Explanatory studies are done under controlled conditions to determine whether a treatment has any efficacy compared to a placebo. Pragmatic studies are designed to assess how the intervention performs in everyday real world practice. Pragmatic studies measure practical success but don’t determine actual efficacy: that requires a proper randomized controlled trial (RCT) with an appropriate control. Pragmatic studies have their place, but they can sometimes make an ineffective treatment look good: a phenomenon I have christened Cinderella Medicine.
Posts Tagged Acupuncture
When an article is published in a medical journal, the authors must disclose any conflicts of interest. This is important, because even if they think owning stock in the drug company won’t influence their scientific judgment, we know that subtle biases can creep in to somehow affect the findings of studies. It has been shown that studies funded by drug companies are more likely to get positive results for their drug than studies funded by independent sources. Andrew Wakefield, author of the infamous retracted Lancet study suggesting a relationship between MMR vaccine and autism, was severely chastised for not disclosing that he received money from autism litigators and expected to earn a fortune from his own patented products if the MMR vaccine could be discredited.
I was recently contacted by an acupuncturist who plans to critique an article I wrote. It was a commentary in the journal Pain that accompanied a systematic review of systematic reviews of acupuncture by Ernst et al. For details of Ernst’s and my articles, see my previous post. He challenged my statement that I had no conflicts of interest to report. He apparently thinks I should have said I have a conflict of interest in that I am anti-CAM and anti-acupuncture. When he writes about my article, he plans to attack me for not declaring this alleged conflict of interest and he plans to set a good example with a conflict of interest statement of his own, divulging that he makes his living practicing acupuncture, has financial investments in it and many personal relationships, that his self-identity and prestige are dependent on his belief in acupuncture’s efficacy, and that he is biased towards constructivism and away from positivism. (I think this is a fancy way of saying he favors experience over the scientific method.) I agree that he has conflicts of interest, but was I wrong to say I had no conflicts of interest? I don’t think so. (more…)
Not only his name and his titles of nobility were forged, but parts of the teachings of the man who introduced acupuncture to Europe were also invented. Even today, treatments are provided based on his fantasies.
– Hanjo Lehmann1
Decades before President Nixon’s visit to communist China, and before the articles in the Western popular press on the use of acupuncture in surgery, a Frenchman by the name of George Soulié de Morant (1878-1955), published a series of colorful accounts of the use of acupuncture in early 20th-century China. His work led to the creation of a school of thought known as “French energetics,” which has become the theoretical foundation for many proponents of acupuncture in the West, including Joseph Helms, MD, the founder and former director of the American Academy of Medical Acupuncture (AAMA), and the founder of the acupuncture certification course for physicians.
But just as the medical community gradually learned that the reports of the use of acupuncture in surgery in communist China were inaccurate, exaggerated, or even fraudulent, we are now learning that the reports on the use and efficacy of acupuncture by Soulié de Morant were also fabricated.
According to a 2010 article published in Germany by Hanjo Lehmann in the Deutsches Ärzteblatt (a short version was published in Süddeutsche Zeitung), there is no real evidence that the Frenchman who is considered the father of Western acupuncture ever stuck a needle in anyone in China, and he probably never witnessed a needling.
Steven Salzberg, a friend of this blog and Director of the Center for Bioinformatics and Computational Biology at the University of Maryland, is on the editorial boards of three of the many journals published by BioMed Central (BMC), an important source of open-access, peer-reviewed biomedical reports. He is disturbed by the presence of two other journals under the BMC umbrella: Chinese Medicine and BMC Complementary and Alternative Medicine. A couple of days ago, on his Forbes science blog, Dr. Salzberg explained why. Here are some excerpts:
The Chinese Medicine journal promotes, according to its own mission statement, studies of “acupuncture, Tui-na, Qi-qong, Tai Chi Quan, energy research,” and other nonsense. Tui na, for example, supposedly “affects the flow of energy by holding and pressing the body at acupressure points.”
Right. What is this doing in a scientific journal?… I support BMC…But their corporate leaders seem to care more about expanding their stable than about maintaining the integrity of science. Chinese Medicine simply does not belong in the company of respectable scientific journals.
Forming a scientific journal whose goal is to validate antiquated, unproven superstitions is simply not science, whatever the editors of Chinese Medicine claim.
BMC should be embarrassed to be publishing journals that promote anti-scientific theories and otherwise muddy the literature. By supporting these journals, they undermine the credibility of many excellent BMC journals. They should cut these journals loose.
The scientific approach to understanding the world includes the process of carefully separating out variables and effects. Experiments, in fact, are designed specifically to control for variables. This can be especially challenging in medicine, since the body is a complex and variable system and there are always numerous factors at play. We often characterize the many variables that can influence the outcome in a clinical study as “placebo effects” or “non-specific effect” – things other than a specific response to the treatment in question.
A common error to make when interpreting clinical studies is to confuse non-specific effects – those that result from the therapeutic interaction or the process of observation – with a specific effect from the treatment being studied. While this is broadly understood within the scientific medical community, it seems that within certain fields proponents are going out of their way to sell non-specific effects as if they were specific effects of the favored treatment.
This is perhaps most true for acupuncture. As has been discussed numerous times on SBM, the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”.
Believers in acupuncture claim it is supported by plenty of published scientific evidence. Critics disagree. Thousands of acupuncture studies have been done over the last several decades, with conflicting results. Even systematic reviews have disagreed with each other. The time had come to re-visit the entire body of acupuncture research and try to make sense out of it all. The indefatigable CAM researcher Edzard Ernst stepped up to the plate. He and his colleagues in Korea and Exeter did an exhaustive study that was published in the April 2011 issue of the medical journal Pain: “Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews.” It is accompanied by an editorial commentary written by yours truly: “Acupuncture’s claims punctured: Not proven effective for pain, not harmless.” (The editorial is reproduced in full below.)
Ernst et al. systematically reviewed all the systematic reviews of acupuncture published in the last 10 years: 57 systematic reviews met the criteria they set for inclusion in their analysis. They found a mix of negative, positive, and inconclusive results. There were only four conditions for which more than one systematic review reached the same conclusions, and only one of the four was positive (neck pain). They explain how inconsistencies, biases, conflicting conclusions, and recent high quality studies throw doubt on even the most positive reviews.
They also demolished the “acupuncture is harmless” myth by reporting 95 published cases of serious adverse effects including infection, pneumothorax, and 5 deaths. Some but not all of these might have been avoided by better training in anatomy and infection control. (more…)
… animals are divided into (a) those that belong to the emperor; (b) embalmed ones; (c) those that are trained; (d) suckling pigs; (e) mermaids; (f) fabulous ones; (g) stray dogs; (h) those that are included in this classification; (i) those that tremble as if they were mad; (j) innumerable ones; (k) those drawn with a very fine camel’s-hair brush; (l) etcetera; (m) those that have just broken the flower vase; (n) those that at a distance resemble flies.
– Jorge Luis Borges (1899–1986)1
Not too long ago, I came across a disease taxonomy proposed by a certain East-West Medical Research Institute (EWMRI), that includes the kind of fantastic afflictions — such as “running piglet” disorder — fit for the best Borgesian list.
This obscure institute, located at Kyung Hee University in Seoul, Korea, is one of the 800 WHO Collaborating Centres designated to carry out various activities in support of the Organization’s programs. With the collaboration of China, Japan, Vietnam, Australia, and the US, this center is working to incorporate medieval Asian disease nomenclature to the 11th version of the International Classification of Disease (ICD-11).
All the world sees us
In grand style wherever we are;
The big and the small
Are infatuated with us:
They run to our remedies
And regard us as gods
And to our prescriptions
Principles and regimens, they submit themselves.
Molière, The Imaginary Invalid (1673)1
The passage above is part of a burlesque doctoral conferment ceremony, where the French playwright Molière (1622-1673) mocks the unscrupulous physicians of his time. “All the excellency of their art consists in pompous gibberish, in a specious babbling, which gives you words instead of reasons, and promises instead of results,” he writes. In Moliere’s plays doctors never cure anyone; they are put on stage just to display their own vanity and ignorance.2 The Spanish painter Francisco de Goya (1746-1828) also took on the same issue by painting in 1799 a well attired jackass taking the pulse of a dying man, in a pose that accentuates the large gem on his hoof.
But if the asinine doctors of Molière and de Goya’s time never cured anyone, it is because they held prescientific views, and believed that disease was caused by imbalances in “humors,” and by malefic influences of the Heavens. Even the most educated among them treated illnesses in good faith by purging, bloodletting and enema at astrologically auspicious times. In contrast, current physicians who for the sake of funding embrace and endorse unscientific views and practices under the guise of CAM or integrative medicine, do so knowing that they often contradict the established principles of physics, chemistry, and biology. Therefore, in addition to promoting “snake oil science”3 (as R. Barker Bausell calls it), these physicians are also guilty of bad faith. Most of this takes place at large academic centers, where funding seems to outweigh the concern for science. As Val Jones, MD, writes in 2009′s Top 5 Threats To Science In Medicine:
Often referred to by David Gorski as “Quackademic” Medical Centers – there is a growing trend among these centers to accept endowments for “integrative” approaches to medical care. Because of the economic realities of decreasing healthcare reimbursements – these once proud defenders of science are now accepting money to “study” implausible and often disproven medical treatments because they’re trendy. Scientists at these centers are forced to look the other way while patients (who trust the center’s reputation that took tens of decades to build) are exposed to placebo medicine under the guise of “holistic” healthcare.
In November 2010, the California Department of Consumer Affairs (DCA) finally decided to act responsibly and forbid the prevalent practice of Chinese bloodletting by licensed acupuncturists.
The practice became a concern for the DCA when allegations of unsanitary bloodletting at a California (CA) acupuncture school surfaced.
The incident allegedly occurred during a “doctoral” course for licensed practitioners. The instructor was reportedly demonstrating advanced needling and bloodletting techniques. During the process, he took an arrow-like lancing instrument that is called a “three-edged needle” (三棱针), sharpened it with sandpaper, cleaned it with alcohol, and then asked a student-volunteer to roll a towel around his neck (similar to what is depicted in Image 1). The instructor then cleaned the student’s temporal region with alcohol, and punctured a superficial blood vessel with the arrow-like instrument. The student then held his head over the garbage can, gushing blood for a while.
Images 1 & 2. Chinese bloodletting. Image 1 shows a technique used to bleed the head or the face, where a towel is rolled around the neck to control the arterial pressure. Image 2 shows the practice of “wet cupping.”
The ancient practice of bloodletting, with or without cupping, is still widely used in Chinese medicine to remove “stagnant blood, expel heat, treat high fever, loss of consciousness, convulsion, and pain.”1 The amount of blood let depends on the condition, and the location of the incision. A contemporary book recommends letting a tiny amount from a point adjacent to the thumbnail for a condition described as “wind-heat invasion” of the lung. The symptoms associated with this unscientific nomenclature include chills and fever, sore throat, stuffy or runny nose, and a yellow discharge,2 which could correspond to many respiratory conditions, including the common cold, influenza, pneumonia, etc.
Bloodletting, of course, was a major aim of early vessel therapy and is frequently described in the Su wen.1
Paul U Unschuld
“Cargo cult” is a metaphor that describes the act of imitating an activity or a practice without any insight into the underlying principles. In the literal sense, it refers to a magico-religious practice observed in tribal societies, where the members ritually imitate the activities of a technologically-advanced society they had contact with, so that they can magically draw their material wealth. For instance, after WWII, indigenous tribes in New Guinea who had come in close contact with cargo planes, started to build landing strips and populated them with plane-like effigies that were made of straw, bamboo, and coconuts, so that they can magically lure the passing planes.2 The term “cargo cult science” was introduced by Richard Feynman in a speech at Caltech in 1974 to describe pseudoscientific studies in which all the superficial aspects of a scientific inquiry are adhered to, but the underlying principles are not scientific. He classified many educational and psychological studies as such, for having the appearance of academic research but lacking the principles of a scientific inquiry.3
Another example of cargo cult science is the plethora of two-arm acupuncture studies that compare a needling regimen using the traditional concepts, and compare it with a non-interventional placebo. These studies might have the appearance of clinical research, but they are inherently flawed and inconclusive, because they do not rule out the possibility that the observed results are mainly due to the painful stimulus and injury caused by a needle, which can occur regardless of the insertion point. Indeed, an acute noxious stimulus from a prickle, heat, or any other painful stimulus – almost anywhere on the skin – can attenuate the perception of pain in another area of the body through a reflex called “counter-irritation,” also called the “pain-inhibiting-pain effect” or “diffuse noxious inhibitory control” (DNIC).4 DNIC was extensively studied by Fauve et al. in the 1980s, who showed in mice that it has an effect equivalent or superior to that of glucocorticoids.5,6