MD, PhD, FMedSci, FSB, FRCP, FRCPEd

TCM

The news that the use of Traditional Chinese Medicine (TCM) positively affects cancer survival might come as a surprise to many readers of this blog; but this is exactly what recent research has suggested. As it was published in one of the leading cancer journals, we should be able to trust the findings – or shouldn’t we?

The authors of this new study used the Taiwan National Health Insurance Research Database to conduct a retrospective population-based cohort study of patients with advanced breast cancer between 2001 and 2010. The patients were separated into TCM users and non-users, and the association between the use of TCM and patient survival was determined.

A total of 729 patients with advanced breast cancer receiving taxanes were included. Their mean age was 52.0 years; 115 patients were TCM users (15.8%) and 614 patients were TCM non-users. The mean follow-up was 2.8 years, with 277 deaths reported to occur during the 10-year period. Multivariate analysis demonstrated that, compared with non-users, the use of TCM was associated with a significantly decreased risk of all-cause mortality (adjusted hazards ratio [HR], 0.55 [95% confidence interval, 0.33-0.90] for TCM use of 30-180 days; adjusted HR, 0.46 [95% confidence interval, 0.27-0.78] for TCM use of > 180 days). Among the frequently used TCMs, those found to be most effective (lowest HRs) in reducing mortality were Bai Hua She She Cao, Ban Zhi Lian, and Huang Qi.

The authors of this paper are initially quite cautious and use adequate terminology when they write that TCM-use was associated with increased survival. But then they seem to get carried away by their enthusiasm and even name the TCM drugs which they thought were most effective in prolonging cancer survival. It is obvious that such causal extrapolations are well out of line with the evidence they produced (oh, how I wished that journal editors would finally wake up to such misleading language!) .

Of course, it is possible that some TCM drugs are effective cancer cures – but the data presented here certainly do NOT demonstrate anything like such an effect. And before such a far-reaching claim is being made, much more and much better research would be necessary.

The thing is, there are many alternative and plausible explanations for the observed phenomenon. For instance, it is conceivable that users and non-users of TCM in this study differed in many ways other than their medication, e.g. severity of cancer, adherence to conventional therapies, life-style, etc. And even if the researchers have used clever statistical methods to control for some of these variables, residual confounding can never be ruled out in such case-control studies.

Correlation is not causation, they say. Neglect of this elementary axiom makes for very poor science – in fact, it produces dangerous pseudoscience which could, like in the present case, lead a cancer patient straight up the garden path towards a premature death.

Advocates of alternative medicine are incredibly fond of supporting their claims with anecdotes, or ‘case-reports’ as they are officially called. There is no question, case-reports can be informative and important, but we need to be aware of their limitations.

A recent case-report from the US might illustrated this nicely. It described a 65-year-old male patient who had had MS for 20 years when he decided to get treated with Chinese scalp acupuncture. The motor area, sensory area, foot motor and sensory area, balance area, hearing and dizziness area, and tremor area were stimulated once a week for 10 weeks, then once a month for 6 further sessions.

After the 16 treatments, the patient showed remarkable improvements. He was able to stand and walk without any problems. The numbness and tingling in his limbs did not bother him anymore. He had more energy and had not experienced incontinence of urine or dizziness after the first treatment. He was able to return to work full time. Now the patient has been in remission for 26 months.

The authors of this case-report conclude that Chinese scalp acupuncture can be a very effective treatment for patients with MS. Chinese scalp acupuncture holds the potential to expand treatment options for MS in both conventional and complementary or integrative therapies. It can not only relieve symptoms, increase the patient’s quality of life, and slow and reverse the progression of physical disability but also reduce the number of relapses and help patients.

There is absolutely nothing wrong with case-reports; on the contrary, they can provide extremely valuable pointers for further research. If they relate to adverse effects, they can give us crucial information about the risks associated with treatments. Nobody would ever argue that case-reports are useless, and that is why most medical journals regularly publish such papers. But they are valuable only, if one is aware of their limitations. Medicine finally started to make swift progress, ~150 years ago, when we gave up attributing undue importance to anecdotes, began to doubt established wisdom and started testing it scientifically.

Conclusions such as the ones drawn above are not just odd, they are misleading to the point of being dangerous. A reasonable conclusion might have been that this case of a MS-patient is interesting and should be followed-up through further observations. If these then seem to confirm the positive outcome, one might consider conducting a clinical trial. If this study proves to yield encouraging findings, one might eventually draw the conclusions which the present authors drew from their single case.

To jump at conclusions in the way the authors did, is neither justified nor responsible. It is unjustified because case-reports never lend themselves to such generalisations. And it is irresponsible because desperate patients, who often fail to understand the limitations of case-reports and tend to believe things that have been published in medical journals, might act on these words. This, in turn, would raise false hopes or might even lead to patients forfeiting those treatments that are evidence-based.

It is high time, I think, that proponents of alternative medicine give up their love-affair with anecdotes and join the rest of the health care professions in the 21st century.

There are numerous types and styles of acupuncture, and the discussion whether one is better than the other has been long, tedious and frustrating. Traditional acupuncturists, for instance, individualise their approach according to their findings of pulse and tongue diagnoses as well as other non-validated diagnostic criteria. Western acupuncturists, by contrast, tend to use formula or standardised treatments according to conventional diagnoses.

This study aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice of a Chinese-born medical doctor trained in both western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups who received either standardized acupuncture or individualized acupuncture. 10 to 15 treatments based on individual symptoms were given with two treatments per week.

The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale. No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7; standardized acupuncture 1482.9; group difference, 285.8).

The authors concluded that individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain.

But perhaps it matters whether the acupuncturist is thoroughly trained or has just picked up his/her skills during a weekend course? I am afraid not: this analysis of a total of 4,084 patients with chronic headache, lower back pain or arthritic pain treated by 1,838 acupuncturists suggested otherwise. There were no differences in success for patients treated by physicians passing through shorter (A diploma) or longer (B diploma) training courses in acupuncture.

But these are just one single trial and one post-hoc analysis of another study which, by definition, cannot be fully definitive. Fortunately, we have more evidence based on much larger numbers. This brand-new meta-analysis aimed to evaluate whether there are characteristics of acupuncture or acupuncturists that are associated with better or worse outcomes.

An existing dataset, developed by the Acupuncture Trialists’ Collaboration, included 29 trials of acupuncture for chronic pain with individual data involving 17,922 patients. The available data on characteristics of acupuncture included style of acupuncture, point prescription, location of needles, use of electrical stimulation and moxibustion, number, frequency and duration of sessions, number of needles used and acupuncturist experience. Random-effects meta-regression was used to test the effect of each characteristic on the main effect estimate of pain. Where sufficient patient-level data were available, patient-level analyses were conducted.

When comparing acupuncture to sham controls, there was little evidence that the effects of acupuncture on pain were modified by any of the acupuncture characteristics evaluated, including style of acupuncture, the number or placement of needles, the number, frequency or duration of sessions, patient-practitioner interactions and the experience of the acupuncturist. When comparing acupuncture to non-acupuncture controls, there was little evidence that these characteristics modified the effect of acupuncture, except better pain outcomes were observed when more needles were used and, from patient level analysis involving a sub-set of 5 trials, when a higher number of acupuncture treatment sessions were provided.

The authors of this meta-analysis concluded that there was little evidence that different characteristics of acupuncture or acupuncturists modified the effect of treatment on pain outcomes. Increased number of needles and more sessions appear to be associated with better outcomes when comparing acupuncture to non-acupuncture controls, suggesting that dose is important. Potential confounders include differences in control group and sample size between trials. Trials to evaluate potentially small differences in outcome associated with different acupuncture characteristics are likely to require large sample sizes.

My reading of these collective findings is that it does not matter which type of acupuncture you use nor who uses it; the clinical effects are similar regardless of the most obvious potential determinants. Hardly surprising! In fact, one would expect such results, if one considered that acupuncture is a placebo-treatment.

For those who know about the subject, this is an old hat, of course. But for many readers of this blog, it might be news: ‘Traditional’ Chinese Medicine (TCM) is not nearly as traditional as it pretends to be. In fact, it is an artefact of recent creation. The man who has been saying that for years is Professor Paul Unschuld, one of the leading sinologist worldwide and an expert who has written many books and journal articles on the subject.

During an interview given in 2004, he defined TCM as “an artificial system of health care ideas and practices generated between 1950 and 1973 by committees in the People’s Republic of China, with the aim of restructuring the vast and heterogenous heritage of Chinese traditional medicine in such a way that it fitted the principles–Marxist Maoist type democracy and modern science and technology on which the future of the PRC was to be built…[the Daoist underpinning for TCM] is incorrect for two reasons.  First . . . TCM is a product of Communist China.  Second, even if we were to apply the term TCM to pre-revolutionary Chinese medicine, the Daoist impact should be considered minimal.”

In a much more recent interview entitled INVENTION FROM THE FAR EAST which he gave to DER SPIEGEL (in German), he explained this in a little more detail (I have tried to translate his words as literally as possible):

What is being offered in our country to patients as TCM is a construct that was created in China on an office desk which has been altered further on its way to the West.

Already at the beginning of the 20th century, reformers and revolutionaries urged that the traditional medicine in China should be abolished and that the western form of medicine should be introduced instead. Traditional thinking was seen as backwards and it was held responsible for the oppressing superiority of the West. The introduction of Western natural sciences, medicine and technology was also thought later, after the foundation of the People’s Republic, to be essential for rendering the country competitive again. Since the traditional Chinese medicine could not be totally abolished then because it offered a living to many citizens, it was reduced to a kernel, which could be brought just about in line with the scientific orientation  of the future communist society. In the 1950s and 60s, an especially appointed commission had been working on this task. The filtrate which they created from the original medical tradition was hence forward to be called TCM vis a vis foreigners.

There is little more to add, I think - perhaps just two brief after-thoughts. TCM is a most lucrative export article for China. So don’t expect Chinese officials to rid TCM of the highly marketable ‘TRADITIONAL’ label. And remember: the appeal to tradition’ argument is a fallacy anyway.

What is ear acupressure?

Proponents claim that ear-acupressure is commonly used by Chinese medicine practitioners… It is like acupuncture but does not use needles. Instead, small round pellets are taped to points on one ear. Ear-acupressure is a non-invasive, painless, low cost therapy and no significant side effects have been reported.

Ok, but does it work?

There is a lot of money being made with the claim that ear acupressure (EAP) is effective, especially for smoking cessation; entrepreneurs sell gadgets for applying the pressure on the ear, and practitioners earn their living through telling their patients that this therapy is helpful. There are hundreds of websites with claims like this one: Auricular therapy (Acupressure therapy of the ear region) has been used successfully for Smoking cessation. Auriculotherapy is thought to be 7 times more powerful than other methods used for smoking cessation; a single auriculotherapy treatment has been shown to reduce smoking from 20 or more cigarettes a day down to 3 to 5 a day.

But what does the evidence show?

This new study investigated the efficacy of EAP as a stand-alone intervention for smoking cessation. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a non-specific EAP (NSEAP) intervention, EAP at points not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times per day. Participants were followed up for three months. The primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS).

Forty-three adult smokers were randomly assigned to SSEAP (n = 20) or NSEAP (n = 23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

And is there a systematic review of the totality of the evidence?

Sure, the current Cochrane review arrives at the following conclusion: There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation…

So?

Yes, we may well ask! If most TCM practitioners use EAP or acupuncture for smoking cessation telling their customers that it works (and earning good money when doing so), while the evidence fails to show that this is true, what should we say about such behaviour? I don’t know about you, but I find it thoroughly dishonest.

Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.

At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.

BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!

Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.

BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!

“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.

NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.

The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.

BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!

Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.

NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?

Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?

IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.

At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.

WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?

Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.

YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?

We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?

NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.

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

Realgar, a commonly used traditional Chinese medicine, has – according to the teachings of Traditional Chinese Medicine (TCM) – acrid, bitter, warm, and toxic characteristics and is affiliated with the Heart, Liver and Stomach meridians. It is used internally against intestinal parasites and treat sore throats, and is applied externally to treat swelling, abscesses, itching, rashes, and other skin disorders.

Chemically, it is nothing other than arsenic sulphide. Despite its very well-known toxicity, is thought by TCM-practitioners to be safe, and it has been used in TCM under the name ‘Xiong Huang’ for many centuries. TCM-practitioners advise that the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically.

Toxicologists from Taiwan report a case of fatal realgar poisoning after short-term use of a topical realgar-containing herbal medicine.

A 24-year-old man with atopic dermatitis had received 18 days of oral herbal medicine and realgar-containing herbal ointments over whole body from a TCM-practitioner. Seven days later, he started to develop loss of appetite, dizziness, abdominal discomfort, an itching rash and skin scaling. Subsequently he suffered generalized oedema, nausea, vomiting, decreased urine amount, diarrhoea, vesico-oedematous exanthemas, malodorous perspiration, fever, and shortness of breath.

He was taken to hospital on day 19 when the dyspnoea became worse. Toxic epidermal necrolysis complicated with soft tissue infection and sepsis were then diagnosed. The patient died shortly afterwards of septic shock and multiple organ failure. Post-mortem blood arsenic levels were elevated at 1225 μg/L. The analysis of the patient’s herbal remedies yielded a very high concentration of arsenic in three unlabelled realgar-containing ointments (45427, 5512, and 4229 ppm).

The authors of this report concluded that realgar-containing herbal remedy may cause severe cutaneous adverse reactions. The arsenic in realgar can be absorbed systemically from repeated application to non-intact skin and thus should not be extensively used on compromised skin.

The notion that a treatment that ‘has stood the test of time’ must be safe and effective is very wide-spread in alternative medicine. This, we often hear, applies particularly to the external use of traditional remedies – what can be wrong with putting a traditional Chinese herbal cream on the skin?? This case, like so many others, should teach us that this appeal to tradition is a classical and often dangerous fallacy. And the ‘realgar-story’ also suggests that, in TCM, the ‘learning-curve’ is very flat indeed.

Chinese and Ayurvedic remedies are often contaminated with toxic heavy metals. But the bigger danger seems to be that some of these traditional ‘medicines’ contain such toxins because, according to ‘traditional wisdom’, these constituents have curative powers. I think that, until we have compelling evidence that any of these treatments do more good than harm, we should avoid taking them.

Australian researchers wanted to know whether acupuncture is effective for alleviating the symptoms of fibromyalgia, a common painful condition for which no universally accepted treatment exists. For this purpose, they conducted a Cochrane review. After extensive literature searches, they identified 9 RCTs, extracted their data and assessed risk of bias.

The results show that all studies except one were at low risk of selection bias; five were at risk of selective reporting bias; two were subject to attrition bias (favouring acupuncture); three were subject to performance bias (favouring acupuncture) and one to detection bias (favouring acupuncture).

Three studies utilised electro-acupuncture (EA) and the remainder manual acupuncture (MA) without electrical stimulation.

Low quality evidence from one study (13 participants) showed EA improved symptoms with no adverse events at one month following treatment.

Moderate quality evidence from six studies (286 participants) indicated that acupuncture (EA or MA) was no better than sham acupuncture, except for less stiffness at one month. Subgroup analysis of two studies (104 participants) indicated benefits of EA. Mean pain was 70 points on 0 to 100 point scale with sham treatment; EA reduced pain by 13% (5% to 22%).

Low-quality evidence from one study suggested that MA resulted in poorer physical function: mean function in the sham group was 28 points (100 point scale); treatment worsened function by a mean of 6 points.

Moderate quality evidence from one study (58 participants) found that, compared with standard therapy alone (antidepressants and exercise), adjunct acupuncture therapy reduced pain at one month after treatment.

Low quality evidence from one study (38 participants) showed a short-term benefit of acupuncture over antidepressants in pain relief.

Moderate-quality evidence from one study (41 participants) indicated that deep needling with or without deqi did not differ in pain, fatigue, function or adverse events.

Four studies reported no differences between acupuncture and control or other treatments described at six to seven months follow-up.

No serious adverse events were reported, but there were insufficient adverse events to be certain of the risks.

The authors draw the following conclusions: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.

What does all that mean? In my view, it means that there is no sound evidence base for acupuncture as a treatment of fibromyalgia – or as we expressed it in our own systematic review of 2007: The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia.

Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.

Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.

There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.

After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.

The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”

This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.

My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.

DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.

HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.

BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.

IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.

PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.

OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.

OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.

RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.

Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.

I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?

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