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

risk/benefit

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Cupping is a so-called alternative medicine (SCAM) that has existed in several ancient cultures. It recently became popular when US Olympic athletes displayed cupping marks on their bodies, and it was claimed that cupping is used for enhancing their physical performance. There are two distinct forms: dry and wet cupping.

Wet cupping involves scarring the skin with a sharp instrument and then applying a cup with a vacuum to suck blood from the wound. It can thus be seen (and was traditionally used) as a form of blood-letting. Wet cupping is being recommended by enthusiasts for a wide range of conditions. But does it work?

This study compared the effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping or conventional treatment. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional treatment group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively.
The results show that there was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups. Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits. The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly superior compared to the conventional treatment group. The final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01).

The authors concluded that wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy.

Perhaps the authors were joking? In any case, their conclusions cannot be taken seriously. Why? There are several reasons, but the most obvious ones are:

  1. There was no adequate control of the presumably substantial placebo effects of wet cupping.
  2. The control group received a treatment that is known to be ineffective or even detrimental.

For people with acute low back pain, advice to rest in bed is less effective than advice to stay active. Thus comparing wet cupping to a control group treated with bed rest is bound to generate a false-positive outcome for wet cupping.

My final point is perhaps the most important: wet cupping can lead to serious complication, and I therefore do not recommend it to anyone – other than masochists, perhaps.

One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

Treating children is an important income stream for chiropractors and osteopaths. There is plenty of evidence to suspect that their spinal manipulations generate more harm than good; on this blog, we have discussed this problem more often than I care to remember (see for instance here, here, here, here and here). Yet, osteopaths and chiropractors carry on misleading parents to abuse their children with ineffective and dangerous spinal manipulations. A new and thorough assessment of the evidence seems to confirm this suspicion.

This systematic review evaluated the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness.

Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. The results showed that:

  • Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis.
  • Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment.

The authors concluded that due to very low quality of the evidence, the effectiveness of gentle, low-velocity mobilizations in infants and HVLA manipulations in children and/or adolescents is uncertain. Assessments of intermediate outcomes are lacking in current pediatric SMT research. Therefore, the relationship between specific treatment and its effect on the hypothesized spinal dysfunction remains unclear. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique. Although scarcely reported, HVLA manipulations in infants and young children could lead to severe harms. Severe harms were likely to be associated with unexamined or missed underlying medical pathology. Nevertheless, there is a need for high quality research to increase certainty about effectiveness and safety of specific SMT techniques in infants, children and adolescents. We encourage conduction of controlled studies that focus on the effectiveness of specific SMT techniques on spinal dysfunction, instead of concluding about SMT as a general treatment approach. Large observational studies could be conducted to monitor the course of complaints/symptoms in children and to gain a greater understanding of potential harms.

The situation regarding spinal manipulation for children might be summarised as follows:

  1. Spinal manipulations are not demonstrably effective for paediatric conditions.
  2. They can cause serious direct and indirect harm.
  3. Chiropractors and osteopaths are not usually competent to treat children.
  4. They nevertheless treat children regularly.

In my view, this is unethical and can amount to child abuse.

It is not that long ago that I published a post entitled HOMEOPATHY IN FRANCE: A TRIUMPH OF PROFIT OVER REASON. Today, I am pleased to post one with the reverse title.

It has taken a few years (compared to the UK where it has taken a few decades, it was nevertheless fast), but now it is done. Very briefly, this is what happened:

  • In 2014, our book was published in French. I might be fooling myself, but I do hope that it helped starting a ball rolling in France where, up to then, homeopathy had enjoyed a free ride.
  • Subsequently, French sceptics began raising their voices against quackery in general and homeopathy in particular.
  • In 2018, they got organised and 124 doctors published an open letter criticising the use of alternative medicine as dangerous practised by charlatans of all kinds.
  • In the same year, the Collège National des Généralistes Engseignants, the national association for teaching doctors, pointed out that there was no rational justification for the reimbursement of homeopathics nor for the teaching of homeopathy in medical schools stating that It is necessary to abandon these esoteric methods, which belong in the history books.
  • Also in 2018, the University of Lille announced its decision to stop its course on homeopathy. The faculty of medicine’s dean, Didier Gosset, said: It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial. Continuing to teach it would be to endorse it.
  • In 2019, the French Academies of Medicine and Pharmacy have published a document entitled ‘L’homéopathie en France : position de l’Académie nationale de médecine et de l’Académie nationale de pharmacie’. It stated that L’homéopathie a été introduite à la fin du XVIIIe siècle, par Samuel Hahnemann, postulant deux hypothèses : celle des similitudes (soigner le mal par le mal) et celle des hautes dilutions. L’état des données scientifiques ne permet de vérifier à ce jour aucune de ces hypothèses. Les méta-analyses rigoureuses n’ont pas permis de démontrer une efficacité des préparations homéopathiques. The academies concluded that no French university should offer degrees in homeopathy, and that homeopathy should no longer be funded by the public purse: “no homeopathic preparation should be reimbursed by Assurance Maladie [France’s health insurance] until the demonstration of sufficient medical benefit has been provided. No university degree in homeopathy should be issued by medical or pharmaceutical faculties … The reimbursing of these products by the social security seems aberrant at a time when, for economic reasons, we are not reimbursing many classic medicines because they are more or less considered to not work well enough …”
  • Only weeks later, the French health regulator (HAS) has recommended with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products.
  • The health minister, Agnès Buzyn, announced “Je me tiendrai à l’avis de la Haute Autorité de santé”.
  • Consequently, the powerful French homeopathy lobby created political pressure in multiple ways, including a petition with over 1000000 signatures and the last minute press-release below.

It is important, I think, to use this occasion for considering the main arguments of the homeopathy lobby in their defence of homeopathy.

  1. Homeopathy is effective. This argument is demonstrably false and can only be made, if one abuses the published evidence. One way to demonstrate this is to look at the official verdicts from around the globe.
  2. Homeopathy may only be a placebo, but it prevents patients taking dangerous drugs instead. This argument is tricky but wrong. If patients are ill, they need an effective therapy and not homeopathy. If they are not ill, they need reassurance and not a placebo. We need to educate the public and doctors to understand this simple message rather than pulling wool over their eyes.
  3. Discontinuing homeopathy is an undesirable curtailment of our freedom of choice. This is a pseudo-argument, because nobody forbids anyone using homeopathy. All we advocate is that the public purse should only pay for effective treatments. Any other strategy means that we jeopardise funds for effective therapies.
  4. Homeopathy employs over 1000 workers, and any cut in reimbursement would jeopardise these jobs. This argument is also tricky (and it is probably the one that created a headache for politicians). It is, however, spurious. Firstly, job preservation is only a good thing, if the jobs in question are worth preserving. If they serve no good service to the public, they are probably not worth preserving. (We don’t need to all start smoking, for instance, in order to preserve the jobs in the tobacco industry.) Secondly, the argument contradicts the other arguments of the homeopathy lobby. If homeopathy were effective and helpful, people would carry on buying homeopathics regardless of any cut in reimbursement. Thirdly, I suspect the figure of > 1000 will turn out to be hugely exaggerated. Fourthly, arguments of this kind are deeply regressive; they have historically stood in the way of progress whenever an innovation was inescapable (think of the industrial revolution, for instance), and they have never succeeded.

To contemplate these arguments carefully is important, I feel, because this will help other rational thinkers to fight for progress, optimal healthcare and good science. There is still plenty of quackery out there. So, let’s celebrate the French triumph (à votre santé, Agnès Buzyn!!!) – and then roll up our sleeves and get cracking!

This press-release caught my attention:

Following the publication in Australia earlier this year of a video showing a chiropractor treating a baby, the Health Minster for the state of Victoria called for the prohibition of chiropractic spinal manipulation for children under the age of 12 years. As a result, an independent panel has been appointed by Safer Care Victoria to examine the evidence and provide recommendations for the chiropractic care of children.

The role of the panel is to (a) examine and assess the available evidence, including information from consumers, providers, and other stakeholders, for the use of spinal manipulation by chiropractors on children less than 12 years of age and (b) provide recommendations regarding this practice to the Victorian Minister for Health.
Members of the public and key stakeholders, including the WFC’s member for Australia, the Australia Chiropractors Association (AusCA), were invited to submit observations. The AusCA’s submission can be read here

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This submission turns out to be lengthy and full of irrelevant platitudes, repetitions and nonsense. In fact, it is hard to find in it any definitive statements at all. Here are two sections (both in bold print) which I found noteworthy:

1. There is no need to restrict parental or patient choice for chiropractic care for children under 12 years of age as there is no evidence of harm. There is however, expressed outcome of benefit by parents70 who actively choose chiropractic care for their children … 

No evidence of harm? Really! This is an outright lie. Firstly, one has to stress that there is no monitoring system and that therefore we simply do not learn about adverse effects. Secondly, there is no reason to assume that the adverse effects that have been reported in adults are not also relevant for children. Thirdly, adverse effects in children have been reported; see for instance here. Fourthly, we need to be aware of the fact that any ineffective therapy causes harm by preventing effective therapies from being applied. And fifthly, we need to remember that some chiropractors harm children by advising their parents against vaccination.

2. Three recent systematic reviews have focused on the effectiveness of manual therapy for paediatric conditions. For example, Lanaro et al. assessed osteopathic manipulative treatment for use on preterm infants. This systematic review looked at five clinical trials and found a reduction of length of stay and costs in a large population of preterm infants with no adverse events (96).

Carnes et al.’s 2018 systematic review focused on unsettled, distressed and excessively crying infants following any type of manual therapy. Of the seven clinical trials included, five involved chiropractic manipulative therapy; however, meta-analyses of outcomes were not possible due to the heterogeneity of the clinical trials. The review also analysed an additional 12 observational studies: seven case series, three cohort studies, one service evaluation survey, and one qualitative study. Overall, the systematic review concluded that small benefits were found. Additionally, the reporting of adverse events was low. Interestingly, when a relative risk analysis was done, those who had manual therapy were found to have an 88% reduced risk of having an adverse event compared to those who did not have manual therapy (97).

A third systematic review by Parnell Prevost et al. in 2019 evaluated the effectiveness of any paediatric condition following manual therapy of any type and summarizes the findings of studies of children 18 years of age or younger, as well as all adverse event information. While mostly inconclusive data were found due to lack of high-quality studies, of the 32 clinical trials and 18 observational studies included, favourable outcomes were found for all age groups, including improvements in suboptimal breastfeeding and musculoskeletal conditions. Adverse events were mentioned in only 24 of the included studies with no serious adverse events reported in them (98).

(96) Lanaro D, Ruffini N, Manzotti A, Lista G. Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis. Medicine (Baltimore). 2017; 96(12):e6408 10.1097/MD.0000000000006408.

(97) Carnes D, Plunkett A, Ellwood J, Miles C. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open 2018;8:e019040. doi:10.1136/bmjopen-2017-019040.

(98) Parnell Prevost et al. 2019.

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And here are my comments:

(96) Lanaro et al is about osteopathy, not chiropractic (4 of the 5 primary trials were by the same research group).

(97) The review by Carnes et al has been discussed previously on this blog. This is what I wrote about it at the time:

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

(98) Parnell et al was easy to find despite the incomplete reference in the submission. This paper has also been discussed previously. Here is my post on it:

This systematic review is an attempt [at] … 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),
      • autism,
      • asthma,
      • cerebral palsy,
      • clubfoot,
      • constipation,
      • cranial asymmetry,
      • cuboid syndrome,
      • headache,
      • infantile colic,
      • low back pain,
      • obstructive apnoea,
      • otitis media,
      • paediatric dysfunctional voiding,
      • paediatric nocturnal enuresis,
      • postural asymmetry,
      • preterm infants,
      • pulled elbow,
      • suboptimal infant breastfeeding,
      • scoliosis,
      • suboptimal infant breastfeeding,
      • temporomandibular dysfunction,
      • torticollis,
      • 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.

      1. 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.
      2. 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.
      3. 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.

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The ACA’s submission ends with the following conclusion:

The Australian Chiropractors Association (ACA) intent is to improve the general health of all Australians and the ACA supports the following attributes to achieve this:

      • The highest standards of ethics and conduct in all areas of research, education and practise
      • Chiropractors as the leaders in high quality spinal health and wellbeing
      • A commitment to evidence-based practice – the integration of best available research evidence, clinical expertise and patient values
      • The profound significance and value of patient-centred chiropractic care in healthcare in Australia.
      • Inclusiveness and collaborative relationships within and outside the chiropractic profession…

After reading through the entire, tedious document, I arrived at the conclusion that

THIS SUBMISSION CAN ONLY BE A CALL FOR THE PROHIBITION OF CHIROPRACTIC SPINAL MANIPULATION FOR CHILDREN.

Kampo, the traditional Japanese herbal medicine, developed out of traditional Chinese herbal medicine after it was introduced into Japan in the 7th century. In the early 20th century, Kampo was further influenced by modern Western medicine and science. The Kampo system is a pragmatic and simplified version of Chinese herbal medicine. Kampo medicines are standardised and not normally individualised as in Chinese herbal medicine. They are based on the symptoms of the patient, interpreted in the tradition of Kampo. Kampo diagnostic criteria consider hypofunction and hyperfunction, heat and cold, superficies and interior, and yin and yang.

Today, Kampō is fully integrated into the Japanese national health care system, and numerous Kampo preparations are registered in Japan and reimbursable from public funds. In Japan, Kampo is thus not a so-called alternative medicine (SCAM), but outside this country it clearly is.

Standardised Kampo formulas contain mixtures of herbal ingredients. They are manufactured under proper quality control. The most commonly used plants include liquorice, ginger and Chinese peony root. Most Japanese doctors routinely prescribe Kampo medicines, and most patients combine Kampo with Western medicine. Since 2002, the teaching of Kampo has been included in Japanese curricula of medical and pharmacy education. The efficacy of Kampo medicines is often less solidly documented than one would hope or expect. There is a remarkable shortage of high-quality clinical trials.

As Kampo medicines contain pharmacologically active ingredients, they can also cause adverse effects and might interact with synthetic drugs. Yet, the risks of Kampo are currently woefully under-investigated. And this is why an analysis of adverse events associated with Kampo formulations that was just published is particularly important.

The researchers obtained reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analysed.

There were 4,232 reported adverse events associated with Kampo. They related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix.

The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba.

The authors concluded that Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.

While this paper presents invaluable data, its authors offer little by way of critical discussion. There is hardly any good evidence to show that any of the Kampo formulas are effective. Thus a discussion needs to be had about the question whether they generate more good than harm. The authors are completely silent on this important issue, and I suspect the reason might be that Kampo is a bit of a ‘holy cow’ in Japan that must not be questioned.

The numbers of adverse events are impressively high, but we do not know how they compare to adverse events in other areas of healthcare. For instance, it would be valuable to have comparative data indicating how many adverse events occurred with Kampo compared to synthetic drugs per 1 000 patients using them.

Thus we are left with the conclusion that, once proper post-marketing methods are employed to monitor SCAM, we are likely to realise that adverse events do occur more frequently than SCAM enthusiasts might have predicted. In my view, it is high time that we have effective adverse event monitoring in all areas of SCAM.

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!

The purpose of this recently published survey was to obtain the demographic profile and educational background of chiropractors with paediatric patients on a multinational scale.

A multinational online cross-sectional demographic survey was conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis.

The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted paediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor’s degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in paediatric chiropractic.

The authors from the Anglo-European College of Chiropractic (AECC), Bournemouth University, United Kingdom, drew the following conclusion: this is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.

A survey with a response rate of 10%?

An investigation published 9 years after it has been conducted?

Who at the AECC is responsible for controlling the quality of the research output?

Or is this paper perhaps an attempt to get the AECC into the ‘Guinness Book of Records’ for outstanding research incompetence?

But let’s just for a minute pretend that this paper is of acceptable quality. If the finding that ~90% of chiropractors tread kids is approximately correct, one has to be very concerned indeed.

I am not aware of any good evidence that chiropractic care is effective for paediatric conditions. On the contrary, it can do quite a bit of direct harm! To this, we sadly also have to add the indirect harm many chiropractors cause, for instance, by advising parents against vaccinating their kids.

This clearly begs the question: is it not time to stop these charlatans?

What do you think?

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.

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?

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