October 15th, 2009 by Steve Novella, M.D. in Better Health Network, News
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Two recent studies concerning the prevalence of autism in the US have been getting a lot of attention, because they indicate that autism prevalence may be higher than previously estimated. This, of course, fuels the debate over whether or not there are environmental triggers of autism.
One study was conducted by the CDC but has yet to be published. The results were announced ahead of publication by the US Health and Human Services Secretary Kathleen Sebelius to the autism community. She reports that the new prevalence of autism spectrum disorder (ASD) is now estimated at 1% or 100 in 10,000 children. This is an increase over the last few years. In 2002 the prevalence was estimated to be 66 per 10,000.
The second study was published in the journal Pediatrics and is a phone survey of 78,037 parents. They asked if they had any children who had ever been diagnosed with an ASD. Here are the results: Read more »
*This blog post was originally published at Science-Based Medicine*
August 20th, 2009 by Steve Novella, M.D. in Better Health Network, Quackery Exposed
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It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.
We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.
With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.
But perhaps the most insidious and damaging double-standard that is being advocated under the banner of CAM is a separate standard of scientific research itself. The normal rules of research that have evolved over the last few centuries are being subtly altered or discarded, with clever newspeak. It is a way for proponents to choose their evidence, rather than having the evidence decide what works and what does not work. We saw this strategy at play with the recent acupuncture study for back pain that clearly showed acupuncture was no more effective than placebo acupuncture. Proponents (propagated by an uncritical media) turned scientific logic on its head by interpreting this result as indicating that placebo acupuncture must work also (if only we could figure out how, they unconvincingly mused).
We see this strategy at work also with the use of so-called “pragmatic” studies – a rebranding of “unblinded” studies. This is a way to choose their evidence – in this case, poorly controlled unblinded studies that are more likely to reflect the bias of the researchers and therefore give them a result that they like. This is their reaction to well-designed placebo controlled trials that show their preferred modality does not work.
Another strategy is to change the meaning of the concept of placebo effects. This one was ready-made, and most people grossly misunderstand the nature of “the” placebo effect. One of my first articles for SBM was about the placebo effect because this concept is so criticial to science-based medicine. To summarize – the placebo effect is really many effects. It is everything other than a physiological response to the treatment. It is not all a real effect of mind-over-matter – it includes every bias and artifact of observation as well. It includes things like subjects reporting they feel better to the researcher because they want the treatment to work and they want to please the authority figure, who also wants the treatment to work and may be encouraging the perception of benefit.
It is most important to understand how the term “placebo effect” is used in the context of a controlled clinical trial. Scientific methodology is about controlling variables – because we want to know which variables work and which ones do not. In any clinical scenario there are a multitude of variables that may affect the outcome or the perception of the outcome. Therefore a well-designed study maximally controls all the variables – ideally so that the one variable of interest (the treatment) is completely isolated. This is accomplished in a number of ways. One method is randomization – randomly assigning subjects to the various treatment and placebo arms of a clinical trial. Randomization combined with sufficiently large trial size (number of subjects) results in all variables not specifically controlled for averaging out among the various arms. Another way to look at is that randomization prevents systematic biases in who gets treated and who gets a placebo from affecting the results.
Another method of controlling variables is the double-blind placebo control. Ideally one group of subjects will receive the treatment being studied while another group will receive a treatment that is identical in every way except that it is inert (i.e. it controls for all possible variables and isolated the one variable of interest – the treatment). Both the subject and the examiner are blinded to which is which to control for psychological effects. In order to conclude that the treatment “works” those subject receiving the active treatment must do statistically significantly better than those receiving the placebo. If the activity of the treatment was the only variable, then we can confidently conclude it was responsible for the improvement.
I know this is all very basic, but it is these very basic concepts that are being challenged by proponents of so-called CAM. They are trying to say the the effect measured in the placebo arm of such studies is a real effect, something valuable and alone is sufficient to justify the treatment. This philosophy has been termed by critics “placebo medicine” and is just the latest attempt at creating a double standard. But the claim is utterly ignorant of the scientific nature of the placebo effect. It is a method of controlling for biases, artifacts, and variables (known and unknown) – it is not a real effect.
There may be some non-specific therapeutic effects mixed into placebo effects. For example, people who are being studied tend to take better care of themselves and are more compliant with treatments (because they are being watched). They may also feel better as a result of the positive attention from a health care provider – old-fashioned good bedside manner. These are some of the variables being controlled for. But it is scientifically absurd to argue that they justify an ineffective treatment. But that is exactly what CAM proponents are doing.
The latest manifestation of this strategy is a report put out in the UK by The Kings Fund – a health policy charity. They put together a committee to examine how the UK can find evidence to support CAM therapies. They are not interested in figuring out “if” such treatments work, but rather how they can show “that” they work. They report:
Explaining the need for different types of research when assessing complementary practice, Professor Dame Carol Black said: ‘It has become widely accepted that a stronger evidence base is needed if we are to reach a better understanding of complementary practices and ensure greater confidence in their clinical and cost effectiveness. The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and non-specific effects that together comprise a particular therapy.’
Got that? We need new kinds of research (read “double standard”) in order to demonstrate the value of these special CAM practices. The reason that we need to find new ways to demonstrate their value is because they fail under the accepted scientific methods. The last sentence is just a fancy way of saying that placebo effects should count as real effects.
It further says:
‘As long as findings from research can provide confidence in the positive effect of the physical intervention at the heart of the treatment, then any added benefit brought by the therapeutic relationship and the context for treatment should count as part of the treatment effect,’ the report says.
‘For complementary therapies such a holistic approach to effectiveness should be adopted by bodies such as NICE, when comparing cost-effectiveness across a range of treatments.’
The “physical intervention at the heart of the treatment” is functionally the same thing as – non-specific placebo effects. They want to take a “holistic” approach to evidence (another useful marketing brand), meaning they get to decide what the evidence means. George Orwell would be proud.
As usual, Edzard Ernst (the go to expert for the media) gets it exactly right. He is quoted as saying:
‘This is the introduction of double standards through the back door.’
‘In this case we might as well allow an ineffective medication on the market, because it too will have a placebo effect.’
That latter point is a favorite of mine as well. Whenever CAM proponents try to change the rules of science to suit their needs, I invite my r
*This blog post was originally published at Science-Based Medicine*
July 2nd, 2009 by Steve Novella, M.D. in Better Health Network, Quackery Exposed
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When patients ask me if a chiropractor can help them with their problem, I often think to myself, “OK, do I give them the short answer or the long answer?” The difficulty is often in the fact that chiropractic is a diverse profession and it is difficult to even characterize what a “typical” chiropractor is likely to do. As a chiropractor once admitted to me – there are a great many things that happen under the umbrella of “chiropractic.”
In this article I will summarize some of the history and practice of chiropractic, highlighting what I consider to be many of the enduring problems with this profession.
History
Chiropractic was founded in 1895 by Daniel David Palmer, a grocer with an intense interest in metaphysics. Prior to his “discovery” of chiropractic, D.D. Palmer was a magnetic healer. He also had interests in phrenology (diagnosing disease based on the bumps of the skull) and spiritualism. Palmer reported to have discovered the principle of chiropractic when he allegedly cured a janitor of his deafness by manipulating his neck. The fact that the nerve which conveys sound information from the ears to the brain does not pass through the neck did not seem to bother Palmer, if he was even aware of this fact.
Palmer created the term “chiropractic,” which literally means “done by hand,” to refer to his new therapy. He argued that all disease is caused by subluxated bones, which 95% of the time are spinal bones, and which disrupt the flow of innate intelligence. He did not subject his ideas to any form of research, but rather went directly to treating patients and to teaching his principles to the first generation of chiropractors.
Subluxation Theory
Palmer believed in the pre-scientific vitalistic notion that health stems from the flow of a spiritual life force. Although vitalism was rapidly declining within scientific thought by the end of the 19th century, it was the centerpiece of early philosophies of health in most cultures. Palmer borrowed this ancient belief and renamed it “innate intelligence” which he claimed flowed from the brain to the rest of the body through the spinal cord and peripheral nerves. All disease, he argued, results from disruption in the flow of innate intelligence. Disruption in flow is caused by spinal subluxations, which are small misalignments in the spine that compress the spinal nerves.
Therefore, liver disease is caused by a subluxation which compresses the spinal nerve which supplies the liver with life force, depriving it of its vital innate intelligence. Palmer therefore believed he could cure by fixing these misalignments with manipulation.
This idea has remained the cornerstone of chiropractic despite advances in neurobiology and anatomy which have failed to show any evidence for innate intelligence or chiropractic subluxations. Many continue to ascribe all disease to the blockage of innate intelligence despite scientific advances in medicine which have discovered infectious, genetic, autoimmune, degenerative, nutritional, and other causes for many of the diseases which plague mankind.
Chiropractic was also not the only tradition based upon manipulating the bones. Of note, osteopathic doctors also developed an art of bone manipulation in order to heal, but they believed they were unblocking blood flow through arteries. Osteopathy and chiropractic had similar roots, but took very different paths, as we will see.
D.D. Palmer’s son, B.J. Palmer, became involved in the chiropractic movement early on, during the formative years. B.J shared his father’s metaphysical bent (prior to chiropractic, he worked with a mesmerist and worked in the circus), his tendency to make sweeping statements about health without justification, and his ignorance of contemporary scientific knowledge. He was reported to state, for example, “When I saw there was no use for a sympathetic nervous system, I threw it out, and then just had to put something better in its place, so I discovered Direct Mental Impulse.” B.J. also “discovered” a non-existent “Duct of Palmer” connecting the spleen to the stomach. In 1907 B.J. engineered a hostile take over of his father’s school of chiropractic.
B.J. Palmer set the tone that would later dominate the field of chiropractic. He emphasized salesmanship, advertising, and practice building. He was highly critical of medicine, stating that M.D. stands for “more death.” He continuously sought new methods for increasing revenues, such as his neurocalometer, which would pinpoint subluxations by measuring skin temperature and he decreed must be rented from him by other practitioners at exorbitant fees.
From the beginning chiropractors were also politically aggressive. They sought licensure as a protection from the growing scientific medicine with which they were completely at odds. Many legislators were reluctant to license chiropractors for this reason, but as more and more states voted in licensure, it became increasingly difficult to fight. Additionally, many legislators looked upon licensure as way of controlling the scope of chiropractic. By 1925, 32 states had instituted licenses for chiropractors. The struggle ended in 1974 when Louisiana instituted licensing.
Many states then began to pass basic science board requirements for licensure, making chiropractors pass the same tests of basic science knowledge as medical and osteopathic students. This was justified by the fact that chiropractors were presenting themselves as primary practitioners. However, where roughly 86 percent of medical students passed their basic science boards between 1927 and 1953, only 23 percent of chiropractors did. Chiropractors who could not pass the boards either moved to another state without the requirement, or practiced without a license. Between 1967 and 1979 all of the basic science laws for chiropractors were repealed.
Over the years chiropractic has never ceased its tireless struggle for growth and acceptance. Despite the fact that scientific medicine has continued to progress and chiropractic has never shed its pseudoscientific origins, they have been quite successful. After licensure, they gained coverage under Medicare. They have also successfully sued the AMA to stop their antichiropractic campaign. Today they continue to lobby hard for increased coverage and access under health insurance and HMO policies.
Straights, Mixers, and Reformers
Almost since the beginning, chiropractic has been fraught with many internal schisms. Today there is a wide range of differences between individual chiropractors, but most can be placed within one of three basic types.
Straight chiropractors consider themselves the only true or pure chiropractors because they limit their practice to the identification and treatment of spinal subluxations. They adhere strictly to Palmer’s concept of disease and believe that all ailments can be treated through manipulation to restore the flow of innate intelligence. Once freely flowing, they believe innate intelligence has unlimited power to naturally heal the body.
Straight chiropractors are the most extreme in their anti-scientific views. They openly advocate a philosophical rather than a scientific basis for health care, calling mainstream medicine “mechanistic” and “allopathic.” They call physicians “drug pushers” and disparage the use of surgery. They are careful not to give diseases names, but none-the-less they claim to cure disease with their adjustments. They oppose vaccinations. They also openly advocate the replacement of scientific medicine with chiropractic as primary health care. The statements of Dr. Wilson A. Morgan (who just passed away earlier this month), previous Executive Officer of Life College School of Chiropractic, are typical:
“Chiropractic: The health care system whose time as the official guardian of the public’s health is fast approaching!”
“On the other hand, it is equally appropriate for chiropractors to be viewed as generalists in that the far-reaching effects of their highly specific spinal adjustments usually are followed by the decrease and often disappearance of a very broad array of symptoms, disabilities and pathological conditions.”
“Unlike the medical profession, chiropractic has a very strong philosophical basis, which no doubt has contributed to its having been labeled ‘unscientific’ by the more mechanistically-oriented scientific community.”
“It appears that education will prove to be the best strategy in the ‘war on drugs,’ including education about the dangers of drugs available on the street and also those available from the physician as prescriptions.”
Mixers, comprising the largest segment of chiropractors, may at first seem more rational. They accept that some disease is caused by infection or other causes and they do not limit their practice to fixing subluxations. Most chiropractors in this group, however, do not supplement subluxation theory with scientific medicine, but rather with an eclectic array of pseudoscientific alternative practices. Mixers commonly prescribe homeopathic and herbal remedies, practice acupuncture and therapeutic touch, diagnose with iridology, contour analysis, and applied kinesiology, and adhere to the philosophy of naturopathy. This broad use of unproven, unscientific, and fanciful so-called “alternative” practices clearly indicates an antiscience attitude, as well as a lack of scientific knowledge, on the part of those chiropractors who employ them.
The rhetoric of Mixers indicates that they are attempting to become accepted into the scientific mainstream, rather than replace scientifically based medicine with a philosophy based approach. They no longer openly oppose immunization, like straights do, but they do advocate the freedom to choose whether or not to be immunized. Their appeal to freedom is emotionally effective, especially in the United States, but it fails to recognize that immunization is far less effective in eliminating or containing infectious diseases when it is not given to everyone. They also advocate a role for chiropractors as a primary care portal of entry system within HealthCare, despite the fact that they lack adequate training as generalists skilled in medical diagnosis.
A small minority of chiropractors, numbering only about 1,000, or 2% of all chiropractors (these are rough estimates because accurate figures are lacking), have been openly critical of their own field. They have called for absolute rejection of the subluxation theory of illness, disposing of pseudoscientific and unethical practices by chiropractors, and the restriction of chiropractic to treating acute musculoskeletal symptoms. They are attempting to bring their field into the scientific mainstream.
Occasionally chiropractic reformers have attempted to forge a new profession, entirely shedding the pseudoscience attached to the chiropractic brand. About ten years ago one group in Canada renamed themselves “Orthopractors,” and considered the new discipline of orthopractic as distinct from chiropractic. Orthopractic is the use of manipulation to provide symptomatic relief from uncomplicated acute back strain. They do not believe in maintenance therapy, treating medical ailments, or the use of pseudoscientific alternative practices.
Unfortunately, this reform effort died because “orthopractic” did not exist as a legal entity. This also partly explains why the “chiropractic” label persists and covers such a wide range of philosophy and practice – because it exists as a recognized licensed profession. It has a regulatory inertia that is hard to combat.
To further complicate things, spinal manipulation exists outside of the chiropractic profession, and not all manipulation is chiropractic manipulation. Some physiatrists, sports medicine doctors, and osteopaths legitimately employ manipulative therapy to relieve muscle strain, mobilize joints, and improve function. Chiropractors do this as well. But some chiropractors also do chiropractic manipulation designed to realign the spine and reduce imaginary chiropractic subluxations.
The Evidence – Subluxations
In the past 100 years, there has been very little research conducted into the basic principles of straight chiropractic. There is no research that indicates the existence of innate intelligence or that such a force plays any role in health and disease. Further, the evidence strongly suggests that chiropractic subluxations are a figment of the chiropractic imagination. And it also seems that spinal manipulation is not capable of realigning the vertebra of the spine.
A study carried out by Edmund Crelin, Ph.D. investigated the amount of force necessary to displace vertebral bones of the spine in order to cause impingement of a spinal nerve. The study was carried out on six corpses within 8 hours after death. His conclusion was that the amount of force necessary to actually displace the vertebra was great enough to break the spine, arguing strongly that chiropractic manipulation cannot significantly affect spinal alignment, and that misaligned spines do not caused pinched nerves (Crelin, 1973).
Pinched or impinged spinal nerves do occur, but they are caused by herniated discs, fractures, tumors, or overgrowth of the vertebral bones. When spinal nerves are impinged they cause pain, numbness, and tingling and may cause a decrease or loss of deep tendon reflexes and weakness of the muscles supplied by the affected nerve. Impinged nerves are not caused by subluxations nor do they result in diseases of the organs. Believers in subluxation theory must claim, implausibly, that nerve impingement causes only a blockage of innate intelligence without causing any of the known signs and symptoms of such impingement.
Ironically, spinal manipulation is contraindicated in cases of actual nerve impingement and should not be performed. In medical studies of manipulation, such as the RAND study, often cited by chiropractors as evidence for manipulation, spinal nerve impingement was considered a reason not to have manipulation and therefore was a criteria for exclusion from the study.
Another source of evidence that the chiropractic theory of subluxations and innate intelligence is completely false comes from the unfortunate victims of spinal trauma. There are many victims of complete transection, or disruption, of the cervical spinal cord in the neck. Such a complete injury leaves its victim quadraplegic, unable to move the arms or legs. If the injury is high enough in the spinal cord the victim may not even be able to breath on their own. In such victims no impulses from the brain are able to travel below the spinal cord in the neck, and therefore most of the communication between the brain and the body is interrupted. Certainly, this is a much more dramatic and complete interference of nerve flow than that of an impinged spinal nerve.
Yet, in these patients, the organs continue to work without difficulty and diseases do not develop at any higher rate than those without such an injury. Of course, there are some effects from the disruption of the autonomic nervous system, that part of the nervous system which regulates the bladder, the degree of bowel motility, and other functions. But all effects of spinal cord damage are caused by known neurological injury. If subluxation theory were correct, then patients with high spinal cord injuries would be ravaged by every conceivable disease.
So chiropractors cannot realign the spine to fix imaginary subluxations and restore the flow of nonexistent innate intelligence. Subluxation theory is pure pseudoscience, like homeopathy or therapeutic touch, and has no place in a 21st century scientific health care system.
Despite the extreme scientific implausibility of subluxation theory, specific applications have been tested with clinical research – with predictable results. For example, many chiropractors will use manipulation to treat asthma is children. The results of this research are soundly negative – chiropractic does not work on asthma.
Despite this many chiropractors persist in treating asthma. This led Simon Singh to write in the Guardian in 2008 that the British Chiropractic Association, which does advocate chiropractic for childhood asthma, “promotes bogus therapies.” In response to this statement the BCA notably did not provide the evidence that Singh claimed was missing. Rather, they sued him for libel (the case is ongoing).
Next week I will cover the evidence for musculoskeletal uses of chiropractic.
*This blog post was originally published at Science-Based Medicine*
June 5th, 2009 by Steve Novella, M.D. in Better Health Network
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The Centers for Disease Control (CDC) currently recommends that children 6 month to 18 years old receive an annual flu vaccine. There are two types of flu vaccines used in the US: a live attenuated virus (LAIV) and a trivalent inactivated virus (TIV) vaccine. Both are safe and effective – while efficacy varies from year to year, they are 70-90% effective in healthy adults. Efficacy is young children appears to be slightly less, about 66%.
There remains, however, many sub-questions about the flu vaccines and by the time researchers have thoroughly explored them vaccine technology is likely to have progressed, and therefore any new vaccines will have to be tested all over again.
One of those sub-questions about vaccine safety and efficacy is the net effect of the flu vaccine in children with asthma. Some have raised concerns that the vaccine may exacerbate asthma, a 1-2% increased wheezing and 3% increased hospitalizations have been reported, although so far the bulk of the data suggests that both types of flu vaccines are safe in children with asthma. There is evidence to suggest that the LAIV may be superior to the TIV in children, particularly with asthma.
A new study, presented but not published, further explores the safety and efficacy of the TIV in children. Study author, Avni Joshi, M.D., of the Mayo Clinic, reports:
“The concerns that vaccination maybe associated with asthma exacerbations have been disproved with multiple studies in the past, but the vaccine’s effectiveness has not been well-established. This study was aimed at evaluating the effectiveness of the TIV in children overall, as well as the children with asthma, to prevent influenza-related hospitalization.”
The study is a retrospective study of 263 children who presented to the Mayo clinic with laboratory confirmed influenza. They found that children who had recieved the TIV vaccine had a 3 times greater risk of hospitalization than those who were not vaccinated. These results raise concerns about the safety and effectiveness of the TIV in children with asthma.
Dr. Joshi concludes:
“While these findings do raise questions about the efficacy of the vaccine, they do not in fact implicate it as a cause of hospitalizations. More studies are needed to assess not only the immunogenicity, but also the efficacy of different influenza vaccines in asthmatic subjects.”
That may seem like a curious conclusion given the results of this study, but it is accurate. The key to understanding the implications of this study is that it is retrospective. That means it looks at children who have the flu and then looks back to see who was vaccinated and who wasn’t. This in turn means that children were not randomized to either be vaccinated or not, and this opens the door to any number of variables that cannot be controlled for in the study.
The authors did look as obvious factors, such as severity of asthma and insurance status, and found that they did not correlate with risk of being hospitalized. But what other factors might there be? The flu vaccine is optional, which means that parents decide whether or not to vaccinate their children, perhaps with advice from their pediatrician. It is likely that sicker or more frail children are more likely to get vaccinated. It is also likely that children who had a bad reaction to the flu in the past are more likely to get vaccinated. The flu vaccine is recommended especially for those who are at high risk for complications if they get the flu.
Therefore while this study raises important questions, it is not designed to answer them definitively. A prospective trial is required for that, and that is what Joshi means by “more studies are needed.” In general, retrospective studies are useful to find correlations and generate hypothesis, but are not capable of determining causation – there are simply too many variables that are not controlled for.
As expected, the anti-vaccinationists have already jumped on this study and misinterpreted its significance. They did not recognize its retrospective nature nor put it into the context of existing research on the safety and efficacy of the flu vaccines.
Clinical trials are complex, and there are many types that each have their own strengths and weaknesses. Often, many independent lines of basic science and clinical evidence need to be brought together to form a reliable conclusion about a specific intervention. That is the essence of science-based medicine. Individual studies typically only provide a tiny slice of information, but are often presented to the public as if they are definitive. This creates a constant background noise of misinformation about medical questions.
It also provides a rich source of data from which to cherry pick, allowing proponents to support almost any notion by shopping from the vast store of often conflicting medical research. This reinforces the need to look thoroughly at the totality of scientific evidence on any claim or question.
When that is done on the question of the flu vaccines, it is clear that both types of vaccines are safe and effective. However, there is also much room for improvement in the vaccine technology itself, as well as evidence-based recommendations for who, exactly, should get which type of vaccine.
This current study adds incrementally to our knowledge on this question, and suggests questions for future research. It is not the kind of evidence, however, that should lead to changes in the current recommendations.
*This blog post was originally published at Science-Based Medicine*
March 23rd, 2009 by Steve Novella, M.D. in Better Health Network, Quackery Exposed
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The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.
The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions. Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.
There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.
These conflicting motives create a disconnect in the minds and behaviors of many people. They pay lip service to science-based medicine, but are good at making juicy rationalizations to justify what they want to be true rather than what the science supports. We all do this to some degree – but, in my opinion, complementary and alternative medicine (CAM) is a cultural institution that is built upon these rationalizations. It is formalized illogic and anti-science conceals as science under a mountain of rationalizations.
Some recent news items and reports dealing with acupuncture demonstrate this disconnect quite well.
The BMJ
The British Medical Journal (BMJ) recently published a review of acupuncture studies in the treatment of chronic pain. Like most other reviews of acupuncture studies, the authors were not impressed. They concluded:
A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.
After decades of study and hundred of clinical trials, this remains the state of acupuncture research. The best studies continue to show an unclear effect, which cannot be separated from bias – which of course is the point of clinical trials. In other words, the signal cannot be separated from the noise. The most parsimonious interpretation of this fact is that there is no significant signal – acupuncture does not work.
But supporters of acupuncture prefer to go through a litany of rationalizations rather than acknowledge that simple fact (more on this later).
It was also recently announced that the BMJ group will be adding a new journal: BMJ Acupuncture. That’s right, an entire journal dedicated to studying (read “promoting”) acupuncture. The press release notes:
Acupuncture in Medicine is a quarterly title, which aims to build the evidence base for acupuncture.
I thought the purpose of research was to discover if a treatment works, not to build a case for it.
BMJ is a strange journal – it is generally of high quality but seems to have a blind spot for certain CAM modalities, like acupuncture. While it will publish critical reviews, like the one above, it also has published some low quality positive reviews – such as this one of acupuncture and IVF (in vitro fertilization). The review glosses over the disparity in study quality and location. Other reviews published around the same time showed no effect from acupuncture in IVF.
And the best individual studies to date show no effect. In fact, the most recent study showed that the placebo acupuncture group had slightly higher pregnancy rates by some measures than the acupuncture group (while other measures showed no difference). Again – the most parsimonious interpretation of this study is the null hypothesis – acupuncture does not work in IVF. But proponents twisted themselves into logical pretzels and offered up the astounding rationalization that placebo acupuncture must have some real effect.
To be clear, I am not against journals that specialize in one area, or practitioners that specialize in one form of treatment. Specialization is essential to deal with the modern complexity of medicine. However, we must recognize the significant risk of specialization – and that is the fallacy that is often summarized as follows: if your only tool is a hammer then every problem will look like a nail. It is unlikely that a journal or practitioner dedicated to acupuncture will ever reach the conclusion that acupuncture is a dead end and science-based medicine should move on. As an extension of this, specialty journals and specialist should follow well-established modalities. Forming a specialty journal dedicated to an unproven and dubious modality is problematic, to say the least.
More Rationalizations
A recent Washington Post article observes in its headline: “Millions embrace acupuncture, despite thin evidence.” It seems this reporter, Ellen Edwards, has grasped the essential disconnect, although she does not sufficiently explore an answer to the implied question – why? Why do so many accept acupuncture despite an enduring absence of scientific evidence? Ironically, the press has much to do with it. They are often complicit in misrepresenting the facts, and abetting the rationalizations that are necessary for those who should know better to continue to promote acupuncture despite the lack of evidence.
Some professional organizations are also complicit. The article notes, for example:
The American Medical Association takes no position specifically on acupuncture; the AMA groups it with other alternative treatments, saying “there is little evidence to confirm the safety or efficacy of most alternative therapies.” It says “well-designed, stringently controlled research” is needed to evaluate its efficacy.
Now, the AMA is not the best place to go for position papers on specific scientific questions in medicine. But if they are going to bother having any position, it should be better informed. They say that research is needed, giving the impression that there isn’t already a large body of research to inform out opinion about whether acupuncture works or not.
The notion that more research is needed is one of the most common rationalizations. That allows someone to put off forever concluding that their pet modality does not work – simply make the case for more research, which is easy to make sound like it’s a good idea. And of course anyone against more research must be closed-minded. For example, the story relates (standard disclaimer – I am aware that experts are often quoted out of context by journalists, so keep that in mind, but for the purposes of this post I will take the quotes at face value):
In 2007, NCCAM spent about $9.1 million on acupuncture research. While more is planned, Brent Bauer, an internist at the Mayo Clinic and director of its complementary and alternative medicine program, said the research is in its “toddlerhood.”
Nice touch – “toddlerhood.” That’s just a cute way of saying that more research is needed and you can comfortably ignore any current negative research. If the assessment were fair, then it could be justified. But we have already had several fairly sophisticated placebo-acupuncture controlled trials. This represents reasonably mature clinical research. I suspect
Bauer just does not like the fact that these best studies (like the IVF study above) are generally negative. I wonder – if these studies were positive would he still think they were imature and could be ignored?
Linda Lee, a gastroenterologist who is director of Johns Hopkins’s new Integrative Medicine and Digestive Center, is quoted as saying:
“We have this double standard. We are completely comfortable using pharmacological therapies that have not been subjected to clinical trials for the purposes we use them, but we are super suspicious of alternative therapies that haven’t been tested with randomized placebo trials. From a research point of view, I understand the criticism. But we physicians are in the healing business, and we have to go beyond the pharmacological solutions to understand the whole person,” she said. “Acupuncturists start with the whole person.”
Ah – the “holistic” gambit. This is just another rationalization to distract people from the uncomfortable fact, that she acknowledged. From a “research point of view” means “I understand that the best quality scientific evidence is negative.” And “we..are in the healing business” means “but I want to believe in this anyway.”
The double standard is also an incredible claim, because the opposite is true. SBM advocates want a single standard. What Dr. Lee is actually referring to is prior plausibility – scientific practitioners are more accepting of treatments that are biologically plausible, and are appropriately skeptical of treatments that are extremely implausible. It is also a tu quoque fallacy – we advocate high standards of science for all treatments, even plausible ones. If some doctors uses drugs unscientifically, that does not justify chucking science whenever it conflicts with our beliefs and desires.
It is, in fact, the CAM proponents who want a double standard. Imagine if after hundreds of studies the best a drug could do for any indication is a weak effect that is likely just placebo – the signal cannot be separated from the noise. Imagine a pharmaceutical company making the exact same rationalizations to put its failed drug on the market anyway that acupuncture proponents make for acupuncture.
The article concludes, as most do, with a positive anecdote from a believer – Elise Feingold:
“I decided to leave my science brain aside,” she said. “I felt it had helped other people, and it might help me. I don’t know how it works, but it’s got 4,000 years of Chinese medicine behind it.”
She begins with what amounts to saying that anecdotal evidence is more compelling that rigorous science. This, of course, makes no sense. The whole point of scientific rigor is for evidence to be more objective and reliable – to control for any many variables as possible. Anecdotes are unreliable because they do not control for any variables. Proponents of acupuncture are happy to cite scientific evidence when they think it supports their beliefs, but then will chuck science in favor of low quality anecdotes as needed.
Feingold finishes with the commonplace appeal to antiquity. The premise of this argument is that a treatment that has no real effect could not survive for thousands of years. History proves that this premise is false (see blood letting), and it also profoundly underestimates the human capacity for self-deception and therefore the need for scientific controls.
Conclusion
There is still no compelling evidence that there is any real effect to acupuncture. It didn’t have to turn out that way, but that is the way the scientific chips fell. The treatment also lacks plausibility (although I usually point out that something is happening, unlike homeopathy, and so there is the physical possibility of an effect), and in medicine you only get two strikes. No evidence and no plausibility means that you’re out.
But the disconnect continues. Proponents keep pretending that there is compelling evidence, or it has not been properly studied yet, or it does not have to be studied because historical anecdotes are enough – whichever argument suits the moment. Meanwhile the media keep breathlessly telling us that acupuncture is gaining ground, while the evidence is standing still.
The premise of SBM is that support and resources should follow scientific support. In the world of CAM, however, support follows belief, and the science seems to be an afterthought or, worse, an obstacle.
**This post was originally published at Science Based Medicine.**
