Low back pain (LBP) is a ‘minor complaint’ in the sense that it does not cost patients’ lives. At the same time, LBP is amongst the leading causes of disability and one of the most common reasons for patients to seek primary care. Chiropractors, osteopaths, physical therapists and general practitioners are among those treating LBP patients, but there is only limited evidence regarding the effectiveness offered by these provider groups.
The aim of this systematic review was to estimate the clinical effectiveness and to systematically review economic evaluations of chiropractic care compared to other commonly used approaches among adult patients with non-specific LBP.
A comprehensive search strategy was conducted to identify 1) pragmatic randomized clinical trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. The primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine estimates of effect sizes. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized.
Six RCTs and three full economic evaluations were included. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). The authors found similar effects for chiropractic care and the other types of care. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Highly divergent conclusions (favours chiropractic, favours medical care, equivalent options) were noted for economic evaluations of chiropractic care compared to medical care.
The authors drew the following conclusions: moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.
This is a thorough and timely review. Its results are transparent and clear, however, its conclusions are, in my view, more than a little odd.
Let me try to re-formulate them such that they are better supported by the actual data: There is no good evidence to suggest that chiropractic care is better or worse that conventional therapeutic approaches currently used for LBP. The pooled sample size dimensions too small to allow any statements about the risks of the various approaches. The data are also too weak for any pronouncements on the relative cost-effectiveness of the various options. Given these limitations, the decision which approach to use should be based on a more comprehensive analysis of the therapeutic risks.
The point I am trying to make is quite simple:
- The fact that RCTs fail to show adverse effects could be due to the small collective sample size and/or to the well-known phenomenon that, in well-controlled trials, adverse effects tend to be significantly rarer than in routine care.
- Hundreds of serious adverse events have been reported after chiropractic spinal manipulations; to these we have to add the fact that ~50% of all chiropractic patients suffer from transient, mild to moderate adverse effects after spinal manipulations.
- If we want to generate a realistic picture of the safety of a therapy, we need to include case-reports, case-series and other non-RCT evidence.
- Conventional treatments of LBP may not be free of adverse effects, but some are relatively safe.
- It seems reasonable, necessary and ethical to consider a realistic picture of the relative risks when deciding which therapy amongst equally (in)effective treatments might be best.
To me, all this seems almost painfully obvious, and I ask myself why the authors of this otherwise sound review failed to consider such thoughts. As one normally is obliged to, the authors included a section about the limitations of their review:
Our review has limitations. First, we did not search the grey literature for clinical effectiveness studies. McAuley et al. showed that the inclusion of results from the grey literature tend to decrease effectiveness estimates in meta-analyses because the unpublished studies tend to report smaller treatment effects. Second, critical appraisal requires scientific judgment that may vary among reviewers. This potential bias was minimized by training reviewers to use a standardized critical appraisal tool and using a consensus process among reviewers to reach decisions regarding scientific admissibility. Most of the original between-group differences and pooled estimates in our meta-analysis did not favour a specific provider group, and we believe it is unlikely that the inclusion of unpublished grey literature would change our conclusions. Third, the low number of clinical trials prevents us from conducting a meaningful investigation for publication bias. Fourth, the majority of the included clinical effectiveness studies (three out of five) and all three economic evaluations were conducted in the United States. Caution should therefore be used when generalizing our findings to other settings or jurisdictions. With respect to economic evaluations in particular, local healthcare systems and insurance plans may have a higher impact on cost than the type of healthcare provider.
Remarkably, this section does not mention their useless assessment of the risks with one word. Why? One answer might be found in the small-print of the paper:
The authors … have the following competing interests: MAB: Personal fees from Ordre des chiropraticiens du Québec for one teaching presentation, outside the submitted work. MJS: Position at the Nordic Institute of Chiropractic and Clinical Biomechanics is funded by the Danish Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication. RBDS: Nothing to disclose. JB: Nothing to disclose. PH: Nothing to disclose. AB: Position at the School of Physical and Occupational Therapy at McGill University is funded by the Canadian Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication.
At first, I thought this survey would be yet another of those useless and boring articles that currently seem to litter the literature of alternative medicine. It’s abstract seemed to confirm my suspicion: “Fifty-two chiropractors in Victoria, Australia, provided information for up to 100 consecutive encounters. If patients attended more than once during the 100 encounters, only data from their first encounter were included in this study. Where possible patient characteristics were compared with the general Australian population…” But then I saw that the chiropractors were also asked to record their patients’ main complaints. That, I thought, was much more interesting, and I decided to do a post that focusses on this particular point.
The article informs us that 72 chiropractors agreed to participate (46 % response rate of eligible chiropractors approached). During the study, 20 (28 %) of these chiropractors withdrew and did not provide any data. Fifty two chiropractors (72 % of those enrolled) completed the study, providing information for 4464 chiropractor-patient encounters. Of these, 1123 (25 %) encounters were identified as repeat patient encounters during the recording period and were removed from further analyses, leaving 3287 unique patients.
The results that I want to focus on indicated that chiropractors give the following reasons for treating patients:
- maintenance: 39%
- spinal problems: 33%
- neck problems: 18%
- shoulder problems: 6%
- headache: 6%
- hip problems: 3%
- leg problems: 3%
- muscle problems: 3%
- knee problems: 2%
(the percentage figures refer to the percentages of patients with the indicated problem)
Yes, I know, there is lots to be criticised about the methodology used for this survey. But let’s forget about this for the moment and focus on the list of reasons or indications which these chiropractors give for treating patients. For which of these is there enough evidence to justify this decision and the fees asked for the interventions? Here is my very quick run-down of the evidence:
- maintenance: no good evidence.
- spinal problems: if they mean back pain by this nebulous term, an optimist might grant that there is some promising but by no means conclusive evidence.
- neck problems: again some promising but by no means conclusive evidence.
- shoulder problems: no good evidence.
- headache: again some promising but by no means conclusive evidence
- hip problems: no good evidence.
- leg problems: no good evidence.
- muscle problems: no good evidence.
- knee problems: no good evidence.
As I said, this is merely a very quick assessment. I imagine that many chiropractors will disagree with it – and I invite them to present their evidence in the comments section below. However, if I am correct (or at least not totally off the mark), this new survey seems to show that most of the things these chiropractors do is not supported by good evidence. One could be more blunt and phrase this differently:
- these chiropractors are misleading their patients;
- they are not behaving ethically;
- they are not adhering to EBP.
Yes, we (I mean rationalists who know about EBM) did suspect this all along – but now we can back it up with quite nice data from a recent survey done by chiropractors themselves.
In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.
According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”
The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”
This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.
Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.
Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:
- the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
- the authors talk about efficacy but seem to mean effectiveness;
- the authors only included RCTs from the US which must result in a skewed and incomplete picture;
- the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
- not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
- the discussion of the paper totally lacks any critical thinking;
- there is no assessment of the quality of the trials included in this review.
My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.
Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.
As has been discussed on this blog many times before, the chiropractic profession seems to be in a bit of a crisis (my attempt at a British understatement). The Australian chiropractor, Bruce Walker, thinks that, with the adoption of his ten point plan, “the chiropractic profession has an opportunity to turn things around within a generation. Importantly, it has an obligation to the public and to successive generations of chiropractors ahead of it. By embracing this plan the profession can be set on a new path, a new beginning and a new direction. This plan should be known as the new chiropractic.”
And now you are. of course, dying to hear this 10 point plan – well, here it is [heavily abbreviated, I am afraid (the footnotes [ ] and the comments referring to them are mine)]:
- There is a need to improve pre professional education for chiropractors.
Universities or private colleges?
Chiropractic education should where possible be conducted at universities  and this does not mean small single purpose institutions that are deemed universities in name only. Why is this recommended? Primarily because unlike some private colleges, government funded universities insist on intellectual evidence based rigour  in their learning and teaching and importantly require staff to be research active. Chiropractic courses need to have an underpinning pedagogy that insists that content  is taught in the context of the evidence  and that students obtain the necessary training to question and critically appraise …
Underpinning chiropractic education is program accreditation and this is also in need of review particularly where vitalistic subluxation  based courses have been legitimised by the accreditation process…
Chiropractic education should also involve specifically relevant hospital access or work experience such as hospital rounds so that students can observe patients that are truly unwell and observe the signs and symptoms taught in their theory classes. Hospital rounds would also allow chiropractic students to interact with other health providers and increase the likelihood of legitimate partnership and respect between health professions .
Who should teach chiropractic students?…
- There is a need to establish a progressive identity.
Chiropractors need to become solely musculoskeletal practitioners with a special emphasis on spinal pain . If the profession becomes the world’s experts in this area it will command the respect deserved . Importantly it will not be seen as a collective of alternative medicine practitioners with a strange belief system …
- The profession should develop a generalised special interest.
…Chiropractic as a profession should also develop a special interest area in the health sciences that can make a worldwide contribution to other related health sciences. This could be either research based or clinically based or indeed both. Some possibilities are: the further development and refinement of evidence based practice , improved posture through motor control, musculoskeletal care for the aged and elderly, improving bone density or the very important area of translating research into practice via implementation science. Whatever chosen we need to develop a special interest that sets us apart as experts in a distinctive area .
- Marginalisation of the nonsensical elements within the profession.
As professionals chiropractors should not tolerate colleagues or leadership in the profession who demonstrate aberrant ideas. If colleagues transgress the boundaries or professionalism they should be reported to authorities and this should be followed up with action by those authorities …
- The profession and individual practitioners should be pro public health.
It is important to speak up openly in favour of evidence-based public health measures and to join public health associations and agencies … For example, chiropractors promoting anti-vaccination views need to be countered …
- Support legitimate organised elements of the profession.
Practitioners should support and become involved in chiropractic organisations that are clearly ethical and evidence based  and add value to them…
…Regular collective professional advertising of the benefits of chiropractic for back pain, for example, is a worthy undertaking but the advertisements or media offerings must be evidence based .
- The profession should strive to improve clinical practice.
Chiropractors contribute to the public health by the aggregated benefit of positive outcomes to health from their clinical practices … Where restrictive practice laws relating to chiropractors prescribing medication exist the profession should seek to overturn them …
- The profession should embrace evidence based practice.
EBP is the amalgam of best scientific evidence plus clinical expertise plus patient values and circumstances. So what could be missing from this equation? It is clear that in the opinion of a sizable minority of the profession the elements that are missing are “practitioner ideology” and “practitioner values and circumstances”. These additional self- serving and dangerous notions should not be entertained. The adoption of evidence based practice is critical to the future of chiropractic and yet there is resistance by elements within the profession. Soft resistance occurs with attempts to change the name of “Evidence-based practice” (EBP) to “Evidence-informed practice” (EIP). It is worth noting that currently there are over 13,000 articles listed in PUBMED on EBP but less than 100 listed on EIP. So why are some of our profession so keen to use this alternate and weaker term?
Hard resistance against EBP occurs where it is stated that the best evidence is that based on practice experience and not research. This apparently is known as Practice Based Evidence (PBE) and has a band of followers …
- The profession must support research.Research needs to become the number one aspiration of the profession. Research informs both practice and teaching. Without research the profession will not progress. Sadly, the research contribution by the chiropractic profession can only be described as seed like. Figure 1 is a comparison of articles published in the past 45 years by decade using the key words “Physiotherapy” or “Physical Therapy” versus “Chiropractic” (source PUBMED). The Y axis is the number of articles published and the X axis is the decade, the red represents physiotherapy articles, the blue chiropractic. The difference is stark and needs urgent change .If the profession at large ignores research whether in its conduct, administration or its results the profession will wither on the vine …
- Individual chiropractors need to show personal leadership to effect change.
Change within the profession will likely only occur if individual chiropractors show personal leadership….
As part of this personal leadership it will be critical to speak out within the profession. Speak out and become a mentor to less experienced colleagues …
Anyone you thinks that with such a strategy “the chiropractic profession has an opportunity to turn things around within a generation” is, in my view, naïve and deluded. The 10 points are not realistic and woefully incomplete. The most embarrassing omission is a clear statement that chiropractors are fully dedicated to making sure that they serve the best interest of their patients by doing more good than harm.
“Conflicts of interest should always be disclosed.”
This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.
Not true!!! I hear some people say. But it is!
I have no financial interest in any ‘Big Pharma’ or ‘TINY CAM’, and I get not a penny for writing this blog.
How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.
Still not convinced?
Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.
So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?
Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!
I believe that:
- good evidence is a prerequisite for progress in healthcare,
- good evidence must be established by rigorous research,
- we should not tolerate double standards in healthcare,
- patients deserve to be treated with the best available treatments,
- making therapeutic claims that are not supported by sound evidence is wrong.
These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.
The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded: “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])
Conflicts of interest? No, not on my side, I think.
But what about the ‘other side’?
The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?
- They earn their money with acupuncture.
- They have invested in acupuncture training often for long periods of time.
- They have invested in practice equipment etc.
- Some of them sell books on acupuncture.
- Others run courses.
- And all of them very clearly and demonstrably have strong beliefs about acupuncture.
I think the latter point constitutes by far the most important conflict of interest in this context.
And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:
I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.
Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.
What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.
I just came across this website entitled 11 HARD QUESTIONS ABOUT CHIROPRACTIC PHYSICIANS. The title fascinated me; I am always in favour of addressing hard questions. I therefore read the 11 questions with interest; and I quite liked them. However, the answers provided by the author, a chiropractor of course, struck me as being more than a little uncritical towards chiropractic (feel free to click on the above link and see for yourself). Therefore, I decided to try my own answers (except for No 5). And then – being in the swing of it – I added a few more supplementary questions as well.
In other words, the first 11 questions are the ones posed by the chiro but the 4 additional ones are mine, and so are all the answers. Here we go:
Question No 1: What can a chiropractic physician do for me that another doctor can’t?
Question No 2: Does chiropractic therapy really work?
No. The best evidence available today fails to show that chiropractic spinal manipulations work for any condition. If one is generous, one might make an exception for back pain, but even for this symptom, the evidence is flimsy.
Question No 3: What other types of health problems can chiropractic treatment help?
Question No 4: What does a chiropractic physician do to find my problem?
He/she often uses non-validated diagnostic techniques that are prone to give fantasy-results. You might also get extensive X-rays – mostly because the chiropractor wants to pay for the expensive equipment.
Question No 5: What therapies do chiropractic physicians use?
Chiropractic physicians may use manual and physical therapies including manipulation of the spine and joints of the arms and legs. Supportive therapies may also include massage, myofascial release, and therapeutic modalities such as ultrasound, electric stimulation and diathermy. Rehabilitative measures are often used such as specific corrective exercises to stabilize your problem. (This is the only answer I roughly agreed with, and I therefore left it unchanged.)
Question No 6: What is the standard length of treatment?
This depends mainly on the patient’s ability to pay. As a rule of thumb, as many treatments as possible will be given. Many chiros even advocate ‘maintenance treatment’ which means you receive regular spinal manipulations even when there is nothing wrong with you. The little porky they give you as an explanation is that this prevents future illnesses.
Question No 7: Is chiropractic care covered by insurance?
Because of very active lobbying by chiro interest groups, it may well be.
Question No 8: If I need a referral, how do I ask my doctor to refer me to a chiropractic physician?
Chiros are presently trying very hard to be accepted as ‘primary care physicians’; this means you can consult them directly without the need of a referral.
Question No 9: If I go see a chiropractor do I need to keep on going?
Only if you believe the nonsense about maintenance treatment they often tell you (see above) for which there is not a jot of convincing evidence.
Question No 10: What training do chiropractors have?
Not enough to realise that their spinal adjustments fail to generate more good than harm.
Question No 11: How should I select a good chiropractic physician?
If you are ill, it’s best to see are real doctor and avoid chiros.
AND NOW MY SUPPLEMENTARY QUESTIONS
No 1 Are chiros really physicians?
The definition of a physician is : ‘A person trained and licensed to practice medicine; a medical doctor’. Therefore, the answer is no.
No 2 What are the risks of spinal manipulations or adjustments, the main treatments used by chiros?
~50% of all patients have mild to moderate adverse effects that last 2-3 days.
In addition, several hundred cases of severe complications have been noted, including strokes and deaths.
No 3 How are such adverse outcomes monitored?
There is no effective monitoring system at all.
No 4 Is such an omission responsible or ethical?
Amidst the current controversy of chiropractic spinal manipulation for new-born babies, the previous director of Chiropractor’s Association of Australia NSW, Alex Fielding, published an interesting article. In it, he declared:
- I do not condone the chiropractic treatment of children for non-musculoskeletal conditions it is simply not our place. There is little to no evidence for it and it should not be done. If a chiro is report them to AHPRA.
- There is no evidence for “subluxation” it simply has not been shown to exist by any credible source.
- Chiropractic does not equal spinal manipulative therapy (SMT) or adjustment. We are trained to assess and treat musculoskeletal conditions, use exercise rehab, various forms of manual therapy including SMT, give sound evidence based advice and refer to better suited health professionals in the appropriate circumstance. To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT.
Here I only want to comment on his last point. I think it is important, not least because we hear it ad nauseam. As soon as there emerges new evidence to show that SMT does little for back or neck pain or is ineffective for non-spinal conditions, chiropractors insist that they do so much more than just SMT, and therefore any such findings do not ever lend themselves to a verdict about chiropractic care.
In my view, this argument is a bit like ‘wanting the cake and eat it’ (chiros want to be different from physios by adhering to SMT, but they don’t want to be judged by the uselessness of SMT). It begs the following questions:
- What other modalities do chiros use?
- For which conditions do they use them?
- What is the evidence for or against them?
- In what percentage of patients do chiros use SMT?
The last question may be the most important one. I am not aware of data from ‘down under’ but, in the UK, the percentage is close to 100%. This is why I often call SMT the ‘hallmark therapy of chiropractors’. No other profession employ it more frequently. It is the treatment that defines the chiropractic profession.
If the evidence for SMT is flimsy or negative or non-existent, it seems not unreasonable to voice doubts about the profession that uses it most. The fact that chiropractors also administer other modalities – most of which, by the way, have a shaky evidence-base too – is simply a smoke-screen used to mislead us.
An example might make this a bit clearer. Imagine a surgeon who takes out the tonsils of every patient he sees, regardless of any tonsillitis or other tonsil-related condition (historically, this fad once existed; tonsillectomy was even used to treat depression). This surgeon also does all sorts of other things: he prescribes pain-killers, gives antibiotics, orders bed-rest, gives life-style advice etc. etc. Yet he is a charlatan because his hallmark intervention is not effective and even puts patients at unnecessary risks.
I know, the analogy is not perfect, but it makes the point: chiropractors refuse to be judged by the uselessness of SMT. Yet it is what defines them and they continue using SMT pretty much regardless of the evidence. Fielding pleads: To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT. I’d say there is no good evidence for SMT nor for chiropractic care that includes SMT.
My advice for chiropractors therefore is: abandon SMT and become physiotherapists. This will make you a bit better grounded in evidence, but at least you would have rid yourself of the Palmer-cult with all the BS that comes with it.
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.
Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”
The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.
Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.
There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.
The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.
At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.
The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”
Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.
In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.
I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.