A recent study looking at acupuncture for the prevention of migraine attacks demonstrates all of the problems with acupuncture and acupuncture research that we have touched on over the years at SBM. Migraine is one indication for which there seems to be some support among mainstream practitioners. In fact the American Headache Society recently recommended acupuncture for migraines. Yet, the evidence is simply not there to support this recommendation, which, in my opinion, is a failure to understand a science-based assessment of the clinical evidence.
The recent study, like many acupuncture studies, was problematic, and was also negative. It showed that acupuncture does not work for migraines, but of course also contains the seeds of denial for those who want to believe in acupuncture. From the abstract:
We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5-8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.
Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5-8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13-16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference -1.06 [95% confidence interval (CI) -1.77 to -0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference -1.22 [95% CI -1.92 to -0.52], p < 0.001; Yangming-specific acupuncture v. control: difference -0.91 [95% CI -1.61 to -0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.
One consistent theme of SBM is that the application of science to medicine is not easy. We are often dealing with a complex set of conflicting information about a complex system that is difficult to predict. That is precisely why we need to take a thorough and rigorous approach to information in order to make reliable decisions.
The same is true when applied to an individual patient. Often times we cannot make a single confident diagnosis based upon objective information. We have to be content with a diagnosis that is based partly on probability or on ruling out other possibilities. Sometimes we rely upon a so-called “therapeutic trial” to help confirm a diagnosis. If, for example, it is my clinical impression that a patient is probably having seizures, but I have no objective information to verify that (EEG and MRI scans are normal, which is often the case) I can help confirm the diagnosis by giving the patient an anti-seizure medication to see if that makes the episodes stop, or at least become less frequent. Placebo effects make therapeutic trials problematic, but if you have an objective outcome measure and a fairly dramatic response to treatment, that at least raises your confidence in the diagnosis.
We can apply the same basic principle on the population level. If a public health intervention is addressing the actual cause of one or more diseases, then we should see some objective markers of disease frequency or severity decrease over time. Putting fluoride in the public water supply decreased the incidence of tooth decay. Adding iodine to salt decreased the incidence of goiter. Fortifying milk with vitamin D decreased the incidence of rickets. However, removing thimerosal from the childhood vaccine schedule did not reduce the incidence of autism (or the rate of increase in autism diagnosis). That is because calcium deficiency causes rickets, but thimerosal (or the mercury it contains) does not cause autism.
I have previously written about psychomotor patterning – an alleged treatment for developmental delay that was developed in the 1960s. The idea has its roots in the notion of ontogeny recapitulates phylogeny, that as we develop we progress through evolutionary stages. This idea, now largely discredited, was extended to the hypothesis that in children who are developmentally delayed their neurological development could be enhanced if they were made to progress through evolutionary stages. Children were put through hours a day of passive crawling, for example, with the belief that this coax the brain into a normal developmental pathway. The treatment was studied extensively in the 1970s showing that the treatment did not work.
However, those who developed this treatment, Doman and Delecato, did not want to give up on their claim to fame simply because it didn’t work and the underlying concepts were flawed. For the last 40 years they have continued to offer the Doman-Delecato treatment for all forms of mental retardation, surviving on the fringe, all but forgotten by mainstream medicine (except by those with an interest in pathological science).
I was recently asked to look into the claims for a disorder known as pyroluria, and what I found was very similar to the history of psychomotor patterning. There was some legitimate scientific interest in this alleged condition in the 1960s. Studies in the 1970s, however, discredited the hypothesis and it was discarded as a failed hypothesis. The published literature entirely dries up by the mid 1970s. But the originators of the idea did not give up, and continue to promote the idea of pyroluria to this day.
When I first heard about studies using smartphones to treat anxiety with cognitive therapy I was intrigued, to say the least. However, I had a misconception about what that actually meant. My assumption was that the smartphone app would be automating some basic cognitive therapy, a virtual therapist that could give some reflective feedback and also give basic cognitive tools to deal with anxiety. That sounded like it might be useful, at least for mild cases, and I hoped that the app was designed to refer severe cases to an actual therapist.
I had already been very interested in the concept of online, virtual, or computer-based therapy. It seems like this is coming, but of course it needs to be researched to see how it works and for which patients.
But that is not what the smartphone app is at all. Rather it has to do with a treatment technique called cognitive bias modification (CBM). This therapy is based on research that finds that those with social anxiety have a cognitive bias which makes them attend more than others to signs of threat or to negative emotions. Further, they have a cognitive bias to interpret ambiguous social cues as hostile or negative. This raises a cause and effect question – are they anxious because they have these cognitive biases, or does the anxiety make them attend to negative emotions and interpret emotions negatively. Perhaps it is both, in a reinforcing feedback loop.
The Bravewell Collabortive is a private organization whose stated mission is to, “accelerate the adoption of integrative medicine within the health care system.” They are well-funded, and they have successfully used their money to advance their mission. They also now appear to be an effective propaganda machine, producing what they are calling a “landmark report” on the use of integrative medicine in the US. The report is indeed revealing, but perhaps not in the way Bravewell intends.
The report is simply a survey of 29 integrative centers in the US. Before presenting the major findings the report defines “integrative medicine:”
“an approach to care that puts the patient at the center and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person’s health. Employing a personalized strategy that considers the patient’s unique conditions, needs, and circumstances, it uses the most appropriate interventions from an array of scientific disciplines to heal illness and disease and help people regain and maintain optimum health.”
This is the standard marketing propaganda, which we have dissected many times before (so one more time won’t hurt). It is important to note that this is not a legitimate philosophy or approach to medicine, but pure marketing hype with the purpose of rebranding medical pseudoscience and quackery. There is a growing list of terms used for this rebranding – first “alternative” or “holistic” then “complementary” now “integrative”, “personalized”, and “patient-centered.” It’s the same nonsense, only the labels have evolved (market-tested, if you will).
The debate about teaching so-called complementary and alternative medicine (CAM) in universities and medical schools rages on. Attention has turned recently to Australia, where the infiltration of CAM into universities is a growing problem. A new group has formed called the Friends of Science in Medicine to advocate for maintaining high standards of science in medical academia. They have been successful in at least invigorating the debate, leading to a slew of articles on the topic, many of which are reasonable. They have also forced CAM proponents to defend their position, which they do with the usual bad logic and invalid arguments.
It is a sign of our times that we even have to defend having standards of good science in the practice of medicine and the teaching of a science-based curriculum in universities. This is an issue we have discussed at length on SBM often. The core philosophy of SBM is that high standards of science in medicine are necessary in order to ensure, as best as we can, that treatments and interventions are safe and effective. It is extremely complicated and tricky to determine safety and efficacy. Humans suffer from numerous mechanisms of self-deception, cognitive flaws and biases, poor grasp of statistics, and perceptual failings that are likely to lead us astray. In fact our biases tend to systematically lead us to false conclusions that we wish to be true, rather than the truth.
Science is the only system that we have developed that systematically controls for all of these biases and flaws to see through to reliable information. Science endeavors to be transparent, thorough, and rigorous. The applications of scientific principles has demonstrably transformed medicine (and human knowledge in general) for the better. As a society we should not lightly abandon the principles of science nor try to change them to meet the needs of the current fads.
By now you have probably heard of the middle and high school children in LeRoy, NY who have come down with what some reports are calling a “mystery” illness. Of course it is almost obligatory to note in such stories that doctors or experts are “baffled.” There are several features of this story that are interesting from a science-based medicine and also just a critical thinking point of view – the media response, how such ailments are diagnosed, the publicity around a private medical condition, and the speculation from many camps that appears ideologically motivated.
To first review the facts of the case, there are now 15 children affected with involuntary tics, which are sudden “jerk-like” motor movements. They all attend the same junior-senior high school and so range in age from 12-18, with onset of symptoms from October to January of the current school year. All but one of them are girls. All of the children have been examined by pediatric neurologists, 12 of the 15 at the Dent neurological institute by the same two neurologists, including Dr. Lazlo Mechtler.
Dr. Mechtler, and in fact all of the pediatric neurologists who have examined any of the children, have come to the same diagnosis: conversion disorder and mass psychogenic illness. A conversion disorder occurs when psychological stress manifests as physical symptoms. We take this for granted to some degree – when people feel anxious they may get sweaty, nauseated, short of breath, and have palpitations. People with panic attacks can have these symptoms and also difficulty swallowing, and episodes that may resemble certain types of seizures with feelings of being separate from reality or from themselves. These are physical symptoms resulting from pure emotional stress. But in some cases psychological stress can also lead to neurological symptoms – pretty much any neurological symptoms, such as weakness, difficulty speaking, loss of vision, and involuntary movements.
One of the themes of science-based medicine is to be suspicious of any form of medicine that is not science-based. In other words, beware of dodgy qualifiers placed before “medicine,” such as: “alternative”, “integrative”, or “complementary” – those that imply that something other than science or evidence is being used to determine which treatments are safe and effective. I would also include “traditional Chinese” medicine in the dodgy category. A recent article defending Traditional Chinese Medicine (TCM) provides, ironically, an excellent argument for the rejection of TCM as a valid form of medicine. The authors, Jingqing Hua and Baoyan Liub, engage in a number of logical fallacies that are worth exploring.
Their introduction sets the tone:
Traditional Chinese medicine (TCM) has a history of thousands of years. It is formed by summarizing the precious experience of understanding life, maintaining health, and fighting diseases accumulated in daily life, production and medical practice. It not only has systematic theories, but also has abundant preventative and therapeutic methods for disease.
It may be trivially true that TCM has a long history, but it is hard to ignore that the placement of this statement at the beginning of a scientific article implies an argument from antiquity – that TCM should be taken seriously because of this long history. I would argue that this is actually a reason to be suspicious of TCM, for it derives from a pre-scientific largely superstition-based culture, similar in this way to the pre-scientific Western culture that produced the humoral (Galenic) theory of biology.
A new review published in The BMJ once again opens the question of the risks vs benefits of daily aspirin as a prevention for heart attacks and strokes. The reviewers looked at nine randomized trials involving over 100,000 patients and found that aspirin is effective in reducing heart attacks and strokes, but also increases the risk of gastrointestinal bleeding and that in some patients this risk outweighs the benefit.
This is an old and enduring controversy, and one with significant public health ramifications. Aspirin is an anti-platelet agent – it inhibits platelets, the cell fragments in the blood that are the first line against bleeding, from aggregating (clumping together). Platelets aggregate in order to quickly stop bleeding from damaged veins or arteries. But they can also aggregate around cholesterol plaques in arteries, causing a large thrombus (blood clot) that can block off the artery, or that can break off and lodge in a downstream artery (an embolus) and cause a stroke or heart attack.
By inhibiting platelet aggregation daily aspirin reduces the risk of forming a thrombus or embolus, and thereby reduces the risk of heart attack or stroke. Of course, the real story is always more complex than our straightforward explanations. There is some research to suggest that the anti-inflammatory effects of aspirin may also be important to their role in reducing vascular risk. The relative contribution of anti-platelet and anti-inflammatory effects have not been fully teased out. Further, the anti-inflammatory effects of daily aspirin may have non-vascular benefits, like reducing the risk of some cancers.
Tonsillectomy remains a common surgical procedure with over half a million cases in the US per year, the most common surgical procedure in children. The indications and effects of tonsillectomy remain a matter of research and debate, as is appropriate. It is also a subject of popular misinformation and alarmism.
A recent article by Seth Roberts raises many of the issues with tonsillectomy, but also reveals the pitfalls of non-experts trying to understand the clinical literature and the effects of bias on evaluating a complex medical question. Throughout the article Roberts displays a persistent bias toward downplaying the benefits and exaggerating the risks of tonsillectomy, while accusing the medical establishment of doing the exact opposite. The purpose of this post is not to defend the practice of tonsillectomy but to review some of the relevant issues and explore how bias can affect an assessment of the evidence.
Indications for Tonsillectomy
Roberts tells the story of Rachael who was offered tonsillectomy for her son and so did some research on her own. She looked on Pubmed (a good place to start) and found a Cochrane review from 2009.
The Cochrane Review that Rachael found (“Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis”) was published in 2009. It describes four experiments that compared tonsillectomy to the care a sick child would otherwise receive. All four involved children like Rachael’s son, and all four had similar results: Tonsillectomies had only a small benefit. (Contrary to what Rachael was told.) During the year after random assignment to treatment — the point at which some children had their tonsils removed, other children did not — children whose tonsils were removed had one less sore throat than children who were not operated on (two instead of three for children like Rachael’s son).