spinal manipulation
Some experts concede that chiropractic spinal manipulation is effective for chronic low back pain (cLBP). But what is the right dose? There have been no full-scale trials of the optimal number of treatments with spinal manipulation. This study was aimed at filling this gap by trying to identify a dose-response relationship between the number of visits to a chiropractor for spinal manipulation and cLBP outcomes. A further aim was to determine the efficacy of manipulation by comparison with a light massage control.
The primary cLBP outcomes were the 100-point pain intensity scale and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.
One hundred patients with cLBP were randomized to each of 4 dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, the patients received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.
For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks, an effect that was sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per 6 manipulation sessions at 12 and 52 weeks for both variables. At 12 weeks, the greatest differences compared to the no-manipulation controls were found for 12 sessions (8.6 pain and 7.6 disability points); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points).
The authors concluded that the number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
This study is interesting because it confirms that the effects of chiropractic spinal manipulation as a treatment for cLBP are tiny and probably not clinically relevant. And even these tiny effects might not be due to the treatment per se but could be caused by residual confounding and bias.
As for the optimal dose, the authors suggest that, on average, 18 sessions might be the best. But again, we have to be clear that the dose-response effects were small and of doubtful clinical relevance. Since the therapeutic effects are tiny, it is obviously difficult to establish a dose-response relationship.
In view of the cost of chiropractic spinal manipulation and the uncertainty about its safety, I would probably not rate this approach as the treatment of choice but would consider the current Cochrane review which concludes that “high quality evidence suggests that there is no clinically relevant difference between spinal manipulation and other interventions for reducing pain and improving function in patients with chronic low-back pain” Personally, I think it is more prudent to recommend exercise, back school, massage or perhaps even yoga to cLBP-sufferers.
Many reader of this blog will remember the libel case of the British Chiropractic Association (BCA) against Simon Singh. Simon had disclosed in a Guardian comment that the BCA was happily promoting bogus chiropractic treatments for 6 paediatric conditions, including infant colic. The BCA not only lost the case but the affair almost destroyed this strange organisation and resulted in an enormous reputational damage of chiropractors worldwide. In an article entitled AFTER THE STORM, the then-president of the BCA later described the defeat in his own words: “in 2009, events in the UK took a turn which was to consume the British Chiropractic Association (BCA) for two years and force the wider profession to confront key issues that for decades had kept it distanced from its medical counterparts and attracting ridicule from its critics…the BCA began one of the darkest periods in its history; one that was ultimately to cost it financially, reputationally and politically…The GCC itself was in an unprecedented situation. Faced with a 1500% rise in complaints, Investigating Committees were assembled to determine whether there was a case to answer…The events of the past two years have exposed a blind adherence to outdated principles amongst a small but significant minority of the profession. Mindful of the adage that it’s the squeaky wheel that gets the grease, the vocalism of this group has ensured that chiropractic is characterised by its critics as unscientific, unsafe and slightly wacky. Claims that the vertebral subluxation complex is the cause of illness and disease have persisted despite the three UK educational establishments advising the GCC that no evidence of acceptable quality exists to support such claims.”
Only a few years AFTER THE STORM, this story seems to have changed beyond recognition. Harald Walach, who is known to readers of this blog because I reported that he was elected ‘pseudo-scientist of the year’ in 2012, recently published a comment on the proceedings of the European Congress of Integrated Medicine where we find the following intriguing version of the libel case:
Mein Freund und Kollege George Lewith aus Southampton hatte einen Hauptvortrag über seine Überblicksarbeit über chiropraktische Interventionen für kleinkindliche Koliken vorgelegt. Sie ist ausgelöst worden durch die Behauptung, die Singh und Ernst vor einigen Jahren erhoben hatten, dass Chiropraktik gefährlich ist, dass es keine Daten dafür gäbe, dass sie wirksam sei und dass sie gefährliche Nebenwirkungen habe, speziell wenn sie bei Kindern angewendet würde. Die Chiropraktiker hatten den Wissenschaftsjournalisten Singh damals wegen Verleumdung verklagt und recht erhalten. George Lewith hatte dem Gericht die Expertise geliefert und nun seine Analyse auf Kinder ausgedehnt.
Kurz gefasst: Die Intervention wirkt sogar ziemlich stark, etwa eine Standardabweichung war der Effekt groß. Die Kinder schreien kürzer und weniger. Und die Durchforstung der Literatur nach gefährlichen Nebenwirkungen hatte keinen, wortwörtlich: nicht einen, Fall zu Tage gefördert, der von Nebenwirkungen, geschweige denn gefährlichen, berichtet hätte. Die Aufregung war seinerzeit dadurch entstanden, dass eine unqualifizierte Person einer zart gebauten Frau über den Rücken gelaufen ist und ihr dabei das Genick gebrochen hat. Die Presse hatte das ganze dann zu „tödlicher Nebenwirkung chiropraktischer Intervention“ aufgebauscht.
Oh, I almost forgot, you don’t read German? Here is my translation of this revealing text:
“My friend and colleague Geoorge Lewith from Southampton gave a keynote lecture on his review of chiropractic interventions for infant colic. This was prompted by the claim, made by Singh and Ernst a few years ago, that chiropractic was dangerous, that no data existed showing its effectiveness, and that it had dangerous side-effects, particularly for children. The chiropractors had sued the science journalist Singh for libel and won the case. George Lewith had provided the expert report for the court and has now extended his analysis on children.
To put it briefly: the intervention is even very effective; the effect-size is about one standard deviation. The children cry less long and more rarely. And the search of the literature for dangerous side-effects resulted in no – literally: not one – case of side-effects, not to mention dangerous ones. The fuzz had started back then because an unqualified person had walked over the back of a thin woman and had thus broken her neck. The press had subsequently hyped the whole thing to a “deadly side-effect of a chiropractic intervention”. (I am sorry for the clumsy language but the original is even worse.)
Now, isn’t that remarkable? Not only has the truth about the libel case been turned upside down, but also the evidence on chiropractic as a treatment for infant colic seems mysteriously improved; other reviews which might just be a bit more independent and objective come to the following conclusions:
And what should we make of all this? I don’t know about you, but I conclude that, for some apologists of alternative medicine, the truth is a rather flexible commodity.
The following is a guest post by Preston H. Long. It is an excerpt from his new book entitled ‘Chiropractic Abuse—A Chiropractor’s Lament’. Preston H. Long is a licensed chiropractor from Arizona. His professional career has spanned nearly 30 years. In addition to treating patients, he has testified at about 200 trials, performed more than 10,000 chiropractic case evaluations, and served as a consultant to several law enforcement agencies. He is also an associate professor at Bryan University, where he teaches in the master’s program in applied health informatics. His new book is one of the very few that provides an inside criticism of chiropractic. It is well worth reading, in my view.
Have you ever consulted a chiropractor? Are you thinking about seeing one? Do you care whether your tax and health-care dollars are spent on worthless treatment? If your answer to any of these questions is yes, there are certain things you should know.
1. Chiropractic theory and practice are not based on the body of knowledge related to health, disease, and health care that has been widely accepted by the scientific community.
Most chiropractors believe that spinal problems, which they call “subluxations,” cause ill health and that fixing them by “adjusting” the spine will promote and restore health. The extent of this belief varies from chiropractor to chiropractor. Some believe that subluxations are the primary cause of ill health; others consider them an underlying cause. Only a small percentage (including me) reject these notions and align their beliefs and practices with those of the science-based medical community. The ramifications and consequences of subluxation theory will be discussed in detail throughout this book.
2. Many chiropractors promise too much.
The most common forms of treatment administered by chiropractors are spinal manipulation and passive physiotherapy measures such as heat, ultrasound, massage, and electrical muscle stimulation. These modalities can be useful in managing certain problems of muscles and bones, but they have little, if any, use against the vast majority of diseases. But chiropractors who believe that “subluxations” cause ill health claim that spinal adjustments promote general health and enable patients to recover from a wide range of diseases. The illustrations below reflect these beliefs. The one to the left is part of a poster that promotes the notion that periodic spinal “adjustments” are a cornerstone of good health. The other is a patient handout that improperly relates “subluxations” to a wide range of ailments that spinal adjustments supposedly can help. Some charts of this type have listed more than 100 diseases and conditions, including allergies, appendicitis, anemia, crossed eyes, deafness, gallbladder problems, hernias, and pneumonia.
A 2008 survey found that exaggeration is common among chiropractic Web sites. The researchers looked at the Web sites of 200 chiropractors and 9 chiropractic associations in Australia, Canada, New Zealand, the United Kingdom, and the United States. Each site was examined for claims suggesting that chiropractic treatment was appropriate for asthma, colic, ear infection/earache/otitis media, neck pain, whiplash, headache/migraine, and lower back pain. The study found that 95% of the surveyed sites made unsubstantiated claims for at least one of these conditions and 38% made unsubstantiated claims for all of them.1 False promises can have dire consequences to the unsuspecting.
3. Our education is vastly inferior to that of medical doctors.
I rarely encountered sick patients in my school clinic. Most of my “patients” were friends, students, and an occasional person who presented to the student clinic for inexpensive chiropractic care. Most had nothing really wrong with them. In order to graduate, chiropractic college students are required to treat a minimum number of people. To reach their number, some resort to paying people (including prostitutes) to visit them at the college’s clinic.2
Students also encounter a very narrow range of conditions, most related to aches and pains. Real medical education involves contact with thousands of patients with a wide variety of problems, including many severe enough to require hospitalization. Most chiropractic students see patients during two clinical years in chiropractic college. Medical students also average two clinical years, but they see many more patients and nearly all medical doctors have an additional three to five years of specialty training before they enter practice.
Chiropractic’s minimum educational standards are quite low. In 2007, chiropractic students were required to evaluate and manage only 15 patients in order to graduate. Chiropractic’s accreditation agency ordered this number to increase to 35 by the fall of 2011. However, only 10 of the 35 must be live patients (eight of whom are not students or their family members)! For the remaining cases, students are permitted to “assist, observe, or participate in live, paper-based, computer-based, distance learning, or other reasonable alternative.”3 In contrast, medical students see thousands of patients.
Former National Council Against Health Fraud President William T. Jarvis, Ph.D., has noted that chiropractic school prepares its students to practice “conversational medicine”—where they glibly use medical words but lack the knowledge or experience to deal appropriately with the vast majority of health problems.4 Dr. Stephen Barrett reported a fascinating example of this which occurred when he visited a chiropractor for research purposes. When Barrett mentioned that he was recovering from an attack of vertigo (dizziness), the chiropractor quickly rattled off a textbook-like list of all the possible causes. But instead of obtaining a proper history and conducting tests to pinpoint a diagnosis, he x-rayed Dr. Barrett’s neck and recommended a one-year course of manipulations to make his neck more curved. The medical diagnosis, which had been appropriately made elsewhere, was a viral infection that cleared up spontaneously in about ten days.5
4. Our legitimate scope is actually very narrow.
Appropriate chiropractic treatment is relevant only to a narrow range of ailments, nearly all related to musculoskeletal problems. But some chiropractors assert that they can influence the course of nearly everything. Some even offer adjustments to farm animals and family pets.
5. Very little of what chiropractors do has been studied.
Although chiropractic has been around since 1895, little of what we do meets the scientific standard through solid research. Chiropractic apologists try to sound scientific to counter their detractors, but very little research actually supports what chiropractors do.
6. Unless your diagnosis is obvious, it’s best to get diagnosed elsewhere.
During my work as an independent examiner, I have encountered many patients whose chiropractor missed readily apparent diagnoses and rendered inappropriate treatment for long periods of time. Chiropractors lack the depth of training available to medical doctors. For that reason, except for minor injuries, it is usually better to seek medical diagnosis first.
7. We offer lots of unnecessary services.
Many chiropractors, particularly those who find “subluxations” in everyone, routinely advise patients to come for many months, years, and even for their lifetime. Practice-builders teach how to persuade people they need “maintenance care” long after their original problem has resolved. In line with this, many chiropractors offer “discounts” to patients who pay in advance and sign a contract committing them for 50 to 100 treatments. And “chiropractic pediatric specialists” advise periodic examinations and spinal adjustments from early infancy onward. (This has been aptly described as “womb to tomb” care.) Greed is not the only factor involved in overtreatment. Many who advise periodic adjustments are “true believers.” In chiropractic school, one of my classmates actually adjusted his newborn son while the umbilical cord was still attached. Another student had the school radiology department take seven x-rays of his son’s neck to look for “subluxations” presumably acquired during the birth process. The topic of unnecessary care is discussed further in Chapter 8.
8. “Cracking” of the spine doesn’t mean much.
Spinal manipulation usually produces a “popping” or “cracking” sound similar to what occurs when you crack your knuckles. Both are due to a phenomenon called cavitation, which occurs when there is a sudden decrease in joint pressure brought on by the manipulation. That allows dissolved gasses in the joint fluid to be released into the joint itself. Chiropractors sometimes state that the noise means that something therapeutic has taken place. However, the noise has no health-related significance and does not indicate that anything has been realigned. It simply means that gas was allowed to escape under less pressure than normal. Knuckles do not “go back into place” when you crack them, and neither do spinal bones.
9. If the first few visits don’t help you, more treatment probably won’t help.
I used to tell my patients “three and through.” If we did not see significant objective improvement in three visits, it was time to move on.
10. We take too many x-rays.
No test should be done unless it is likely to provide information that will influence clinical management of the patient. X-ray examinations are appropriate when a fracture, tumor, infection, or neurological defect is suspected. But they are not needed for evaluating simple mechanical-type strains, such as back or neck pain that develops after lifting a heavy object.
The average number of x-rays taken during the first visit by chiropractors whose records I have been asked to review has been about eleven. Those records were sent to me because an insurance company had flagged them for investigation into excessive billing, so this number of x-rays is much higher than average. But many chiropractors take at least a few x-rays of everyone who walks through their door.
There are two main reasons why chiropractors take more x-rays than are medically necessary. One is easy money. It costs about 35¢ to buy an 8- x 10-inch film, for which they typically charge $40. In chiropractic, the spine encompasses five areas: the neck, mid-back, low-back, pelvic, and sacral regions. That means five separate regions to bill for—typically three to seven views of the neck, two to six for the low back, and two for each of the rest. So eleven x-ray films would net the chiropractor over $400 for just few minutes of work. In many accident cases I have reviewed, the fact that patients had adequate x-ray examinations in a hospital emergency department to rule out fractures did not deter the chiropractor from unnecessarily repeating these exams.
Chiropractors also use x-ray examinations inappropriately for marketing purposes. Chiropractors who do this point to various things on the films that they interpret as (a) subluxations, (b) not enough spinal curvature, (c) too much spinal curvature, and/or (d) “spinal decay,” all of which supposedly call for long courses of adjustments with periodic x-ray re-checks to supposedly assess progress. In addition to wasting money, unnecessary x-rays entail unnecessary exposure to the risks of ionizing radiation.
11. Research on spinal manipulation does not reflect what takes place in most chiropractic offices.
Research studies that look at spinal manipulation are generally done under strict protocols that protect patients from harm. The results reflect what happens when manipulation is done on patients who are appropriately screened—usually by medical teams that exclude people with conditions that would make manipulation dangerous. The results do not reflect what typically happens when patients select chiropractors on their own. The chiropractic marketplace is a mess because most chiropractors ignore research findings and subject their patients to procedures that are unnecessary and/or senseless.
12. Neck manipulation is potentially dangerous.
Certain types of chiropractic neck manipulation can damage neck arteries and cause a stroke. Chiropractors claim that the risk is trivial, but they have made no systematic effort to actually measure it. Chapter 9 covers this topic in detail.
13. Most chiropractors don’t know much about nutrition.
Chiropractors learn little about clinical nutrition during their schooling. Many offer what they describe as “nutrition counseling.” But this typically consists of superficial advice about eating less fat and various schemes to sell you supplements that are high-priced and unnecessary.
14. Chiropractors who sell vitamins charge much more than it costs them.
Chiropractors who sell vitamins typically recommend them unnecessarily and charge two to three times what they pay for them. Some chiropractors center their practice around selling vitamins to patients. Their recommendations are based on hair analysis, live blood analysis, applied kinesiology muscle-testing or other quack tests that will be discussed later in this book. Patients who are victimized this way typically pay several dollars a day and are encouraged to stay on the products indefinitely. In one case I investigated, an Arizona chiropractor advised an 80+-year-old grandma to charge more than $10,000 for vitamins to her credit cards to avoid an impending stroke that he had diagnosed by testing a sample of her pubic hair. No hair test can determine that a stroke is imminent or show that dietary supplements are needed. Doctors who evaluated the woman at the Mayo Clinic found no evidence to support the chiropractor’s assessment.
15. Chiropractors have no business treating young children.
The pediatric training chiropractors receive during their schooling is skimpy and based mainly on reading. Students see few children and get little or no experience in diagnosing or following the course of the vast majority of childhood ailments. Moreover, spinal adjustment has no proven effectiveness against childhood diseases. Some adolescents with spinal stiffness might benefit from manipulation, but most will recover without treatment. Chiropractors who claim to practice “chiropractic pediatrics” typically aim to adjust spines from birth onward and are likely to oppose immunization. Some chiropractors claim they can reverse or lessen the spinal curvature of scoliosis, but there is no scientific evidence that spinal manipulation can do this.6
16. The fact that patients swear by us does not mean we are actually helping them.
Satisfaction is not the same thing as effectiveness. Many people who believe they have been helped had conditions that would have resolved without treatment. Some have had treatment for dangers that did not exist but were said by the chiropractor to be imminent. Many chiropractors actually take courses on how to trick patients to believe in them. (See Chapter 8)
17. Insurance companies don’t want to pay for chiropractic care.
Chiropractors love to brag that their services are covered by Medicare and most insurance companies. However, this coverage has been achieved though political action rather than scientific merit. I have never encountered an insurance company that would reimburse for chiropractic if not forced to do so by state laws. The political pressure to mandate chiropractic coverage comes from chiropractors, of course, but it also comes from the patients whom they have brainwashed.
18. Lots of chiropractors do really strange things.
The chiropractic profession seems to attract people who are prone to believe in strange things. One I know of does “aura adjustments” to treat people’s “bruised karma.” Another rents out a large crystal to other chiropractors so they can “recharge” their own (smaller) crystals. Another claims to get advice by “channeling” a 15th Century Scottish physician. Another claimed to “balance a woman’s harmonics” by inserting his thumb into her vagina and his index finger into her anus. Another treated cancer with an orange light that was mounted in a wooden box. Another did rectal exams on all his female patients. Even though such exams are outside the legitimate scope of chiropractic, he also videotaped them so that if his bills for this service were questioned, he could prove that he had actually performed what he billed for.
19. Don’t expect our licensing boards to protect you.
Many chiropractors who serve on chiropractic licensing boards harbor the same misbeliefs that are rampant among their colleagues. This means, for example, that most boards are unlikely to discipline chiropractors for diagnosing and treating imaginary “subluxations.”
20. The media rarely look at what we do wrong.
The media rarely if ever address chiropractic nonsense. Reporting on chiropractic is complicated because chiropractors vary so much in what they do. (In fact, a very astute observer once wrote that “for every chiropractor, there is an equal and opposite chiropractor.”) Consumer Reports published superb exposés in 1975 and 1994, but no other print outlet has done so in the past 35 years. This lack of information is the main reason I have written this book.
References
1. Ernst E, Gilbey A. Chiropractic claims in the English-speaking world. New Zealand Medical Journal 123:36–44, 2010.
2. Bernet J. Affidavit, April 12, 1996. Posted to Chirobase Web site.
3. Standards for Doctor of Chiropractic Programs and Requirements for Institutional Status. Council on Chiropractic Education, Scottsdale, Arizona, Jan 2007.
4. Jarvis WT. Why becoming a chiropractor may be risky. Chirobase Web site, October 5, 1999.
5. Barrett S. My visit to a “straight” chiropractor. Quackwatch Web site, Oct 10, 2002.
6. Romano M, Negrini S. Manual therapy as a conservative treatment for idiopathic scoliosis: A review. Scoliosis 3:2, 2008.
One would have thought that, after losing their libel case against Simon Singh, chiropractors across the world might have got their act together and stopped claiming that their ‘bogus’ treatments are effective for conditions that lack both supporting evidence and scientific rationale. However, our investigation which was carried out in 2010, well after the libel action and the embarrassing defeat for chiropractors, sadly suggests otherwise.
It was aimed at determining the frequency of claims of chiropractors and their associations to treat a range of pre-defined conditions: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash as examples of indications not supported by sound evidence, and lower back pain as an example of a condition supported by some evidence.
For this purpose, we conducted a review of 200 websites of individual chiropractors and 9 websites of chiropractic associations from Australia, Canada, New Zealand, the United Kingdom, and the United States between 1 October 2008 and 26 November 2008. Our outcome measure was either direct or indirect claims regarding the eight above-named conditions.
We found evidence that 95% chiropractor websites made unsubstantiated claims regarding at least one of these conditions. Four of the 9 (44%) associations made justified claims about lower back pain. All 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were also made about asthma, ear infection/earache/otitis media, neck pain.
We concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
Criticism regarding unsubstantiated claims have been raised even from within the profession of chiropractors (albeit very, very rarely); two chiropractors suggested that they are “evidence of a lack of professionalism and of quackery” that have evolved within a “tradition of dogma, fallacious reasoning, and unconventional attitudes about research and science”. I quite agree; instead of self-critical attitudes, chiropractors seem to develop a pathological state of denial.
The codes of ethics of chiropractors vary, of course, from nation to nation, but they tend to agree that information used must be factual and verifiable and should not be misleading or inaccurate. Unsubstantiated claims such as those disclosed by our investigation thus violate the rules of these codes. More importantly perhaps, they also misinform unsuspecting consumers and put public health at risk. This has now been going on for such a long time that it truly is embarrassing – not just for chiropractors (who seem to be immune to embarrassment) but to regulators and even to society at large who tolerates such abuse at the hands of the chiropractic profession.
Considering more recent events in the realm of chiropractic, it seems highly unlikely that the situation is going to improve any time soon. Misinformation in the name of maximising income , it often seems to me, is what chiropractic is really about.
Swiss chiropractors have just published a clinical trial to investigate outcomes of patients with radiculopathy due to cervical disk herniation (CDH). All patients had neck pain and dermatomal arm pain; sensory, motor, or reflex changes corresponding to the involved nerve root and at least one positive orthopaedic test for cervical radiculopathy were included. CDH was confirmed by magnetic resonance imaging. All patients received regular neck manipulations.
Baseline data included two pain numeric rating scales (NRSs), for neck and arm, and the Neck Disability Index (NDI). At two, four and twelve weeks after the initial consultation, patients were contacted by telephone, and the data for NDI, NRSs, and patient’s global impression of change were collected. High-velocity, low-amplitude thrusts were administered by experienced chiropractors. The proportion of patients reporting to feel “better” or “much better” on the patient’s global impression of change scale was calculated. Pre-treatment and post-treatment NRSs and NDIs were analysed.
Fifty patients were included. At two weeks, 55.3% were “improved,” 68.9% at four and 85.7% at twelve weeks. Statistically significant decreases in neck pain, arm pain, and NDI scores were noted at 1 and 3 months compared with baseline scores. 76.2% of all sub-acute/chronic patients were improved at 3 months.
The authors concluded that most patients in this study, including sub-acute/chronic patients, with symptomatic magnetic resonance imaging-confirmed CDH treated with spinal manipulative therapy, reported significant improvement with no adverse events.
In the presence of disc herniation, chiropractic manipulations have been described to cause serious complications. Some experts therefore believe that CDH is a contra-indication for spinal manipulation. The authors of this study imply, however, that it is not – on the contrary, they think it is an effective intervention for CDH.
One does not need to be a sceptic to notice that the basis for this assumption is less than solid. The study had no control group. This means that the observed effect could have been due to:
a placebo response,
the regression towards the mean,
the natural history of the condition,
concomitant treatments,
social desirability,
or other factors which have nothing to do with the chiropractic intervention per se.
And what about the interesting finding that no adverse-effects were noted? Does that mean that the treatment is safe? Sorry, but it most certainly does not! In order to generate reliable results about possibly rare complications, the study would have needed to include not 50 but well over 50 000 patients.
So what does the study really tell us? I have pondered over this question for some time and arrived at the following answer: NOTHING!
Is that a bit harsh? Well, perhaps yes. And I will revise my verdict slightly: the study does tell us something, after all – chiropractors tend to confuse research with the promotion of very doubtful concepts at the expense of their patients. I think, there is a name for this phenomenon: PSEUDO-SCIENCE.
Chiropractors across the world tend to make false claims. This has been shown with such embarrassing regularity that there is no longer any question about it. Should someone have the courage to disclose and criticises this habit, chiropractors tend to attack their critic, rather than putting their house in order. One of their more devious strategies, in my view, is their insistence on claiming to effectively treat all sorts of childhood conditions.
What could be more evil than treating sick children with ineffective and harmful spinal manipulations? The answer is surprisingly simple: PREVENTING CHILDREN FROM PROFITTING FROM ONE OF THE MOST BENEFICIAL INTERVENTIONS EVER DISCOVERED!
The National Vaccine Information Center (NVIC) is an organisation which seems to support anti-vaxers of various kinds. Officially they try hard to give the image of being neutral about vaccinations and state that they are dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic in medicine. As an independent clearinghouse for information on diseases and vaccines, NVIC does not advocate for or against the use of vaccines. We support the availability of all preventive health care options, including vaccines, and the right of consumers to make educated, voluntary health care choices.
In my view, this is thinly disguised promotion of an anti-vaccination stance. The NVIC recently made the following announcement:
The International Chiropractic Pediatric Association (ICPA), which was founded by Dr. Larry Webster and represents doctors of chiropractic caring for children, has supported NVIC’s mission to prevent vaccine injuries and deaths through public education and to protect informed consent rights for more than two decades. ICPA’s 2013 issue of Pathways to Family Wellness magazine features an article written by Barbara Loe Fisher on “The Moral Right to Religious and Conscientious Belief Exemptions to Vaccination.”
Pathways to Family Wellness is a full-color, quarterly publication that offers parents timely, relevant information about health and wellness options that will help them make conscious health choices for their families. ICPA offers NVIC donor supporters and NVIC Newsletter subscribers a complimentary digital version or print version of Pathways to Family Wellness magazine at a significant discount. Visit the Pathways subscription page and, when checking out in the shopping cart, add the exclusive code: NVIC.
ICPA also has initiated parenting support groups that meet monthly to discuss health and parenting topics. Meetings are hosted by local doctors of chiropractic and the Pathways website features a directory of local groups. ICPA Executive Director Dr. Jeanne Ohm said “We look forward to many more years of collaborating with NVIC to forward our shared goal of enhancing and protecting the ability of parents to make fully informed health and wellness choices for their children.”
Why, we may well ask, are so many chiropractors against immunisations? The answer might be found in the history of chiropractic. Their founding fathers believed and taught that “subluxations” are the cause of all human diseases. To uphold this ridiculous creed, it was necessary to deny that infections play an important role in many illnesses. In other words, early chiropractors negated the germ theory of disease. Today, of course, they claim that all of this is ancient history – but the stance of many chiropractors against immunisations discloses fairly clearly, I think, that this is not true. Many chiropractic institutions still teach obsolete pseudo-knowledge and many chiropractors seem unable to totally free themselves from such obvious nonsense.
But back to the ICPA: they profess to be a non-profit organization whose mission is to engage and serve family chiropractors worldwide through education, training, and research, establishing evidenced informed practice, excellence in professional skills and unity in a global community which cooperatively and enthusiastically participates in advancing chiropractic for both the profession and the public.
What does “evidence informed practice” mean? This bizarre creation is alarmingly popular with quacks of all kinds and seems to aim at misleading the unsuspecting public. It clearly has little to do with EVIDENCE-BASED PRACTICE as globally adopted by responsible clinicians. If not, the ICPA would inform its members and the public at large that immunisations are amongst the most successful preventive measures in the history of medicine. It is hard to think of another medical intervention where the benefits so clearly and hugely outweigh the risks. Immunisations have saved more lives than most other medical treatments. To not make this crystal clear to concerned parents is, in my view, wholly irresponsible.
In a recent comment, US chiropractors stated that there is a growing recognition within the profession that the practicing chiropractor must be able to do the following: formulate a searchable clinical question, rapidly access the best evidence available, assess the quality of that evidence, determine if it is applicable to a particular patient or group of patients, and decide if and how to incorporate the evidence into the care being offered. In a word, they believe, that evidence-based chiropractic is possible, perhaps even (almost) a reality. For evidence-based practice to penetrate and transform a profession, the penetration must occur at two levels, they explain. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature.
The second level, the authors explain, relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. The authors believe that a growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies. Is this really true, I wonder.
In support of these fairly bold statements, they cite a paper by Bronfort et al which, in their view, is currently the most comprehensive review of the evidence for the efficacy of manual therapies. According to these authors, the ‘Bronfort-report’ stated that evidence is inconclusive for pneumonia, stage 1 hypertension, pre-menstrual syndrome, nocturnal enuresis, and otitis media. The authors also believe that it is unlikely manipulation of the neck is causally related to stroke.
When I read this article, I could not stop myself from giggling. It seems to me that it provides pretty good evidence for the fact that the chiropractic profession is nowhere near reaching the stage where anyone could reasonably claim that chiropractors practice evidence-based medicine – not even the authors themselves seem to abide by the rules of evidence-based medicine! If they had truly been able to access the best evidence available and assess the quality of that evidence surely they would not have (mis-) quoted the ‘Bronfort-report’.
Bronfort’s overview was commissioned by the General Chiropractic Council, it was hastily compiled by ardent believers of chiropractic, published in a journal that non-chiropractors would not touch with a barge pole, and crucially it lacks some of the most important qualities of an unbiased systematic review. In my view, it is nothing short of a white-wash and not worth the paper it was printed on. Conclusions, such as the evidence regarding pneumonia, bed-wetting and otitis is inconclusive are just embarrassing; the correct conclusion is that the evidence fails to be positive for these and most other indications.
Similarly, if the authors had really studied and quoted the best evidence, how on earth could they have stated that manipulation of the neck cannot cause a stroke? The evidence for that is fairly overwhelming, and the only open question here is, how often do such complications occur? And even the biased ‘Bronfort-report’ states: Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.
Evidence-based practice? Who are these chiropractors kidding? This article very neatly reflects the exact opposite. It ignores hundreds of peer-reviewed papers which are critical of chiropractic. The best one can do with this paper, I think, is to use it as a hilarious bit of involuntary humour or as a classic example of cherry-picking.
Come to think of it, chiropractic and evidence-based practice are contradictions in terms. Either a therapist claims to adjust mystical subluxations, in which case he/she does not practice evidence-based medicine. Or he/she practices evidence-based medicine, in which case adjusting mystical subluxations cannot be part of their therapeutic repertoire.
Towards the end of the article, we learn further fascinating things: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article – oh, really?!?! Furthermore, we are told that this ‘research’ was funded by the ‘National Center of Complementary and Alternative Medicine’ (NCCAM) of the National Institutes of Health.
Can it be true? Does the otherwise most respectable NIH really give its name for such overt nonsense? Yes, it is true, and it is by no means the first time. In fact, our analysis shows that, when it comes to chiropractic, this organisation has sponsored almost nothing but utter rubbish, and our conclusion was blunt: the criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.
Upper spinal manipulation, the signature-treatment of many chiropractors is by no means free of serious risks. Most chiropractors negate this, but can any reasonable person deny it? Neurosurgeons from New York have just published an interesting case-report in this context:
A 45 year old male with presented to his internist with a two-week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination revealed nothing abnormal, except for a decreased range of motion of the right arm. He referred the patient to a chiropractor who performed plain X-rays which apparently showed “mild spasm” (how anyone can see spasm on an X-ray is beyond me!). No magnetic resonance imaging study was done.
The chiropractor proceeded manipulating the patient’s neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining a magnetic resonance study, the chiropractor manipulated the patient’s neck for a third time.
Thereafter, the patient immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the magnetic resonance scan, the patient remained quadriplegic. There seemed to be very little doubt that the quadriplegia was caused by the chiropractic spinal manipulation.
The authors of this report also argue that a major point of negligence in this case was the failure of both the referring internist and chiropractor to order a magnetic resonance study of the cervical spine prior to the chiropractic manipulations. In his defence, the internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet. Even the quickest of literature searches discloses this assumption to be wrong. The first such case seems to have been published as early as 1957. Since then, numerous similar reports have been documented in the medical literature.
The internist furthermore claimed that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. As we have pointed out repeatedly, this argument is pure speculation; under-reporting of such cases is huge, and therefore exact incidence figures are anybody’s guess.
The patient sued both the internist and the chiropractor, and the total amount of the verdict was $14,596,000.00 the internist’s liability was 5% ($759,181.65).
Some people will probably think that I am obsessed with writing about the risk of chiropractic. True, I have published quite a bit on this subject, both in the peer-reviewed literature as well as on this blog – but not because I am obsessed; on this blog, I will re-visit the topic every time a relevant new piece of evidence becomes available because it is indisputably such an important subject. Writing about it might prevent harm.
So far, we know for sure that mild to moderate as well as serious complications, including deaths, do occur after chiropractic spinal manipulations, particularly those of the upper spine. What we cannot say with absolute certainty is whether they are caused by the treatment or whether they happened coincidentally. Our knowledge in this area relies mostly on case-reports and surveys which, by their very nature, do not allow causal inferences. Therefore chiropractors have, in the past, been able to argue that a causal link remains unproven.
A brand-new blinded parallel group RCT might fill this gap in our knowledge and might reject or establish the notion of causality once and for all. The authors’ objective was to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. They thus conducted the first ever RCT with the specific aim to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20-85, with spinal pain. Ninety two participants received individualized care consistent with the chiropractors’ usual treatment approach; 91 participants received a sham intervention. Each participant received two treatment sessions.
Completed adverse questionnaires were returned by 94.5% of the participants after the first appointment and 91.3% after the second appointment. Thirty three per cent of the sham group and 42% of the usual care group reported at least one adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), headache (sham 17%; usual care 9%). The relative risk was not significant for either adverse event occurrence (RR = 1.24 95% CI 0.85 to 1.81); occurrence of severe adverse events (RR = 1.9; 95% CI 0.98 to 3.99); adverse event onset (RR = 0.16; 95% CI 0.02 to 1.34); or adverse event duration (RR = 1.13; 95% CI 0.59 to 2.18). No serious adverse events were reported.
The authors concluded that a substantial proportion of adverse events following chiropractic treatment may result from natural history variation and non-specific effects.
If we want to assess causality of effects, we have no better option than to conduct an RCT. It is the study design that can give us certainty, or at least near certainty – that is, if the RCT is rigorous and well-made. So, does this study reject or confirm causality? The disappointing truth is that it does neither.
Adverse events were clearly more frequent with real as compared to sham-treatment. Yet the difference failed to be statistically significant. Why? There are at least two possibilities: either there was no true difference and the numerically different percentages are a mere fluke; or there was a true difference but the sample size was too small to prove it.
My money is on the second option. The number of patients was, in my view, way too small for demonstrating differences in frequencies of adverse effects. This applies to the adverse effects noted, but also, and more importantly, to the ones not noted.
The authors state that no serious adverse effects were observed. With less that 200 patients participating, it would have been most amazing to see a case of arterial dissection or stroke. From all we currently know, such events are quite rare and occur perhaps in one of 10 000 patients or even less often. This means that one would require a trial of several hundred thousand patients to note just a few of such events, and an RCT with several million patients to see a difference between real and sham treatment. It seems likely that such an undertaking will never be affordable.
So, what does this new study tell us? In my view, it is strong evidence to suggest a causal kink between chiropractic treatment and mild to moderate adverse effects. I dose not prove it, but merely suggests it – yet I am fairly sure that chiropractors, once again, will not agree with me.
A recent post of mine seems to have stimulated a lively discussion about the question IS THERE ANY GOOD EVIDENCE AT ALL FOR OSTEOPATHIC TREATMENTS? By and large, osteopaths commented that they are well aware that their signature interventions for their most frequently treated condition (back pain) lack evidential support and that more research is needed. At the same time, many osteopaths seemed to see little wrong in making unsubstantiated therapeutic claims. I thought this was remarkable and feel encouraged to write another post about a similar topic.
Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:
STRUCTURAL PROBLEMS, such as those affecting the proper mobility and function of the body’s framework, can lead to a range of problems. These may include:
- Postural – such as scoliosis
- Respiratory – such as asthma
- Manifestations of brain injury – such as cerebral palsy and spasticity
- Developmental – with delayed physical or intellectual progress, perhaps triggering learning behaviour difficulties
- Infections – such as ear and throat infections or urinary disturbances, which may be recurrent.
OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth transition into normal, healthy adult life.
As children cannot give informed consent, this is even more tricky than treating adults with therapies of questionable value. It is therefore important, I think, to ask whether osteopathic treatments of children is based on evidence or just on wishful thinking or the need to maximise income. As it happens, my team just published an article about these issues in one of the highest-ranking paediatrics journal.
The objective of our systematic review was to critically evaluate the effectiveness of osteopathic manipulative treatment (OMT) as a treatment of paediatric conditions. Eleven databases were searched from their respective inceptions to November 2012. Only randomized clinical trials (RCTs) were included, if they tested OMT against any type of control intervention in paediatric patients. The quality of all included RCTs was assessed using the Cochrane criteria.
Seventeen trials met our inclusion criteria. Only 5 RCTs were of high methodological quality. Of those, 1 favoured OMT, whereas 4 revealed no effect compared with various control interventions. Replications by independent researchers were available for two conditions only, and both failed to confirm the findings of the previous studies. Seven RCTs suggested that OMT leads to a significantly greater reduction in the symptoms of asthma, congenital nasolacrimal duct obstruction, daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic, otitis media, or postural asymmetry compared with various control interventions. Seven RCTs indicated that OMT had no effect on the symptoms of asthma, cerebral palsy, idiopathic scoliosis, obstructive apnoea, otitis media, or temporo-mandibular disorders compared with various control interventions. Three RCTs did not report between-group comparisons. The majority of the included RCTs did not report the incidence rates of adverse-effects.
Our conclusion is likely to again dissatisfy many osteopaths: The evidence of the effectiveness of OMT for paediatric conditions remains unproven due to the paucity and low methodological quality of the primary studies.
So, what does this tell us? I am sure osteopaths will disagree, but I think it shows that for no paediatric condition do we have sufficient evidence to show that OMT is effective. The existing RCTs are mostly of low quality. There is a lack of independent replication of the few studies that suggested a positive outcome. And to make matters even worse, osteopaths seem to be violating the most basic rule of medical research by not reporting adverse-effects in their clinical trials.
I rest my case – at least for the moment.
