Recently, the UK Advertising Standards Authority (ASA) together with the UK General Osteopathic Council (GOsC) have sent new guidance to over 4,800 UK osteopaths on the GOsC register. The guidance covers marketing claims for pregnant women, children and babies. It also provides examples of what kind of claims can, and can’t, be made for these patient groups.
Regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions only if they hold convincing evidence. Claims for treating conditions specific to pregnant women, children and babies are not supported by the evidence available to date.
The new ASA guidance is intended to help osteopaths talk about the healthcare they provide in a way that complies with the Advertising Codes and to protect consumers from being misled. It provides some basic principles and many examples of claims that are, and aren’t, acceptable. The ASA hopes it will provide greater clarity to osteopaths on how to advertise osteopathic care for pregnant women, children and babies responsibly.
Specifically, the guidance points out that “osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies, provided they are qualified to do so. Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.”
Examples of claims previously made by UK osteopaths which are “unlikely to be acceptable” include:
- Osteopaths often work with lactation consultations where babies are having difficulty feeding.
- Osteopaths are qualified to advise and treat patients across the full breadth of primary care practice.
- Osteopaths often work with crying, unsettled babies.
- Birth is a stressful process for babies.
- Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help.
- If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help.
- Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains.
- Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull.
- Midwives often recommend an osteopathic check-up for babies after birth.
- Osteopathy can help with breast soreness or mastitis after birth.
- If your baby is having difficulty breastfeeding, osteopathy might be able to help.
- Many pregnant women experience pain in the pelvic girdle area. Osteopaths offer safe, gentle manipulation and stretches.
- Many pregnant women find osteopathy relieves common symptoms such as nausea and heartburn.
- Use of osteopathy can limit perineum or pelvic floor trauma.
- If your baby suffers from constipation then osteopathy could help.
- Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health.
- In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established.
- Cranial osteopathy releases stresses and strains in the skull and throughout the body.
- Osteopaths can feel involuntary motion and mechanisms within the body.
- Cranial osteopathy aims to reduce restrictions in movement.
Elsewhere in the ASA announcement, we find the statement that “The effectiveness of osteopathy for treating some conditions is underpinned by robust evidence”. The two examples provided are rheumatic pain and joint pain. I have to say I was mystified by this. I am not aware of robust evidence for these two indications. Perhaps someone could help me out here and provide some references?
The only condition for which there is enough encouraging evidence is, as far, as I know low back pain – and even here I would not call the evidence ‘robust’. Am I mistaken? If you think so, please supply the evidence with links to the references.
But, in general, the new guidance is certainly a step in the right direction. Now we have to wait and see whether osteopaths change their advertising and behaviour accordingly and what happens to those who don’t.
WATCH THIS SPACE
Some osteopaths – similar to their chiropractic, naturopathic, homeopathic, etc. colleagues – claim they can treat almost any condition under the sun. Even gynaecological ones? Sure! But is the claim true? Let’s find out.
The aim of this recent review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review.
In total, 24 studies were included. They addressed the following conditions: back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT was considered to be effective for pregnancy related back pain. For all other gynaecological and obstetrical conditions the evidence was considered to be uncertain. Only three studies mentioned adverse events after OMT.
The authors concluded that, although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.
Given the fact that the lead authors of this review come from the “Accademia Italiana Osteopatia Tradizionale, Pescara, Italy, we can probably answer the question in the title of this blog with a straight NO. I see no reason why OMT should work for gynaecological conditions, and I am not in the least surprised to read that there is no clinical evidence for this notion. Sadly, this is unlikely to stop osteopaths to claim otherwise and continue to prey on the desperate and the gullible.
One might thus say that this review is totally unremarkable – but I would beg to differ: it highlights yet again one very important finding, namely the fact that trials of alternative therapies far too often fail to report adverse effects. I have stated this often already, but I will say it again: THIS OMISSION IS A VIOLATION OF RESEARCH ETHICS WHICH GIVES US A FALSE POSITIVE OVERALL PICTURE OF THE RISKS ASSOCIATED WITH ALTERNATIVE MEDICINE.
Would you like to see a much broader range of approaches such as nutrition, mindfulness, complementary therapies and connecting people to green spaces become part of mainstream healthcare?
Well, let me tell you about this exciting new venture anyway!
It is being promoted by Dr Dixon’s ‘College of Medicine’ and claims to be “the only accredited Integrative Medicine diploma currently available in the UK… [It] will provide you with an accredited qualification as an integrative medicine practitioner. The Diploma is certified by Crossfields Institute and supported by the College of Medicine and is the only one currently available in the UK. IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients. The model embraces conventional approaches as well as other modalities centred on lifestyle and mind-body techniques like mindfulness and nutrition.”
Dr Dixon? Yes, this Dr Michael Dixon.
College of Medicine? Yes, this College of Medicine.
Crossfields Institute? Yes this Crossfields Institute which promotes the Steiner/’Waldorf quackery and has Simon Fielding as the chair of trustees.
Simon Fielding? Yes, the Simon Fielding who “devoted much of his professional life to securing the recognition of osteopathy as an independent primary contact healthcare profession and this culminated in the passing of the Osteopaths Act in 1993. He was appointed by ministers as the first chair of the General Osteopathic Council responsible for bringing the Osteopaths Act into force… He is currently vice-chair of the board of trustees of The College of Medicine… In addition Simon has… served as a long term trustee on the boards of The Prince of Wales’s Foundation for Integrated Health… and was the founder chair of the Council for Anthroposophical Health and Social Care.”
You must admit, this IS exciting!
Now you want to know what modules are within the Diploma? Here they are:
- The Modern Context of IM: Philosophy, History and Changing Times in Medicine
- IM Approaches and Management of Conditions (part 1)
- Holistic Assessment: The Therapeutic Relationship, Motivational Interviewing & Clinical Decision Making in Integrative Medicine
- Critical Appraisal of Medicine and IM Research
- Holistic assessment: Social prescribing, a Community Approach in Integrative Medicine
- Managing a Dynamic IM Practice and Developing Leadership Skills
- IM Approaches and Management of Conditions (part 2)
- Independent Study on Innovation in Integrative Medicine
Sounds terrific, and it reminds me a lot of another course Michael Dixon tried to set up 13 years ago in Exeter. As it concerned me intimately, I wrote about this extraordinary experience in my memoir; here is a short excerpt:
…in July 2003… I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:
“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: ‘The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies’.”
When I stumbled on this announcement I was taken aback. Is Tooke envisaging a course for me to run? Has he forgotten to tell me about it? When I inquired, Tooke informed me that the medical school planned to offer a postgraduate “Pathway in Integrated Health” which had been initiated by Dr Michael Dixon, a general practitioner who had at that stage become one of the UK’s most outspoken proponents of spiritual healing and other dubious forms of alternative medicine, and for this reason was apparently very well regarded by Prince Charles.
A few days after I received this amazing news, Dr Dixon arrived at my office and explained with visible embarrassment that Prince Charles had expressed his desire to establish such a course in Exeter. His Royal Highness had already facilitated its funding which, in fact, came from Nelson’s, the manufacturer of homoeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit I had struggled – and even paid – to be separated from almost a decade ago because of its overtly anti-scientific agenda. The whole thing had been in the planning for several months. I was, it seemed, the last to know – but now that I had learnt about it, Dixon and Tooke urged me to contribute to this course by giving a few lectures.
I could no more comply with this request than fly. Apart from anything else, I was opposed in principle to the concept of “integration.” As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerous idea of equivalence – i.e., the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.
To add insult to injury, the course was to be sponsored by a major manufacturer of homoeopathic remedies. In all conscience, this seemed to me to be the last straw. Study after study carried out by my unit had found homoeopathy to be not only conceptually absurd but also therapeutically worthless. If we did not take a stand on this issue, we might just as well all give up and go home…
END OF QUOTE FROM MY MEMOIR
Dixon’s Exeter course was not a brilliant success; I think it folded soon after it was started. Well, better luck up the road in Bristol, Michael – I am sure there must be a market for quackery somewhere!
The queue outside my ‘ALT MED HALL OF FAME’ was getting restless because I did not admit any new members for some time. So, I better get cracking!
You remember, of course, who has been honoured so far; the list of members (main research interest, country) is as follows:
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
Today, we are going to have a look at Prof David Peters. This is what our friends from the ‘COLLEGE OF MEDICINE’ say about him:
“David Peters MB, ChB, DRCOG, DMSMed MFHom FLCOM trained as a GP, a musculoskeletal physician and also as a homeopathic and osteopathic practitioner. For fifteen years he directed the complementary therapies development programme at Marylebone Health Centre. Professor Peters is one of the founding faculty of the University of Westminster’s School of Life Sciences, where he is Clinical Director. Professor Peters is a member of the Council and former chair of the British Holistic Medical Association and Editor of its Journal of Holistic Healthcare. He has co-authored or edited six books about integrated healthcare. His research interests include the role of non-pharmaceutical treatments in mainstream medicine, wellbeing in long-term conditions and the development of integrated practitioners.”
I did my usual Medline search but found only 16 Medline-listed articles authored by David Peters. This is amazing because he has been involved in UK alt med much longer than I have. Even more amazing is that none of these papers seem to refer to clinical trials. Perhaps he is not convinced of this type of research?
In order to evaluate his output, I took the sentence that came nearest to a conclusion from the most recent 10 articles. Below you find first the titles of each paper (with the link to it), second the list of its authors and third the sentence that formulated a conclusion (in bold).
Cheshire A, Polley M, Peters D, Ridge D.
BMC Complement Altern Med. 2013 Nov 1;13:300. doi: 10.1186/1472-6882-13-300.
The BBPS provided a MSK pain management service that many patients found effective and valuable. Combining self-management with acupuncture was found to be particularly effective, although further consideration is required regarding how best to engage patients in self-management.
Cheshire A, Polley M, Peters D, Ridge D.
BMC Fam Pract. 2011 Jun 13;12:49. doi: 10.1186/1471-2296-12-49.
Provision of acupuncture and osteopathy for MSK pain is achievable in General Practice. A GP surgery can quickly adapt to incorporate complementary therapy provided key principles are followed.
Unwin J, Peters D.
Acupunct Med. 2009 Mar;27(1):21-5. doi: 10.1136/aim.2008.000083.
The Gateway Clinic has become an increasingly popular referral resource. The influences that drive referral to the clinic are multiple and follow “tacit guidelines”. GPs select patients on the basis of their individual clinical experience, informed by positive patient feedback and often only after more conventional medical treatment options have been exhausted.
Lewith GT, Breen A, Filshie J, Fisher P, McIntyre M, Mathie RT, Peters D.
Clin Med (Lond). 2003 May-Jun;3(3):235-40. Review.
This paper describes the current status and evidence base for acupuncture, homeopathy, herbal and manipulative medicine, as well as the regulatory framework within which these therapies are provided. It also explores the present role of the Royal College of Physicians’ Subcommittee on Complementary and Alternative Medicine (CAM) in relation to these developments. A number of CAM professions have encouraged the Royal College of Physicians Subcommittee to act as a reference point for their discussions with the conventional medical profession and the subcomittee believes that they are able to fulfil this function.
Peters D, Pinto GJ, Harris G.
Br Homeopath J. 2000 Jul;89 Suppl 1:S14-9
It is possible to introduce rigour and reflectiveness when providing a homeopathic service in general practice by assessing the needs of patient and practitioners, agreeing intake guidelines, developing referral processes, implementing audit cycles. Clear lines of communication can be established and a patient-centred outcome measure can be introduced into the treatment cycle.
I could not find any further articles that I could classify as providing data; so I stopped well short of the envisaged 10 papers. I have to admit, I was hesitant: does David deserve to be in the ALT MED HALL OF FAME? In the end, I gave him the benefit of the doubt. Why? Mainly because I am impressed with his scope of practice. Here is what he himself wrote about this aspect:
“I use a range of approaches: osteopathy and medical acupuncture, as well as nutrition and mind-body medicine – meditation, relaxation techniques, breath-work, self-hypnosis, biofeedback, and simple yoga-based exercises. Sometimes herbal medicines, complex homeopathy, nutritional supplements, trigger-point or joint injections can be a valuable too. Somatic Experiencing is a gentle form of body-centred psychotherapy for problems that have come on after traumatic incidents. When I want to assess the impact of stress on the body I use a painless approach involving computer-based heart rate variability testing and breath analysis; sometimes salivary cortisol profiling too. Where required I can prescribe conventional medicine and were they are needed I might suggest scans, X-rays or blood tests.”
Peter is perhaps not the most industrious researcher when it comes to publishing papers, but he fulfils the criterion of not ever publishing anything negative that might rock the boat or distract from the true value of alternative medicine.
LONG LIVE THE POSITIVE RESULT!
Recently, I came across a good article where someone had assessed 100 websites by UK osteopaths. The findings are impressive:
57% of websites in the survey published the ‘self-healing’ claim
70% publicised the fact they offered cranial therapy;
61% made a claim to treat one or more specific ailments not related to the musculoskeletal system;
48% of practitioners also personally offered another CAM therapy;
71% of all sites surveyed located in a setting where other CAM was immediately available.
In total, 93% of the randomly selected websites checked at least one, often more, of the criteria for pseudoscientific claims. The author concluded that quackery is far from existing only on the fringe of osteopathic practice.
In a previous article, the author had stated that “there’s some (not strong) evidence that manual therapy may have some benefit in the case of lower back pain.” This evidence for the assumption that osteopathy works for back pain seems to rely heavily on one researcher: Licciardone JC. He comes from ‘The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth‘. which also is the flag-ship of research into osteopathy with plenty of funds and a worldwide reputation.
In 2005, he and his team published a systematic review/meta-analysis of RCTs which concluded that “osteopathic manipulative therapy (OMT) significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.”
This is the article cited regularly to support the statement that osteopathy is an effective therapy for back pain. As the paper is now over 10 years old, we clearly need a more up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for chronic non-specific low back pain (CNSLBP) was recently published by an Australian team. A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.
In other words, there seems to be an overt contradiction between the conclusions of Licciardone JC and those of the Australian team. Why? we may well ask. Perhaps the Osteopathic Research Center is not in the best position to be impartial? In order to check them out, I decided to have a closer look at their publications.
This team has published around 80 articles mostly in very low-impact osteopathic journals. They include several RCTs, and I decided to extract the conclusions of the last 10 papers reporting RCTs. Here they are:
RCT No 1 (2016)
Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions.
RCT No 2 (2016)
The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP.
RCT No 3 (2014)
Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.
RCT No 4 (2014)
These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.
RCT No 5 (2013)
The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.
RCT No 6 (2013)
The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.
RCT No 7 (2012)
This study found associations between IL-1β and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.
RCT No 8 (2010)
Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.
RCT No 8 (2004)
The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.
RCT No 9 (2003)
Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.
RCT No 10
Sorry, there is no 10th paper reporting an RCT.
Most of the remaining articles listed on Medline are comments and opinion papers. Crucially, it would be erroneous to assume that they conducted a total of 9 RCTs. Several of the above cited articles refer to the same RCT.
However, the most remarkable feature, in my view, is that the conclusions are almost invariably positive. Whenever I find a research team that manages to publish almost nothing but positive findings on one subject which most other experts are sceptical about, my alarm-bells start ringing.
In a previous blog, I have explained this in greater detail. Suffice to say that, according to my theory, the trustworthiness of the ‘Osteopathic Research Center’ is nothing to write home about.
What, I wonder, does that tell us about the reliability of the claim that osteopathy is effective for back pain?
On this blog, I have repeatedly pleaded for a change of the 2010 NICE guidelines for low back pain (LBP). My reason was that it had become quite clear that their recommendation to use spinal manipulation and acupuncture for recurrent LBP was no longer supported by sound evidence.
Two years ago, a systematic review (authored by a chiropractor and published in a chiro-journal) concluded that “there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP.” A the time, I wrote a blog explaining that “whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently) is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of chronic LBP – and consequently consulting a chiropractor should not be the first choice for chronic LBP patients.”
Three years ago, a systematic review of acupuncture for LBP (published in a TCM-journal) concluded that the effect of acupuncture “is likely to be produced by the nonspecific effects of manipulation.” At that time I concluded my blog-post with this question: Should NICE be recommending placebo-treatments and have the tax payer foot the bill? Now NICE have provided an answer.
The new draft guideline by NICE recommends various forms of exercise as the first step in managing low back pain. Massage and manipulation by a physiotherapist should only be used alongside exercise; there is not enough evidence to show they are of benefit when used alone. Moreover, patients should be encouraged to continue with normal activities as far as possible. Crucially, the draft guideline no longer recommends acupuncture for treating low back pain.
NICE concluded that the evidence shows that acupuncture is not better than sham treatment. Paracetamol on its own is no longer recommended either, instead non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin should be tried first. Talking therapies are recommended in combination with physical therapies for patients who had no improvement on previous treatments or who have significant psychological and social barriers to recovery.
Professor Mark Baker, clinical practice director for NICE, was quoted stating “Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”
Good news for us all, I would say:
- good news for patients who now hear from an accepted authority what to do when they suffer from LBP,
- good news for society who does no longer need to spend vast amounts of money on questionable therapies,
- good news for responsible clinicians who now have clear guidance which they can show and explain to their patients.
Not so good news, I admit, for acupuncturists, chiropractors and osteopaths who just had a major source of their income scrapped. I have tried to find some first reactions from these groups but, for the moment, they seemed to be stunned into silence – nobody seems to have yet objected to the new guideline. Instead, I found a very recent website where chiropractic is not just recommended for LBP therapy but where patients are instructed that, even in the absence of pain, they need to see their chiropractor regularly: “Maintenance chiropractic care is well supported in studies for controlling chronic LBP.”
NEVER LET THE TRUTH GET IN THE WAY OF YOUR CASH-FLOW…they seem to conclude.
Chiropractors and osteopaths have long tried to convince us that spinal manipulation and mobilisation are the best we can do when suffering from neck pain. But is this claim based on good evidence?
This recent update of a Cochrane review was aimed at assessing the effects of manipulation or mobilisation alone compared with those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up, and when appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes.
Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). They also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies.
Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain were included in this assessment.
Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). The authors calculated pooled risk ratios (RRs) and standardised mean differences (SMDs).
Fifty-one trials with a total of 2920 participants could be included. The findings are diverse. Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up. Cervical manipulation versus another active treatment: For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up. Thoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality). Thoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain. Mobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control. Mobilisation versus another active treatment: For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality).
Confused? So am I!
In my view, these analyses show that the quality of most studies is wanting and the evidence is weak – much weaker than chiropractors and osteopaths try to make us believe. It seems to me that no truly effective treatments for neck pain have been discovered and that therefore manipulation/mobilisation techniques are as good or as bad as most other options.
In such a situation, it might be prudent to first investigate the causes of neck pain in greater detail and subsequently determine the optimal therapies for each of them. Neck pain is a SYMPTOM, not a disease! And it is always best to treat the cause of a symptom rather than pretending we know the cause as chiropractors and osteopaths often do.
The authors of the Cochrane review seem to agree with this view at least to some extent. They conclude that although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.
The call for further research is, of course, of no help for patients who are suffering from neck pain today. What would I recommend to them?
My advice is to be cautious:
- Consult your doctor and try to get a detailed diagnosis.
- See a physiotherapist and ask to be shown exercises aimed at reducing the pain and preventing future episodes.
- Do these exercises regularly, even when you have no pain.
- Make sure you do whatever else might be needed in terms of life-style changes (ergonomic work place, correct sleeping arrangements, etc.).
- If you are keen on seeing an alternative practitioner for manual therapy, consult a osteopath rather than a chiropractor; the former tend to employ techniques which are less risky than the latter.
- Avoid both chiropractors and long-term medication for neck pain.
Alternative medicine encompasses many bizarre treatments, but one of the weirdest must be craniosacral therapy (CST). The assumptions underlying CTS are:
- light manual touch of the head moves the joints of the cranium;
- this movement stimulates the flow of the cerebrospinal fluid;
- the enhanced flow has profound and positive effects on human health.
None of these assumptions are supported by evidence. In fact, they are as implausible as assumptions in alternative medicine get.
CST was developed by the osteopath John Upledger, D.O. in the 1970s, as an offshoot osteopathy in the cranial field, or cranial osteopathy, which was developed in the 1930s by William Garner Sutherland. Apart from this confusing terminology, we are also confronted with a confusing array of therapeutic claims; CST seems to be recommended for most conditions.
And the evidence? As good as none!
This is why any new trial is worth a mention. A recent study tested CST in comparison to sham treatment in chronic non-specific neck pain patients. 54 blinded patients were randomized to either 8 weekly units of CST or light touch sham treatment. Outcomes were assessed before and after treatment (week 8) and a further 3 months later (week 20). The primary outcome was pain intensity on a visual analogue scale; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients’ global impression of improvement and safety.
In comparison to sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 as well as at week 20. Minimal clinically important differences in pain intensity at week 20 were reported by 78% of the CST patients, while 48% even had substantial clinical benefit. Significant differences at week 8 and 20 were also found for pain on movement, functional disability, physical quality of life and patients’ global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8; anxiety only at week 20. No serious adverse events were reported.
The authors from the Department of Internal and Integrative Medicine, University of Duisburg-Essen and the Institute of Integrative Medicine, University of Witten/Herdecke, Germany, concluded that CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and quality of life up to 3 months post intervention.
Oddly, this is not even close to the conclusion I am going to draw: inadequate control for placebo and other non-specific effects generated a false-positive result.
Who is correct?
I suggest we wait for an independent replication to decide.
Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.
The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.
Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.
Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.
Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.
The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.
The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
These are odd conclusions, in my view, and I think I ought to add a few points:
- As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
- Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
- The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
- As the authors mention, it is hardly ever the chiropractor who reports a serious complication when it occurs.
- In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
- Therefore their true rate is anyone’s guess.
- As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
- Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
- Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.
And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.
Osteopathy is a difficult subject. In the US, osteopaths are (almost) identical with doctors who have studied conventional medicine and hardly practice any manipulative techniques at all. Elsewhere, osteopaths are alternative healthcare providers specialising in what they like to call ‘osteopathic manipulative therapy’ (OMT). As though this is not confusing enough, osteopaths are doing similar things as chiropractors but are adamant that they are a distinct profession. Despite these assertions, I have seen little to clearly differentiate the two – with one exception perhaps: osteopaths tend to use techniques that are less frequently associated with severe harm.
Despite this confusion, or maybe because of it, we need to ask: DOES OMT WORK?
A recent study was aimed at assessing the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. All patients admitted to the Department of Neurology of Ancona’s United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for this 3-armed RCT.
Patients were randomly divided into three (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only and received 8 treatments during 6 months. Changes in the HIT-6 score were considered as the main outcome measure.
A total of 105 subjects were included. At the end of the study, OMT significantly reduced HIT-6 score, drug consumption, days of migraine, pain intensity and functional disability.
The investigators concluded that these findings suggest that OMT may be considered a valid procedure for the management of migraineurs.
Similar results have been reported elsewhere:
One trial, for instance, concluded: “This study affirms the effects of OMT on migraine headache in regard to decreased pain intensity and the reduction of number of days with migraine as well as working disability, and partly on improvement of HRQoL. Future studies with a larger sample size should reproduce the results with a control group receiving placebo treatment in a long-term follow-up.”
Convinced? No, I am not.
Why? Because the studies that do exist seem a little too good to be true; because they are few and far between, because the few studies tend to be flimsy and have been published in dodgy journals, because they lack independent replications, and because critical reviews seem to conclude that OMT is nowhere near as promising as some osteopaths would like us to believe: “Further studies of improved quality are necessary to more firmly establish the place of physical modalities in the treatment of primary headache disorders. With the exception of high velocity chiropractic manipulation of the neck, the treatments are unlikely to be physically dangerous, although the financial costs and lost treatment opportunity by prescribing potentially ineffective treatment may not be insignificant. In the absence of clear evidence regarding their role in treatment, physicians and patients are advised to make cautious and individualized judgments about the utility of physical treatments for headache management; in most cases, the use of these modalities should complement rather than supplant better-validated forms of therapy.”