MD, PhD, FMedSci, FSB, FRCP, FRCPEd

conflict of interest

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For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:

  • The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
  • This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
  • Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
  • The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
  • As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
  • Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.

The consequences of these fairly recent developments are serious:

  • Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
  • Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
  • At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
  • Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
  • They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
  • In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
  • Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
  • The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.

In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.

I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.

A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.

The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.

Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.

The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.

The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.

My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!

Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.

The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.

There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!

The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers

The abstract was equally promising:

Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.

Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.

Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.

Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.

One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why:  All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.

There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.

Such overt exaggerations are sadly no rarities in the realm of alternative medicine.  I think, this begs a number of serious questions:

  1. Does this cross the line between flawed research and scientific misconduct?
  2. Why did the reviewers not pick up these flaws?
  3. Why did the editor pass this article for publication?
  4. How can the publisher tolerate such dubious behaviour?
  5. Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?

I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.

The BMJ is my favourite medical journal by far; I think it is full of good science as well as entertaining to read, and I look forward to finding it in my letter box every Friday. It is thus hard for me to criticise the BMJ, and this is not made easier by the fact that I am the author of one of the two pieces in question. However, the current ‘HEAD TO HEAD’ entitled ‘SHOULD DOCTORS RECOMMEND HOMEOPATHY’ does, in my view, not mark the finest hour of this journal. Let me explain why.

The first question that arises is whether homeopathy is a good subject for such a debate. As several commentators have pointed out, it is not – the debate has long been closed; to serious scientists and many doctors, homeopathy tends to be a subject that is nothing more than an odd, obsolete triviality that does not even deserve a mention in the BMJ or any other serious publication. In a way, this notion has almost been proven wrong by the high level of interest the subject quickly generated. So, I will not dwell on this point any longer.

The second issue that arises just from nothing more than merely reading the title of the debate is that the question posed is imprecise. ‘Homeopathy’ is too broad a term for a focussed discussion; it includes amongst other phenomena empathetic encounters, remedies with material doses of highly active ingredients (e.g. Arsenic D1) and remedies that contain absolutely nothing at all (any ‘potency’ beyond C12). In my piece, I tried to make it clear that I speak mostly about ultra-molecular dilutions. This is less obvious in Peter Fisher’s article, and there is doubtlessly a lot of confusion in the debate as well as the comments that follow.

The two articles had to be written without either author knowing the text of the other. Consequently the issues raised by one author were not necessarily addressed by the other. This is somewhat frustrating, as it fails to clarify issues that could easily have been dealt with. In a previous post, I have already explained that the peer-review process of the two articles was seriously flawed. It failed to correct the many misleading statements in Fisher’s piece, as Alan Henness has pointed out in his response both in the BMJ and on this blog. In fact, reading Fisher’s article, I fail to find a single passage that is not factually wrong or highly misleading (the accompanying podcast is even worse, in my view). To me it is obvious that the debate about homeopathy cannot advance, if one side continues to behave in this fashion.

Homeopaths are very adept at recruiting ‘grass roots’ for public relation activities. We know this from various previous experiences. It was therefore predictable that this would swiftly get organised also in this instance. I happen to know from more than one source that there was a highly active campaign by homeopaths trying to persuade their supporters to post responses on the BMJ site and to vote on the BMJ straw poll (scientists, by contrast, know that such polls are silly gadgets and tend to view homeopathy as a triviality that is not worth the effort). In this way, they try to generate the impression that the majority of the public stands firmly behind homeopathy and want doctors to recommend it. It does not need too much to realise that popularity is not a measure of efficacy. Homeopaths, however, tend to relish logical fallacies and therefore will rejoice at such nonsense and celebrate it as their very own victory.

So, was this ‘HEAD TO HEAD’ a mistake? Should I have refused to participate? With hindsight, perhaps. My main reason for accepting was that, had I declined the offer, someone else would have written the piece (there are plenty of excellent scientists who could do an excellent job at this). As sure as hell, that person would subsequently gotten attacked for not ever having researched and/or practiced homeopathy (in the podcast, Fisher even tried to undermine my authority by pointing out that 1) I have not worked as a clinician for decades and 2) I have no NHS contract). I think I may be one of the few critics of homeopathy who cannot possibly be accused of not knowing enough about homeopathy to discuss the subject.

My hope is that, because the BMJ is such an excellent journal, the two articles will survive the current hoo-hah and some people will read them carefully, look up and study the references, analyse all this critically and weigh the arguments responsibly. Then they must be able to discern the fiction from the facts. And in this case, perhaps it was worth it after all.

The last time I had contact with Dr Fisher was when he fired me from the editorial board of his journal ‘Homeopathy’. He did that by sending me the following letter:

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 did not expect to have any more dealings with him after this rather unpleasant encounter. But, as it turns out, I recently did have a further encounter.

When the BMJ invited me to write a debate article about the question whether homeopathy should continue to be available on the NHS, I accepted (with some reservations, I hasten to add). At the time, I did not know who would do the ‘other side’ of this debate. It turned out to be Peter Fisher, and our two articles have just been published.

As one would expect from a good journal, the articles were both peer reviewed. One of the peer-reviewers of my piece was most scathing of it essentially claiming that it was entirely worthless. Feeling that this was a bit harsh and very impolite, I was keen to see who this reviewer had been; it was none other than Andrew Vickers. This is remarkable because Vickers had not only published several homeopathic papers with Fisher, but also had been in the employment of the ‘Royal London Homeopathic Hospital’ under Fisher. To the best of my knowledge, his conflicts of interested had not been disclosed. I did point that out to the BMJ, but they seemed to think nothing of it.

Anyway, I was pleased to eventually (the whole procedure took many months) see the articles published, but at the same time somewhat irritated by Fisher’s piece. It contained plenty of misleading information that the peer-reviewers obviously had failed to correct. Here is a small sample from Fishers piece:

… recent overviews have had more favourable conclusions, including a health technology assessment commissioned by the Swiss federal government that concluded that homeopathy is “probably” effective for upper respiratory tract infections and allergies.

Readers interested in the clinical evidence can access the CORE-HOM database of clinical research in homeopathy free of charge (www.carstens-stiftung.de/core-hom). It includes 1117 clinical trials of homeopathy, of which about 300 are randomised controlled trials.

In the podcast that accompanies the articles Fisher insists that, on this database, there are well over 300 RCT, and I had to admit that this was new to me. Keen to learn more, I registered with the database and had a look. What I found startled me. True, the database does claim that almost 500 RCTs are available, but just a very superficial scrutiny of these studies reveals that

  • some are not truly randomised,
  • some are not even clinical trials,
  • the list includes dual publications, re-analyses of already published studies as well as aborted trials,
  • many have never been peer-reviewed,
  • many are not double-blind,
  • many are not placebo controlled,
  • the majority are of poor methodological quality.

As to the other thing mentioned in the above excerpt from Fisher’s article, the famous ‘health technology assessment commissioned by the Swiss federal government’, I can refer my readers to a blog post by J W Nienhuys which probably says it all, if not, there is plenty more criticism of this report available on the Internet.

My conclusion from all this?

THE QUEEN’S HOMEOPATH USES ARGUMENTS THAT SEEM JUST AS BOGUS AS HOMEOPATHY ITSELF.

I have always wondered how pharmacists might justify using or recommending or selling homeopathic remedies. So far, I have not come across a pharmacist who would want to stick his/her neck out for homeopathy. Many pharmacists earn money by selling homeopathic preparations – but most seem to be embarrassed by this fact and don’t want to defend it.

Therefore, I was pleased when I found this interview with the pharmacist Christophe Merville. He got introduced to homeopathy as a 11 year old boy suffering from hay fewer; after using homeopathy, “the crises became less severe and less frequent”. Later, he studied to become a pharmacist in France and, in 1990, he joined Boiron, the world’s largest manufacturer of homeopathic remedies. The following is an extensive excerpt (I did not want to cite him ‘out of context’) from his interview about his views on homeopathy.

I remember attending the delivery of a woman and the contractions were very strong, and painful. She had some homeopathic medicine to take just at that time to make those contractions more regular and useful: less intense but longer and less brusque. I saw that happening within minutes, and I was thinking, “That’s very impressive.” That’s probably the time when I concluded that there is something to it. 

I witnessed the action of homeopathic medicines on pets also, on young children. I had enough personal anecdotes that I could say there is something more than just suggestion, or placebo, or just the simple act of being cared for. My attitude is to say, “There are enough signs to say that it’s really worth exploring more why it works, how it works, when does it work.” We are past the stage where we can say, “No, there is nothing.” It has been around for a long time and if was just mere placebo effect, it would have gone away, as so many different techniques did. 

If you look at the history of science, you find many instances where people first said, for example, “The theory of gravity explains everything.” And when some things are discovered that show it didn’t work in certain very narrow cases, there’s an understanding that we have to adjust. But every time you have to make that adjustment, there is a great body of people who say, “No, it cannot be.” 

The main argument against homeopathy is that a remedy is very, very diluted, so it cannot work. My reaction to that is to examine what happens when you dilute something. The act of dilution is not very simple. Those molecules are interacting together, they are interacting with the walls of the container, they are interacting with the solvent, and this interaction does not adhere to a precise mathematical law. The skeptics say, “You divide the number of molecules by 100 each time, so after awhile, there is less than one chance to find one single molecule.” They have their math right, but they have their physics wrong. 

Chemists try to use very pure substances. When you buy your reagent, you buy it at 99.999 percent pure. But you don’t have anything that’s 100 percent pure. It would take an infinite amount of energy to get rid of the last impurity. What I think we should explore is the fact that after a certain number of dilutions, the process is not very efficient at removing the last molecules. So there is always something that stays. That’s one thing. 

The second thing is in pharmacology for years, we were interested in the ability of large quantities of substances. But what about small ones? I always use the example of butterflies that can sense pheromones at great distances, salmon finding their way back to their native creek from far away, to sharks being able to detect blood in a huge amount of water. Biology uses very small quantities. In cells, you have communication between cells using a few molecules of a certain substance—and it works. 

I don’t pretend that I’ve put A and B and C together, and I’m able to provide you with a complete explanation. But I would say those are things to explore. Already the research that exists points to possible action of homeopathic dilution on activation or deactivation of genes. I won’t go into details, but I welcome the skepticism, I think it’s very constructive. But what I don’t really like is people whose mind is set on their misconception of what exactly a dilution is. Of course homeopathy doesn’t violate the laws of physics and chemistry, because that’s absurd. 

My first role is pharmacy development. I look at what are the tools that allow pharmacists to know what homeopathy is and for a certain number of them, how to use homeopathy. I consider how to train them, how to have them integrate homeopathy in their practice, because the goal isn’t about replacing other medicines with homeopathy. My first role is to say to pharmacists, “You have to know what it is because these are drugs. If you don’t believe in them, you don’t have to use them, but at least you need to be able to answer customers, your patients.”

And the second thing is that for those who are interested in knowing more, I translate books from France, I design trainings, activities, interactions, so they are placed in a situation of recommending and deciding if it is appropriate to recommend homeopathy, and what treatment is adapted to that particular person. 

“Before coming to the conference, I researched what homeopathy is, and you will have a hard time telling me that it can work.” I talk with them to explore a little bit more what it is. We speak the language of pharmacology together, and what strikes me is that very soon, they are into it. They say, “Okay, we see the logic of it.” They realize that they have a tool where they can relieve without doing any harm, without interactions, so their interest is piqued. And they recognize that the mode of action of conventional medicines is not as clear as we thought.

Pharmacists are very pragmatic people—you cannot tell them fairy tales. When they see it, explore it, and use it, then when I meet them later, they tell me, “That stuff works.” And I ask, “Yeah, but do you know how it works?” They don’t, but they see the patient coming back happy. 

Of course, they are interested in the research and knowing how it works, but I just give them what we know in clinical research and we discuss it. They see that there is ongoing research and one day we’ll find more. But meanwhile, they are using the product. 

 You have two approaches. What I call “the user approach” is when people may not really completely understand how a medicine works, but they’re interested in taking it for stress or for allergies, whatever it might be, to see if it works for them. They’re interested in how this medicine will affect them, how should they take it. If it works for them, then great. 

Then you have what I call the “intellectual approach”—which is concerned about more cultural, philosophical, and social questions: what is the place of homeopathic medicine in today’s medicine, what are its principles, its history, its perspective. Is it a philosophy, is it a cult, what is it? My role is to try to give context for what homeopathy is. It’s a simple tool in the toolbox—we don’t exactly know all the details of how it works. And this is what we know, and this is what we don’t know, and this is what we speculate might be the way it works. People educate themselves. 

 Every day, I say, homeopathy doesn’t vaccinate, homeopathy doesn’t cure cancer, homeopathy doesn’t cure diabetes. It can relieve some of the symptoms or side effects of the treatments, but it has limits like every therapy. I fight against those outrageous claims and sometimes people that are really fanatical advocates for homeopathy do much worse for the cause. And I have to tell them: You cannot say that. It is untrue and it is dangerous. This is why I think pharmacists listen to me, because I’m not telling them to change their practice and their ethics. I’m telling them, this is another tool and this is how to use it properly. But there are fundamentals that are still there and will be there for a long time. You cannot replace vaccination by any other techniques—it’s unethical, it’s dangerous, it’s deadly. So we don’t do that. I’m completely against these kinds of claims.

 Let’s explore that: a patient suffering with AIDS, advanced infection with HIV, with immunity that decreases. Or a patient treated with antiretroviral therapy, they still have sometimes diarrhea, because their immune system is not able to fight everything. They still have side effects or anxiety. We want their treatment to be as comfortable as possible, because we want them to keep using the treatment. The same thing with cancer. The patient says, “I don’t want to have chemotherapy because it’s hurting me, it’s very difficult and uncomfortable.” We have with homeopathy ways to reduce nausea, for instance, then we increase the comfort of the patient, and the outcome is always better. That’s the framework. Someone who would say, “Oh, you have AIDS, throw away your antiretrovirals, I’m going to treat you with homeopathy”—that person would be a murderer

We develop tools to help people self-medicate. We say, “Okay, you’re stressed out, you need to sleep a little bit, you’re lacking sleep. Take this for a certain period of time—if it works for you, fine. If it doesn’t, doesn’t, stop it.” For people with what we call “self-limiting conditions”— a cold or a cough—we have good tools with warnings and precautions and things like that for them to self-medicate. And in the warnings, we tell them, “If you experience that kind of fever, if you have that symptom, see a doctor.” We don’t say see a homeopath, we say see a doctor. And among these doctors, there are doctors who have added in different techniques and some of them are using homeopathy when appropriate. For me, what is most important, is that a patient sees someone who is medically qualified.  

For people who want to further explore the possibilities that homeopathy offers, I recommend that they see a physician who is skilled in homeopathy but will not use homeopathy for everything. And is able to diagnose. A physician will tell you, “In this case, I can do something with homeopathy, or, in that case, I cannot use homeopathy.”

As I have once worked as a junior doctor in a homeopathic hospital (the full story is here), I knew of course all these arguments and fallacies. Nevertheless, I still ask myself: HOW CAN PHARMACISTS GET CONVINCED IN THIS WAY? ARE THEY REALLY CONVINCED? OR DO THEY JUST DO IT FOR THE MONEY?

I do not feel like prejudging these questions just now. But I do hope to hear from my readers, particularly from the pharmacists amongst them, what they think.

One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.

Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.

Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.

But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.

The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.

Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.

The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.

Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:

  • As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
  • The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
  • The trials had small sample sizes.
  • They were mostly not blinded.
  • They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
  • Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.

As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.

Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:

  • They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
  • They might prompt some families to spend sizable amounts of money for no real benefit.
  • They might initiate further research into this area, thus drawing money away from research into much more promising avenues.

IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.

If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.

1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS

This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.

The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.

2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE

Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.

The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.

For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.

3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS

I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.

And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!

4) HOMEOPATHY IS SAFE

Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.

The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.

5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS

The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.

6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT

I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.

7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK

The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.

8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT

It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.

9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY

In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.

10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY

With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.

11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS

The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.

This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.

12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY

Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.

Dear Professor Robinson,

please forgive me for writing to you in a matter that, you might think, is really none of my business. I have been following the news and discussions about the BLACKMORE CHAIR at your university. Having been a professor of complementary medicine at Exeter for ~20 years and having published more papers on this subject than anyone else on the planet, I am naturally interested and would like to express some concerns, if you allow me to.

With my background, I would probably be the last person to argue that a research chair in alternative medicine is not a good and much-needed thing. However, accepting an endowment from a commercially interested source is, as you are well aware, a highly problematic matter.

I am confident that you intend to keep the sponsor at arm’s length and plan to appoint a true scientist to this post who will not engage in the promotional activities which the alternative medicine scene might be expecting. And I am equally sure that the money will be put to good use resulting in good and fully independent science.

But, even if all of this is the case, there are important problems to consider. By accepting Blackmore’s money, you have, perhaps inadvertently, given credit to a commercially driven business empire. As you probably know, Blackmores have a reputation of being ‘a bit on the cavalier side’ when it comes to rules and regulations. This is evidenced, for instance, by the number of complaints that have been upheld against them by the Australian authorities.

For these reasons, the creation of the new chair is not just a step towards generating research, it could (and almost inevitably will) be seen as a boost for quackery. It is foremost this aspect which might endanger the reputation of your university, I am afraid.

My own experience over the last two decades has taught me to be cautious and sceptical regarding the motives of many involved in the multi-billion alternative medicine business. I have recently published my memoir entitled ‘A SCIENTIST IN WONDERLAND. SEARCHING FOR TRUTH AND FINDING TROUBLE'; it might be a helpful read for you and the new professor.

I hope you take my remarks as they were meant: constructive advice from someone who had to learn it all the hard way. If I can be of further assistance, please do not hesitate to ask me.

Sincerely

Edzard Ernst

This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.

In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.

In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.

What result do we expect?

Will the quality of life after all this be equal in both groups?

Will it be better in the miffed controls?

Or will it be higher in those lucky ones who got all this extra pampering?

I don’t think I need to answer these questions; the answers are too obvious and too trivial.

But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?

I would argue the latter!

Why?

Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.

But, in truth, there is no question at all!

Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients. 

The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.

My question is ARE SUCH TRIALS ETHICAL?

I would very much appreciate your opinion.

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