Old bad studies: Fantastical autopsy results
I found the following quote at “Chiropractic care can treat more than just bad backs” (FYI. Chiropractic can’t):
Luse references a study published in The Medical Times authored by Dr. Henry Windsor [sic], M.D. that showcases the correlation of spinal health to overall wellness. Windsor dissected 75 human cadavers to investigate their causes of death. The study showed that 138 of the 139 diseases of the internal organs that were present were in connection to the misalignments of the vertebrae.
But I was intrigued. So I went to the video tape. Well, the PDF.
It is an interesting read by a physician who was looking for an association between curvature of the spine and visceral pathology.
He had 50 corpses, age unknown, that he dissected, looked at the spine for curvature and then looked for pathology in organs in the same distribution of sympathetic nervous system as the level of the spine curvature.
It would be important to know the age and co-morbidities of the patients, since curvature of the spine is a natural result of aging and can be found in normal people and those with nutritional and other metabolic problems.
More importantly, there is no description of the definition of what constitutes a curvature of the spine beyond the obscenity definition: He knows it when he sees it. In fact he finds curvatures where:
such a curve would have been considered normal by many.
He found the curves then found internal pathology then lined up the diseases with the curvature and found associations. 50 cadavers, 105 curvatures of which 100 were ‘minor’ and of these 105 curvatures, 96:
showed evidence of disorders in some of the structures supplied by that portion of the sympathetic system coming from the vertebral segments of the curvature.
Why only some? What was minor? Why are not all the organs in the sympathetic distribution diseased? Um. Because it is an imaginary association?
Or reversing the process of thought, 221 structures other than the spine were found diseased. Of these, 212 were observed to belong to the same sympathetic segment as the vertebrae in curvature
And when there wasn’t an association, it was due to the levels one vertebrae up or down; close enough, right?
Without knowing how abnormal curvature is defined and how the spines were examined, as far as I can tell this is a massive example of confirmation bias. He saw what he wanted to see.
There were a hodgepodge of problems discovered: infections, tumors and cirrhosis, that, as he philosophically notes, are:
the ordinary diseases of adult life
It is curious that diseases with radically different pathophysiologies were thought to be perhaps due to spine curvature and involvement of the sympathetic nervous system. I can think of no reality-based physiology that would result in cancer and infection from interference with the sympathetic nervous system, and we have no way of knowing if the sympathetic nervous system was even impaired in these cadavers. It is a hypothesis, not a conclusion, from his studies, and an awful one at that.
Some of the processes do not seem to be diseases at all: one small bladder, one unduly large bladder, eight large and seven small red kidneys, one degenerated pancreas, whatever that is, one groin wound, four dilated stomachs, seven large and five atrophic spleens. So many subjective findings. It seemed as if when there was no pathology he found some anyway.
This is as curious an example of presuming causation from association as I have ever seen.
It is fun to read old studies (this study was from 1921), in part due to the style of speech used and in part to see the complete lack of rigor in how information was measured and reported. By modern standards this was a truly awful study. This report would be a nice example for students on how not to do a study for if a mistake could be made, it was.
He concludes that children and dogs like to curl up to sleep because it:
[relaxes] the sympathetic nervous system, induces contraction of the great vessels [and empties] the cerebral vessels.
A unique explanation of sleep: depriving the brain of blood by curling up. The report was from the 1920′s so I suppose we can cut the author a little slack for his unique hypothesis of sleep physiology.
And how this fanciful study applies to the equally fanciful adjustments of subluxations of the spine performed by chiropractors is uncertain as:
All curvatures and deformities of the spine were ridged, apparently of long duration: irreducible by ordinary manual force: extension, counter-extension, rotation, even strong lateral movement failed to remove them or even cause them to change their relative positions.
Nothing there a chiropractor could alter, unless they used a hammer. Or perhaps a spring-loaded rod.
Modern bad studies: Frightening autistic children
“Hope for Autism” reads the title. From a chiropractor. I thought, I’m skeptical. I can’t see how the manipulation of the spine to correct fanciful subluxations could do anything for autism . So I went looking for the original paper, which is in a journal so obscure, J. Vertebral Subluxation Res., it is not on PubMed. But the original, “Clinical Efficacy of Upper Cervical Versus Full Spine Chiropractic Care on Children with Autism: A Randomized Clinical Trial,” is available for download.
Their introduction is humorous, although I suspect not deliberately:
Since the primary problem in autistic children is neurological, it is prudent to research the efficacy of chiropractic care in these children.
Since at its heart chiropractic has nothing to do with neurology, or reality.
They decide to answer the question as to:
which is the recommended chiropractic technique in these cases of autism?
I would wager none.
It is every bit as methodologically horrible as you could predict: 14 patients, no randomization or blinding, no control, short follow-up and outcomes based on parents observations and the Autism Treatment Evaluation Checklist. Any results, given the zero prior plausibility of chiropractic, are going to be due to bias. The study, and its results, are best described as garbage.
If the study was approved by an IRB it is not mentioned in the methods nor is there any mention of informed consent. The study mentions how stressful it was for these autistic children, and all for no valid reason.
A few of the children displayed aggressive behavior such as pushing, falling, flaying arms in the air, and kicking. These actions were usually momentary. Chiropractic care was resumed when he child was able to continue… X-ray examination proved to be the most difficult procedure for autistic children…Light from the collimator bulb either scared or fascinated the children.
They used the percussion adjustment instrument of the Atlas Orthogonal technique on these poor children:
The patient is placed on his side with head support at four inches below the mastoid. A metal stylus is placed between the mastoid and the ramus of the mandible. An adjustment, an impulse imparted to the stylus by a plunger that excites a compressional wave in the stylus, is then delivered to the patient. At the patient-stylus interface, a portion of the wave energy is transmitted to the patient and a portion is reflected back to the plunger. The former portion of energy is enough to direct the atlas vertebra to move to its normal orthogonal position.
No wonder they thrashed about in terror, being held down so a rod could thump them behind the ear like a mob execution. There is zero literature on the PubMeds to support the use of Atlas Orthogonal technique and the patter used to justify its use sounds science-y, but, as one chiropractor recognizes, it:
is an outdated, unproven, unsubstantiated technique system.
The kids also received an unhealthy dose of useless radiation:
To attain this, the technique recommends four pre-adjustment cervical x-rays and two post-adjustment x-rays be taken immediately after the first adjustment in the cervical area.
X-rays are not a benign diagnostic modality (although the data is from CT scans, ionizing radiation should not be given as part of tooth fairy science without IRB approval and informed consent):
Risk estimates are derived for paediatric head computed tomographies (CTs) as well as for brain tumours in adults. On the basis of estimates for Germany about the number of head scans, the annual rate of radiation-induced diseases is calculated. About 1000 annual paediatric CT investigations of the skull will lead to about three excess neoplasms in the head region, i.e. the probability of an induced late effect must be suspected in the range of some thousands.
The scant literature on the topic of autism and chiropractic summarized by the “Hope for Autism” authors is also horrible:
Our systematic review of the literature revealed a total of five articles consisting of three case reports, one cohort study and one randomized comparison trial. The literature is lacking on documenting the chiropractic care of children with ASD…However, given the ineffectiveness of pharmaceutical agents, a trial of chiropractic care for sufferers of autism is prudent and warranted.
The ‘since airplane design has flaws, flying carpets should be used’ argument.
A worthless study that only served to scare and irradiate autistic children and proved nothing about the efficacy of chiropractic for autism. If it had been approved by an IRB, they ought to be ashamed for allowing autistic children to be frightened and irradiated without good reason.
Chiropractors, primary Care and vaccines
Some chiropractors want to become primary care providers. Jann Bellamy and Harriet Hall have written about this fantasy. There are several issues with having chiropractors function as if there were knowledgeable and competent physicians.
The first is that their education in school is woefully inadequate to diagnose and treat common medical problems.
The second is that their practical training is even less adequate. I have yet to meet a new medical school graduate who is even barely competent to take care of patients. It is why they have a residency. Most of the real meat of medical training occurs during the 3 to 7 years after medical school. Chiropractors do not have any meaningful post graduate training.
And third, they do not want to participate in the key concepts that make up primary care. Part of primary care is to diagnosis and treat acute and chronic medical problems and they have no training for this. But another part is health maintenance: doing the testing and treatments for the prevention of diseases such as colonoscopy, mammograms and vaccines.
Vaccines are a key part of health maintenance and arguably the most important intervention to improve human health. Maybe fresh water and flush toilets were more important. Part of health maintenance is making sure your patients are up to date in their vaccines.
And chiropractors are often loudly and proudly against vaccines: Immunizations by Colorado DCs: Really?
Are You Prepared to Vaccinate?
Did no one in Colorado get the memo? Based on the feedback I’ve received from previous columns, not many doctors of chiropractic support prescriptive injectables2 and precious few would be willing to give immunizations to infants.
In my opinion, providing risky immunizations to Colorado babies for the purpose of accomplishing a pro-drug agenda is much like a betrayal of those infants for “30 pieces of silver.”
Chiropractors do not subscribe to the reality that vaccines have been and are one of the key tools in the prevention of infections.
A greater than 92% decline in cases and a 99% or greater decline in deaths due to diseases prevented by vaccines recommended before 1980 were shown for diphtheria, mumps, pertussis, and tetanus. Endemic transmission of poliovirus and measles and rubella viruses has been eliminated in the United States; smallpox has been eradicated worldwide. Declines were 80% or greater for cases and deaths of most vaccine-preventable diseases targeted since 1980 including hepatitis A, acute hepatitis B, Hib, and varicella. Declines in cases and deaths of invasive S pneumoniae were 34% and 25%, respectively.
Chiropractors ‘heck no’ antagonism is further evidence against them being responsible for primary care.
Are you willing to administer all of those vaccinations to your infant, adolescent and adult patients so you can meet the accepted standard of a primary care physician? I suspect the majority of you will not just say, “No,” but will say, “Heck no!” So, if we are not willing to do that, then maybe it’s time for us to stop trying to be something we don’t want to be and trying to obtain authority to do things we don’t want to do…However, I do not think the majority of the chiropractic profession believes that primary care – when it includes the medical “Holy Grail” of vaccinations – is the right course to follow.
It is not an isolated opinion but part of the chiropractic world view.
Anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit… But this puts the chiropractic profession outside the greater healthcare community and may contribute to its continued marginalization and small market impact.
And it disqualifies them as primary care providers. One would think that to practice primary care people would need to understand the concepts behind primary care and this chiropractor has the correct conclusion for his field. They have no business being in primary care.
Chiropractic, stroke and patient safety
I learned early in my career that even simple interactions can lead to harm. I had a patient as an intern who had an out-of-hospital cardiac arrest. In the field they placed an IV for resuscitation. The IV site became infected, she became bacteremic, the infection went to her aortic valve, which blew out acutely and she died.
It is why I roll my eyes when people say the first rule of medicine is to do no harm. Everything you do in medicine has the potential for harm, including doing nothing. All actions and all inactions can have bad consequences.
The real rule of medicine is that the odds of providing benefit should be greater than the odds of doing harm. There is also a fudge factor for the disease being treated. I once took care of a patient who died of acute liver failure due to medication she was taking for toenail fungus. I always mention this to patients when they ask for terbinafine. There is a low likelihood of death to treat a trivial problem but most people find the risk/benefit unacceptable when I mention my case. And there are other, less toxic, therapies for nail fungus.
If the disease, like leukemia, offers certain death, patients are more likely to accept the risk of serious complications from chemotherapy or a bone marrow transplant since the potential payoff, life, is worth the risks for the treatment. Risks and benefits are variable and deciding what to do is complex calculus filtered through patients’ expectations and values that is not done justice by the simplistic phrase ‘Do no harm.’
The issue with most of the pseudo-medicines is they do nothing, they alter no physiologic process, and so any side effect is not acceptable. If the benefit is zero, the risk should also be zero.
Cervical manipulative therapy has little real proven indication, especially if being used to fix mythical subluxations. Chiropractors are remarkably adamant that their adjustments are safe and do not cause stroke from vertebral artery dissection (VAD). They love to point to “Risk of Vertebrobasilar Stroke and Chiropractic Care Results of a Population-Based Case-Control and Case-Crossover Study” as evidence that chiropractic is safe and suggest patients are seeking chiropractic care for their prior VAD. In point of fact the study confirms the risk of stoke following CMA.
A passive hanging (no drop) gives about 686 Newton’s of force around the neck for a 70 kg human. In chiropractic, “the mean force of all manual applications [is] 264 Newton’s and the mean force duration [is] 145 milliseconds”. So a chiropractic neck manipulation, for a short period of time, can provide 38% the force of a hanging. And a bad hanging at that.
Neck injuries are not that frequent because the muscles of the neck prevent injury by preventing sudden, disastrous, movement. If you want to increase the chance of injury from relatively minor trauma, have the person relax. If the muscles are relaxed because the person is not expecting the trauma, the chance of injury goes up. It is why whiplash can occur after minor injuries. Chiropractors often have their patients relax just before the coup de grace, I mean manipulation, helping to maximize the chance of injury despite having less force applied to the neck than a noose and gravity.
Given the above, to claim that the [vertebrobasilar artery stroke] occurred before the patient had chiropractic neck manipulation is like saying the hanging victim had a broken neck, but it occurred on the steps up to the scaffold.
There is now a position paper “Cervical Arterial Dissections and Association With Cervical Manipulative Therapy” from the American Heart Association/American Stroke Association and discussed by Dr. Novella.
They review the literature and anatomy/physiology of stroke and CMA. The money quote:
Although current biomechanical evidence is insufficient to establish the claim that CMT causes CD [Cervical artery dissections], clinical reports suggest that mechanical forces play a role in a considerable number of CDs and most population controlled studies have found an association between CMT [cervical manipulative therapy] and VAD [vertebral artery dissection] stroke in young patients. Although the incidence of CMT-associated CD in patients who have previously received CMT is not well established, and probably low, practitioners should strongly consider the possibility of CD as a presenting symptom, and patients should be informed of the statistical association between CD and CMT prior to undergoing manipulation of the cervical spine.
In epidemiology, Hill’s Criteria provides a framework for considering whether association is causation and is helpful when there are no definitive studies. We will never have a prospective trial of cervical manipulation to see if it can induce a stroke and given the rarity of the event will have to rely on less definitive data. Hills Criteria are:
- Strength: A small association does not mean that there is not a causal effect, though the larger the association, the more likely that it is causal.
- Consistency: Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.
- Specificity: Causation is likely if a very specific population at a specific site and disease with no other likely explanation. The more specific an association between a factor and an effect is, the bigger the probability of a causal relationship.
- Temporality: The effect has to occur after the cause (and if there is an expected delay between the cause and expected effect, then the effect must occur after that delay).
- Biological gradient: Greater exposure should generally lead to greater incidence of the effect. However, in some cases, the mere presence of the factor can trigger the effect. In other cases, an inverse proportion is observed: greater exposure leads to lower incidence.
- Plausibility: A plausible mechanism between cause and effect is helpful (but Hill noted that knowledge of the mechanism is limited by current knowledge).
- Coherence: Coherence between epidemiological and laboratory findings increases the likelihood of an effect. However, Hill noted that “… lack of such [laboratory] evidence cannot nullify the epidemiological effect on associations”.
- Experiment: “Occasionally it is possible to appeal to experimental evidence”.
- Analogy: The effect of similar factors may be considered.
Hill’s Criteria has been applied to the concept of Chiropractic subluxation and the reality of subluxation was found wanting.
There is a significant lack of evidence to fulfill the basic criteria of causation. This lack of crucial supportive epidemiologic evidence prohibits the accurate promulgation of the chiropractic subluxation.
For stroke causation, Hill’s criteria are modestly met. The preponderance of information points to CMT as a risk for dissection and stroke and there is certainly plausibility for what is fortunately a rare event. The case reports of stoke immediately after CMT give one pause; they may reach the level of parachute evidence.
I have spent a significant part of my career in infection control and quality, where we strive apply the literature to maximize patient safety and to good effect.
To date the only pseudo-medical quality initiative that led to an increase in patient safety of which I am aware is the use of sterile disposable acupuncture needles, an intervention they work hard to subvert by ignoring all other infection control interventions like gloves. A hallmark of pseudo-medicines is they do no change because of data.
In real medicine we recognize the potential for harm and strive to reduce it. In my institutions we try to always put patient safety first. The question is the response by the chiropractic community to the position paper. I predict denial rather than changes in practice to increase the safety of their clients.
Well what do you know? From the American Chiropractic Association
The largest and most credible study, Cassidy et al., found that a patient is as likely to have seen a primary care medical doctor as a doctor of chiropractic prior to experiencing a cervical arterial dissection (CD).
Neck manipulation is a safe, conservative treatment option for neck pain and headache. The evidence presented in the AHA paper fails to show that neck manipulation is a significant risk factor in CD. In addition, the paper fails to put into context risks associated with other neck pain treatments such as neck surgery, steroid injections and prescription drugs.
In an Aug. 8 speech, Christine Goertz, DC, PhD, vice chancellor for research and health policy at Palmer College of Chiropractic, explained that medical doctors and doctors of chiropractic need to be vigilant in assessing patients who may be in the early stages of vertebral arterial dissection (VAD). It’s also extremely important that the data regarding the risk of VAD is presented to patients in an accurate manner.
“The facts are that VADs are very, very rare events, and there’s absolutely no research that shows a cause-and-effect relationship between chiropractic care and stroke,” Goertz said.
We have very rare events in real medicine as well. We used to use the antibiotic trovafloxacin at the rate of 300,000 prescriptions a month, but there were 6 deaths and handful of severe liver failures from the medication.
And now? We no longer use it because we have safer therapies with equal efficacy. And unlike cervical manipulation for neck pain, an intervention that has no benefit, trovafloxacin was an effective antibiotic.
To use massive understatement, the pharmaceutical industry has not always been forthcoming about the risks of their products. But when they are discovered by physicians, we respond in a way to maximize patient safety. The President of the Infectious Disease Society of America doesn’t give a speech release saying
The facts are that liver failure are very, very rare events, and there’s absolutely no research that shows a cause-and-effect relationship between trovafloxacin and liver failure
trovafloxacin is a safe, conservative treatment option for infection. The evidence presented fails to show that trovafloxacin is a significant risk factor in liver failure.
In medicine we balance the risk and the benefit of an intervention and try to do what is in the best interest of the patient by changing practice. When in doubt we try and maximize patient safety
Chiropractic is more interested in keeping their business model active than changing to decrease patient risk. But that is the case for all pseudo-medicines.
Lets increase the chance of more strokes
A while back I mentioned a study that wasn’t a study by the British Chiropractor Association that suggested that texting could kill you.
Their completely unsubstantiated theory is that texting, by causing the head to lean forward, would lead to hyper-kyphosis, restrictive lung disease and death. This idea has no basis in the medical literature I can find.
However, the English need some entrepreneurial sprint because it took
Dr. Dean Fishman, a chiropractor (to) create and trademark the phrase “text neck.”
Hereby referred to as TN.
He has an Android app ($2.99 and free version) to let you know if you are using your phone at a dangerous angle. Why might you do this? Because TN, according to the Text-Neck Institute:
… IS A GLOBAL EPIDEMIC! ‘Text Neck’ is a world-wide health concern, affecting millions of all ages and from all walks of life. Widespread overuse of handheld mobile technology is resulting in a harmful and dangerous physical condition on the human body, which is known as Text Neck.
that will lead to:
Flattening of the Spinal Curve, Onset of Early Arthritis, Spinal Degeneration, Spinal Misalignment, Disc Herniation, Disc Compression, Muscle Damage, Nerve Damage, Loss of Lung Volume Capacity, (and) Gastrointestinal Problems.
TN is based on almost no data and/or wild extrapolation as the search term “text neck” has no hits on PubMed.
I do not doubt a stiff neck and tension headache may occur from prolonged use of a mobile device in an awkward position. I certainly get a sore neck at the computer, especially as the screen is not at bifocal level.
But disc herniation? Loss of lung volume? Gastrointestinal problems? Color me skeptical.
FHP has been shown to flatten the normal neck curve, resulting in disc compression, damage, and early arthritis.
The abstract from 1986, long before cell phones and texting, concerns normal changes in the neck with aging:
The purpose of this study was to determine the incidence and severity of degenerative changes seen on lateral roentgenograms in 200 asymptomatic men and women in five age groups with an age range of 20-65 years and to determine the normal values of cervical lordosis and spinal canal sagittal diameters and their relationship to degenerative changes. It was found that by age 60-65, 95% of the men and 70% of the women had at least one degenerative change on their roentgenograms. A small sagittal diameter correlated with the presence of degenerative changes at the same disc level, and the strongest correlation was with the size of the posterior osteophytes at C5-6 (r = 0.52). Cervical lordosis measurements did not relate to degenerative changes except for subjects over age 50 with moderate or severe intervertebral narrowing. It is important to realize that although roentgenographic abnormalities represent structural changes in the spine, they do not necessarily cause symptoms.
He conveniently ignores the association between cervical spine curvature and neck pain which suggests:
In conclusion, we suggest that when so-called “abnormalities” of the sagittal profile are observed in the older patient with neck pain they must be considered coincidental, i.e. not necessarily indicative of the cause of pain. This should be given due consideration in the differential diagnosis of patients with non-specific neck pain.
In the Cephalalgiaarticle, used as a reference,
the study demonstrated a strong association between an increased forward head posture and decreased respiratory muscle strength in neck patients.
Was in a whopping 24 patients.
Not the most robust of literature to support the concept of TN.
But the biggest concern with making TN a worry to people is the ‘solution’ to the problem. Somehow I suspect the treatment will be chiropractic manipulation of the neck.
And that could lead to an increase in strokes. Great.