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

progress

When NHS England announced several months ago that they plan to stop the reimbursement of homeopathy, UK homeopaths were understandably upset and decided to launch a legal challenge to this decision. Yesterday, the result of this challenge has been published in a NHS press-release:

START OF QUOTE

NHS chief Simon Stevens has today welcomed the High Court’s decisive rejection of a legal challenge by the British Homeopathic Association to overturn plans to no longer routinely fund homeopathy on the NHS.

As part of action to clamp down on waste, over the last two years NHS England has taken action to curb prescriptions for medicines that can be bought over the counter or are of low value.

At the end of last year NHS England published guidance to curb prescriptions for 18 ineffective, unsafe or low clinical priority treatments, such as coproxamol, some dietary supplements, herbal treatments and homeopathy, saving up to £141 million a year. Earlier this year NHS England published a further list of 35 minor, short-term conditions for which over the counter medicines should not routinely be prescribed, saving around a further £100 million a year.

Savings form a key building block of the NHS’s 10 point efficiency plan contained in the Next Steps on the NHS Five Year Forward View, published in March 2017.

NHS chief, Simon Stevens said: “There is no robust evidence to support homeopathy which is at best a placebo and a misuse of scarce NHS funds.

“So we strongly welcome the High Court’s clear cut decision to kick out this costly and spurious legal challenge.”

Guidance on items which should not be routinely prescribed in primary care is available on the NHS England website.

END OF QUOTE

The reaction of UK homeopaths was as swift and deluded as it was predictable. The British Homeopathy Association, for instance, commented thus:

… The charity’s main claims against NHS England were that the consultation misrepresented homeopathy and therefore was unfair; and a report used in the consultation to inform the public was so complicated it would deter rather than encourage people to respond. Although the judge found there were sufficient grounds for a judicial review, after four days of lengthy legal arguments he dismissed the claims. Margaret Wyllie, BHA Chair, said the case highlighted how health bosses were unfairly manipulating the consultation process and making decisions about healthcare services without genuine patient engagement. “That NHS England attracted fewer than 3,000 responses from patients to a national consultation that ran for three months highlights its failure to genuinely engage with the public on important decisions about healthcare provision. Although 18 medicines were under review the only negative statement in NHS England’s press release promoting its public consultation was about homeopathy. The statement was so prejudicial it was widely reported in the media that the decision to deny patients homeopathic medicines had already been taken. How the judge failed to recognise that this was a deliberate attempt by NHS England to unfairly influence the public is astonishing,” said Mrs Wyllie.

In The Telegraph, Wyllie is quoted saying: It appears NHS England can fail to engage with patients properly on removing services and get away with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.”

One can only marvel at the lack of insight and self-criticism. I should to add that the BHA is a charity; with this court case, they have wasted significant amounts of public money for their own, hopelessly misguided interests. To me, this indicates that they no longer deserve a charitable status.

Personally, I had very little doubt that the court would decide as it did. The evidence was simply overwhelming and indisputable. In the written judgement, the judge stated that “I am satisfied that NHSE was rigorous in the discharge of the duty to have “due regard” to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, “would [enable] patients to have access to the most effective medications to achieve the best outcomes”.

 

In all this, the open questions, in my view, were whether

  1. Prince Charles, the prime defender of quackery in the UK, would intervene,
  2. and whether his intervention might change anything.

So, did he try to intervene?

I do not know. It could be that, after all the hoo-ha about his spider memos, he now is a little more cautions about meddling in health politics. It could also be that, as he is getting ready to become king, he wants to keep a low profile about his more bizarre ideas. Lastly, it could be that his opinion does not weigh as heavily as I had feared.

In any case, The High Court ruling is most welcome and unquestionably just, progressive, and long-overdue. I applaud all who have worked hard to bring it about, and am sure that (most of) my readers agree.

Personally, I find our good friend Dana Ullman truly priceless. There are several reasons for that; one is that he is often so exemplarily wrong that it helps me to explain fundamental things more clearly. With a bit of luck, this might enable me to better inform people who might be thinking a bit like Dana. In this sense, our good friend Dana has significant educational value.

Recently, he made this comment:

According to present and former editors of THE LANCET and the NEW ENGLAND JOURNAL OF MEDICINE, “evidence based medicine” can no longer be trusted. There is obviously no irony in Ernst and his ilk “banking” on “evidence” that has no firm footing except their personal belief systems: https://medium.com/@drjasonfung/the-corruption-of-evidence-based-medicine-killing-for-profit-41f2812b8704

Ernst is a fundamentalist whose God is reductionistic science, a 20th century model that has little real meaning today…but this won’t stop the new attacks on me personally…

END OF COMMENT

Where to begin?

Let’s start with some definitions.

  • Evidence is the body of facts that leads to a given conclusion. Because the outcomes of treatments such as homeopathy depend on a multitude of factors, the evidence for or against their effectiveness is best based not on experience but on clinical trials and systematic reviews of clinical trials (this is copied from my book).
  • EBM is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences (and this is from another book).

Few people would argue that EBM, as it is applied currently, is without fault. Certainly I would not suggest that; I even used to give lectures about the limitations of EBM, and many experts (who are much wiser than I) have written about the many problems with EBM. It is important to note that such criticism demonstrates the strength of modern medicine and not its weakness, as Dana seems to think: it is a sign of a healthy debate aimed at generating progress. And it is noteworthy that internal criticism of this nature is largely absent in alternative medicine.

The criticism of EBM is often focussed on the unreliability of the what I called above the ‘best research evidence’. Let me therefore repeat what I wrote about it on this blog in 2012:

… The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors, and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.

Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.

Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.

Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.

Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.

There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.

Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.

In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.

END OF QUOTE

Other criticism is aimed at the way EBM is currently used (and abused). This criticism is often justified and necessary, and it is again the expression of our efforts to generate progress. EBM is practised by humans; and humans are far from perfect. They can be corrupt, misguided, dishonest, sloppy, negligent, stupid, etc., etc. Sadly, that means that the practice of EBM can have all of these qualities as well. All we can do is to keep on criticising malpractice, educate people, and hope that this might prevent the worst abuses in future.

Dana and many of his fellow SCAMers have a different strategy; they claim that EBM “can no longer be trusted” (interestingly they never tell us what system might be better; eminence-based medicine? experience-based medicine? random-based medicine? Dana-based medicine?).

The claim that EBM can no longer be trusted is clearly not true, counter-productive and unethical; and I suspect they know it.

Why then do they make it?

Because they feel that it entitles them to argue that homeopathy (or any other form of SCAM) cannot be held to EBM-standards. If EBM is unreliable, surely, nobody can ask the ‘Danas of this world’ to provide anything like sound data!!! And that, of course, would be just dandy for business, wouldn’t it?

So, let’s not be deterred  or misled by these deliberately destructive people. Their motives are transparent and their arguments are nonsensical. EBM is not flawless, but with our continued efforts it will improve. Or, to repeat something that I have said many times before: EBM is the worst form of healthcare, except for all other known options.

Nipah virus (NiV) infection is a zoonosis that causes severe disease in both animals and humans. The natural host of the virus are fruit bats of the Pteropodidae Family, Pteropus genus. Human-to-human transmission has also been documented, including in a hospital setting in India. Clinical presentations range from asymptomatic infection to acute respiratory syndrome and fatal encephalitis. There is no vaccine for either humans or animals. The primary treatment for human cases is intensive supportive care. In Kerala, India, several people have died of the deadly NiV.  The infection has a mortality rate of around 70%.

It was predictable that such events would bring homeopaths to the fore. This article explains:

The Indian Homeopathic Medical Association’s Kerala unit has claimed to have the medicines to treat Nipah virus. B Unnikrishnan, an association official, said homeopathy has the appropriate medicines for all types of fever and hence they should be allowed to treat the infected patients. The association has requested the state Health Minister KK Shailaja to allow their professionals to examine the records of all those patients who have been tested positive for Nipah… So far, 16 people have died and two are recovering. Some 2,000 people who came in contact with the infected patients are also being monitored.

Knowing that an international delegation of homeopaths travelled to Liberia to treat Ebola (with the official support of their respective professional organisations), this news cannot surprise anyone.

Homeopaths dilute their remedies and delude themselves.

Sadly, the victims of their dilutions/delusions are: 

  • their patients,
  • public health,
  • progress,
  • and rationality.

I have said it often, and I say it again: I do like well-conducted systematic reviews; and Cochrane reviews are usually the best, i. e. most transparent, most thorough and least biased. Thus, I was pleased to see a new Cochrane review of acupuncture aimed at assessing the benefits and harms of acupuncture in patients with hip OA.

The authors included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short-term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. The authors are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in 4 RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites.

The authors concluded that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

This is an excellent review of data that (because of contradictions, methodological limitations, heterogeneity etc.) are not easy to evaluate fairly. The review shows that previous verdicts about acupuncture for osteoarthritis might have been too optimistic. Acupuncture has no or only very small specific therapeutic effects. As we have much better therapeutic options for this condition, it means that acupuncture can no longer be recommended as an effective therapy.

That surely must be big news in the little world of acupuncture!

I have been personally involved in several similar reviews:

In 1997, I concluded that the most rigorous studies suggest that acupuncture is not superior to sham-needling in reducing pain of osteoarthritis: both alleviate symptoms to roughly the same degree.

In 2006, the balance of evidence seemed to have shifted and more positive data had emerged; consequently our review concluded that sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Now, it seems that my initial conclusion of 1996 was more realistic. To me this is a fascinating highlight on the fact that in EBM, we change our minds based on the current best evidence. By contrast, in alternative medicine, as we have often lamented on this blog, minds do not easily change and all too often dogma seems to reign.

The new Cochrane review is important in several ways. Firstly, it affirms an appropriately high standard for such reviews. Secondly, it originates from a research team that has, in the past, been outspokenly pro-acupuncture; it is therefore unlikely that the largely negative findings were due to an anti-acupuncture bias. Thirdly – and most importantly – osteoarthritis has been THE condition for which even critical reviewers had to admit that there was at least some good, positive evidence.

It seems therefore, that yet again a beautiful theory has been slain by an ugly fact.

Switzerland seems to be something like the ‘promised land’ for homeopaths – at least this is what many homeopaths seem think. However, homeopaths’ thinking is rarely correct, and the situation of homeopathy in Switzerland is not quite what they believe it to be.

This article explains (my English explanations are below for all those you cannot do German):

________________________________________________________________________________

Die Schweiz bekommt die steigenden Gesundheitskosten einfach nicht in den Griff. In den 20 Jahren zwischen 1996 und 2016 haben sie sich um rund 255,2 Prozent erhöht…
Einer der Gründe für den Anstieg: Seit 2017 sind Komplementärmedizinische Methoden wie beispielsweise Homöopathie auch in der Grundversorgung inbegriffen. Das Volk hatte im Jahr 2009 einen entsprechenden Verfassungsartikel angenommen. Damals hoffte man noch, dass mit dem erleichterten Zugang zur Komplementärmedizin die Gesundheitskosten sinken würden.
Doch es kam anders. Die Komplementärmedizin verursachte letztes Jahr zusätzliche Kosten von 30 Millionen Franken, wie Sandra Kobelt, Sprecherin Krankenkassenverbandes Santésuisse, gegenüber BLICK bestätigt.

Die Komplementärmedizin sorgt entsprechend weiter für Diskussionen. Auch, weil zum Beispiel die Wirkung der beliebten Globuli-Kügeli bis heute höchst umstritten bleibt. Doch auch sie werden laut neuem Gesetz in jedem Fall von der Krankenkasse bezahlt, sofern sie von einem Homöopathen mit medizinischem Fachausweis verschrieben wurden…

Aus wissenschaftlicher Sicht macht diese Bevorzugung der Homöopathie wenig Sinn. Denn: In einem Statement aus dem Jahr 2017 bestritten insgesamt 25 europäische Wissenschaftsvereinigungen die Wirksamkeit von Globuli. Darunter auch die Akademien der Wissenschaft Schweiz, die mit den Schweizer Hochschulen zusammenarbeiten. Sie halten fest, dass Homöopathie sogar gefährlich sein kann, da zu ihren Gunsten eine schulmedizinische Therapie aufgeschoben oder gar abgelehnt wird.

Dieser Meinung ist auch Beda Stadler, der ehemalige Leiter des Instituts für Immunologie an der Uni Bern. «Globuli verursachen nur unnötige Gesundheitskosten», sagt er. Man habe das Volk 2009 getäuscht, indem man ihm erzählte, Globuli wären ja günstig. «Doch viele Allergiker setzen die Globuli nicht ab, nachdem sie keine Wirkung festgestellt haben. Stattdessen schlucken sie noch zusätzlich medizinische Tabletten – das verursacht doppelte Kosten», so Stadler.

Homöopathin und Ärztin Doktor Gisela Etter hält dagegen. «Ich erlebe jeden Tag, wie Homöopathie bei Allergikern wirkt. Bei vielen treten die Symptome nach einiger Zeit überhaupt nicht mehr auf», sagt sie. Das Problem: Den Wirkungsmechanismus der Globuli kann die Medizinerin nicht erklären. «Das ist mit den herkömmlichen Naturwissenschaften gar nicht möglich», so Etter…

_________________________________________________________________________

Let me try to translate the key points of this article:

  • The costs for healthcare have exploded in Switzerland; an increase of > 255% during the last 10 years.
  • One reason for this development is that, since 2017, the Swiss get various alternative therapies reimbursed, including homeopathy.
  • That move has cost 30 000 000 Francs last year.
  • The efficacy of homeopathic remedies is controversial.
  • Yet they are being paid for by Swiss health insurances, provided they are prescribed by a qualified doctor.
  • This does not make sense from a scientific perspective.
  • In 2017, 25 European scientific societies, including the Swiss academies, stated that homeopathy does not work and can even be dangerous, if it replaces effective treatments.
  • Beda Stadler, former director of the Institute of Immunology, Uni Bern said “Globuli only cause unnecessary healthcare costs”
  • Homoeopath Gisela Etter said “I see every day how homeopathy works for allergies… to explain the mechanism of action is not possible with conventional science.”

__________________________________________________________________________________

I suppose, we will have to wait for some unconventional science then!

Many charities in the UK (and most other countries) openly promote bogus treatments. After having been reminded of this fact regularly, the UK Charity Commission have decided to look into this issue. Arguably, such charities – I have previously discussed ‘YES TO LIFE’  as an example (in total there are several hundred ‘SCAM charities’ operating in the UK today)-  do not provide a valuable public service and should therefore not benefit from such status and tax privileges. While the commission is contemplating, an article in the NEW SCIENTIST provided more information on this important issue. Here are a few excerpts:

A commission briefing document says the most important issue is the level of evidence it will require to judge whether a provider of complementary therapy dispenses services of benefit to public health, thereby qualifying legally for charitable status. The document says that at present, suitable evidence includes peer-reviewed research in recognised medical journals such as The Lancet or the BMJ, or recognition by the Department of Health or other government regulatory bodies. Personal testimonies and anecdotal evidence are not sufficient to demonstrate efficacy, says the commission, and nor are non-scientific articles and features promoting methods, treatments or therapies.

However, organisations such as the Good Thinking Society have presented evidence that these standards are not being applied rigorously, meaning some organisations may have been granted charitable status without the necessary evidence that their therapies are of benefit to public health. The commission is reassessing how its existing guidelines are enforced. It is also seeking guidance on how to deal with conflicting or inconsistent evidence, or evidence that certain therapies might cause harm – by displacing conventional therapies, for example.

Complementary providers argue that it’s unfair to be judged purely on evidence in mainstream medical journals, as demanded by the Good Thinking Society. “We know there’s a well-being factor with some complementary medicines which could be palliative, or a placebo effect,” says Jayney Goddard, director of The Complementary Medical Association. “These include massage or meditation, for example, which have tremendously supportive effects, but if the evidence isn’t forthcoming, it means those charities currently offering them might not be able to in future.” If the consultation does ultimately result in revocation of charitable status for some providers, Goddard argues that this would make it harder for them to raise donations and benefit from tax breaks that make their services more affordable.

END OF QUOTE

The argument of Jayney Goddard borders on the ridiculous, of course. If treatment X improves well-being beyond placebo and generates more good than harm, it is clearly effective and the above debate does not even apply. But it obviously does not suffice to claim that treatment X improves well-being, it is mandatory to demonstrate it with sound evidence. If, on the other hand, treatment X has not been shown to be effective beyond placebo, it must be categorised as unproven or bogus. And promoting bogus treatments/ideas/concepts (including diverting patients from evidence-based treatments and undermining rational thought in our society at large) is unquestionably harmful both to individual patients and to society as a whole.

SCAM charities are thus dangerous, unethical and an obstacle to progress. They not only should lose their charitable privileges as a matter of urgency, but they should also be fined for endangering public health.

 

 

You may remember my post entitled “How turn a negative trial into a positive one? Simple, just cheat!

No?

Let me remind you by copying the relevant parts of my original post of 20/2/2018:

…The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.

The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.

From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.

Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!

As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.

This level of scientific misconduct is remarkable, even for the notoriously poor ..

END OF QUOTE

This article prompted me to do something I have only done once before: I filed an official complaint with the journal. I received a reply that they would look into it. Then there was silence; then came 2 or 3 emails that they are still considering my complaint. Yesterday, I finally received the following response:

Dear Dr. Ernst,

With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article.  The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email.  Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”

I look forward to hearing from you.

Kind regards…

And the attachment reads as follows:

Corrigendum to “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial”
Dear Dr. Ernst,

With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article. The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email. Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”

I look forward to hearing from you.

Kind regards…
Chunhoo Cheon,1 Jeong-Eun Yoo,2 Hwa-Seung Yoo,2 Chong-Kwan Cho,2 Sohyeon Kang,1 Mia Kim,3 Bo-Hyoung Jang,1 Yong-Cheol Shin,1 and Seong-Gyu Ko1

1Department of Preventive Medicine, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea 2Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea 3Department of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea

In the article titled “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial” [1], there was an error in the conclusion of the Abstract where the text reading “Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy” should be corrected to “In the present study, Sipjeondaebo-tang did not show a significant effect on anorexia in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess the efficacy”.

References

1. Chunhoo Cheon, Jeong-Eun Yoo, Hwa-Seung Yoo, et al., “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial,” Evidence-Based Complementary and Alternative Medicine, vol. 2017, Article ID 8780325, 9 pages, 2017. doi:10.1155/2017/8780325


So, what should we make of all this?

On the one hand, it is laudable that the Journal does correct the mistake. Bravo!!!

On the other hand, I find it odd that only the authors seem to be found guilty of an ‘error’. Even if it was just a error – and I am happy to give them the benefit of the doubt – there are other parties involved. The reviewers have a responsibility and so does the editor! Should they not own up to it?

In the end, this sorry tale does not restore my confidence in this Journal, quite the opposite. In view of all this, I have to repeat what I stated in my previous post:

I strongly suggest that:

  1. The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
  2. The paper is withdrawn because it can only mislead vulnerable patients.

PS

Needless to say that my reply to the above-cited email was to uphold my complaint and urge the Journal to publish an adequate response that includes and explains the failures of the reviewers and the editor. So: watch this space!

The RCC is a relatively new organisation. It is a registered charity claiming to promote “professional excellence, quality and safety in chiropractic… The organisation promotes and supports high standards of education, practice and research, enabling chiropractors to provide, and to be recognised for providing, high quality care for patients.”

I have to admit that I was not impressed by the creation of the RCC and lately have not followed what they are up to – not a lot, I assumed. But now they seem to plan a flurry of most laudable activities:

The Royal College of Chiropractors is developing a range of initiatives designed to help chiropractors actively engage with health promotion, with a particular focus on key areas of public health including physical activity, obesity and mental wellbeing.

Dr Mark Gurden, Chair of the RCC Health Policy Unit, commented:

“Chiropractors are well placed to participate in public health initiatives. Collectively, they have several million opportunities every year in the UK to support people in making positive changes to their general health and wellbeing, as well as helping them manage their musculoskeletal health of course.

Our recent AGM & Winter Conference highlighted the RCC’s intentions to encourage chiropractors to engage with a public health agenda and we are now embarking on a programme to:

  • Help chiropractors recognise the importance of their public health role;
  • Help chiropractors enhance their knowledge and skills in providing advice and support to patients in key areas of public health through provision of information, guidance and training;
  • Help chiropractors measure and recognise the impact they can have in key areas of public health.

To take this work forward, we will be exploring the possibility of launching an RCC Public Health Promotion & Wellbeing Society with a view to establishing a new Specialist Faculty in due course.”

END OF QUOTE

A ‘Public Health Promotion & Wellbeing Society’. Great!

As this must be new ground for the RCC, let me list a few suggestions as to how they could make more meaningful contributions to public health:

  • They could tell their members that immunisations are interventions that save millions of lives and are therefore in the interest of public health. Many chiropractors still have a very disturbed attitude towards immunisation: anti-vaccination attitudes still abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit. In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)
  • They could tell their members that chiropractic for children is little else than a dangerous nonsense for the sake of making money. Not only is there ‘not a jot of evidence‘ that it is effective for paediatric conditions, it can also cause serious harm. I fear that this suggestion is unlikely to be well-received by the RCC; they even have something called a ‘Paediatrics Faculty’!
  • They could tell their members that making bogus claims is not just naughty but hinders public health. Whenever I look on the Internet, I find more false than true claims made by chiropractors, RCC members or not.
  • They could tell their members that informed consent is not an option but an ethical imperative. Actually, the RCC do say something about the issue: The BMJ has highlighted a recent UK Supreme Court ruling that effectively means a doctor can no longer decide what a patient needs to know about the risks of treatment when seeking consent. Doctors will now have to take reasonable care to ensure the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. Furthermore, what counts as material risk can no longer be based on a responsible body of medical opinion, but rather on the view of ‘a reasonable person in the patient’s position’. The BMJ article is available here. The RCC feels it is important for chiropractors to be aware of this development which is relevant to all healthcare professionals. That’s splendid! So, chiropractors are finally being instructed to obtain informed consent from all their patients before starting treatment. This means that patients must be told that spinal manipulation is associated with very serious risks, AND that, in addition, ~ 50% of all patients will suffer from mild to moderate side effects, AND that there are always less risky and more effective treatments available for any condition from other healthcare providers.
  • The RCC could, for the benefit of public health, establish a compulsory register of adverse effects after spinal manipulations and make the data from it available to the public. At present such a register does not exist, and therefore its introduction would be a significant step in the right direction.
  • The RCC could make it mandatory for all members to adhere to the above points and establish a mechanism of monitoring their behaviour to make sure that, for the sake of public health, they all do take these issues seriously.

I do realise that the RCC may not currently have the expertise and know-how to adopt my suggestions, as these issues are rather new to them. To support the RCC in their praiseworthy endeavours, I herewith offer to give one or more evidence-based lectures on these subjects (at a date and place of their choice) in an attempt to familiarise the RCC and its members with these important aspects of public health. I also realise that the RCC may not have the funds to pay professorial lecture fees. Therefore, in the interest of both progress and public health, I offer to give these lectures for free.

I can be contacted via this blog.

I have often criticised papers published by chiropractors.

Not today!

This article is excellent and I therefore quote extensively from it.

The objective of this systematic review was to investigate, if there is any evidence that spinal manipulations/chiropractic care can be used in primary prevention (PP) and/or early secondary prevention in diseases other than musculoskeletal conditions. The authors conducted extensive literature searches to locate all studies in this area. Of the 13.099 titles scrutinized, 13 articles were included (8 clinical studies and 5 population studies). They dealt with various disorders of public health importance such as diastolic blood pressure, blood test immunological markers, and mortality. Only two clinical studies could be used for data synthesis. None showed any effect of spinal manipulation/chiropractic treatment.

The authors concluded that they found no evidence in the literature of an effect of chiropractic treatment in the scope of PP or early secondary prevention for disease in general. Chiropractors have to assume their role as evidence-based clinicians and the leaders of the profession must accept that it is harmful to the profession to imply a public health importance in relation to the prevention of such diseases through manipulative therapy/chiropractic treatment.

In addition to this courageous conclusion (the paper is authored by a chiropractor and published in a chiro journal), the authors make the following comments:

Beliefs that a spinal subluxation can cause a multitude of diseases and that its removal can prevent them is clearly at odds with present-day concepts, as the aetiology of most diseases today is considered to be multi-causal, rarely mono-causal. It therefore seems naïve when chiropractors attempt to control the combined effects of environmental, social, biological including genetic as well as noxious lifestyle factors through the simple treatment of the spine. In addition, there is presently no obvious emphasis on the spine and the peripheral nervous system as the governing organ in relation to most pathologies of the human body.

The ‘subluxation model’ can be summarized through several concepts, each with its obvious weakness. According to the first three, (i) disturbances in the spine (frequently called ‘subluxations’) exist and (ii) these can cause a multitude of diseases. (iii) These subluxations can be detected in a chiropractic examination, even before symptoms arise. However, to date, the subluxation has been elusive, as there is no proof for its existence. Statements that there is a causal link between subluxations and various diseases should therefore not be made. The fourth and fifth concepts deal with the treatment, namely (iv) that chiropractic adjustments can remove subluxations, (v) resulting in improved health status. However, even if there were an improvement of a condition following treatment, this does not mean that the underlying theory is correct. In other words, any improvement may or may not be caused by the treatment, and even if so, it does not automatically validate the underlying theory that subluxations cause disease…

Although at first look there appears to be a literature on this subject, it is apparent that most authors lack knowledge in research methodology. The two methodologically acceptable studies in our review were found in PubMed, whereas most of the others were identified in the non-indexed literature. We therefore conclude that it may not be worthwhile in the future to search extensively the non-indexed chiropractic literature for high quality research articles.

One misunderstanding requires some explanations; case reports are usually not considered suitable evidence for effect of treatment, even if the cases relate to patients who ‘recovered’ with treatment. The reasons for this are multiple, such as:

  • Individual cases, usually picked out on the basis of their uniqueness, do not reflect general patterns.
  • Individual successful cases, even if correctly interpreted must be validated in a ‘proper’ research design, which usually means that presumed effect must be tested in a properly powered and designed randomized controlled trial.
  • One or two successful cases may reflect a true but very unusual recovery, and such cases are more likely to be written up and published as clinicians do not take the time to marvel over and spend time on writing and publishing all the other unsuccessful treatment attempts.
  • Recovery may be co-incidental, caused by some other aspect in the patient’s life or it may simply reflect the natural course of the disease, such as natural remission or the regression towards the mean, which in human physiology means that low values tend to increase and high values decrease over time.
  • Cases are usually captured at the end because the results indicate success, meaning that the clinical file has to be reconstructed, because tests were used for clinical reasons and not for research reasons (i.e. recorded by the treating clinician during an ordinary clinical session) and therefore usually not objective and reproducible.
  • The presumed results of the treatment of the disease is communicated from the patient to the treating clinician and not to a third, neutral person and obviously this link is not blinded, so the clinician is both biased in favour of his own treatment and aware of which treatment was given, and so is the patient, which may result in overly positive reporting. The patient wants to please the sympathetic clinician and the clinician is proud of his own work and overestimates the results.
  • The long-term effects are usually not known.
  • Further, and most importantly, there is no control group, so it is impossible to compare the results to an untreated or otherwise treated person or group of persons.

Nevertheless, it is common to see case reports in some research journals and in communities with readers/practitioners without a firmly established research culture it is often considered a good thing to ‘start’ by publishing case reports.

Case reports are useful for other reasons, such as indicating the need for further clinical studies in a specific patient population, describing a clinical presentation or treatment approach, explaining particular procedures, discussing cases, and referring to the evidence behind a clinical process, but they should not be used to make people believe that there is an effect of treatment…

For groups of chiropractors, prevention of disease through chiropractic treatment makes perfect sense, yet the credible literature is void of evidence thereof. Still, the majority of chiropractors practising this way probably believe that there is plenty of evidence in the literature. Clearly, if the chiropractic profession wishes to maintain credibility, it is time seriously to face this issue. Presently, there seems to be no reason why political associations and educational institutions should recommend spinal care to prevent disease in general, unless relevant and acceptable research evidence can be produced to support such activities. In order to be allowed to continue this practice, proper and relevant research is therefore needed…

All chiropractors who want to update their knowledge or to have an evidence-based practice will search new information on the internet. If they are not trained to read the scientific literature, they might trust any article. In this situation, it is logical that the ‘believers’ will choose ‘attractive’ articles and trust the results, without checking the quality of the studies. It is therefore important to educate chiropractors to become relatively competent consumers of research, so they will not assume that every published article is a verity in itself…

END OF QUOTES

YES, YES YES!!!

I am so glad that some experts within the chiropractic community are now publishing statements like these.

This was long overdue.

How was it possible that so many chiropractors so far failed to become competent consumers of research?

Do they and their professional organisations not know that this is deeply unethical?

Actually, I fear they do and did so for a long time.

Why then did they not do anything about it ages ago?

I fear, the answer is as easy as it is disappointing:

If chiropractors systematically trained to become research-competent, the chiropractic profession would cease to exist; they would become a limited version of physiotherapists. There is simply not enough positive evidence to justify chiropractic. In other words, as chiropractic wants to survive, it has little choice other than remaining ignorant of the current best evidence.

I hear this argument so regularly that it might be worth analysing it (yet again) a bit closer.

It is used with the deepest of convictions by proponents of all sorts of quackery who point out that science does not know or explain everything – and certainly not their (very special) therapy. Science is just not sophisticated enough, they say; in fact, a few years ago, it could not even explain how Aspirin works. And just like Aspirin, their very special therapy – let’s call it energy healing (EH) for the sake of this post – does definitely and evidently work. There even is ample proof:

  • Patients get better after using EH, and surely patients don’t lie.
  • Patients pay for EH, and who would pay for something that does not work?
  • EH has survived hundreds of years, and ineffective therapies don’t.
  • EH practitioners have tons of experience and therefore know best.
  • They are respected by very important people and organisations.
  • EH is even reimbursed by some insurance companies.

You have all heard the argument, I’m sure.

How to respond?

The ‘proofs’ listed above are simply fallacies; as such they do not need more detailed discussions, I hope.

But how can we refute the notion that science is not yet sufficiently advanced to explain EH?

The simplest approach might be to explain that science has already tested EH and found it to be ineffective. There really is nothing more to say. And the often-quoted example of Aspirin does clearly not wash. True, a few decades ago, we did not know how it worked. But we always knew that it worked because we conducted clinical trials, and they generated positive results. These findings we the main reasons why scientists wanted to find out how it works, and eventually they did (and even got a Nobel Prize for it). Had the clinical trials not shown effectiveness, nobody would have been interested in alleged mechanisms of action.

With EH, things are different. Rigorous clinical trials of EH have been conducted, and the totality of this evidence fails to show that EH works. Therefore, chasing after a mechanism of action would be silly and wasteful. It’s true, science cannot explain EH, but this is not because it is not yet sophisticated enough; it is because there is nothing to explain. EH has been disproven, and waffling about ‘science is not yet able to explain it’ is either a deliberate lie or a serious delusion.

So far so good. But what if EH had not been submitted to clinical trials?

In such cases, the above line of argument would not work very well.

For instance, as far as I know, there is not a single rigorous clinical trial of crystal healing (CH). Does that mean that perhaps CH-proponents are correct when claiming that it does evidently work and science simply cannot yet understand how?

No, I don’t think so.

Like most of the untested alternative therapies, CH is not based on plausible assumptions. In fact, the implausibility of the underlying assumptions is the reason why such treatments have not and probably never will be submitted to rigorous clinical trials. Why should anyone waste his time and our money running expensive tests on something that is so extremely unlikely? Arguably doing so would even be unethical.

With highly implausible therapies we need no trials, and we do not need to fear that science is not yet sufficiently advance to explain them. In fact, science is sufficiently advanced to be certain that there can be no explanation that is in line with the known laws of nature.

Sadly, some truly deluded fans of CH might still not be satisfied and respond to our reasoning that we need a ‘paradigm shift’. They might say that science cannot explain CH because it is stuck in the straightjacket of an obsolete paradigm which does not cater for phenomena like CH.

Yet this last and desperate attempt of the fanatics is not a logical refuge. Paradigm shifts are not required because some quack thinks so, they are needed only if data have been emerging that cannot possibly be explained within the current paradigm. But this is never the case in alternative medicine. We can explain all the experience of advocates, positive results of researchers and ‘miracle’ cures of patients that are being reported. We know that the experiences are real, but are sure that their explanations of the experience are false. They are not due to the treatment per se but to other phenomena such as placebo effects, natural history, regression towards the mean, spontaneous recovery, etc.

So, whichever way we turn things, and whichever way enthusiasts of alternative therapies twist them, their argument that ‘SCIENCE IS NOT YET ABLE TO EXPLAIN’ is simply wrong.

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