Herbal medicine is popular. Consumers seem to be attracted by the notion that they are natural – and if it’s natural, it must be safe!!! But do we really know what is in the product that we might be buying? A recently published analytical study aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination.
The researchers used DNA barcoding to conduct a blind test of the authenticity for (i) 44 herbal products representing 12 companies and 30 different species of herbs, and (ii) 50 leaf samples collected from 42 herbal species. They also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples.
DNA barcodes from 91% of the herbal products and all leaf samples could be recovered. 59% of the products tested contained DNA barcodes from plant species not listed on the labels. 48% of the products could be authenticated but one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30 of the 44 products tested and only 2 of the 12 companies sold products without any substitution, contamination or fillers. Some of the contaminants we found pose serious health risks to consumers.
Based on these findings, the authors drew the following conclusions: Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. These activities dilute the effectiveness of otherwise useful remedies, lowering the perceived value of all related products because of a lack of consumer confidence in them. We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products. The use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for ‘best practices’ in the manufacturing of herbal products. This would provide consumers with safe, high quality herbal products.
These findings are fairly alarming. I have previously blogged about the fact that herbal products are far to often adulterated or contaminated. Now it seems that we have to add to this list of dangers the substitution of the herbal ingredient with a presumably less expensive but potentially toxic herb that should not legally be there at all.
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.
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.
Can anyone think of celebrities promoting conventional treatments? Jane Fonda advertising blood pressure control? Brad Pit advocating early intervention after stroke? Boris Johnson making sure that diabetics check their metabolic control? Angelina Jollie suggesting that we all immunise our kids? Well, I cannot - not many anyway. But I certainly could list numerous VIPs doing their very best to promote quackery and anti-vaccination propaganda.
We may smile about such vain attempts to catch the lime-light, but the influence of celebrities on consumers’ behaviour might be huge and detrimental. It is difficult to estimate, and I am not aware of much reliable research data in this area. But my instinct tells me that, in the realm of alternative medicine, the ‘celebrity-factor’ is a very strong determinant of alternative medicine usage, and one that significantly contributes to the ‘sea of misinformation’ in this area.
With one of our research projects at Exeter, we wanted to identify reports on celebrities’ use of alternative medicine. We searched our department’s extensive data files, the Internet via the Google search engine, and the UK popular press via LexisNexis using the search terms “celebrity”, “alternative medicine” and “complementary medicine”. We considered articles published during 2005 and 2006 for inclusion in our study.
Using this strategy, we identified 38 celebrities using a wide range of alternative medicine interventions. Homeopathy, acupuncture and Ayurveda were the most popular modalities. The conclusion we drew from this investigation was that there may be many reasons why consumers use alternative medicine, and wanting to imitate their idols is one of them.
Some pro-alternative sites even boast with the fact that celebrities use quackery: Oprah is into it; so are Madonna, Uma and Gwyneth. No, it’s not a club for high-profile women with unique names. It’s alternative medicine. As ABC News describes, alternative medicine remains an option outside of “standard care” practices that physicians employ. But it has had a sweeping effect on the country, and celebrities have played a role in its popularity.
This, I think, indicates that celebrities are being used as a marketing tool for the alternative medicine industry. Both seem to feed of each other: the industry turns the celebrity endorsements into profit, and the celebrities turn the interest of the press into the all-important fame needed for remaining a celebrity. If a star displays her shapely back in a low-cut dress, nobody bats an eyelash; if, however, her back is covered with marks from today’s cupping-therapy, the press goes crazy – and, as a consequence, cupping therapy experiences a boost. The fact that there is no good evidence for this treatment becomes entirely irrelevant, and so is the fact that thousands of people will hence forward waste their money on ineffective treatments, some of them possibly even losing valuable time for curing a life-threatening disease.
Who wants such a pedestrian thing as evidence? We are in the realm of the high-fliers who cannot be bothered with such trivialities – unless, of course, they are really ill, in which case they will not consult their local quack but use the best conventional medicine on offer. Has anyone heard of a member of the Royal family being rushed to a homeopathic hospital when acutely ill?
In my experience, a VIP’s conviction in promoting quackery is inversely correlated to his expertise and intelligence. Prince Charles seems to want the entire British nation to be force-fed on quackery – anything from Gerson diet to homeopathy. He knows virtually nothing about medicine, but makes up for this deficit through a strong and quasi-religious belief in quackery. Scientists tend to laugh about his quest and might say with a slightly pitiful smile ”but he is full of good will!”. Yet I am not sure that it is all that funny, nor am I convinced that good will is enough. Misleading the public about matters of health care is not amusing. And good will and conviction render quacks not less but more dangerous.
Colonic irrigation is the alternative therapy of celebrities (and those who like to imitate them): they tend to use it for all sorts of ailments, predominantly for loosing weight. And it works! When they have paid for the session, they are relieved of some cash as well as of about half a kilo of body weight. By the time they wake up the next morning, the money is still gone, but the weight is back. This is a most effective method for getting rid of some £s, but NOT an effective way for shedding a few pounds.
Numerous synonyms for colonic irrigation exist, e.g. colonic treatment, colon cleansing, rectal irrigation, colon therapy, colon hydrotherapy, colonic. The treatment is based on the ancient but obsolete theory of ‘autointoxication’, i.e. the body is assumed to poison itself with, ‘autotoxins’ which, in turn, cause various illnesses. So, it is implausible and there is also no evidence to suggest it is effective. But this does not stop professional organisations to make claims which are good for business.
My analysis of the claims made by professional organisations of practitioners of colonic irrigation across the globe aimed at assessing the therapeutic claims made by these institutions. Six such organisations were identified, and the contents of their websites were studied. The results showed that all of the six organisations make therapeutic claims on their websites. Frequently mentioned themes are ‘detoxification’, normalisation of intestinal functions, treatment of inflammatory bowel diseases and body weight reduction. The claims are mostly confined to symptomatic improvements – but there are exceptions, e.g. prevention of bowel cancer or sorting out Irritable Bowel Syndrome ‘once and for all’ . Other therapeutic claims pertain to asthma, menstrual irregularities, circulatory disorders, skin problems, improvement in energy levels and no longer requiring pharmacotherapy. All these claims represent testable hypotheses.
The question therefore arises whether these hypotheses have been tested and, if so, what the results of such investigations suggest? The use of colonic irrigation by alternative practitioners for any indications is not supported by any sound evidence at all. There are simply no trials to show effectiveness. Even worse is the fact that, although touted as safe, colonic irrigation can lead to serious complications.
The conclusion is therefore simple: colonic irrigation is neither demonstrably effective nor safe, and the information supplied by its professional organisations is therefore a significant contributor to the sea of misinformation in the realm of alternative medicine.
Realgar, a commonly used traditional Chinese medicine, has – according to the teachings of Traditional Chinese Medicine (TCM) – acrid, bitter, warm, and toxic characteristics and is affiliated with the Heart, Liver and Stomach meridians. It is used internally against intestinal parasites and treat sore throats, and is applied externally to treat swelling, abscesses, itching, rashes, and other skin disorders.
Chemically, it is nothing other than arsenic sulphide. Despite its very well-known toxicity, is thought by TCM-practitioners to be safe, and it has been used in TCM under the name ‘Xiong Huang’ for many centuries. TCM-practitioners advise that the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically.
Toxicologists from Taiwan report a case of fatal realgar poisoning after short-term use of a topical realgar-containing herbal medicine.
A 24-year-old man with atopic dermatitis had received 18 days of oral herbal medicine and realgar-containing herbal ointments over whole body from a TCM-practitioner. Seven days later, he started to develop loss of appetite, dizziness, abdominal discomfort, an itching rash and skin scaling. Subsequently he suffered generalized oedema, nausea, vomiting, decreased urine amount, diarrhoea, vesico-oedematous exanthemas, malodorous perspiration, fever, and shortness of breath.
He was taken to hospital on day 19 when the dyspnoea became worse. Toxic epidermal necrolysis complicated with soft tissue infection and sepsis were then diagnosed. The patient died shortly afterwards of septic shock and multiple organ failure. Post-mortem blood arsenic levels were elevated at 1225 μg/L. The analysis of the patient’s herbal remedies yielded a very high concentration of arsenic in three unlabelled realgar-containing ointments (45427, 5512, and 4229 ppm).
The authors of this report concluded that realgar-containing herbal remedy may cause severe cutaneous adverse reactions. The arsenic in realgar can be absorbed systemically from repeated application to non-intact skin and thus should not be extensively used on compromised skin.
The notion that a treatment that ‘has stood the test of time’ must be safe and effective is very wide-spread in alternative medicine. This, we often hear, applies particularly to the external use of traditional remedies – what can be wrong with putting a traditional Chinese herbal cream on the skin?? This case, like so many others, should teach us that this appeal to tradition is a classical and often dangerous fallacy. And the ‘realgar-story’ also suggests that, in TCM, the ‘learning-curve’ is very flat indeed.
Chinese and Ayurvedic remedies are often contaminated with toxic heavy metals. But the bigger danger seems to be that some of these traditional ‘medicines’ contain such toxins because, according to ‘traditional wisdom’, these constituents have curative powers. I think that, until we have compelling evidence that any of these treatments do more good than harm, we should avoid taking them.
Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?
Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.
We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.
Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.
For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.
Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.
And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:
1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.
2) Placebo-effects are unreliable, small and usually of short duration.
3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).
4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.
The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!
So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?
They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.
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).
A cult can be defined not just in a religious context, but also as a” usually nonscientific method or regimen claimed by its originator to have exclusive or exceptional power in curing a particular disease.” After ~20 years of researching this area, I have come to suspect that much of alternative medicine resembles a cult – a bold statement, so I better explain.
One characteristic of a cult is the unquestioning commitment of its members to the bizarre ideas of their iconic leader. This, I think, chimes with several forms alternative medicine. Homeopaths, for instance, very rarely question the implausible doctrines of Hahnemann who, to them, is some sort of a semi-god. Similarly, few chiropractors doubt even the most ridiculous assumptions of their founding father, D D Palmer who, despite of having been a somewhat pathetic figure, is uncritically worshipped. By definition, a cult-leader is idealised and thus not accountable to anyone; he (yes, it is almost invariably a male person) cannot be proven wrong by logic arguments nor by scientific facts. He is quite simply immune to any form of scrutiny. Those who dare to disagree with his dogma are expelled, punished, defamed or all of the above.
Cults tend to brain-wash their members into unconditional submission and belief. Likewise, fanatics of alternative medicine tend to be brain-washed, i.e. systematically misinformed to the extend that reality becomes invisible. They unquestioningly believe in what they have been told, in what they have read in their cult-texts, and in what they have learnt from their cult-peers. The effects of this phenomenon can be dramatic: the powers of discrimination of the cult-member are reduced, critical questions are discouraged, and no amount of evidence can dissuade the cult-member from abandoning even the most indefensible concepts. Internal criticism is thus by definition non-existent.
Like religious cults, many forms of alternative medicine promote an elitist concept. Cult-members become convinced of their superiority, based not on rational considerations but on irrational beliefs. This phenomenon has a range of consequences. It leads to the isolation of the cult-member from the rest of the world. By definition, critics of the cult do not belong to the elite; they are viewed as not being able to comprehend the subtleties of the issues at hand and are thus ignored or not taken seriously. For cult-members, external criticism is thus non-existent or invalid.
Cult-members tend to be on a mission, and so are many enthusiasts of alternative medicine. They use any conceivable means to recruit new converts. For instance, they try to convince family, friends and acquaintances of their belief in their particular alternative therapy at every conceivable occasion. They also try to operate on a political level to popularize their cult. They cherry pick data, often argue emotionally rather than rationally, and ignore all arguments which contradict their belief system.
Cult-members, in their isolation from society, tend to be assume that there is little worthy of their consideration outside the cult. Similarly, enthusiasts of alternative medicine tend to think that their treatment is the only true method of healing. Therapies, concepts and facts which are not cult-approved are systematically defamed. An example is the notion of BIG PHARMA which is employed regularly in alternative medicine. No reasonable person assumes that the pharmaceutical industry smells of roses. However, the exaggerated and systematic denunciation of this industry and its achievements is a characteristic of virtually all branches of alternative medicine. Such behaviour usually tells us more about the accuser than the accused.
There are many other parallels between a cult and alternative medicine, I am sure. In my view, the most striking one must be the fact that any spark of cognitive dissonance in the cult-victim is being extinguished by highly effective and incessant flow of misinformation which often amounts to a form of brain-washing.
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.
On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.
Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.
The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.
The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.
The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.
This review is timely and sound. Yet several factors need consideration:
1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.
2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.
3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]
4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.
Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.
Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.
The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.