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.
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.