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.
Craniosacral therapy (CST), which, confusingly, is sometimes also called ‘cranial osteopathy’, was invented less than half a century ago by an osteopath. He thought that the spinal fluid is pulsating, the cranial bones are sufficiently movable to enable a therapist feel this pulse from the outside, and that it is possible to influence this process with very gente manual manipulations which, in turn, would restore health in sick individuals. According to the inventor, the CST-practitioner uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.
But how does CST work? Let’s ask a practitioner who surely must know best:
When a self-development issue is linked to the illness, it is enough for that issue to be acknowledged by the client (without any further discussion unless the client desires it) for the body to release the memory of that issue – sensed by the therapist as tightness, tension, inertia within the body’s systems – so that the healing can proceed.
Several treatment sessions may still be needed, especially if the condition is a long lasting one. Our bodies’ self healing mechanisms rely on a combination of the various fluid systems of the body (blood and lymph flow and the fluid nature of the cells making up all the organs and systems within our bodies) and the body’s energy fields. Our hearts generate their own electrical signal independently of the control of our brains. Such signals travel around the body through the blood and other fluid systems. Blood is an excellent conductor of electricity and, when electricity flows through a conductor, magnetic fields are created. It is with these fields that the craniosacral therapist works.
These same fields store the memory of the events of our life – rather like the hard disk on a computer – but these memories can only be accessed when the underlying Body intelligence ‘decides’ it is needed as part of the healing process. There is absolutely no danger, therefore, of more being revealed than is strictly necessary to encourage the client back onto their self development route and to enable healing to take place.
To many desperate patients or distressed parents of ill children – CST is often advocated for children, particularly those suffering from cerebral palsy - this sort of lingo might sound impressive; to anyone understanding a bit of physiology, anatomy etc. it looks like pure nonsense. CST has therefore been considered by most independent experts to be on the lunatic fringe of alternative medicine.
Of course, this does not stop proponents to make and publicise big therapeutic claims for CST; it would be quite difficult to think of a condition that some CST-practitioner does not claim to cure or alleviate. One UK organisation boldly states that any symptom a patient may present with will improve in the hands of one of their members; in the eyes of its proponents, CST clearly is a panacea.
But, let’s be fair, the fact that it is implausible does not necessarily mean that CST is useless. The theory might be barmy and wrong, yet the treatment might still be effective via a different, as yet unknown mechanism. What we need to decide is evidence from clinical trials.
Recently, I have evaluated the findings from all randomised clinical trials of CST. I was pleasantly surprised to find that 6 such trials had been published, one would not normally expect so many studies of something that seems so utterly implausible. Far less impressive was the fact that the quality of the studies was, with the exception of one trial, deplorably poor.
The conditions treated in the trials were diverse: cerebral palsy, migraine, fibromyalgia and infant colic. All the badly-flawed studies reported positive results. The only rigorous trial was the one with children suffering from cerebral palsy – and here the findings were squarely negative. The conlusion of my review was blunt and straight forward: “the notion that CST is associated with more than non-specific effects is not based on evidence from rigorous randomised clinical trials“. This is a polite and scientific way of saying that CST is bogus.
Why should this matter? CST is popular, particularly for children. It is a very gentle technique, and some might argue that no harm [apart from the cost] can be done; on the contrary, the gentle touch might even calm over-excited children and could thus be helpful. Who then cares that it has no specific therapeutic effects?
Few people would argue against the potential benefits of gentle touch or other non-specific effects. But we should realise that, for achieving them, we do not need CST or other placebo-treatments. An effective therapy that is given with compassion and empathy will do the same trick; and, in addition, it will also generate specific therapeutic effects.
What follows is simple: administering CST or other bogus treatments [by this, I mean a treatment for which claims are being made that are not supported by sound evidence] means preventing the patient from profiting from the most important element of any good treatment. In such cases, patients will not be treated adequately which can not just cost money but, in extreme cases, also lives.
In a nutshell: 1) ineffective therapies, such as CST, may seem harmless but, through their ineffectiveness, they constitute a serious threat to our health; 2) bogus treatments become bogus through the false claims which are being made for them; 3) seriously flawed studies can be worse than none at all: they generate false positive results and send us straight up the garden path.