MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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Dr Gabriella Day is a GP in England who describes herself and her beliefs as follows: “I began training in homeopathy as it is clear that for many conditions conventional treatment options are not effective and can have unwanted side effects. It seemed to me that there must be another way to help people suffering from symptoms such as these… I believe in whole person medicine. No illness exists in isolation. The human body is immensely sophisticated and complicated and we do not understand it fully. Therefore the illness cannot be separated from the person suffering the disease. This may be as simple as stress impairing the immune system to far more complex interactions. Homeopathic treatment seeks to match the underlying disturbance in the system and stimulate the body to correct itself.”

I do not know Dr Day, but she caught my attention recently when she published an article in THE HIPPOCRATIC POST (I had never heard of this publication before!). It is, I think, sufficiently noteworthy to show you some excerpts (the references [in square brackets] were added by me, and they refer to my comments below):

START OF QUOTES

…Homeopathy can be helpful for pretty much any condition [1], whether as the main treatment [1], as a complement to a conventional treatment [2] to speed up the healing process [1], or to lessen the side-effects of a pharmacological medication [1]. It can be helpful in the treatment of emotional problems [1], physical problems [1] and for multi-morbidity patients [1]. I find it an invaluable tool in my GP’s toolbox and regularly see the benefits of homeopathy in the patients I treat [3]…

There are many conditions for which I have found homeopathy to be effective [1]… There are, however, a multitude of symptomatic treatments available to suppress symptoms, both on prescription and over-the-counter. Most symptoms experienced by patients in this context result from the body’s attempt to eliminate the infection. Our immune systems have spent thousands of years refining this response; therefore it seems counter-intuitive to suppress it [4].
For these types of acute conditions homeopathy can work with the body to support it [1]. For instance, homeopathic Arsenicum album (arsenic) is a classic remedy for diarrhoea and vomiting that can be taken alongside essential oral rehydration [1]. And in influenza I’ve found Eupatorium perfoliatum (ague or feverwort) to be very helpful if the patient is suffering with bony pain [3].
…Unless it is clinically imperative for a pharmacological intervention, I will always consider homeopathy first [5] and have successfully prescribed the homeopathic remedy Nux vomica (strychnine) for women suffering from morning sickness [5]. Problems associated with breastfeeding such as mastitis have also responded well to the classic remedies Belladonna (deadly nightshade) and Phytolacca (pokeweed), while I have found Urtica urens (dog nettle) effective in switching off the milk supply to prevent engorgement when the mother stops breastfeeding [3].
…“heart sink” patients are clearly suffering from pain and discomfort, which is blighting their lives. This is understandably frustrating for them, for they know full well something is awry but there is no medical evidence for this… Homeopathy affords me another approach in trying to help these patients [1,3]. It doesn’t work for them all, but I’m frequently surprised at how many it does help [3].

Positive side-effects

The beauty of homeopathy is that it combines mental and emotional symptoms with physical symptoms [3]. When the right remedy is found it appears to stimulate the body to recognise how it is being dysfunctional and corrects this, with no suppression, just a correction of the underlying disturbance [3]. Thus homeopathy not only eliminates unwanted symptoms [1], it dramatically improves a patient’s overall well-being [1].
…homeopathy… enables me to reduce the number of painkillers and other drugs I’m prescribing [1,3]. This is particularly true for older multi-morbidity, polypharmacy patients [1] who are often taking huge amounts of medication.
Contrary to what most homeopaths will tell you, I believe homeopathic treatment does have side-effects – positive side-effects! [1] It fosters an enhanced doctor patient relationship [1]. The process of eliciting the relevant information to select a remedy enables me to better understand the patient’s condition and helps me to get to know them better [3]. And the patient, seeing that the doctor is interested in the idiosyncrasies and detail of their disease, finds themselves heard and understood [3]. In short, since training in homeopathy I enjoy my job as a GP and my relationship with patients so much more [3].
Dr Gabriella Day BSc, MBBS, MRCP, DCH, MRCGP, MFHom

END OF QUOTES

MY COMMENTS:

  1. statement without good evidence,
  2. Hahnemann was vehemently against combining homeopathy with other treatments and called clinicians who disregarded this ‘traitors’,
  3. statement of belief,
  4. wrong assumption,
  5. questionable ethics.

I have recently attempted to slip into the brain of lay-homeopaths and shown how illogical, misguided and wrong the arguments of such enthusiasts really are. Surely, the logic of a doctor homeopath must be better, I then thought. Once you have studied medicine, you have learnt an awful lot of things about the body, disease, therapy, etc., etc., I felt.

Judging from the above article, I might have been wrong.

The ‘Daily Mail’ is not a paper famed for its objective reporting. In politics, this can influence elections; in medicine, it can endanger public health.

A recent article is a case in point, I think.

START OF QUOTE

Traditional Chinese medicines could help prevent heart disease and the progression of pre-diabetes, according to research. Some herbal treatments proved as effective in lowering blood pressure as Western drugs and improved heart health by lowering cholesterol, scientists found. Certain alternative medicines could lower blood sugar and insulin levels, too.

Chinese medicines could be used alongside conventional treatments, say researchers from Shandong University Qilu Hospital in China. Or they can be beneficial as an alternative for patients intolerant of Western drugs, they said in their review of medical studies over a ten-year period. Senior review author from the university’s department of traditional Chinese medicine said: ‘The pharmacological effects and the underlying mechanisms of some active ingredients of traditional Chinese medications have been elucidated. Thus, some medications might be used as a complementary and alternative approach for primary and secondary prevention of cardiovascular disease.”

It’s potentially good news for people living with diabetes, which is now a global epidemic and has proved a tricky condition to manage for many people. High blood pressure is very common too, affecting more than one in four adults in the UK,  although many won’t show symptoms and realise it. If untreated, it increases your risk of serious problems including heart disease, the number one killer globally.

The Chinese have used herbs for treating diseases for thousands of years and have become increasingly popular in Europe and North America, mainly as complement to Western medicine. But the researchers also warn that much of the research conducted have limitations and so their long-term effects are not proven.

Key findings  

Herbs for high blood pressure

The blood pressure-lowering effect of herb zhongfujiangya was found to be similar to that of oral anti-hypertension medication benazeprilm, which goes by the brand name Lotensin. Similarly, patients treated for eight weeks with herbal tiankuijiangya had a lower reading than those given a placebo. Herbal Jiangya tablets were found to ‘significantly lower’ systolic blood pressure, that is the amount of pressure in your arteries during contraction of your heart muscle compared to a fake treatment. The herb Jiangyabao also had a significant effect compared to a placebo, but just at night. But overall, compared to the drug Nimodipine, a calcium channel blocker, it worked just as well. Qiqilian capsules also proved more effective compared to a placebo.

Herbs for diabetes

The team report some Chinese medicines medications – such as xiaoke, tangminling, jinlida, and jianyutangkang – have a ‘potent’ effect on lowering blood sugar levels and b-cell function, which controls the release of insulin. Some remedies – such as tangzhiping and tianqi – might prevent the progression of pre-diabetes to diabetes, they note.

Herbs for cholesterol 

The researchers looked at research on dyslipidemia, the term for unbalanced or unhealthy cholesterol levels. They found that jiangzhitongluo, salviamiltiorrhiza and pueraria lobata, and zhibitai capsule all have a ‘potent lipid-lowing effect’.

Herbs for heart disease

Some traditional Chinese medicines such as qiliqiangxin, nuanxin, shencaotongmai, and yangxinkang, might be effective in improving function in patients with chronic heart failure, they wrote.

Limitations with trials

But Western scientists often reject Chinese medicine for specific reasons, warned Dr Zhao’s team. Chinese medicines are frowned upon because they do not go through the same exhaustive approval process as trials conducted domestically, they pointed out. Plus, one treatment can be made of many different ingredients with various chemical compounds, making it hard to pinpoint how their benefits work. ‘One should bear in mind that traditional Chinese medicine medications are usually prescribed as complex formulae, which are often further manipulated by the practitioner on a personalized basis,’ said Dr Zhao.

END OF QUOTE

Apart from the fact that this article is badly written, it is also misleading to the point of being outright dangerous. Regular readers of my blog will be aware that Chinese research is everything but reliable; there are practically no Chinese TCM-trials that report negative results. Furthermore, the safety of Chinese herbal preparations is as good as unknown and they are often contaminated with toxic substances as well as adulterated with synthetic drugs. Most of these preparations are also unavailable outside China. Moreover, Chinese herbal treatments are usually individualised (mixtures are tailor-made for each individual patient), and there is no good evidence that this approach is effective. Crucially, the trial evidence is often of such poor quality that it would be a dangerous mistake to trust these findings.

None of these important caveats, it seems, are important enough to get a mention in the Daily Mail.

Don’t let the truth get in the way of a sensational story!

Let’s just for a moment imagine what would happen if people took the Mail article seriously (is there anyone out there who does take the Mail seriously?). In a best case scenario, they would take Chinese herbs in addition to their prescribed medication. This might case plenty of unwanted side-effects and herb-drug interactions. In addition, people would lose a lot of their hard-earned cash. In a worst case scenario, they would abandon their prescribed medication for dubious Chinese herbal mixtures. This could cause thousands of premature deaths.

With just a little research, I managed to find the original article on which the Mail’s report was based. Here is its abstract:

Traditional Chinese medicine (TCM) has more than 2,000 years of history and has gained widespread clinical applications. However, the explicit role of TCM in preventing and treating cardiovascular disease remains unclear due to a lack of sound scientific evidence. Currently available randomized controlled trials on TCM are flawed, with small sample sizes and diverse outcomes, making it difficult to draw definite conclusions about the actual benefits and harms of TCM. Here, we systematically assessed the efficacy and safety of TCM for cardiovascular disease, as well as the pharmacological effects of active TCM ingredients on the cardiovascular system and potential mechanisms. Results indicate that TCM might be used as a complementary and alternative approach to the primary and secondary prevention of cardiovascular disease. However, further rigorously designed randomized controlled trials are warranted to assess the effect of TCM on long-term hard endpoints in patients with cardiovascular disease.

In my view, the authors of this review are grossly over-optimistic in their conclusions (but nowhere near as bad as the Mail journalist). If the trials are of poor quality, as the review-authors admit, no firm conclusions should be permissible about the usefulness of the therapies in question.

As the Mail article is obviously based on a press release (several other papers worldwide reported about the review as well), it seems interesting to note what the editor of the Journal of the American College of Cardiology (the journal that published the review) recently had to say about the responsibility of journalists and researchers:

START OF QUOTE

…I would like to suggest that journalists and researchers must share equally in shouldering the burden of responsibility to improve appropriate communication about basic and clinical research.

First, there is an obligation on the part of the researchers not to inflate the importance of their findings. This has been widely recognized as damaging, especially if bias is introduced in the paper…

Second, researchers should take some responsibility for the creation of the press release about their research, which is written by the media or press relations department at their hospital or society. Press releases are often how members of the media get introduced to a particular study, and these releases can often introduce errors or exaggerations. In fact, British researchers evaluated 462 press releases on biomedical and health-related science issued by 20 leading U.K. universities in 2011, alongside their associated peer-reviewed research papers and the news stories that followed (n = 668). They found that 40% of the press releases contained exaggerated advice, 33% contained exaggerated causal claims, and 36% contained exaggerated inference to humans from animal research. When press releases contained such exaggeration, 58%, 81%, and 86% of news stories, respectively, contained further exaggeration, compared with rates of 17%, 18%, and 10% in the news when the press releases were not exaggerated. Researchers should not be excused from being part of the press release process, as the author(s) should at least review the release before it gets disseminated to the media. I would even encourage researchers to engage in the process at the writing stage and to not allow their hospital’s or society’s public relations department to extrapolate their study’s results. Ultimately, the authors and the journals in which the studies are published will be held accountable for the information that trickles into the headlines, not the public relations departments, so we must make sure that the information is accurate and representative of the study’s actual findings.

END OF QUOTE

Sound advice indeed.

Now we only need to ALL follow it!!!

According to Wikipedia, “the Bundesverband der Pharmazeutischen Industrie (BPI) with headquarters in Berlin is an Eingetragener Verein and the German industry association/trade group for the pharmaceutical industry. It represents 240 German pharmaceutical and Biotech companies in with altogether approximately 70,000 employees. BPI has an office in Brussels. The focus of the BPI is on political consulting and public relations on the EU-level.” 

The BPI has recently published a remarkable press-release about homeopathy. As it is in German, I will translate it for you (and append the original text for those who can read German).

HERE WE GO:

Homeopathy is a recognised and proven therapy for patients in Germany [1]. This is demonstrated by a new, BPI-sponsored survey [2]. About half of all questioned had experience with homeopathic remedies [3]. More than 70% of those people are satisfied or very satisfied with their effectiveness and safety [4].

“Homeopathic remedies are important for many patients in Germany”[3], says Dr. Norbert Gerbsch, deputy chair of the BPI. ” If therapists and patients use them correctly, they can support the therapeutic success [5]. Therefore, they should be recognised by conventional medicine as an integrative medicine [5] – that is what patients in Germany clearly want [6].”

Two thirds of the people surveyed think it is important or very important, that therapies like anthroposophical medicine and homeopathy are supported politically next to conventional medicine [7]. More than 70% find it personally important or very important that health insurances pay for selected anthroposophical and homeopathic services [8]. More than 80% said they would favour this. Thus, the majority is for keeping homeopathy amongst the services that can be chosen by the insurances for reimbursement [8].

Dr. Norbert Gerbsch: “The survey proves that very many individuals integrate, use and treasure homeopathy as an additional and usually safe therapy [3]. Those who aim at curtailing therapeutic freedom patronise numerous patients in Germany who can benefit from it [9]. There are numerous diseases for which homeopathy can be used as an integrative therapeutic option [10]. Thus, many conventional physicians employ homeopathic and anthroposophic remedies in parallel to guideline-orientated medicine [3, 11].”

(Homöopathie ist eine anerkannte und bewährte Therapieform für Patienten in Deutschland. Das belegt eine neue, vom BPI beauftragte Forsa-Umfrage. Rund die Hälfte der Befragten hat demnach bereits Erfahrung mit homöopathischen Arzneimitteln. Über 70 Prozent von ihnen sind zufrieden oder sehr zufrieden mit der Wirksamkeit und Verträglichkeit.

„Homöopathische Arzneimittel haben für viele Patienten in Deutschland einen hohen Stellenwert“, sagt Dr. Norbert Gerbsch, stellvertretender BPI-Hauptgeschäftsführer. „Wenn Behandler und Patienten sie richtig und verantwortungsvoll einsetzen, kann sie den Therapieerfolg unterstützen. Sie sollte insofern als wichtige Ergänzung der Schulmedizin im Sinne einer Integrativen Medizin anerkannt werden – das wünschen sich die Patienten in Deutschland eindeutig.“

Fast zwei Drittel der von Forsa Befragten finden es wichtig bis sehr wichtig, dass sich die Politik neben schulmedizinischen Behandlungsmethoden auch aktiv für Heilmethoden wie etwa Homöopathie oder Anthroposophische Medizin einsetzt. Über 70 Prozent finden es persönlich wichtig bis sehr wichtig, dass Krankenkassen ihren Versicherten auch die Kosten für ausgewählte Leistungen aus dem Bereich der homöopathischen Medizin erstatten. Mit über 80 Prozent überdurchschnittlich häufig plädieren Befragte mit Homöopathie-Erfahrung für die Kostenübernahme ausgewählter Leistungen durch die Krankenkassen. Damit stimmt die Mehrheit für den Erhalt der Homöopathie im Rahmen von sogenannten Satzungsleistungen, die von den Krankenkassen individuell festgelegt werden können.

Dr. Norbert Gerbsch: „Die Umfrage belegt, dass sehr viele Menschen Homöopathie als ergänzende und in der Regel nebenwirkungsarme Therapieoption in die Behandlung integrieren, sie nutzen und achten. Wer die Therapiefreiheit und -vielfalt beschneiden will, bevormundet zahlreiche Patienten in Deutschland, die davon profitieren können. Es gibt eine Vielzahl an Erkrankungen, bei denen homöopathische Arzneimittel als integraler Bestandteil von Therapien einsetzbar sind. So nutzen viele Schulmediziner neben dem gesamten Spektrum der leitlinienorientierten Medizin gleichzeitig die integrativen Angebote der Homöopathie und Anthroposophischen Medizin.“)

I DO APPOLOGISE FOR MY POOR TRANSLATION; I HAVE ALWAYS FOUND THAT IT IS VERY HARD TO TRANSLATE SOMETHING THAT SIMPLY DOES NOT MAKE SENSE!

I have rarely seen such an unscientific, irrational, nonsensical and promotional comment from an organisation and an individual that should know better. Mr. Gerbsch studied biotechnology and graduated in 1997 in bioprocess engineering. He headed a scientific team following his promotion to director of a trans-departmental research topic with 13 professorships at the Technical University of Berlin. He later took on responsibilities as commissioner, officer and director of various companies. Since 2006, Mr. Gerbsch works as department manager of biotechnology / research & development at BPI and is responsible for the biotechnology department and innovation & research committee.

Here are just a few short points of criticism referring to the numbers I have added in my translation:

  1. Homeopathy is recognised and proven to be a pure placebo-therapy.
  2. A survey of this nature can at best gauge the current opinion.
  3. Fallacy: appeal to popularity.
  4. Perceived effectiveness/safety is not the same as true effectiveness/safety.
  5. There is no good evidence for this statement.
  6. What patients want might be interesting, but it cannot determine what they need; medicine is not a supermarket!
  7. I suspect this is the result of a leading question.
  8. This is where the BPI discloses the aim of the survey and their comment about it: they want the German health insurances to continue paying for homeopathic and anthroposophical placebos because some of their member companies earn their money selling them. In other words, the BPI actively hinder progress.
  9. No, those who advocate not paying for placebos want to encourage progress in healthcare for the benefit of patients and society.
  10. “Can be used” is an interesting phraseology! It is true, one can use homeopathy – but one cannot use it effectively because it has no effect beyond placebo.
  11. Yes, many physicians are sadly more focussed on their own cash-flow than on the best interest of their patients. Not all that different from the BPI, it seems.

It is beyond me how an organisation like the BPI can produce such shamefully misleading, dangerous and unethical drivel. Not one word about the fact that all international bodies have condemned homeopathy as being a useless and dangerous placebo-therapy! Who ever thought that the BPI was an independent organisation (homeopathy manufacturers belong to its membership) has been proven wrong by the above press-release.

The BPI clearly needs reminding of their duty to inform the public responsibly. I recommend that the leading heads of this organisation urgently attend one course on critical thinking followed by another on medical ethics.

Since more than 20 years, I have been writing about the risks of alternative therapies. One of my first papers on this issue was published in 1995 and focussed on acupuncture. Here is its abstract:

The use of acupuncture is widespread. The procedure is often claimed to be totally, or at least reasonably, safe. The published evidence regarding its potential risks is reviewed. The repeated and/or inappropriate use of an acupuncture needle carries the risk of infections. Amongst others, AIDS and hepatitis have been transmitted. Acupuncture needles may also traumatise tissues and organs. Pneumothorax is the most frequent complication caused in this way. Finally, needles may break and fragments can be dislodged into distant organs. A serious and more general concern related to the safety of acupuncture is the competence of the therapist, whether or not medically qualified. The “philosophy” of acupuncture is not in line with orthodox diagnostic skills; therefore acupuncturists can be dangerously unconcerned with diagnostic categories. Thus indirect risks might add significantly to the direct risks of acupuncture. It is concluded that the true risk of acupuncture cannot be estimated. Whatever its extent, it could and probably should be lowered by enforcing educational and clinical standards.

My reason for banging on about the potential harms (direct and indirect risks) of alternative medicine is fairly obvious: I want to alert healthcare professionals and consumers to the fact that these treatments may not be as harmless as they are usually advertised to be. Yet, I have often be called an alarmist fear-monger. In my view, nothing could be further from the truth.

Thinking about fear-mongering, I began to ask myself whether those who regularly accuse me are the ones guilty of the deed. Are alternative practitioners fear-mongers? Surely not all of them, but some clearly are. Here are a few of the strategies they use for their fear-mongering.

NON-EXISTING DIAGNOSES

Perhaps the most obvious way to instil fear into people is to tell them that they are affected by a disease or condition they do not have. Many alternative practitioners do exactly that!

  • A chiropractor might tell you that you have a subluxation in your spine.
  • A naturopath would inform you that your body is full of toxins.
  • An acupuncturist will tell you that your life energy is blocked.
  • A homeopath might warn you that your vital force is too low.

These diagnoses have one thing in common: they do not exist. They are figments of the therapist’s imagination. And they have another thing in common: the abnormalities need to be corrected, and – surprise, surprise – the very therapy that the practitioner specialises in happens to be just the ticket for that purpose.

  • The chiropractor will tell you that a simple spinal adjustment will solve the problem.
  • The naturopath will inform you that a bit of detox will eliminate the toxins.
  • The acupuncturist will tell you that his needles will de-block your chi.
  • The homeopath will persuade you that he can find the exact remedy to revive your vital force.

And there we have the third thing these diagnoses have in common: they are all treatable, will all result in a nice bill, and will all improve the cash-flow of the therapist.

MEDICALIZING TRIVIALITIES

But often, it is not even necessary for an alternative therapist to completely invent a diagnosis. Patients usually consult an alternative practitioner with some sort of symptom – frequently with what one might call a medical triviality that does not need any treatment at all but can be dealt with differently, for instance, by issuing some life-style advice or just simple re-assurance that nothing major is amiss. But for the fear-monger, this is not enough. He feels the need to administer his therapy, and for that purpose he needs to medicalize trivialities :

  • A low mood thus becomes a clinical depression.
  • A sore back is turned into a nasty lumbago.
  • A tummy upset morphs into a dangerous gastritis.
  • Abdominal unrest is diagnosed to be a leaky gut syndrome.
  • A food aversion turns into a food intolerance, etc., etc.

The common denominator is again the fact that fear is instilled into the patient. And again, a useless therapy is administered, if at all possible in the form of a lengthy series of treatments. This, of course, generates significant benefit – not therapeutic, but financial!

DEMONIZING CONVENTIONAL MEDICINE

But there is always the risk that the patient is wiser than expected. She might be so scared learning of her condition that she decides to see her doctor. That would mean a loss of income which has to be avoided! The trick to achieve this is usually not difficult: conventional healthcare professionals must be demonized.

  • They are not treating the root cause of the problem.
  • They are in the pocket of BIG PHARMA.
  • They prescribe medicines with terrible side-effects.
  • They have no idea about holism.
  • They never have enough time to listen, etc., etc.

I know, some of these criticisms are not entirely incorrect (for instance, many conventional medicines do have serious side-effects but, as I try to point out ad nauseam, we need to consider their risk/benefit balance). But that is hardly the point here; the point is to scare the patient off conventional medicine. Only a person who is convinced that the ‘medical mafia’ is out to get her, will prove to be a loyal customer of all things alternative.

DISEASE PREVENTION

And a loyal customer is someone who comes not just once or twice but regularly, ideally from cradle to grave. The way to achieve this ultimate stimulus of the practitioners cash flow is to convince the patient that she needs regular treatments, even when she feels perfectly alright. The magic word here is PREVENTION! The masters here are the chiropractors, I guess; they promote what they call ‘maintenance care’, i.e. the regular treatment of healthy individuals to keep their spines subluxation-free. It goes without saying that maintenance care is a money-making scam.

The strategy requires two little lies, but that’s forgivable considering the good cause, boosting the income of the practitioner:

  1. Conventional doctors don’t do prevention.
  2. The alternative treatment is an effective preventative.

The first statement can be shown to be an obvious lie. All we know about effective disease prevention today comes from conventional medicine and science; nothing originates from the realm of alternative medicine. Remarkably, the most efficacious preventative measure of all times, immunisation, is frequently defamed and neglected by alternative practitioners.

The second statement is a necessary lie; how else would a patient agree to pay regularly for the practitioner’s services? I am not aware of any alternative therapy that can effectively prevent any disease.

CONCLUSIONS

  • Some alternative practitioners regularly instil fear into consumers.
  • Several strategies are being used for this purpose.
  • They have the aim of maximising the therapists’ income.
  • Fear-mongering is unethical and despicable.
  • Pointing out that a certain therapy might fail to generate more good than harm is not fear-mongering.

In 2006, the World Health Organization and UNICEF created the ‘Global Immunization Vision and Strategy’, a 10-year strategy with 4 main goals:

  1. to immunize more people against more diseases,
  2. to introduce a range of newly available vaccines and technologies,
  3. to integrate other critical health interventions with immunization,
  4. to manage vaccination programmes within the context of global interdependence.

More than a decade later, we have to realise that this vision has been frustrated, not least by fans of alternative medicine (FAMs). They are almost by definition more negative about the value and achievements of conventional medicine and science. This shows in all sorts of ways; the clearest this phenomenon is documented must be the FAMs’ attitude towards immunisations. Few rational thinkers would doubt that vaccinations are amongst the most important achievement in the history of medicine.

Vaccination is a miracle of modern medicine. In the past 50 years, it’s saved more lives worldwide than any other medical product or procedure.”

Yet FAMs are not impressed by such statements and often refuse to have their kids vaccinated according to the recommended schedule. This trend has significantly contributed to vaccination rates that, in some parts of the world, are now dropping so low that our ‘herd immunity’ is jeopardised.

One such place is Germany, and the German government is now making a controversial move against parents who choose to refrain from vaccinating their children. Germany is presently passing a law that will force kindergartens to inform the authorities, if parents don’t provide evidence that they have gotten advice from their doctor on vaccinations for their children.

The NHMRC report on homeopathy is the most thorough, independent and reliable investigation into the value of homeopathy ever. As its conclusions are devastatingly negative about the value of homeopathy, it is hardly surprising that homeopaths tried everything and anything to undermine it. This new article gives what I believe to be a fair account of the allegations and their validity:

START OF QUOTE

Since the NHMRC declared homeopathy to be ineffective in treating any health condition, a number of disputes have been made by major organisations in favour of homeopathy. Australia’s two peak industry organisations, Complementary Medicines Australia (CMA) and the AHA, both argue in their letters to the NHRMC that the position was prejudiced based on a draft position statement leaked in 2012 stating it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy (as a medicine or procedure) has been shown not to be efficacious [19,20]. Furthermore, both the CMA and AHA highlight serious concerns regarding the prelude to and instigation of the work of the NHMRC’s HWC as well as the conduct of the review itself to finalise their conclusion on the use of homeopathy. Several grave issues were raised in both letters with five common key flaws cited: (1) no explanation was provided as to why level 1 evidence including randomised control trials were excluded from the review; (2) the database search used was not broad enough to capture complementary medicine and homeopathic specific content, and excluded non-human and non-English studies; (3) no homeopathic expert was appointed in the NHMRC Review Panel; (4) prior to publication, the concerns raised over the methodology and selective use of data by research contractor(s) engaged for the HWC review were abandoned for unknown reasons; and (5) no justification was provided as to why only systematic reviews were used [19,20]. Other serious accusations made by the AHA in their response letter to the NHMRC involved the blatant bias of the NHMRC evident by: the leakage of their draft position statement in April 2011 and early release of the HWC Draft Review regarding homeopathy to the media; no discussion of prophylactic homeopathy i.e. preventative healthcare; and no reference to the cost-effectiveness, safety, and quality of homeopathic medicines [19].

Despite the NHMRC findings being strongly disputed, they are further supported by positions taken by a number of large and respected organisations. For example, in 2009, the World Health Organization (WHO) advised against the use of homeopathic medicines for various serious diseases following significant concerns being raised by major health authorities, pharmaceutical industries, and consumers regarding its safety and quality [21]. They reported the clinical effects were compatible with placebo effects [21]. Similarly, in Australia, the Australian Medical Association (AMA) further supports the NHMRC findings by stating in their position statement released in 2012 that there is limited efficacy evidence regarding most complementary medicines, thereby posing a risk to patient health [22]. More recently, in May 2015, the Royal College of General Practitioners (RACGPs) strongly advocated in their position statement against general practitioners prescribing homeopathic medicines, and pharmacists against supporting or recommending it, given the lack of evidence regarding its efficacy [23]. This is particularly pertinent to conventional vaccines given the recent case between the Australian Competition and Consumer Commission (ACCC) vs. Homeopathy Plus! Australia Pty Ltd. The Federal Court found Homeopathy Plus! Australia Pty Ltd guilty of contravening the Australian Consumer Law by engaging in misleading and deceptive conduct through claiming that homeopathic remedies were a proven, safe, and effective alternative to the conventional vaccine against whooping cough [24].

The positions of the NHMRC, WHO, AMA, and the RACGPs regarding homeopathy is further supported by Cochrane reviews, which provide high-quality evidence with minimal bias [25]. Of the twelve homeopathy Cochrane reviews available in the database, only seven address homeopathic remedies directly and were related to the following conditions: irritable bowel syndrome [26], attention deficit/hyperactivity disorder or hyperkinetic disorder [27], chronic asthma [28], dementia [29], induction of labour [30], cancer [31], and influenza [32]. Given most of these reviews were authored by homeopaths, bias against homeopathy is unlikely [26-32]. The overarching conclusions from these reviews fail to reveal compelling evidence regarding the efficacy of homeopathic remedies [26-32]. For example, Mathie, Frye and Fisher show that there is “no significant difference between the effects of homeopathic Oscillococcinum® and placebo in prevention of influenza-like illness: risk ratio (RR) = 0.48, 95% confidence interval (CI) 0.17-1.34, p-value = 0.16 [31]. The key reasons given for this failure to provide compelling evidence relate to low quality or unclear data, and lack of replicability, suggesting homeopathic remedies are unlikely to have clinical effects beyond placebo [26-32].

Sadly, the ACCC vs. Homeopathy Plus! Australia Pty Ltd is not the only case that has made headlines in Australia in recent years. An article in the Journal of Law and Medicine coincided with the NHMRC report regarding the number of deaths attributable to favouring homeopathy over conventional medical treatment in recent years [33]. One such case was that of Jessica Ainscough, who passed away earlier this year after losing her battle with a rare form of cancer “epithelioid sarcoma“ after rejecting conventional treatment in favour of alternative therapies [34]. Although doctors recognise Ms. Ainscough’s right to choose her own cancer treatments and understand why she refused the disfiguring surgery to save her life, they fear her message may influence others to reject conventional treatments that could ultimately save their lives [35]. Another near death case was that of an eight-month-old boy whose mother was charged with “reckless grievous bodily harm and failure to provide for a child causing danger to death” after ceasing conventional medical and dermatological treatment for her son’s eczema as advised by her naturopath (an umbrella term that includes homeopathy) [36]. The all-liquid treatment plan left the boy severely malnourished and consequently, he now suffers from developmental issues [37]. This case is rather similar to that of R vs. Sam in 2009, where the parents of a nine-month-old girl were convicted of manslaughter by criminal negligence after favouring homeopathic treatment over conventional medical treatment for their daughter’s eczema. The girl died from septicaemia after her eczema became infected [36,37].

[references are provided in the original document]

END OF QUOTE

The NHMRC report stated that

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. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

Few other reports have previously expressed our concerns about homeopathy so clearly – little wonder then that the world of homeopathy was (and still is) up in arms.

The last time something similar happened was during the Third Reich when homeopathy had been evaluated thoroughly by leading scientists and the conclusions turned out to be just as devastatingly negative. At the time, German homeopaths allegedly made the report disappear, and all we have today about this comprehensive research programme is a very detailed eye witness report of a homeopath who had been intimately involved in the research.

Today, it is thankfully no longer possible to make major research documents disappear. So, homeopaths have to think of other strategies to defend their trade. In the case of the NHMRC report, they act like all cults tend to do and resort to misleading statements and slanderous allegations. This, I feel, is unsurprising and will inevitably turn out to be unsuccessful.

The fact that some alternative medicine (the authors use the abbreviation ‘CAM’) practitioners recommend against vaccination is well-known and often-documented. Specifically implicated are:

As a result, children consulting homeopaths, naturopaths or chiropractors are less likely to receive vaccines and more likely to get vaccine-preventable diseases. These effects have been noted for several childhood infections but little is known about how child CAM-usage affects influenza vaccination.

A new nationally representative study fills this gap; it analysed ∼9000 children from the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey. Adjusting for health services use factors, it examined influenza vaccination odds by ever using major CAM domains: (1) alternative medical systems (AMS; eg, acupuncture); (2) biologically-based therapies, excluding multivitamins/multi-minerals (eg, herbal supplements); (3) multi-vitamins/multi-minerals; (4) manipulative and body-based therapies (MBBT; eg, chiropractic manipulation); and (5) mind-body therapies (eg, yoga).

Influenza vaccination uptake was lower among children ever (versus never) using AMS (33% vs 43%; P = .008) or MBBT (35% vs 43%; P = .002) but higher by using multivitamins/multiminerals (45% vs 39%; P < .001). In multivariate analyses, multivitamin/multimineral use lost significance, but children ever (versus never) using any AMS or MBBT had lower uptake (respective odds ratios: 0.61 [95% confidence interval: 0.44-0.85]; and 0.74 [0.58-0.94]).

The authors concluded that children who have ever used certain CAM domains that may require contact with vaccine-hesitant CAM practitioners are vulnerable to lower annual uptake of influenza vaccination. Opportunity exists for US public health, policy, and medical professionals to improve child health by better engaging parents of children using particular domains of CAM and CAM practitioners advising them.

There is hardly any need to point out that CAM-use is associated with low vaccination-uptake. We have discussed this on my blog ad nauseam – see for instance here, here, here and here. Too many CAM practitioners have an irrational view of vaccinations and advise against their patients against them. Anyone who needs more information might find it right here by searching this blog. Anyone claiming that this is all my exaggeration might look at these papers, for instance, which have nothing to do with me (there are plenty more for those who are willing to conduct a Medline search):

  • Lehrke P, Nuebling M, Hofmann F, Stoessel U. Attitudes of homeopathic physicians towards vaccination. Vaccine. 2001;19:4859–4864. doi: 10.1016/S0264-410X(01)00180-3. [PubMed]
  • Halper J, Berger LR. Naturopaths and childhood immunizations: Heterodoxy among the unorthodox. Pediatrics. 1981;68:407–410. [PubMed]
  • Colley F, Haas M. Attitudes on immunization: A survey of American chiropractors. Journal of Manipulative and Physiological Therapeutics. 1994;17:584–590. [PubMed]

One could, of course, argue about the value of influenza vaccination for kids, but the more important point is that CAM practitioners tend to be against ANY immunisation. And the even bigger point is that many of them issue advice that is against conventional treatments of proven efficacy.

In a previous post I asked the question ‘Alternative medicine for kids: when is it child-abuse?’ I think that evidence like the one reported here renders this question all the more acute.

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

The website of BMJ Clinical Evidence seems to be popular with fans of alternative medicine (FAMs). That sounds like good news: it’s an excellent source, and one can learn a lot about EBM when studying it. But there is a problem: FAMs don’t seem to really study it (alternatively they do not have the power of comprehension to understand the data); they merely pounce on this figure and cite it endlessly:

They interpret it to mean that only 11% of what conventional clinicians do is based on sound evidence. This is water on their mills, because now they feel able to claim:

THE MAJORITY OF WHAT CONVENTIONAL CLINICIANS DO IS NOT EVIDENCE-BASED. SO, WHY DO SO-CALLED RATIONAL THINKERS EXPECT ALTERNATIVE THERAPIES TO BE EVIDENCE-BASED? IF WE NEEDED PROOF THAT THEY ARE HYPOCRITES, HERE IT IS!!!

The question is: are these FAMs correct?

The answer is: no!

They are merely using a logical fallacy (tu quoque); what is worse, they use it based on misunderstanding the actual data summarised in the above figure.

Let’s look at this in a little more detail.

The first thing we need to understand the methodologies used by ‘Clinical Evidence’ and what the different categories in the graph mean. Here is the explanation:


So, arguably the top three categories amounting to 42% signify some evidential support (if we decided to be more rigorous and merely included the two top categories, we would still arrive at 35%). This is not great, but we must remember two things here:

  • EBM is fairly new;
  • lots of people are working hard to improve the evidence base of medicine so that, in future, these figures will be better (by contrast, in alternative medicine, no similar progress is noticeable).

The second thing that strikes me is that, in alternative medicine, these figures would surely be much, much worse. I am not aware of reliable estimates, but I guess that the percentages might be one dimension smaller.

The third thing to mention is that the figures do not cover the entire spectrum of treatments available today but are based on ~ 3000 selected therapies. It is unclear how they were chosen, presumably the choice is pragmatic and based on the information available. If an up-to date systematic review has been published and provided the necessary information, the therapy was included. This means that the figures include not just mainstream but also plenty of alternative treatments (to the best of my knowledge ‘Clinical Evidence’ makes no distinction between the two). It is thus nonsensical to claim that the data highlight the weakness of the evidence in conventional medicine. It is even possible that the figures would be better, if alternative treatments had been excluded (I estimate that around 2 000 systematic reviews of alternative therapies have been published [I am the author of ~400 of them!]).

The fourth and possibly the most important thing to mention is that the percentage figures in the graph are certainly NOT a reflection of what percentage of treatments used in routine care are based on good evidence. In conventional practice, clinicians would, of course, select where possible those treatments with the best evidence base, while leaving the less well documented ones aside. In other words, they will use the ones in the two top categories much more frequently than those from the other categories.

At this stage, I hear some FAMs say: how does he know that?

Because several studies have been published that investigated this issue in some detail. They have monitored what percentage of interventions used by conventional clinicians in their daily practice are based on good evidence. In 2004, I reviewed these studies; here is the crucial passage from my paper:

“The most conclusive answer comes from a UK survey by Gill et al who retrospectively reviewed 122 consecutive general practice consultations. They found that 81% of the prescribed treatments were based on evidence and 30% were based on randomised controlled trials (RCTs). A similar study conducted in a UK university hospital outpatient department of general medicine arrived at comparable figures; 82% of the interventions were based on evidence, 53% on RCTs. Other relevant data originate from abroad. In Sweden, 84% of internal medicine interventions were based on evidence and 50% on RCTs. In Spain these percentages were 55 and 38%, respectively. Imrie and Ramey pooled a total of 15 studies across all medical disciplines, and found that, on average, 76% of medical treatments are supported by some form of compelling evidence — the lowest was that mentioned above (55%),6 and the highest (97%) was achieved in anaesthesia in Britain. Collectively these data suggest that, in terms of evidence-base, general practice is much better than its reputation.”

My conclusions from all this:

FAMs should study the BMJ Clinical Evidence more thoroughly. If they did, they might comprehend that the claims they tend to make about the data shown there are, in fact, bogus. In addition, they might even learn a thing or two about EBM which might eventually improve the quality of the debate.

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

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