Edzard Ernst

MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Dana Ullman is an indefatigable promotor of bogus claims and an unwitting contributor of hilarity. Therefore he has become a regular feature of this blog (see for instance here, here and here). His latest laughable assertion is that lead and other poisonings can be successfully treated with homeopathy.

Just to make sure: lead poisoning is no joke. The greatest risk is to brain development in babies, where irreversible damage can occur. Higher levels can damage the kidneys and nervous system in both children and adults. Very high lead levels may cause seizures, unconsciousness and death.

In view of this, Ullman’s claim is surprising, to say the least. In order to persuade the unsuspecting public of his notion, Ullman first cites a review of basic research on homeopathy and toxins published in Human and Experimental Toxicology. “Of forty high-quality studies, 27 showed positive results from homeopathic treatment”, Ullman states.

Now, now, now Dana!

Has your mom not taught you that telling porkies is forbidden?

Or did you perhaps miss this line in the article’s abstract? “The quality of evidence in these studies was low with only 43% achieving one half of the maximum possible quality score and only 31% reported in a fashion that permitted re-evaluation of the data. Very few studies were independently replicated using comparable models.”

Hardly ‘high quality studies’, wouldn’t you agree?

But this review was of pre-clinical studies; what about the much more important clinical evidence?

Here Ullman cites one trial where a potentized homeopathic remedy, Arsenicum Album 30C, was administered to  55 people who were entered into a double-blind, placebo-controlled trial. According to Ullman, the homeopathically treated group “experienced higher excretion of arsenic in their urine for the first eleven days, compared to those given a placebo.”

Na, na, na, Dana, this is getting serious!!!

Another porky – and not even a little one.

The authors of this study clearly stated that, at the end of the 11-day RCT, there was no significant difference between the homeopathy and the placebo group: “The differences in the concentration between the two groups (drug versus placebo) were generally a little higher during the first week, but subsequently the differences were not so palpable, particularly at the 11th day.” And for those who are a bit slow on the uptake, they even included a graph that makes it abundantly clear.

The only other clinical study cited by Ullman in support of his surprising claim is a double-blind randomized trial which was conducted with 131 workers who suffered lead poisoning at the Ajax battery plant in Bauru, São Paulo State, Brazil. Subjects were prescribed homeopathic doses of lead (Plumbum metallicum 15C) or placebo which they took orally for 35 days. The results of this RCT show that homeopathy is not better than placebo.

So, we seem to have all of two RCTs on the subject (I did a quick Medline-search and also found no further RCTs), and both are negative.

Anyone who is not given to compulsive porky-telling would, I guess, conclude from this evidence that people suffering from lead poisoning should urgently see conventional experts and avoid homeopaths at all costs – not so Dana Ullman who boldly concludes his article with these words:

“As an adjunct to conventional medical treatment, professional homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… Even if you do not have a professional homeopath in your town, many homeopathic practitioners “see” their patients via Skype or do consultations over the telephone. Unlike acupuncturists, who put needles in you, or chiropractors, who adjust your spine, homeopaths are not “hands-on”: they simply need to conduct a detailed interview… If your symptoms are serious or potentially serious, it is important to see a professional homeopath and/or physician. While a homeopath will commonly prescribe a safe homeopathic dose of the toxic substance to which one was exposed, the homeopath may instead decide that a different substance more closely matches the patient’s unique symptoms…”

It takes a lot these days to make me speechless but there, Dana, you almost succeeded!

A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).

The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”

The authors were, of course, well advised to be so atypically cautious:

  • Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
  • Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
  • The effect size of the benefit is tiny and of doubtful clinical relevance.

My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.

So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.

‘Natural News’ are not my favourite source of information. In fact, they consistently misinform the public about vaccines, alternative therapies and many other things. In other words, they have proven themselves to be vile mis-informers and a danger to public health.

Yet recently they have provided a valuable service to all of us: they have shown that the natural treatments they regularly promote for every ailment do not actually work for paranoia. Let me explain.

Natural News just announced that Google have “blacklisted the entire Natural News domain and removed over 140,000 pages from its index. The take down of Natural News happened this morning, and it follows a pattern of censorship we’re seeing being leveled against other pro-Trump websites. Google sent no warning whatsoever to our “webmaster tools” email address on file with them. The shut off of Natural News was clearly driven by a human decision, not an algorithm. We’re currently attempting to determine Google’s claimed justification for censoring our entire website, and we hope to have NaturalNews.com restored in Google’s index.”

The announcement continues:

Natural News is, of course, one of the world’s top educational and activism sources exposing the lies of dangerous medicine, toxic mercury in vaccines, the corporate-quack science behind GMOs, cancer industry fraud and so on. By providing truthful, empowering and passionate information to the public, we harm the profit model of the corrupt medical cartels that fund the media, lobby the government and influence internet gatekeepers with advertising money. (Google has already declared war on natural medicine and nutritional supplements, all but banning them from being advertised on Google Adsense.)

“The removal of Natural News from Google’s index means that millions of people may now be unnecessarily harmed by toxic medicines, herbicides and brain-damaging mercury in vaccines because they are being denied the “other side of the story” that’s censored by the corporate-controlled media. By censoring Natural News, Google is, in effect, siding with the criminal pharmaceutical industry that has been charged with multiple felony crimes and caught bribing doctors, fraudulently altering scientific studies, conducting medical experiments on children and price fixing their drugs to maximize profits.

“In effect, censorship of Natural News is part of the establishment’s war on humanity which includes depopulation measures (Bill Gates), covert infertility vaccines, corporate-run media disinfo campaigns and a full-on assault against scientific truth and free speech conducted in the public interest…

“It’s clear to me that Natural News is being targeted primarily because of our support for President Trump and his review of vaccine safety. It is now apparent that any person who engages in real science, critical thinking or any attempt to protect children from the brain damaging effects of mercury in vaccines is going to be silenced, discredited, smeared and blacklisted. This is an astonishing realization about the depths of total corruption in society today and how the medical cartels control information to maximize their profits off human suffering…”

END OF QUOTE

Regular readers of my blog might remember that Natural News have caught my eye several times before. Here are just 4 of the many more posts where they featured prominently:

Like so many in alternative medicine, Natural News seems to be driven by conspiracy theories to a point where paranoia is hard to deny. And that is precisely the service Natural News are providing us today; after so many years of disservice this must surely be celebrated! They demonstrate quite clearly that none of the treatments they are deeply involved in works for this condition. They do that by not even considering that Google banned them because they are constantly endangering the health of the public in the most vile, libellous and objectionable ways imaginable.

Hardly surprising, you will say, the therapies in question are all bogus!

Yes, of course, but it is nice to have a confirmation directly from the horse’s mouth, isn’t it?

Prof Walach has featured on this blog before, for instance here, and here. He is a psychologist by training and a vocal and prominent advocate of several bogus treatments, including homeopathy. He also is the editor in chief of the journal ‘Complementary Medicine Research’ and regularly uses this position to sing the praise of homeopathy. There is a degree of mystery about his affiliation: he informed me about 10 months ago that he has left his post at the Europa Universität Viadrina, Frankfurt/Oder (“Dass ich als “ehemaliger Professor” geführt werde liegt daran, dass ich  Ende Januar aufgehört habe. Meine Stelle ist ausgelaufen und ich habe
sie nicht mehr verlängert.”). Yet all, even his recent papers still carry this address.

His latest article is entitled ‘The future of homeopathy’ is no exception. It is remarkable not just because of the mysterious affiliation but also – and mostly – because of its content. Here is my translation of a brief passage from this paper [I added some numbers in square brackets which refer to footnotes below].

START OF MY TRANSLATION

It is entirely undisputed that homeopathy with its therapeutic principles runs against the mainstream of science; and in this, Weymayr [1] is correct. However, to build on this fact a veritable research prohibition, such as the ‘scientability-concept’ suggests, is not just wrong from a science theoretical perspective, but… also discloses a dogmatic and unscientific stance.

If we see things soberly, homeopathy is – from a science theory point of view – an anomaly: empiric data prove that effects appear regularly and more and more frequently [2].  This is being demonstrated with meta-analyses of placebo-controlled clinical trials. And this also shows with our own provings, which conform well with the newly developed standards as well as with the newer provings. Effects are furthermore noted with such frequency in animal and plant-based studies. Contrary to often voiced statements, there are also models which produce replicated effects – for instance the model of children with ADHD which is currently being replicated. Repeatedly high quality pilot studies emerge, such as the one by Gassmann et al., which show that unexpected effects also appear with higher potencies, documented with objective methods. Homeopathy proves itself as useful in large pragmatic trials of which we, however, have far too few. And let’s not forget: homeopathy is pragmatically useful. Even though aggravations do occur occasionally during homeopathic treatments, the claim that homeopathy is dangerous is a careless interpretation of the data. [3]

In what way is homeopathy an anomaly? I have already years ago argued that the signature of the data does not suggest that we are dealing with a classical local effect. This would be an effect which would conform with the usual criterion of causality and would thus be stable, regular and more and more evident with improved experimentation. It is unnecessary to repeat this argument [4] for the purpose of this editorial. But precisely the question of the classic causal effect is the controversy. And exactly this is the issue used by the new wave of critic of homeopathy which is openly aimed at the demise of homeopathy. This situation occurs because also the homeopaths are victims of the misapprehension  that homeopathy is based on a classic causal process. But this assumption is most likely wrong, and homeopaths would be well-advised on the one side to point to the empiric evidence, and on the other side to practice theoretical chastity making clear that, for the time being, we have not a clue how homeopathy functions. This is the typical situation when a scientific anomaly occurs…

My prognosis would be: if we stop to misunderstand homeopathy as a classic causal phenomenon and instead view and research it as a non-classical phenomenon, homeopathy would have a chance and science would get richer by a new category of phenomena. This approach will prompt criticism, because it renders the world more complex rather than simpler. But this cannot be changed. Perhaps a new era of therapeutics might even emerge which does not abolish the molecular paradigm but makes it appear as one of several possibilities. [5]

END OF MY TRANSLATION

For those of you who can read German, here is the original text with references:

Dass die Homöopathie mit ihren therapeutischen Prinzipien dem Hauptstrom der Wissenschaft immer schon zuwiderlief, ist völlig unbestritten, und darin hat Weymayr recht. Aber auf dieser Tatsache ein regelrechtes «Forschungsverbot» aufbauen zu wollen, wie es das Szientabilitätskonzept vorsieht, das ist nicht nur wissenschaftstheoretisch absolut falsch, wie wir in einer Replik gezeigt haben [2], sondern offenbart auch eine dogmatische und unwissenschaftliche Einstellung.

Wenn man die Sache nüchtern sieht, ist die Homöopathie – wissenschaftstheoretisch betrachtet – eine Anomalie [3]: Empirische Daten belegen, dass immer wieder und insgesamt häufiger als zufällig erwartet Effekte auftreten. Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf. Entgegen oft gehörten Äußerungen gibt es durchaus auch Modelle, die replizierte Effekte ergeben – etwa das Modell homöopathischer Behandlung von Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätssyndrom [17,18], das gerade repliziert wird [19]. Immer wieder gibt es qualitativ hochwertige Pilotstudien, wie die unlängst publizierte von Gassmann et al. [20], die zeigen, dass unerwartete Effekte auch unter höheren Potenzen und dokumentiert mit objektiven Methoden zu beobachten sind. Homöopathie erweist sich in großen pragmatischen Studien, von denen es allerdings viel zu wenige gibt, als nützlich [21,22,23]. Und nicht zu vergessen: Homöopathie ist pragmatisch hilfreich [24,25,26,27]. Zwar kommt es bei homöopathischer Behandlung gelegentlich zu einer Erstverschlimmerung [28,29], aber die Behauptung, Homöopathie sei gefährlich [30], ist eine fahrlässige Interpretation der Daten [31].

Inwiefern ist die Homöopathie dann eine Anomalie? Ich habe schon vor Jahren argumentiert, dass die Signatur der Daten in der Homöopathie nicht dafür spricht, dass wir es mit einem klassischen, lokalen Effekt zu tun haben [32]. Das wäre ein Effekt, der dem gewöhnlichen Kriterium der Kausalität entspräche und somit stabil, regelmäßig und bei immer besserer Experimentierkunst immer deutlicher hervorträte. Dieses Argument jetzt wieder aufzurollen, ist im Rahmen eines Editorials müßig. Aber genau die Frage nach einem klassisch-kausalen Effekt ist letztlich der Stein des Anstoßes. Und genau diesen Anstoß nimmt nun die neue Welle der Homöopathiekritik, die erklärtermaßen auf die Abschaffung der Homöopathie abzielt, zu ihrem Anlass. Diese Situation ergibt sich, weil auch die Homöopathen dem Selbstmissverständnis aufsitzen, Homöopathie sei ein klassisch-kausaler Prozess. Das ist höchstwahrscheinlich falsch, und die Homöopathie wäre gut beraten, einerseits auf die empirischen Befunde hinzuweisen und auf der anderen Seite theoretische Enthaltsamkeit zu üben und klarzulegen, dass wir vorläufig keinerlei Ahnung haben, wie Homöopathie funktioniert. Das ist die typische Situation, wenn eine wissenschaftliche Anomalie vorliegt…

Meine Prognose wäre: Wenn wir aufhören, die Homöopathie als klassisches Phänomen misszuverstehen, und sie stattdessen als ein mögliches nichtklassisches Phänomen betrachten und beforschen, dann hat die Homöopathie eine Chance und die Wissenschaft wird um eine neue Kategorie von Phänomenen reicher. Dieser Ansatz wird Kritik hervorrufen, denn er macht die Welt eher komplexer als einfacher. Aber das lässt sich nicht ändern. Vielleicht kann sogar eine neue Ära der Therapie beginnen, die das molekulare Paradigma nicht abschafft, aber als eine von mehreren Möglichkeiten erscheinen lässt.


Rather than commenting on this text in full detail, I simply want to provide a few explanations [they refer to the numbers in square brackets inserted by me into my translation] in order to facilitate understanding. I hope, however, that my readers will comment as much as they feel like.

1) Weymayr argued that certain fields lack plausibility to a degree that they do not merit being investigated. Here is an abstract of an article by him:

Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.

2) A scientific anomaly is “something which cannot be explained by currently accepted scientific theories. Sometimes the new phenomenon leads to new rules or theories, e.g., the discovery of x-rays and radiation.

3) Even a minimal amount of critical thinking leads to the conclusion that the claims made about homeopathy in this paragraph are mostly not true or exaggerated. On this blog, there is plenty of evidence to contradict Walach on all the points he made here.

4) Walach’s argument is detailed in this article:

Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, ‘information’ or ‘energy’ is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung’s notion of synchronicity and make some predictions following this analysis.

5) In a nutshell, Walach seems to be saying:

  • the empirical evidence for homeopathy is strong;
  • nobody understands the mechanisms by which the effects of homeopathy are brought about;
  • if we all claim that homeopathy is a ‘scientific anomaly’ which operates according to Jung’s notion of synchronicity, the discrepancy between strong evidence and lack of plausible explanation disappears and everyone can be happy.

This is wrong for the following reasons, in my view:

  • the evidence is not strong but negative or extremely weak;
  • we understand very well that the effects of homeopathy are due to non-specific effects;
  • therefore there is no need for a new paradigm;
  • Jung’s notion of synchronicity is pure speculation and not applicable to therapeutics.

In summary, Prof Walach would do well to stop philosophising about homeopathy, read up about critical analysis, fine-tune his BS-detector and familiarise himself with Occam’s razor.

 

The objective of the ‘Portland Centre for Integrative Medicine’ in Bristol, UK is to “offer an Integrative Medicine (IM) approach to healthcare that seeks to deliver the best complementary care and lifestyle approaches”. Specifically, they

  • “Aim to maximise individual choice and care to improve health, wellbeing and quality of life
  • Support a whole person care approach through a working collaboration between people and practitioners to improve health and well-being
  • Work to raise awareness about IM and increasing the availability of quality IM services for service users and their referring clinicians
  • Support ‘Self Care Strategies’ across the South West by promoting and supporting self-care and self-management of health and well-being by using healthy living solutions
  • Offer a centre for academic excellence for IM education and training, research and evaluation.”

Academic excellence does not normally entail telling porkies – but the Portland Centre seems willing to make an exception for a good cause: homeopathy. At least, this is the impression I got when reading their recent post entitled HOMEOPATHY, THE FACTS (surprisingly similar title as my latest book: HOMEOPATHY, THE UNDILUTED FACTS). The 6 ‘Portland facts’ turn out to be so surprising that I could simply not resist copying them here:

START OF QUOTE

1 It’s more than just a placebo

Homeopathy has been used successfully on babies, young children and animals. In these cases, the patients have no idea what medication they are taking, so the placebo argument does not hold.

2 Homeopathy costs the NHS very little

The total amount spent on Homeopathy in the NHS is approximately £4 million per year, representing less than 1% of the total NHS budget. In contrast, the NHS spends £282 million annually on anti-depressants which one study suggests only benefit 11% of patients diagnosed with depression.

3 Homeopathy is more than a passing fad

Homeopathy has been used for over 200 years and has been available on the NHS since the health service was formed in 1948. It is an important part of the health systems in many European countries including France, Germany and Italy.

4 Homeopathy is safe

When used approximately the practice is extremely safe as it produces no dangerous side-effects and can be used in conjunction with conventional medicines. In comparison, the European Commission estimated in 2008 that adverse reactions to conventional drugs kill 197,000 EU citizens each year.

5 Many treatments have limited evidence

A clinical evidence surgery carried out by the British Medical Journal found that out of 3000 medical treatments 50% were classified as having “unknown effectiveness”.

6 In support of high dilutions

What I can say now is that the high dilutions are right. High dilutions of something are not nothing. They are water structures which mimic the original molecules. It’s no pseudoscience. It’s no quackery. These are real phenomena which deserve further study,” Professional Luc Montagnier, French virologist and Nobel Laureate speaking in 2010.

END OF QUOTE

Regular readers of this blog will not really need any comments; in their absurdity, the 6 ‘Portland facts’ speak almost for themselves. For those who are not regulars, let me briefly add a few words (in doing so, I follow the numbering above).

1) The most comprehensive and independent review of the evidence in the history of homeopathy has failed to confirm that homeopathy has any therapeutic effects beyond placebo. This applies to kids as much as it applies to animals. Placebo effects in animals and kids are well documented.

2) Much more important than the costs of homeopathy is the fact that the continued use of homeopathy on the NHS makes a mockery of the principles of EBM. Either we believe in evidence (in which case, homeopathy has no place in the NHS), or we don’t (in which case, anything goes and we regress to the dark ages of healthcare).

3) Appeal to tradition is a classic fallacy and not an argument in support of anything.

4) Most, but not all, homeopathic remedies are safe. However, homeopaths are often very unsafe, for instance when they insist to treat life-threatening conditions with their placebos, or when they advice against vaccinating children. Conventional medicines can certainly cause harm but, on balance, they unquestionably generate more good than harm – and this is clearly not the case for homeopathy.

5) Tu quoque is another classic fallacy and no argument in favour of homeopathy. EBM is a relatively new concept and progress in conventional medicine is now breathtakingly fast. By contrast, homeopathy did not progress since the days Hahnemann invented it.

6) The appeal to authority is yet another classic fallacy. The ‘Montagnier story’ merely shows that even Nobel laureates can make foolish mistakes, particularly if they venture outside their area of expertise. Poor Montaigner lost all credibility since he embarked on high dilutions.

I hope that you had as much fun reading the ‘Portland porkies’ as I had commenting on them. I think they are hilarious, particularly if we consider that the Portland Centre is the direct successor of the Bristol Homeopathic Hospital. Here is what Wikipedia has to say about this institution:

“Bristol Homeopathic Hospital was a hospital in the city of Bristol in south-west England, specializing in homeopathic treatments. It was founded in 1852 but had a history as a dispensary dating back to 1832.[1] It later became a National Health Service hospital.

From 1925, the hospital was based in its own building, Cotham House,[2] in the Cotham area of Bristol. On 7 January 2013 the hospital moved operations from Cotham to the South Bristol Community Hospital.[3] In-patient services had been provided at Cotham House until 1986, when they were moved to the Bristol Eye Hospital, with out-patients continuing at Cotham House.[2][3]

Homeopathic services ceased at the Hospital in October 2015,[4][5] partly in response to a campaign against the public funding of homeopathy lead by the Good Thinking Society[6] and public figures such as Simon Singh and Edzard Ernst. University Hospitals Bristol confirmed to the Clinical Commissioning Group that it would cease to offer homeopathic therapies from October 2015, at which point homeopathic therapies would no longer be included in the contract.[5]

Homeopathic services in the Bristol area were relocated to the Portland Centre for Integrative Medicine, described as “a new independent social enterprise.”[5] In response to a FOI request, Bristol Clinical Commissioning Group revealed that “there are currently no (NHS) contracts for homeopathy in place with the Portland Centre.”[5]

END OF WIKI QUOTE

Of course, this Wiki page is slightly misleading on at least one issue (No, I don’t mean the fact that I am called a ‘public figure’ rather than a professor and expert in alternative medicine who has published more on the subject than anyone else): Hospitals are never closed in response to a campaign (as far as I know) but hospitals might get closed because of what a campaign discloses. In the Bristol case, the campaign disclosed that there is no good evidence for homeopathy (see above) and therefore no good reason to carry on wasting scarce NHS funds on it – perhaps just a slight but, I think, important difference!

Back to the 6 ‘Portland porkies’.

As we have seen, they are nowhere close to real facts – but they certainly are funny.

While studying the services offered by the Portland Centre, I found a course on ‘creative writing’. Aha, I thought, this must be the explanation: the 6 ‘Portland porkies’ are not the result of research, study or knowledge. Far from it! They clearly are the fruits of exceedingly creative writing.

So, well done Portland Centre: at least one of your aims seems to be within reach!


You may recall, we have dealt with the JCAM many times before; for instance here, here, here and here. Now they have come out with another remarkable paper. This study – no, the authors called it a ‘pilot study’ – was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Sixty-three American high-ability students in grades 6–12, ages 10–18 years, who scored in the moderate to high ranges for anxiety on the Revised Children’s Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to one of three groups:

  • CBT (n = 21),
  • EFT (n = 21),
  • or waitlist control (n = 21).

EFT is an alternative therapy that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants.

EFT participants showed significant reduction in anxiety levels compared with the waitlist control group with a moderate to large effect size. CBT participants did not differ significantly from the EFT or control.

The authors concluded that EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.

They also state in their abstract that EFT is an evidence-based treatment for anxiety…

Are you happy with these conclusions?

Are you convinced that this trial lends itself to establish efficacy of anything?

Are you impressed with the trial design, the sample size, etc?

Are you sure that EFT is plausible, credible or evidence-based in any way?

No?

Me neither!

If you look up EFT, you will find that there is a surprising amount of papers on it. Most of them have one thing in common: they were published in highly dubious journals. The field does not inspire trust or competence. The authors of the study state that EFT is an easily implemented strategy that uses such techniques as awareness building, exposure, reframing of interpretation, and systematic desensitization, while teaching the participant to self-stimulate protocol-identified acupoints (i.e., acupuncture points) by tapping. The effectiveness of acupuncture for treating anxiety has been well documented. Rather than using acupuncture needles, EFT relies on the manual stimulation of the acupoints. A recent meta-analysis indicated that interventions using acupoint stimulation had a moderate effect size (Hedge’s g = −0.66 95% CI [−0.99, −0.33]) in reducing symptoms. In EFT, the client stimulates the protocol-identified acupoints by tapping on them. Preliminary studies have suggested that tapping and other alternative ways of stimulating acupuncture points to be as effective as acupuncture needling. The EFT protocol and identified acupoints that were used in this study are the ones recommended for research purposes by the Association for Comprehensive Energy Psychology…

Wikipedia tells us that “Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy (TFT). It is best known through Gary Craig’s EFT Handbook, published in the late 1990s, and related books and workshops by a variety of teachers. EFT and similar techniques are often discussed under the umbrella term “energy psychology”. Advocates claim that the technique may be used to treat a wide variety of physical and psychological disorders, and as a simple form of self-administered therapy.[1] The Skeptical Inquirer describes the foundations of EFT as “a hodgepodge of concepts derived from a variety of sources, [primarily] the ancient Chinese philosophy of chi, which is thought to be the ‘life force’ that flows throughout the body.” The existence of this life force is “not empirically supported”.[2] EFT has no benefit as a therapy beyond the placebo effect or any known-effective psychological techniques that may be provided in addition to the purported “energy” technique.[3] It is generally characterized as pseudoscience and it has not garnered significant support in clinical psychology.”

A recent systematic review of EFT concluded that “there were too few data available comparing EFT to standard-of-care treatments such as cognitive behavioral therapy, and further research is needed to establish the relative efficacy of EFT to established protocols.”

Notwithstanding these and many other verdicts on EFT, we now are asked to agree with the new study that EFT IS EFFICACIOUS.

Is this a joke?

They want us to believe this on the basis of  a PILOT STUDY? Such studies are not even supposed to test efficacy! (Yet the authors of the trial state that this study was designed to meet the American Psychological Association (APA) Division 12 quality control criteria and the Consolidated Standards for Reporting Trials (CONSORT) criteria. I have to admit, they could have fooled me!)

No, it is not a joke, it is yet another nonsense from the ‘The Journal of Complementary and Alternative Medicine’ which, in my view, should henceforth be called THE JOURNAL OF ALTERNATIVE FACTS (JAF).

We have discussed the risks of (chiropractic) spinal manipulation more often than I care to remember. The reason for this is simple: it is an important subject; making sure that as many consumers know about it will save lives, I am sure. Therefore, any new paper on the subject is likely to be reported on this blog.

Objective of this review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. Systematic searches were performed in 6 electronic databases. Of the initial 1043 studies, 144 studies were included.

They reported 227 cases. 117 cases described male patients with a mean age of 45 (SD 12) and a mean age of 39 (SD 11) for females. Most patients were treated by chiropractors (66%) followed by non-clinicians (5%), osteopaths (5%), physiotherapists (3%) and other medical professions. Manipulation was reported in 95% of the cases (mobilisations only in 1.7%), and neck pain was the most frequent indication.

Cervical arterial dissection (CAD) was reported in 57% of the cases and 46% had immediate onset symptoms; in 2% onset of symptoms took for more than two weeks. Other complications were disc rupture, spinal cord swelling and thrombus. The most frequently reported symptoms included disturbance of voluntary control of movement, pain, paresis and visual disturbances.

In most of the reports, patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted. However, women seem more at risk for CAD.

The authors concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

I do not want to repeat what I have stated in previous posts on this subject. So,let me just ask this simple question: IF THERE WERE A DRUG MARKTED FOR NECK PAIN BUT NOT SUPPORTED BY GOOD EVIDENCE FOR EFFICACY, DO YOU THINK IT WOULD BE ON THE MARKET AFTER 227 CASES OF SEVERE ADVERSE EFFECTS HAD BEEN DESCRIBED?

I think the answer is NO!

If we then consider the huge degree of under-reporting in this area which might bring the true figure up by one or even two dimensions, we must ask: WHY IS CERVICAL MANIPULATION STILL USED?

A recent article in the Guardian revealed that about one third of Australian pharmacists are recommending alternative medicines with little-to-no evidence for their efficacy, including useless homeopathic products and potentially harmful herbal products.

For this survey of 240 Australian pharmacies, mystery shoppers were sent in to speak to a pharmacist at the prescription dispensing counter and ask for advice about feeling stressed. The results show that three per cent of the pharmacists recommended homeopathic products, despite a comprehensive review of all existing studies on homeopathy finding that there is no evidence they work in treating any condition and that ‘people who choose homeopathy may put their health at risk if they reject or delay treatments’. Twenty-six percent of all pharmacists recommended Bach flower remedies to relieve stress. A comprehensive review of all existing studies on Bach flower remedies found no difference between the remedies and placebos. Fifty-nine per cent of people were just told the complementary and alternative product recommended to them worked, and 24% were told the product was scientifically proven, without any evidence being provided to them.

Asked about these findings, Dr Ken Harvey, a prominent Australian expert, said they demonstrated that some pharmacists were failing in their professional duty to consumers. “Pharmacists are giving crazy advice, and it is dangerous in some cases,” he said. “My view is that pharmacists, if they are going to sell these products, need to have a big shining sign over the shelves of the complementary and alternative medicine section that says ‘these products have not been assessed by the government regulators to see if they work, please talk to pharmacist’.Pharamacists are giving poor advice and they clearly have a conflict of interest,” Harvey said.

If you had hoped that in other countries pharmacists behave more responsibly, I must disappoint you. The information available shows that, when it comes to alternative medicine, pharmacists across the globe act much more like shop-keepers than like health care professionals. They are in the habit of putting profit before their duty to abide by the rules of evidence-based practice. And, in doing do, they violate their own ethical codes so regularly that I ask myself why they bothered to even implement one.

On this blog I have written so often about this issue that one could come to the conclusion that I have a bee under my bonnet:

The truth, however, is not that I am the victim of a bee.

The truth is that this is a very important public health issue.

The truth is that pharmacists show little signs of even trying to get to grips with it.

The truth is that pharmacists who sell bogus medicines put profit before professional ethics.

The truth is that such behaviour is not that of health care professionals but that of shop-keepers.

The truth is that I intend to carry on reminding these pharmacists that they are behaving like charlatans.

Although many conservative management options are being promoted for shoulder conditions, there is little evidence of their effectiveness. This review investigated one manual therapy approach, thrust manipulation, as a treatment option.

A systematic search was conducted of the electronic databases from inception to March 2016: PubMed, PEDro, ICL, CINAHL, and AMED. Two independent reviewers conducted the screening process to determine article eligibility. Inclusion criteria were manuscripts published in peer-reviewed journals with human participants of any age. The intervention included was thrust, or high-velocity low-amplitude, manipulative therapy directed to the shoulder and/or the regions of the cervical or thoracic spine. Studies investigating secondary shoulder pain or lacking diagnostic confirmation procedures were excluded. Methodological quality was assessed using the PEDro scale and the Cochrane risk-of-bias tool.

The initial search rendered 5041 articles. After screening titles and abstracts, 36 articles remained for full-text review. Six articles studying subacromial impingement syndrome met inclusion criteria. Four studies were randomized controlled trials (RCTs) and two were uncontrolled clinical studies. Five studies included one application of a thoracic spine thrust manipulation and one applied 8 treatments incorporating a shoulder joint thrust manipulation. Statistically significant improvements in pain scores were reported in all studies. Three of 4 RCTs compared a thrust manipulation to a sham, and statistical significance in pain reduction was found within the groups but not between them. Clinically meaningful changes in pain were inconsistent; three studies reported that scores met minimum clinically important difference, one reported scores did not, and two were unclear. Four studies found statistically significant improvements in disability; however, two were RCTs and did not find statistical significance between the active and sham groups.

The authors concluded that there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain or disability associated with subacromial impingement syndrome. Studies consistently reported a reduction in pain and improvement in disability following thrust manipulation. In RCTs, active treatments were comparable to shams suggesting that addressing impingement issues by manipulation alone may not be effective. Thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Higher-quality studies with safety data, longer treatment periods and follow-up outcomes are needed to develop a stronger evidence-based foundation for thrust manipulation as a treatment for shoulder conditions.

This is yet another very odd conclusion from an otherwise almost acceptable analysis (but why include non-randomised studies on a subject where randomised trials are available?) . If pain reductions are found within groups but not between real and sham manipulation, the evidence is as clear as it can be: manipulations have no specific effects. In other words, they are a pure placebo therapy.

And what about this nonsense: there is limited evidence to support or refute thrust manipulation as a solitary treatment for shoulder pain? For responsible healthcare, we don’t need such weasel words, all we need is to stress loud and clear that there is no good positive evidence. This means the therapy is not evidence-based and we therefore should not recommend or use manipulation for shoulder pain.

But, in my view, the worst part in the conclusion section is this: thrust manipulative therapy appears not to be harmful, but AE reporting was not robust. Even if there had been adequate reporting of side-effects and even if this had not disclosed any problems, the safety of manipulation cannot be judged on the basis of such a small sample. Any responsible researcher should make it abundantly clear that the nasty habit by chiropractic pseudo-researchers of not reporting adverse effects is unethical and totally unacceptable.

My conclusion from all this: yet another attempt to white-wash a dodgy alternative therapy.

 

The British Homeopathic Association (BHA) is a registered charity founded in 1902. Their objectives are “to promote and develop the study and practice of homeopathy and to advance education and research in the theory and practice of homeopathy…” and their priority is “to ensure that homeopathy is available to all…” The BHA believes that “homeopathy should be fully integrated into the healthcare system and available as a treatment choice for everyone…”

This does not bode well, in my view. Specifically, it does not seem as though we can expect unbiased information from the BHA. Yet, from a charity we certainly do not expect a packet of outright lies – so, let’s have a look.

The BHA have a website (thank you Greg for reminding me of this source; I have long known about it and used it often for lectures when wanting to highlight the state of homeopathic thinking) where they provide “THE EVIDENCE FOR HOMEOPATHY“. I find the data presented there truly remarkable, so much so that I present a crucial section from it below:

START OF QUOTE

The widely accepted method of proving whether or not a medical intervention works is called a randomised controlled trial (RCT). One group of patients, the control group, receive placebo (a “dummy” pill) or standard treatment, and another group of patients receive the medicine being tested. The trial becomes double-blinded when neither the patient nor the practitioner knows which treatment the patient is getting. RCTs are often referred to as the “gold standard” of clinical research.

Up to the end of 2014, a total of 104 papers reporting good-quality placebo-controlled RCTs in homeopathy (on 61 different medical conditions) have been published in peer-reviewed journals. 41% of these RCTs have reported a balance of positive evidence, 5% a balance of negative evidence, and 54% have not been conclusively positive or negative. For full details of all these RCTs and more in-depth information on the research in general, visit the research section of the Faculty of Homeopathy’s website. Also, see 2-page evidence summary with full references.

END OF QUOTE

Impressive!

But is it true?

Let’s have a closer look at the percentage figures: according to the BHA

  • 41% of all RCT are positive,
  • 5% are negative,
  • 54% are inconclusive.

These numbers are hugely important because they are being cited regularly across the globe as one of the most convincing bit of evidence to date in support of homeopathy. If they were true, many more RCT would be positive than negative. They would, in fact, constitute a strong indicator suggesting that homeopathic remedies are more than placebos.

One does not need to look far to find that these figures are clearly not correct! To disclose the ‘mistake’, we do not even need to study any of the 104 RCTs in question, we only need to straighten out the BHA’s ‘accounting error’ and ask: what on earth is an ‘inconclusive’ RCT?

A positive RCT obviously is one where homeopathy generated better outcomes than the placebo; similarly a negative RCT is one where the opposite was the case; in other words, where the placebo generated better outcomes than homeopathy. But what is an ‘inconclusive’ RCT? It turns out that, according to the BHA, it is one where there was no significant difference between the results obtained with placebo and homeopathy.

WHAT???

Yes, you understood correctly!

Outside homeopathy such RCTs are categorised as negative studies – they fail to show that homeopathy out-performs placebo and therefore confirm the null-hypothesis. An RCT is a test of the null-hypothesis (the experimental treatment is not better than the control) and can only confirm or reject this hypothesis. Certainly finding that the experimental treatment is not better than the control is not inconclusive bit a confirmation of the null-hypothesis. In other words it is a negative result.

So, let’s look at the little BHA – statistic again, and this time let’s do the accounting properly:

  • 41% of all RCTs are positive,
  • 59% are negative.

This means that, according to this very simplistic method, the majority of RCTs is negative. I say ‘very simplistic’ because, for a proper analysis of the trial evidence, we need to account, of course, for the quality of each trial. If the quality of the positive RCTs is, on average, less rigorous than that of the negative RCTs, the overall result would become yet more clearly negative. Most assessments of homeopathy that consider this essential factor do, in fact, confirm that this is the case.

Once all this has been analysed properly, we still have to account for factors like publication bias. Negative trials get often not published and therefore the overall picture gets easily distorted and generates a false-positive image. At the end of a sound evaluation along these lines, the result would fail to show that homeopathy differs from placebo.

Regardless of all these necessary and important considerations, the BHA website then tells us that the RCT method is problematic when it comes to testing homeopathy: “The RCT model of measuring efficacy of a drug poses some challenges for homeopathic research. In homeopathy, treatment is usually tailored to the individual. A homeopathic prescription is based not only on the symptoms of disease in the patient but also on a host of other factors that are particular to that patient, including lifestyle, emotional health, personality, eating habits and medical history. The “efficacy” of an individualised homeopathic intervention is thus a complex blend of the prescribed medicine together with the other facets of the in-depth consultation and integrated health advice provided by the practitioner; under these circumstances, the specific effect of the homeopathic medicine itself may be difficult to quantify with precision in RCTs.”

What are they trying to say here?

I am not sure.

Are they perhaps claiming that, even if an independent scientist disclosed their ‘accounting error’ and demonstrated that, in fact, the RCT evidence fails to support homeopathy, the BHA would still argue that homeopathy works?

I think so!

It looks to me that the BHA is engaged in the currently popular British past-time: THEY WANT THE CAKE AND EAT IT.

All this is more than a little disturbing, and I think it begs several questions:

  • Is this type of behaviour in keeping with the charitable status of the BHA?
  • Does it really ‘promote and develop the study and practice of homeopathy and to advance education and research’?
  • Is it not rather unethical to mislead the public in such a gross and dishonest fashion?
  • Is it not fraudulent to insist on false accounting?

I would be interested to get your views on this.

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