MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

critical thinking

The Canadian Chiropractic Association (CCA)… published a report to support clearer understanding of the chiropractic profession… Here are a few crucial quotes (in bold print) from this document (my are comments in normal print).

Put simply, chiropractors are spine, muscle and nervous system experts specifically trained to diagnose the underlying cause and recommend treatment options to relieve pain, restore mobility and prevent re occurrence without surgery or pharmaceuticals…

By this definition, I am a chiropractor! – and so are osteopaths, physiotherapists, several other SCAM practitioners, and most doctors.

… there is a concept in the pharmaceutical industry known as a risk-benefit analysis which is used to assess how much benefit a medication has compared to the potential risk. The riskier the medication, the less likely it will become mainstream.(2)

The concept of risk/benefit analysis applies to all medicine. It needs, of course, good knowledge of both the risks and the benefits. The second sentence of this paragraph is nonsense and suggests that the CCA fails to understand the concept.

Spinal manipulations should be recommended for patients when a similar risk-benefit assessment has been conducted. This assessment on the safety of chiropractic treatments is performed via the patient intake form and physical examination.

As there is no reporting system of adverse effects of spinal manipulations, a risk/benefit analysis is impossible. The second sentence of this paragraph is nonsense; there are no examinations that tell us about the risks of spinal manipulation.

Adverse reactions lasting less than 24 hours include headaches, stiffness, fatigue, local pain, prickling sensation, nausea, hot skin/flushing, and fainting. In up to 50% of patients, one or more of these have been reported over the span of a lifetime.(3, 4)

Perhaps adverse reactions last ON AVERAGE 24 hours; they can last up to 3 days.  About half of all patients experience such reactions.

Exact numbers on adverse events from chiropractic manipulation are difficult to extract due to variables such as research design, inclusion criteria and study selection. There is still a lot of research to be conducted on the role of spinal manipulation in individuals with serious adverse events.

The frequency of adverse events is unknown because there is no adequate reporting scheme.

Chiropractic treatment is a safe option for the prevention, assessment, diagnosis and management of musculoskeletal conditions and associated neurological system. Canadian chiropractors have over 4,200 hours of core competency training in the musculoskeletal system. It is up to each individual patient and their healthcare provider to assess the safety of chiropractic treatments and potential risks associated, and decide if spinal manipulation is right for them.

There is no good evidence that chiropractic treatment is safe.

There is no good evidence that chiropractic treatment is effective for disease prevention.

Chiropractic treatment is an option for assessment and diagnosis??? This is another nonsensical claim.

Chiropractic treatment is an option for associated neurological system??? Another nonsense!

Each individual patient and their healthcare provider assessing the safety is not an option.

References used in the quotes:

2 Risk: benefit analysis of drugs in practice Drug and Therapeutics Bulletin 1995;33:33-35.

3 Non-drug management of chronic low back pain Drug and Therapeutics Bulletin 2009;47:102-107.

4 Gibbons P, Tehan P. HVLA thrust techniques: what are the risks? International Journal of Osteopathic Medicine. 2006 Mar 1;9(1):4-12.

The references cited are pitiful!

In conclusion, I suggest the CCA re-read their statement and revise it according to the evidence, common sense and the rules of the English language. As it stands, it’s just too embarrassing – even for chiropractic standards!

Chiropractic spinal manipulative therapy (CSMT) for migraine?

Why?

There is no good evidence that it works!

On the contrary, there is good evidence that it does NOT work!

A recent and rigorous study (conducted by chiropractors!) tested the efficacy of chiropractic CSMT for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3). The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment. The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was sustained throughout the RCT. The authors concluded that the effect of CSMT observed in our study is probably due to a placebo response.

One can understand that, for chiropractors, this finding is upsetting. After all, they earn a good part of their living by treating migraineurs. They don’t want to lose patients and, at the same time, they need to claim to practise evidence-based medicine.

What is the way out of this dilemma?

Simple!

They only need to publish a review in which they dilute the irritatingly negative result of the above trial by including all previous low-quality trials with false-positive results and thus generate a new overall finding that alleges CSMT to be evidence-based.

This new systematic review of randomized clinical trials (RCTs) evaluated the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.

The searches identified 6 RCTs eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. The results showed that spinal manipulation reduced migraine days with an overall small effect size as well as migraine pain/intensity.

The authors concluded that spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Bob’s your uncle!

Perhaps not perfect, but at least the chiropractic profession can now continue to claim they practice something akin to evidence-based medicine, while happily cashing in on selling their unproven treatments to migraineurs!

But that’s not very fair; research is not for promotion, research is for finding the truth; this white-wash is not in the best interest of patients! I hear you say.

Who cares about fairness, truth or conflicts of interest?

Christine Goertz, one of the review-authors, has received funding from the NCMIC Foundation and served as the Director of the Inter‐Institutional Network for Chiropractic Research (IINCR). Peter M. Wayne, another author, has received funding from the NCMIC Foundation and served as the co‐Director of the Inter‐Institutional Network for Chiropractic Research (IINCR)

And who the Dickens are the  NCMIC and the IINCR?

At NCMIC, they believe that supporting the chiropractic profession, including chiropractic research programs and projects, is an important part of our heritage. They also offer business training and malpractice risk management seminars and resources to D.C.s as a complement to the education provided by the chiropractic colleges.

The IINCR is a collaborative effort between PCCR, Yale Center for Medical Informatics and the Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School. They aim at creating a chiropractic research portfolio that’s truly translational. Vice Chancellor for Research and Health Policy at Palmer College of Chiropractic Christine Goertz, DC, PhD (PCCR) is the network director. Peter Wayne, PhD (Osher Center for Integrative Medicine at Brigham and Women’s Hospital and Harvard Medical School) will join Anthony J. Lisi, DC (Yale Center for Medical Informatics and VA Connecticut Healthcare System) as a co-director. These investigators will form a robust foundation to advance chiropractic science, practice and policy. “Our collective efforts provide an unprecedented opportunity to conduct clinical and basic research that advances chiropractic research and evidence-based clinical practice, ultimately benefiting the patients we serve,” said Christine Goertz.

Really: benefiting the patients? 

You could have fooled me!

Exactly 20 years ago, I published a review concluding that the generally high and possibly growing prevalence of complementary/alternative medicine use by children renders this topic an important candidate for rigorous investigation. Since then, many papers have emerged, and most of them are worrying in one way or another. Here is the latest one.

This Canadian survey assessed chiropractic (DC) and naturopathic doctors’ (ND) natural health product (NHP) recommendations for paediatric care. It was developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across paediatric age ranges (from newborn to 16 years) for each practitioner’s top five NHPs were assessed. Data were analysed using descriptive statistics, t-tests, and non-parametric tests.

Of the 421 respondents seeing one or more paediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as:

  • vitamins and minerals (89 practitioners, 127 recommendations),
  • probiotics (110 practitioners, 110 recommendations),
  • essential fatty acids (EFAs: 72 practitioners, 72 recommendations),
  • homeopathics (56 practitioners, 66 recommendations),
  • botanicals (29 practitioners, 31 recommendations),
  • other NHPs (33 practitioners, 34 recommendations).

Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category:

  • 596 total indications for probiotics,
  • 318 indications for essential fatty acids,
  • 138 indications for vitamin D,
  • 71 indications for multi-vitamins.

Good evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce or even absent. Therefore, the finding that so many DCs and NDs recommend unproven NHPs for use in children is worrying, to say the least. It seems to indicate that, at least in Canada, DCs and NDs are peddling unproven, mostly useless  and potentially harmful children.

In an earlier, similar survey the same group of researchers had disclosed that the majority of Canadian DCs and NDs seem to see infants, children, and youth for a variety of health conditions and issues, while, according to their own admission, not having adequate paediatric training.

Is this a Canadian phenomenon? If you think so, read this abstract:

AIM:

This systematic review is aimed at estimating the prevalence of complementary and alternative medicine (CAM)-use by paediatric populations in the United Kingdom (UK).

METHOD:

AMED, CINAHL, COCHRANE, EMBASE and MEDLINE were searched for English language peer-reviewed surveys published between 01 January 2000 and September 2011. Additionally, relevant book chapters and our own departmental files were searched manually.

RESULTS:

Eleven surveys were included with a total of 17,631 paediatric patients. The majority were of poor methodological quality. Due to significant heterogeneity of the data, a formal meta-analysis was deemed inappropriate. Ten surveys related to CAM in general, while one was specifically on homeopathy. Across all surveys on CAM in general, the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. In surveys with a sample size of more than 500, the prevalence rates were considerably lower than in surveys with the sample size of lower than 500. Herbal medicine was the most popular CAM modality, followed by homeopathy and aromatherapy.

CONCLUSIONS:

Many paediatric patients in the UK seem to use CAM. Paediatricians should therefore have sufficient knowledge about CAM to issue responsible advice.

This means, I fear, that children are regularly treated by SCAM practitioners who are devoid of the medical competence to do so, and  who prescribe or recommend treatments of unknown value, usually without the children needing them.

Why are regulators not more concerned about this obvious abuse?

The aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.

Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.

The authors of this review come from:

  • the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
  • the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
  • the Homoeopathy University Jaipur, Jaipur, India;
  • the Central Council of Homeopathy, Hooghly,
  • the Central Council of Homeopathy, Howrah, India

They state that they have no conflicts of interest.

The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:

  • According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
  • The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
  • The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
  • The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
  • Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
  • Several of the included studies are not of homeopathy but of isopathy.
  • The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
  • Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
  • No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
  • Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
  • The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.

Confusion?

Incompetence?

Scientific misconduct?

Fraud?

YOU DECIDE!

Spinal manipulative therapy (SMT), especially hyperextension and rotation. have often been associated with cervical artery dissection (CAD), a tear in the internal carotid or the vertebral artery resulting in an intramural haematoma and/or an aneurysmal dilatation. But is the association causal? This question is often the subject of fierce discussions between chiropractors and the real doctors.

The lack of established causality relates to the chicken and egg discussion, i.e., whether the CAD symptoms lead the patient to seek cervical SMT or whether the cervical SMT provokes CAD along with the non-CAD presenting headache and/or neck complaint.

The aim of a new review was to provide an updated step-by-step risk-benefit assessment strategy regarding manual therapy and to provide tools for clinicians to exclude cervical artery dissection.

In light of the evidence provided, the reality, according to the review-authors, is:

  • a) that there is no firm scientific basis for direct causality between cervical SMT and CAD;
  • b) that the internal carotid artery (ICA) moves freely within the cervical pathway, while 74% of cervical SMTs are conducted in the lower cervical spine where the vertebral artery (VA) also moves freely;
  • c) that active daily life consists of multiple cervical movements including rotations that do not trigger CAD, as is true for a range of physical activities;
  • d) that a cervical manipulation and/or grade C cervical mobilization goes beyond the physiological limit but remains within the anatomical range, which theoretically means that the artery should not exceed failure strain.

These factors underscore the fact that no serious adverse event (AE) was reported in a large prospective national survey conducted in the UK that assessed all AEs in 28,807 chiropractic treatment consultations, which included 50,276 cervical spine manipulations.

The figure outlines a risk-benefit assessment strategy that should provide additional knowledge and improve the vigilance of all clinicians to enable them to exclude CAD, refer patients with suspected CAD to appropriate care, and consequently prevent CAD from progressing.

It has been argued that most patients present with at least two physical symptoms. The clinical characteristics and recommendations in the figure follow this assumption. This figure is intended to function as a knowledge base that should be implemented in preliminary screening and be part of good clinical practice. This knowledge base will likely contribute to sharpening the attention of the clinicians and alert them as to whether the presenting complaint, combined with a collection of warning signs listed in the figure, deviates from what he or she considers to be a usual musculoskeletal presentation.

Even though this is a seemingly thoughtful analysis, I think it omits at least two important points:

  1. The large prospective UK survey which included 50,276 cervical spine manipulations might be less convincing that it seems. It recorded about one order of magnitude less minor adverse effects of spinal manipulation than a multitude of previously published prospective surveys. The self-selected, relatively small group of participating chiropractors (32% of the total sample) were both experienced (67% been in practice for 5 or more years) and may not always have adhered to the protocol of the survey. Thus they may have employed their experience to intuitively select low-risk patients rather than including all consecutive cases, as the protocol prescribed. This hypothesis would firstly account for the unusually low rate of minor adverse effects, and secondly, it would explain why no serious complications occurred at all. Given that about 700 such complications are on record, the low incidence of serious adverse events could well be a gross underestimate.
  2. The effect of chiropractic spinal manipulative therapy is probably due to a placebo response. This means that it should probably not be done in the first place.

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.

The statement is as predictable as it is wrong.

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:

OBJECTIVES:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

Why?

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!

Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.

A recent case-report  suggests that it might not be as safe as often assumed.

A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.

After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.

The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.

Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).

Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.

Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.

The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.

The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).

The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.

The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.

I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:

In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.

Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?

But why do SCAM-fans not get it?

Why do we see trial after trial and review after review ignoring this simple and obvious fact?

I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!

But that’s cheating!

And isn’t cheating unethical?

My answer is YES!

(If you want to read a more detailed answer, please read our in-depth analysis here)

 

 

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?

In recent years, I have found myself getting irritated with researchers finishing their evaluation of a so-called alternative medicine (SCAM) with the sentence ‘MORE RESEARCH IS NEEDED’ (or similar). It is irritating because it fails to draw a line under assessments of even the most hopelessly implausible treatment. And, because it leaves things open, it seems to imply that, until further research is available, things can go on as before.

When I realised that plenty of my own papers ended with this statement, I was first taken aback and then even more irritated. How could I have been guilty of repeatedly publishing such nonsense?

Here are just 5 examples of my blundering:

further trials of high methodological quality with sufficient sample size and follow-up are needed

Future rigorous randomised clinical trials with larger sample sizes will be necessary

Future investigations in this area should overcome the multiple methodological weaknesses of the previous research.

More and larger long-term, high-quality trials are needed.

Larger and more rigorous trials are needed to objectively assess the effects of this herbal supplement.

But subsequently I re-considered and asked myself: what does ‘MORE RESEARCH IS NEEDED’, a phrase used by so many researchers, really mean?

Contrary to how it seems often to be understood in SCAM, it cannot (should not) mean that, until there is more evidence, we are all free to employ the treatment in question.

Let’s take my first two of my articles quoted above as examples. The first was an assessment of qigong for the primary prevention of cardiovascular disease, and the second an evaluation of acupuncture as a treatment of ankle sprains. When concluding that, in both cases, more research is needed, I did certainly not mean to issue a ‘carte blanche’ to clinicians for carrying on using an evidently unproven SCAM!

What the sentence ‘MORE RESEARCH IS NEEDED’ actually means is almost the opposite:

  1. at present, the evidence is insufficient;
  2. more research is needed for a firm verdict;
  3. currently, the effectiveness of the treatment is unproven;
  4. it is unwise and possibly even unethical to employ unproven treatments in clinical routine, particularly in situations for which evidence-based therapies are available.

And, if this is so, one also needs to express that NO MORE RESEARCH IS NEEDED, whenever this applies. In the realm of SCAM, this would be the case, if a therapy is hopelessly implausible, for instance. I am glad to say that, occasionally, I did do just that:

… There are hundreds of different homeopathic remedies which can be prescribed for thousands of symptoms in dozens of different dilutions. Thus we would probably need to work flat out for several lifetimes in order to arrive at a conclusion that fully substantiates my opening statement*.

This seems neither possible nor desirable. Perhaps it is preferable to simply combine common sense with the best existing knowledge. These two tell us that 1) homeopathy is biologically implausible, 2) its own predictions seem to be incorrect and 3) the clinical evidence is largely negative…

… the conundrum of homeopathy seems to be solved. ‘Heavens!’ I hear the homeopathic fraternity shout. ‘We need more research!’ But are they correct? How much research is enough to show that any treatment does not work (sorry, is not superior to placebo)? Here we go full circle: should we really spend several lifetimes in order to arrive at a more robust conclusion?

*homeopathy is not better than placebo

 

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