MD, PhD, FMedSci, FSB, FRCP, FRCPEd

research

The efficacy or effectiveness of medical interventions is, of course, best tested in clinical trials. The principle of a clinical trial is fairly simple: typically, a group of patients is divided (preferably at random) into two subgroups, one (the ‘verum’ group) is treated with the experimental treatment and the other (the ‘control’ group) with another option (often a placebo), and the eventual outcomes of the two groups is compared. If done well, such studies are able to exclude biases and confounding factors such that their findings allow causal inference. In other words, they can tell us whether an outcome was caused by the intervention per se or by some other factor such as the natural history of the disease, regression towards the mean etc.

A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about NON-CONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo NON-CONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘NON-CONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

This article was posted a few months ago. Then it mysteriously vanished without a trace; nobody knows quite why or how. Today I found an old draft on my computer, so I post the article again. It might not be identical with the original but it is close enough, I think.

Some time ago, Andy Lewis formulated a notion which he called ‘Ernst’s law’. Initially, I felt this was a bit o.t.t., then it made me chuckle, and eventually it got me thinking: could there be some truth in it, and if so, why?

The ‘law’ stipulates that, if a scientist investigating alternative medicine is much liked by the majority of enthusiasts in this field, the scientist is not doing his/her job properly. In any other area of healthcare, such a ‘law’ would be absurd. Why then does it seem to make sense, at least to some degree, in alternative medicine? The differences between any area of conventional and alternative medicine are diverse and profound.

Take neurology, for instance: here we have an organ-system, anatomy, physiology, pathophysiology, etiology and nosology all related more or less specifically to this field and all based on facts, rigorous science and substantial evidence. None of this knowledge, science and evidence is static, but each has evolved and can be predicted to do so in future. What we knew about neurology 50 years ago, for example, was dramatically different from what we know today. Scientific discovery discoveries in neurology link up with the knowledge gathered in other areas of medicine to generate a (more or less) complete bigger picture.

In alternative medicine or any single branch thereof, we have no specific organ-system, anatomy, physiology, pathophysiology, etiology or nosology to speak of. We also have few notions that are transferable from one branch of alternative medicine to another – on the contrary, the assumptions of homeopathy, for example, are in overt contradiction to those of acupuncture which, in turn, are out of sync with those of reflexology, aromatherapy and Reiki.

Instead, each branch of alternative medicine has its own axioms that are largely detached from reality or, indeed, from the axioms of other branches of alternative medicine. In acupuncture, for instance, we have concepts such as yin and yang, qi, meridians and acupuncture points, and there is hardly any development of these concepts. This renders them akin to dogmas, and there is no chance in hell that the combination of all the branches of alternative medicine would add up to provide a sensible ‘bigger picture’.

If a scientist were to instill scientific, critical, progressive thought in a field like neurology, thus overthrowing current concepts and assumptions, they would be greeted with open arms among many like-minded researchers who all pursue the aim of advancing their field and contributing to the knowledge base by overturning wrong assumptions and discovering new truths. If researchers were to spend their time trying to analyse the concepts or treatments of alternative medicine, thus overthrowing current concepts and assumptions, they would not only not be appreciated by the majority of the experts working in this field, they would be castigated for their actions.

If a scientist dedicated decades of hard work to the rigorous assessment of alternative medicine, that person would become a thorn in the flesh of believers. Instead of welcoming him with open arms, some disappointed enthusiasts of alternative treatments might even pay for defaming them.

On the other hand, if a researcher merely misused the tools of science to confirm the implausible assumptions of alternative medicine, he would quickly become the celebrated ‘heroes’ of this field.

This is the bizarre phenomenon that ‘Ernst’s law’ seems to capture quite well – and this is why I believe the ‘law’ is worth more than a laugh and a chuckle. In fact, ‘Ernst’s law’ might even describe the depressing reality of retrograde thinking in alternative medicine more accurately than most of us care to admit.

What do my readers feel? Their comments following this blog may well confirm or refute my theory.

Having disclosed in my previous post that, on 1 October, I have been in full-time alternative medicine research for exactly 20 years, I thought it might be interesting to briefly reflect on these two decades. One thing I ought to make clear from the beginning: I truly enjoy my work (well, ~90% of it anyway). When I came to Exeter, I never expected it to get so fascinating, and I am surprised to see how it gripped me.

A PERIOD OF TWO HALVES

One could divide these two decades in two periods of roughly equal length. The first half was characterised by defining my aims, assembling a team, getting the infrastructure sorted and doing plenty of research. I had made it very clear from the beginning that I was not going to promote alternative medicine; my aim was to critically evaluate it. Once I realised how controversial and high profile some of our work could become, I made a conscious effort to keep out of any disputes and tried to avoid the limelight. I wanted to first do my ‘homework’, analyse the evidence, produce own results and be quite sure of my own position before I entered into any public controversies. During this time, we therefore almost exclusively published in medical journals, lectured to medical audiences and generally kept as low a public profile as possible.

The second half was characterised by much more research and my increasing willingness to stick my head out and stand up publicly for the findings I had reasons to be confident about. The evidence had reached a point where it was simply no longer possible nor ethical to keep silent. I felt we had a moral duty to speak up and present the evidence clearly; and that often meant going public: after all, alternative medicine is an area where the public often make the therapeutic decisions without consulting a health care professional – so they need accurate and reliable information. Therefore, I began publishing in the daily papers, lecturing to lay audiences more regularly and addressing the public in many other ways.

THE PLEASURE OF SUPPORTING YOUNG SCIENTISTS

One of the most gratifying aspects of directing a research team is to meet and befriend scientists from all over the world. When several independent analyses had shown that our team had grown into the most productive research unit in alternative medicine worldwide, we started receiving numerous requests from young scientists across the globe to join us. Many of those individuals later went back to their home countries to occupy key positions in research. Our concept of critical evaluation thus spread around the world – at least this is what I hope when I feel optimistic about our achievements.

Amongst the ~90 staff who have worked with me during the last 20 years, we had many enthusiastic and gifted scientists. I owe thanks to all of those who advanced our research and helped us to make progress through critical evaluation.  Unfortunately, we also had a few co-workers who, despite of our best efforts, proved to be unable of critical thinking, and more than once this created unrest, tension and trouble. When I analyse these cases in retrospect, I realise how quasi-religious belief  must inevitably get in the way of good science. If a person is deeply convinced about the value of his/her particular alternative therapy and thus decides to become a researcher in order to prove his/her point, serious problems are unavoidable.

THE THREE MOST IMPORTANT MESSAGES

But generally speaking, my team worked both very well and extremely  hard. Perhaps the best evidence for that statement is the fact that we published more than 1000 articles in the peer review literature, including ~30 clinical trials and 300 systematic reviews/meta-analyses. If I had to extract what I consider to be the three the most important messages from these papers, I might make the following points:

  • The concepts that underpin alternative treatments are often not plausible and must be assessed critically.
  • Most claims made for alternative medicine are unproven and quite a few should be regarded as disproven.
  •  Very few alternative therapies demonstrably generate more good than harm.

Looking back to those 20 years, I am struck by the frequency with which I encountered intellectual dishonesty and denial of facts and evidence. Medical research, I had previously assumed is a rather dry and unemotional business – not so when it comes to research into alternative medicine! Here it is dominated by people who carry so much emotional baggage that rational analysis becomes the exception rather than the rule.

GROWING OPPOSITION

The disappointment of alternative medicine apologists had been noticeable virtually from the start; they had quickly realised that I was not in the business of promoting quackery. My remit was to test hypotheses, and when you do that, you have to try to falsify them. To those who fail to understand the rules of science – and that is the vast majority of alternative medicine fans – this process can appear like a negative, perhaps even destructive activity. Consequently, some people began to suspect that I was working against their interests. In fact, as a researcher, I had little patience with such people’s petty interests; all I wanted is to do good science, hopefully for the benefit of the patient.

These sentiments grew dramatically during the second decade when I began to go public with the evidence which often failed to confirm the expectations of alternative medicine enthusiasts. To see the truth published in relatively obscure medical journals might have already been tough for them; to see it in the daily papers or hear it on the radio from someone whom they could not easily accuse of incompetence was obviously more than the evangelic believers could take. Their relatively cautious attitude towards our work soon changed into overt aggression, particularly after our book ‘TRICK OR TREATMENT…‘. The second decade was therefore also characterised by numerous attacks, challenges, defamations and conflicts, not least the ‘run ins’ with Prince Charles and his sycophants. Unfortunately, my own University as well as my newly formed Medical School had no stomach for such battles; the top officials of both institutions seemed more concerned about their knighthoods than about defending me against obviously malicious attacks which could only have one aim: to silence me.

OUTLOOK

But silence they did me not! It is simply not in my character to give up when I know that I have done nothing wrong and fighting ‘the good fight’. On the contrary, each attack merely strengthened my resolve to fight harder for what I knew was right, ethical and necessary. Eventually, my peers became so frustrated with my resilience that they pulled the plug: they stopped all support. This meant my team had to be dismissed and I had to go into early retirement.

Since about a year, I am ‘Emeritus Professor’, a status which has disadvantages (no co-workers to help with the research, no salary) but also important advantages. I can finally speak the truth without fearing that some administrator suffering from acute ‘knighthood starvation syndrome’ is going to try to discipline me for my actions.

This blog, I think, is pretty good evidence for the fact that I continue to enjoy my work in alternative medicine. I cannot promise to do another 20 years but, for the time being, I continue to be research-active and am involved in numerous other activities. Currently I am also writing a book which will provide a full account of those remarkable last 20 years (almost finished but I have no publisher yet) and I am working on the concept of another book that deals with alternative medicine in more general terms. They did not silence me yet, and I do not assume they will soon.

Can one design a clinical study in such a way that it looks highly scientific but, at the same time, has zero chances of generating a finding that the investigators do not want? In other words, can one create false positive findings at will and get away with it? I think it is possible; what is more, I believe that, in alternative medicine, this sort of thing happens all the time. Let me show you how it is done; four main points usually suffice:

  1.  The first rule is that it ought to be an RCT, if not, critics will say the result was due to selection bias. Only RCTs have the reputation of being ‘top notch’.
  2.  Once we are clear about this design feature, we need to define the patient population. Here the trick is to select individuals with an illness that cannot be quantified objectively. Depression, stress, fatigue…the choice is vast. The aim must be to employ an outcome measure that is well-accepted, validated etc. but which nevertheless is entirely subjective.
  3.  Now we need to consider the treatment to be “tested” in our study. Obviously we take the one we are fond of and want to “prove”. It helps tremendously, if this intervention has an exotic name and involves some exotic activity; this raises our patients’ expectations which will affect the result. And it is important that the treatment is a pleasant experience; patients must like it. Finally it should involve not just one but several sessions in which the patient can be persuaded that our treatment is the best thing since sliced bread - even if, in fact, it is entirely bogus.
  4.  We also need to make sure that, for our particular therapy, no universally accepted placebo exists which would allow patient-blinding. That would be fairly disastrous. And we certainly do not want to be innovative and create such a placebo either; we just pretend that controlling for placebo-effects is impossible or undesirable. By far the best solution would be to give the control group no treatment at all. Like this, they are bound to be disappointed for missing out a pleasant experience which, in turn, will contribute to unfavourable outcomes in the control group. This little trick will, of course, make the results in the experimental group look even better.

That’s about it! No matter how ineffective our treatment is, there is no conceivable way our study can generate a negative result; we are in the pink!

Now we only need to run the trial and publish the positive results. It might be advisable to recruit several co-authors for the publication – that looks more serious and is not too difficult: people are only too keen to prolong their publication-list. And we might want to publish our study in one of the many CAM-journals that are not too critical, as long as the result is positive.

Once our article is in print, we can legitimately claim that our bogus treatment is evidence-based. With a bit of luck, other research groups will proceed in the same way and soon we will have not just one but several positive studies. If not, we need to do two or three more trials along the same lines. The aim is to eventually do a meta-analysis that yields a convincingly positive verdict on our phony intervention.

You might think that I am exaggerating beyond measure. Perhaps a bit, I admit, but I am not all that far from the truth, believe me. You want proof? What about this one?

Researchers from the Charite in Berlin just published an RCT to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress.

To prevent allegations of exaggeration, selective reporting, spin etc. I take the liberty of reproducing the abstract of this study unaltered:

Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS) after 4 weeks between intervention and control.

Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001).

Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up

This whole thing could just be a bit of innocent fun, but I am afraid it is neither innocent nor fun, it is, in fact, quite serious. If we accept manipulated trials as evidence, we do a disservice to science, medicine and, most importantly, to patients. If the result of a trial is knowable before the study has even started, it is unethical to run the study. If the trial is not a true test but a simple promotional exercise, research degenerates into a farcical pseudo-science. If we abuse our patients’ willingness to participate in research, we jeopardise more serious investigations for the benefit of us all. If we misuse the scarce funds available for research, we will not have the money to conduct much needed investigations. If we tarnish the reputation of clinical research, we hinder progress.

Research is essential for progress, and research in alternative medicine is important for advancing alternative medicine, one would assume. But why then do I often feel that research in this area hinders progress? One of the reasons is, in my view, the continuous drip, drip, drip of misleading conclusions usually drawn from weak studies. I could provide thousands of examples; here is one recently published article chosen at random which seems as good as any other to make the point.

Researchers from the Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany set out to investigate associations of regular yoga practice with quality of life and mental health in patients with chronic diseases. Using a case-control study design, 186 patients with chronic diseases who had elected to regularly practice yoga were selected and compared to controls who had chosen to not regularly practice yoga. Patients were matched individually on gender, main diagnosis, education, and age. Patients’ quality of life, mental health, life satisfaction, and health satisfaction were also assessed. The analyses show that patients who regularly practiced yoga had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 than those who did not.

The authors concluded that practicing yoga under naturalistic conditions seems to be associated with increased physical health but not mental health in chronically diseased patients.

Why do I find these conclusions misleading?

In alternative medicine, we have an irritating abundance of such correlative research. By definition, it does not allow us to make inferences about causation. Most (but by no means all) authors are therefore laudably careful when choosing their terminology. Certainly, the present article does not claim that regular yoga practice has caused increased physical health; it rightly speaks of “associations“. And surely, there is nothing wrong with that – or is there?

Perhaps, I will be accused of nit-picking, but I think the results are presented in a slightly misleading way, and the conclusions are not much better.

Why do the authors claim that patients who regularly practiced yoga had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 than those who did not than those who did not? I know that the statement is strictly speaking correct, but why do they not write that “patients who had a significantly better general health status, a higher physical functioning, and physical component score  on the SF-36 were more likely to practice yoga regularly”? After all, this too is correct! And why does the conclusion not state that better physical health seems to be associated with a greater likelihood of practicing yoga?

The possibility that the association is the other way round deserves serious consideration, in my view. Is it not logical to assume that, if someone is  relatively fit and healthy, he/she is more likely to take up yoga (or table-tennis, sky-diving, pole dancing, etc.)?

It’s perhaps not a hugely important point, so I will not dwell on it – but, as the alternative medicine literature is full with such subtly  misleading statements, I don’t find it entirely irrelevant either.

Yesterday, I received a letter from the editor-in-chief of the journal ‘Homeopathy‘ informing me that I have been struck off the editorial board of his publication. As the letter is not marked confidential, I feel that I can reproduce parts of it here:

Dear Professor Ernst,

This is to inform you that you have been removed from the Editorial Board of Homeopathy.  The reason for this is the statement you published on your blog on Holocaust Memorial Day 2013 in which you smeared homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis.

I should declare a personal interest….[Fisher goes on to tell a story which is personal and which I therefore omit]…  I mention this only because it highlights the absurdity of guilt by association arguments.

Sincerely

Peter Fisher Editor-in-Chief, Homeopathy

I do agree with Dr Fisher that guilt by association is absurd. However, I disagree with the notion that I used this fallacy in my post the full text of which be found here. After re-reading it several times, I still do not see that it employs a ‘guilt by association argument’. It merely recounts historical facts which are not well-known and therefore worth mentioning. Importantly, the post consits in essence of quotes from my previous publications on the subject. My motives for writing it could not have been clearer and are emphacised in the last paragraph:

So, why bring all of this up today? Is it not time that we let grass grow over these most disturbing events? I think not! For many years, I actively researched this area (you can find many of my articles on Medline) because I am convinced that the unprecedented horrors of Nazi medicine need to be told and re-told – not just on HOLOCAUST MEMORIAL DAY, but continually. This, I hope, will minimize the risk of such incredible abuses ever happening again.

Perhaps a comparison might make it a little clearer why, in my opinion, Fisher’s is so utterly bizarre. Imagine an eminent researcher in the area of psychiatry who has been on the editorial board of a journal in his area for many years and contributed numerous articles to this journal. He then decides to research and subsequently write about the infamous Nazi past of German psychiatry. As a result, he is fired from his editorial board position because the editor feels that he has smeared the reputation of psychiatry.

I think most observers might find this odd and unjustified. Such a thing would not happen, I think, in a field with a mature research-culture. That it did happen in homeopathy might be interpreted as a reflection of the fact that homeopathy lacks such a culture.

So how precisely can we explain my dismissal? My article and my motives for writing it could have been thoroughly misunderstood – in my view, this is unlikely because I explained my motives in some detail both in the article and in the comments that follow the article. Here is my last of several posts clarifying my motives:

i am sorry that some have misunderstood the message of this blog and the reason why i wrote it.
i did certainly not want to engage in the GUILTY BY ASSOCIATION fallacy.
here is the truth:
i have had a research interest in nazi medicine and published about it.
in the course of these activities, i discovered that, contrary to what most people seem to assumue, alt med was involved as well. so i published this too many years ago.
this blog was simply and purely aimed at re-telling this story because it deserves to be re-told, in my view.
i regret that some people have read things into it which i did not intend.

Another explanation could be that Dr Fisher, who also is the Queen’s homeopath, lacks sufficient skills of critical thinking to understand the article and its purpose. Alternatively, he has been waiting for an occasion to fire me ever since I became more openly critical of homeopathy about five years ago.

Whatever the explanation, I think it is regrettable that the journal ‘Homeopathy’ has now lost the only editorial board member who had the ability to openly and repeatedly display a critical attitude about homeopathy – remember: without a critical attitude progress is unlikely!

There probably is no area in health care that produces more surveys than alternative medicine. I estimate that about 500 surveys are published every year; this amounts to about two every working day which is substantially more than the number of clinical trials in this field.

I have long been critical of this ‘survey-mania’. The reason is simple: most of these articles are of such poor quality that they tell us nothing of value.

The vast majority of these surveys attempts to evaluate the prevalence of use of alternative medicine, and it is this type of investigation that I intend to discuss here.

For a typical prevalence survey, a team of enthusiastic researchers might put together a few questions and design a questionnaire to find out what percentage of a group of individuals have tried alternative medicine in the past. Subsequently, the investigators might get one or two hundred responses. They then calculate simple descriptive statistics and demonstrate that xy% (let’s assume it is 45%) use alternative medicine. This finding eventually gets published in one of the many alternative medicine journals, and everyone is happy – well, almost everybody.

How can I be such a spoil-sport and claim that this result tells us nothing of value? At the very minimum, some might argue, it shows that enthusiasts of alternative medicine are interested in and capable of conducting research. I beg to differ: this is not research, it is pseudo-research which ignores most of the principles of survey-design.

The typical alternative medicine prevalence survey has none of the features that would render it a scientific investigation:

1) It lacks an accepted definition of what is being surveyed. There is no generally accepted definition of alternative medicine, and even if the researchers address specific therapies, they run into huge problems. Take prayer, for instance – some see this as alternative medicine, while others would, of course, argue that it is a religious pursuit. Or take herbal medicine – many consumers confuse it with homeopathy, some might think that drinking tea is herbal medicine, while others would probably disagree.

2) The questionnaires used for such surveys are almost never validated. Essentially, this means that we cannot be sure they evaluate what we think they evaluate. We all know that the way we formulate a question can determine the answer. There are many potential sources of bias here, and they are rarely taken into consideration.

3) Enthusiastic researchers of alternative medicine usually use a  small convenience sample of participants for their surveys. This means they ask a few people who happen to be around to fill their questionnaire. As a consequence, there is no way the survey is representative of the population in question.

4) The typical survey has a low response rate; sometimes the response rate is not even provided or remains unknown even to the investigators. This means we do not know how the majority of patients/consumers who received but did not fill the questionnaire would have answered. Often there is good reason to suspect that those who have a certain attitude did respond, while those with a different opinion did not. This self-selection process is likely to produce misleading findings.

And why I am so sure about all of theses limitations? To my embarrassment, I know about them not least because I have made most these mistakes myself at some time in my career. You might also ask why this is important: what’s the harm in publishing a few flimsy surveys?

In my view, these investigations are regrettably counter-productive because:

they tend to grossly over-estimate the popularity of alternative medicine,

they distract money, manpower and attention from the truly important research questions in this field,

they give a false impression of a buoyant research activity,

and their results are constantly misused.

The last point is probably the most important one. The argument that is all too often spun around such survey data goes roughly as follows: a large percentage of the population uses alternative medicine; people pay out of their own pocket for these treatments; they are satisfied with them (if not, they would not pay for them). BUT THIS IS GROSSLY UNFAIR! Why should only those individuals who are rich enough to afford alternative medicine benefit from it? ALTERNATIVE MEDICINE SHOULD BE MADE AVAILABLE FOR ALL.

I rest my case.

Still in the spirit of ACUPUNCTURE AWARENESS WEEK, I have another critical look at a recent paper. If you trust some of the conclusions of this new article, you might think that acupuncture is an evidence-based treatment for coronary heart disease. I think this would be a recipe for disaster.

This condition affects millions and eventually kills a frighteningly large percentage of the population. Essentially, it is caused by the fact that, as we get older, the blood vessels supplying the heart also change, become narrower and get partially or even totally blocked. This causes lack of oxygen in the heart which causes pain known as angina pectoris. Angina is a most important warning sign indicating that a full blown heart attack might be not far.

The treatment of coronary heart disease consists in trying to let more blood flow through the narrowed coronaries, either by drugs or by surgery. At the same time, one attempts to reduce the oxygen demand of the heart, if possible. Normalisation of risk factors like hypertension and hypercholesterolaemia are key preventative strategies. It is not immediate clear to me how acupuncture might help in all this - but I have been wrong before!

The new meta-analysis included 16 individual randomised clinical trials. All had a high or moderate risk of bias. Acupuncture combined with conventional drugs (AC+CD) turned out to be superior to conventional drugs alone in reducing the incidence of acute myocardial infarction (AMI). AC+CD was superior to conventional drugs in reducing angina symptoms as well as in improving electrocardiography (ECG). Acupuncture by itself was also superior to conventional drugs for angina symptoms and ECG improvement. AC+CD was superior to conventional drugs in shortening the time to onset of angina relief. However, the time to onset was significantly longer for acupuncture treatment than for conventional treatment alone.

From these results, the authors [who are from the Chengdu University of Traditional Chinese Medicine in Sichuan, China] conclude that “AC+CD reduced the occurrence of AMI, and both acupuncture and AC+CD relieved angina symptoms and improved ECG. However, compared with conventional treatment, acupuncture showed a longer delay before its onset of action. This indicates that acupuncture is not suitable for emergency treatment of heart attack. Owing to the poor quality of the current evidence, the findings of this systematic review need to be verified by more RCTs to enhance statistical power.”

As in the meta-analysis discussed in my previous post, the studies are mostly Chinese, flawed, and not obtainable for an independent assessment. As in the previous article, I fail to see a plausible mechanism by which acupuncture might bring about the effects. This is not just a trivial or coincidental observation – I could cite dozens of systematic reviews for which the same criticism applies.

What is different, however, from the last post on gout is simple and important: if you treat gout with a therapy that is ineffective, you have more pain and eventually might opt for an effective one. If you treat coronary heart disease with a therapy that does not work, you might not have time to change, you might be dead.

Therefore I strongly disagree with the authors of this meta-analysis; “the findings of this systematic review need NOT to be verified by more RCTs to enhance statistical power” — foremost, I think, the findings need to be interpreted with much more caution and re-written. In fact, the findings show quite clearly that there is no good evidence to use acupuncture for coronary heart disease. To pretend otherwise is, in my view, not responsible.

There might be an important lesson here: A SEEMINGLY SLIGHT CORRECTION OF CONCLUSIONS OF SUCH SYSTEMATIC REVIEWS MIGHT SAVE LIVES.

There are at least two dramatically different kinds of herbal medicine, and the proper distinction of the two is crucially important. The first type is supported by some reasonably sound evidence and essentially uses well-tested herbal remedies against specific conditions; this approach has been called by some experts RATIONAL PHYTOTHERAPY. An example is the use of St John’s Wort for depression.

The second type of herbal medicine. It entails consulting a herbal practitioner who takes a history, makes a diagnosis (usually according to obsolete concepts) and prescribes a mixture of several herbal remedies tailor-made to the characteristics of his patient. Thus 10 patients with the identical diagnosis (say depression) might receive 10 different mixtures of herbs. This is true for individualized herbalism of all traditions, e.g. Chinese, Indian or European, and virtually every herbalist you might consult will employ this individualized, traditional approach.

Many consumers know that, in principle, there is some reasonably good evidence for herbal medicine. They fail to appreciate, however, that this does only apply to (sections of) rational phytotherapy. So, they consult herbal practitioners in the belief that they are about to receive an evidence-based therapy. Nothing could be further from the truth! The individualised approach is not evidence-based; even if the individual extracts employed were all supported by sound data (which they frequently are not) the mixutres applied are clearly not.

And this is where the danger of traditional herbalism lies; over the years, herbalists have fooled us all with this fundamental misunderstanding. In the UK, they might even achieve statutory regulation on the back of this self-serving misconception. When this happens, we would have a situation where a completely unproven practice has obtained the same status as doctors, nurses and physiotherapists. If this is not grossly misleading for the consumer, I do not know what is!!!

Some claim that individualized herbalism cannot be tested in clinical trials. This notion can very easily be shown to be wrong: several such studies testing individualized herbalism have been published. To the dismay of traditional herbalists, their results fail to confirm that such treatments are effective for any condition.

Now a further trial has become available that importantly contributes to this knowledge-base. Its authors (all enthusiasts of individualized herbalism) randomized 102 patients suffering from hip or knee-osteoarthritis into two groups. The experimental group received tailor-made mixtures of 7 to 10 Chinese herbs which were traditionally assumed to be helpful. The control group took a mixture of plants known to be ineffective but tasting similar. After 20 weeks of treatment, there were no differences between the groups in any of the outcome measures: pain, stiffness and function. These results thus confirm that this approach is not effective. Not only that, it also carries more risks.

As individualized herbalism employs a multitude of ingredients, the dangers of adverse-effects and herb-drug interactionscontamination, adulteration etc. are bigger that those with the use of single herbal extracts. It seems to follow therefore that the risks of individualized herbalism do not outweigh its benefit.

My recommendations are thus fairly straight forward: if we consider herbal medicine, it is vital to differentiate between the two types. Rational phytotherapy might be fine – of course, depending on the remedy and the condition we are aiming to treat. Individualised or traditional herbalism is not fine; it is not demonstrably effective and has considerable risks. This means consulting a herbalist is not a reasonable approach to treating any human ailment. It also means that regulating herbalists (as we are about to do in the UK) is a seriously bad idea: the regulation of non-sense will result in non-sense!

 

Rigorous studies of homeopathy are a bit like gold dust; they are so rare that we see perhaps only one or two per year. It is therefore good news that very recently one such trial has been published.

This randomized, placebo-controlled study tested the efficacy of a complex homeopathic medicine, Cocculine, for chemotherapy-induced nausea and vomiting (CINV) in non-metastatic breast cancer patients treated by standard chemotherapy regimens.

Chemotherapy-naive patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy were randomized to receive standard anti-emetic treatment plus either the complex homeopathic remedy or the matching placebo. The primary endpoint was nausea score measured after the 1st chemotherapy course.

In total, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis scores were not statistically different at any time between the two study arms.

The authors’ conclusions could not be clearer: “This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.”

COCCULINE is manufactured by Boiron and contains Cocculus indicus 4CH, Strychnos nux vomica 4CH, Nicotiana tabacum 4CH, Petroleum rectificatum 4CH   aa 0,375 mg. Boiron informs us that “this homeopathic preparation is indicated in sickness during travelling (kinetosis). Preventive dosage is 2 tablets 3 times a day one day before departure and on the day of journey. Treatment dosage is 2 tablets every hour. The interval is prolonged in dependence on improvement. Dosage in children is the same as in adults. The tablets are left to dissolve in mouth or in a small amount of water.”

Homeopaths might argue that this trail did not follow the rules of classical homeopathy where treatments need to be individualised. This may be true but, in this case, they should campaign for all OTC homeopathy to be banned. As they do not do that, I suggest they live with yet another rigorous clinical trial demonstrating that homeopathic remedies are pure placebos.

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