The mechanisms thorough which spinal manipulative therapy (SMT) exerts its alleged clinical effects are not well established. A new study investigated the effects of subject expectation on clinical outcomes.
Sixty healthy subjects underwent quantitative sensory testing to their legs and low backs. They were randomly assigned to receive a positive, negative, or neutral expectation instructional set regarding the effects of a spe cific SMT technique on pain perception. Following the instructional set, all subjects received SMT and underwent repeat sensory tests.
No inter-group differences in pain response were present in the lower extremity following SMT. However, a main effect for hypoalgesia was present. A significant interaction was present between change in pain perception and group assignment in the low back with participants receiving a negative expectation instructional set demonstrating significant hyperalgesia.
The authors concluded that this study provides preliminary evidence for the influence of a non- specific effect (expectation) on the hypoalgesia associated with a single session of SMT in normal subjects. We replicated our previous findings of hypoalgesia in the lower extremity associated with SMT to the low back. Additionally, the resultant hypoalgesia in the lower extremity was independent of an expectation instructional set directed at the low back. Conversely, participants receiving a negative expectation instructional set demonstrated hyperalgesia in the low back following SMT which was not observed in those receiving a positive or neutral instructional set.
More than 10 years ago, we addressed a similar issue by conducting a systematic review of all sham-controlled trials of SMT. Specifically, we wanted to summarize the evidence from sham-controlled clinical trials of SMT. Eight studies fulfilled our inclusion/exclusion criteria. Three trials (two on back pain and one on enuresis) were judged to be burdened with serious methodological flaws. The results of the three most rigorous studies (two on asthma and one on primary dysmenorrhea) did not suggest that SMT leads to therapeutic responses which differ from an inactive sham-treatment. We concluded that sham-controlled trials of SMT are sparse but feasible. The most rigorous of these studies suggest that SMT is not associated with clinically relevant specific therapeutic effects.
Taken together, these two articles provide intriguing evidence to suggest that SMT is little more than a theatrical placebo. Given the facts that SMT is neither cheap nor devoid of risks, the onus is now on those who promote SMT, e.g. chiropractors, osteopaths and physiotherapists, to show that this is not true.
As promised in the last post, I will try to briefly address the issues which make me uncomfortable about the quotes by Anthony Campbell. Readers will recall that Campbell, an ex-director of what was arguably the most influential homeopathic hospital in the world and a long-time editor of the journal HOMEOPATHY, freely admitted that homeopathy was unproven and its effects were most likely not due to any specific properties of the homeopathic remedies [which are, in fact, pure placebos] but largely rely on non-specific effects.
I agree with much that Campbell wrote but I disagree with one particular implication of his conclusions: “Homeopathy has not been proved to work but neither has it been conclusively disproven….” and “…it is impossible to say categorically that all the remedies are without objective effect…”
This is an argument, we hear from proponents of alternative medicine with unfailing regularity: “MY TREATMENT MAY NOT BE SUPPORTED BY GOOD SCIENCE [BECAUSE GOOD SCIENCE IS EXPENSIVE, AND WE CANNOT AFFORD IT] BUT IT HAS NOT BEEN DISPROVEN EITHER – AND, AS LONG AS IT IS NOT DISPROVEN, NOBODY SHOULD STOP US USING IT”
Campbell does not explicitly draw this latter conclusion but he certainly implies it. In his book, he explains that, even though homeopathic remedies probably are placebos, homeopathy does a lot of good through the placebo effect and through its spiritual aspects. And that is, in his view, sufficient reason to employ it for healing the sick. The very last sentence of his book reads: “Love it or loathe it, homeopathy is here to stay”
So the implication is there: alternative therapies can be as bizarre, nonsensical, implausible, unscientific or idiotic as they like, if we scientists cannot disprove them, they must be legitimate for general use. But there are, of course, two obvious errors in this line of reasoning:
- Why on earth should scientists waste their time and resources on testing notions which are clearly bonkers? It is hard to imagine research that is less fruitful than such an endeavour.
- Disproving homeopathy [or similarly ridiculous treatments] is a near impossibility. Proving a negative is rarely feasible in science.
In the best interest of patients, responsible health care has to follow an entirely different logic: we must consider any treatment to be unproven, while it is not supported with reasonably sound evidence for effectiveness; and in clinical routine, we employ mostly such treatments which are backed by sound evidence, and we avoid those that are unproven. In other words, whether homeopathy or any other medicine is unproven or disproven is of little practical consequence: we try not to use either category.
While I applaud Campbell’s candid judgement regarding the lack of effectiveness of homeopathic remedies, I feel the need to finish his conclusion for him giving it a dramatically different meaning: Homeopathy has not been proved to work but neither has it been conclusively disproven; this means that, until new evidence unambiguously demonstrates otherwise, we should classify homeopathy as ineffective – and this, of course, applies not just to homeopathy but to ALL unproven interventions.
A meta-analysis compared the effectiveness of spinal manipulation therapies (SMT), medical management, physical therapies, and exercise for acute and chronic low back pain. Studies were chosen based on inclusion in prior evidence syntheses. Effect sizes were converted to standardized mean effect sizes and probabilities of recovery. Nested model comparisons isolated non-specific from treatment effects. Aggregate data were tested for evidential support as compared to shams.
The results suggest that, of 84% acute pain variance, 81% was from non-specific factors and 3% from treatment. No treatment was better than sham. Most acute results were within 95% confidence bands of that predicted by natural history alone. For chronic pain, 66% out of 98% was non-specific, but treatments influenced 32% of outcomes. Chronic pain treatments also fitted within 95% confidence bands as predicted by natural history. The evidential support for treating chronic back pain as compared to sham groups was weak, but chronic pain appeared to respond to SMT, while whole systems of chiropractic management did not.
The authors of this intriguing paper conclude: Meta-analyses can extract comparative effectiveness information from existing literature. The relatively small portion of outcomes attributable to treatment explains why past research results fail to converge on stable estimates. The probability of treatment superiority between treatment arms was equivalent to that expected by random selection. Treatments serve to motivate, reassure, and calibrate patient expectations – features that might reduce medicalization and augment self-care. Exercise with authoritative support is an effective strategy for acute and chronic low back pain.
This essentially indicates that none of these treatments for low back pain are convincingly effective. In turn this means we might as well stop using them. Alternatively, we could opt for the therapy that carries the least risks and cost. As the authors point out, this treatment is exercise.
Several sceptics including myself have previously commented on this GP’s bizarre promotion of bogus therapies, his use of disproven treatments, and his advocacy for quackery. An interview with Dr Michael Dixon, OBE, chair of the ‘College of Medicine’, and advisor to Prince Charles, and chair of NHS Alliance, and president of the ‘NHS Clinical Commissioners’ and, and, and…was published on 15 November. It is such a classic example of indulgence in fallacies, falsehoods and deceptions that I cannot resist adding a few words.
To make it very clear what is what: the interviewer’s questions are in bold Roman; MD’s answers are in simple Roman; and my comments are in bold italic typeface. The interview itself is reproduced without changes or cuts.
How did you take to alternative medicine?
I started trying out alternative medicine after 10 years of practising as a general physician. During this period, I found that conventional medicine was not helping too many patients. There were some (patients) with prolonged headaches, backaches and frequent infections whom I had to turn away without offering a solution. That burnt me out. I started looking for alternative solutions.
The idea of using alternative treatments because conventional ones have their limits is perhaps understandable. But which alternative therapies are effective for the conditions mentioned? Dr Dixon’s surgery offers many alternative therapies which are highly unlikely to be effective beyond placebo, e.g. ‘Thought Field Therapy’, reflexology, spiritual healing or homeopathy.
But alternative medicine has come under sharp criticism. It was even argued that it has a placebo effect?
I don’t mind what people call it as long as it is making patients better. If the help is more psychological than physiological, as they argue, all the better. There are less side-effects, less expenses and help is in your own hands.
I have posted several articles on this blog about this fundamental misunderstanding. The desire to help patients via placebo-effects is no good reason to employ bogus treatments; effective therapies also convey a placebo-response, if administered with compassion. Merely administering placebos means denying patients the specific effects of real medicine and is therefore not ethical.
Why are people unconvinced about alternative medicine?
One, there are vested interests – professional and organizational impact on it. Two, even practitioners in conventional medicine do not know much about it. And most importantly, we need to develop a scientific database for it. In conventional medicine, pharmaceutical companies have the advantage of having funds for research. Alternative medicine lacks that. Have people who say alternative medicine is rubbish ever done research on it to figure out whether it is rubbish? The best way to convince them is through the age-old saying: Seeing is believing.
1) Here we have the old fallacy which assumes that ‘the establishment’ (or ‘BIG PHARMA’ ) does not want anyone to know how effective alternative treatments are. In truth, everyone would be delighted to have more effective therapies in the tool-kit and nobody does care at all where they originate from.
2) GPs do not know much about alternative medicine, true. But that does not really explain why they are ‘unconvinced’. The evidence shows that they need more convincing evidence to be convinced.
3) Dixon himself has done almost no research into alternative medicine (I know that because the few papers he did publish were in cooperation with my team). Contrary to what Dixon says, there are mountains of evidence (for instance ~ 20 000 articles on acupuncture and ~5000 on homeopathy in Medline alone); and the most reliable of this evidence usually shows that the alternative therapy in question does not work.
4) Apologists lament the lack of research funds ad nauseam. However, there is plenty of money in alternative medicine; currently it is estimated to be a $ 100 billion per year business worldwide. If they are unable to channel even the tiniest of proportions into a productive research budget, only they are to blame.
5) Have people who say alternative medicine is rubbish ever done research on it to figure out whether it is rubbish? Yes, there is probably nobody on this planet who has done more research on alternative medicine than I have (and DM knows it very well, for about 15 years, he tried everything to be associated with my team). The question I ask myself is: have apologists like Dixon ever done rigorous research or do they even know about the research that is out there?
6) Seeing is believing??? No, no, no! I have written several posts on this fallacy. Experience is no substitute for evidence in clinical medicine.
Will alternative medicine be taught in UK universities?
US already has 16 universities teaching it. The College of Medicine, UK, is fighting hard for it. We are historically drenched in conventional medicine and to think out of the box will take time. But we are at it and hope to have it soon.
1) Yes, the US has plenty of ‘quackademia‘ – and many experts are worried about the appalling lack of academic standards in this area.
2) The College of Medicine, UK, is fighting hard for getting alternative medicine into the medical curriculum. Interesting! Now we finally know what this lobby group really stands for.
3) Of course, we are ‘drenched’ in medicine at medical school. What else should we expose students to?
4) Thinking ‘out of the box’ can be productive and it is something medicine is often very good at. This is how it has evolved during the last 150 years in a breath-taking speed. Alternative medicine, by contrast, has remained stagnant; it is largely a dogma.
What more should India do to promote integrated medicine?
India needs to be prouder of its institutions and more critical of the West. The West has made massive mistakes. It has done very little about long-term diseases and in preventing them. India needs to be more cautious as it will lead the world in some diseases like the diabetes. It should not depend on conventional medicine for everything, but take the best for the worst.
To advise that India should not look towards the ‘West’ for treating diabetes and perhaps use more of their Ayurvedic medicines or homeopathic remedies (both very popular alternatives in India) is a cynical prescription for prematurely ending the lives of millions prematurely.
Homeopaths can bear criticism only when it is highly diluted. Any critique from the ‘outside’ is therefore dismissed by insisting that the author fails to understand the subtleties of homeopathy. And criticism from the ‘inside’ does not exist: by definition, a homeopath does not criticise his/her own trade. Through these mechanisms, homeopaths have more or less successfully shielded themselves from all arguments against their activities and have, for the last 200 years, managed to survive in a world of make-belief.
As I will show below, I started my professional life on the side of the homeopaths – I am not proud of this fact, but there is no use denying it. When the evidence told me more and more clearly that I had been wrong, about 10 years ago, I began expressing serious doubts about the plausibility, efficacy and safety of using homeopathic remedies to treat patients in need. Homeopaths reacted not just with anger, they were also at a loss.
Their little trick of saying ‘He does not understand homeopathy and therefore his critique is invalid’ could not possibly work in my case - I had been one of them: I had attended their meetings, chaired some of their sessions, edited a book on homeopathy, accepted an invitation to join the editorial board of the journal ‘HOMEOPATHY‘ as well as a EU-panel investigating homeopathy, conducted trials, systematic reviews and meta-analyses, published over 100 articles on the subject, accepted money from Prince Charles as well as from the ‘ueber-homeopath’ George Vithoulkas for my research, and even contributed to THE INTERNATIONAL DICTIONARY OF HOMEOPATHY. It would have not looked reasonable to suddenly deny my previously accepted expertise. Homeopaths thus found themselves in a pickle: critique from the ‘inside’ is not what they were used to or could easily cope with.
The homeopathic idyll was under threat, and a solution to the problem had to be found with some urgency. And soon enough, it was found. Homeopaths from across the world started claiming that I had been telling porkies about my training/qualifications in homeopathy: “Edzard Ernst has admitted that he has over the years lied or supported a lie about having homeopathic training. In reality he has had none at all! The leading so-called ‘expert’ and critic of homeopathy, Professor Edzard Ernst, has admitted that he has no qualifications in homeopathy. etc. etc. Diluting the truth to the extreme, they almost unanimously insisted that, contrary to my previous assertions, I had no training/qualifications in homeopathy. Thus, they began to argue, that I was an imposter and had insufficient knowledge, expertise and experience after all: Professor Edzard Ernst the leading ‘authority’ on homeopathy, and perhaps its most referenced critic, has no qualifications in homeopathy. William Alderson of HMC21 also claims that Ernst’s book Trick or Treatment? shows Ernst to be unreliable as a researcher into homeopathy. Opposition to homeopathy is based on propaganda, they stated. Others wrote that Edzard Ernst’ failure as a homeopath only proves he lacked some basic qualities essential to become a successful homeopath. He failed as a homeopath, and then turned a skeptic. His failure is only his failure- it does not disprove homeopathy by any way. Once he failed in putting a mark as a successful homeopath or CAM practitioner, he just tried the other way to become famous and respectable- he converted himself into a skeptic, which provided him with ample opportunities to appear on ‘anti-homeopathy’ platforms’ as an ‘authority’, ‘expert’ and ‘ex-homeopath’! Some went even further claiming that I had also lied about my medical qualifications.
These notions has been going around the internet for several years now and conveniently served as a reason to re-categorise me into the camp of the homeopathically unqualified pseudo-experts: ‘We believe that it is time to recognise that opposition to homeopathy is largely based on the opinions of individuals who are unqualified or unwilling to judge the evidence fairly’. I, by contrast, believe it is time that I disclose the full truth about ‘my double-life as a homeopath’. What exactly is my background in this area? Have I really been found out to be a confidence-trickster?
THE HOMEOPATHIC CLINICIAN
I graduated from medical school in Munich in the late 1970s and, looking for a job, I realised that there weren’t any. At the time, Germany had a surplus of doctors and all the posts I wanted were taken. Eventually, I found one in the only hospital that was run almost entirely homoeopathically, the KRANKENHAUS FUER NATURHEILWEISEN in Munich. Within about half a year, I learned how to think like a homeopath, diagnose like a homeopath and treat patients like a homeopath. I never attended formal courses or aspired to get a certificate; as far as I remember, none of the junior doctors working in the homeopathic hospital did that either. We were expected to learn on the job, and so we did.
Our teachers at medical school had hardly ever mentioned homeopathy, but one thing they had nevertheless made abundantly clear to us: homeopathy cannot possibly work; there is nothing in these pills and potions! To my surprise, however, my patients improved, their symptoms subsided and, in general, they were very happy with the treatment we provided. My professors had told me that homeopathy was rubbish, but they had forgotten to teach me a much more important lesson: critical thinking. Therefore, I might be forgiven for proudly assuming that my patients’ improvement was due to my skilful homeopathic prescriptions.
But then came another surprise: the boss of the homeopathic hospital, Dr Zimmermann, took me under his wings, and we had occasional discussions about this and that and, of course, about homeopathy. When I shyly mentioned what I had been told at medical school ( about homeopathy being entirely implausible), he agreed! I was speechless. Crucially, he considered that there were other explanations: “Our patients might improve because we look after them well and we discontinue all the unnecessary medication they come in with; perhaps the homeopathic remedies play only a small part”, he said.
THE INVESTIGATOR OF HOMEOPATHY
This may well have been the first time I started looking critically at homeopathy and my own clinical practice - and this is roughly where I left things as far as homeopathy is concerned until, in 1993, it became my job to research alternative therapies systematically and rigorously. Meanwhile I had done a PhD and tried my best to learn the skills of critical analysis. As I began to investigate homeopathy scientifically, I found that my former boss had been right: patients do indeed improve because of a multitude of factors: placebo-effects, natural history of the disease, regression towards the mean, to mention just three of a multitude of phenomena. At the same time, he had not been entirely correct: homeopathic remedies are pure placebos; they do not play a ‘small part’ in patients’ improvement, they play no part in this process.
As I began to state this more and more clearly, all sorts of ad hominem attacks were hauled in my direction, and recently I was even fired from the editorial board of the journal ‘HOMEOPATHY’ because allegedly I “…smeared homeopathy and other forms of complementary medicine…” I don’t mind any of that - but I do think that the truth about ‘my double-life as a homeopath’ should not be diluted like a homeopathic remedy until it suits those who think they can defame me by claiming I am a liar and do not know what I am talking about.
This rather depressing story shows, I think, that some homeopaths, rather than admitting they are in the wrong, are prepared to dilute the truth until it might be hard for third parties to tell who is right and who is wrong. But however they may deny it, the truth is still the truth: I have been trained as a homeopath.
“Wer heilt hat recht”. Every German knows this saying and far too many believe it. Literally translated, it means THE ONE WHO HEALS IS RIGHT, and indicates that, in health care, the proof of efficacy of a treatment is self-evident: if a clinician administers a treatment and the patient improves, she was right in prescribing it and the treatment must have been efficacious. The only English saying which is vaguely similar (but rarely used for therapies) is THE PROOF OF THE PUDDING IS IN THE EATING, translated into a medical context: the proof of the treatment is in the clinical outcome.
The saying is German but the sentiment behind it is amazingly widespread across the world, particularly the alternative one. If I had a fiver for each time a German journalist has asked me to comment on this ‘argument’ I could probably invite all my readers for a beer in the pub. The notion seems to be irresistibly appealing and journalists, consumers, patients, politicians etc. fall for it like flies. It is popular foremost as a counter-argument against scientists’ objections to homeopathy and similar placebo-treatments. If the homeopath cured her patient, then she and her treatments are evidently fine!
It is time, I think, that I scrutinise the argument and refute it once and for all.
The very first thing to note is that placebos never cure a condition. They might alleviate symptoms, but cure? No!
The next issue relates to causality. The saying assumes that the sole reason for the clinical outcome is the treatment. Yet, if a patient’s symptoms improve, the reason might have been the prescribed treatment, but this is just one of a multitude of different options, e.g.:
- the placebo-effect
- the regression towards the mean
- the natural history of the condition
- the Hawthorne effect
- the compassion of the clinician
- other treatments that might have been administered in parallel
Often it is a complex mixture of these and possibly other phenomena that is responsible and, unless we run a proper clinical trial, we cannot even guess the relative importance of each factor. To claim in such a messy situation that the treatment given by the clinician was the cause of the improvement, is ridiculously simplistic and overtly wrong.
But that is precisely what the saying WER HEILT HAT RECHT does. It assumes a simple mono-causal relationship that never exists in clinical settings. And, annoyingly, it somewhat arrogantly dismisses any scientific evidence by implying that the anecdotal observation is so much more accurate and relevant.
The true monstrosity of the saying can be easily disclosed with a little thought experiment. Let’s assume the saying is correct and we adopt it as a major axiom in health care. This would have all sorts of terrible consequences. For instance, any pharmaceutical company would be allowed to produce colourful placebos and sell them for a premium; they would only need to show that some patients do experience some relief after taking it. THE ONE WHO HEALS IS RIGHT!
The saying is a dangerously misleading platitude. That it happens to be German and that the Germans remain so frightfully fond of it disturbs me. That the notion, in one way or another, is deeply ingrained in the mind of charlatans across the world is worrying but hardly surprising - after all, it is said to have been coined by Samuel Hahnemann.
In 2010, NICE recommended acupuncture for chronic low back pain (cLBP). Acupuncturists were of course delighted; the British Acupuncture Council, for instance, stated that they fully support NICE’s (National Institute for Health and Clinical Excellence) decision that acupuncture be made available on the NHS for chronic lower back pain. Traditional acupuncture has been used for over 2,000 years to alleviate back pain and British Acupuncture Council members have for many many years been successfully treating patients for this condition either in private practice or working within the NHS. In effect, therefore, these new guidelines are a rubber stamp of the positive work already being undertaken as well as an endorsement of the wealth of research evidence now available in this area.
More critical experts, however, tended to be surprised about this move and doubted that the evidence was strong enough for a positive recommendation. Now a brand-new meta-analysis sheds more light on this important issue.
Its aim was to determine the effectiveness of acupuncture as a therapy for cLBP. The authors found 13 RCTs which matched their inclusion criteria. Their results show that, compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life. These effects were, however, not observed when real acupuncture was compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected.
The authors conclude that acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation.
In plain English, this means that the effects of acupuncture on cLBP are most likely due to placebo. Should NICE be recommending placebo-treatments and have the tax payer foot the bill? I think I can leave it to my readers to answer this question.
Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?
Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.
We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.
Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.
For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.
Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.
And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:
1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.
2) Placebo-effects are unreliable, small and usually of short duration.
3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).
4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.
The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!
So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?
They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.
Acupuncture remains a highly controversial treatment: its mechanism of action is less than clear and the clinical results are equally unconvincing. Of course, one ought to differentiate between different conditions; the notion that acupuncture is a panacea is most certainly nonsense.
In many countries, acupuncture is being employed mostly in the management of pain, and it is in this area where the evidence is perhaps most encouraging. Yet, even here the evidence from the most rigorous clinical trials seems to suggest that much, if not all of the effects of acupuncture might be due to placebo.
Moreover, we ought to be careful with generalisations and ask what type of pain? One very specific pain is that caused by aromatase inhibitors (AI), a medication frequently prescribed to women suffering from breast cancer. Around 50 % of these patients complain of AI-associated musculoskeletal symptoms (AIMSS) and 15 % discontinue treatment because of these complaints. So, can acupuncture help these women?
A recent randomised, sham-controlled trial tested whether acupuncture improves AIMSS. Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to eight weekly real or sham acupuncture sessions. The investigators evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS). Serum estradiol, β-endorphin, and proinflammatory cytokine concentrations were also measured pre and post-intervention. In total, 51 women were enrolled of whom 47 were evaluable (23 randomized to real and 24 to sham acupuncture).
Baseline characteristics turned out to be balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group. The results failed to show a statistically significant difference in reduction of HAQ-DI or VAS between the two groups. Following eight weekly treatments, a significant reduction of IL-17 was noted in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group. No difference in AIMSS changes between real and sham acupuncture was seen.
Even though this study was not large, it was rigorously executed and well-reported. As many acupuncturists claim that their treatment alleviates pain and as many women suffering from AM-induced pain experience benefit, acupuncture advocates will nevertheless claim that the findings of this study are wrong, misleading or irrelevant. The often remarkable discrepancy between experience and evidence will again be the subject of intense discussions. How can a tiny trial overturn the experience of so many?
The answer is: VERY EASILY! In fact, the simplest explanation is that both are correct. The trial was well-done and its findings are thus likely to be true. The experience of patients is equally true – yet it relies not on the effects of acupuncture per se, but on the context in which it is given. In simple language, the effects patients experience after acupuncture are due to a placebo-response.
This is the only simple explanation which tallies with both the evidence and the experience. Once we think about it carefully, we realise that acupuncture is highly placebo-genic:
It is exotic.
It is invasive.
It is slightly painful.
It involves time with a therapist.
It involves touch.
If anyone had the task to develop a treatment that maximises placebo-effects, he could not come up with a better intervention!
Ahhh, will acupuncture-fans say, this means that acupuncture is a helpful therapy. I don’t care how it works, as long as it does help. Did we not just cover this issues in some detail? Indeed we did - and I do not feel like re-visiting the three fallacies which underpin this sentence again.
In my last post, I strongly criticised Prince Charles for his recently published vision of “integrated health and post-modern medicine”. In fact, I wrote that it would lead us back to the dark ages. “That is all very well”, I hear my critics mutter, “but can Ernst offer anything better?” After all, as Prof Michael Baum once remarked, Charles has his authority merely through an accident of birth, whereas I have been to medical school, served as a professor in three different countries and pride myself of being an outspoken proponent of evidence-based medicine. I should thus know better and have something to put against Charles’ odd love affair with the ‘endarkenment’.
I have to admit that I am not exactly what one might call a visionary; all my life I have been slightly weary of people who wear a ‘vision’ on their sleeve for everyone to see. But I could produce some concepts about what might constitute good medicine (apart from the obvious statement that I think EBM is the correct approach). To be truthful, these are not really my concepts either - but, as far as I can see, they simply are ideas held by most responsible health care professionals across the world. So, for what it’s worth, here it is:
In a nut-shell, good medicine consists of two main elements: the science and the ‘art’ of medicine. This division is, of course, somewhat artificial; for instance, the art of medicine does not defy science, and compassion is an empty word, if it is not combined with effective therapy. Yet for clarity it can be helpful to separate the two elements.
Medicine has started to make progress about 150 years ago when we managed to free ourselves from the dogmas and beliefs that had previously dominated heath care. The first major randomised trial was published only in 1948. Since then, progress in both basic and clinical research has advanced at a breath-taking speed. Consequently, enormous improvements in health care have occurred, and the life-expectancy as well as the quality of life of millions have grown to a remarkable degree.
These developments are fairly recent and tend to be frustratingly slow; it is therefore clear that there is still much room for improvement. But improvement is surely being generated every day: the outlook of patients who suffer from MS, AIDS, cancer and many other conditions will be better tomorrow than it is today. Similar advances are being made in the areas of disease prevention, rehabilitation, palliative care etc. All of these improvements is almost exclusively the result of the hard work by thousands of brilliant scientists who tirelessly struggle to improve the status quo.
But the task is, of course, huge and virtually endless. We therefore need to be patient and remind ourselves how very young medicine’s marriage with science still is. To change direction at this stage would be wrong and lead to disastrous consequences. To doubt the power of science in generating progress displays ignorance. To call on “ancient wisdom” for help is ridiculous.
The ‘art of medicine’ seems a somewhat old-fashioned term to use. My reason for employing it anyway is that I do not know any other word that captures all of the following characteristics and attributes:
Time to listen
Good therapeutic relationships
Provision of choice, information, guidance
They are all important features of good medicine – they always have been and always will be. To deny this would be to destroy the basis on which health care stands. To neglect them risks good medicine to deteriorate. To call this “ancient wisdom” is grossly misleading.
Sadly, the system doctors have to work in makes it often difficult to respect all the features listed above. And sadly, not everyone working in health care is naturally gifted in showing compassion, empathy etc. to patients. This is why medical schools do their very best to teach these qualities to students. I do not deny that this endeavour is not always fully successful, and one can only hope that young doctors make career-choices according to their natural abilities. If you cannot produce a placebo-response in your patient, I was taught at medical school, go and train as a pathologist!
Science and art
Let me stress this again: the science and the art of medicine are essential elements of good medicine. In other words, if one is missing, medicine is by definition not optimal. In vast areas of alternative medicine, the science-element is woefully neglected or even totally absent. It follows, that these areas cannot be good medicine. In some areas of conventional medicine, the art-element is weak or neglected. It follows that, in these areas, medicine is not good either.
My rough outline of a ‘vision’ is, of course, rather vague and schematic; it cannot serve as a recipe for creating good medicine nor as a road map towards improving today’s health care. It is also somewhat naive and simplistic: it generalises across the entire, diverse field of medicine which problematic, to say the least.
One challenge for heath care practitioners is to find the optimal balance between the two elements for the situation at hand. A surgeon pulling an in-grown toenail will need a different mix of science and art than a GP treating a patient suffering from chronic depression, for instance.
The essential nature of both the science and the art of medicine also means that a deficit of one element cannot normally be compensated by a surplus of the other. In the absence of an effective treatment, even an over-dose of compassion will not suffice (and it is for this reason that the integration of alt med needs to be seen with great scepticism). Conversely, science alone will do a poor job in many others circumstances (and it is for that reason that we need to remind the medical profession of the importance of the ‘art’).
We cannot expect that the introduction of compassionate quacks will improve health care; it might make it appear more human, while, in fact, it would only become less effective. And is it truly compassionate to pretend that homeopathic placebos, administered by a kind and empathetic homeopath, generate more good than harm? I do not think so. The integration of alternative medicine makes sense only for those modalities which have been scientifically tested and demonstrated to be effective. True compassion must always include the desire to administer those treatments which demonstrably generate more good than harm.
I must admit, I do feel slightly embarrassed to pompously entitle this post “a vision of good medicine”. It really amounts to little more than common sense and is merely a reflection of what many health care professionals believe. Yet it does differ significantly from the ‘integrated health and post-modern medicine’ as proposed by Charles – and perhaps this is one reason why it might not be totally irrelevant.