Evidence in medicine
Among ways of caring for health, there are two poles: working with a condition or diagnosis, and working with an individual person. Osteopathy is closer to the second, but we will begin with medicine.
For modern evidence-based medicine, the first approach is central, although there is a move towards personalisation. Personalised treatment choices are still based on findings such as “in women of reproductive age with migraine with aura, drug X reduces attack frequency by Y%”. Without this, medicine would remain in the Middle Ages. Such studies follow fixed rules:
1) A large group of people with the same condition or diagnosis.
2) The greatest possible homogeneity within the group.
3) A double-blind study. When testing a drug, neither patient nor doctor knows who receives the drug and who receives a placebo.
How achievable are the ideals of evidence in medical practice?
The same diagnosis. It is relatively convenient when diagnoses can be defined very precisely. Usually these are either clearly established through laboratory or genetic tests and similar investigations, or serious and dangerous conditions, often definitively established after death. What about diagnoses such as “dorsalgia”, which simply means back pain? The back hurts in different places, with different movements (or independently of them), and improves or worsens under different circumstances. How homogeneous can a sample united by a diagnosis of dorsalgia be? The good news is that some heterogeneity can be compensated for by sample size, and homogeneity can also be tested separately using statistical methods.
Sample homogeneity: ideally, all participants would be the same age, have had the same previous illnesses, be of the same sex, and have their menstrual cycles in the same phase during the study. Statistical methods could then be applied as correctly as possible. This is why mouse studies use particular genetic strains and, where possible, males. These are all attempts to make samples as homogeneous as possible, while recognising that true homogeneity is unattainable.
Placebo control works well when studying medication and much less well for technically more complex methods. How can you perform a dental procedure that feels indistinguishable from the real one but omits the key elements that determine its result?
Evidence in medicine is therefore very different from proof in physics. There is a saying that “medicine is the second most exact science after theology”. Nevertheless, this kind of evidence is the best we have today, and is sufficient to solve many problems effectively.
Is an evidence base possible in osteopathy?
The short answer is: to a certain extent, usually under the following conditions:
Large, preferably very large samples.
Or, conversely, case studies: individual cases described in detail.
With large samples, the osteopath’s actions should not be restricted by a protocol: osteopaths simply do not work to protocols, so such studies are not appropriate.
Osteopathy is highly personalised: it works with an individual person rather than a diagnosis, taking account of lifestyle, needs and personality. The choice of strategy and specific techniques is therefore very individual. Repeating the same strategy for another person with the same diagnosis makes little sense, because their spinal loading, physical activity, history of surgery and injuries are different.
In osteopathy, unlike science and evidence-based medicine, reproducibility of results is generally not the focus. Just as no two patients are identical, no two osteopaths are identical. We build our approach and select techniques differently. Every case is unique. The only way to check is to retest movement at the end of a session and assess the patient’s subjective experience. In effect, an osteopath compares a person with themselves more than with others.
While medicine without protocols would descend into chaos, working to a protocol in osteopathy represents very low-quality work: protocols are used only for teaching osteopaths. Good osteopathic studies now mainly interpret the osteopath’s work as a black box: there is a group of patients with similar concerns, osteopaths who do what they consider appropriate for each individual rather than perform the same procedure, and an assessment of results.
What research exists on osteopathy’s effectiveness?
Let us consider several papers assessing effectiveness. They address different clinical conditions and use different methodologies. Together, they give a contradictory impression, which is to be expected given the nature of osteopathy, patients presenting with less severe conditions (making statistical analysis harder), and other methodological difficulties discussed at the end of this section.
Migraine
Migraine. An Italian study involved 225 participants with migraine and 6 osteopaths. Participants were divided into three groups: osteopathic treatment, placebo (simulated osteopathic work) and control (no manual intervention). All received medication. An important feature was that each patient was treated by one of the six osteopaths, allowing a long-term strategy to develop. Patients received 8 sessions over six months. By the end, the osteopathic treatment group was significantly better than the other groups, assessed using the Headache Impact Test HIT-6.
Cerritelli, F., Ginevri, L., Messi, G., Caprari, E., Di Vincenzo, M., Renzetti, C., Cozzolino, V., Barlafante, G., Foschi, N., Provinciali, L., 2015. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complementary Therapies in Medicine 23, 149–156. https://doi.org/10.1016/j.ctim.2015.01.011
Lower back pain
Lower back pain. A British study involved 330 people with lower back pain lasting at least 3 months. Participants were assigned to osteopathic treatment, group exercise, or individual physiotherapy combining exercise and manual techniques. All three groups improved. However, there was no control group (how would you simulate exercise?), so the results cannot be compared with spontaneous improvement. This problem was partly addressed by including only people who had experienced pain for a considerable time. Interestingly, 80% completed the full osteopathy course, compared with only 40% completing the exercise course. This suggests that osteopathy, or other manual approaches, may be a method of choice for patients with lower back pain who are not currently ready, for whatever reason, to exercise regularly with an instructor.
Chown, M., Whittamore, L., Rush, M., Allan, S., Stott, D., Archer, M., 2008. A prospective study of patients with chronic back pain randomised to group exercise, physiotherapy or osteopathy. Physiotherapy 94, 21–28. https://doi.org/10.1016/j.physio.2007.04.014
Osteoarthritis and circulation
Osteoarthritis and circulation: 30 patients with X-ray-confirmed osteoarthritis were referred for osteopathic consultation by general practitioners. The same osteopath worked with all of them and, unusually, used a provisional protocol. It was provisional because regions and techniques were fixed, but not the details of their execution. Techniques included work with the thoracic and pelvic diaphragms, cranial work and direct work with the femoral artery to normalise circulation. All 30 received the same osteopathic assessment, but only 15 received treatment afterwards. Results were assessed using orthopaedic tests, ultrasound and patients’ subjective ratings.
This paper is interesting because the problem chosen was localised and similar in its manifestations. This, together with one osteopath performing techniques in a relatively similar way for everyone, made a protocol possible. This is a significant advantage for correct statistical processing and the applicability of mathematical statistics. Designing a similar study for lower back pain, for example, is much harder.
Jardine, W.M., Gillis, C., Rutherford, D., 2012. The effect of osteopathic manual therapy on the vascular supply to the lower extremity in individuals with knee osteoarthritis: A randomized trial. International Journal of Osteopathic Medicine 15, 125–133. https://doi.org/10.1016/j.ijosm.2012.07.001
Newborns
Newborns: a review by Dr Roland and colleagues describes osteopathic work in neonatal intensive care units. The most noticeable result was earlier discharge when an osteopath worked with patients. This means earlier establishment of breastfeeding, weight gain and respiratory function, for example after pneumonia. Methodologically, however, the paper falls short of rigorous meta-analyses. It does not provide article inclusion and exclusion criteria, combined patient numbers, and so on. This is a wider problem in osteopathic publications: the process of bringing research and reporting into line with international standards is still underway. Until recently, publications along the lines of “my colleagues and I tried this and it worked wonderfully” were called research articles within the community.
Roland, H., Brown, A., Rousselot, A., Freeman, N., Wieting, J., Bergman, S., Mondal, D., 2022. Osteopathic Manipulative Treatment Decreases Hospital Stay and Healthcare Cost in the Neonatal Intensive Care Unit. Medicines 9, 49. https://doi.org/10.3390/medicines9100049
Obstetrics and gynaecology
Obstetrics and gynaecology: a detailed review of osteopathy as an additional therapy examined almost 50,000 papers and 2,500 patients. It considered both randomised controlled studies and individual clinical cases. One interesting case used ultrasound to confirm that an ovary located behind the uterus returned to its normal position. Improvements were reported in lower back pain during and after pregnancy, various pelvic pains, labour and menopausal symptoms, and reduced painkiller use for dysmenorrhoea. The authors separately examined adverse-effect reports, which were limited to weakness after a session, sleepiness and mild temporary discomfort. They concluded that although the data were too heterogeneous to support clinical recommendations, there were grounds to consider osteopathy a safe complementary approach to women’s health.
Ruffini, N., D’Alessandro, G., Pimpinella, A., Galli, M., Galeotti, T., Cerritelli, F., Tramontano, M., 2022. The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review. Healthcare (Basel) 10, 1566. https://doi.org/10.3390/healthcare10081566
Neurology
Neurology: a systematic review by Italian researchers examined osteopathy for neurological conditions. Its overall conclusion resembled many other reviews: data were very heterogeneous, many studies had methodological weaknesses, only a small number of neurological conditions had been studied, and no unambiguous conclusion on effectiveness was possible. Nevertheless, the paper contains a valuable collection of studies with differing results and general methodological recommendations, discussed at the end of this section.
Migraine. Two papers were considered: one found no statistically significant improvement, the other a substantial improvement in quality of life.
Parkinson’s disease. A cited study found that osteopathic work significantly improved walking in people with Parkinson’s.
Tension headaches. Four papers all found statistically significant improvement with osteopathic work.
Cerebral palsy. Of three papers, one found no improvement (only cranial techniques were used, clearly limiting osteopathy’s possibilities), another found improvement, and a third focused on constipation in cerebral palsy and found significant improvement in patients’ condition.
Cerritelli, F., Ruffini, N., Lacorte, E., Vanacore, N., 2016. Osteopathic manipulative treatment in neurological diseases: Systematic review of the literature. Journal of the Neurological Sciences 369, 333–341. https://doi.org/10.1016/j.jns.2016.08.062
Temporomandibular joint
Temporomandibular joint (TMJ): 50 people participated in an Italian study of osteopathy for TMJ pain and clicking. Twenty-five received osteopathic treatment from the same osteopath. This increases sample homogeneity, but also indicates the effectiveness of this particular practitioner’s treatment, rather than osteopathy in general. The control group of 25 received conservative treatment. None of the 50 participants received orthodontic treatment during the study. Assessments included a subjective pain scale, the TMJ index, lateral movement of the joint head, and painkiller use. On most measures, the osteopathic group was better. Results were statistically significant and included a fairly long follow-up: treatment lasted six months, and participants returned for assessment two months after it ended. TMJ problems were significantly fewer in the osteopathic group both at treatment completion and two months later.
Cuccia, A.M., Caradonna, C., Annunziata, V., Caradonna, D., 2010. Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: A randomized controlled trial. Journal of Bodywork and Movement Therapies 14, 179–184. https://doi.org/10.1016/j.jbmt.2009.08.002
Plagiocephaly
Plagiocephaly (asymmetrical head shape in infants): a study involved 96 infants, half receiving osteopathic treatment and half receiving only gentle head touching. Head measurements were assessed at the end of three months of treatment and when the children reached one year of age. At both assessments, differences favouring the osteopathic group were statistically significant.
Bagagiolo, D., Priolo, C.G., Favre, E.M., Pangallo, A., Didio, A., Sbarbaro, M., Borro, T., Daccò, S., Manzoni, P., Farina, D., 2022. A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly. Am J Perinatol 39, S52–S62. https://doi.org/10.1055/s-0042-1758723
So, does osteopathy work?
This appears to depend greatly on the individual osteopath’s skills and the individual patient’s condition, as well as research methods, discussed below. This probably explains why papers on the same problem can show either statistically significant improvement or no benefit. Hence the appropriate conclusion of reviews: we do not know whether the method works as a whole.
One major methodological problem is that although osteopaths in the European understanding of the profession train in fairly standardised ways, they work very differently. As usual, the devil is in the detail. Palpation skills, reasoning and experience create enormous differences between individual osteopaths’ results, making general statements such as “osteopathy helps with…” difficult. It is more accurate to say “osteopath Jim Watson works very well with various shoulder problems, but for a headache, see Fred Simmons”. An elegant study by Dr Sabini and colleagues supports this: Sabini, R.C., Leo, C.S., Moore, A.E., 2013. The relation of experience in osteopathic palpation and object identification. Chiropr Man Therap 21, 38. https://doi.org/10.1186/2045-709X-21-38. People with very different experience and training — renowned osteopaths, osteopathy students and other volunteers — were asked to identify small objects by touch through layers of fabric and foam. Results showed no relationship to experience. Some individuals performed very well, but they came from all categories.
Other methodological difficulties in osteopathic research are well described in Dr Cerritelli and colleagues’ paper on osteopathy for neurological problems, cited above.
Great sample heterogeneity. Even when patients share a diagnosis, some feel fairly well while others have a dozen other diagnoses and poor quality of life. Good papers test homogeneity statistically, but many osteopathic papers do not, and some do not demonstrate the homogeneity required to compare treatment and control groups.
Researchers pay little attention to treatment patients receive alongside osteopathy. Information on medication and dosage, lifestyle, physical activity and so on is absent.
Adverse effects of osteopathy are not examined either. Although usually minor, it is inappropriate to omit them.
The authors conclude that osteopathic studies struggle to balance rigorous reasoning and reproducible results with individual experience and clinical intuition.
What should a patient do? Whom should they see?
Above all, osteopathy should not take precedence over evidence-based medicine. There are exceptions: for example, the British NHS recommends osteopaths as a first point of contact for musculoskeletal problems. Responsibility for identifying red flags and referring the patient then lies with the osteopath, and British osteopathic training prepares practitioners for this.
You should certainly not spend time seeing osteopaths in cases of:
Acute injury.
Acute circulatory problems.
Other emergencies.
Broken skin.
Acute psychiatric conditions.
Lack of patient consent.
In other cases, osteopathic work generally involves working alongside doctors. A competent and responsible osteopath always asks what an orthopaedist, gynaecologist, paediatrician or other doctor has said about the concern. Osteopaths cooperate closely with doctors, which is both ethically appropriate and leads to better patient outcomes.
At the same time, many problems can be addressed through osteopathic sessions alone. This mainly concerns musculoskeletal problems but is not limited to them.
A prospective patient effectively faces two questions:
Is osteopathy acceptable to them in principle, knowing that it offers no guarantees but generally involves small risks?
Which particular osteopath should they choose?
Judging by the studies discussed above, practitioner choice is a fundamental factor in success. One may succeed where another does not. Follow recommendations, check the osteopath’s experience and qualifications, and trust your intuition. A practical solution may be to agree on three sessions, for example, and if there is no noticeable effect, try another osteopath or look for a different kind of practitioner. Osteopaths often suggest this themselves.
Who are you to draw these conclusions?
The author is Natalia Ermachenko, osteopath (European School of Osteopathy, UK), PhD in physiology and neurobiology (Lomonosov Moscow State University), founder and head of Still Point osteopathy centre in Yerevan, and president of the professional association of osteopaths registered in the Republic of Armenia.