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Archived Comments for: Cranial osteopathy: its fate seems clear

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  1. Cranial Therapeutic Care: Is There any Evidence?

    Charles Blum, Sacro Occipital Technique Organization - USA

    12 July 2006

    Cranial Therapeutic Care: Is There any Evidence?

    Charles L. Blum, DC

    Scott Cuthbert, DC

    It appears from a review of past letters by. Hartman [1] and Norton [2] that they are making a concerted effort to gain some recognition for their premise by questioning the efficacy of cranial osteopathy or cranial therapeutic care. One way they have chosen to elicit a response has been by making far overreaching statements, which are ironic since Hartman thinly veils himself in a gossamer cloak of science, research, and evidence-based healthcare. While it is common for researchers to have preferences and exhibit a bias we will note that our preference is for an open-minded dialogue of the risk/benefit ratio of a treatment, its biological plausibility, and its evidence base, which includes case histories, observational studies, and the depth of papers published over the years. To pick an isolated diagnostic procedure or treatment, such as cerebrospinal fluid (CSF) pulsation palpation, question its reliability and validity, and then use this fractional aspect of a method of care to condemn it all, is something that really should not have graced the electronic pages of this journal. What can be said by Norton and Hartman [3], and fairly so, is that from their review of selected studies regarding CSF palpation as discussed in cranial therapeutic care, further study to investigate its validity and reliability is warranted and this component of cranial diagnosis should not be used as a sole criteria for cranial diagnosis or treatment.

    With regard to evidence supporting cranial therapies what has come to light is that it is difficult for interexaminers to reliably measure the "cranial rhythmic impulse (CRI)" or “primary respiratory motion (PRM)” associated with a CSF pulse wave purportedly independent of vascular or pulmonary influences. If this pulse wave were the only way cranial treatment was directed or determined to be efficacious, then we might agree with Hartman’s assessment. At this time the evidence on CRI/PRM is considered tenuous and according to Norton, might be associated with patient-doctor pulse summations or related to various types of pressure variants, which present with different frequency of impulse[4]. If Sutherland and cranial practitioners focused their research on the CRI/PRM solely, as inaccurately implied by Hartman, then he would have a case for his position.

    Much of Hartman’s position is refuted by, at the very least, reviewing the difference between the gross mechanical aspects of cranial care, which has documentation that will be presented in the body of this comment, and the subtle mechanical aspects, which remain controversial. The subtle mechanical aspects have some researchers questioning the efficacy of cranial therapy [5-10] and others attempting to find answers [11-8]. Chaitow comprehensively discusses a difference between "mechanical (orthopedic) motion, which demonstrates physically measurable motion of and between cranial bones (however infinitesimal)" and relatively subtle cranial rhythms [19], which he notes at this time, do not fit easily into our arena of evidence-based medicine [20].

    It appears as though Hartman has chosen not to read some of the books which have compiled vast amounts of data and information helping to explain the cranial phenomena found clinically by thousands of practitioners for decades. Leon Chaitow’s most recent book Cranial Manipulation: Theory and Practice (Second Edition), describes in detail more than 100 studies (employing radiologic, neuro-imaging, dissection, histological, ultrasonography, electrical, and numerous mechanical devises for measurement) showing the movement of the brain and the bones and sutures of the skull. This monumental, highly referenced work would be a good starting point for all of that research Hartman has no doubt inadvertently missed in his investigation of cranial therapy. Aside from Chaitow’s book other well-referenced texts include: Osteopathic Manipulative Medicine Approaches to the Primary Respiratory Mechanism [21], The Cranium and its Sutures [22], Cranial Sutures: Analysis, Morphology & Manipulative Strategies [23], A bibliography of research related to osteopathy in the cranial field [24], and Clinical Cranial Osteopathy: Selected Readings [25]. While it is acknowledged that there is duplication between some referenced articles in the above texts, they represent a significant amount of data representing the clinical, mechanical, and physiological aspects of cranial therapy and definitively demonstrate the biological plausibility of cranial therapeutic care.

    There are specific premises that lend cranial therapy biological plausibility. Studies have found that there is cranial bone mobility in humans and mammals [26-9] Also there are other studies showing that the cranial sutures do not fuse and that a degree of sutural patency and cranial bone pliability remains in later life[30-2]. The very beveling of the cranial sutures anatomically allow for a type of shock absorption effect by the transmission of pressure variants internally as well as tension from the myofascia externally to be dissipated and translated throughout the cranial structure [33-5]. For instance, Pick demonstrated on a preliminary MRI investigation that pressure upon the bregma and maxilla changed the shape of the fornix (by 4mm) and corpus collosum (by 5mm) [36]. Whether the transmission of force was through the flexibility of the cranial suture [37] or the bone itself [38] warrants further exploration, but pressures upon the cranium were found to alter the shape of neural tissues.

    The dural membranes form the walls of the cranial venous sinuses, help maintain the position of cerebellum, cerebrum and spinal cord, and provide some supportive structure to the cranial capsular matrix by passing through the sutures to become the external periostieum of the cranium [39].There is support for this functional aspect of the cranial sutures and dural membranes discussed by anatomists focused on cranial morphology [40-1] and the dental profession dealing with orthopedic or orthodontic force translation [42-3]. Perpetuation of stress to the dura via cranial suture stress or dysfunction due to myofascial tensions [44] has been viewed on dissection studies and full color photographs in the prior mentioned text, “The Cranium and its Sutures” (pages 95-106)[22]. The connection of muscles (e.g., rectus capitus posterior minor[45], spinal ligaments (e.g., ligamentum nuchae [46], ligamentum flava [47], Hofmann [48], and Trolard [49]) to the dura, as well as the dentate ligament connecting the spinal cord to the dura, all indicate a relationship between spinal dynamics and its perpetuation into the meningeal fascial tissue. There is current clinical research supporting the cranial manipulative theory that altered postural and myofascial function will affect body patterns, and the cranial bones, sutures and related meninges are a part of this closed myofascial kinematic chain [50-6].

    Why might cranial sutural fixation or increased asymmetrical meningeal tension be an issue? There are various theories, including the premise that the CSF is a specialized lymphatic system for the nervous system. Therefore the CSF pressure variants and pulsations that occur throughout the craniospinal system may have an affect on CSF mixing and circulation, and CSF stagnation due to asymmetric dural tensions may have adverse biological repercussions. In the cranium the venous sinuses that function also as a low-pressure system would likewise be affected by dural tension that affected drainage [57-8].

    The cranial nerves also carry dural sleeves with them for some distance; therefore any abnormal meningeal tension may be transmitted to a nerve and affect its function. Tension anywhere along the contiguous meninges can therefore be transmitted to the cranial nerves. This is because the peripheral and the central nervous systems are a continuous tissue tract. The neuropathies that may result from cranial bone dysfunction are postulated to be motor and/or sensory, and their severity depends on the amount of compression and neural irritation as well as the amount of ischemic radiculopathy. Breig has shown that problems come about primarily because of the entrapment neuropathy’s effects on the vasculature of the nerve root[59]. The effects of ischemia on cranial and peripheral nerve tissue have been well studied, and increasing interest in the pathophysiology of nerve compression has indicated that any rise in intrafascicular pressure – as a result of edema, compression, or torsion of the nerve root, for example – can also be damaging to neural tissue and function[60-4]. Throughout the cranium there may be a number of sites where cranial nerves may be impinged upon by soft tissue at bony ridges or foraminal openings. These sites may reflect mechanical or physiological changes in neural function, leading to a mechanical subset of cranial neuropathies that have been or can be successfully treated clinically by cranial practitioners [64-79].

    So then the question is can doctors palpate cranial fixation, pressure compliance variants, and craniospinal imbalances? So far the reliability of most manual methods of evaluation and treatment are in question, but the most recent discussion of these studies, pro and con, with reasoned commentary on their implications may be found in Chaitow’s recent book [20]. Currently all investigation into various manual therapeutic treatments whether chiropractic, osteopathic, physical therapy or otherwise indicate that palpation for pain seems to offer the best reliability, whereas most other commonly used evaluation procedures have limited reliability. Therefore the current research suggests that further study in cranial diagnosis and the treatment rendered might best focus (at this time) on patient pain to palpation and its relief following treatment. Outcome assessment tools should also be used evaluating pre and post treatment for quality of life, increase in functional status, and other objective instruments to determine changes in physiological status.

    Who will do this? Commonly the onus is placed upon those performing cranial therapeutic care to support the necessity of their care. The dilemma is that those performing these procedures in clinical practice are not the ones capable or knowledgeable to perform extensive forays into costly and complex research studies. In reality most clinicians are primarily practitioners who attempt to share in the literature what has been found in a typical office setting. Practitioners of cranial therapy have been published in peer-reviewed literature and at research conferences (See Table 1), but most practitioners are not “true” researchers. Ideally this is not an excuse but a call for help and collaborative efforts.

    At this time we are left with an extensive (but preliminary) clinical evidence base of cranial therapeutic interventions for patient health, little indication of procedure risk [80], and sufficient biological plausibility to warrant continued use of this modality for patient care. Since alternatives to cranial therapy tend to be pharmaceutical and/or surgical, or other common options such as benign neglect, most of the clinical success of cranial therapy has been patient driven. In our present day and age patients demand results from the care rendered, want low risk procedures, and prefer to enjoy the process, when possible. The gentle caring touch a patient receives along with the expertise from a cranial practitioner is currently satisfying a group of patients seeking this care, and often paying out of their own “pocket” for this care. Cranial practitioners are being sought for care by patients “in need” looking for alternatives to the more invasive traditional options.

    Most of the manual therapeutic procedures currently rendered can be criticized for having limited validity and reliability, yet manual therapies appear to offer clinical value with low risk as compared to other possible therapeutic interventions.

    “To assume that the entire range of clinical treatment for any modality has been successfully captured by the precision of analytical methods in the scientific literature,” indicates Horwitz [80], “would be tantamount to claiming that a medical librarian who has access to systematic reviews, meta-analyses, Medline, and practice guidelines provides the same quality of health care as an experienced physician” [82].

    In Hartman’s summary he states that “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.” We believe that based on the extensive literature written on the topic (See Tables 1), its low risk, and track record of benefit we disagree.

    Hartman denies dogmatically the therapeutic research, concepts and outcomes of cranial therapy such as to say that cranial therapy is impossible (as he does in his articles [1,3,83,84]) but to assert this is to claim, tacitly, that he already knows the full spectrum of the possible. This is impossible.

    While the onus to do the research is upon those who are proponents of a method of care, there is also an onus upon those who call for its virtual abolition to be familiar with all the published research on the topic and how evidence based clinical practice is formulated.

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    Table 1. Cranial Manipulative Therapy: Various Cranial Manipulative Related Studies Relating to Clinical Outcomes,

    Biological Plausibility and Efficacy of Treatment.

    Cuthbert S. Motion Sickness Disorder: A Review, Treatment Strategy, and Case Series Report J Chiro Med Spring 2006.

    Nelson KE, Sergueef N. Recording the Rate of the Cranial Rhythmic Impulse J Am Osteopath Assoc, Jun 2006;106(6): 337-41.

    Sergueef N, Nelson KE, Glonek T., Palpatory diagnosis of plagiocephaly. Complement Ther Clin Pract. 2006 May;12(2):101-10. Epub 2006 Mar 29.

    Lancaster DG, Crow WT. Osteopathic Manipulative Treatment of a 26-Year-Old Woman With Bell's Palsy J Am Osteopath Assoc May 2006; 106(5):285-89.

    Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract. 2006 May;12(2):83-90. Epub 2006 Feb 8.

    Cuthbert S., Blum C Symptomatic Arnold-Chiari malformation and cranial nerve dysfunction: a case study of applied kinesiology cranial evaluation and treatment J Manipulative Physiol Ther. 2005 May;28(4):e1-6.

    McPartland JM, Giuffrida A, King J, Skinner E, Scotter J, Musty RE. Cannabimimetic effects of osteopathic manipulative treatment. J Am Osteopath Assoc. 2005 Jun;105(6):283-91.

    Cutler,M.J.Holland, B.S.; Stupski, B.A.; Gamber, R.G.; Smith, M.L. Cranial manipulation can alter sleep latency and sympathetic nerve activity inhumans: a pilot study. Journal of Alternative and Complementary Medicine 2005;11(1):103-8.

    Pederick F. Cranial and Other Chiropractic Adjustments in the Conservative Treatment of Chronic Trigeminal Neuralgia: A Case Report Chiro J Aust, 2005; 35:9-15.

    Cook, A. The mechanics of cranial motion—the sphenobasilar synchondrosis (SBS) revisited Journal of Bodywork and Movement Therapies 2005;9(3):177-188.

    Sabini RC, Elkowitz DE. Patency and Obliteration of the Cranial Sutures: Is There a Clinical Significance? J Am Osteopath Assoc, Jan 2005;105(1):25.

    Quezada D Chiropractic care of an infant with plagiocephaly Journal of Clinical Chiropractic Pediatrics, 2004;6(1):342-8.

    Vallone S. Chiropractic Evaluation and Treatment of Musculoskeletal Dysfunction in Infants Demonstrating Difficulty Breastfeeding Journal of Clinical Chiropractic Pediatrics, 2004; 6(1):349-61.

    Nelson, K.E.; Sergueef, N.; Glonek, T. Cranial Manipulation Induces Sequential Changes in Blood Flow Velocity on Demand The American Academy of Osteopathy Journal 2004;14(3):15-7.

    Fink M, Wahling K, Stiesch-Scholz M, Tschernitschek H. The functional relationship between the craniomandibular system, cervical spine, and the sacroiliac joint: a preliminary investigation Cranio. 2003 Jul;21(3):202-8.

    King HH, Tettambel MA, Lockwood MD, Johnson KH, Arsenault DA, Quist R. Osteopathic manipulative treatment in prenatal care: a retrospective case control design J Am Osteopath Assoc. 2005 Jun;105(6):283-91.

    Cuthbert S. Applied Kinesiology and Down Syndrome: a Study of Fifteen Cases The International Journal of Applied Kinesiology and Kinesiologic Medicine, 2003;16:16-21.

    Sergueef, N.; Nelson, K.E.; Glonek, T. Cranial manipulation induces sequential changes in blood-flow velocity, on demand Journal of the American Osteopathic Association 2003;103(8):380.

    Blum, C.L. Chiropractic Treatment of Mild Head Trauma: A Case History Proceedings of the 2002 International Conference on Spinal Manipulation. 2002.

    Rivera-Martinez, S., Wells, M., Capobianco, J. A retrospective study of cranial strain patterns in patients with idiopathic Parkinson’s disease Journal of the American Osteopathic Association, August 2002;102(8):417-422.

    Oleski, S, Smith G, Crow W Radiographic Evidence of Cranial Bone Mobility Cranio: The Journal of Craniomandibular Practice; Jan 2002;20(1):34-8.

    Cuthbert S. An applied Kinesiology evaluation of facial neuralgia: A case history of Bell’s palsy The International Journal of Applied Kinesiology and Kinesiologic Medicine Summer 2001:42-45.

    Sergueef, N.; Nelson, KE.; Glonek, T. Changes in the Traube-Herring Wave Following Cranial Manipulation The American Academy of Osteopathy Journal 2001;11(1):17.

    Farasyn, A.; Vanderschueren, F. The Decrease of the Cranial Rhythmic Impulse During Maximal Physical Exertion: an Argument for the Hypothesis of Venomotion? Journal of Bodywork and Movement Therapies 2001;5(1):56-69.

    Holtrop DP. Resolution of suckling intolerance in a 6-month-old chiropractic patient J Manipulative Physiol Ther. 2000 Nov-Dec;23(9):615-8.

    Funk, SL. Osteopathic Manipulative Treatment and Down Syndrome The American Academy of Osteopathy Journal 2000;10(2):36-7.

    Miller RI, Clarren SK. Long-term developmental outcomes in patients with deformational plagiocephaly Pediatrics, 2000 Feb;105(2):E26.

    Hewitt EG. Chiropractic Care For Infants with Dysfunctional Nursing: A Case Series Journal of Clinical Chiropractic Pediatrics. 1999 May ; 4(1): 241-4.

    Blum CL. Cranial Therapeutic Treatment of Down’s Syndrome Chiropractic Technique, May 1999; 11(2): 66-76.

    Moskalenko YE, Kravchenko TI, Gaidar BV, Vainshtein GB, Semernia VN, Maiorova NF, Mitrofanov VF The periodic mobility of the cranial bones in man Fiziol Cheloveka, 1999 Jan-Feb;25(1):62-70.

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    Pick MG Spinal-cranial morphology and physiology: A review of the relationships between osseous, meningeal and neuronal structures and their role in the cranio-sacral respiratory rhythms Association of Swiss Chiropractors Conference: BŸrgenstock Hotels and Resorts : September 18, 1998.

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    Competing interests

    I am president of Sacro Occipital Technique Organization (SOTO) - USA and have been involved with researching Sacro Occipital and Cranial Techniques. While this obviously gives the appearance of a potential bias, I do not believe that to be the case. I am not receiving any financial benefit from the writing of this comment nor do I receive any financial payment from SOTO-USA for anything. My co-author Scott Cuthbert is the co-chair of the International College of Applied Kinesiology (ICAK) - USA, and likewise is not garnering any financial benefit from this comment

  2. Is There Evidence?: Reply to Drs. Blum and Cuthbert

    Steve Hartman, College of Osteopathic Medicine, University of New England

    26 July 2006

    Is There Evidence?: Reply to Drs. Blum and Cuthbert

    Dr. Norton and I are grateful that Drs. Blum and Cuthbert (hereafter, "Drs. B and C") have taken the time to highlight what they perceived as deficiencies in our research. Others may have had similar reactions and this gives us an opportunity to put some illuminating flesh on these bones. We first will try to summarize the authors' main points. We then will react to each point (in order) and close with a suggestion that we hope will help us be productive in any further dialogue.

    The authors' main points:

    1) In our critiques, Dr. Norton and I have put too much emphasis on aspects of Sutherland's biological mechanism. For that reason and because we lacked familiarity with relevant literature (see item 3), some of our critical conclusions have been "overreaching" (first paragraph).

    2) Repeated, independent measures showing total absence of interexaminer reliability are inconsequential because the feature tested (frequency of the "cranial rhythm") is unimportant clinically.

    3) Contrary to our conclusions, perusal of relevant literature will "definitively demonstrate the biological plausibility of cranial therapeutic care."

    4) Personal clinical observation can provide reliable evidence for clinical efficacy.

    * * *

    1) We put too much emphasis on aspects of Sutherland's mechanism:

    By our reckoning, the longest standing, most widely held, most influential biological mechanism thought to underlie the cranial arts is Sutherland's. It is taught at our and apparently all other American osteopathic medical schools [1], it is endorsed by the Cranial Academy [2], and many thousands of practitioners have been trained at The Upledger Institute [3] in a version of this mechanism. Even Chaitow [4(p3)], in the volume lauded by Drs. B and C as "monumental [and] highly referenced" (fourth paragraph), said that, although validity needs to be examined, "these concepts . . . are fundamental to much of modern cranial manipulation as currently taught."

    If Drs. B and C favor a different mechanism and it has been proven valid, we would appreciate specific references to literature supporting this mechanism, associated diagnostic reliability, or practitioners' ability to modify mechanistic parameters to a patient's health advantage. We prefer references to the peer-reviewed literature rather than abstracts or book-length presentations. However, if important material has been presented for the first time in a book, we would like to know of it and a detailed page reference would make our study more manageable. In the absence of such evidence, we will stand by our impression that, although efficacy remains to be properly tested, all forms of "cranial" treatment grounded in Sutherland's mechanism probably are without clinical merit except as placebos or as vehicles for the important psychological benefits of "gentle caring touch" (Drs. B and C, six paragraphs from end). "Cranial" treatments with other hypothetical foundations should be considered with comparable skepticism, until similar evidence is forthcoming.

    2) Cranial rhythm-based interexaminer reliability of zero is inconsequential because the rhythm is unimportant clinically:

    As implied in item one, sources at the core of American osteopathy put the cranial rhythm at the heart of "cranial" practice. Of this rhythm, even Chaitow [4(p7)] said that "it is a basic precept of all cranial teaching" and that it "is widely assessed and employed as a means of cranial evaluation—since the speed [and numerous other properties of the rhythm] is widely believed, a direct means of assessing the status of the cranial mechanism."

    Furthermore, when tests of diagnostic reliability have been undertaken, only one of many research groups has examined features other than frequency of this rhythm. What conclusion should we have drawn if not that the cranial rhythm was clinically important? If Drs. B and C believe reliability researchers' have erred by focusing on rate of the rhythm--rather than one or more of its purportedly more complex qualities--then, as we said in 2002 [5(p31)]: "if phases of the phenomenon labeled 'cranial rhythm' or 'primary respiratory rhythm' cannot even be counted, then it is unlikely that its other, more derivative and complex features (e.g., amplitude, symmetry, and quality) can be evaluated reliably either. We consider this to be the case, whatever the cause of the rhythm."

    Frankly, we are reluctant to accept at face value the reasons that so many practitioners give for disregarding such plainly negative findings on reliability. As we also said earlier [5(p31)]: "given that this one presumed biomedical parameter of cranial osteopathy has been the nearly unanimous choice for reliability testing and has failed utterly, we are suspicious of practitioners who now claim that this parameter was a poor selection because of its minimal clinical value."

    3) Perusal of relevant literature will "definitively demonstrate the biological plausibility of cranial therapeutic care":

    Drs. B and C believe that, in general, "the depth of papers published" (first paragraph) provides evidence for a health treatment. They cited 84 references, provided 176 more in their table (several appearing more than once), and believe that, together, these "definitively demonstrate the biological plausibility of cranial therapeutic care" (fourth paragraph). Is this abundance of titles, by itself, evidence for mechanistic validity (of Sutherland's or some other model), diagnostic reliability, or clinical efficacy? Hardly: we are familiar with many of the references provided and have judged many to be tangentially (if at all) applicable to "cranial" questions, relevant but over-interpreted, preliminary in form and so hard to evaluate, or logically flawed [e.g., see 6]. Research described often has been weakly designed, poorly conducted, badly reported, or all of these and, accordingly, we have learned to be skeptical of every new report. Drs. B and C apparently have a different impression than we do regarding what constitutes good evidence.

    Dr. Norton and I have examined relevant literature and have concluded that the most popular biological mechanism purported to underlie "cranial" treatments is plainly invalid. On the other hand, based on their reading of the literature, Drs. B and C have concluded that it "definitively demonstrate[s] the biological plausibility of cranial therapeutic care." Without time for diligent study, it might be hard for our readers to determine which of these divergent claims comes closest to the truth. Rather than force them to digest further the many references provided by Drs. B and C and by us, we suggest we assist our readers by "cutting to the chase": if Drs. B and C will advise us of the particularly persuasive one or two research reports validating any "cranial" mechanism, we will review it(them) and report our conclusions. For example, if they use a model related to Sutherland's, then such reports might include evidence for motility of the human central nervous system, palpable movement within the spheno-occipital base post-adolescence, palpable calvarial bone movement in adult humans, body-wide synchronicity of any "cranial" rhythm, reliability of any diagnostic measure, or efficacy of any treatment grounded in aspects of this mechanism.

    4) Personal perception of clinical success can be a reliable indicator of clinical efficacy:

    We agree that medicine is art as well as science and, at least in what we call "the western world," good practitioners will be skilled in both. Using their artistic license, Drs. B and C have concluded that many decades of uncontrolled clinical experience suggests that cranial treatments "appear to offer clinical value" (five paragraphs from end) and show a "track record of benefit" (three paragraphs from end). We believe uncontrolled clinical experience sometimes can point to areas for future study but anecdotes are still anecdotal, even if offered in profusion. Unfortunately, expanding understanding of the imperfections in human perception, interpretation, and memory has helped explain why clinical experience, by itself, is such a crude and unreliable measure of success. In fact, the importance of controlled (i.e., scientific) observation has become so axiomatic in the practice of 21st century ("western") medicine that we would feel odd even to offer references in support of this observation.

    Over many centuries, valueless medical techniques beyond number have won the passionate allegiance of innumerable patients and practitioners. An example probably known to all in the medical field is bloodletting. Based on a number of successive, misguided "biological" foundations (e.g., release of evil spirits or balance of the four humors), the procedure was practiced with passion and confidence, in various ways, in a wide range of clinical situations, over several millennia. Now, of course (at least, in the developed world), we make little medical use of evil spirits and know that, through bloodletting, many more patients must have been killed than cured. Drs. B and C probably are as familiar with the history of medicine as we are but, apparently based on their perception of clinical success, they seem willing to judge recent (yet to be validated) "cranial" mechanistic hypotheses more optimistically than we can.

    It was not just serendipity that brought science into "western" medicine. Instead, progressively and especially over the past century or so, medicine was recognized for what it was: a millennia-long history of magical thinking, guesswork, and failure. Now, many researchers (and practitioners wishing to supplement their artistic skills) have learned to seek answers using experimental and clinical procedures that include various controls over human cognitive imperfections. This is not the place for a lecture on factors that conspire to mislead patients' and practitioners' perception of clinical success. However, readers seeking an introduction to how real, physiological improvements might occur in the absence of any direct treatment effect, will not have far to go: in addition to the natural tendency for most human maladies to improve on their own, the Google genie quickly will introduce readers to "regression to the mean," and the "placebo effect." Similarly, those curious about how patients and practitioners may perceive improvement when none actually has occurred will learn, with fascination, of the "demand characteristics" of the therapeutic encounter and "subjective validation." Especially for these latter psychological factors, a good place to start would be any of the references we have provided in the past [5] to Beyerstein. Understanding of these phenomena could not be more relevant to the practice of good medicine and we strongly recommend that readers "jump in with both feet."

    * * *

    In closing:

    We have concluded that the "cranial" mechanism most influential in the practicing community (Sutherland's) is biologically invalid and that associated diagnostic reliability and proper tests of efficacy are entirely lacking. Other models have been proposed but, as far as we know, none has been validated and none has been associated scientifically with diagnoses/treatments that are reliable/effective. Until research convincingly redresses these deficiencies, we will stand by our conclusion that "cranial" methods should be abandoned.

    Dr. Norton and I have concluded that cranial osteopathy is a "textbook example" of a pseudoscience. Practitioners cannot feel good when they read this but we believe it is the truth of the matter, we believe practitioners must come to grips with it, and recent reliance on quantum mechanics and energy fields does not represent progress. Now, of course, paraphrasing Carl Sagan [7]: "We may be wrong." Perhaps one day we will see replicated, convincing demonstrations of efficacy. If we were practitioners, this is where we would put our time: by establishing that some form of cranial treatment really does provide a direct clinical effect, it becomes much easier to justify search for a mechanism or study of reliability. In the meantime, it seems obvious that Drs. B and C have reached different conclusions than Dr. Norton and I. Therefore, in case we have missed something . . .

    . . . if they will advise us of the best one or two research reports validating any "cranial" mechanism, the one or two best reports showing diagnostic reliability for any "cranial" technique, or the one or two best controlled studies showing a direct and positive clinical effect for any form of "cranial" treatment, we will review all and report our conclusions. This will permit us to focus our discussion in a way that may be more likely to lead to some common understanding.

    References

    1. King HH, Lay EM: Osteopathy in the cranial field, In Foundations for osteopathic

    medicine, 2nd ed., Edited by Ward RC. New York: Lippincott Williams & Wilkins;

    2002:985-1001.

    2. The Cranial Academy: Osteopathy in the cranial field. 2006. Available at:

    http://www.cranialacademy.com/cranial.html. Accessed July 21, 2006.

    3. Upledger JE: Frequently asked questions about craniosacral therapy. Available at:

    http://www.upledger.com/therapies/cst_faq.htm. Accessed July 21, 2006.

    4. Chaitow L: Cranial manipulation: Theory and practice. New York: Elsevier; 2005.

    5. Hartman SE, Norton JM: Interexaminer reliability and cranial osteopathy. Sci Rev

    Altern Med 2002. 6,1:23-34. [University of New England,

    http://faculty.une.edu/com/shartman/sram.pdf]

    6. Hartman SE, Norton JM: A review of King HH and Lay EM, "Osteopathy in the

    Cranial Field," in Foundations for Osteopathic Medicine, 2nd ed. Sci Rev Altern

    Med 2004-2005. 8,2:24-28. [University of New England,

    http://faculty.une.edu/com/shartman/Library/H-N%202004-05%20on%20KL%

    20in%20SRAM.pdf]

    7. Sagan C: The demon-haunted world: Science as a candle in the dark. New York: Ballantine; 1996.

    Competing interests

    None additional to those expressed with the original publication.

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