MD, PhD, FMedSci, FSB, FRCP, FRCPEd

EBM


You may recall, we have dealt with the JCAM many times before; for instance here, here, here and here. Now they have come out with another remarkable paper. This study – no, the authors called it a ‘pilot study’ – was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Sixty-three American high-ability students in grades 6–12, ages 10–18 years, who scored in the moderate to high ranges for anxiety on the Revised Children’s Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to one of three groups:

  • CBT (n = 21),
  • EFT (n = 21),
  • or waitlist control (n = 21).

EFT is an alternative therapy that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants.

EFT participants showed significant reduction in anxiety levels compared with the waitlist control group with a moderate to large effect size. CBT participants did not differ significantly from the EFT or control.

The authors concluded that EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.

They also state in their abstract that EFT is an evidence-based treatment for anxiety…

Are you happy with these conclusions?

Are you convinced that this trial lends itself to establish efficacy of anything?

Are you impressed with the trial design, the sample size, etc?

Are you sure that EFT is plausible, credible or evidence-based in any way?

No?

Me neither!

If you look up EFT, you will find that there is a surprising amount of papers on it. Most of them have one thing in common: they were published in highly dubious journals. The field does not inspire trust or competence. The authors of the study state that EFT is an easily implemented strategy that uses such techniques as awareness building, exposure, reframing of interpretation, and systematic desensitization, while teaching the participant to self-stimulate protocol-identified acupoints (i.e., acupuncture points) by tapping. The effectiveness of acupuncture for treating anxiety has been well documented. Rather than using acupuncture needles, EFT relies on the manual stimulation of the acupoints. A recent meta-analysis indicated that interventions using acupoint stimulation had a moderate effect size (Hedge’s g = −0.66 95% CI [−0.99, −0.33]) in reducing symptoms. In EFT, the client stimulates the protocol-identified acupoints by tapping on them. Preliminary studies have suggested that tapping and other alternative ways of stimulating acupuncture points to be as effective as acupuncture needling. The EFT protocol and identified acupoints that were used in this study are the ones recommended for research purposes by the Association for Comprehensive Energy Psychology…

Wikipedia tells us that “Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy (TFT). It is best known through Gary Craig’s EFT Handbook, published in the late 1990s, and related books and workshops by a variety of teachers. EFT and similar techniques are often discussed under the umbrella term “energy psychology”. Advocates claim that the technique may be used to treat a wide variety of physical and psychological disorders, and as a simple form of self-administered therapy.[1] The Skeptical Inquirer describes the foundations of EFT as “a hodgepodge of concepts derived from a variety of sources, [primarily] the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body.” The existence of this life force is “not empirically supported”.[2] EFT has no benefit as a therapy beyond the placebo effect or any known-effective psychological techniques that may be provided in addition to the purported “energy” technique.[3] It is generally characterized as pseudoscience and it has not garnered significant support in clinical psychology.”

A recent systematic review of EFT concluded that “there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.”

Notwithstanding these and many other verdicts on EFT, we now are asked to agree with the new study that EFT IS EFFICACIOUS.

Is this a joke?

They want us to believe this on the basis of  a PILOT STUDY? Such studies are not even supposed to test efficacy! (Yet the authors of the trial state that this study was designed to meet the American Psychological Association (APA) Division 12 quality control criteria and the Consolidated Standards for Reporting Trials (CONSORT) criteria. I have to admit, they could have fooled me!)

No, it is not a joke, it is yet another nonsense from the ‘The Journal of Complementary and Alternative Medicine’ which, in my view, should henceforth be called THE JOURNAL OF ALTERNATIVE FACTS (JAF).

It would be wrong to call the Czech Republic the promised land for homeopathy. For instance, the only research paper by Czech authors related to the subject that I could locate was published in the Journal ‘Homeopathy‘ and, on even superficial reading, it has little to do with homeopathy. Here is the abstract:

We discovered a previously unknown phenomenon in liquid water, which develops over time when water is left to stand undisturbed, and which made precise gravimetric measurement impossible. We term this property autothixotropy (weak gel-like behaviour developing spontaneously over time) and propose a possible explanation. The results of quantitative measurements, performed by two different methods, are presented. We also report the newly discovered phenomenon of autothixotropy-hysteresis and describe the dependence of autothixotropy on the degree of molecular translative freedom. A very important conclusion is that the presence of very low concentration of salt ions, these phenomena do not occur in deionized water. Salt ions may be the determinative condition for the occurrence of the phenomena.

In fact, historically, homeopathy had had a hard time in this country. Until World War II only very few doctors practiced homeopathy on Czech territory. Dr. Quin, founder of British homeopathy, practiced a short time in the small town of Tisnov. A Catholic homeopathic hospital existed at Kromeriz since 1860. During the communist era of 1948-89, homeopathy was prohibited, and, until 1991, no books about homeopathy were available in the Czech language. More recently, about 20 titles were published by the Alternativa Publishing house. The Czech Homeopathic Medical Chamber is an organisation that only permits MDs and currently has about 1000 members. The Czech Medical Homeopathic Society has only about 300 members.

After the fall of the ‘iron curtain’, homeopathy evidently became more popular. It has recently been reported that the number of homeopathic remedies sold in the Czech Republic rose by over 50% during the past 15 years. Last year, Czechs bought homeopathic preparations for over 170 million crowns, which is 10% more than a year ago.  “The patients most frequently use homeopathics against the problems associated with common viral diseases,” said Ales Krebs, deputy chairman of the Czech Pharmacy Chamber.  The homeopathic flu remedy Oscillococcinum seems to be one of the most popular homeopathic preparation in the Czech Republic. Yet Czech chemists say that it is ‘absolute nonsense’.

Most physicians seem to be equally cynical about homeopathy and its practitioners: “Homeopathics are perfect drugs. The manufacturing is dirt cheap and they sell for 60 crowns. They cannot be forged because the fakes have the same effect as the original product,” Czech doctors joke about the growing interest in homeopathy. Stepan Svacina, chairman of the Czech Medical Society, says: “The doctor can use a placebo in a psychological therapy. It does not matter whether this may be a homeopathic preparation or jumping on one leg.” Another doctor is quoted as stating that “Advocates of homeopathy often argue with doctors’ conspiracy with pharmaceutical makers, but they themselves certainly do not offer their methods for free as a sort of philanthropy.”

The cost for a first consultation with a Czech homeopath ranges between 100 to 3,000 crowns. The patient pays another 800-1,000 crowns for each next examination. ($1 = 24.846 crowns)

In 2014, the Czech Republic Ministry of Health issued a press-release stating that…although the Ministry for Health of the Czech Republic does not perceive the evidence base for homeopathy to be strong enough yet, this does not prevent doctors from utilising this if it is desired and appropriate…

Because the use of homeopathy cannot ever be considered to be ‘appropriate’, this declaration could arguably be interpreted by those who insist on evidence as a new prohibition of homeopathy in the Czech Republic.

“When orthodox medicine has nothing more to offer” is the title of an article by Dr Elizabeth Thompson, a UK medical homeopath. The article was written years ago, but it is still an excellent example for disclosing the dangerously false and deeply unethical reasoning used by many alternative practitioners. The notion that all sorts of disproven treatments like homeopathy are justified when orthodox medicine has nothing more to offer is so very prevalent that I decided to do this post analysing it.

In the following, you see the most relevant sections of Dr Thompson’s original article (in normal print) and my brief comments (in brackets and in bold):

…Some people come when conventional treatments can no longer offer them anything to save their lives. This is a frightening time for them and although the homeopathic approach may not offer a cure at this late stage of their illness (Is she implying that, in some cases, homeopathy can cure cancer?), it can often offer hope of a different kind. (Surely, one does not need homeopathy for giving patients hope). Sometimes it helps people to outlive the prognosis given to them by months or even years. (A prognosis is not a precise time of death; it is based on statistics and therefore depicts a likelihood, not a certainty. Thus patients outlive their prognosis all the time regardless of treatments.) Sometimes it helps them need less (less than what? there is no control group and therefore the statement seems nonsensical) in the way of conventional medicine including pain killers and offers them continuing support despite progressive disease (is she trying to say that in conventional medicine patients with progressive disease do not get continuing support?).

As a doctor working in both conventional and complementary cancer care I have learned the importance of integrating these two perspectives (the integration of unproven therapies into EBM can only render the latter less effective). Ideally the doctor practising homeopathy would work as an integral part of a much wider team which would include family members, nurses, general practitioners, oncologists, surgeons, palliative physicians and other complementary therapists (the concept of a multi-disciplinary team for cancer is one from conventional medicine where it has long been routine). It is disappointing sometimes to see that other healthcare professionals can be unsupportive of a person’s desire to use complementary therapies and for some people the knowledge that the team is not working together can cause doubt and insecurity (for the majority of patients, however, it might be reassuring to know that their oncology-team is evidence-based).

Some patients come at the beginning of their diagnosis wanting to support their bodies with gentler (homeopathic remedies are not gentler, they are ineffective) approaches and help themselves recover from some difficult and powerful treatments such as chemotherapy and radiotherapy (Why are they being told that alternative therapies are effective in achieving these aims when there is no good evidence to show that this is true? Isn’t that unethical?). As well as using homeopathic medicines (no good evidence of effectiveness!!!), the GHH also has experience in using Mistletoe which is given by injection and has been shown to stimulate the group of white cells whose numbers can be depleted during chemotherapy and radiotherapy (also no good evidence that it works clinically!!!).

Other patients come when they have finished most of their treatments but may still not be feeling well despite being given the all clear by their doctors (same again: no good evidence!!!)…

One wonderful aspect of the homeopathic approach is that it can be a very important opportunity to help someone re-evaluate their life and their health (We don’t need to prescribe placebos for that, this aim is better reached by employing a clinical psychologist).

Sometimes hurts in the past have never been healed and sitting with someone as they describe difficult experiences can be itself therapeutic. Combining this therapeutic listening time with substances from nature that gently stimulate the body’s own healing potential (where is the evidence for that claim?) can be an approach that through patient demand and research (what research?) we can demonstrate is really worth offering to many more people…

END OF QUOTE

 

This text shows in an exemplary fashion how desperate patients can be convinced to make dramatically wrong choices. If you read Dr Thompson’s text without my comments, it probably sounds fairly reasonable to many people. I can understand why patients and carers end up thinking that homeopathy or other disproven therapies are reasonable options WHEN ORTHODOX MEDICINE HAS NOTHING MORE TO OFFER.

But the claim of homeopaths and others that mainstream medicine has, in certain cases, nothing more to offer is demonstrably wrong. Supportive and palliative care are established and important parts of conventional medicine. To deny this fact amounts to a lie! The implied scenario where a patient is told by her oncology team: “sorry but we cannot do anything else for you”, does quite simply not exist. The argument is nothing else but a straw-man – and a vicious one at that.

Moreover, the subsequent argument of homeopaths, “as ‘they’ have given you up, we now offer you our effective homeopathic remedies”, is not supported by good evidence. In other words, one lie is added to another. To call this unethical, would be the understatement of the year, I think.

Guest post by Pete Attkins

Commentator “jm” asked a profound and pertinent question: “What DOES it take for people to get real in this world, practice some common sense, and pay attention to what’s going on with themselves?” This question was asked in the context of asserting that personal experience always trumps the results of large-scale scientific experiments; and asserting that alt-med experts are better able to provide individulized healthcare than 21st Century orthodox medicine.

What does common sense and paying attention lead us to conclude about the following? We test a six-sided die for bias by rolling it 100 times. The number 1 occurs only once and the number 6 occurs many times, never on its own, but in several groups of consecutive sixes.

I think it is reasonable to say that common sense would, and should, lead everyone to conclude that the die is biased and not fit for its purpose as a source of random numbers.

In other words, we have a gut feeling that the die is untrustworthy. Gut instincts and common sense are geared towards maximizing our chances of survival in our complex and unpredictable world — these are innate and learnt behaviours that have enabled humans to survive despite the harshness of our ever changing habitat.

Only very recently in the long history of our species have we developed specialized tools that enable us to better understand our harsh and complex world: science and critical thinking. These tools are difficult to master because they still haven’t been incorporated into our primary and secondary formal education systems.

The vast majority of people do not have these skills therefore, when a scientific finding flies in the face of our gut instincts and/or common sense, it creates an overwhelming desire to reject the finding and classify the scientist(s) as being irrational and lacking basic common sense. It does not create an intense desire to accept the finding then painstakingly learn all of the science that went into producing the finding.

With that in mind, let’s rethink our common sense conclusion that the six-sided die is biased and untrustworthy. What we really mean is that the results have given all of us good reason to be highly suspicious of this die. We aren’t 100% certain that this die is biased, but our gut feeling and common sense are more than adequate to form a reasonable mistrust of it and to avoid using it for anything important to us. Reasons to keep this die rather than discard it might be to provide a source of mild entertainment or to use its bias for the purposes of cheating.

Some readers might be surprised to discover at this point that the results I presented from this apparently heavily-biased die are not only perfectly valid results obtained from a truly random unbiased die, they are to be fully expected. Even if the die had produced 100 sixes in that test, it would not confirm that the die is biased in any way whatsoever. Rolling a truly unbiased die once will produce one of six possible outcomes. Rolling the same die 100 times will produce one unique sequence out of the 6^100 (6.5 x 10^77) possible sequences: all of which are equally valid!

Gut feeling plus common sense rightfully informs us that the probability of a random die producing one hundred consecutive sixes is so incredibly remote that nobody will ever see it occur in reality. This conclusion is also mathematically sound: if there were 6.5 x 10^77 people on Earth, each performing the same test on truly random dice, there is no guarantee that anyone would observe a sequence of one hundred consecutive sixes.

When we observe a sequence such as 2 5 1 4 6 3 1 4 3 6 5 2… common sense informs us that the die is very likely random. If we calculate the arithmetic mean to be very close to 3.5 then common sense will lead us to conclude that the die is both random and unbiased enough to use it as a reliable source of random numbers.

Unfortunately, this is a perfect example of our gut feelings and common sense failing us abysmally. They totally failed to warn us that the 2 5 1 4 6 3 1 4 3 6 5 2… sequence we observed had exactly the same (im)probability of occurring as a sequence of one hundred 6s or any other sequence that one can think of that doesn’t look random to a human observer.

The 100-roll die test is nowhere near powerful enough to properly test a six-sided die, but this test is more than adequately powered to reveal some of our cognitive biases and some of the deficits in our personal mastery of science and critical thinking.

To properly test the die we need to provide solid evidence that it is both truly random and that its measured bias tends towards zero as the number of rolls tends towards infinity. We could use the services of one testing lab to conduct billions of test rolls, but this would not exclude errors caused by such things as miscalibrated equipment and experimenter bias. It is better to subdivide the testing across multiple labs then carefully analyse and appropriately aggregate the results: this dramatically reduces errors caused by equipment and humans.

In medicine, this testing process is performed via systematic reviews of multiple, independent, double-blind, placebo-controlled trials — every trial that is insufficiently powered to add meaningfully to the result is rightfully excluded from the aggregation.

Alt-med relies on a diametrically opposed testing process. It performs a plethora of only underpowered tests; presents those that just happen to show a positive result (just as a random die could’ve produced); and sweeps under the carpet the overwhelming number of tests that produced a negative result. It publishes only the ‘successes’, not its failures. By sweeping its failures under the carpet it feels justified in making the very bold claim: Our plethora of collected evidence shows clearly that it mostly ‘works’ and, when it doesn’t, it causes no harm.

One of the most acidic tests for a hypothesis and its supporting data (which is a mandatory test in a few branches of critical engineering) is to substitute the collected data for random data that has been carefully crafted to emulate the probability mass functions of the collected datasets. This test has to be run multiple times for reasons that I’ve attempted to explain in my random die example. If the proposer of the hypothesis is unable to explain the multiple failures resulting from this acid test then it is highly likely that the proposer either does not fully understand their hypothesis or that their hypothesis is indistinguishable from the null hypothesis.

Complementary treatments have become a popular (and ‘political correct’) option to keep desperate cancer patients happy. But how widely accepted is their use in oncology units? A brand-new article tried to find the answer to this question.

The principal aim of this survey was to map centres across Europe prioritizing those that provide public health services and operating within the national health system in integrative oncology (IO). A cross-sectional descriptive survey design was used to collect data. A questionnaire was elaborated concerning integrative oncology therapies to be administered to all the national health system oncology centres or hospitals in each European country. These institutes were identified by convenience sampling, searching on oncology websites and forums. The official websites of these structures were analysed to obtain more information about their activities and contacts.

Information was received from 123 (52.1 %) out of the 236 centres contacted until 31 December 2013. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) had research in progress or carried out until the deadline of the survey. The complementary and alternative medicines (CAMs) more frequently provided to cancer patients were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %). Treatments are mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The CAMs were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %).

As so often with surveys of this nature, the high non-response rate creates a problem: it is not unreasonable to assume that those centres that responded had an interest in IO, while those that failed to respond tended to have none. Thus the figures reported here for the usage of alternative therapies might be far higher than they actually are. One can only hope that this is the case. The idea that 40% of all cancer patients receive homeopathy, for instance, is hardly one that is in accordance with the principles of evidence-based practice.

The list of medical reasons for using largely unproven treatments is interesting, I think. I am not aware of lots of strong evidence to show that any of the treatments in question would generate more good than harm for any of the conditions in question.

What follows from all of this is worrying, in my view: thousands of desperate cancer patients are being duped into having bogus treatments paid for by their national health system. This, I think, begs the question whether these most vulnerable patients do not deserve better.

Getting good and experienced lecturers for courses is not easy. Having someone who has done more research than most working in the field and who is internationally known, might therefore be a thrill for students and an image-boosting experience of colleges. In the true Christmas spirit, I am today making the offer of being of assistance to the many struggling educational institutions of alternative medicine .

A few days ago, I tweeted about my willingness to give free lectures to homeopathic colleges (so far without response). Having thought about it a bit, I would now like to extend this offer. I would be happy to give a free lecture to the students of any educational institution of alternative medicine. I suggest to

  • do a general lecture on the clinical evidence of the 4 major types of alternative medicine (acupuncture, chiropractic, herbal medicine, homeopathy) or
  • give a more specific lecture with in-depth analyses of any given alternative therapy.

I imagine that most of the institutions in question might be a bit anxious about such an idea, but there is no need to worry: I guarantee that everything I say will be strictly and transparently evidence-based. I will disclose my sources and am willing to make my presentation available to students so that they can read up the finer details about the evidence later at home. In other words, I will do my very best to only transmit the truth about the subject at hand.

Nobody wants to hire a lecturer without having at least a rough outline of what he will be talking about – fair enough! Here I present a short summary of the lecture as I envisage it:

  • I will start by providing a background about myself, my qualifications and my experience in researching and lecturing on the matter at hand.
  • This will be followed by a background on the therapies in question, their history, current use etc.
  • Next I would elaborate on the main assumptions of the therapies in question and on their biological plausibility.
  • This will be followed by a review of the claims made for the therapies in question.
  • The main section of my lecture would be to review the clinical evidence regarding the efficacy of therapies in question. In doing this, I will not cherry-pick my evidence but rely, whenever possible, on authoritative systematic reviews, preferably those from the Cochrane Collaboration.
  • This, of course, needs to be supplemented by a review of safety issues.
  • If wanted, I could also say a few words about the importance of the placebo effect.
  • I also suggest to discuss some of the most pertinent ethical issues.
  • Finally, I would hope to arrive at a few clear conclusions.

You see, all is entirely up to scratch!

Perhaps you have some doubts about my abilities to lecture? I can assure you, I have done this sort of thing all my life, I have been a professor at three different universities, and I will probably manage a lecture to your students.

A final issue might be the costs involved. As I said, I would charge neither for the preparation (this can take several days depending on the exact topic), nor for the lecture itself. All I would hope for is that you refund my travel (and, if necessary over-night) expenses. And please note: this is  time-limited: approaches will be accepted until 1 January 2015 for lectures any time during 2015.

I can assure you, this is a generous offer  that you ought to consider seriously – unless, of course, you do not want your students to learn the truth!

(In which case, one would need to wonder why not)

Most of the underlying assumptions of alternative medicine (AM) lack plausibility. Whenever this is the case, so the argument put forward by an international team of researchers in a recent paper, there are difficulties involved in obtaining a valid statistical significance in clinical studies.

Using a mostly statistical approach, they argue that, since the prior probability of a research hypothesis is directly related to its scientific plausibility, the commonly used frequentist statistics, which do not account for this probability, are unsuitable for studies exploring matters in various degree disconnected from science. Any statistical significance obtained in this field should be considered with great caution and may be better applied to more plausible hypotheses (like placebo effect) than the specific efficacy of the intervention.

The researchers conclude that, since achieving meaningful statistical significance is an essential step in the validation of medical interventions, AM practices, producing only outcomes inherently resistant to statistical validation, appear not to belong to modern evidence-based medicine.

To emphasize their arguments, the researchers make the following additional points:

  • It is often forgotten that frequentist statistics, commonly used in clinical trials, provides only indirect evidence in support of the hypothesis examined.
  • The p-value inherently tends to exaggerate the support for the hypothesis tested, especially if the scientific plausibility of the hypothesis is low.
  • When the rationale for a clinical intervention is disconnected from the basic principles of science, as in case of complementary alternative medicines, any positive result obtained in clinical studies is more reasonably ascribable to hypotheses (generally to placebo effect) other than the hypothesis on trial, which commonly is the specific efficacy of the intervention.
  • Since meaningful statistical significance as a rule is an essential step to validation of a medical intervention, complementary alternative medicine cannot be considered evidence-based.

Further explanations can be found in the discussion of the article where the authors argue that the quality of the hypothesis tested should be consistent with sound logic and science and therefore have a reasonable prior probability of being correct. As a rule of thumb, assuming a “neutral” attitude towards the null hypothesis (odds = 1:1), a p-value of 0.01 or, better, 0.001 should suffice to give a satisfactory posterior probability of 0.035 and 0.005 respectively.

In the area of AM, hypotheses often are entirely inconsistent with logic and frequently fly in the face of science. Four examples can demonstrate this instantly and sufficiently, I think:

  • Homeopathic remedies which contain not a single ‘active’ molecule are not likely to generate biological effects.
  • Healing ‘energy’ of Reiki masters has no basis in science.
  • Meridians of acupuncture are pure imagination.
  • Chiropractic subluxation have never been shown to exist.

Positive results from clinical trials of implausible forms of AM are thus either due to chance, bias or must be attributed to more credible causes such as the placebo effect. Since the achievement of meaningful statistical significance is an essential step in the validation of medical interventions, unless some authentic scientific support to AM is provided, one has to conclude that AM cannot be considered as evidence-based.

Such arguments are by no means new; they have been voiced over and over again. Essentially, they amount to the old adage: IF YOU CLAIM THAT YOU HAVE A CAT IN YOUR GARDEN, A SIMPLE PICTURE MAY SUFFICE. IF YOU CLAIM THERE IS A UNICORN IN YOUR GARDEN, YOU NEED SOMETHING MORE CONVINCING. An extraordinary claim requires an extraordinary proof! Put into the context of the current discussion about AM, this means that the usual level of clinical evidence is likely to be very misleading as long as it totally neglects the biological plausibility of the prior hypothesis.

Proponents of AM do not like to hear such arguments. They usually insist on what we might call a ‘level playing field’ and fail to see why their assumptions require not only a higher level of evidence but also a reasonable scientific hypothesis. They forget that the playing field is not even to start with; to understand the situation better, they should read this excellent article. Perhaps its elegant statistical approach will convince them – but I would not hold my breath.

I have often asked myself whether it is right/necessary to scientifically test things which are entirely implausible. Should we, for instance test the effectiveness of treatments which have a very low prior probability of generating a positive effect such as paranormal healing, homeopathy or Bach flower remedies? If you believe in the principles of evidence-based medicine you might focus on the clinical evidence and see biological plausibility as secondary. If you are a basic scientist, you are likely to do the reverse.

A recent article addressed this issue. The author points out that evaluating the absurd is absurd. Specifically, he noted that the empirical evaluation of a therapy would normally assume a plausible rationale regarding the mechanism of action. However, examination of the historical background and underlying principles for reflexology, iridology, acupuncture, auricular acupuncture, and some herbal medicines, reveals a rationale founded on the principle of analogical correspondences, which is a common basis for magical thinking and pseudoscientific beliefs such as astrology and chiromancy. Where this is the case, it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd.

This makes a lot of sense – but is it really entirely true? Are there no legitimate reasons at all for testing alternative treatments that lack biological plausibility? Ten or twenty years ago, I would have disagreed with the notion that plausibility is an essential prerequisite for scientific testing; today, I have changed my mind a little, but not as much as to agree completely with the assumption. In other words, I still see more than one good reason why evaluating the absurd might be reasonable or even advisable.

  1. Using plausibility as the only arbiter of scientific ‘evaluability’, assumes that we understand everything about plausibility there is to know. Yet it might just be possible that we mis-categorise something as implausible simply because we are not yet fully aware of all the facts.
  2. Declaring something as plausible and another thing as implausible are not hard and fast verdicts but judgements which, at least to some degree, are subjective. Sceptics find the axioms of homeopathy utterly implausible, for instance – but ask a homeopath, and you will hear all sorts of explanations which, at least to them, sound plausible.
  3. If an implausible alternative treatment is in wide-spread use, we arguably have a responsibility to test it scientifically in order to demonstrate the truth about it (to those proponents of that therapy who are willing to accept that rigorous science can find the truth). If we fail to do this, it will be the enthusiasts of that therapy who conduct less than rigorous science and produce false positive results. In turn, this will give the impression that the treatment is effective and mislead consumers, politicians, journalists etc. Seen from this perspective, it might even be unethical to not do the science.

So, I am in two minds about this (which might be a reflection of the fact that, during different periods of my life, I have been a clinician, a basic scientist and a clinical researcher). I realise that plausibility and prior probability are important – much more so than I appreciated years ago. But I think they should not be the only criteria. The clinical evidence should not be pushed aside completely.

I’d be interested to learn your views on this tricky issue.

As I write these words, I am travelling back from a medical conference. The organisers had invited me to give a lecture which I concluded saying: “anyone in medicine not believing in evidence-based health care is in the wrong business”. This statement was meant to stimulate the discussion and provoke the audience who were perhaps just a little on the side of those who are not all that taken by science.

I may well have been right, because, in the coffee break, several doctors disputed my point; to paraphrase their arguments: “You don’t believe in the value of experience, you think that science is the way to know everything. But you are wrong! Philosophers and other people, who are a lot cleverer than you, tell us that science is not the way to real knowledge; and in some forms of medicine we have a wealth of experience which we cannot ignore. This is at least as important as scientific knowledge. Take TCM, for instance, thousands of years of tradition must mean something; in fact it tells us more than science will ever be able to. Qi-energy, for instance, is a concept based on experience, and science is useless at verifying it.”

I disagreed, of course. But I am afraid that I did not convince my colleagues. The appeal to tradition is amazingly powerful, so much so that even well-seasoned physicians fall for it. Yet it nevertheless is a fallacy, I am sure.

So what does experience tell us, how is it generated and why should it be unreliable?

On the level of the individual, experience emerges when a clinician makes similar observations several times in a row. This is so persuasive that few doctors are immune to the phenomenon. Let’s assume the experience is about acupuncture, more precisely about acupuncture for smoking cessation. The acupuncturist presumably has learnt during his training that his therapy works for that indication via stimulating the flow of Qi, and promptly tries it on several patients. Some of them come back for more and report that they find it easier to give up cigarettes after consulting him. This happens repeatedly, and our clinician forthwith is convinced – in fact, he knows – that acupuncture is effective for smoking cessation.

If we critically analyse this scenario, what does it tell us? It tells us very little of relevance, I am afraid. The scenario is entirely compatible with a whole host of explanations which have nothing to do with the effects of acupuncture per se:

  • Those patients who did not manage to stop smoking might not have returned. Only seeing his successes without his failures, the acupuncturist would have got the wrong end of the stick.
  • Human memory is selective such that the few patients who did come back and reported failure might easily get forgotten by the clinician. We all remember the good things and forget the disappointments, particularly if we are clinicians.
  • The placebo-effect might have played a dirty trick on the experience of our acupuncturist.
  • Some patients might have used nicotine patches that helped him to stop smoking without disclosing this fact to the acupuncturist who then, of course, attributed the benefit to his needling.
  • The acupuncturist – being a very kind and empathetic clinician – might have involuntarily induced some of his patients to show kindness in return and thus tell porkies about their smoking habits which would have created a false positive impression about the effectiveness of his treatment.
  • Being so empathetic, the acupuncturists would have provided lots of encouragement to stop smoking which, in some patients, might have been sufficient to kick the habit.

 

The long and short of all this is that our acupuncturist gradually got convinced by this interplay of factors that Qi exists and that acupuncture is an ineffective treatment. Hence forth he would bet his last shirt that he is right about this – after all, he has seen it with his own eyes, not just once but many times. And he will doubt anyone who shows him evidence that says otherwise. In fact, he is likely become very sceptical about scientific evidence in general – just like the doctors who talked to me after my lecture.

On a population level, such experience will be prevalent in not just one but most acupuncturists. Our clinician’s experience is certainly not unique; others will have made it too. In fact, as an acupuncturist, it is hard not to make it. Acupuncturists would have told everyone else about it, perhaps reported it on conferences or published it in articles or books. Experience of this nature is passed on from generation to generation, and soon someone will be able to demonstrate that acupuncture has been used ’effectively’ for smoking cessation since decades or centuries. The creation of a myth out of unreliable experience is thus complete.

Am I saying that experience of this nature is always and necessarily wrong or useless? No, I am not. It can be and often is correct. But, at the same time, it is frequently incorrect. It can serve as a valuable indicator but not more. Experience is not a tool for reliably informing us about the effectiveness of medical interventions. Experience based-medicine is an obsolete pseudo-medicine burdened with concepts that are counter-productive to optimal health care.

Philosophers and other people who are much cleverer than I am have been trying for some time to separate good from bad science and evidence from experience. Most recently, two philosophers, MASSIMO PIGLIUCCI and MAARTEN BOUDRY, commented specifically on this problem in relation to TCM. I leave you with some extensive quotes from what they wrote.

… pointing out that some traditional Chinese remedies (like drinking fresh turtle blood to alleviate cold symptoms) may in fact work, and therefore should not be dismissed as pseudoscience… risks confusing the possible effectiveness of folk remedies with the arbitrary theoretical-metaphysical baggage attached to it. There is no question that some folk remedies do work. The active ingredient of aspirin, for example, is derived from willow bark…

… claims about the existence of “Qi” energy, channeled through the human body by way of “meridians,” though, is a different matter. This sounds scientific, because it uses arcane jargon that gives the impression of articulating explanatory principles. But there is no way to test the existence of Qi and associated meridians, or to establish a viable research program based on those concepts, for the simple reason that talk of Qi and meridians only looks substantive, but it isn’t even in the ballpark of an empirically verifiable theory.

…the notion of Qi only mimics scientific notions such as enzyme actions on lipid compounds. This is a standard modus operandi of pseudoscience: it adopts the external trappings of science, but without the substance.

…The notion of Qi, again, is not really a theory in any meaningful sense of the word. It is just an evocative word to label a mysterious force of which we do not know and we are not told how to find out anything at all.

Still, one may reasonably object, what’s the harm in believing in Qi and related notions, if in fact the proposed remedies seem to help? Well, setting aside the obvious objections that the slaughtering of turtles might raise on ethical grounds, there are several issues to consider. To begin with, we can incorporate whatever serendipitous discoveries from folk medicine into modern scientific practice, as in the case of the willow bark turned aspirin. In this sense, there is no such thing as “alternative” medicine, there’s only stuff that works and stuff that doesn’t.

Second, if we are positing Qi and similar concepts, we are attempting to provide explanations for why some things work and others don’t. If these explanations are wrong, or unfounded as in the case of vacuous concepts like Qi, then we ought to correct or abandon them. Most importantly, pseudo-medical treatments often do not work, or are even positively harmful. If you take folk herbal “remedies,” for instance, while your body is fighting a serious infection, you may suffer severe, even fatal, consequences.

…Indulging in a bit of pseudoscience in some instances may be relatively innocuous, but the problem is that doing so lowers your defenses against more dangerous delusions that are based on similar confusions and fallacies. For instance, you may expose yourself and your loved ones to harm because your pseudoscientific proclivities lead you to accept notions that have been scientifically disproved, like the increasingly (and worryingly) popular idea that vaccines cause autism.

Philosophers nowadays recognize that there is no sharp line dividing sense from nonsense, and moreover that doctrines starting out in one camp may over time evolve into the other. For example, alchemy was a (somewhat) legitimate science in the times of Newton and Boyle, but it is now firmly pseudoscientific (movements in the opposite direction, from full-blown pseudoscience to genuine science, are notably rare)….

The borderlines between genuine science and pseudoscience may be fuzzy, but this should be even more of a call for careful distinctions, based on systematic facts and sound reasoning. To try a modicum of turtle blood here and a little aspirin there is not the hallmark of wisdom and even-mindedness. It is a dangerous gateway to superstition and irrationality

Acupuncture has remained one of the most controversial topics in the area of alternative medicine. Is it plausible? Is it safe? Is it effective? The arguments have been raging for decades and are by no means settled yet. The June issue of Anesth. Analg. is partly dedicated to this debate; the editor has invited two teams of experts to put forward their contrasting views.

The team of experts arguing in support of acupuncture conclude as follows: “clinical trials support the efficacy of acupuncture in reducing post-operative nausea and vomiting and postoperative pain; however, evidence supporting acupuncture as a treatment for chronic pain conditions is mixed. It should be noted that acupuncture trials in chronic pain have concluded that acupuncture treatment is often superior to standard of care or wait list controls and that acupuncture has minimal side effects and is cost effective. Brain imaging studies have demonstrated that there are different neural correlates between verum and sham acupuncture stimulation. Additionally, all clinical trials and many research studies have assumed that the acupuncture effect is equal to the “needle” effect, failing to recognize that factors in addition to specific effects of needling are also important contributors to the therapeutic effect of acupuncture in the setting of chronic pain.

Last, acupuncture is an ancient medical intervention first developed in an era when there were no laboratory tests, technology, or science of anatomy. The reason that the practice of acupuncture has survived for thousands of years is because it has evolved over time, with changes ranging from the number of acupuncture points to the practice techniques. Instead of criticizing this ancient art with arguments culled from modern medicine and science, physicians and scientists should try to integrate current knowledge into this ancient, yet ever-evolving practice so it may be used to treat conditions for which pharmaceutical interventions are ineffective and/or potentially dangerous. Over the last decade, there has been a growing green movement and eco-sustainability trend as well as an increased awareness that the same medication may not be effective in treating every patient with the same biomedical diagnosis. This “new age-integrative medicine in Western culture promotes a patient-oriented medical practice that complements the ancient Chinese theory behind acupuncture practice. Overall, acupuncture practice should not be seen as a placebo intervention or merely a needle therapy, but a medical option that not only treats disorders but also fosters a greater awareness of how harmonic interactions between self, family, work, and environment play a role in promoting health and restoring order”.

The two experts arguing against the usefulness of acupuncture draw the following conclusions: “It is clear from meta-analyses that results of acupuncture trials are variable and inconsistent, even for single conditions.  After thousands of trials of acupuncture and hundreds of systematic reviews,arguments continue unabated. In 2011, Pain published an editorial that summed up the present situation well.

“Is there really any need for more studies? Ernst et al. point out that the positive studies conclude that acupuncture relieves pain in some conditions but not in other very similar conditions. What would you think if a new pain pill was shown to relieve musculoskeletal pain in the arms but not in the legs? The most parsimonious explanation is that the positive studies are false positives. In his seminal article on why most published research findings are false, Ioannidis points out that when a popular but ineffective treatment is studied, false positive results are common for multiple reason, including bias and low prior probability.”

Since it has proved impossible to find consistent evidence after more than 3000 trials, it is time to give up. It seems very unlikely that the money that it would cost to do another 3000 trials would be well-spent.

A small excess of positive results after thousands of trials is most consistent with an inactive intervention. The small excess is predicted by poor study design and publication bias. Furthermore, Simmons et al. demonstrated that exploitation of “undisclosed flexibility in data collection and analysis” can produce statistically positive results even from a completely nonexistent effect. They say this is “… not driven by a willingness to deceive but by the self-serving interpretation of ambiguity, which enables us to convince ourselves that whichever decisions produced the most publishable outcome must have also been the most appropriate.”

With acupuncture, in particular, there is documented profound bias among proponents. Existing studies are also contaminated by variables other than acupuncture, such as the frequent inclusion of “electroacupuncture” which is essentially transdermal electrical nerve stimulation masquerading as acupuncture.

The best controlled studies show a clear pattern, with acupuncture the outcome does not depend on needle location or even needle insertion. Since these variables are those that define acupuncture, the only sensible conclusion is that acupuncture does not work. Everything else is the expected noise of clinical trials, and this noise seems particularly high with acupuncture research. The most parsimonious conclusion is that with acupuncture there is no signal, only noise.

The interests of medicine would be best-served if we emulated the Chinese Emperor Dao Guang and issued an edict stating that acupuncture and moxibustion should no longer be used in clinical practice.

No doubt acupuncture will continue to exist on the “High Streets” where they can be tolerated as a voluntary self-imposed tax on the gullible (as long as they do not make unjustified claims).”

The readers of this blog will no doubt make up their own mind as to which arguments are stronger, more logical, more convincing, and based on more reliable evidence. I recommend reading the full articles and studying the references.

Personally, I have no hesitation in agreeing with the second, more sceptical view, and I have to admit finding the pro-acupuncture arguments weak as well as full of clichés, fallacies and errors.

I look forward to a lively discussion.

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