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.
Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.
At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.
BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!
Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.
BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!
“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.
NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.
The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.
BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!
Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.
NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?
Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?
IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.
At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.
WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?
Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.
YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?
We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?
NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.
Postoperative ileus (POI), the phenomenon that after an operation the intestines tend to be inactive for a few days, can cause intense pain and thus contributes significantly to human suffering. It also prolongs hospital stay and increases the risks of post-operative complications. There is no known effective treatment for POI.
In China, POI is often treated with acupuncture, and due to this fact acupuncture became known in the West: James Reston, a journalist who accompanied Nixon on his first trip to China, had to have an appendectomy in a Beijing hospital, he subsequently suffered from POI, was treated with acupuncture and moxibustion, experienced symptom-relief, and subsequently wrote about it in the New York Times. This was the beginning of the present acupuncture-boom.
Since then, thousands of acupuncture trials have been published but, intriguingly, very few have tested the effectiveness of acupuncture for POI. Now researchers from the Sloan Kettering Cancer Center in New York have conducted a randomized, sham-controlled trial to test whether acupuncture reduces POI more effectively than sham acupuncture.
Ninety colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first three postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first three postoperative days. Eighty-one patients received the allocated intervention: 39 the true acupuncture and 42 the sham acupuncture. The mean time to GI-3 was 149 hours and 146 hours for the acupuncture group and the sham acupuncture group. No significant differences were found between groups for secondary endpoints.
The authors’ conclusion was clear: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture.
So, did a mere misunderstanding start the present acupuncture boom? POI inevitably normalises with time. Did the journalist just imagine that acupuncture helped, while nature cured the condition? It would seem so, according to this study. But perhaps things are not just black or white. Almost at the same time as the New York trial, another study was emerged.
Researchers from Hong Kong conducted an RCT with 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer. Patients were assigned randomly to receive electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. The results showed that patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation.
The Chinese researchers’ conclusion is equally clear: electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer.
The only other trial I know in this area failed to show that acupuncture shortens POI. What should we make of these data? A systematic review would be nice, of course, but, to the best of my knowledge, none is currently available.
Is this a question of everyone being able to pick and chose the evidence they like? Is it a question of who we trust, the researchers in New York or those in China? Is it a question of where the treatment was done authentically? Is it a question of critically analysing which study had the higher risks of bias? Or is it a question of simply saying that two negative studies are more than one positive trial?
Confused? Me too, a little!
Whatever answers we chose, several things seems fairly certain to me. It would be wrong to say that there is good evidence for acupuncture as a treatment of POI. And the acupuncture-boom that ensued after Reston’s article was to a very large degree built on a simple misunderstanding: POI is a condition that resolves literally into thin air whether we treat it or not.
Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?
The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.
But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.
Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.
Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF”
There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:
2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.
3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.
4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?
It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.
Whenever I have the occasion to discuss with practitioners of alternative medicine the pros and cons of their methods, I hear sooner or later the argument “WE TREAT THE ROOT CAUSES OF DISEASE !!!” This remark emerges regularly regardless of the type of treatment the practitioner uses, and regardless of what disease we might have been talking about.
The statement is regularly pronounced with such deep conviction (and almost audible exclamation marks) that I am inclined to conclude these practitioners fully and wholeheartedly believe it. The implication usually is that, in conventional medicine, we only treat the symptoms of our patients. Quite often, this latter notion is not just gently implied but also forcefully expressed.
I have often wondered where this assumption and the fierce conviction with which it is expressed come from. The answer, I have come to conclude after many years of having such debates, is quite simple: it is being taught over and over again during the practitioners’ training, and it constitutes a central message of most ‘textbooks’ for the aspiring alternative practitioner.
It is not difficult to find the actual origin of all this. The notion that alternative practitioners treat the root causes is clearly based on the practitioners’ understanding of aetiology. If a traditional acupuncturist, for instance, becomes convinced that all disease is the expression of an imbalance of life-forces, and that needling acupuncture points will re-balance these forces thus restoring health, he must automatically assume that he is treating the root causes of any condition. If a chiropractor believes that all diseases are due to ‘subluxations’ of the spine, it must seem logical to him that spinal ‘adjustment’ is synonymous with treating the root cause of whatever complaint his patient is suffering from. If a Bowen therapist is convinced that “the Bowen Technique aims to balance the whole person, not just the symptoms“, he is bound to be equally sure that “practically any problem can potentially be addressed” by this intervention.
Let us assume for a minute that all these practitioners are correct in believing that their interventions are causal treatments, i.e. therapies directed against the cause of a disease. Successful treatment of any root cause can only mean that the therapy in question completely heals the problem at hand. If we abolish the cause of a disease, we would expect the disease to disappear for good.
This, I think, begs a crucial question: ARE THERE ANY DISEASES WHICH ARE REPRODUCIBLY CURED BY AN ALTERNATIVE THERAPY?
I have contemplated it frequently and discussed it often with practitioners but, so far, I have not identified a single one. I have no problem naming diseases which conventional medicine can cure - but, in alternative medicine, I only draw blanks. Even those alternative therapies which might be effective are not causal but symptomatic by nature. Honestly, I have not yet come across a single alternative treatment for which there is compelling evidence proving that it can produce more than symptom-relief.
But, of course, I might be wrong, over-critical, blind, bought by the pharmaeutical industry, dishonest or stupid. So, the purpose of this post is to clarify this issue once and for all. I herewith invite practitioners to name a disease for which there is sound evidence proving that it can be cured by their therapy.