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:
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.
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
Cranio-sacral therapy has been a subject on this blog before, for instance here, here and here. The authors of this single-blind, randomized trial explain in the introduction of their paper that “cranio-sacral therapy is an alternative and complementary therapy based on the theory that restricted movement at the cranial sutures of the skull negatively affect rhythmic impulses conveyed through the cerebral spinal fluid from the cranium to the sacrum. Restriction within the cranio-sacral system can affect its components: the brain, spinal cord, and protective membranes. The brain is said to produce involuntary, rhythmic movements within the skull. This movement involves dilation and contraction of the ventricles of the brain, which produce the circulation of the cerebral spinal fluid. The theory states that this fluctuation mechanism causes reciprocal tension within the membranes, transmitting motion to the cranial bones and the sacrum. Cranio-sacral therapy and cranial osteopathic manual therapy originate from the observations made by William G. Sutherland, who said that the bones of the human skeleton have mobility. These techniques are based mainly on the study of anatomic and physiologic mechanisms in the skull and their relation to the body as a whole, which includes a system of diagnostic and therapeutic techniques aimed at treatment and prevention of diseases. These techniques are based on the so-called primary respiratory movement, which is manifested in the mobility of the cranial bones, sacrum, dura, central nervous system, and cerebrospinal fluid. The main difference between the two therapies is that cranial osteopathy, in addition to a phase that works in the direction of the lesion (called the functional phase), also uses a phase that worsens the injury, which is called structural phase.”
With this study, the researchers wanted to evaluate the effects of cranio-sacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. Sixty-four patients with chronic non-specific low back pain were assigned to an experimental group receiving 10 sessions of craniosacral therapy, or to the control group receiving 10 sessions of classic massage. Craniosacral therapy took 50 minutes and was conducted as follows: With pelvic diaphragm release, palms are placed in transverse position on the superior aspect of the pubic bone, under the L5–S1 sacrum, and finger pads are placed on spinal processes. With respiratory diaphragm release, palms are placed transverse under T12/L1 so that the spine lies along the start of fingers and the border of palm, and the anterior hand is placed on the breastbone. For thoracic inlet release, the thumb and index finger are placed on the opposite sides of the clavicle, with the posterior hand/palm of the hand cupping C7/T1. For the hyoid release, the thumb and index finger are placed on the hyoid, with the index finger on the occiput and the cupping finger pads on the cervical vertebrae. With the sacral technique for stabilizing L5/sacrum, the fingers contact the sulcus and the palm of the hand is in contact with the distal part of the sacral bone. The non-dominant hand of the therapist rested over the pelvis, with one hand on one iliac crest and the elbow/forearm of the other side over the other iliac crest. For CV-4 still point induction, thenar pads are placed under the occipital protuberance, avoiding mastoid sutures. Classic massage protocol was compounded by the following sequence techniques of soft tissue massage on the low back: effleurage, petrissage, friction, and kneading. The maneuvers are performed with surface pressure, followed by deep pressure and ending with surface pressure again. The techniques took 30 minutes.
Disability (Roland Morris Disability Questionnaire RMQ, and Oswestry Disability Index) was the primary endpoint. Other outcome measures included the pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical analyses of interstitial fluid. All outcomes were measured at baseline, after treatment, and one-month follow-up.
No statistically significant differences were seen between groups for the main outcome of the study, the RMQ. However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p ≤ 0.008), hemoglobin oxygen saturation (p ≤ 0.028), and systolic blood pressure (p ≤ 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage.
The authors concluded that 10 sessions of cranio-sacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain.
Given the results of this study, the conclusion is surprising. The primary outcome measure failed to show an inter-group difference; in other words, the results of this RCT were essentially negative. To use secondary endpoints – most of which are irrelevant for the study’s aim – in order to draw a positive conclusion seems odd, if not misleading. These positive findings are most likely due to the lack of patient-blinding or to the 200 min longer attention received by the verum patients. They are thus next to meaningless.
In my view, this publication is yet another example of an attempt to turn a negative into a positive result. This phenomenon seems embarrassingly frequent in alternative medicine. It goes without saying that it is not just misleading but also dishonest and unethical.
Alternative medicine encompasses many bizarre treatments, but one of the weirdest must be craniosacral therapy (CST). The assumptions underlying CTS are:
- light manual touch of the head moves the joints of the cranium;
- this movement stimulates the flow of the cerebrospinal fluid;
- the enhanced flow has profound and positive effects on human health.
None of these assumptions are supported by evidence. In fact, they are as implausible as assumptions in alternative medicine get.
CST was developed by the osteopath John Upledger, D.O. in the 1970s, as an offshoot osteopathy in the cranial field, or cranial osteopathy, which was developed in the 1930s by William Garner Sutherland. Apart from this confusing terminology, we are also confronted with a confusing array of therapeutic claims; CST seems to be recommended for most conditions.
And the evidence? As good as none!
This is why any new trial is worth a mention. A recent study tested CST in comparison to sham treatment in chronic non-specific neck pain patients. 54 blinded patients were randomized to either 8 weekly units of CST or light touch sham treatment. Outcomes were assessed before and after treatment (week 8) and a further 3 months later (week 20). The primary outcome was pain intensity on a visual analogue scale; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients’ global impression of improvement and safety.
In comparison to sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 as well as at week 20. Minimal clinically important differences in pain intensity at week 20 were reported by 78% of the CST patients, while 48% even had substantial clinical benefit. Significant differences at week 8 and 20 were also found for pain on movement, functional disability, physical quality of life and patients’ global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8; anxiety only at week 20. No serious adverse events were reported.
The authors from the Department of Internal and Integrative Medicine, University of Duisburg-Essen and the Institute of Integrative Medicine, University of Witten/Herdecke, Germany, concluded that CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and quality of life up to 3 months post intervention.
Oddly, this is not even close to the conclusion I am going to draw: inadequate control for placebo and other non-specific effects generated a false-positive result.
Who is correct?
I suggest we wait for an independent replication to decide.
In my last post, I made a fairly bold statement without any evidence to support it: “[this] demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.”
I felt that my statement was supported by so many websites that it was almost self-evident. But, as it happens, I was alerted today to another website that provides impressive first had evidence of what I meant:
“The purpose of this site is to provide the public with information about Craniosacral Therapy
Craniosacral therapists recognise health as an active principle. This health is the expression of life – an inherent ordering force, a natural internal intelligence. Craniosacral Therapy is a subtle and profound healing form which assists this natural bodily intelligence.
It is clear that a living human organism is immensely complex and requires an enormous amount of internal organisation. Craniosacral Therapy helps nurture these internal ordering principles. It helps increase physical vitality and well-being, not only effecting structural change, but also having much wider implications e.g. improving interpersonal relationships, managing life more appropriately etc…
The work can address issues in whatever way the client wishes; physical aches and pains, acute and chronic disease, emotional or psychological disturbances, or simply developing well-being, health and vitality.
Craniosacral Therapy is so gentle that it is suitable for babies, children, and the elderly, as well as adults; and also in fragile or acutely painful conditions. As a whole-body therapy, treatment may aid almost every condition, raising the vitality and enabling the body’s own self-healing process to be utilised.”
I find this text rather typical and very revealing: the authors first make several bland statements which are little more that politically correct platitudes. Eventually, they try to tell us what their therapy is good for: it is suitable for babies adults and the elderly. In other words, it is for everyone!
And what is so truly brilliant, it can be used to treat acute and chronic conditions. In other words, it is effective for every disease afflicting mankind!
Once you have realised it, the strategy of such ‘position statements’ (or whatever they might call it) is all too obvious: behind a smokescreen of empty platitudes, quackery is being promoted for profit. The phraseology used is such that there can be little concrete objections in legal or regulatory terms. All the therapeutic claims are general, cleverly hidden and operate merely by implication.
Quackery? Yes, absolutely!
Craniosacral therapy has not been proven to be effective for anything and, as a therapy, it is therefore not ‘suitable’ for anyone. To me, this is almost the definition of quackery.
The question whether infant colic can be effectively treated with manipulative therapies might seem rather trivial – after all, this is a benign condition which the infant quickly grows out of. However, the issue becomes a little more tricky, if we consider that it was one of the 6 paediatric illnesses which were at the centre of the famous libel case of the BCA against my friend and co-author Simon Singh. At the time, Simon had claimed that there was ‘not a jot of evidence’ for claiming that chiropractic was an effective treatment of infant colic, and my systematic review of the evidence strongly supported his statement. The BCA eventually lost their libel case and with it the reputation of chiropractic. Now a new article on this intriguing topic has become available; do we have to reverse our judgements?
The aim of this new systematic review was to evaluate the efficacy or effectiveness of manipulative therapies for infantile colic. Six RCTs of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions were included with a total of 325 infants. Of the 6 included studies, 5 were “suggestive of a beneficial effect” and one found no evidence of benefit. Combining all the RCTs suggested that manipulative therapies had a significant effect. The average crying time was reduced by an average of 72 minutes per day. This effect was sustained for studies with a low risk of selection bias and attrition bias. When analysing only those studies with a low risk of performance bias (i.e. parental blinding) the improvement in daily crying hours was no longer statistically significant.
The quality of the studies was variable. There was a generally low risk of selection bias but a high risk of performance bias. Only one of the studies recorded adverse events and none were encountered.
From these data, the authors drew the following conclusion: Parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not and this difference was statistically significant. Most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias the results did not reach statistical significance.
Does that mean that chiropractic does work for infant colic? No, it does not!
The first thing to point out is that the new systematic review included not just RCTs of chiropractic but also osteopathy and cranio-sacral therapy.
The second important issue is that the effects disappear, once performance bias is being accounted for which clearly shows that the result is false positive.
The third relevant fact is that the majority of the RCTs were of poor quality. The methodologically best studies were negative.
And the fourth thing to note is that only one study mentioned adverse effects, which means that the other 5 trials were in breach of one of rather elementary research ethics.
What makes all of this even more fascinating is the fact that the senior author of the new publication, George Lewith, is the very expert who advised the BCA in their libel case against Simon Singh. He seems so fond of his work that he even decided to re-publish it using even more misleading language than before. It is, of course, far from me to suggest that his review was an attempt to white-wash the issue of chiropractic ‘bogus’ claims. However, based on the available evidence, I would have formulated conclusions which are more than just a little different from his; something like this perhaps:
The current best evidence suggests that the small effects that emerge when we pool the data from mostly unreliable studies are due to bias and therefore not real. This systematic review therefore fails to show that manipulative therapies are effective. It furthermore points to a serious breach of research ethics by the majority of researchers in this field.
Guest post by Dr. Richard Rawlins MB BS MBA FRCS, Consultant Orthopaedic and Trauma Surgeon
On 14th November 2013 the Daily Telegraph advised that ‘Meditation could help troops overcome the trauma of war: Troops suffering post traumatic stress should take up yoga and acupuncture to get over the horrors of war. The Royal Navy and Royal Marines Children’s Fund is urging troops to try alternative therapies to get over psychological disorders when they return from conflict zones. After receiving a Whitehall grant, the charity has written a book aimed at helping families understand and cope with the impact and stresses suffered by troops before, during and after warfare. It suggests servicemen try treatments such as massage, reflexology, reiki and meditation.’
As a former Surgeon Lieutenant Commander in the Royal Naval Reserve I treated servicemen on their return from the Falklands. As a father of a platoon commander who served with the Grenadier Guards in Helmand I support Combat Stress. As a member of the Magic Circle I am well acquainted with methods of deceit, deception and delusion. As a doctor I care and hope to see all patients treated appropriately, but alternative therapies must be considered critically.
To assist management of Post Traumatic Stress Disorder the Children’s Fund book provides details of relevant therapies, institutions providing them and knitting patterns for making dolls representing the service personnel and their families. The title Knit the Family is both a suggestion for practical help by making dolls and a metaphor for knitting families back together after deployment. All of which is highly laudable and deserving of substantial support. But…
I do not doubt yoga, meditation, relaxation and doll making can provide valuable emotional support for one of the most pernicious outcomes of combat. I do not doubt that support from an empathic caring practitioner or a conscientious counsellor is of benefit. But what is the added value of pressing on ‘zones’ in the feet? Of positioning hands around a patient and providing them with charms? Of feeling for and adjusting ‘subtle rhythms in cerebro-spinal fluid’? Of inserting needles in the skin? Unless there is evidence that such manoeuvres and modalities actually do provide benefit greater than any other method for producing placebo effects – why spend any valuable funds on such practices? Would not the charitable funds be better spent on psychotherapy, counselling, yoga and meditation? There is no need for CAM therapy. The RN & RM Children’s Fund suggests that complementary and alternative medicine can help PTSD. I know of no evidence alternatives such as reiki, reflexology, CST, acupuncture, Emotional Freedom Techniques (utilising ‘finger tapping’), Thought Field Therapy and Somatic Experiencing all of which are set out in the charity’s book, can provide any benefit. Indeed, the book admits there is no scientific evidence of such benefit. Spending time in a therapeutic relationship helps, but there is no evidence the therapies have any effect on their own account – and there is plenty of evidence they almost certainly do not. That is why they are referred to as being implausible and are termed ‘alternative medicine’.
In order service personnel and their families can give fully informed consent to any proposed treatment they will need to consider the probability that they are wasting time and scarce funds on implausible treatments. And members of the public who might wish to support the charity will need to carefully consider the use to which their funds might be put.
The National Institute for Clinical Excellence (NICE) has Guidelines for the management of Post Traumatic Stress Disorder and emphasises ‘Families and carers have a central role in supporting people with PTSD and many families may also need support for themselves …Healthcare professionals should identify the need for appropriate information about the range of emotional responses that may develop and provide practical advice on how to access appropriate services for these problems.’
Note that the NICE guidelines, quoted in Knit the Family, require that PTSD support services should be ‘appropriate’. So presumably the Fund has decided that implausible non-evidenced based modalities of treatment are appropriate. But just how did it come to such a decision? I have asked questions on this and a number of other points and await an answer.
And there is more to this matter. Knit the Family acknowledges the support it has received from Whitehall’s Army Covenant Libor Fund and also from the Barcarpel Foundation. Barcarpel’s website tells us it ‘is a particularly enthusiastic supporter of Complementary Medicine’ and ‘has made substantial donations to the Homeopathic Trust for Research & Education as well as establishing the Nelson Barcapel Teaching Fellowship at Exeter, specifically to enable medical practitioners to take the Integrated Healthcare programme.’ ‘Nelson’ not for the Admiral but for the firm which manufactures homeopathic remedies, sponsored the inaugural meeting of the ‘College of Medicine’, and whose Chairman Robert Wilson is also Chairman of Barcarpel. And ‘integrated medicine’ means the incorporation of non-evidenced based therapies with orthodox care. Which might be reasonable if there was evidence CAMs had an effect on PTSD – but there is no such evidence.
‘Special thanks are given to Jonathan Poston, Chair of the Craniosacral Therapy Association, for assistance with setting up the project; Liz Kalinowska, Fellow of the Craniosacral Therapy Association, for wise advice; Michael Kern, Founder/Principal of Craniosacral Therapy Educational Trust; Cathy Cremer, whose experience with the UK Forces Project has contributed to an understanding of how best to explain the benefits of CST for those suffering from PTSD; Silvana Calzavara whose experience working at Headway East London (acquired brain injury) proved invaluable at the Portsmouth CST clinic; Monica Tomkins, Eva Kretchmar, Sally Christian, Talita Harrison, Cathy Brooks and Simon Copp for their contribution in carrying the CST project forward.’
So we see that a group of enthusiasts for CST have inveigled their way into the Children’s Fund and are set on promoting the use of this implausible therapy for some of our most vulnerable patients. An insurgency if ever there was one. They have not been able to offer any evidence that ‘subtle rhythms’ can be felt in the cerebro-spinal fluid, let alone manipulative methods can influence the flow of cerebro-spinal fluid. And if they are not doing that, they are not doing CST. The care and attention provided by these practitioners can be applauded, but not the methods they purport to use. In which case, why use them? Would the Children’s Fund not do better to spend its funds on plausible evidence based therapies? How has the Fund assessed whether or not the promoters of CST and other CAMs are quacks? Or whether or not they are frauds? The public who are considering donations need to be reassured. The service personnel who so deservedly need support should be treated with honestly, integrity and probity – not metaphysics.