Edzard Ernst

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

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!

Researchers from the National Institute of Homoeopathy (an autonomous organisation under the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy, Government of India) tested a Dysentery Compound (DC), a ‘bowel nosode’, against individualized homeopathy (IH) in the treatment of irritable bowel syndrome (IBS). For this purpose, they used an open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial with 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the primary outcome measure; assessed at baseline and after 3 months.

Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favouring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.

The authors concluded that non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.

This trial is a treasure trove of methodological flaws. Here I want to focus on merely one of them: The idea of conducting a non-inferiority study of two treatments, none of which have previously been shown to be effective.

Most clinical trials are ‘superiority studies’ designed to test whether one treatment is more effective than another one. This is fundamentally different in non-inferiority or equivalence studies. They aim to test whether one treatment is as effective as another therapy that has already been fully researched and is generally accepted to be effective for the condition in question. This approach avoids the ethical problems that can arise in superiority studies from giving placebos to patients who require an effective treatment for their condition. Equivalence studies can have many of the features of superiority studies but require a different statistical approach and usually need much larger sample sizes.

This means that the new study never had the slightest chance to generate a result that was in any way meaningful. Such a waste of resources is hardly surprising in the realm of homeopathy; over the years, we have become used to it. But, coming from the National Institute of Homeopathy, it is significant. On their website, the Institute claims this:

The mission of National Institute of Homoeopathy is to foster excellence in Homoeopathic Medical Education and Research, to educate and train undergraduate, post graduate students and research scholars of homoeopathy in accordance with highest professional standards and ethical values unfettered by the barriers of nationality, language, culture, plurality, religion and to meet the healthcare needs of the community through dissemination of knowledge and service. 

Excellence in homeopathic research?

Well, you could have fooled me!

 

George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.

Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?

1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)

2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place []. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)

This factor was also ignored in most trials []. At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study [], where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo []. (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)

3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies []. Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)

4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case [], the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)

5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)

In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.

First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)

Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)

Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles []. (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)

Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)

Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.

___________________________________________________________________

I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:

  1. A well-designed study of homeopathy can always be recognised by its positive result.
  2. Any trial that fails to yield a positive finding is, by definition, wrongly designed.

I was alerted to this recent and most interesting announcement by the Australian Government:

From 1 April 2019 the following natural therapies will be excluded from the definition of private health insurance general treatment and will no longer receive the private health insurance rebate as part of a general treatment policy: Alexander technique, aromatherapy, Bowen therapy, Buteyko, Feldenkrais, Western herbalism, homeopathy, iridology, kinesiology, naturopathy, Pilates, reflexology, Rolfing, shiatsu, tai chi, and yoga.

Rules have been made to exclude these natural therapies from the definition of general treatment under section 121-10 of the Private Health Insurance Act 2007. Insurers will then not be able to offer benefits for these therapies as part of a complying health insurance policy.

Insurers can offer incentives to purchasers of private health insurance as long as the incentives meet the requirements of the Private Health Insurance (Complying Product) Rules. These incentives could include services provided by a natural therapist. It will be up to each insurer to decide whether to offer this type of incentive.

Consumers will still be able to choose to access these natural therapies outside the private health insurance system.

Why is this important?

A review chaired by the former Commonwealth Chief Medical Officer found there is no clear evidence demonstrating the efficacy of the excluded natural therapies.

This review was informed by an evaluation of the evidence undertaken by the National Health and Medical Research Council (NHMRC). NHMRC was tasked with reviewing scientific literature examining the effectiveness and, where available, the safety and cost effectiveness of 17 natural therapies. This was conducted in line with NHMRC’s approach to assessing evidence, and was undertaken for the specific purpose of informing the Australian Government’s Natural Therapies Review.

Changing coverage for the excluded natural therapies will ensure taxpayer funds are spent appropriately and are not directed to therapies that do not demonstrate evidence of clinical efficacy.

Who will benefit?

Around 54 per cent of the Australian population is covered by general treatment (extras) insurance. Changing coverage for the excluded natural therapies will remove costs from the system and contribute to reducing private health insurance premium growth.

What impact will this change have on private health insurance?

This change will contribute to reducing private health insurance premium price increases.

_____________________________________________________________________

The attempt to make health insurance more evidence based is no doubt laudable. I therefore commend this decision and hope other countries are following suit. Despite my general agreement, I feel compelled to make a few critical comments:

  1. Some of the banned treatments are not entirely devoid of good evidence. I am thinking of herbalism and tai chi, for instance.
  2. Iridology is a diagnostic technique and not a ‘natural therapy’.
  3. The term ‘natural therapy’ is of debatable value: not all of the listed modalities are natural (nothing natural about homeopathy, for instance). Personally, I much prefer ‘so-called alternative medicine (SCAM).
  4. I can think of many more SCAMs that should be on this list.

It will be fascinating to see whether the stated prediction that the ban will reduce health insurance premiums will be borne out by data. Many SCAM enthusiasts have in the past argued that it will have the opposite effect. Therefore, it would seem very important that the economic effects of this decision are being accurately monitored and that, in time, the results are analysed and published.

This article reports that Medicare is exploring whether to pay for acupuncture. Coverage would be for chronic low-back pain only. In its request for comments on acupuncture, the Department of Health and Human Services said that “in response to the U.S. opioid crisis, HHS is focused on preventing opioid use disorder and providing more evidence-based non-pharmacologic treatment options for chronic pain.” The agency said it hopes “to determine if acupuncture for [chronic low-back pain] is reasonable and necessary under the Medicare program.” A proposal is due by July 15, with a final decision by Oct. 13.

Medicare coverage “is long overdue,” said Tony Y. Chon, director of integrative medicine and health at the Mayo Clinic in Minnesota. “The opioid epidemic is going to be the momentum that’s really needed to push not just acupuncture but other kinds of non-pharmacological interventions to the forefront.”

Some proponents also note that acupuncture is one of the safest interventions available for pain — though some accidents have been reported. Even if it works only for some people, they argue, there is little harm in trying it when other options are not effective.

However, research shows that acupuncture is little more effective than placebo in many cases. When the government’s Agency for Healthcare Research and Quality reviewed research on a wide range of therapies for chronic pain in 2018, it found the “strength of evidence” that acupuncture works for chronic low-back pain is “low.”

The National Center for Complementary and Integrative Health, part of NIH, says “research suggests that acupuncture can help manage certain pain conditions, but evidence about its value for other health issues is uncertain.”

Critics go further, noting that hundreds of years of anatomical studies have not found evidence of the points in the body linked to the “energy channels” that acupuncture claims to be stimulating to provide pain relief. They contend that acupuncture shows all the signs of the placebo effect, with providers and recipients who believe it works and the elaborate ritual of placing the needles in specially selected spots. “The whole thing is a big scam,” said Steven Novella, an assistant professor of neurology at the Yale School of Medicine and editor of the “Science-Based Medicine” website. “The only honest interpretation of the data is that acupuncture is a theatrical placebo.” Novella said that the efficacy attributed to acupuncture could easily be explained by various research biases and that no drug would be allowed on the market based on that level of proof. “We never get that threshold of evidence that you need in medicine, where you get that persistent effect, and it’s replicable” across numerous studies, he said.

The evidence is indeed far from clear. NICE stated that it no longer recommends acupuncture because the evidence is not strong. Others have shown that acupuncture is superior to sham as well as no acupuncture control for back pain, with differences between groups close to .5 SDs compared with no acupuncture control, and close to .2 SDs compared with sham.

A further systematic review stated that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Yet another systematic review found that acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain.

The recent Lancet papers excited alternative therapists and their organisations who quickly jumped on the LBP  bandwagon. Others have claimed that my often critical verdicts of alternative therapies for LBP are out of line with this evidence. I am broadly in agreement with the evidence presented in Lancet-paper! But I also want to caution that things are complex.

I have therefore copied the non-pharmacological, non-operative treatments listed in the Lancet-paper together with the authors’ verdicts regarding their effectiveness for both acute and persistent LBP. I feel compelled to point out that the Lancet-paper merely lists the effectiveness of several therapeutic options, and that the value of a treatment is not only determined by its effectiveness. Crucial further elements are a therapy’s cost and its risks, the latter of which also determines the most important criterion: the risk/benefit balance. In my version of the Lancet table, I have therefore added these three variables for non-pharmacological and non-surgical options:

EFFECTIVENESS ACUTE LBP EFFECTIVENESS PERSISTENT LBP RISKS COSTS RISK/BENEFIT BALANCE
Advice to stay active +, routine +, routine None Low Positive
Education +, routine +, routine None Low Positive
Superficial heat +/- Ie Very minor Low to medium Positive (aLBP)
Exercise Limited +/-, routine Very minor Low Positive (pLBP)
CBT Limited +/-, routine None Low to medium Positive (pLBP)
Spinal manipulation +/- +/- vfbmae
sae
High Negative
Massage +/- +/- Very minor High Positive
Acupuncture +/- +/- sae High Questionable
Yoga Ie +/- Minor Medium Questionable
Mindfulness Ie +/- Minor Medium Questionable
Rehab Ie +/- Minor Medium to high Questionable

Routine = consider for routine use

+/- = second line or adjunctive treatment

Ie = insufficient evidence

Limited = limited use in selected patients

vfbmae = very frequent, minor adverse effects

sae = serious adverse effects, including deaths, are on record

aLBP = acute low back pain

So, should Medicare pay for acupuncture or any other SCAM? Please advise!

A bibliometric or scientometric evaluation of the homeopathy literature has been published by a Turkish author (someone who I do not know and have never before heard of). He (of maybe she?) collected data from 4 electronic databases. All documents published between 1975 and 2017 were included. The keywords searched for in detail were “homeopathy“, “homeopathic”, “homoeopathy” and “homoeopathic”. He used Spearman’s correlation test to investigate a possible correlation between publication numbers or the productivity and features of the countries. We created infographics and infomaps by using GunnMap and VOSviewer sources. Gross domestic product (GDP) ranking data of countries was procured from The World Data Bank.

A total of 4183 articles were found. The great majority of documents were original articles (n = 3043, 72.75%). The UK dominated homeopathy literature with 950 articles followed by the USA, Germany, India and Brazil (n = 636, 590, 277 and 246 items, respectively). Switzerland was found to be most productive country (20.41) followed by the UK, Norway and Israel (14.35, 11.31 and 8.41, respectively). University of Exeter (UK) was the leading institution with 204 items (4.88%).

The most productive journal was ‘Homeopathy’ dominating which had published 24% of all the articles. A very high correlation was detected between publication number and citation number by year (r = 0.95, p < 0.001). A high correlation was also seen between gross domestic product (GDP) per capita and productivity of the countries. A moderate correlation was found between GDP and publication number of the countries (r = 0.66 and p < 0.001). In scientometric network analysis, the USA, the UK and Germany were noted to be three major association centres.

University of Exeter (UK) was the leading institution!

As far as I know, all homeopathy papers from Exeter are (co)authored by me …

… I must be the HOMEOPATHIC WORLD CHAMPION!

(Sorry guys)

If homeopaths can make the Berlin Wall into a homeopathic remedy, they can use anything!

That’s true; I am not aware of any material that could not be used by clever manufacturers of homeopathics to make a fast buck. But I did not think that they would venture as far as visiting the vagina. This website taught me that I was wrong. VAGIN is a homeopathic remedy made by Boiron out of vaginal mucosa (tempting to make all sorts of bad taste jokes, but I will resist):

Muqueuse Vaginale Pillules is a homoeopathic remedy created by Laboratoires Boiron.

Homeopathic Potency

4C 5C 7C 9C 12C 15C 30C same as 4CH 5CH 7CH 9CH 12CH 15CH 30CH

Ingredients

Muqueuse Vaginale

Dilutants with known effect: lactose, saccharose

Do not use

Do not use the homeopatic remedy if you are allergic to some sugars

To be taken

The Muqueuse Vaginale pillules have to be taken orally

Instructions for Use of Muqueuse Vaginale

For adults and children over 6 years, allow to melt under the tongue.

For children under 6 years, dissolve in a small quantity of water.

Packaging

Tube of homoeopathic pillules.

Approximately 80 to 90 pills per tube.

About Laboratoires Boiron

Laboratoires Boiron, a French pharmaceutical company, produces and distributes homoeopathic drug preparations both within France and overseas.

______________________________________________________________

So far, so good!

But what is VAGIN good for?

I tried to find out, but unfortunately was not very successful. To be absolutely honest, I haven’t got a clue. I suspect, it might be good for Boiron’s profits, but for what ailments do homeopaths recommend VAGIN?

Perhaps someone could enlighten me?

In Switzerland, so-called alternative medicine (SCAM) is officially recognised within the healthcare system and mainly practised in conjunction with conventional medicine. So far no research has been published into the attitude towards, training in and offer of SCAM among paediatricians in Switzerland. This survey addresses this gap by investigating these topics with an online survey of paediatricians in Switzerland.

It employed a 19-item, self-reporting questionnaire among all ordinary and junior members of the Swiss Society of Paediatrics (SSP). A comparison of the study sample with the population of all paediatricians registered with the Swiss Medical Association (FMH) allowed an assessment of the survey’s representativeness. The data analysis was performed on the overall group level as well as for predefined subgroups (e.g. sex, age, language, workplace and professional experience).

A total of 1890 paediatricians were approached and 640, from all parts of Switzerland, responded to the survey (response rate 34%). Two thirds of respondents were female, were aged between 35 and 55 years, trained as paediatric generalist and worked in a practice. Apart from young paediatricians in training, the study sample was representative of all Swiss paediatricians.

According to the authors’ statistics, the results suggest that

  • 23% had attended training in SCAM, most frequently in phytotherapy, homeopathy, acupuncture/traditional Chinese medicine (TCM) and anthroposophic medicine
  • 8% had a federal certificate in one or more SCAM methods.
  • 44% did not routinely ask their patients about their use of SCAM.
  • 84% did not offer SCAM.
  • 65% were interested in SCAM courses and training.
  • 16% provided SCAM services to their patients.
  • 97% were asked by patients/parents about SCAM therapies.
  • More than half of the responding paediatricians use SCAM for themselves or their families.
  • 42% were willing to contribute to paediatric SCAM research.

The authors concluded that in a representative sample of paediatricians in Switzerland, the overall attitude towards SCAM was positive, emphasised by great interest in SCAM training, willingness to contribute to SCAM research and, in particular, by the high rate of paediatricians using SCAM for themselves and their families. However, given the strong demand for SCAM for children, the rate of paediatricians offering SCAM is rather low, despite the official recognition of SCAM in Switzerland. Among the various reasons for this, insufficient knowledge and institutional barriers deserve special attention. The paediatricians’ great interest in SCAM training and support for SCAM research offer key elements for the future development of complementary and integrative medicine for children in Switzerland.

SCAM suffers from acute survey mania. I am anxiously waiting for a survey of SCAM use in left-handed, diabetic policemen in retirement from Devon. But every other variation of the theme has been exploited. And why not? It provides the authors with a most welcome addition to their publication list. And, of course, it lends itself very nicely to SCAM-promotion. Sadly, there is not much else that such surveys offer.

Except perhaps for an opportunity to do an alternative evaluation of their results. Here is an assessment the devil’s advocate in me proposes. Based on the reasonable assumption that those 34% of paediatricians who responded did so because they had an interest in SCAM, and the 64% who did not reply couldn’t care less, it is tempting to do an analysis of the entire population of Swiss paediatricians. Here are my findings:

  • Hardly anyone had attended training in SCAM.
  • Hardly anyone had a federal certificate in one or more SCAM methods.
  • Very few did not routinely ask their patients about their use of SCAM.
  • Hardly anyone offered SCAM.
  • Very few were interested in SCAM courses and training.
  • Hardly anyone provided SCAM services to their patients.
  • Quite a few were asked by patients/parents about SCAM therapies.
  • Very few paediatricians use SCAM for themselves or their families.
  • Few were willing to contribute to paediatric SCAM research.

These results might be closer to the truth but they have one very important drawback: they do not lend themselves to drawing the SCAM-promotional conclusions formulated by the authors.

Oh Yes, reality can be a painful thing!

A few days ago, I reported that the German homeopathy manufacturer Hevert has taken legal action against German critics of homeopathy. This caused a storm of protests on twitter, in the press and even on TV. Hevert has remained silent in all this, but now a spokesperson and part owner of the firm, Mr Mathias Hevert, has given an interview to ‘Pharma Relations’ in an attempt to explain and justify Hevert’s position.

The interview does not tell us much, except for one particular passage:

Frau Grams hat sich meines Wissens nach gar nicht konkret auf die Produkte der Firma Hevert bezogen. Warum fühlten Sie sich dennoch aufgerufen, sozusagen stellvertretend für die Branche juristische Schritte einzuleiten?

Da homöopathische Arzneimittel neben pflanzlichen und schulmedizinischen Präparaten einen wichtigen Teil des breiten Hevert-Sortiments darstellen, fühlen wir uns bereits seit der Firmengründung 1956 eng mit der durch Pastor Emanuel Felke begründeten Komplexmittel-Homöopathie verbunden. Seit Monaten beobachten wir, wie die Homöopathie von Meinungsbildnern in den Sozialen Medien, der Presse und dem Fernsehen undifferenziert und ohne wissenschaftliche Grundlage denunziert wird. In Großbritannien wurden bereits einflussreiche Lobbygruppen aktiv, um die Homöopathie als Ganzes und ohne differenzierte Betrachtung der Datenlage zu verunglimpfen. Mit ihren Bemühungen schafften sie es sogar, die Politik zu gesetzlichen Einschränkungen des Feldes zu drängen. Um ähnliches in Deutschland – dem Mutterland der Homöopathie – zu verhindern, geht Hevert entschlossen gegen ungerechtfertigte und nicht fundierte Diskreditierungen der Homöopathie durch Lobbygruppen und andere Meinungsbildner vor.

Here is my translation of the bit that concerns me:

Q: Frau Grams has, as far as I know, not even concretely referred to the products of Hevert. Why do you still feel compelled to start legal procedures, so to speak for the sector?

A: … We observe since months how homeopathy is being denounced in an undifferentiated manner and without a scientific basis by opinion leaders in social media, the press, an on TV. In England, influential lobby groups have been active to denigrate homeopathy as a whole and without differentiated consideration of the data. Through their efforts, they have even managed to force politicians to implement legal restrictions in this area…

_________________________________________________________

I must admit, I find this response quite extraordinary!

I am not aware of anyone or any group in England denigrating homeopathy without differentiated consideration of the data. All we did was to point out what the best available evidence tells us, exercise our critical thinking abilities, and report facts. And I do strongly object anyone claiming otherwise. In fact, I ask myself whether the above remarks by a representative of a manufacturer of homeopathics are not libellous and thus actionable.

What do you think?

PS

But perhaps I have misunderstood something; in this case, could Mr Hevert please name the UK critics he had in mind when he made these comments?

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

_________________________________________________________

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.

____________________________________________________________________

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.

_________________________________________________________________

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.

If you want to be able to edit your comment for five minutes after you first submit it, you will need to tick the box: “Save my name, email, and website in this browser for the next time I comment.”

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Categories