Whenever there are discussions about homeopathy (currently, they have reached fever-pitch both in France and in Germany), one subject is bound to emerge sooner or later: its cost. Some seemingly well-informed person will exclaim that USING MORE HOMEOPATHY WILL SAVE US ALL A LOT OF MONEY.
Of course, homeopathic remedies tend to cost, on average, less than conventional treatments. But that is beside the point. A car without an engine is also cheaper than one with an engine. Comparing the costs of items that are not comparable is nonsense.
What we need are proper analyses of cost-effectiveness. And these studies clearly fail to prove that homeopathy is a money-saver.
Even researchers who are well-known for their pro-homeopathy stance have published a systematic review of economic evaluations of homeopathy. They included 14 published assessments, and the more rigorous of these investigations did not show that homeopathy is cost-effective. The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Probably the most meaningful study in this area is an investigation by another pro-homeopathy research team. Here is its abstract:
This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.
Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache.
Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients.
The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.
A recent analysis confirms this situation. It concluded that patients who use homeopathy are more expensive to their health insurances than patients who do not use it. The German ‘Medical Tribune’ thus summarised the evidence correctly when stating that ‘Globuli are m0re expensive than conventional therapies’. This quote mirrors perfectly the situation in Switzerland which as been summarised as follows: ‘Globuli only cause unnecessary healthcare costs‘.
But homeopaths (perhaps understandably) seem reluctant to agree. They tend to come out with ever new arguments to defend the indefensible. They claim, for instance, that prescribing a homeopathic remedy to a patient would avoid giving her a conventional treatment that is not only more expensive but also has side-effects which would cause further expense to the system.
To some, this sounds perhaps reasonable (particularly, I fear, to some politicians), but it should not be reasonable argument for responsible healthcare professionals.
Because it could apply only to the practice of bad and unethical medicine: if a patient is ill and needs a medical treatment, she does certainly not need something that is ineffective, like homeopathy. If she is not ill and merely wants a placebo, she needs assurance, compassion, empathy, understanding and most certainly not an expensive and potentially harmful conventional therapy.
To employ the above analogy, if someone needs transport, she does not need a car without an engine!
So, whichever way we twist or turn it, the issue turns out to be quite simple:
WHITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS!
The ‘International Federation of Anthroposophic Medical Associations’ have just published a ‘Statement on Vaccination‘. Here it is in its full beauty:
Vaccines, together with health education, hygiene and adequate nutrition, are essential tools for preventing infectious diseases. Vaccines have saved countless lives over the last century; for example, they allowed the eradication of small pox and are currently allowing the world to approach the elimination of polio.
Anthroposophic Medicine fully appreciates the contribution of vaccines to global health and firmly supports vaccination as an important measure to prevent life threatening diseases. Anthroposophic Medicine is not anti-vaccine and does not support anti-vaccine movements.
Physicians with training in Anthroposophic Medicine are expected to act in accordance with national legislation and to carefully advise patients (or their caregivers) to help them understand the relevant scientific information and national vaccination recommendations. In countries where vaccination is not mandatory and informed consent is needed, this may include coming to agreement with the patient (or the caregivers) about an individualized vaccination schedule, for example by adapting the timing of vaccination during infancy.
Taking into account ongoing research, local infectious disease patterns and socioeconomic risk factors, individual anthroposophic physicians are at times involved in the scientific discussion about specific vaccines and appropriate vaccine schedules. Anthroposophic Medicine is pro-science and continued scientific debate is more important than ever in today’s polarized vaccine environment.
Already in 2010, The European Council for Steiner Waldorf Education published a press release, implying a similar stance:
We wish to state unequivocally that opposition to immunization per se, or resistance to national strategies for childhood immunization in general, forms no part of our speciﬁc educational objectives. We believe that a matter such as whether or not to innoculate a child against communicable disease should be a matter of parental choice. Consequently, we believe that families provide the proper context for such decisions to be made on the basis of medical, social and ethical considerations, and upon the perceived balance of risks. Insofar as schools have any role to play in these matters, we believe it is in making available a range of balanced information both from the appropriate national agencies and qualiﬁed health professionals with expertise in the ﬁled. Schools themselves are not, nor should they attempt to become, determiners of decisions regarding these matters.
Such statements sound about right. Why then am I not convinced?
Perhaps because there are hundreds of anthroposophic texts that seem to contradict this pro-vaccination stance (not least those from Rudolf Steiner himself). Today, anthroposophy enthusiasts are frequently rampant anti-vax; look at this quote, for instance:
… anthroposophic and conventional medicine have dramatically different viewpoints as to what causes common childhood illnesses. Conventional medicine views childhood illnesses for which vaccines have been developed as a physical disease, inherently bad, to be prevented. Their main goal, therefore, is protection against contracting the disease making one free of illness. In contrast, these childhood illnesses are viewed by anthroposophic medicine as a necessary instrument in dealing with karma and, as discussed by Husemann, and Wolff, 6 the incarnation of the child. During childhood illnesses, anthroposophic medical practitioners administer medical remedies to assist the child in dealing with the illness not only as a disease affecting their physical body in the physical plane, but also for soul spiritual development, thereby promoting healing. In contrast, allopathic medicaments are aimed at suppression of symptoms and not necessarily the promotion of healing.
In Manifestations of Karma, Rudolf Steiner states that humans may be able to influence their karma and remove the manifestation of certain conditions, i.e., disease, but they may not be liberated from the karmic effect which attempted to produce them. Says Steiner, “…if the karmic reparation is escaped in one direction, it will have to be sought in another … the souls in question would then be forced to seek another way for karmic compensation either in this or in another incarnation.” 7
In his lecture, Karma of Higher Beings 8, Steiner poses the question, “If someone seeks an opportunity of being infected in an epidemic, this is the result of the necessary reaction against an earlier karmic cause. Have we the right now to take hygienic or other measures?” The answer to this question must be decided by each person and may vary. For example, some may accept the risk of disease but not of vaccine side effects, while others may accept the risk associated with vaccination but not with the disease.
Anthroposophic medicine teaches that to prevent a disease in the physical body only postpones what will then be produced in another incarnation. Thus, when health measures are undertaken to eliminate the susceptibility to a disease, only the external nature of the illness is eliminated. To deal with the karmic activity from within, Anthroposphy states that spiritual education is required. This does not mean that one should automatically be opposed to vaccination. Steiner indicates that “Vaccination will not be harmful if, subsequent to vaccination, a person receives a spiritual education.”
Or consider this little statistic from the US:
Waldorf schools are the leading Nonmedical Exemption [of vaccinations] schools in various states, such as:
- Waldorf School of Mendocino County (California) – 79.1%
- Tucson Waldorf Schools (Arizona) – 69.6%
- Cedar Springs Waldorf School (California) – 64.7%
- Waldorf School of San Diego (California) – 63.6%
- Orchard Valley Waldorf School (Vermont) – 59.4%
- Whidbey Island Waldorf School (Washington) – 54.9%
- Lake Champlain Waldorf School (Vermont) – 49.6%
- Austin Waldorf School (Texas) – 48%
Or what about this quote?
Q: I am a mother who does not immunize my children. I feel as though I have to keep this a secret. I recently had to take my son to the ER for a tetanus shot when he got a fish hook in his foot, and I was so worried about the doctor asking if his shots were current. His grandmother also does not understand. What do you suggest?
A: You didn’t give your reasons for not vaccinating your children. Perhaps you feel intuitively that vaccinations just aren’t good for children in the long run, but you can’t explain why. If that’s the case, I think your intuition is correct, but in today’s contentious world it is best to understand the reasons for our decisions and actions.
There are many good reasons today for not vaccinating children in the United States I recommend you consult the book, The Vaccination Dilemma edited by Christine Murphy, published by SteinerBooks.
So, where is the evidence that anthroposophy-enthusiasts discourage vaccinations?
It turns out, there is plenty of it! In 2011, I summarised some of it in a review concluding that numerous reports from different countries about measles outbreaks centered around Steiner schools seem nevertheless to imply that a problem does exist. In the interest of public health, we should address it.
All this begs a few questions:
- Are anthroposophy-enthusiasts and their professional organisations generally for or against vaccinations?
- Are the statements above honest or mere distractions from the truth?
- Why are these professional organisations not going after their members who fail to conform with their published stance on vaccination?
I suspect I know the answers.
What do you think?
I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:
Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.
I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.
So, let’s try again.
Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.
Dr Geer published a short article explaining the nature of naprapathy:
Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.
What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:
1st study (2007)
Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.
At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.
This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.
2nd study (2010)
Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.
89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.
Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.
3rd study (2016)
Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.
At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.
The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.
I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:
Chronic Neck Pain
Hip Muscle Strain
Knee Ligament Injuries
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Spinal Stenosis
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Sports Injuries of the Knee
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Odd, I’d say! Did all this change my mind about naprapathy? Not really.
But nobody – except perhaps Dr Greer – can say I did not try.
And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.
Chiropractic may be nonsense, but it nevertheless earns chiros very good money. Chiropractors tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure. It was reported that over 80% of the money that the US Medicare paid to chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens thus spent roughly $359 million on unnecessary chiropractic care that year.
Such expenditure may not benefit patients, but it surely benefits the chiropractors. A recent article in Forbes informed us that, according to the US Bureau of Labor Statistics’ Occupational Outlook Handbook, the employment of chiropractors is expected to grow 12% from 2016 to 2026, faster than the average for all occupations.
According to the latest data from the Bureau Occupational Employment Statistics, as of 2017, the average income of an US chiropractor amounts to US $ 85,870. However, chiropractors’ salaries aren’t this high in every US state. The lowest average income (US$ 45 000) per year is in the state of Wyoming.
Below you’ll find a breakdown of where chiropractors’ incomes are the highest.
These are tidy sums indeed – remember, they merely depict the averages. Individual chiropractors will earn substantially more than the average, of course. And there are hundreds of websites, books, etc. to teach chiros how to maximise their cash-flow. Some of the most popular ‘tricks of the chiro trade’ include:
- maintenance therapy,
- treatment of children,
- making unsupported therapeutic claims,
- disregarding the risks of spinal manipulation,
- selling useless dietary supplements.
Considering the sums of money that are at stake, I am beginning to understand why chiropractors tend to get so nervous, often even furious and aggressive, when I point out that they might be causing more harm than good to their patients.
Its the money, stupid!
My friend Roger, the homeopath, alerted me to the ‘Self-Controlled Energo Neuro Adaptive Regulation‘ (SCENAR). He uses it in his practice and explains:
The scenar uses biofeedback; by stimulating the nervous system, it is able to teach the body to heal itself. The device sends out a series of signals through the skin and measures the response. Each signal is only sent out when a change, in response to the previous signal, is recorded in the electrical properties of the skin. Visible responses include reddening of the skin, numbness, stickiness (the device will have the feeling of being magnetically dragged), a change in the numerical readout and an increase in the electronic clattering of the device.
The C-fibres, which comprise 85% of all nerves in the body, react most readily to the electro-stimulation and are responsible for the production of neuropeptides and other regulatory peptides. A TENS unit will only stimulate the A & B-fibres for temporary relief.
The body can get accustomed to a stable pathological state, which may have been caused by injury, disease or toxicity. The Scenar catalyses the process to produce regulatory peptides for the body to use where necessary, by stimulation of C-fibres . It is these neuropeptides that in turn reestablish the body’s natural physiological state and are responsible for the healing process. As these peptides last up to several hours, the healing process will continue long after the treatment is over. The large quantity of neuropeptides and C-fibres in the Central Nervous System can also result in the treatment on one area aiding with other general regulatory processes, like chemical imbalances, correcting sleeplessness, appetite and behavioral problems.
Sounds like science fiction?
Or perhaps more like BS?
But, as always, the proof of the pudding is in the eating. Roger explains:
What conditions can Scenar treat?
In the UK, the devices are licensed by the British Standards Institute for pain relief only. Likewise the FDA has approved the Scenar for pain relief. However, because of the nature of the device, viz., stimulating the nervous system, the Russian experience is that Scenar affects all the body systems in a curative manner.
The Russian experience suggests that it can be effective for a very broad range of diseases, including diseases of the digestive, cardio-vascular, respiratory, musculo-skeletal, urinary, reproductive and nervous systems. It is also useful for managing ENT diseases, eye diseases, skin conditions and dental problems. It has also been found beneficial in burns, fractures, insect bites, allergic reactions, diseases of the blood and disorders involving immune mechanisms; endocrine, nutritional and metabolic disorders; stress and mental depression, etc.
It is known to give real relief from many types of pain. It does so because it stimulates the body to heal the underlying disease causing the pain!
Another SCENAR therapist is much more specific. He tells us that SCENAR is effective for:
- Sports and other injuries
- Musculoskeletal problems
- Issues with circulation
- Respiratory diseases
- Digestive disorders
- Certain infections
- Immune dysfunctions
Perhaps I was a bit hasty; perhaps the SCENAR does work after all. It is certainly offered by many therapists like Roger. They cannot all be charlatans, or can they?
Time to do a proper Medline search and find out about the clinical trials that have been done with the SCENAR. Disappointingly, I only found three relevant papers; here they are:
A new technique of low-frequency modulated electric current therapy, SCENAR therapy, was used in treatment of 103 patients with duodenal ulcer (DU). The influence of SCENAR therapy on the main clinical and functional indices of a DU relapse was studied. It was shown that SCENAR therapy, which influences disturbed mechanisms of adaptive regulation and self-regulation, led to positive changes in most of the parameters under study. Addition of SCENAR therapy to the complex conventional pharmacotherapy fastened ulcer healing, increased the effectiveness of Helicobacter pylori eradication, and improved the condition of the gastroduodenal mucosa.
Administration of artrofoon in combination with SCENAR therapy to patients with localized suppurative peritonitis in the postoperative period considerably reduced plasma MDA level, stabilized ceruloplasmin activity, and increased catalase activity in erythrocytes compared to the corresponding parameters in patients receiving standard treatment in combination with SCENAR therapy.
The author recommends a self-control energoneuroadaptive regulator (SCENAR) as effective in the treatment of neurogenic dysfunction of the bladder in children with nocturnal enuresis. This regulator operates according to the principles of Chinese medicine and may be used in sanatoria and at home by the children’s parents specially trained by physiotherapist.
While the quantity of the ‘studies’ is lamentable, their quality seems quite simply unacceptable.
We are thus left with two possibilities: either the SCENAR is more or less what its proponents promise and the science has for some strange reason not caught up with this reality; or the reality is that SCENAR is a bogus treatment used by charlatans who exploit the gullible public.
I know which possibility I favour – how about you?
Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.
The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.
Sounds more than a little weird?
Yes, I agree.
Perhaps we need some real evidence.
The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).
Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.
The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:
- The theory on which PPT is based is not plausible (to put it mildly).
- It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
- The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
- The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
- Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
- The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.
So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.
An impressive 17% of US chiropractic patients are 17 years of age or younger. This figure increases to 39% among US chiropractors who have specialized in paediatrics. Data for other countries can be assumed to be similar. But is chiropractic effective for children? All previous reviews concluded that there is a paucity of evidence for the effectiveness of manual therapy for conditions within paediatric populations.
This systematic review is an attempt to shed more light on the issue by evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.
Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:
- attention deficit hyperactivity disorder (ADHD),
- cerebral palsy,
- cranial asymmetry,
- cuboid syndrome,
- infantile colic,
- low back pain,
- obstructive apnoea,
- otitis media,
- paediatric dysfunctional voiding,
- paediatric nocturnal enuresis,
- postural asymmetry,
- preterm infants,
- pulled elbow,
- suboptimal infant breastfeeding,
- suboptimal infant breastfeeding,
- temporomandibular dysfunction,
- upper cervical dysfunction.
Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.
The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.
There are many things that I find remarkable about this review:
- The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
- A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
- Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
- Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
- Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.
Allow me to have a closer look at these three conditions.
- Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
- Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
- Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.
So, what can be concluded from this?
I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.
And why do the authors of this new review arrive at such dramatically different conclusion? I am not sure. Could it perhaps have something to do with their affiliations?
- Palmer College of Chiropractic,
- Canadian Memorial Chiropractic College,
- Performance Chiropractic.
What do you think?
A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.
The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.
Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.
Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.
In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.
Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)
About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:
- SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
- If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
- Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
- Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
- Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
- Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
- Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
- Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
- The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
- The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.
After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.
“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.
Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:
- vitamin D3.
Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.
The therapeutic claims made for the product are numerous:
- it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
- it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
- it will improve cognitive function,
- it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
- it will improve quality of life,
- it will improve sleep (reducing insomnia by 70%),
- it will improve immunity,
- it will reduce inflammation,
- it will improve your memory,
- it will improve osteoporosis (reduce risk of osteoporosis by 37%).
These claims are backed up by 197 clinical trials, we are being told.
If true, this would be truly sensational – but is it true?
I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.
I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?
The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”
It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!
Having the choice, I might think again.
I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:
- Vitamin C (it has over 61 000 Medline listed articles to its name),
- Vitanin E (it has over 42 000 Medline listed articles to its name),
- Collagen (it has over 210 000 Medline listed articles to its name),
- Coffee (it has over 14 000 Medline listed articles to its name),
- Aloe vera (it has over 3 000 Medline listed articles to its name).
I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.
But this would be wrong, misleading, even bogus!!!, I hear you object.
On the one hand, I agree.
On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.
*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).
We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.
The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.
- The paper mentions the 4 key factors for evaluation of diagnostic methods:
Analytic validity of a test deﬁnes its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
- Clinical validity deﬁnes the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, speciﬁcity, and an understanding of how these parameters change in different populations.
- Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
- Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.
The tests used by SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.
In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.
The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.
The paper also discusses possible reasons why SCAM-tests are appealing:
- Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are beneﬁting from a scientiﬁc approach.
- Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large proﬁles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical ﬁndings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or ﬁbromyalgia where a deﬁnitive cause has not been established and treatment options are limited.
- Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
- By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.
Regulation of SCAM laboratory testing is clearly deﬁcient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.
I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.
Sadly, my warning has so far had no effect whatsoever.
I hope this new paper is more successful.