The objective of this systematic review was to assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Different databases were screened up to 20 August 2020. Randomised clinical trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.
A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:
- SM/chiropractic (7 studies, 567 participants).
- Osteopathy (5 trials, 645 participants).
- Kinesiology (1 trial, 58 participants).
- Articular mobilisations (6 trials, 445 participants).
- Muscular release (5 trials, 304 participants).
Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).
Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.
The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.
Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.
The authors of the review also provide this further comment:
Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.52
Rubinstein et al 53 compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.53
If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple:
These days, I live in France (some of my time) and I am often baffled by the number of osteopaths and the high level of acceptance of osteopathy in this country. The public seems to believe everything osteopaths claim and even most doctors have long given up to object to the idiocies they proclaim.
The website of the Institute of Osteopathy in Renne is but one of many examples. The Institute informed us as follows (my translation):
In addition to back pain, the osteopath can act on functional disorders of the digestive, neurological, cardiovascular systems or conditions related to ear, nose and throat. Osteopaths can promote recovery in athletes, relieve migraines, musculoskeletal disorders such as tendonitis, or treat sleep disorders. Less known for its preventive aspect, osteopathy also helps maintain good health. It can be effective even when everything is going well because it will prevent the appearance of pain. Osteopathy is, in fact, a manual medicine that allows the rebalancing of the major systems of the body, whatever the age of the patient and his problems. The osteopath looks for the root cause of your complaint in order to develop a curative and preventive treatment.
Who are osteopathic consultations for?
Osteopathic consultations at the Institute of Osteopathy of Rennes-Bretagne are intended for the following types of patients and pathologies
BABY / CHILD
GERD (gastric reflux), plagiocephaly (cranial deformities), recurrent ENT disorders (sinusitis, ear infections…), digestive, sleep and behavioural disorders, motor delay, following a difficult birth…
Prevention, comfort treatment of osteoarthritis, musculoskeletal pain, functional abdominal pain, digestive disorders, headaches, dizziness, postural deficiency, facial pains…
Musculoskeletal pain (lumbago, back pain), digestive disorders, preparation for childbirth, post-partum check-up.
Prevention and treatment of MSDs (musculoskeletal disorders) linked to workstation ergonomics, stress, pain due to repetitive movements, poor posture at work, etc.
Scoliosis, prevention of certain pathologies linked to growth, fatigue, stress, follow-up of orthodontic treatment.
Musculoskeletal pain, tendonitis, osteopathic preparation for competition, osteopathic assessment according to the sport practised, repetitive injury.
In case you are not familiar with the evidence for osteopathy, let me tell you that as good as none of the many claims made in the above text is supported by anything that even resembles sound evidence.
So, how can we explain that, in France, osteopathy is allowed to thrive in a virtually evidence-free space?
In France, osteopathy started developing in the 1950s. In 2002, osteopathy received legislative recognition in France, and today, it is booming; between 2016 and 2018, 3589 osteopaths were trained in France. Osteopaths can be DO doctors, DO physiotherapists, DO nurses, DO midwives, DO chiropodists, or even DO dentists.
Thus, in 2018, and out of a total of 29,612 professionals practising osteopathy, there were 17,897 osteopaths DO and 11,715 DO health professionals. The number of professionals using the title of osteopath has roughly tripled in 8 years (11608 in 2010 for 29612 in 2018). There are currently around 30 osteopathic schools in France. About 3 out of 5 French people now consult osteopaths.
But this does not answer my question why, in France, osteopathy is allowed to thrive in a virtually evidence-free space! To be honest, I do not know its answer.
Perhaps someone else does?
If so, please enlighten me.
The aims of this bibliometric analysis are to describe the characteristics of articles published on the efficacy of osteopathic interventions and to provide an overall portrait of their impacts in the scientific literature. A bibliometric analysis approach was used. Articles were identified with searches using a combination of relevant MeSH terms and indexing keywords about osteopathy and research designs in MEDLINE and CINAHL databases. The following indicators were extracted: country of the primary author, year of publication, journals, impact factor of the journal, number of citations, research design, participants’ age group, system/body part addressed, primary outcome, indexing keywords and types of techniques.
A total of 389 articles met the inclusion criteria. The number of empirical studies doubled every 5 years, with the United States, Italy, Spain, and the United Kingdom being the most productive countries. Twenty-three articles were cited over 100 times. Articles were published in 103 different indexed journals, but more than half (53.7%) of articles were published in one of three osteopathy-focused readership journals. Randomized control trials (n = 145; 37.3%) and case reports (n = 142; 36.5%) were the most common research designs. A total of 187 (48.1%) studies examined the effects of osteopathic interventions using a combination of techniques that belonged to two or all of the classic fields of osteopathic interventions (musculoskeletal, cranial, and visceral).
The authors concluded that this bibliometric analysis shows that publications about efficacy of osteopathy are relatively recent and have increased at a rapid pace over the last three decades. More than half of these publications are published in three osteopathic journals targeting a limited, disciplinary-focused readership. Our results highlight important needs for large efficacy and effectiveness trials, as well as study designs to further understanding of the mechanisms of action of the techniques being investigated. Finally, this bibliometric analysis can assist to identify osteopathy techniques and populations where further clinical research is required.
What the authors fail to state is that their analysis discloses osteopathy to be an area of utter unimportance. Less than 400 studies in 52 years is a dismal result. The fact that they were mostly published in journals of no impact makes it even worse. Twenty-three articles were cited more than 100 times; this is dismal! To put it in perspective, I have ~250 articles that were cited more than 100 times. Does that suggest that my work has made about 10 times more impact than the entire field of osteopathy?
My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:
“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago. Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM), and they certainly are relevant to chiropractic.
Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame, is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.
I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:
- How well-established is chiropractic?
- What treatments do chiropractors use?
- What conditions do they treat?
- What claims do they make?
- Are their assumptions reasonable?
- Are chiropractic spinal manipulations effective?
- Are these manipulations safe?
- Do chiropractors behave professionally and ethically?
Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.
I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.
In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?
This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.
Guest post by Richard Rawlins
Ever since its inception, Homeopathy has struggled to establish principled medical ethics amongst its practitioners. For sure, Samuel Hahnemann was good doctor who achieved much by denying his patients the bleeding, emetics, expectorants, laxatives and poly-pharmacy conventional at the turn of the nineteenth century. But he then lost his way in spiritism and vitalism, devised a system of care which could not, and did not, provide any benefit beyond placebo responses, and inveigled many colleagues to share his delusion. Many derided him.
As medicine in all developed countries became better regulated, so the associated ethics became better focussed. “First do no harm” is common to all systems, but in the UK, the four ‘A’s of avoiding adultery with a patient, alcohol whilst in a clinical situation, advertising, and association formed the next domain. ‘Association’ meant having a professional medical relationship with anyone not also a GMC registrant. Times, and standards have changed, but quackery, charlatanism and health care fraud has always been unethical. The problem for society has been the GMC’s reluctance to take any action against its registrants who lack integrity, promote quackery, or seek to defraud. The general response has been “we only act on complaints by a patient, health authority or fellow registrant – and complaints have to be specific.”
So it is that about 400 registrants of the GMC continue practising homeopathy with impunity. Sir Simon Stevens has now all but banned homeopathy from the NHS, but a medically qualified practitioner, in the private sector can do as they please, no matter how vulnerable and gullible the patient.
Doctors are of course required to obtain fully informed consent to treatment, and that should mean advising patients that homeopathic remedies are but placebos. Many patients so treated will declare they “feel better” and are content – but in practice, no explanation is offered to patients attending homeopaths. A classic charlatonnade (a charade promulgated by a charlatan).
But perhaps the vicissitudes of Covid-19 is exposing the hypocrisy of the GMC’s position, and might yet enable some redress for patients seeking redress for unethical medically qualified homeopathic attention.
The Guardian and Sunday Times of 22nd March 2020 reported that Dr Mark Ali allegedly made £1.7M profit in one week from selling kits to test for COVID -19.
“The GMC said no doctor should try to ‘profit from the fear and uncertainly caused by the pandemic…We would be concerned to learn that doctors are exploiting patient’s vulnerability or lack of medical knowledge, in order to profit from fear and uncertainty…’ “
The rationale for that fear is surely irrelevant – any health practice which takes advantage of the patient’s vulnerability or lack of medical knowledge is unethical. Simple.
“We also expect doctors… not to offer or recommend tests that are unproven, clinically unverified or otherwise unreliable.”
This is in the context of the serious issues of SARS-CoV-2 (the name of the corona virus which causes the illness COVID-19) – but it is helpful that the GMC’s ethical principles have been clearly stated.
May we take it the GMC will be equally as stringent with their registrants (doctors) who take advantage of the patient’s vulnerability or lack of medical knowledge, and recommend tests such as homeopathic provings “that are unproven, clinically unverified or otherwise unreliable.”?
And if not, why not?
All homeopathic remedy prescriptions are ‘tests’: “Take this, see how you go, I’ll adjust if needed…”. The German word pruefung used by Hahnemann (meaning ‘testing’ or ‘examination’) has been translated into English as ‘proving’. But the word for ‘to prove’ is beweisen, and that is not the word Hahnemann used. The use of ‘proving’ in English implies merit which is not deserved. All part of the delusion.
Clearly, any doctor who recommends homeopathic remedies, but does not explain the conventional view of the remedy, lacks integrity and is unethical – by definition. If the doctor is GMC registered (which a ‘doctor’ does not have to be – e.g., dentists are not) – they should be subject to sanction by the GMC. The GMC should do its duty to protect the public, and not wait for a crisis to stir them into action.
Sadly, if practitioners are not GMC registered, caveat emptor.
The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.
Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.
Compared to treatment as usual, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
- disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).
Compared to manual/non-manual sham, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
- disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;
Compared to active manual treatments, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
- disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .
At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.
The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.
Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:
- The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
- Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
- The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
- This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
- One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
- The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
- Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.
Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.
So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:
Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:
- all alternative therapies are effective,
- the ‘Trustworthiness Index’ of Prof Dobos is unusual.
I let my readers chose which possibility they deem to be more likely.
As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:
- There are hardly any SCAMs that have been shown to work for paediatric conditions.
- Most SCAMs can cause considerable harm to children.
- Some might even amount to child abuse.
- Most SCAM practitioners lack adequate training to treat children.
- Many SCAM providers offer dangerous advice to parents.
- Parents are sometimes unable to differentiate between nonsense and medicine.
- Informed consent can present a trick subject when treating children.
In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:
Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.
Of course, not all SCAM professions focus on children. The following, however, treat children regularly:
- anthroposophical doctors
- craniosacral therapists
- energy healers
I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.
Cranio-sacral therapy is firstly implausible, and secondly it lacks evidence of effectiveness (see for instance here, here, here and here). Yet, some researchers are nevertheless not deterred to test it in clinical trials. While this fact alone might be seen as embarrassing, the study below is a particular and personal embarrassment to me, in fact, I am shocked by it and write these lines with considerable regret.
Why? Bear with me, I will explain later.
The purpose of this trial was to evaluate the effectiveness of osteopathic manipulative treatment and osteopathy in the cranial field in temporomandibular disorders. Forty female subjects with temporomandibular disorders lasting at least three months were included. At enrollment, subjects were randomly assigned into two groups: (1) osteopathic manipulative treatment group (n=20) and (2) osteopathy in the cranial field [craniosacral therapy for you and me] group (n=20). Examinations were performed at baseline (E0) and at the end of the last treatment (E1), and consisted of subjective pain intensity with the Visual Analog Scale, Helkimo Index and SF-36 Health Survey. Subjects had five treatments, once a week. 36 subjects completed the study.
Patients in both groups showed significant reduction in Visual Analog Scale score (osteopathic manipulative treatment group: p = 0.001; osteopathy in the cranial field group: p< 0.001), Helkimo Index (osteopathic manipulative treatment group: p = 0.02; osteopathy in the cranial field group: p = 0.003) and a significant improvement in the SF-36 Health Survey – subscale “Bodily Pain” (osteopathic manipulative treatment group: p = 0.04; osteopathy in the cranial field group: p = 0.007) after five treatments (E1). All subjects (n = 36) also showed significant improvements in the above named parameters after five treatments (E1): Visual Analog Scale score (p< 0.001), Helkimo Index (p< 0.001), SF-36 Health Survey – subscale “Bodily Pain” (p = 0.001). The differences between the two groups were not statistically significant for any of the three endpoints.
The authors concluded that both therapeutic modalities had similar clinical results. The findings of this pilot trial support the use of osteopathic manipulative treatment and osteopathy in the cranial field as an effective treatment modality in patients with temporomandibular disorders. The positive results in both treatment groups should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field and support the importance of an interdisciplinary collaboration in patients with temporomandibular disorders. Implications for rehabilitation Temporomandibular disorders are the second most prevalent musculoskeletal condition with a negative impact on physical and psychological factors. There are a variety of options to treat temporomandibular disorders. This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life after osteopathic manipulative treatment and osteopathy in the cranial field. Our findings support the use of osteopathic manipulative treatment and osteopathy in the cranial field and should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field in patients with temporomandibular disorders. Rehabilitation experts should consider osteopathic manipulative treatment and osteopathy in the cranial field as a beneficial treatment option for temporomandibular disorders.
This study has so many flaws that I don’t know where to begin. Here are some of the more obvious ones:
- There is, as already mentioned, no rationale for this study. I can see no reason why craniosacral therapy should work for the condition. Without such a rationale, the study should never even have been conceived.
- Technically, this RCTs an equivalence study comparing one therapy against another. As such it needs to be much larger to generate a meaningful result and it also would require a different statistical approach.
- The authors mislabelled their trial a ‘pilot study’. However, a pilot study “is a preliminary small-scale study that researchers conduct in order to help them decide how best to conduct a large-scale research project. Using a pilot study, a researcher can identify or refine a research question, figure out what methods are best for pursuing it, and estimate how much time and resources will be necessary to complete the larger version, among other things.” It is not normally a study suited for evaluating the effectiveness of a therapy.
- Any trial that compares one therapy of unknown effectiveness to another of unknown effectiveness is a complete and utter nonsense. Equivalent studies can only ever make sense, if one of the two treatments is of proven effectiveness – think of it as a mathematical equation: one equation with two unknowns is unsolvable.
- Controlled studies such as RCTs are for comparing the outcomes of two or more groups, and only between-group differences are meaningful results of such trials.
- The ‘positive results’ which the authors mention in their conclusions are meaningless because they are based on such within-group changes and nobody can know what caused them: the natural history of the condition, regression towards the mean, placebo-effects, or other non-specific effects – take your pick.
- The conclusions are a bonanza of nonsensical platitudes and misleading claims which do not follow from the data.
As regular readers of this blog will doubtlessly have noticed, I have seen plenty of similarly flawed pseudo-research before – so, why does this paper upset me so much? The reason is personal, I am afraid: even though I do not know any of the authors in person, I know their institution more than well. The study comes from the Department of Physical Medicine and Rehabilitation, Medical University of Vienna, Austria. I was head of this department before I left in 1993 to take up the Exeter post. And I had hoped that, even after 25 years, a bit of the spirit, attitude, knowhow, critical thinking and scientific rigor – all of which I tried so hard to implant in my Viennese department at the time – would have survived.
Perhaps I was wrong.
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.