As I get older I get more grumpy. Issues that at one time I was rather sanguine about, now irritate the hell out of me. It is not like it was when I started practice. Information was hard to come by. Going through the Index Medicus, with the world’s tiniest font, wandering the stacks looking for papers, sending off for reprints, getting a precious Xerox (or even a mimeograph) of a classic paper from an attending.
You understood the value of eminence-based medicine, as it took a career to acquire and master the literature. You relied on the wisdom of old geezers like me who had decades of experience and reading.
That was then. Now? The world’s information is available almost instantaneously. You may not be able to master a new topic spending a day on Google and Pubmed, but you can acquire a reasonable understanding, especially of you have some background.
Because of Google and Pubmed, the only reasons for ignorance of your area of expertise in medicine are time, laziness, or stupidity. As a specialist, only time is an excuse. It is my job to keep up with infectious diseases, although with over 10,000 articles a year in ID, it is impossible to read everything. But if I have a question concerning patient care, I need to look it up. I have another blog whose raison d’être is looking up answers to the daily questions that arise in practice.
On the characteristics of a useful clinical trial
So the characteristics of a useful clinical trial are not hard to determine: Randomized, double blind, placebo controlled, adequately powered. Because you want to avoid spending time and money on a study only to end up with no useful conclusions. This is especially important with acupuncture where it not does matter what kind of acupuncture is used, if needles are used, where the needles are placed or even if you mime acupuncture or perform acupuncture on a rubber hand. The key features for success in acupuncture are belief that the patient is receiving acupuncture and that the patient believes the acupuncture will be effective. And the stronger the belief, the better the subjective response.
Those characteristics of acupuncture and clinical trials are not hard to discover. It you want a rigorous study of acupuncture, it has to be placebo controlled, double blind and you need to assess both the belief in acupuncture and the adequacy of blinding.
They never do that. Probably because deep in their heart of hearts they know that quality studies will not support their particular SCAM. The current buzzword is pragmatic, which the OED defines as ‘not wishing to do a quality study that will not support my pseudo-scientific belief.’
There have been a gaggle of bad acupuncture studies the last few months, well, few years, well few decades. It is apparent that those who do acupuncture research have zero interest in doing a quality study. Let’s look at a few. Prepare for an acupuncture crapfest.
Acupuncture is theatrical placebo. Specifically Peter Pan.
Acupuncture, as has mentioned so many times, is a theatrical placebo. But what theatrical performance? I tend towards tragedy, mostly Macbeth:
It is a tale
Told by an acupuncturist, full of sound and fury,
But perhaps I should consider Peter Pan as a more apt metaphor.
Remember when Tinker Bell had chronic wing pain and was getting acupuncture and it didn’t appear to be effective? And Peter turns to the audience:
“Do you believe in acupuncture? … If you believe,” Peter shouted, “clap your hands; don’t let Tink hurt.”
And Tink’s pain went away for a while? You don’t? I do.
There is a Tinker Bell effect, where:
things that are thought to exist only because people believe in them.
That describes the effect of acupuncture perfectly. There are multiple studies that have demonstrated that patients who believe in the efficacy of acupuncture are those most likely to have an effect and the stronger the belief, the stronger the effect. And that the placebo effect is significant:
When compared to waitlist, standard care, or no treatment, the effect size of acupuncture is moderate, around 0.50, meaning that a large part of the acupuncture effect is due to placebo elements.
There is now another study to show the theater that is acupuncture is Peter Pan: “Response to placebo acupuncture in insomnia: a secondary analysis of three randomized controlled trials.”
conducted a post-hoc analysis of three randomized, double- blind, placebo-controlled trials of acupuncture for primary insomnia and residual insomnia in depressed patients. The aim of the exploratory analysis is to determine patient characteristics that are predictive of a response to noninvasive placebo acupuncture for insomnia.
And it was the belief in acupuncture that was important in responding to placebo acupuncture:
higher expectation toward acupuncture were associated with greater placebo response.
Belief is why it doesn’t matter where the needles are placed, if the needles are placebo, if toothpicks are used, if acupuncture is mimed, or if acupuncture is done on a rubber hand. The effects are the same as long as you believe you are getting acupuncture and you believe it will work.
It is also why any acupuncture study is a waste of time if it does not include a sham/placebo intervention, reporting if blinding was successful, and reporting of the beliefs of the patients in the intervention.
Otherwise you will not know why Tink got better.
The ongoing decline of quality in the Annals of Internal Medicine
Not like the Annals is paying any attention. As an example there is “Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.”
Patients with chronic neck pain were randomized to:
12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone.
Sham comparison for acupuncture? Nope. Belief in the interventions determined? Nope. So you would expect patients to get better with the intervention when compared to usual care. That is what ALWAYS occurs. Spend extra time (in this case an extra 10 hours) and energy with a patient with a subjective problem and you would expect them to report improvement, compared to usual care.
And given that the authors are members of the British Acupuncture Society, the results are obviously part of the Big Acupuncture conspiracy. Or potentially subject to significant bias. Go to Midas, get a muffler.
And so much for holistic care. Neck pain is a symptom of some underling process; we have no idea what these patients had. It was like a study that evaluated antibiotic for fever.
And what kind of acupuncture? The methods state:
Acupuncture practice was based on traditional Chinese medical theory, encompassing acupuncture-specific diagnostic explanations and related lifestyle advice.
That is quite a nonspecific intervention. You need to look in the table in the appendix, the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying beware of the leopard of medical papers, where you find they used between 5 and 35 needles per session (average of 14) with 259 acupuncture points used that were left in between 1 and 60 minutes (average of 20).
They could use moxibustion, electroacupuncture, ear seeds, cupping, acupressure, and heat lamps.
Give advice relating to exercise, relation, diet and rest.
And you say it was acupuncture that led to improvement? Really? Color me skeptical. This is what passes for peer review these days at the Annals. Peer review with peer as in ‘to look at’. I imagine an old person, peering over the top of their glasses, saying “that ‘peers to be an acupuncture paper. Let’s publish it.” Or, in this case, publishit ( ™,©,®), my new neologism for the production of SCAM papers. Email me for volume discounts.
So the results of the study are what we would expect and consistent with every acupuncture study that does not control for bias. It is, like all such studies, a waste of time and resources.
The summary for patients says:
Both acupuncture and Alexander Technique lessons may provide long-term relief from chronic neck pain and associated disability.
I have come to the conclusion that when it comes to SCAM papers, those who review them never really read them with anything that approaches a critical eye.
Dr. Edzard Ernst said in response to this article:
I am truly surprised that a top journal like the Annals of Internal Medicine decided to publish it.
Sorry, I must disagree. As a practicing Internist I have to say that the Annals has been slipping for years, with a long history of publishing gullible studies on pseudo-medicine. So much so they have lost at least one ‘n’ in my mind.
It has often been noted that pseudo-medicines are immune to data. Practices are never abandoned or changed because of information that suggests a lack of safety or efficacy.
Pseudo-medicines, as a recent US News article suggests, do not really require data to support them, which is good for its proponents, since such data does not exist. They can be satisfied with anecdote, knowing that it works.
However, when a study is done that fails to show efficacy of a pseudo-medicine such as acupuncture, it is always interesting to watch the authors squirm and try and rationalize their negative results.
No one has ever said after a negative study ‘looks like acupuncture is useless for this condition. Stop using it’. That would require a bit of honesty about what is probably a wasted career in acupuncture.
As two recent examples, there is “Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial“.
In reality-based medicine, there is no reason to think laser acupuncture would do anything. And it doesn’t. When compared to sham laser acupuncture,
…there was no significant difference in outcomes between the two groups…
When an intervention is equal to placebo, in reality-based medicine we conclude that it has no efficacy. It is why, as an example, we abandoned internal mammary ligation for angina.
But in the non-falsifiable world of pseudo-medicine?
…the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain…
Or take No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. People received needle, laser, sham needle, sham laser acupuncture, and no intervention after exercise to see if there was efficacy in treating muscle soreness.
Nope. Didn’t work. And why would it? The authors suggest:
From a mechanistic point of view, these results have implications for further studies…the traditional acupuncture regimen, targeting muscle pain, might have been inappropriate as the DOMS mechanisms seem limited to the muscular unit and its innervation.
Or maybe acupuncture does nothing and is inappropriate for any intervention.
And as always, negative studies mean bigger, better studies need to be done:
Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.
Almost 50 years of clinical trials and still more studies need to be done. Only in the world of pseudo-medicine are the results of yet another negative study used as indication for further studies.
No acupuncture on infants and children for China
If you have been a parent you probably remember just how vulnerable newborns and young children are. I remain amazed we survived as a species before the advent of civilization; crying babies at night must have been the signal for all-you-can-eat for predators on the veldt.
Acupuncture has long been popular in China but there are differences between its practice in the West and East, as “‘Big needles, small bodies’—the absence of acupuncture treatment for infants in contemporary Shanghai: a qualitative” study makes clear.
At the Longhau Hospital acupuncture clinic it was noted that no infants and very few children were seen in the acupuncture clinic. They wondered why, conducting:
Formal interviews and informal conversations with acupuncturists and other TCM professionals [which] revealed that acupuncture was neither routinely practiced nor recommended for infants and small children.
There were a variety of reasons for the lack of acupuncture in kids:
- ‘Nobody does paediatric acupuncture’. Lack of experience.
- ‘Not convenient’. Lack of recommendations.
- ‘No classic, no modern’. Lack of textbooks and training.
- ‘For now, zero’. The lack of a strong research base.
- ‘Of course it is painful’. The possibility of pain.
- ‘Eighty percent of acupuncture on children is CP or other neurology’. Indications for acupuncture. “Acupuncturists and other TCM clinicians expressed the clear opinion that needle acupuncture was indicated for very few paediatric conditions in general.”
- ‘TCM paediatrics is herbs’. The availability of TCM alternatives: Herbal medicine and Tui na.
- ‘The whole TCM world is shrinking in China, or at least in Shanghai’. The money and the system.
- It is a vicious cycle’. The slipping confidence.
And most interesting:
- ‘Now parents take children to the Western Children Hospitals’. Trust in Western paediatrics. “The vast majority of paediatric cases in Shanghai, particularly infants and toddlers, are treated at these hospitals. These hospitals provide treatment for a range of illnesses, from minor ailments to chronic or life-threatening conditions. Western medical hospitals are widely regarded as the first choice by Shanghainese parents seeking assessment, consultation and treatment for their children.”
When it comes to their children, parents in Shanghai appear know that science-based, or Western as they call it, medicine, delivers. This, unfortunately, is not always recognized by parents in the US.
And, as they note, not only is acupuncture not used in children, its use in the West is not based on either data or tradition in China:
This study adds to the ongoing discussion on the evidence, utility and limitations of acupuncture in children, as well as in medicine in general. Contrary to our observations in Shanghai, acupuncturists in the Western world encourage acupuncture for children, including infants. One rationale underpinning this trend is that acupuncture is widely considered in the West to be an integral part of TCM tradition, for patients of all ages. According to our study, Western beliefs that acupuncture is routinely indicated and recommended for infants and small children within TCM are unfounded. Such beliefs may appear to be a Western interpretation, and are not based on actual Chinese modern-day practices or therapeutic recommendations. Recent controlled trials investigating the efficacy of acupuncture treatment in the infant population yield conflicting results, and little clear empirical evidence is available to support the use of acupuncture. As such, it appears that the rise of infant acupuncture in the West could be partly attributable to Western acupuncturists’ own clinical observations and theoretical beliefs. In line with the principles of biomedical ethics, however, this study underscores that this rationale is insufficient to recommend a potentially painful treatment for infants and small children who lack the competence to provide informed consent.
No data for efficacy, no rationale within the context of TCM, potentially harmful, and unethical. That sums up acupuncture in children for China. Now if only doctors in the US would pay attention. For example…
When IRBs fail, babies suffer
I have been practicing medicine for 30 years. I spent most of my time in acute care hospitals, so I am well acquainted with the many ways people can suffer. Being 58, I have also had my share of medical problems that have caused a reasonable amount of pain and suffering.
As a result I have a list of processes that I do not want to experience. At the top of the list are kidney stones, followed by a disk infection. Another disease on the list is opiate withdrawal. I always have a heroin addict or two under my care with one infection or another from injection drug use and going cold turkey looks really miserable. The worst I am likely to experience is caffeine withdrawal.
There are children who are born to addicted mothers and after birth will go through withdrawal unless treated. Poor little things, their first experiences in life the misery of withdrawal and they are unable to really ask for help.
There is a horrible, unconvincing literature on using ear acupuncture for withdrawal in adults; the literature for children is even worse:
This study, a painfully unnecessary attempt to determine the feasibility and efficacy of acupuncture in neonatal and pediatric intensive care unit patients at risk of withdrawal, was a complete waste of time. You cannot determine efficacy at all based on it and the question of feasibility was answered a long time ago. This study added nothing to our understanding of withdrawal or even of acupuncture.
Considering the reams of research showing that there are no benefits associated with the insertion of needles into, or pressing on, particular points on the body beyond placebo, it never should have happened.
The preponderance of the literature suggests that acupuncture is a theatrical placebo and that it is belief in acupuncture that is the main predictor of a response. Newborns, of course, can’t have a belief in the efficacy of acupuncture nor can they complain if they are suffering. So why would you try acupuncture on babies with withdrawal? Or laser acupuncture? Every time I see the phrase laser acupuncture, I think really? You think that laser acupuncture will do something? It just so flabbers my gaster than anyone with even a modicum of understanding thinks laser acupuncture would be effective.
So here is the reasoning: ear acupuncture may help withdrawal in adults so we will use laser acupuncture on 5 ear and 4 body acupuncture points, bilaterally on babies. All men die. Socrates was a man. All dead men are Socrates.
Why, oh why, would anyone would who lives in reality would think that shining a red light on the skin would do anything for drug withdrawal? I wouldn’t. And the reason the authors think it would help?
There isn’t any. None. They best they can offer is that it would be safe. That is the level of reasoning behind the study. And the editors of Pediatrics accepted it as reasonable. More ‘peer’ review.
But there is zero plausible reason offered by the authors that laser acupuncture, an intervention even more worthless and implausible than needle acupuncture, would help babies with addiction symptoms.
It did not stop the Ethics Committee of the Medical University of Graz from approving it.
So children in withdrawal were assigned to laser acupuncture or control.
There was no blinding or sham procedure, except that the whole study was a sham in the more conventional use of the word.
The kids who received laser acupuncture had fewer drug treatment days although they had the same Finnegan score, an objective and subjective measurement of withdrawal symptoms in children.
So I read the study as newborns with equal amounts of withdrawal symptoms and suffering had less medication for their withdrawal as the staff thought they were being treated with the laser acupuncture. The laser-treated kids were simply detoxed faster than their nonlaser controls. And probably suffered more. My wife, who worked for years in addictions, thinks it is a reasonable explanation that the laser-treated were detoxed more rapidly.
Every time I read a pediatric acupuncture study I realize just how broken the IRB system is when it comes to protecting vulnerable populations from being abused by pseudo-medical providers.
Children and mice do not have a chance
There are 385 hits searching the PubMed for ‘acupuncture mice’. Assume 40 mice per study. I would wager that is a marked underestimate that does not include all the mice used in establishing models and failed studies.
I am not a PETA person but that is 15,400 mice essentially being abused trying to prove TCPM (Traditional Chinese Pseudo-Medicine) is effective.
Guidelines for ethical animal research state:
…there should be a reasonable expectation that the research will:
…Provide results that benefit the health or welfare of humans or other animals.
…The scientific purpose of the research should be of sufficient potential significance to justify the use of nonhuman animals.
Given that in humans acupuncture is a theatrical placebo based on concepts divorced from reality, I would say that any acupuncture research in animals is unethical.
The animal welfare committees do not seem to be doing their job at numerous facilities.
But then, why would you expect ethical treatment of animals when we can’t even protect our own newborns from jaw-droppingly stupid studies?
From the Baskent University in Turkey.
Academic physicians actually thinking that:
Acupuncture is a new non-pharmacological method for preventing pain in newborns
But not just acupuncture, laser acupuncture.
was applied to the Yintang point using a Laser PREMIO–30 unit for 30 s
The Yintang point is:
Midway between the medial ends of the eyebrows
Surprise. Low level lasers and acupuncture, two interventions totally divorced from reality was judged:
less effective than oral sucrose for reducing the discomfort of this procedure.
Who would have thought? I mean besides anyone with even the barest understanding of medicine, physiology, and physics? Certainly not those whose responsibility it was to review the research.
This nonsense was approved by an Institutional Review Board whose ostensible task is to look out for the wellbeing of research subjects. I suppose IRB should now stand for Ineffective Review Board? Incompetent Review Board? Inadequate Review Board?
Mice and children. They don’t have a chance of being protected from the investigation of magical pseudo-medicine.
BS (blood stasis) syndrome
I receive a lot of push notifications from Google and Pubmed covering a variety of pseudo-medical topics.
There is a phenomenal amount of research coming out of China that I would perhaps classify as basic pseudo-science, not unlike the basic science of reality-based medicine.
What they do is apply modern techniques and measurements to Traditional Chinese Pseudo-Medicine, TCPM, trying to validate their ancient pseudo-science. I am sure the recent Nobel Prize will only lead to further encouragement of this process. Like blood stagnation.
Today I saw in one of my patient’s chart the diagnosis qi deficiency and blood stagnation as a reason for acupuncture. Don’t get me started. It was so very dispiriting to see ancient nonsense in an EMR as if it were actually meaningful. I knew that it was really a problem with too much phlegm and the patient needed to be bled with leeches, but would they listen to me? No.
At least qi and blood stagnation don’t have ICD codes, even if acupuncture does.
The theory of TCPM, including qi and meridians, with diagnosis based on tongue and pulse evaluation, was developed without the benefit of understanding anatomy, physiology, microbiology etc, the basic sciences that are the foundations of medicine. Because of that TCPM is not grounded in reality and this results in a most peculiar literature such as “Practical Diagnostic Criterion of Blood Stasis Syndrome: Introduction, Reliability, and Validity.”
What, you may ask, is BS? I mean blood stagnation? The other question is way too open ended when directed at TCPM.
Simply put, it means the flow of Blood is slowed down and brought to a static state.
We call that a clot in medicine.
Normally, Blood is stored in the Liver
and propelled by the Heart Qi to flow through the body.
And here I thought it was the ventricular contractions of the heart.
If Blood circulation is Stagnant or slowed down by certain factors, it will lead to retention of Blood in any part of the body or overflow of blood out of the vessels, resulting in Blood Stasis.
Huh? There are nouns and verbs and all the other parts of grammar but there no content that maps to reality. As another author writes:
Note for students: “The Liver stores Blood … when a person moves, Blood goes to the channels, when at rest it goes to the Liver.” (Maciocia, Foundations, p. 78) When you’re asleep or resting, the Blood collects and is stored in the Liver. When you’re active, the Blood is sent out to nourish and moisten the muscles.
Students of what I do not know (gibberish?), but I would hope they are not involved with patient care. I don’t think they are speaking metaphorically, which is really sad and nicely demonstrates how removed from reality the BS in TCPM is.
In TCPM, BS is bad:
If blood stasis occurs within the body, known as “blood stasis syndrome (BSS),” characteristic symptoms such as pain in a fixed position, nyctalgia, dark-purple coloring of the tongue or face, infraorbital darkness, sublingual varicosis, blood spots under the skin or tongue, or an astringent pulse can manifest. In clinical practice, many diseases include these signs and symptoms, such as ischemic heart disease, cerebral vascular accident, diabetes mellitus, chronic gastritis, chronic renal failure, chronic hepatitis, trauma, and dysmenorrhea
Almost total nonsense. The manifestation of blood stasis are numerous. BS can involve any organ. Just check out this diagram.
BS is disease as metaphor, although practitioners of BS do not think so although even its practitioners evidently do not know what BS is:
Of the 678 respondents, more than half (53%) had difficulties with the diagnosis of BSS because objective measurement methods were not readily available. Most respondents (88%) thought that the development of an objective diagnostic method for BSS was necessary.
It is too bad that I only have access to the abstracts as the original are in Chinese, because I really want to know more about phlegm-stasis cementation syndrome in mini-swine. Who knew that:
The interaction of phlegm, blood stasis and toxin syndromes helps promote the progress and development of AS plaques, which is the key pathogenesis of phlegm-stasis cementation syndrome in coronary heart disease.
Like so much of the TCPM research, time and money is being devoted to validate with modernity BS concepts that are fundamentally grounded in fantasy.
Tongue acupuncture reigns supreme
There are innumerable forms of acupuncture, perhaps as many as there are practitioners. Which acupuncture is best? Now there is a hint in the treatment of post-stroke dysphagia.
The patients were assigned into 2 groups: 90 in the Tongue acupuncture group received tongue acupuncture on the basis of conventional medication, 90 in the conventional acupuncture group received acupuncture on the neck and wrist.
And tongue is better!
On the basis of the conventional medication, tongue acupuncture would effectively improve the swallow functions, decrease the neurological deficit and reduce the incidence of pneumonia in patients with post-stroke dysphagia.
Which one would expect as:
Traditional Chinese medicine holds: post-stroke dysphagia is pathogenesis of blocking meridians by the wind, fire, phlegm, blood stasis. Diseases in brain are related to the spleen, kidney and the heart. Tongue is closely related to zang-fu organs through the channels and collaterals directly or indirectly… By needling tongue, the heart, spleen, kidney meridian awake brain, dredge the bullishness and finally improve the swallowing functions.
Dredge the bullishess. They are dredging up something with acupuncture studies. It isn’t bullishess. Close though. I think that was a slight misspelling during translation.