We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.
Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.
They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.
Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.
In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.
The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.
I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?
I think the answer is NO!
If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?
Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.
This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.
A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.
The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.
The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.
In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…
Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”
This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.
Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.
We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.
We must insist that regulators protect us from such quackery and prevent the serious harm it can do.
Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.
This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.
There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).
The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.
The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:
- better education of general practitioners,
- tightening of healthcare budgets,
- recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
- the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
- the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
- a more general realisation that these therapies can cause very serious harm,
- a mixture of the above factors.
Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.
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.