“Can you provide evidence that the treatment you are offering is effective for the conditions you are claiming to treat? Osteopaths must ensure that the information you provide to your patients and the public that names conditions which may respond well to osteopathic treatment is based on solid evidence from high-quality research.”
The GOsC’s latest guidance also references the ‘Effectiveness of manual therapies’ report commissioned by the GCC and links to the NCOR’s statement on this report. This report is critical of a number of manual therapies, including OMT in relation to the treatment of a range of non-musculoskeletal conditions.
This was covered when I first contacted the GOsC on the subject of evidence: Osteopaths: Talking a good game (included NCOR statement)
At present there are still a large number of UK osteopathy websites making claims that would not seem to be substantiated by any good quality research! It didn’t take long to produce a list of sites and claims that are deserving of scrutiny, the majority seem to be those practicing cranial osteopathy. Now what is needed is for these osteopaths to take action on this advice.
Either remove those claims from your advertising literature and websites, or perhaps it’s time to look out that evidence …… just in case you are asked to produce it!
Just in case there is any doubt as to the requirements, Section 3 of the CAP Codes General Rules is perfectly clear.
Substantiation
3.1 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove all claims, whether direct or implied, that are capable of objective substantiation. Relevant evidence should be sent without delay if requested by the ASA or CAP. The adequacy of evidence will be judged on whether it supports both the detailed claims and the overall impression created by the marketing communication. The full name and geographical business address of marketers should be provided without delay if requested by the ASA or CAP.
3.2 If there is a significant division of informed opinion about any claims made in a marketing communication they should not be portrayed as generally agreed.
3.3 Claims for the content of non-fiction books, tapes, videos and the like that have not been independently substantiated should not exaggerate the value, accuracy, scientific validity or practical usefulness of the product.
3.4 Obvious untruths or exaggerations that are unlikely to mislead and incidental minor errors and unorthodox spellings are all allowed provided they do not affect the accuracy or perception of the marketing communication in any material way.
It’s probably fair to say it will take a short while for any changes to be implemented on the websites that need to change. Perhaps this time next month would be a good time to see just how many osteopaths choose to ignore the guidance!
The GOsC have also stated:
“Your additional queries relating to “cranial osteopathy” highlight another area where information could be fuller in the public interest.”
Hopefully they will issue some guidance to the public on these areas.
skepticbarista
May 28, 2010
Many thanks to @alextravellion for posting this GOsC bulletin & link out on Twitter.
John Doe
June 24, 2010
It is my understanding that there was a batch if complaints sent to the GOsC, in a similer vein to that initiated by Simon Perry but they refused to process them as they felt they were of a malicious natures. Is that right?
I am also led to believe that the wording by the Osteopathic Council in relation to advertising also makes it more difficult to get complaints processed in relation to website content and advertising? Is that also correct.
I am intrigued in relation to the different approach of the Chiropractic and Osteopathic councils as I understand that the acts are the same? Can you enlighten me?
d tolson
October 16, 2010
As a doctor i am hugely encouraged by your watchful eye on some of these therapies. It seems the chiropractors were daft to cross Simon Singh. The Osteos are seeming now to sort their house out and only advertise evidence based claims, it does take time to change websites though!
My concern is, as a surgeon (28 years) , there are MANY things i do daily that are yet to have an evidence base behind them….. but they save lives!
Good to be vigilant, but most pioneering techniques within surgery and medicine have little evidence behind them…..just a thought,
D Tolson
Oz
January 19, 2011
Hi Skepticbarista
Some research for you to look through related to Cranial Osteopathy with a few references…..
The motility of the brain and spinal cord is widely accepted; this motion appears to be related to circulatory changes and the cardiac cycle. It also appears intracranial structures move slower and in a smaller range than the spinal cord (Mikulis, et al. 1994), (Poncelet, et al. 1992) and (Grietz et al. 1992).
The movement of CSF from the carotid plexus through the ventricles of the brain is a well-established phenomenon (Du Bolay et al. 1971), (O’Connell, 1943) and (Levy et al. 1988). These effects are considered to be the driving force behind the Primary Respiratory Mechanisms (PRM) and they infer a possible link between vasomotor sympathetic activity of blood circulation, the cardiac cycle and the PRM. Some of the earliest effects of cranial manipulation recorded are in text by Magoun (1966) showing an apparent reduction in sweat production (associated with a decrease in sympathetic tone) before and after the application of the compression of the fourth ventricle (CV4) technique. Cutler et al. (2005) postulated that due to the reported relaxing nature of the CV4 technique, Magoun’s findings and that the autonomic nervous system played an important role in sleep latency (Moldofsky and Luk, 2003, cited in Culter et al. 2005). The CV4 technique may have an effect on sleep latency through the autonomic nervous system. Nelson et al. 2001 also noted the similarities between the Traube-Hering-Mayer (THM) measurement of blood pressure and blood velocity, and the Cranial Rhythmic Impulse (CRI). The authors postulated whether changes in the THM wave could be observed after making changes to the CRI.
Cutler et al (2005) http://www.ncbi.nlm.nih.gov/pubmed/15750368
Sergueef et al (2002) http://www.ncbi.nlm.nih.gov/pubmed
Mikulis, D.J., Wood, M.L., Zerdoner, O.A.M, and Poncelet, B.P. (1994). Oscillatory Motion of the normal cervical spinal cord. Radiology. (193), pp 477-483
Nelson, K.E. (2002). The primary respiratory mechanism. American Academy of Osteopathy Journal, 12, pp 24-33
Poncelet, B.P., Wedeen, V.J., Weiskoff, R.M. & Cohen, M.S. (1992). Brain parenchyma motion: measurement with cine echo-planar MR imaging. Radiology, 185, pp 645-651
Grietz, D., Wirestam, R., Franck, A, Nordell, B., Thomsen, C. and Stahlberg, F. (1992). Pulsatile brain movement and associated hydrodynamics studied by magnetic resonance phase imaging: The Monro-Kellie doctrine revisited. Neuroradiology, 34, pp 370-380.
Levy, L.M., DiChiro, G.D., McCullough, D.C., Dwyer, A.J., Johnson, D.L. & Yang, S.S.L. (1988). Fixed Spinal Cord: Diagnosis with MR Imaging. Radiology, 169, pp 773-778.
On going long term reliable research is essential especially in cranial manipulation in order to assess the full effect of these treatments from a clinical stand point using multi-systemic outcome measures. Trials assessing cranial manipulations need a higher level of methodological quality in order to facilitate ease of future analysis and so that the significance of results found are harder to dispute.
This is also a brief summary of some available evidence
http://www.brighton.ac.uk/ncor/summaries/Osteopathy%20in%20the%20Cranial%20Field.pdf
The main point to mention in all of this is that, most osteopath’s use a variety of different techniques ‘cranial’ itself is a bit of a misnomer. It is difficult to research as the subtle nature of what is done is very much an interaction from patient to practitioner and can vary each time. It is also for this reason hard to test accurately within the medical double blind, gold standard model. Unfortunately for the time being the proof is really in that it helps people and families everyday and in their testimonials. As long as people don’t make outrageous claims to cure or falsify facts Osteopath’s should be left in peace to get on with what they do best. I agree with a message I read on your blogspot above
“My concern is, as a surgeon (28 years) , there are MANY things i do daily that are yet to have an evidence base behind them….. but they save lives! Good to be vigilant, but most pioneering techniques within surgery and medicine have little evidence behind them…..just a thought,”
skepticbarista
January 20, 2011
Thanks for that ….. Yesterday when I asked about evidence, you said there was lots …. what I actually asked for was ‘robust, high quality evidence’ … there is a huge difference!
I’ll have a look at those studies. I’ve already seen the NCOR summary and if the best the can report on evidence is ……. ‘opinion‘ ‘unreferenced‘ ‘lower grade‘ and ‘hypotheses‘ then there are certainly problems with the evidence base… (you didn’t mention anything about lower grade evidence on air!)
“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. A small number of 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. The case study, however, should not be undervalued; it is frequently the most interesting type of study to many clinicians.”
it isn’t anywhere near strong enough to support claims to treat conditions such as colic, ear infections, learning difficulties and allergies, all very common claims and almost exclusively targetted at babies and young children … some even claim to be able to ‘help’ Cerebral Palsy <— Cynical targetting of vulnerable people!
That summary of evidence was published about a year ago, following a review of the literature. Within the last few days I have been told by NCOR that they are doing another literature review, this is covering the old evidence and also some new reports.
The recently published results of the SDC show that it is widely offered to children as a first treatment option …. some osteopaths even hold 'competitions' (radio & twitter) for a free treatment – Don't you think that could encourage people to seek cranial osteo, even if they don't actually need it! (exploiting the worried well)
If it is that widespread and being used on babies & children then there really should be a robust evidence base to support it!
It is also worth highlighting that many of the papers they reference are NOT related to cranial osteopathy, they refer to craniosacral therapy (something the ASA has already blown apart: http://www.asa.org.uk/Asa-Action/Adjudications/2010/9/Craniosacral-Therapy-Association/TF_ADJ_49005.aspx )
I understand there are similarities between CST and Cranial Osteo …. but which therapy do you do – are you a craniosacral therapist?
I am currently talking to the GOsC and NCOR about the evidence and despite asking for what they consider to be robust evidence – - – none has been supplied.
The type of evidence I’m looking for is that considered to be of a high enough quality to satisfy the requirements of the ASA/CAP. This is also the level of evidence that is required to meet the standards laid out in the GOsC Code of Practice:
“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”
If the evidence base doesn’t conform to that level ….. then making those claims puts you (and other cranial osteos) in breach of your own code of practice.
These are not MY requirements and not MY standards of evidence …. they are the GOsC’s requirements and standards laid down by the Osteopathic statutory regulator.
All I am asking for is confirmation that this evidence exists and asking to see it – what is it they find so difficult about living up to their own standards.
I first started to ask about it in March 2010 and as yet have not seen any! The best the GOsC can offer is it isn’t their job (it’s NCOR’s) and:
“research development within UK Osteopathy is in its formative stages”
“Formative stages” ….. how long has cranial osteopathy been around & they are still talking about formative stages – maybe another couple of centuries will be enough.
Happily there are quite a few Osteopathy who also think cranial osteo is rubbish and I’ve had comments and emails from them – the sensible side of osteopathy. However those osteo’s need to recognise that they come under the same banner as the cranial side of the profession, if they’re not happy with that then they should speak out!
With regards to those studies you quote. Don’t forget that even if there was any evidence to support the notion of cranial rhythmic impulse – that doesn’t mean you can detect or manipulate it with your bare hands and even if you could …. it doesn’t mean it can effectively treat any specific condition!
You offer to treat colic … how many of those studies are specific to colic ?
NCOR should have finnished their review within about 6 weeks, which is quite handy as the ASA’s remit gets extended on 1 March to cover misleading claims made on websites. I strongly suspect that the GOsC will be offering some urgent advertising guidance in the very near future.
…… There is certainly more to come on this!
skepticbarista
February 1, 2011
Oz,
Please see this for more on the evidence:
http://skepticbarista.wordpress.com/2011/02/01/osteopathya-question-of-evidence-part-1/