Biopuncture is a therapy whereby specific locations are injected with biological products. The majority of the products are derived from plants. Most of these injections are given into the skin or into muscles. Products commonly used in Biopuncture are, for example, arnica, echinacea, nux vomica and chamomile. Arnica is used for muscle pain, nux vomica is injected for digestive problems, echinacea is used to increase the natural defense system of the body. Biopuncturists always inject cocktails of natural products. Lymphomyosot is used for lymphatic drainage, Traumeel for inflammations and sports injuries, Spascupreel for muscular cramps. Injections with antiflogistics, hyaluronic acid, blood platelets, blood, procaine, ozon, cortisone or vitamin B are not considered as Biopuncture…
How can such a small dose influence your body and stimulate healing? Scientists don’t have the final proof yet, but they postulate that these injections are working through the stimulation of the immune system (which is in fact your defense system). Let’s compare it with a vaccination. When you receive a tetanus vaccination, only small amounts of a particular product are necessary to stimulate the immune system against lockjaw. In other words, just a few injections can protect your body for years…
An important issue in Biopuncture is the detoxification of the body. It literally means “cleaning the body” from all the toxins that have accumulated: for example from the environment (air pollution, smoking), from bad nutrition, or from medication (e.g., antibiotics and steroids you’ve taken). These toxins can block your defense system. Some injections work specifically on the liver and others on the kidneys. Cleaning up the lymphatic system with Lymphomyosot is considered very important in Biopuncture. It is like taking the leaves out of the gutter. The down side of such an approach is that old symptoms (which have been suppressed earlier on) may come to the surface again. But that is sometimes part of the healing strategy of the body…
That sounds strange, to say the least. But remember: strange treatments might still work! The question is therefore: IS BIOPUNCTURE AN EFFECTIVE THERAPY? If you ask it to Dr Oz, the answer would be a resounding YES – but let’s not ask Oz, let’s try to find some reliable evidence instead. In my quest to locate such evidence, I came across claims like these.
Examples of some acute conditions we treat with biopuncture:
- Knee and ankle sprains
- Muscle sprains- quadriceps, hamstring, adductors, rotator cuff
Examples of some chronic conditions we treat with biopuncture:
- Achilles tendinitis
- Tennis elbow
- Chronic arthritis of the knee, hip, shoulder
- Back pain
- Myofascial pains
- Irritable bowel syndrome
- TMJ syndrome
Somehow I had the feeling that this was more than a little too optimistic, and I decided to conduct a rudimentary Medline search. The results were sobering indeed: not a single clinical trial seems to be available that supports any of the claims that are being made for biopuncture.
So, what should we conclude? I don’t know about you, but to me it seems that biopuncture is quackery at its purest.
On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.
The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).
Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don’t have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.
The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.
No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.
Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.
Kinesiology tape is all the rage. Its proponents claim that it increases cutaneous stimulation, which facilitates motor unit firing, and consequently improves functional performance. But is this just clever marketing, wishful thinking or is it true? To find out, we need reliable data.
The current trial results are sparse, confusing and contradictory. A recent systematic review indicated that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury; however, depending on the conditions, the reduction in pain may not be clinically meaningful. Kinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles.
The authors concluded that kinesiology tape may be used in conjunction with or in place of more traditional therapies, and further research that employs controlled measures compared with kinesiology tape is needed to evaluate efficacy.
This need for further research has just been met by Korean investigators who conducted a study testing the true effects of KinTape by a deceptive, randomized, clinical trial.
Thirty healthy participants performed isokinetic testing of three taping conditions: true facilitative KinTape, sham KinTape, and no KinTape. The participants were blindfolded during the evaluation. Under the pretense of applying adhesive muscle sensors, KinTape was applied to their quadriceps in the first two conditions. Normalized peak torque, normalized total work, and time to peak torque were measured at two angular speeds (60°/s and 180°/s) and analyzed with one-way repeated measures ANOVA.
Participants were successfully deceived and they were ignorant about KinTape. No significant differences were found between normalized peak torque, normalized total work, and time to peak torque at 60°/s or 180°/s (p = 0.31-0.99) between three taping conditions. The results showed that KinTape did not facilitate muscle performance in generating higher peak torque, yielding a greater total work, or inducing an earlier onset of peak torque.
The authors concluded that previously reported muscle facilitatory effects using KinTape may be attributed to placebo effects.
The claims that are being made for kinesiology taping are truly extraordinary; just consider what this website is trying to tell us:
Kinesiology tape is a breakthrough new method for treating athletic sprains, strains and sports injuries. You may have seen Olympic and celebrity athletes wearing multicolored tape on their arms, legs, shoulders and back. This type of athletic tape is a revolutionary therapeutic elastic style of support that works in multiple ways to improve health and circulation in ways that traditional athletic tapes can’t compare. Not only does this new type of athletic tape help support and heal muscles, but it also provides faster, more thorough healing by aiding with blood circulation throughout the body.
Many athletes who have switched to using this new type of athletic tape report a wide variety of benefits including improved neuromuscular movement and circulation, pain relief and more. In addition to its many medical uses, Kinesiology tape is also used to help prevent injuries and manage pain and swelling, such as from edema. Unlike regular athletic taping, using elastic tape allows you the freedom of motion without restricting muscles or blood flow. By allowing the muscles a larger degree of movement, the body is able to heal itself more quickly and fully than before.
Whenever I read such over-enthusiastic promotion that is not based on evidence but on keen salesmanship, my alarm-bells start ringing and I see parallels to the worst type of alternative medicine hype. In fact, kinesiology tapes have all the hallmarks of alternative medicine and its promoters have, as far as I can see, all the characteristics of quacks. The motto seems to be: LET’S EARN SOME MONEY FAST AND IGNORE THE SCIENCE WHILE WE CAN.
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.
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.
In my very first post on this blog, I proudly pronounced that this would not become one of those places where quack-busters have field-day. However, I am aware that, so far, I have not posted many complimentary things about alternative medicine. My ‘excuse’ might be that there are virtually millions of sites where this area is uncritically promoted and very few where an insider dares to express a critical view. In the interest of balance, I thus focus of critical assessments.
Yet I intend, of course, report positive news when I think it is relevant and sound. So, today I shall discuss a new trial which is impressively sound and generates some positive results:
French rheumatologists conducted a prospective, randomised, double blind, parallel group, placebo controlled trial of avocado-soybean-unsaponifiables (ASU). This dietary supplement has complex pharmacological activities and has been used since years for osteoarthritis (OA) and other conditions. The clinical evidence has, so far, been encouraging, albeit not entirely convincing. My own review arrived at the conclusion that “the majority of rigorous trial data available to date suggest that ASU is effective for the symptomatic treatment of OA and more research seems warranted. However, the only real long-term trial yielded a largely negative result”.
For the new trial, patients with symptomatic hip OA and a minimum joint space width (JSW) of the target hip between 1 and 4 mm were randomly assigned to three years of 300 mg/day ASU-E or placebo. The primary outcome was JSW change at year 3, measured radiographically at the narrowest point.
A total of 399 patients were randomised. Their mean baseline JSW was 2.8 mm. There was no significant difference on mean JSW loss, but there was 20% less progressors in the ASU than in the placebo group (40% vs 50%, respectively). No difference was observed in terms of clinical outcomes. Safety was excellent.
The authors concluded that 3 year treatment with ASU reduces the speed of JSW narrowing, indicating a potential structure modifying effect in hip OA. They cautioned that their results require independent confirmation and that the clinical relevance of their findings require further assessment.
I like this study, and here are just a few reasons why:
It reports a massive research effort; I think anyone who has ever attempted a 3-year RCT might agree with this view.
It is rigorous; all the major sources of bias are excluded as far as humanly possible.
It is well-reported; all the essential details are there and anyone who has the skills and funds would be able to attempt an independent replication.
The authors are cautious in their interpretation of the results.
The trial tackles an important clinical problem; OA is common and any treatment that helps without causing significant harm would be more than welcome.
It yielded findings which are positive or at least promising; contrary to what some people seem to believe, I do like good news as much as anyone else.
I WISH THERE WERE MORE ALT MED STUDIES/RESEARCHERS OF THIS CALIBER!
Musculoskeletal and rheumatic conditions, often just called “arthritis” by lay people, bring more patients to alternative practitioners than any other type of disease. It is therefore particularly important to know whether alternative medicines (AMs) demonstrably generate more good than harm for such patients. Most alternative practitioners, of course, firmly believe in what they are doing. But what does the reliable evidence show?
To find out, ‘Arthritis Research UK’ has sponsored a massive project lasting several years to review the literature and critically evaluate the trial data. They convened a panel of experts (I was one of them) to evaluate all the clinical trials that are available in 4 specific clinical areas. The results for those forms of AM that are to be taken by mouth or applied topically have been published some time ago, now the report, especially written for lay people, on those treatments that are practitioner-based has been published. It covers the following 25 modalities:
Chiropractic (spinal manipulation)
Kinesiology (applied kinesiology)
Magnet therapy (static magnets)
Osteopathy (spinal manipulation)
Qigong (internal qigong)
Our findings are somewhat disappointing: only very few treatments were shown to be effective.
In the case of rheumatoid arthritis, 24 trials were included with a total of 1,500 patients. The totality of this evidence failed to provide convincing evidence that any form of AM is effective for this particular condition.
For osteoarthritis, 53 trials with a total of ~6,000 patients were available. They showed reasonably sound evidence only for two treatments: Tai chi and acupuncture.
Fifty trials were included with a total of ~3,000 patients suffering from fibromyalgia. The results provided weak evidence for Tai chi and relaxation-therapies, as well as more conclusive evidence for acupuncture and massage therapy.
Low back pain had attracted more research than any of the other diseases: 75 trials with ~11,600 patients. The evidence for Alexander Technique, osteopathy and relaxation therapies was promising by not ultimately convincing, and reasonably good evidence in support of yoga and acupuncture was also found.
The majority of the experts felt that the therapies in question did not frequently cause harm, but there were two important exceptions: osteopathy and chiropractic. For both, the report noted the existence of frequent yet mild, as well as serious but rare adverse effects.
As virtually all osteopaths and chiropractors earn their living by treating patients with musculoskeletal problems, the report comes as an embarrassment for these two professions. In particular, our conclusions about chiropractic were quite clear:
There are serious doubts as to whether chiropractic works for the conditions considered here: the trial evidence suggests that it’s not effective in the treatment of fibromyalgia and there’s only little evidence that it’s effective in osteoarthritis or chronic low back pain. There’s currently no evidence for rheumatoid arthritis.
Our point that chiropractic is not demonstrably effective for chronic back pain deserves some further comment, I think. It seems to be in contradiction to the guideline by NICE, as chiropractors will surely be quick to point out. How can this be?
One explanation is that, since the NICE-guidelines were drawn up, new evidence has emerged which was not positive. The recent Cochrane review, for instance, concludes that spinal manipulation “is no more effective for acute low-back pain than inert interventions, sham SMT or as adjunct therapy”
Another explanation could be that the experts on the panel writing the NICE-guideline were less than impartial towards chiropractic and thus arrived at false-positive or over-optimistic conclusions.
Chiropractors might say that my presence on the ‘Arthritis Research’-panel suggests that we were biased against chiropractic. If anything, the opposite is true: firstly, I am not even aware of having a bias against chiropractic, and no chiropractor has ever demonstrated otherwise; all I ever aim at( in my scientific publications) is to produce fair, unbiased but critical assessments of the existing evidence. Secondly, I was only one of a total of 9 panel members. As the following list shows, the panel included three experts in AM, and most sceptics would probably categorise two of them (Lewith and MacPherson) as being clearly pro-AM:
Professor Michael Doherty – professor of rheumatology, University of Nottingham
Professor Edzard Ernst – emeritus professor of complementary medicine, Peninsula Medical School
Margaret Fisken – patient representative, Aberdeenshire
Dr Gareth Jones (project lead) – senior lecturer in epidemiology, University of Aberdeen
Professor George Lewith – professor of health research, University of Southampton
Dr Hugh MacPherson – senior research fellow in health sciences, University of York
Professor Gary Macfarlane (chair of committee) – professor of epidemiology, University of Aberdeen
Professor Julius Sim – professor of health care research, Keele University
Jane Tadman – representative from Arthritis Research UK, Chesterfield
What can we conclude from all that? I think it is safe to say that the evidence for practitioner-based AMs as a treatment of the 4 named conditions is disappointing. In particular, chiropractic is not a demonstrably effective therapy for any of them. This, of course begs the question, for what condition is chiropractic proven to work! I am not aware of any, are you?