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

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.

18 Responses to A new RCT of craniosacral therapy … for once, I am really embarrassed

  • It would appear that the authors of this study don’t have the faintest idea how to conduct research to test treatment effectiveness. It’s also very concerning that the peer reviewers failed to detect the many flaws in this study and reject it for publication. Neither the authors nor the peer reviewers have considered the possibility that both of these treatments are equally ineffective for temporomandibular disorders. Given what we know about the lack effectiveness of both manipulative osteopathy and cranial osteopathy for most conditions (as well as the lack of plausability of cranial osteopathy) that seems by far and away the most likely outcome. When I see papers as truly awful as this getting published, I worry about the future of research.

  • This post makes me sad, not so much the uselessness of the trial, rather your disappointment, Dr. Ernst. Imparting rationality in a field such as research in medicine is a very difficult effort of a beneficence. Oftentimes, it appears as if there would be no hope. I would like to ease your embarrassment a bit, by saying that the footprint of your positive influence extends far beyond what you would even hope for. Your Department may slip one or two travesties but whoever comes across your work cannot help but put up a fight, either against his own preconceptions, or against his prior illusions that this world is ruled by reason. In the rare occasion, where somebody has already had an idea of how much chaos exists in the minds of the general population with respect to the mechanisms that govern this world, an encounter with your work reminds them of how important it is to never let the guard down and think that everybody’s got what they deserve.

    Although I, personally, was very well aware of how much bullshit runs around all over our world, your efforts always remind me that a robust conclusion is not the ending point of proper research, it is the beginning point of the tough endeavour of proper dissemination. Do not feel embarrassed, Dr. Ernst, a series of butterfly effects, both older and more recent, is already beginning to have a strong impact in medical research. With all due respect, Dr. Ernst, you may or may not be here to witness the magnitude of the impact of your intervention in the world of medical research when it’s full-blown due, but let me reassure you that it is going to be greater than any present situation or state of things might illustrate. I hope, of course, you are here with us for a very long time and keep disappointing all sorts of promoters of implausible claims in this world.

    Finally, not being sure as to whether this has been proposed in the past, I believe that Dr. Ernst’s influence on alternative medicine research has accummulated the critical mass to be considered sensational. I propose we should set forth the concept of the Ernst number in Alternative Medicine, in the same way that the Erdős number is defined in Mathematics:

    To be assigned an Erdős number, someone must be a coauthor of a research paper with another person who has a finite Erdős number. Paul Erdős has an Erdős number of zero. Anybody else’s Erdős number is k + 1 where k is the lowest Erdős number of any coauthor.

    Ernst number:
    To be assigned an Ernst number, someone must be a coauthor of a research paper with another person who has a finite Ernst number. Edzard Ernst himself has an Ernst number of zero. Anybody else’s Ernst number is k + 1, where k is the lowest Ernst number of any coauthor.

    So, Ernst’s immediate coauthors have an Ernst number of 1, etc. Extravagant, some may say? I say, it is not so much for the Ernst numbers themselves, which I still find utterly interesting, as there is to the recognition coming forth from establishing a formal metric, which will ultimately show, in my opinion, in due course, how much confidence we can have in the results of various alternative medicine writings, judging by the Ernst number of the various authors. In my modest experience, the time for this kind of recognition is due. Other folks in here will have, of course, both much more experience than myself to judge whether it is this “high-time”, and much more authority than myself to achieve the formal establishment of that metric, should they agree with the idea. Whatever the case, I will always be intrigued by the thought of acquiring a finite Ernst number, and this should be enough by itself to demonstrate to you, Dr. Ernst, that you should not be embarrassed, your efforts are recognized and acknowledged, it just takes time and there are natural fluctuations.

  • I couldn’t do a decent critical appraisal of a paper if it ran up and bit me on the arse, but even I can see this for the utter garbage it is. Not worth the paper it is printed on.

  • It’s possible that there was no peer review – it appears that peer reviewed editions of the journal may be the exception and not the rule. True enough, the results reported in this paper are meaningless – in scientific terms. If the real purpose was to test for treatment effectiveness then the authors should go back to square one. They haven’t got a clue.

    Was that the real purpose? Was the purpose simply to get a paper published with their names on it? The paper is potentially useful to true believers and practitioners. Perhaps they are just that. Their Ernst numbers must surely be off the scale?

    Shame on Vienna University for facilitating junk science.

    • A small overview of some of the authors’ scientific research yield (in terms of papers) and background reveals a relative lack of insight into “alternative medicine”. The head of the department’s Wikipedia page has a weird statement at the top:

      This article may have been created or edited in return for undisclosed payments, a violation of Wikipedia’s terms of use. It may require cleanup to comply with Wikipedia’s content policies.

      Furthermore, the “stellvertretende” Leiter (Keilani M.) is a bit of a mystery, only source of information is on Pubmed publication records. The Department’s webpage does not expose much info about the staff.

      Taking a look at their publications in general, all in all, they don’t seem to make a distinction between what is and what isn’t alternative medicine. It is quite probable that they are genuinely studying all types of interventions, in which case they need to be made aware of the limitations of their subject of study. In other words, they seem to be honest in their approach, but they are unaware that they have stepped in woo-territory.

      On the other hand, comparing two interventions of doubtful efficacy to each other is a rather lame mistake to make and these mistakes cost considerable amounts of money, but the authors state inside the paper, in the acknowledgements section:

      We would like to thank the patients and the medical staff who collaborated on this study There is no financial or material support to report for the present study.

      Most evidence points to the direction of an honest mistake. I think they should be made aware of this limitation. The peer-review process has failed yet again, unfortunately. I am beginning to think that peer-reviewers have adopted a compassionate mentality towards the effort and resource spending related to research and are behaving far more leniently in their duties. That, or they are “hired”/hand-picked for the job, I can’t find any other explanation for letting such obviously flawed work get published.

      Another interesting note to be made is that the paper was actually accepted and published in 2016, and the Journal of the American Osteopathic Association has already had a chance to comment on it, I assume positively, although I cannot access their commentary to be totally certain.

      Finally, although it will take a considerable amount of effort and time to calculate preliminary Ernst numbers from whatever raw data is available in aggregate structures, something that I plan to carry out in the not-so-distant future (I hope before the end of this year, I will keep you updated), judging by the type of research of the authors of this paper, and their history, it is unlikely that they have a finite Ernst number, i.e. they have probably not collaborated with anyone that has a finite co-authorship path to Dr. Ernst.

      This is indeed a bad paper overall…

  • As I went for some osteopathic trainings to Vienna long ago it was interesting that in those times the concept of CRAFTA from the Netherlands started and the osteopaths tried to take the knowledge over anf to make their own courses out of this. The CRAFTA books were sold in the Osteopathic school of Vienna.

    Later the Osteopathic School of Vienna started to work together with the Dungl Center in Graz and both started their new program for a M.Sc. (ost) with a minimum of credit points with the private University of Krems.

    So you might find other studies about manual therapy in cranio mandibular dysfunctions in the CRAFTA webpages. It is interesting to compare the CRAFTA concept with this study here..
    CRAFTA claims to be evidence based … really??
    https://crafta.net/blog-section/about_crafta/artikelen

  • As a neurologist. I am amazed (and disgusted) that a certain university clinic claims to be treating epilepsy by manipulating the bones of the skull in adults.

    • very good!
      thanks

    • The WHO benchmarks on osteopathy in their INTRODUCTION are telling us that the founder of the name “Osteopathy” (which is a weird and crude translation of the word “bone-setting”) A.T. Still was a “physician and surgeon” and that he created his system in the mid-1800s…

      That’s definitely wrong. During the Civil War he was a hospital servant and after the war he joined a course in millery.

      Later in 1874 A.T. Still advertised himself as “Magnetic Healer” and after that he suddenly called himself a “Dr.” on his business card “Dr. A.T. Still lightning bone-setter”. Astonishing isn’t it?

      To get a pension for being a surgeon in the army during Civil War he said that “everybody knows that I did the surgeon” but the military documents about the surgeons serving the US army during the Civil War were very precise and showed no A.T. Still at all. The Government denied to pay a pension to this self-declared physician and surgeon.

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