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

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A few days ago, I received this email:

Dear Dr. Edzard Ernst,

I am xxyy*, Editorial assistant from xxxzzz* Publishing Group Ltd. contacting you with the reference from our editorial department. Basing on your outstanding contribution to the scientific community, we would like to write a book for you.

Researchers like you are adding so much value to the scientific community, yet you are not getting enough exposure. No matter how many papers you publish in famous journals, you will be still unknown to common people. To solve this problem, we came up with this unique solution.

With our book writing service, we will write your research contributions in common man’s language. We will also include all your published papers into this book in a way that a common man can understand it. And then, we will publish your book with our publishing group. Before, publication, we will send the draft to you for scientific accuracy, once you approve our draft, we then proceed for publication. You will get all the rights of your book, and all the sales generated from your book will be credited to you.

Your book will then be listed on famous websites like Amazon, eBay, Goodreads, and many other popular book websites. As a result, you will get good credit and people will recognize your hard work and your scientific contributions.

Last but not least, after the publication of your book, it will be published in Google News, Yahoo, and other major news channels. What more can you ask for?

All we need is your book writing contract, and you will get all the rights for your book.

Will be waiting to hear from you.

Best Regards,

xxyy

__________________________________________________

Amazed and curious, I replied:

Thanks xxyy,

that sounds interesting; please let me know what costs are involved.

Regards

E Ernst

____________________________________________________

The answer came a few days later. Here is the passage that addressed my question:

Usually, Researchers want their articles converted into common man’s language and make them into a book. But if you have a special requirement, then please let us know, so that our writers can write according to your needs. And once the drafting has finished, we will send it for your review for scientific accuracy. This includes book cover & page design, ISBN (International Standard Book Number) for your book, proofreading service and publication fee. And Our service fee for this is $1895. And it will take around 1 month to complete your project. Last but not least, once your book is published, we will write a news article about you and your book and will publish it in major newspapers to get proper publicity.

Image result for ghost writer, comic

_______________________________________________________

I have to admit, I am still amazed! The price seems not high (though, judging from the quality of their English, the price/value balance might still be doubtful). Whenever I write a book, it takes me the best part of a year. Once I calculate a realistic $-figure for this effort, it would surely be more than one dimension higher.

So, am I going to have my next book ghost-written by this or any other service?

No, thanks!

(*Yes, I deleted the names)

The question whether chiropractic spinal manipulations are an effective treatment of infantile colic has been raging ever since the BCA sued Simon Singh over it (and lost). On this blog, I have discussed the evidence several times (see here, here, here and here). Now a new paper has emerged with the title ‘MEDICAL MANAGEMENT OF INFANTILE COLIC AND OTHER CONDITIONS WITH SPINAL MANIPULATION: A NARRATIVE REVIEW OF THE EUROPEAN MEDICAL LITERATURE’. As it was published on a journal not listed in Medline (J Contemporary Chiropr 2019;2:60-75), I will quote more extensively from it than I do normally. Here is the abstract in its original form:

Objective: Strong evidence is found for European medical management of ‘infantile colic’ by spinal manipulation. This paper identifies and describes this body of evidence. We apply the social research method of document analysis to the European medical literature and report the medical practices regarding the management of infantile colic by manual means including manipulation.
Data Sources: Primary data sources were Medline, accessed via PubMed, and the Index to Chiropractic Literature (ICL). Secondary material was sourced from the private collections of the authors. Acceptability criterion included a report of the medical management of infantile colic.
Data Synthesis: A range of languages were accepted and either translated or interpreted by clinicians known to the authors. Each retrieved paper was then hand-searched to identify additional citations which were also collected. A total of 69 papers met the acceptance criteria. The statements accepted for appraisal were those of methods descriptive of the clinical assessment and management of patients classified by the practitioner as a child with infantile colic.
Results: The medical management of infantile colic by spinal manipulation is well reported in the European medical literature. Triangulation also identified reports of medical management of a range of pediatric nonneuromusculoskeletal conditions. European medical papers report a number of positive outcomes for infantile colic with care broadly considered to be manipulative care. These outcomes parallel those known to be widely reported in the chiropractic literature.
Conclusion: We report strong evidence from the European medical literature related to the management by manipulation of infants with infantile colic and other conditions.

In the article proper, the authors conclusions are more detailed and very much longer:

It is difficult to reconcile the positive evidence for manipulative management of infantile colic recorded in
the European medical literature and the known safety of chiropractic management with the need for the 2019 Safer Care Victoria inquiry into Chiropractic manipulation of infants. We consider there is no reasonable evidential basis for this inquiry.
The evidence is that “Infantile colic is an easily identified childhood entity that has no clear treatment guidelines. The management of infantile colic varies among physicians, and families are often frustrated by the medical community’s inability to prescribe a cure for colic.” (163)
Infantile colic remains a medical enigma with no evidence of safety for medical management, in fact the determination of terminology for reporting such adverse events is relatively new. (164) On the other hand the remarkable safety of chiropractic management is known and the finding that European medical literature strongly indicates manipulative management of infantile colic as a safe and effective practice, places conventional chiropractic as a safe evidence-based choice to meet parental demand.
Alcantara et al (165) show support for this position by stating “chiropractic care is a viable alternative to the care of infantile colic and congruent with evidence-based practice, particularly when one considers that medical care options are no better than placebo or have associated adverse events.”
In the absence of consistently effective management options, accepting the evidence of the European medical literature shows the benefit of manipulative care for infantile colicky patients and the wider collateral beneficial effect on parents. (166,167)
We consider it important to report the uncertainty of medical management of infantile colic and to recognize manual therapy as a legitimate management option as actively utilized by mostly European medical doctors. Multiple case reports document the efficacy of manual therapy of infants. There is a distinct absence of original evidence contradicting the efficacy of spinal manipulative management of infantile colic and an absence of evidential contraindications for its implementation.
This paper reports considerable material in the European medical literature on the manipulative management of infants, particularly infantile colic. Although supportive in safety (150,158) and efficacy (145), the chiropractic literature on these topics was not the primary focus at this time. However in relation to safety, Funabashi and colleagues noted providers of spinal manipulation have similar or better dimension scores compared to the 2016 medical data base of the Agency for Healthcare Research and Quality. (158)

On balance we can state with confidence that the published, indexed evidence places conventional chiropractic management of infantile colic as safe and effective in the manner clearly documented as clinical methods in the European Medical literature.

I find it hard to decide where to begin. The problem is that there is almost nothing right with this review.

Let’s start with the title, MEDICAL MANAGEMENT OF INFANTILE COLIC AND OTHER CONDITIONS WITH SPINAL MANIPULATION: A NARRATIVE REVIEW OF THE EUROPEAN MEDICAL LITERATURE’. What do they mean with ‘other conditions’? As the review does, in fact, include plenty of non-European papers, this title is simply nonsensical.

Next is the objective: it states that there is good evidence for spinal manipulation as a treatment of infantile colic. The authors thus managed to disclose their bias in the very first sentence of their paper.

The rest of the abstract is similarly incompetent. Crucially, we do not learn what inclusion/exclusion criteria the authors applied and how they evaluated the methodological quality of the included studies. Remarkably, this information is also not provided anywhere else in the paper. Thus, this article lacks all the essential elements of a scientific review and turns out to be little more than a highly biased opinion piece. In fact, it is worse; the introduction, for instance, begins with what I can only call a rant: Within Australia there is a government-manufactured controversy regarding the management of infants by chiropractors…

The results section is equally remarkable. Here are a few direct quotes to give you a flavour:

Forty-five papers were accepted as valid clinical reports of the management of infantile colic by medical manipulation (Table 1). There are over 60 papers relating to infantile colic on ICL; we do not report these. The Chiropractic Resource Organisation (CRO) website essentially carries the same papers as ICL. Many of these listings are case reports and outcome-based studies. (33, 34) Reference lists were also obtained from indexed papers as well a range of medical and chiropractic textbooks. (35 – 37)

The truth is that the 45 papers are not ‘valid clinical reports’ but a mixture of comments, case reports, opinion pieces, observational studies and a few clinical trials. The latter are identical with those discussed in proper systematic reviews of the subject. There is thus no reason for arriving at different conclusions than these reviews. But, of course, the authors do exactly that, and they do not explain why. They claim that European doctors use spinal manipulation routinely for colicky babies; this is not true (I am a European doctor and have never seen this happening). They claim that unearthing the European literature revealed more positive evidence; this is also not true: this literature was not hidden but it simply does not measure up to the standard required for evidence and was thus not included in previous reviews.

The authors could not identify any original research study report that rejected spinal manipulation of infants for colic on the grounds of being unsafe or with negative clinical outcomes.

As the authors did cite a few (by no means all) review papers that clearly showed the risks of spinal manipulation, one must ask what this statement was intended for. Was it to give the false impression that chiropractic spinal manipulations are safe?

The criticism of commentators seems to be that chiropractic care for infantile colic is no better than a placebo (147), the same finding for a common colic medication. (148) In other words, chiropractic care is equal to or just as effective as placebo and medication and therefore becomes the preferred clinical option on
the basis of safety and the absence of potential adverse effects. (63,149-151)

I fail to understand the logic behind this argument. The authors seem to admit that chiropractic care is a placebo therapy. To any reasonable person, this means that any benign and cost-free intervention (such as a gentle massage or cuddle by a parent) is preferable to an expensive and potentially harmful chiropractic treatment.

Chiropractic has been examined with rigour and found safe. Our interpretation of this evidence is that there is virtually no danger to infants from carefully applied manual methods by qualified providers and perhaps the best of both worlds is concomitant care among chiropractors and medical practitioners.

This conclusion is not supported by the evidence presented, and the authors do not explain how they arrived at it.

In addition to such irrational passages, we find plenty of nonsensical or factually incorrect statements in the authors’ pseudo-review. Here are a few examples that I found amusing:

Spinal manipulation as it is known today was brought to European medical doctors by chiropractors and osteopaths, (105) and since then it has become an entrenched medical practice in most European countries, particularly Germany. In Europe, the use of spinal manipulation within the medical profession for the management of infantile colic has been a well-recognised procedure for some decades. (38,43,63,106)

The chiropractic vertebral subluxation is recognised in the medical literature (107) contrary to unsupported claims that it cannot be identified. It is this type of mechanical spinal lesion that has been identified to address as a vertebrogenic factor under this model.

However, my favourite bit is this direct quote:

The evidence is that “Infantile colic is an easily identified childhood entity that has no clear treatment guidelines. The management of infantile colic varies among physicians, and families are often frustrated by the medical community’s inability to prescribe a cure for colic.”

The authors quote here from my own review, and remarkably it is the only quote from it. The authors otherwise ignore it completely and, crucially, they do also not list it as one of the 45 included papers. Why? To answer this question, we need to see what my review says. Here is its very short 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.

Call me biased, but I do believe that this is much closer to the truth than the lengthy pseudo-review above.

Let me finish this post by revealing who its authors are.

  • Peter Rome, Chiropractor, retired
  • John Waterhouse, Private practice of chiropractic
  • Glenn Maginness, Private practice of chiropractic
  • Phillip Ebrall, Tokyo College of Chiropractic

No funding was received for this study.

No author declared a conflict of interest (at least, this is what they claim).

No further contact details were provided.

My conclusion of all this:

We have to search long and far before we find a SCAM article that is more misleading and less competent than this one.

Let’s be clear: pseudoscience kills. And they are being employed with total impunity thanks to European laws that protect them.

They kill thousands of people, with names and family. People such as Francesco Bonifaz, a 7-year-old boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy [1]. People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain [2]. People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland [3]. People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine” [4]. He died in England. People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France [5]. People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment.  She died in Russia [6]. People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark [7]. People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German New Medicine to treat her breast cancer. She died in Germany [8]. People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in Netherlands [9].

European directive 2001/83/CE has made –and still makes— possible the daily deceiving of thousands of hundreds of European citizens [10]. Influential lobbies have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield under economic interests, especially when it means deceiving patients and violating their rights.

Europe is facing very serious problems regarding public health. Over-medicalization, multiresistant bacteria or the financial issues of the public systems are already grave enough, and there is no need to add to that gurus, fake doctors or even qualified doctors who claim they can cure any disease by manipulating chakras, making people eat sugar or employing “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams, which implicate more than 150 pseudo-therapies in our territory. Thousands of citizens lives depend on that. In fact, according to recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived [11].

Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks the right to true information about their health. This way, even if a citizen has a right to refuse medical treatment when properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could we allow homeopathy—or any other pseudo-therapy—to continue to be sold to citizens.

Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is already too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.

Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is true indeed. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.

Every country has to face the issue with pseudo-therapies in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.

We, the signatories of this manifest, therefore declare that:

  1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case of homeopathy.
  2. European laws that protect homeopathy are not admissible in a scientific and technological society that respects the right of the patients not to be deceived.
  3. Homeopathy is the most known pseudo-therapy, but it is not the only one nor the most dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology, biomagnetism, orthomolecular therapy and many more, are gaining ground and causing victims.
  4. Measures must be taken to stop pseudo-therapies, since they are not harmless and result in thousands of people affected.
  5. Europe needs to work towards creating legislation that will help stop this problem.

Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and has already costed the life of too many.

Sign the manifesto

References:

[1] Homeopathy boy died of encephalitis. Redazione ANSA, 2017.http://www.ansa.it/english/news/general_news/2017/05/29/homeopathy-boy-died-of-encephalitis-3_13e02493-4e62-4787-9162-12d831121ef6.html

[2] Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.

https://www.thelocal.es/20160412/grieving-father-sues-naturopath-over-son-cure-cancer-vitamins-leukaemia

[3] Asthmatic ‘told to give up drugs’. The Irish News, 2001.

https://www.independent.ie/irish-news/asthmatic-told-to-give-up-drugs-26063764.html

[4] Homeopaths warn of further tragèdies. BBC News, 2000.

http://news.bbc.co.uk/2/hi/health/702699.stm

[5] Alternative cure doctor suspended. BBC News, 2007. http://news.bbc.co.uk/2/hi/uk_news/england/london/6255356.stm

[6] Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.

https://sport24.ru/news/football/2018-08-28-futbolist-rasskazal-tragichnuyu-istoriyu-zheny-ona-umerla-ot-raka-v-25-let

[7] Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.

http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-mod-behandleren

[8] The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012. https://scienceblogs.com/insolence/2012/08/30/the-price-of-refusing-science-based-medical-and-surgical-therapy-in-breast-cancer

[9] Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004

http://web.archive.org/web/20070208144309/http://www.expatica.com/actual/article.asp?subchannel_id=19&story_id=4821

[10] Directiva 2001/83/CE del parlamento europeo y del consejo:6 de noviembre de 2001

https://www.boe.es/doue/2001/311/L00067-00128.pdf

[11] Use of complementary and alternative medicine in Europe: Health-related and sociodemographic determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989251/

Homeopathy is harmless; after all, the typical homeopathic remedy contains no active ingredient! Such claims can be seen abundantly. Sadly, however, they are not true. The remedies might be mostly (but, depending on potency and proper quality control, not totally) risk-free, yet homeopathy can and does kill patients. There is a depressingly long list of fatalities to prove this point. And here is another sad case that confirms it; this short article provides the essential facts:

The parents of a seven-year-old boy who died after they decided to treat his otitis only with homeopathy were convicted of manslaughter Thursday.

Francesco, from Cagli near Pesaro, died on May 27 2017 from bilateral bacterial otitis.

His parents were found guilty of complicity in aggravated culpable manslaughter.

They were given a suspended sentence of three months in jail.

The parents entrusted their son’s care to Pesaro homeopathic doctor Massimiliano Mecozzi, who is set to go on trial on September 24.

The homeopath advised treatment with homeopathic products instead of the antibiotics which would have saved him, the court found.

Francesco died after the otitis degenerated into encephalitis.

Another article offers a few more details about the case:

Francesco suffered from otitis media. The doctor Massimiliano Mecozzi (55) treated the child exclusively with homeopathic remedies. When the parents brought Francesco to the hospital a few days later, it was already too late: The boy died soon afterwards. According to “Corriere della Sera”, the parents decided to not give their child antibiotics since he was only three years old. Francesco’s illness had begun with a severe cold and fever, and his frequented the homeopathic doctor Mecozzi who discouraged the parents from bringing their child to a hospital. “He scared them by claiming that the doctors would give medicaments to Francesco that would make him deaf or would damage his liver. He promised them that Francesco will recover soon”, said grandfather Maurizio to “Il Mattino”.

But Francesco’s condition worsened over the course of the following days, and the infection spread to the head. When the parents brought their son to the emergency admission, a festering abscess had already formed. Francesco was brought to a hospital in Ancona for an emergency operation. An antibiotic shock therapy didn’t help at this point either, and the child died.

According the “Corriere”, the physician had a questionable career: After having been temporarily expelled from the physician’s association, he even worked as a doorman and as an allrounder in a supermarket. Then he came into contact with a religious community in Varese, whose founders have been accused of fraud. When the physician’s association in Pesaro inquired to his occupation as a homeopath, Mecozzi replied: “I have no interest in telling you about it.”

And a further article adds even more details: the 7 year-old boy was hospitalized in an intensive care unit at the Hospital Salesi of Ancona. The child, born in Cagli (Pesaro), had been treated with homeopathy instead of antibiotics and had arrived in hospital in a serious condition. The child subsequently went into a neurological coma; an EEG revealed the absence of electrical activity, and brain death was certified. The death occurred as the result of an ear infection treated with homeopathy.

Such cases are tragic but (hopefully!) rare. They are due to the neglect (failure to provide adequate medical care) by a homeopath. Obviously, such neglect does not always have to be fatal. I would guess that milder forms of medical neglect through homeopathy are, in fact, extremely common (nobody knows the exact figure). One could even argue that, by definition, homeopathic treatment amounts to medical neglect which falls into three overlapping categories:

  • In the majority of cases, it has no or very little symptomatic consequences. For instance, if a homeopath prescribes a homeopathic remedy for a self-limiting condition, such as a common cold, and the patient soon improves due to the benign nature of the condition (often thinking that homeopathy was effective). There is, however, invisible harm such as the expense of the remedies and the false trust into a bogus therapy created by this experience (which might prove to be extremely harmful later on).
  • In many instances, the neglect does cause unnecessary suffering of patients because the optimally effective treatment of their disease is not administered or delayed. Many doctor homeopaths would argue that this is not usually true because, for such patients, they also prescribe conventional treatments in parallel. But even if this were true, these clinicians would still cause harm through the waste of resources.
  • In a sizable but unknown number of cases, homeopathy does cause very serious harm and, as the above case shows, even deaths.

The point I am trying to make is this: we usually only hear of the dramatic cases of neglect through homeopathy (or other forms of ineffective SCAM). What we tend to forget is that such cases are only the extreme end of a much wider spectrum, and that all clinicians who prescribe homeopathy are guilty of neglect. The symptomatic harm done ranges from almost zero to 100%, and the damage caused is merely a question of degree.

 

 

 

 

PS

Before some homeopathy-fan comments, “but the harm from conventional therapies is sooooooooo much more significant!!!”, let me stop you in your tracks by recommending you consider the concept of risk/benefit balance.

Chiropractors, I have repeatedly found, are somewhat slow at learning lessons even from their biggest mistakes. A new paper seem to confirm my suspicion. The purpose of this study was to investigate the report by mothers of their infants’ condition before and after a trial of care provided by chiropractors in addition to ratings of satisfaction, cost of care, and reports of any adverse events. A second purpose was to report the demographic profile of infants who presented for care to 16 chiropractic clinics in the United Kingdom.

The authors prospectively collected reports by mothers of their infants’ demographic profiles and outcomes across several domains of infant behaviour and their own mental state using the United Kingdom Infant Questionnaire. Participating chiropractors were recruited through the Royal College of Chiropractors annual meeting in January 2016. A total of 15 UK clinics and the Anglo-European College of Chiropractic University College teaching clinic volunteered to participate.

In all, 2001 mothers completed intake questionnaires and 1092 completed follow-up forms. Statistically significant improvements were reported across all aspects of infant behaviour, including:

  • feeding problems,
  • sleep issues,
  • excessive crying,
  • problems with supine sleep position,
  • infant pain,
  • restricted cervical range of motion,
  • time performing prone positioning.

Maternal ratings of depression, anxiety, and satisfaction with motherhood also demonstrated statistically significant improvement. In total, 82% reported definite improvement of their infants on a global impression of change scale. In addition, 95% reported feeling that the care was cost-effective, and 90.9% rated their satisfaction 8 or higher on an 11-point scale. Minor self-limiting side effects were reported (5.8%) but no adverse events.

The authors concluded that mothers reported that chiropractic care for their infants was effective, safe, and cost-effective. Although the observational design makes it impossible to determine efficacy, the study’s findings indicate that, on average, the changes observed by mothers were positive and may be clinically relevant.

Where to begin? Let me try to list at least some of the most obvious flaws of this study:

  • The fact that mothers (where were the fathers?) reported positive outcomes is hardly surprising. After all, they chose to consult a chiropractor and paid for the treatments. Install yourself in a McDonald’s, ask customers whether they like hamburgers, and you get a similarly meaningless result.
  • Cost-effectiveness is measured in Bournemouth by asking people, ‘was it worth it’? I feel like going back there and teaching them some research methodology!
  • The observational design is by no means the only reason why ‘efficacy’ cannot be determined by such a study. What about the non-validated nature of the outcome measures?
  • Do the researcher mean effectiveness or efficacy? And do they know the difference at all?
  • What do they think is the difference between side effects and adverse events?
  • Do they think they can establish safety by asking the mothers of their patients?

So, does this study show anything useful at all?

Yes, perhaps.

I think it shows that, despite all the shameful and unpleasant history that severely damaged the reputation of chiropractic in the UK and beyond, chiropractors are still treating infants for conditions for which there is ‘not a jot of evidence‘. It seems almost as though they are ‘happily promoting bogus treatments’!

The Center for Inquiry (CFI) is a non-profit educational, advocacy, and research organization headquartered based in the US. It is also home to the Richard Dawkins Foundation for Reason & Science, the Committee for Skeptical Inquiry, and the Council for Secular Humanism. The Center for Inquiry strives to foster a secular society based on reason, science, freedom of inquiry, and humanist values. The CFI has just issued a press-release about their legal action against Walmart. Here are some quotes from it:

Walmart is committing wide-scale consumer fraud and endangering the health of its customers though its sale and marketing of homeopathic medicines … the mega-retailer is deceiving consumers by making no meaningful distinction between real medicine and useless homeopathic treatments on its shelves and in its online store, misrepresenting homeopathy’s safety and efficacy.

Click here to access the official complaint (PDF).

CFI is currently engaged in a similar suit against CVS, the nation’s largest drug retailer, which was filed in June of 2018 and is still ongoing.

“Walmart sells homeopathics right alongside real medicines, in the same sections in its stores, under the same signs,” said Nicholas Little, CFI’s Vice President and General Counsel. “Searches on its website for cold and flu remedies or teething products for infants yield pages full of homeopathic junk products. It’s an incredible betrayal of customers’ trust and an abuse of Walmart’s titanic retail power.”

“Walmart can’t claim it doesn’t know that homeopathy is snake oil, because it runs its own enormous pharmacy business and make its own homeopathic products,” said Little. “So whether it’s a scientifically proven remedy like aspirin or flatly denounced junk like homeopathic teething caplets for babies, Walmart sells all of it under its in-house ‘Equate’ branding. It’s all the same to Walmart.”

Choosing homeopathic treatments to the exclusion of evidence-based medicines can result in worsened or prolonged symptoms, and in some cases, even death. Several products have been found to contain poisonous ingredients which have affected tens of thousands of adults and children in just the last few years. As recently as May 14, the Food and Drug Administration issued warnings to five manufacturers of homeopathic products for numerous safety violations.

“Despite being among the richest corporations on Earth and the largest retailer in the United States, Walmart chooses to further pad its massive wealth by tricking consumers into throwing their money away on sham medicinal products that are scientifically proven to be useless and potentially dangerous,” said Robyn Blumner, president and CEO of the Center for Inquiry. “We intend to put a stop to it.”

CFI has lobbied for tighter regulation of homeopathic products for many years, becoming the leading advocate for science-based medicine and against the proliferation of snake oil. In 2015 CFI was invited by the FDA and the Federal Trade Commission to provide expert testimony. As a result, the FTC declared in 2016 that the marketing of homeopathic products for specific diseases and symptoms is only acceptable if consumers are told: “(1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” Last year, the FDA announced a new “risk-based” policy of regulatory action against homeopathic products.

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I have long come to the conclusion that the dangers of homeopathy and other SCAMs should best be tackled legally. The medical case against many forms of SCAM has been clear for some time. They have been published a thousand times, yet these efforts have brought little progress in practice. Politicians tend to think in terms of their chances of re-election and thus often lack the resolve to act decisively. It is therefore now largely up to the legal professions to effectively protect consumers and patients from the many types of harm SCAM can do.

My hope is therefore that the action of the CFI against Walmart will be successful. More crucially, I hope that it will become a signal for activists from other countries to consider similar actions.

German homeopathy has had a free ride for about 200 years. But, since a few years, critics have started voicing their opposition pointing out that homeopathy lacks evidence of effectiveness. Sales figures, previously in excess of 600 million Euros, have thus started to decline. As a result the homeopathic industry has begun to fight back – as previously discussed, not always by honest or fair means.

Now, a new development has taken place; a manufacturer of homeopathic remedies, Hevert, has sent legal letters to several critics of homeopathy in an attempt to stop them stating that homeopathy is not effective beyond placebo. Failing to abide by this demand would be punishable with a huge find of 5 100 Euros.

After I learnt about this, I had a look on the website of Hevert and found an article detailing the evidence on homeopathy. I think it makes certain things more understandable.

The article concedes that the evidence for homeopathy is often of poor quality and not entirely positive. One problem, the article claims, is the fact that these analyses are usually sponsored by interested parties and that independent, reviews financed through public funds have not been available.

Das Hauptproblem liegt darin, dass die klinische Homöopathieforschung bisher fast ausschließlich über Gelder von komplementärmedizinischen Stiftungen bzw. über die homöopathischen Arzneimittelhersteller selbst finanziert wird. Das heißt, dass eine mit öffentlichen Forschungsgeldern unterstützte systematische Erforschung der klinischen Wirksamkeit von homöopathischen Arzneimitteln bisher nicht stattgefunden hat….

Could it be that Hevert is not well-informed about this point? The fact is that there are now numerous such analyses. Here are the key passages from some of these ‘official verdicts’:

 “The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available”

Russian Academy of Sciences, Russia

Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.

National Health and Medical Research Council, Australia

“These products are not supported by scientific evidence.”

Health Canada, Canada

“Homeopathic remedies don’t meet the criteria of evidence-based medicine.”

Hungarian Academy of Sciences, Hungary

“The incorporation of anthroposophical and homeopathic products in the Swedish directive on medicinal products would run counter to several of the fundamental principles regarding medicinal products and evidence-based medicine.”

Swedish Academy of Sciences, Sweden

There is little evidence to support homeopathy as an effective treatment for any specific condition

National Centre for Complementary and Integrative Health, USA

There is no good-quality evidence that homeopathy is effective as a treatment for any health condition

National Health Service, UK

Homeopathic remedies perform no better than placebos, and the principles on which homeopathy is based are “scientifically implausible”

House of Commons Science and Technology Committee, UK

“Homeopathy has not definitively proven its efficacy in any specific indication or clinical situation.”

Ministry of Health, Spain

“… homeopathy should be treated as one of the unscientific methods of the so called ‘alternative medicine’, which proposes worthless products without scientifically proven efficacy.”

National Medical Council, Poland

“… there is no valid empirical proof of the efficacy of homeopathy beyond the placebo effect.”

Federaal Kenniscentrum voor de Gezondheidszorg, Belgium

The Hevert article also points out that systematic reviews assessing homeopathy globally are perhaps not ideal, the article claims, and therefore systematic reviews targeted at specific conditions might be preferable and, indeed yield positive findings.

Mittlerweile geht man bei der Auswertung von klinischen Studien sinnvollerweise mehr dazu über, nicht mehr „die Homöopathie“ als Ganzes auf die Probe zu stellen, sondern kleinere Metaanalysen zu festen Indikationen durchzuführen, da dies eindeutigere Ergebnisse liefert….

Again, I suspect that the firm Hevert is not well-informed. I, for instance, have published about a dozen of such reviews which they fail to cite in their article. Let me copy the abstracts of just 4 examples here:

EXAMPLE 1

BACKGROUND:

Homeopathy is often advocated for patients with eczema.

OBJECTIVES:

This article systematically reviews the evidence from controlled clinical trials of any type of homeopathic treatment for any type of eczema.

METHODS:

Electronic searches were conducted in Medline, Embase and the Cochrane Library with no restrictions on time or language. In addition, the bibliographies of the retrieved articles and our departmental files were hand searched. All controlled trials of homeopathy in patients with eczema were considered. Their methodological quality was estimated using the Jadad score.

RESULTS:

One randomized and two nonrandomized clinical trials met the inclusion criteria. All were methodologically weak. None demonstrated the efficacy of homeopathy.

CONCLUSIONS:

The evidence from controlled clinical trials therefore fails to show that homeopathy is an efficacious treatment for eczema.

EXAMPLE 2

Homoeopathy is often advocated for fibromyalgia (FM) and many FM patients use it. To critically evaluate all randomised clinical trials (RCTs) of homoeopathy as a treatment for FM, six electronic databases were searched to identify all relevant studies. Data extraction and the assessment of the methodological quality of all included studies were done by two independent reviewers. Four RCTs were found, including two feasibility studies. Three studies were placebo-controlled. None of the trials was without serious flaws. Invariably, their results suggested that homoeopathy was better than the control interventions in alleviating the symptoms of FM. Independent replications are missing. Even though all RCTs suggested results that favour homoeopathy, important caveats exist. Therefore, the effectiveness of homoeopathy as a symptomatic treatment for FM remains unproven.

EXAMPLE 3

OBJECTIVE:

To assess the evidence of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments.

METHODS:

Systematic literature searches were conducted through January 2006 in MEDLINE, EMBASE, AMED, CINAHL, Cochrane Central, British Homeopathic Library, ClinicalTrials.gov, and the UK National Research Register. Bibliographies were checked for further relevant publications. Studies were selected according to predefined inclusion and exclusion criteria. All double-blind, placebo-controlled randomized clinical trials of any homeopathic intervention for preventing or treating childhood and adolescence ailments were included. According to the classification of the World Health Organization, the age range defined for inclusion was 0 to 19 years. Study selection, data extraction, and assessment of methodological quality were performed independently by 2 reviewers.

RESULTS:

A total of 326 articles were identified, 91 of which were retrieved for detailed evaluation. Sixteen trials that assessed 9 different conditions were included in the study. With the exception of attention-deficit/hyperactivity disorder and acute childhood diarrhea (each tested in 3 trials), no condition was assessed in more than 2 double-blind randomized clinical trials. The evidence for attention-deficit/hyperactivity disorder and acute childhood diarrhea is mixed, showing both positive and negative results for their respective main outcome measures. For adenoid vegetation, asthma, and upper respiratory tract infection each, 2 trials are available that suggest no difference compared with placebo. For 4 conditions, only single trials are available.

CONCLUSION:

The evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.

EXAMPLE 4

Many cancer patients use homeopathic approaches to increase their body’s ability to fight cancer, improve their physical and emotional well-being, and alleviate their pain resulting from the disease or conventional treatments. Homeopathy is highly controversial as there is no plausible mode of action for these highly diluted remedies. The aim of this systematic review is to summarize and critically evaluate the efficacy of homeopathic remedies used as a sole or additional therapy in cancer care. We have searched the literature using the databases: Amed (from 1985); CINHAL (from 1982); EMBASE (from 1974); Medline (from 1951); and CAMbase (from 1998). Randomised and non-randomised controlled clinical trials including patients with cancer or past experience of cancer receiving single or combined homeopathic interventions were included. The methodological quality of the trials was assessed by Jadad score. Six studies met our inclusion criteria (five were randomised clinical trials and one was a non-randomised study); but the methodological quality was variable including some high standard studies. Our analysis of published literature on homeopathy found insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care.

I hasten to add that all of these analyses were funded by public (University) money and not by the industry.

I suspect that Hevert have overlooked all this evidence (no problem, we all can do mistakes!) and therefore, I offer herewith to help them correcting the omissions. In particular, I offer to give an instructive, evidence-based lecture to their staff followed by an in-depth discussion and correction of their website. As homeopathy is under pressure in Germany, I would not even insist on a fee. All I would ask is this: abandon all legal actions against critics of homeopathy; these legal actions are ill-advised and will turn out to be a mere waste of your dwindling profits.

The debate what might be the optimal treatment of back pain has been going on for many years. This new study provides important further insights.

The RCT assessed the comparative effectiveness of adding spinal manipulative therapy (SMT) or supervised rehabilitative exercise to home exercise in adults 65 or older suffering from sub-acute or chronic low back pain (LBP). Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyse outcomes. The primary analysis included longitudinal outcomes in the short (week 4–12) and long-term (week 4–52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration.

A total of 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favouring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favouring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone.

The authors concluded that adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care.

It is rare to find such a well designed, conducted and reported study in the realm of SCAM. Its results are clear and show that SMT offers no benefit over exercise in this LBP population. The better satisfaction rate with SMT is to be expected; it is probably due to the extra attention this option offers. The most recent systematic review addressing non-pharmacologic treatments for chronic LBP has found evidence of modest short-term improvements in function and/or pain for both exercise and SMT when compared to usual care, attention control, sham, or placebo, and no clear differences between exercise and SMT. In view of the facts that

  1. SMT might cause adverse effects,
  2. exercise is cheaper,
  3. exercise conveys benefits beyond back pain,

the new findings are a very clear verdict: exercise is preferable to SMT in the treatment of LBP.

Acupuncture is often promoted as a totally safe therapy. This may be good advertising but, as we have so often discussed on this blog, it is not true. A recent paper evaluated 17 systematic reviews on this subject. Four major categories of adverse effects (AEs) were identified:

  • organ or tissue injuries (13 reviews, median: 36 cases, median deaths: 4),
  • infections (11 reviews, median: 17 cases, median deaths: 0.5),
  • local AEs or reactions (12 reviews, median: 8.5 cases, no deaths were reported),
  • other complications such as dizziness or syncope (11 reviews, median: 21 cases, no deaths were reported).

The incidence of any AEs per patient was reported to be 42.4% with traditional acupuncture, 40.7% with minimal acupuncture and 16.7% with non-invasive sham acupuncture. But, as there is no AE-monitoring system, the frequency of serious AEs is essentially unknown, and more AEs are being reported regularly.

Here are two further case reports that are too recent to be included in any review.

Greek doctors reported a case of acupuncture-induced haemothorax in a 37-year-old healthy woman who had acupuncture treatments for neck and right upper thoracic non-specific musculoskeletal pain. Subsequently, she developed dyspnoea and chest discomfort. After some delay while trying other treatment, she was eventually transferred to the emergency department where a chest X-ray revealed a right pneumothorax and fluid collection. She was admitted to hospital and a chest tube inserted into the right hemithorax drained 800 mL of bloody fluid (haematocrit (Hct) 17.8%) in 24 h and 1200 mL over the following 3 days. Her blood Hct fell from 39.0% to 30.8% and haemoglobin from 12.7 to 10.3 g/dL. The patient recovered completely and was discharged after 9 days of hospitalisation.

Another case report told the story of a patient who had received the acupuncture treatment from a practitioner licensed in acupuncture, while on an international business trip. Following the acupuncture treatment, the practitioner realized that a needle had fractured and remained in the patient’s neck. After failing to retrieve the needle, the patient was sent for imaging. Radiograph revealed that the patient had two needle fragments located in his cervical tissue. After determining that the needles did not pose an immediate threat, the patient boarded a flight home to the United States. Following his flight, the patient presented to an American hospital where it was discovered that the needle fragments had migrated during the flight, with one needle now located 2 mm from the patient’s vertebral artery. Surgical intervention was required to retrieve the needles, resulting in the patient needing physical therapy to increase cervical range of motion and mediate pain relief. The authors concluded that clinicians utilizing single-use filiform needles in their practice, whether for acupuncture or dry needling, should be aware of the potential for this type of adverse event. Further, to minimize the risk of similar adverse events occurring in the future, clinicians should make sure that they are using high quality needles and make a habit of counting in and counting out the needles that they use to verify that all needles are accounted for.

I think this is sound advice for clinicians. To patients, I would furthermore recommend the following:

  • Ask yourself whether you really need acupuncture. Once you have done some research, you might find that, for your condition, there are more effective treatments.
  • If you want acupuncture nevertheless, consult a practitioner who is competent not just in the process of needling but in recognising AEs, diagnostics, contra-indications, etc. In my book, this is someone who has studied medicine, ie a doctor.
  • Ask the clinician of your choice to provide you with the full information relating to the following questions: How many treatments will you need? What will this cost? What are the chances of success? What other therapeutic options are there? What are the risks?
  • If the clinician cannot provide you with satisfactory answers, don’t let him/her treat you.

 

The ‘Freewinds is operated by International Shipping Partners and owned by San Donato Properties, which is a company affiliated with the CoS.

The luxury cruise ship Freewinds with about 300 passengers on board has been quarantined in port of St. Lucia after a crew member or passenger (the reports are contradictory) was diagnosed with measles. That news would not be funny – however, it gets positively hilarious when we learn that the ship is linked to the Church of Scientology (CoS) and currently packed with its members.

 

Scientology is legally recognized as a tax-exempt religion in the US and other countries. The CoS emphasizes the harmful effects of drugs, toxins and chemicals that, according to the CoS, lodge in the body and create a biochemical barrier to spiritual well-being. Many scientologists are anti-vaccination, and some prominent opponents of vaccinations, including Kirstie Alley and Jenna Elfman, are Scientologists.

The CoS’s also promotes the “Purification Rundown” (“Purif” for short) and the closely related Narconon detox programmes. They consist of regular exercise, sauna and nutrition, with industrial doses of vitamins and minerals added for good measure. Both programmes were developed by L Ron Hubbard (1911-1986). He taught his followers that, at their core, humans contain a “thetan”. After creating the universe, thetans accidentally became trapped in physical bodies and, through scientology, we can restore the immortal, omnipotent, god-like powers of the “thetan” within us.

The Freewinds plays an important spiritual role for Scientologists, according to the CoS. Passengers receive training in the CoS’s spiritual practice. The ship is staffed by members of the CoS’s Sea Organization. The Sea Organization is a religious order for the Scientology religion and is composed of the singularly most dedicated Scientologists individuals who have committed their lives to the volunteer service of their religion. The Sea Organization is a fraternal religious order and is not incorporated. Members of the Sea Organization are therefore wholly responsible to the Church of Scientology to which they are assigned and are responsible, as are all other staff, to officers and directors of that Church. 

To a member of the CoS, boarding the Freewinds for New OT VIII is the pinnacle of a deeply spiritual journey. Years of training and auditing have brought him to this ultimate point. It is the most significant spiritual accomplishment of his lifetime and brings with it the full realization of his immortality, the CoS’s website says.

The ship doctor has now vaccinated all previously non-vaccinated crew and passengers and is currently monitoring the situation.

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