The “Suppressed First Report” of the NHMRC – Source of “Encouraging Evidence”?

Waste paper (symbol picture)

The Central Association of Homeopathic Physicians (DZVhÄ) has recently published an article on its website under the heading “Encouraging Evidence on Homeopathy” (in German) and also sent out several press releases.

The largest (but by no means the only) review of homeopathic studies currently available is the 2015 “NHMRC” review, published by the Australian Health Authority in a summary information paper, which concluded that no homeopathically treated condition has been shown to be effective (beyond placebo and contextual effects). Of course, this did not suit homeopath’s ideas and they tried for years to obtain a former version of the review, which was claimed to have originally spoken for homeopathy, but was then “suppressed”. Under “Release the first Report” homoeopaths from all over the world kept on raging until the Australian health authorities agreed to publish the “first version” from 2012. The homeopathic fraction is now trying to capitalize on this release and derive “encouraging evidence” from it.

This is astonishing, because the own homeopathic research of the highest evidence class (among others four systematic reviews by R.T. Mathie on behalf of the Homeopathic Research Institute) corresponds exactly with the findings of the NHMRC review of 2015: There is no reliable evidence that homeopathy is specifically effective in any clinical picture.

From the preliminary draft of a major review, one suddenly wants to derive results that not even one’s own homeopathic research was able to achieve with years of effort?

A review of the “prehistory”

In a press release dated 12.04.2017, the DZVhÄ reported on a complaint against the review of the Australian Health Authority NHMRC of 2015, which found no reliable evidence for homeopathy for any indication. The DVZhÄ coined the term “deception of the public” by allegedly serious failures of the NHMRC.

They announced that the English Homeopathy Research Institute (HRI) had “filed a complaint with an official Commonwealth office and published the first results of its research”. This “official Commonwealth office” was the Ombudsman of Her Majesty in Australia, who – to this day – was obviously somewhat astounded being expected to make a decision on a scientific question. This is probably the reason why such a decision – now after several years – does not exist. The existence of the complaint was confirmed after a long back and forth, but neither the HRI was the complainant nor was the text of the complaint ever disclosed. By the way, just as little as the “results of the research” by the HRI, nothing ever published did go beyond the enumeration of several points of a rather general nature (there was always talk of a “200-page paper”, which at any rate nobody outside the HRI got to see).

One, if not the central point, of the excitement was the allegation that there had been a first version of the NHMRC review, which, since it had allegedly been positive for homeopathy, had then been “suppressed” and replaced by the version published in 2015. Even petitions in Australia and England called for their disclosure. At the end of August then somewhat unexpected happened – the disclosure of the draft by the Australian health authority.

Now nobody could imagine, apart from the homoeopaths, who in the meantime had gotten stuck into this matter, that a state medical research centre had “suppressed” a draft of a major review, which – contrary to all previous investigations – would have come to a positive result for homoeopathy. And this is exactly what the NHMRC explained on the occasion of the publication of the draft: they wanted to “take the wind out of the sails” of the circulating rumours by the best of all possibilities, namely transparency. One may assume that this was done on the recommendation of Her Majesty’s Ombudsman in Australia, who has been sitting there with the complaint for several years now and obviously can’t do anything with it.

We will let representatives of the NHMRC have their say on the classification of the publication. First of all, the Executive Director Research Translation Branch , Alan Singh. Among other things, he writes:

“I would like to inform you that I am releasing an unfinished draft report, in an annotated form, of an overview of systematic reviews of homeopathy that was started in 2012 but never completed (frequently referred to as the 2012 draft report). There have been a number of enquiries about the 2012 draft report and requests for its release. I am aware of ongoing community interest in the content of this draft report, and that a substantial body of misinformation has grown up about it.

To address this misinformation, an annotated version of the 2012 draft report will be made available on the NHMRC website. The annotations provide context as to why the report was not developed further for use in NHMRC’s Homeopathy Review that produced the NHMRC Statement on Homeopathy and the NHMRC Information Paper: Evidence of the effectiveness of homeopathy for treating health conditions (2015). The 2012 draft report is simply an initial summary of the authors’ findings of systematic reviews on homeopathy: it was never completed and has not undergone the usual NHMRC quality assurance steps (for publication). (…)

NHMRC strongly encourages interested members of the community to refer to the 2015 NHMRC Information Paper: Evidence of the effectiveness of homeopathy for treating health conditions. This states that ‘based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.”

So the draft was the first – deficient – collection of material done by an external contractor – and no longer. The numerous comments of the NHMRC in the now published draft explain these deficiencies in detail. Ultimately, the accumulation of these shortcomings has been the deciding factor in abandoning and restarting the project. As you can see, it is basically an exaggeration to speak of a draft report at all.

This is simply the background to the “secret first draft/report”.

Science does not mean cherrypicking

What makes the DZVhÄ think to draw conclusions on homeopathic evidence from such a disordered and unevaluated conglomerate? Very simple – or even not. Just take the draft and use the proven method of “cherrypicking” to find passages from the preliminary assessments by the first contractor that seem to fit best. In addition, ignore the NHMRC’s numerous marginal comments, which explain why these classifications were not useful. The following illustration from a “homeopathic” tweet, which claimed to have “convicted” the NHMRC and discovered “evidence”, shows this visually in all clarity. One refers to the original statements in the first material collection and completely ignores (or sees in it a “suppression of the facts”) what the NHMRC noted in detail thereon. Color lottery: Black is valid, blue not, red is the color for cherrypicking?

So you reach into the trash of the NHMRC, pull out a crumpled note and think you can find in the original text “evidence” for misconduct, a “suppression” of valid results? To top it all off, you also ignore the accompanying remarks, which prove why the original statements were not usable? By the way, the systematic reviews compiled by the first contractor had all been known for a long time – nobody would have had to wait for the NHMRC to “suppress” them. Let’s remember: the draft (this time the right one) of the 2015 review was pre-published with the request to report publications not yet covered in it. This has indeed been done, the final review took into account a number of “post-notified” publications. More transparency? Nearly impossible.

One thing should be noted at this point. A systematic review is an overall view of many studies or – as here – of many previous reviews under methodical and statistically comparative evaluation of the work involved. The fact that studies / reviews with different results being included there is inherent in the system and precisely intended – it is a matter of the overall result. To select and uphold individual results with positive evidence, even if they are real, from the preparation of a review is an absurd reversal of the meaning of a review / a meta-analysis – namely the methodical determination of the “over-all evidence” just without “cherrypicking” – into its complete opposite. A review / a meta-analysis can only be viewed and criticized from the point of view of the final result. Even if one finds problematic evaluations of the studies / reviews included, the first question to be clarified is always whether they have any effect at all on the final result.

Solid evidence versus “encouraging evidence”

Here we come up to the term “encouraging evidence” again.To be seen in the screenshoat, the NHMRC rightly notes that the term “encouraging evidence” does not exist in the context of this study. Why not? Well, it does not exist at all as a term, it is simply not a scientific category, but a euphemism that the first contractor had inserted by “free fantasy”, so to speak. It is highly significant that precisely this passage, which convincingly proves the lack of qualification of the first contractors, is now also used as a positive term by the DDZVhÄ and widely quoted.

Prof. Anne Kelso, the general director of the NHMRC, becomes even clearer in her official statement on the publication of the draft (after all, this is the statement of the head of a high-ranking institution of the Australian government):

 “As part of the process to develop the NHMRC Statement on Homeopathy, an initial contractor was engaged to review the scientific evidence on the effectiveness of homeopathy in treating a variety of clinical conditions with the aim of providing Australians with reliable information about its use. Thecontract was terminated in August 2012 with the mutual agreement of NHMRC and the contractor. The draft of the unfinished report, titled The Effectiveness of Homeopathy: an overview review of secondary evidence (i.e. the 2012 draft report), was not endorsed by the expert Homeopathy Working Committee.

 A second reviewer was contracted and provided an overview of published systematic reviews and a review of submitted literature. The second contractor developed the NHMRC Information Paper: Evidence of the effectiveness of homeopathy for treating health conditions (published in March 2015 at the same time as the NHMRC Statement on Homeopathy).

The document I am releasing comprises the 2012 draft report in its entirety, with annotations that have been reviewed by the previous Chair of the Homeopathy Working Committee. These annotations have been made for context and to avoid misunderstanding of the draft report. ”

Truth or oppression?

Now one might still think that all this is just the next step in the suppression and manipulation of an alleged “truth”. One should only be aware that the threshold for the establishing of a veritable conspiracy theory would be finally crossed by that. What if the whole NHMRC review didn’t exist – what would that change? For the lack of evidence for homeopathy: nothing at all. There would be ten instead of eleven major systematic reviews to prove this.

But this is how one abuses the openness and transparency of the NHMRC: instead of disproving the conclusions of the 2015 review in a scientifically sound and reliable way (there has been sufficient time to do so), poking through the waste paper basket and searching for anything seeming useful für alleged evidence – for promoting a desired but not factual opinion.

It is significant that of all things the scientifically nonsensical term of an “encouraging evidence” is used for this as well. What this has to do with a scientific discussion about a medical question remains the secret of the DZVhÄ. Well, perhaps that’s the only way to keep in the debate a question being decided long ago at all – and to call for “more research” after more than 200 years without proof of efficacy. Isn’t that more in the direction of conspiracy theory, away from serious scientific discourse? We wish a good journey.


Previous publications of the INH on the NHMRC report:

Statement of the Homoeopathy Information Network on the HRI’s complaint about the Australian Ministry of Health (NHMRC) Review (in English available soon)

Open letter of the INH to the interview with Dr. Tournier (HRI) on “Homöopathie online”

Infinite Stories – once again to the Homeopathy Review of the NHMRC


Picture credits:  41330 on Pixabay / Screenshot twitter.com

Homeopathic preparations also don’t act through nanoparticles

Representatives of homeopathy often claim that nanoparticles of the mother tincture are the carriers of the effectiveness of homeopathic preparations. That this is not possible at all can be seen after quite simple considerations:

The image shows nanoparticles in an electron microscope image with a size scale in nanometers.
Nanoparticles in an electron microscope image

Nanoparticles are particles that consist of comparatively few atoms or molecules and are therefore very small. The size is measured according to “nanometres”, which is the millionth part of a millimetre. Because of their small size, nanoparticles have astonishing properties; they can penetrate cell membranes, for example, are very reactive and much more.

If homeopathy with nanoparticles is to work, such particles would have to be present in the finished preparation the patient is taking. These are particles from the mother tincture, the original substance with which the production of the homeopathic remedy began. And that is the key with which this assertion can quite simply be reduced to absurdity.

Potentiation is also dilution. This means that the more often you potentiate, the less of the starting material is present in the solution. And already from very early potencies the quantity of these atoms or molecules is no longer sufficient to form nanoparticles in appreciable numbers.

No problem, say the homeopaths, these nanoparticles are certainly somehow passed from one potency to the next quite completely. But nobody can explain how this is supposed to happen, how to make sure that the particles are also noticed if only one tenth or even one hundredth of the solution is removed in order to then potentiate them further. Nor what the point of this undertaking would be if it were successful. If the nanoparticles remain the same as before, what will change in the efficacy that is to be increased by potentiation?

Yes, homoeopaths say again, perhaps the particles will become smaller through the subsequent shaking and thus more reactive and thus more effective? Good answer, but why do we have to keep on diluting? Why can’t we just prepare the solution once, say one gram of primary substance to one litre of water or a mixture of water and alcohol, and then simply shake until the desired strength is reached? No more answer.

There is also no answer to the objection that in order to be effective via nanoparticles, the original substance itself must first form nanoparticles in the solution. This is precisely what substances that are soluble in solvents do not do. Just some of the most universally applicable homeopathic remedies, sodium chloratum, potassium carbonicum and arsenic album, are salts that form differently electrically charged particles (“ions”) in the solution, but no nanoparticles.

Now, however, nanoparticles have been found in sodium chloratum, even at highest potencies, there is even research on it? Yes, you did – but how? One has examined highly potentiated solution of sodium chloratum with an electron microscope for nanoparticles. The only problem is that the sample, i.e. the drop to be examined, has to be dried. The impurities contained in the solvent – 10 milligrams per cubic centimeter – remain and form crystals. And this is what can be found under the microscope: Crystals of impurities, the most common of which is the ubiquitous table salt, i.e. sodium chloratum. Of course, these crystals can also be found on the globules, theoretically at least, but when the patient takes them, the salt dissolves again in the saliva – and the nanoparticles observed are gone.

That should be enough. Let us spare ourselves the thought of how nanoparticles would actually have to be imagined if primordial substances from the animal and plant kingdoms were used. What do the nanoparticles contain in these cases? Which of the many thousands of different substances that make up an animal or a plant are combined to form nanoparticles? Or is the nanoparticle an extremely miniaturised image of the original organism that contains everything? If not, how is the right component selected? And what do the nanoparticles look like when non-material primary substances are used? Light, electricity or vacuum?

As you can see: The concept of nanoparticles as carriers of the effectiveness of homeopathic remedies generates more questions than answers and is absolutely not suitable to explain the effectiveness of homeopathic remedies.

Author: Dr. Norbert Aust

Further information:

Nanoparticles and homeopathy – how is that possible?

Picture credits: Wikimedia Commons; Lmackenzie89 – Own work, CC BY-SA 4.0,
https://commons.wikimedia.org/w/index.php?curid=56937308

Infinite Stories – once again to the Australian NHMRC’s 2015 review on homeopathy

The homoeopaths have long since discovered the title of Michael Ende’s well-known work “Die unendliche Geschichte” (“The Infinite Story”) as a quiet motto for themselves, as their constantly repeated “arguments” in favour of homeopathy prove. In a special context, they once again prove impressively that they are not about more than a constant warming up of the familiar on the hearth of rumours and half-truths.

In an article on “Nature and Medicine” Jens Behnke tries to keep the “serious accusations” against the review of the Australian health authority NHMRC, which have been floating freely in the homeopathic universe for more than two years, at operating temperature.

Let us remember that the Australian Health Authority’s review, conducted in rare cases with transparency and explicit involvement of the homeopathic side, is considered to be the most comprehensive study of the effectiveness of homeopathy ever. What was extremely badly received in some circles: Some time after the review was published in 2015, the information circulated that three homeopathic organisations from Australia had lodged a complaint against the NHMRC with Her Majesty’s Ombudsman (the “grievance box” for citizens’ concerns), complaining of “serious shortcomings” in the review. Significantly, the first news of this in Europe appeared in April 2016 (about eight months after the complaint had been lodged) in an institution that – quoting Prof. Ernst – had “often been at war with the truth”. The German Central Association of Homeopathic Physicians immediately circulated this report (original link expired, wording here) and, in particular, coined the word of “deception of the public” which has been recurring ever since.

The British Homeopathy Research Institute picked up this story in Europe, made itself, so to speak, the advocate of the matter and, according to its own statements, also prepared a “paper of evidence”. Since then, the ominous “deficiencies” of the review have been haunting the homoeopathic scene time and again and serve as arguments “against” the criticism of homoeopathy – now, once again, on “Nature and Medicine”.

Which is remarkable:

  • The text of the complaint was never made public,
  • the three complainants in Australia refuse to provide any information upon request (and have since erased any reference to the input from their websites),
  • the Ombudsman does not appear to be moving (a decision normally takes a maximum of three months, the filing date is August 2016 – which is only worth Mr Behnke a succinct final sentence on an alleged “ongoing procedure”) and
  • what has become known about the alleged “shortcomings” of the review has long since been invalidated.

Furthermore it was and is not recognizable in the least, what the known “complaints” are supposed to change in the result of the review – which in the end is no different than all other homeopathy reviews since 1991. Especially not different than the meanwhile three reviews of Robert H. Mathie, his sign employee of the British HRI. Just like the NHMRC, Mathie comes to the conclusion that there is no reliable evidence for homeopathic treatments.

We reported several times, contentwise here and here, to the history here, in detail in the Homöopedia. Compared to the status of these contributions, nothing has simply changed in the matter. Nevertheless, Mr. Behnke considers it necessary to remind the homeopathic fan community once again of the alleged “scandal” about the NHMRC review, which is slowly reminding us of a tabloid report.

In all this, the question is allowed: What is all this about? What is the point of reheating this rumour conglomerate, which has been kept warm on the stove of rumours for far too long? The intention to keep a “never ending story” alive here at the expense of critical voices is obvious. Recently, the – unexplained – fate of the complaint to the Australian Ombudsman has even been joined by a “petition” for “disclosure” of an alleged “first version” of the NHMRC review.

Incidentally, where does the homeopathic faction get its “findings” from on a “first version” of the review – a point apparently perceived as central – and what are the conclusions drawn from it? With the best will in the world, we do not know. In view of the “criticism” on this point, can we perhaps hope in the future for a section under “Nature and Medicine” in which all draft stages of Mr. Behnke’s articles will be published without interruption?

We find this – amazing. Because in the end all this shows a complete lack of interest in a real dissolution of the node protected by the homeopaths. Since when has a complaint to Her Majesty’s citizens’ grief box or a petition based on completely unproven rumours been a form of scientific debate?


Credits: Pixabay Creative Commons Lizenz CC0

Homeopathic study: The legend of the five times eight rats

Scientific Reports, quite a medical journal of good reputation, published on 10.09.2018 a paper entitled “Ultra-diluted Toxicodendron pubescens attenuates pro-inflammatory cytokines and ROS- mediated neuropathic pain [1] in rats“. The paper concludes that homeopathic high potencies based on Rhus toxicondendron (poison ivy, a traditional homeopathic remedy for pain symptoms) are at least as effective as Gabapentin in reducing pain and its molecular correlates (i.e. changes in the cellular signalling pathway), both in cell experiments (in vitro) and in animal experiments with rats.

Once again, parts of the homeopathic scene (associated with the exaggeration that the article appeared directly in “Nature“) announced the ultimate breakthrough in the effort to prove homeopathy “scientifically”. The Italian daily La Repubblica drew more attention to the matter with an article that was entranced by the statement:

The studies published in Scientific Reports confirm the effectiveness of homeopathic ultra-thin dilutions: Homeopathic medicine works and has statistically significant biological effects in alleviating neuropathic pain in rats. The effect of the dynamised dilutions was similar to that of Gabapentin […]”.

Note the lack of subjunctive, also the uncritical use of the term “statistically significant”, which as a statistical probability value does not allow conclusions to be drawn about the actual effect size, but which is suggested by the formulation. No reproach against a daily newspaper, but a suggestion for the public that is welcome in homeopathy and never corrected.

Proof of the efficacy of homeopathic high potencies – a bold statement, which must be considered in view of the contradiction to the homeopathic study situation according to the postulate “extraordinary claims require extraordinary proof”.

First of all, it is a completely unscientific conclusion that the paper “confirms the effectiveness of homeopathic ultra-thin dilutions”. A single study has no evidential value, but at most an indicative value, especially if it produces a highly unlikely result. Such a result must be replicated independently – preferably several times – before the described effect can be assumed with sufficient probability to be actually present and further scientific discussion can be initiated. All this is missing here.

A first glance shows that the in vivo tests on rats involved a total of 40 animals, which were divided into five test groups (n=8). This is astonishing with regard to the small number of test subjects. Should the “groundbreaking” result of the study be seriously based on the data of a verum group of eight animals? It can’t be inferred from the study that case number planning was carried out, highly required for intervention studies and representing a factor for the validity of the later results. Above all, if differences – as here – are to be determined in five differently parameterized groups (not only verum versus placebo or standard means), the careful determination of a sufficient and meaningful number of test objects is anything but trivial.

The publication also shows relatively easily identifiable uncleanliness / abnormalities, which the portal RESIS – Research Integrity Solutions – explains in a contribution by Enrico Bucci from Temple University in Philadelphia.

This starts with the fact that graphical representations of the in vitro results are partly incorrectly labeled, partly the same graphics were published for different parameters. Even more important is the fact that different effect/time diagrams (one for a cold test, one for a heat test in animal experiments) in all (!) displayed data points (“every experimental point”) correspond 1 : 1 (which is not immediately visible due to the differently selected axis sizes), so that RESIS draws the conclusion that something elementary cannot be correct here – random chance excluded. The raw data are not published – of course not. RESIS states: If there are really two different experiments, the shown coincidence of the data is simply impossible.

RESIS points out that these are not the only statistical-numerological inconsistencies and rightly believes that this is enough to discredit the validity of the study. Other portals and forums have also already taken a critical look at the work, e.g. PubPeer, where the panelists go into even more critical detail.

A particularly strange circumstance, in which journals usually tend to react very sensitively, is added. One of the authors of the Indian research group names a mail address that was demonstrably used in another work by an author of another name. This is not only completely unusual, but also doesn’t correspond in any way to good practice and integrity in publishing.

The pharmacology professor Silvio Garattini, who has discovered further methodological shortcomings on the sanita24 portal, concludes: “Homeopathy remains a method without scientific proof, and there is no change of that because of the alleged efficacy claimed by the studies published in Scientific Reports”.

We agree – and ask ourselves together with RESIS, how such a work can survive a peer review for a journal, also in view of the responsibility a journal has towards the scientific community and the public. This does not mean, however, that there can be no mistakes in scientific publishing, not at all. However, one can rely on the self-control of the scientific community, as in this case.

After all, the publication of Scientific Reports now carries an editor’s note that refers to the objections against the work and announces “appropriate editorial measures” “as soon as this matter has been clarified”. The quick-shot statement of the authors of the study that this may be all, but does not change the result seems to no longer satisfy the editors of Scientific Reports.


Supplement, 11.10.2018, 15:00 o’clock:

In the meantime, “Nature”, the “mother journal” of Scientific Reports, also reports on the matter. They are striving for neutrality, but with a rather critical undertone.


Supplement, 11.06.2019:

As Retraction Watch reports, the study has just been retracted by Scientific Reports. Scientific Reports published a comprehensive retraction note today (11.06.2019). It says:

Following publication, the journal received criticisms regarding the rationale of this study and the plausibility of its central conclusions. Expert advice was obtained, and the following issues were determined to undermine confidence in the reliability of the study.

The in vitro model does not support the main conclusion of the paper that Rhus Tox reduces pain. The qualitative and quantitative composition of the Rhus Tox extract is unknown. Figures 1G and 1H are duplicates; and figures 1I and 1J are duplicates. The majority of experimental points reported in figure 3 panel A are duplicated in figure 3 panel B. The collection, description, analysis and presentation of the behavioural data in Figure 3 is inadequate and cannot be relied upon.

As a result the editors are retracting the Article. The authors do not agree with the retraction.

In other words, everything that was already the main object of criticism eight months ago bears out. Nature resp. Scientific Reports must not be criticized for the period of time that has elapsed until the retraction, here is carefully examined and external neutral expert knowledge is used. All the more important is a complete retract. It is noteworthy that the main author of the study does not agree at all with the withdrawal and repeats his indications that it is a matter of “typos” and perhaps a little laxity in the publication. This can probably be seen as a mixture between massive confirmation bias and defensive strategy. More interesting, the question remains how such a work could “slip” through the peer review of a highly respected scientific publication.

Our conclusion:

Another case from the colourful wreath of the famous “many studies” that “undoubtedly prove the effectiveness of homeopathy”, as it is heard every day. The special thing about this case compared to many others is its deep fall: After all, it was loudly exclaimed as the ultimate proof of the “efficacy of homeopathic ultra-dilutions” and thus settled even a few floors above the well-known “results” of Jacques Benveniste and Luc Montagnier – these two had “only” postulated that they had found “differences” between pure solvent and homeopathic high potencies, not more. Here in the case of the “rat study” it was even up to “efficacy of homeopathy”…

Failed, once more. The lack of evidence of homeopathy is a fact; it has not been able to prove such evidence either for individual indications or as a method. With studies such as this, she at least continues to contribute to its discrediting. We rest our case.


 

1] ROS: Reactive Oxygene Species, known as “free radicals”. A mediating role of ROS in intra- and intercellular signalling processes is considered to be assured


Picture credits: Screenshot Scientific Reports online

Criticism on criticism on Homeopathy #1: “There is no evidence”

“There is no scientific evidence that homeopathy works.”

It is evident that homeopathy associations are dealing with critical arguments more intensively than before, e.g. with the work of the Information Network on Homeopathy (INH), a Germany-based team of doctors, pharmacists and other scientists with a skeptic’s approach on homeopathy. The Homeopathy Research Institute (HRI) on the other hand is a London-based organization that promotes more homeopathy research and tries to present homeopathy as scientifically proven.

On the HRI website, you can find a menu item “FAQ Homeopathy”, where they try to argue some of the key statements made by homeopathy critics. The articles are presented in English, German and a few other languages. These articles seem to be meant as templates to refute critics like us, and they were used for a small brochure by DHU (Deutsche Homöopathie Union), which will very likely be distributed at the various lectures and training sessions DHU promotes. DHU by their own account is the leading manufacturer of homeopathic preparations in Germany, offering and sponsoring trainings for doctors, pharmacists, midwives etc., not to forget their support for a lot of health-related websites targeted at a lay audience.

In a short series of articles, we want to examine how and why we homeopathy critics come to our conclusions, and what to think of the counter-arguments of homeopathy promoters. Our articles will be published in three text versions in German, which will be posted simultaneously on my blog, on the website of the INH, and at Susannchen; and if these pieces are received favorably, we will translate the most detailed version to English, too (this is what you see here).

Background: Why do we need scientific evidence of efficacy?

It certainly is of advantage if the doctor you consult for your complaints uses a therapy that they know is suitable for having a beneficial effect on your complaints. The therapist’s personal experience is certainly not enough to establish the efficacy of a therapy – not to mention the question of what happens to the patients on whom the experience is gathered by trial and error.

After all, it is not so easy to identify if a therapy is successful. One of the reasons is the pronounced tendency to self-healing, without which we would have gone extinct as a species long ago. This means that people (or animals or plants) become healthy and may recover even from life-threatening conditions without the help of medical interventions. Even in severe infectious diseases, there are people who survive them. If a doctor administers a therapy and the patient recovers afterwards, it is not certain that it was the therapy that caused the improvement. In pre-scientific times, for example, a lot of things were considered effective cures that today seem outright bizarre, like using the dust of church bells, crushed sketches of saints, or the fat and bones of executed criminals. Assuming that not all doctors from the Middle Ages up to the middle of the 19th century were charlatans, these people were convinced that they could actually heal with their cures, simply because they saw that patients became healthy afterwards, sometimes maybe even despite their interventions. The gathering of experience by the therapist may lead to misconceptions about the power of his cures.

It is obvious that medicine will improve – and has done so in the recent past – by identifying and discarding ineffective therapies. Doctors of today have a wide range of effective methods at their disposal, with data on the conditions they may be useful for, and the probabilities of success, or they can find out risks and benefits. Waiving evidence of efficacy would mean a step backwards into the pre-scientific era, when it was more or less a matter of good luck whether the doctor prescribed an actually helpful medicine.

Background: What is scientific evidence?

Evidence of efficacy requires a drug to show an effect in patients which is established by scientific experiments. Such trials are performed on a larger number of patients so that the results are not distorted by individual patients’ characteristics. The participants are randomly divided into two groups, one of which takes the drug to be tested (“verum group”), the other a placebo without any active substance (“control group”). It is important that the patients themselves are “blinded” and do not know whether or not they received the actual medication. The same holds for the doctors or caregivers, so that all the patients receive the same care. Scientifically sound evidence of efficacy will be based on such studies. This is the gold standard of evidence, the placebo-controlled, randomized, double-blinded clinical trial (PCT). This study design is suitable for the individualized therapy approach of homeopathy as well. There are a number of such studies (also systematic reviews of them): all subjects go through the initial consultation and a drug is prescribed. In the pharmacy either the prescribed drug or a placebo is randomly supplied to the patient.

If the remedy under test is effective, the outcomes between the two groups will differ, but it is necessary to determine whether the difference observed really is likely to be caused by the drug. Even in a control group that actually remains untreated, improvements occur which are evidently not caused by the drug. This may be due to the self-healing powers of the immune system, natural self-limiting disease propagation, or the often-cited placebo effect, in which the patient’s expectations and trust in the cure cause an improvement in the patient’s condition, or at least they strongly promote the improvement.

Since both the placebo and verum group usually show improvements in symptoms, the result must be evaluated with statistical methods to check if different outcomes between the groups may have been caused by chance alone, due to allocation of the patients to their groups. So the result of a clinical study is not a clear yes-or-no. Only if the probability that the difference between the groups has been caused by chance is below a scientifically agreed threshold of 5%, it is concluded that the drug may have caused the difference, and hence may be having an effect.

However, even ineffective drugs may produce improbable results occasionally, that look like a telltale sign of a less than 5% probability, but still are a product of mere chance alone. Therefore a single positive study cannot be a scientific “proof”, but it must be replicated independently – at least by a different team of researchers with a different set of patients. Almost certainly there will be fluctuations during replications, some may even yield quite different results. To arrive at a final conclusion from a set of trials, a systematic review is required, in which all published studies on a particular cure for a given clinical condition are examined and an overall result is determined. It is important that all available studies are taken into consideration, not only the positive ones. Such a review would then be considered reliable evidence if the data basis is adequate – but still would not be considered an eternal “proof” in the sense that it’s impossible for this conclusion to be wrong. Individual studies can only provide a more or less strong indication of potential efficacy.

To note: Even if a systematic review would yield positive findings for homeopathy, this could establish the effectiveness of homeopathy for the specific condition under investigation only. No study or review can prove the efficacy of homeopathy in general.

Background: Why are case studies and individual reports not proof of an effect?

Due to the self-healing powers already referred to, which certainly exist at different levels in different individuals, there are always people who can improve even in serious conditions without any cure – people that can survive the most serious infectious diseases or even cancer, for example. There may be only a few of them, but they do exist. “Mortality of 80% when untreated” indicates that 20% of untreated people survive. As a result, there will always be patients who can report that they have (supposedly) been cured because of this or that therapy, or because of whatever they did – like prayer, or promising to be good in the future, or erecting a church, or whatever –, even if it did not contribute anything real to progress their recovery. On the other hand, there always will be people who do not respond to an otherwise effective treatment and who may die from a disease despite a usually successful cure.

Consider the results of a recent study on alternative medical treatment of cancer. The results seven years after diagnosis and after alternative or conventional treatment looked like this (data transformed to meaningful numbers and entities) [1]:

Patients after seven years Alternative Therapy Conventional Therapy
Survived 144 208
Deceased 136 72

From the 144 patients who survived for seven years under the alternative therapy, certainly a whole lot of case studies can be derived, all of which indicate the success of alternative medicine. You may even refer to the 72 patients that died under conventional cancer therapy to stress the point of alleged superior performance of the alternative therapy.

Even if positive cases under conventional therapy may find their way into case studies as well: what for sure will remain unnoticed is the fact that considerably more of the conventionally treated patients survived than under alternative treatment. And for sure there will be very few case studies of the deaths under alternative treatment, if any at all. At least the author of this piece is not aware of any such case studies from alternative medicine that had a negative outcome. But this does not mean, they do not exist – only that the therapist is unwilling to share his failure.

The fact that considerably more patients under alternative medicine died than in the conventional group is completely lost in case studies. After all, those who have died in excess are lying in their graves and do not boast their failure in talk shows, books, or interviews.

After all, it is hardly to be expected that therapists will publish their failures in case studies and disseminate them as widely as their positive results advertising them with the same rigor: A very important point to assess the effectiveness of a therapy is therefore missing. That would be like counting only the goals that your team scored – forgetting they received a lot more from their opponents.

In a nutshell: Case studies of successful treatments, even in large numbers, only show that there are a number of people who recover under the alternative treatment – and nothing else. There is no denying that these cases exist, but this is no indication if there might be many more patients who did not fare so well. But the real patients and their therapists would need some information on the chances of recovery – which includes the ratio of failed treatments.

Facts: What evidence is available?

HRI states that by the end of 2014 there have been 189 randomized controlled clinical studies, 104 of which compared homeopathy with placebo. Of these, 43 allegedly showed positive results for homeopathy, 5 were negative, and 56 were “unclear” – which brings them to the conclusion, that there are more positive than negative studies which is considered to indicate some efficacy of homeopathy.

What’s strange: Apparently, the authors of this HRI article consider the fact that the efficacy of a homeopathic remedy is “unclear”, that is it cannot be reliably distinguished from a placebo, i. e. it works in the same way as a piece of sugar, is not a negative result. That’s quite amazing. One wonders whether patients who spend their money on an ineffective, sugar-like remedy and perhaps hope for an improvement of their condition would see it the same way?

In any case, by no means the majority of studies have yielded positive results.

The ratio of more than 40% of successful studies looks impressive at first, but is misleading still.

First of all, because of the probability of the false-positive results of 5%, it is to be expected that there will be some positive studies, which are nevertheless random results.

Then there is the so-called publication bias, also known as file-drawer effect: the fact that positive results are readily and willingly published, whereas negative ones tend to remain in the file-drawer forever, never to be spoken or heard of again.

In addition, there are shortcomings in the published studies, such as inadequate blinding of the test subjects, or inappropriate methods of evaluation, which can lead to the results being skewed in a positive direction, and a lot more issues that render a study of poor quality. All of this increases the proportion of positive studies in the database.

As already explained, evidence for efficacy of homeopathy for any indication can only be derived if studies have been independently repeated and the results of all of them pooled in a systematic review. It goes without saying that this review should cover the entire available evidence, not just the positive results.

Such reviews do exist indeed. Starting with a work by Kleijnen et al. from 1991 [2] to the recent work by Mathie et al. in 2019 [3], there are twelve major reviews, which examine homeopathy across indications, and all more or less yield the same result: On first glance the evidence in total may indicate that there could be small effects above placebo, but the quality of the available studies is so poor that no reliable conclusions can be drawn. Neither for homeopathy in general nor for any indication is there reliable evidence that homeopathy outperforms placebo. The largest review published so far, the one by the Australian Ministry of Health in 2015, comes to this conclusion [4], as does Mathie whose affiliation is the Homeopathy Research Institute.

Conclusion
There is in fact no scientific evidence that homeopathy works.

 

What homeopaths tell us about it

The HRI muses that 43% of positive studies are the same ratio of success as in conventional medicine. So what? What is such a comparison supposed to show? If I want to compare my literary skills with those of Charles Dickens, it is certainly not helpful to ascertain that my ratio of torn and discarded pages may be the same as his. It would be important to compare what remains – in terms of quality of course, not quantity. Or does this article sound anything like David Copperfield?

Such an approach based on the motto “Who won?” is absurd. In addition, homeopathic studies are confirmation research, i. e. the search for a positive result. In the lore of homeopathy there is no need for clinical trials, and in Europe homeopathic preparations are exempt from providing data on evidence in the recognition process to become a medicine to be sold in pharmacies only. This may well lead to an increased confirmation bias. Compared to real research you should expect the positive evidence might be expected to be exaggerated due to lack of scientific skepticism. Taking into account the strong claim of homeopaths that their treatment is on the same level as conventional medicine – if not better –, you should expect a much more convincing database of positive evidence than there is available today.  You should expect the homeopaths to take great pains to explain how the negative results came about; their ratio of successful trials looks very poor for such a powerful treatment.

Another aspect is raised, namely the lack of public funding for research into homeopathy. Please note the following: DHU belongs to the Dr. Willmar Schwabe group, like the largest manufacturer of homeopathic medicines in Austria, Peintner. According to their website, Schwabe sells products for 900 million euros per year and spends a meager 32 million euros on research. Typical research spending for the pharmaceutical industry is about 14%, for Schwabe this would be around 125 million euros. There seems a lot of potential room for further research funding. [5, 6].

Quintessence:

We critics of homeopathy maintain our position: there is no scientific evidence for an effect of homeopathy that exceeds placebo – and this is not due to the lack of money that could be invested in research.

 


Dr.-Ing. Norbert Aust,
Informationsnetzwerk Homöopathie (INH)
drnorbertaust@t-online .de

Thanks to Udo Endruscheit and Sven Rudloff for their support in preparing this english version. 


Sources / References:

  1. Johnson SB, Park HS, Gross CP, Yu JB: ”Use on Alternative Medicine for Cancer and its Impact on Survival”; JNCI J Natl Cancer Inst (2018) 110(1): djx145, doi: 10.1093/jnci/djx145 [https://academic.oup.com/jnci/article/doi/10.1093/jnci/djx145/4064136]
  2. Kleijnen J, Knipschild P, ter Riet G: “Clinical trials of homeopathy“, BMJ 1991; 302:316-23, [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1668980/pdf/bmj00112-0022.pdf]
  3. Mathie RT et al.: Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Non-Individualised Homeopathic Treatment.
  4. National Health and Medical Research Council. 2015. “NHMRC Statement on Homeopathy“, Canberra: NHMRC 2015  [https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02_nhmrc_statement_homeopathy.pdf]
  5. NN: „Statistics 2015 – Die Arzneimittelindustrie in Deutschland“, vfa-Brochure, S. 10, [https://www.vfa.de/embed/statistics-2015.pdf]
  6. Website Fa. Wilmar Schwabe, Facts and Figures per December 31, 2016 [https://www.schwabepharma.com/about-us/facts-figures/]

Update, May 2019: Supplemented by the latest study situation (Mathie 2019)


Picture credits: Fotolia_130625327_XS

Criticism on criticism on Homeopathy #2: “Missing positive trials”

 

The second part of our series about the “homeopathic criticism on criticism on homeopathy” covers why critics conclude that there is no reliable evidence for the efficacy of homeopathy beyond placebo.

„There is not a single good quality trial showing homeopathy works“

This is how the UK-based Homeopathic Research Institute (HRI) cites their critics on their website “Homeopathy FAQs” [1]. The above statement is absolutely correct, though somewhat trivial: One single study never can “show” that “homeopathy” works. At best, if a trial is of good quality, it may give an indication that homeopathy might be more effective than placebo in the one medical condition that was tested in the trial, but not more. For reasons why this is the case, please refer to our previous article “Criticism on criticism on Homeopathy Pt.1: There is no evidence” [2].

“There is no reliable evidence that homeopathy is more effective than placebo in any clinical condition“

This is the correct, no longer trivial statement of the critics on homeopathy, for it can be falsified by presenting reliable evidence for efficacy in the case of a single clinical condition only. Though HRI does not explicitly refer to the proper wording, it is clear they want to argue against the notion of non-existing positive results. To identify examples of clinical conditions where homeopathy is shown as effective beyond placebo is a proper way in the attempt to contradict us critics, for the existence of just one such condition would prove the statement wrong.

Background: What is reliable evidence?

State-of-the-art evidence would include clinical trials designed as placebo-controlled double-blinded randomized clinical trials (RCT), which we explained comprehensively in part 1 of this series [2].

However, one single study alone cannot be reliable evidence. Evidence requires at least that a study has been replicated independently, i. e. repeated with other patients by another independent research team, which came to similar results. Since it is usually not easy to evaluate and pool different studies, a systematic review is required to build a solid conclusion, in which all available studies are considered, not just the most favorable ones.

To properly appreciate a study it is essential to consider its quality, which indicates how reliable it resembles reality. This is done by checking whether some essential criteria are met. Current procedure is to check for the “risk of bias” as set forth by the Cochrane Collaboration [3]. Eventually, a study is rated to be of “low”, “unclear” or “high” risk of bias from what could be expected in the real world. Naturally, a low risk would indicate a good quality study, a high risk of bias a poor one.

To determine this risk of bias, researchers refer to a list of criteria mainly to assess if the procedures for blinding and randomization were sufficient, and if the results of all the patients are reported completely. Authors must disclose these items in their report, otherwise the study is considered to be of unclear risk of bias, which indicates neither good nor bad quality.

It should be evident that reliable evidence can consist of low risk of bias studies only, where chances are good that the result is for real. If, for example, blinding of patients was insufficient, then patients in the placebo group, who now know they did not receive a possibly active treatment, might not attribute any positive development to the treatment and might not report it. On the other hand, patients who know of having received the (possibly) active drug, might be on a lookout for any positive development and might overrate its impact. Especially in studies on homeopathy, many of the data are assessed by asking for a patient’s subjective ratings of their experience, which renders it very important that the patient is “unbiased” in filling out the questionnaire or in answering the interviewers.

Not only insufficient blinding is likely to distort the outcome of a clinical study in favor of homeopathy. As evidence indicates, on average any shortcoming in quality does the same and yields more positive results [3, Chapter 8.5]

In a nutshell:

Reliable evidence consists of a number of independently replicated RCTs, a systematic review checking the quality of all the relevant studies in the field, and compiling a conclusion which resembles the best guess at what is to be expected in the real world.

HRI does quite acknowledge that more research is needed to replicate the available “promising” studies and that this has not yet been done sufficiently. But what does that mean for the question of existing evidence? Well, an independent replication may or may not yield similar results as before, which gives way to a somewhat unclear position: Homeopaths are certainly wrong assuming that future replications will surely corroborate the original findings, while critics cannot prove that successful replications are impossible. Consequently, the statement “there is no reliable evidence” is an absolutely correct scientific statement, not excluding that this could change in the future. This is in fact the strongest possible reservation against the evidence base in homeopathy, in accordance with todays sciences self-perception – which should not be misunderstood as assertion about that this might not happen in the future.

What good evidence is available?

However, the HRI points out positive studies on homeopathy for some clinical conditions, in order to refute the above statement of the critics. Here is a short overview:

(1) Individualized homeopathic treatment of childhood diarrhea

There is a review by Jacobs et al. where three studies with herself as lead author are considered [4]. All studies were performed under the same protocol. So, this is certainly not a summary of independent replications. Any shortcomings in study design or protocol or even handling might go unnoticed.

In the review of Jacobs, three studies are considered:

Jacobs (1993) with a small number of children in Nicaragua [5],
Jacobs (1994) with a larger number of children also in Nicaragua [6],
Jacobs (2000) with children in Nepal [7].

In the CORE-Hom database of the Carstens-Foundation [8] only one more study for the same clinical condition is listed (Cadena (1991)), but the record indicates that no statistical evaluation was included in that particular study. The three studies above thus completely reflects the available evidence for the homeopathic treatment of childhood diarrhea.

An assessment of the quality of these studies can be found in the systematic review on individualized homeopathy by Mathie et al. [9]: Only the paper from 1994 was rated “unclear risk of bias”, while the other two were rated as “high risk of bias”, that is, of poor quality.

Conclusion: Due to the poor quality of the available studies, there is no reliable evidence for a homeopathic treatment of childhood diarrhea. Note: There is a fourth paper on childhood diarrhea by the same author using non-individualized homeopathy, which could not show any advantage of homeopathy either.

(2) Individualized homeopathic treatment of otitis media in children

The HRI cites two works here:

Jacobs (2001) [10]
In the review of Mathie (2014), this study is rated as of medium quality only [9]. In this preliminary study the results were not statistically significant, some minor advantages of homeopathy beyond placebo occurred but are likely to be attributed to random effects. In order to prove this effect, the authors wrote that a considerably larger study would be required (243 evaluated subjects, not only 72, as in this paper).

Sinha (2012) [11]
According to the authors of this study, this was only a pilot study that was carried out without any blinding – which prevents it from being reliable. This study was not yet subject to quality assessment in any systematic review. But even on first glance the study looks very doubtful: The authors compared homeopathy to standard treatment, which, in this setting in India, consisted in 95 % of the cases of the use of antibiotics, which most authors consider useless as the condition is mostly caused by viral infection. Also, they looked at a condition which according to German guidelines remits in 78% of the cases within two to seven days. This corresponds very poorly with the study’s timeline of observations at 3, 7, 14, and 21 days after diagnosis, whereby the first three days remained without intervention – which renders the only statistically significant result occurring at day three meaningless.

A review performed by the Australian Ministry of Health lists another study, Harrison (1999), which was judged to be of poor quality only [21].

The CORE-Hom database lists another PCT [8]. In this work by Mössinger (1985) the data of 38 children were analyzed. According to the database, no significant advantage beyond placebo was achieved.

Conclusion: There is not a single high-quality study here that would have produced a reliable positive result.

(3) Use of the homeopathic remedy Galphimia glauca against hay fever

Here the HRI refers to a work by Wiesenauer (1996), which represents a systematic review of essentially his own work on this subject [13]. He comes to a positive conclusion, not shared by other authors:

Linde (1997) investigates four works by Wiesenauer [14], which pooled together show a positive effect (odds ratio 2.03 in favor of homeopathy), although Linde concludes that he has found no indication for which there is sufficient evidence that homeopathy is effective beyond placebo. Obviously, this statement is not based on the figures alone but allows for the questionable quality of the studies.

Mathie in his systematic review of non-individualized homeopathy found insufficient quality in three of Wiesenauer’s studies (1 medium, 2 poor) and has included two other works in his meta-analysis of hay fever (”allergic rhinitis“) [15]. He also concludes that there is a lack of reliable evidence for the efficacy of homeopathy for any clinical condition.

The review by the Australian Ministry of Health comes to the same conclusion.

Conclusion: In contrast to the author of the one review cited by HRI, all other reviews agree that there is no reliable evidence. Since the lead author of the studies himself is probably more prone to be biased in favor of his results, the negative assessment from the other three reviews appears more solid.

(4) Use of pollen C30 as an isopathic remedy against hay fever

HRI cites a study by Reilly (1986) [16], which is indeed considered by most reviewers to be of high quality – except for Mathie (2017). He considers this paper of poor quality due to unclear reporting of the blinding and incomplete reporting of results [15].

Even if we admitted that this study was rated as good quality by most reviewers and yielded a positive result, there is still no replication of this promising work for homeopathy – for more than 30 years now. Why this is the case is open to speculation: it is impossible to judge whether an attempt to replicate the positive result has failed or not.

(5) Use of the homeopathic remedy Oscillococcinum for the treatment of influenza

The HRI indicates a study in which Oscillococcinum is supposed to be effective against influenza. This work by Mathie (2012) is a Cochrane review, i. e. a systematic review carried out according to strict rules [17] and, if the statement of the HRI would apply, should actually be counted as reliable evidence.

First of all, it was not influenza that was treated, but influenza-like infections, i. e. common colds. Then Mathie, who works for the Homeopathy Research Institute himself and for sure is not an opponent of homeopathy, comes to the conclusion:

“There is not enough evidence to draw solid conclusions about Oscillococcinum for the prevention or treatment of influenza or flu-related infections. Our results do not exclude the possibility that Oscillococcinum may have a useful clinical effect, because of the low quality of the studies in question, the evidence is not convincing.“

Well, a reliable proof of thoroughly positive effects looks different.

(6) Use of the homeopathic complex remedy Vertigoheel against vertigo

The paper by Schneider et al. is a review of four papers that examined the remedy Vertigoheel for the treatment of vertigo in comparison to other therapies [18]. Only two of the papers (Weiser 1998 [19] and Issing 2004 [20]) were randomized controlled studies. Unfortunately, these works are not included in Mathie’s reviews. In the review of the NHMRC, the work of Issing is rated at medium to high risk of bias, while the work of Weiser is rated at medium risk [21].

In all four papers, it was found that the results obtained with Vertigoheel did not differ from the conventional therapies – although this is only meaningful if these conventional treatments are effective beyond placebo themselves and have been applied properly.

If Vertigoheel actually was effective, however, this is a point more against the teaching of homeopathy than in favor. The prescription was not based on an individual assessment of similarity between symptoms and the drug’s “remedy-picture”, which should be established in a detailed first session. Instead it was based on the not very specific diagnosis of ”dizziness“, which can have a large variety of different causes. Secondly, Vertigoheel is a complex remedy of four different homeopathic remedies, which, according to homeopathic teachings, at least makes it very difficult to achieve healing. It should be noted that Heel’s complex remedies are not considered to be homoeopathic drugs, but should act in accordance with homotoxicology, a doctrine of salvation based on the alleged detoxification of the body and not on influencing the alleged vital force as in homeopathy [22].

Conclusion: Once again there is no reliable evidence of homeopathy as an effective treatment for this condition. Based on the quality of the relevant studies, the results should not be considered as valid. But if homeopaths insist on their validity, then the studies rather indicate that the foundations of homeopathy are wrong.

In summary

At best, there is only a single good study that showed some benefit of homeopathy – Reilly – amongst all the examples given by the HRI. It is unclear how many clinical conditions were considered in PCTs of homeopathy, as many different figures are given: The UK-based Faculty of Homeopathy says 61 conditions, 85 conditions were considered in the review by the Australian Ministry of Health, and the German CORE-Hom database lists more than 50 indications under the letter “A” alone. With the standard risk of an Type I error (false positive result) of 5%, it is to be expected that there are a few studies that are of good quality and in favor of homeopathy. In this respect, Reilly’s study seems more the exception proving the rule (which is further mitigated by the fact that this work has not been reproduced for decades – or has been reproduced with a negative result, but this never came to be published – we don’t know that).

Clinical relevance

It is well known that homeopathy raises strong claims of its efficacy:

“A carefully selected homeopathic medicine can relieve quickly, safely, gently and without side-effects the symptoms of severe, acute and chronic complaints, such as migraine, neurodermitis, bronchial asthma, colitis, rheumatism and many other diseases. This also applies to acute conditions of a bacterial or viral origin.” [23]

This is what the president of the German Central Association of Homeopathic Doctors, essentially the highest German homeopath, writes on her practice homepage. Thus the patient who decides in favor of homeopathic therapy can expect that their state of health will improve substantially more and/or faster than if they hadn’t done anything at all. Therefore, studies of homeopathy should not only result in a statistically significant benefit beyond placebo; this would only mean that the effect is just strong enough to be recognized in sophisticated statistical analysis and might be of no practical benefit. But it should also be clinically relevant, i. e. show a noticeable and substantial improvement for the patient.

The clinical relevance in a study results from two aspects: On one hand, if the study authors have chosen a characteristic as main outcome measure that meets the expectations of the patient well enough for them to judge the treatment as a success or not. On the other hand, however, the difference must also be substantial, so the benefit should be of a magnitude the patient can really experience. Irrespective of the quality of the studies cited by the HRI – i. e. their credibility – here is a short look into what their results indicate regarding clinical relevance:

Childhood diarrhea:

Jacobs chooses the number of unformed stoolson the third day of treatment. At this point in time, this figure has decreased significantly in both study groups, from an average of 7.7 events per day to 3.1 in the control group and to 2.1 under homeopathic treatment. This advantage of only one event per day disappeared completely on day 4:2.0 events in the homeopathic group, 2.1 under placebo, i. e. hardly distinguishable. By the way: the third day is the only day with a significant result. The difference of one event on day three alone certainly is some relief for the family – but is it a substantial improvement over placebo?

Otitis media:

Jacobs‘ placebo-controlled study did not even yield a significant benefit, so there is no need to worry about clinical relevance.

Galphimia glauca in hay fever:

Two weeks after the start of treatment, 34 (of 41) patients in the homeopathy group were free of symptoms or experienced significant relief, in the control group it was 21 (of 45) patients. After four weeks, 30 (of only remaining 37) patients in the homeopathy group were free of symptoms or had a significant improvement. In the control group, it was 20 (of only 35) patients [24]. Further out, only relative figures from other works are available, which do not permit an assessment of relevance.

Whether this will show a substantial effect remains to be seen.

Pollen C30 against hay fever:

In Reilly’s work, the severity of hay fever symptoms was determined by the patients themselves ever day, given on a visual analogue scale ranging from 0 to 100 (0 = no symptoms at all, 100 = extremely bad). At the beginning, the mean value in both groups was about 45, but with a big variance. The same showed in the changes: In the homeopathy group, scores ranged from an improvement by 80 points to a deterioration by 50 points. Practically the same thing happened in the control group: The range was from an improvement by 80 points to a deterioration by 60 points. If the patients had compared their results, they would not have been able to identify individual patients whose results were so good or so bad as to clearly identify them to be of the homeopathy or control group. The higher mean improvement of 17.1 points in homeopathy compared to only 2.1 points in the control group is a difference that no patient can actually perceive.

Oscillococcinum for influenza:

This is the graph on Ferley's work which is discussed in this paragraphIn the two works by Ferley [25] and Papp [26] the success of the therapy is judged by the recovery rate on the second day after start of treatment. In fact, there is a statistically significant advantage of the homeopathy group – which is only present on this very day, neither the day before nor the day after. This is illustrated in the graphic, which also shows how „radical“ homeopathy has been.

The graph shows the results of Ferley’s work [25], which were converted to even numbers of participants in both groups. From day 1 to day 2, the homeopathy group has achieved a small advantage indeed, but the parallel curves show otherwise that the recovery rates are practically the same.

The average duration of the illness was reduced only by about 6 hours, which should be meaningless, especially at night, if they happen while the patient is asleep. This is certainly not the therapeutic success that patients would want to achieve.

Vertigoheel against dizziness:

No comparison with placebo possible, as the drug was not compared with placebo but with other therapies.

In summary:

Even if one ignores the lack of credibility of the studies and takes a look at the results alone, the assertion that homeopathy can quickly achieve a drastic improvement of the patient’s situation is by no means apparent in the studies quoted by the HRI. At best, there is one potential use, Galphimia glauca in hay fever, but this would still have to be verified on the basis of independent study replications.

Quintessence

The works presented by the HRI as ”good studies“do not satisfy this claim – by far. Studies have been judged to be of inadequate quality in existing reviews of homeopathy. At best, there could be just one indication where a good study shows a positive result. This promising work on isopathy in hay fever has not been replicated for thirty years now, however. In addition, for statistical reasons, it is to be expected that even good studies will occasionally yield positive results, due to the risk of a Type I error (probability for false-positive results).

The clinical effects, on the other hand, are relatively minor and in no way support the claim of homeopathy to be a thoroughly effective therapy, helping patients to a substantial degree.

The HRI’s arguments against ”There is not a single good quality trial showing homeopathy works“ is thus not supported by evidence.


Acknowledgement:

This article is published here with kind permission of the author, Dr. Norbert Aust. The author would like to thank Udo Endruscheit and Sven Rudloff for their help with this English version of his original blog-article: http://www.beweisaufnahme-homoeopathie.de/?p=3312


References

[1] NN.: „There isn’t a single good quality trial showing homeopathy works“, webpage of the Homeopathy Research Institute, checked 01.12.2017, Link

[2] Aust, N: Criticism on criticism on Homeopathy Pt. 1: There is no evidence, blog-article (Link) and INH website (Link)

[3] Higgins JPT, Green S.: Cochrane Handbook for Systematic Reviews of Interventions; The Cochrane Library, 2008. Link
(Chapter 8: Asessing Risk of Bias)

[4] Jacobs J, Jonas WB, Jiminez-Perez M et al.: “Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials“, Pediatr Infect Dis J (2000);22:228-234 Link

[5] Jacobs J, Jiminez LM, Gloyd S et al.:“Homoeopathic treatment of acute childhood diarrhea – a randomized clinical trial in Nicarague“,British Homeopathic Journal (1993);82:83-86

[6] Jacobs J, Jiminez LM, Gloyd SS et al.: “Treatment of Acute Childhood Diarrhea with Homeopathic Medicine: A Randomized Trial in Nicaragua“, Pediatrics(1994);93(5):719-725 Link

[7] Jacobs J, Jiminez M, Mathouse S et al.: “Homeopathic Treatment of Acute Childhood Diarrhea: Results from a Clinical Trial in Nepal“, Journal of Alternative and Complementary Medicine(2000);6(2):131-139 Link

[8] NN: “CORE-Hom database, A database on Clinical Outcome Research in Homeopathy“, database of the Carstens-Foundation, free access requires registration , Link

[9] Mathie RT, Lloyd SM, Legg LA et al.: “Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis“, Systematic Reviews 2014;3:142, Link

[10] Jacobs J, Springer DA, Crothers D: “Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial“, Pediatr Infect Dis J (2001);20(2):177-83 Link 

[11] Sinha MN, Siddiqui VA, Nayak C et al.: “Randomized controlled pilot study to cpmpare Homeopathy and Conventional therapy in Acute Otitis Media“, Homeopathy (2012);101:5-12, Link

[12] NN: DEGAM-Leitlinie Nr. 7: Leitlinie „Ohrenschmerzen“, aktualisierte Fassung 2014, Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin, AWMF-Registernummer 053/009 Link (in German)

[13] Wiesenauer M, Lüdtke R:“A Meta-Analysis of the Homeopathic treatment of Pollinosis with Galphimia Glauca“, Forschende Komplementärmedizin (1996);3:230-234, Link

[14] Linde K, Clausius N, Ramirez G et al.: “Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials“, The Lancet (1997);350:834-843 Link

[15] Mathie RT, Ramparsad N, Legg LA et al.: “Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: Systematic review and meta-analysis“, Systematic Reviews 2017;6:663 Link

[16] Reilly TR, Taylor MA, McSharry C et al.: “Is homeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model“, The Lancet (1986) 328:8512:811-816 Link

[17] Mathie RT, Frye J, Fisher P:“Homeopathic Oscillococcinum (R) for preventing an treating influenza and influenzy-like illness (Review)“, Cochrane Database of Systematic Reviews 2012 Issue 12 Art.No.: CD001957 Link

[18] Schneider B, Klein P, Weiser M: “Treatment of Vertigo with a Homeopathic Complex Remedy Compared with Usual treatments“, Arnzneim.-Forsch./Drug Res.(2005);55(1):23-29 Link

[19] Weiser M, Strösser W, Klein P: “Homeopathic vs. Conventional Treatment of Vertigo: A Randomized Double-blind Controlled Clinical Study“, Arch Otolaryngol Head Neck Surg. (1998);124(8):879-995 Link

[20] Issing W, Klein P, Weiser M: “The Homeopathic Preparation Vertigoheel(R) Versus Gingko biloba in the Treatment of Vertigo in an Elderly Population: A Double-Blinded, Randomized, Controlled Trial“, J. Altern. Complement. Med. (2005);11(1):155-160 Link

[21] National Health and Medical Research Council. 2015. “NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions “, Canberra: NHMRC;2015 Link

[22] NN: Homotoxikologie, article in Homöopedia.eu (in German) Link

[23] Entry „Homöopathie“ on the website of C. Bajic  Link  – checked 25.11.2017 (in German)

[24] Wiesenauer M, Häussler S, Gaus W: “Pollinosis-Therapie mit Galphimia Glauca”, Fortschr. Med (1983);101(17): 811-814 Link

[25] Ferley JP, Tmirou D, D’Adhemar D et al.: “Evaluation of a Homeopathic Preparation in the Treatment of Influenza-Like Syndromes“, Br. J. clin Pharmac. (1989);27:329-335  Link

[26] Papp R, Schuback G, Beck E, et al.: “Oscillococcinum(R) in patients with influenzy-like syndromes: A placebo-controlled double-blind evaluation“, British Homeopathic Journal (1998);87(2):69-76 Link


Picture credits: Fotolia_130625327_XS

Criticism on criticism on homeopathy #3 – “Homeopathy is impossible”

“Scientists claim that homeopathy is not possible”

… states the Homeopathy Research Institute as allegedly supposed dictum of critics on homeopathy.

The third part of our series about homeopathic criticism on criticism of homeopathy deals with the Homeopathy Research Institute’s statement: “Scientists claim homeopathy is impossible”.

Whether scientists would use this wording to express their views on homeopathy seems to be rather doubtful, the Homeopathy Research Institute (HRI) does not offer any reference of such a statement in their article anyway (https://www.hri-research.org/resources/homeopathy-faqs/scientists-say-homeopathy-is-impossible/). However, this is not very likely, because a serious scientist would utter such a statement only if there was clear evidence for anything. But this is impossible in our case, since the non-existence of something cannot be proven. What scientists actually say about homeopathy is:

  • Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
  • Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect. There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies. [1]

So there is no statement of homeopathy being “impossible” as such, but only that it contradicts everything we know from science, technology and everyday life about how nature works. Of course, this can be all wrong, since our knowledge is an approximation of reality only. Therefore, a scientist will always refer to the current state of knowledge –  which does not necessarily mean that they consider it likely that this will really be proven false.

Background: Why is homeopathy implausible?

The world exists and develops quite obviously in a multitude of processes and phenomena. The fundamental laws that control these processes and which are being researched by science must therefore be compatible and must not contradict each other. A natural law cannot be valid in one case and invalid in another under the same conditions. If such problems arise, this is an indication that our understanding of the matter is not yet complete, e.g. some important conditions might not have been identified yet.

Any inconsistency in our knowledge indicates an error in our understanding. Usually this triggers research to find the root cause and to result in a better understanding of nature’s laws. Consequently, to be plausible in science, any doctrine would have to be consistent, showing no internal contradictions and not being in conflict with other branches of science.

Homeopathy does not meet these requirements, because it is full of internal contradictions and there is no reasonably plausible explanation for any effectiveness of the remedies in use, which would not be in conflict with well-established knowledge.

To cover all the issues in detail would exceed the limits of an article as this one, so a few examples will have to suffice.

  • Internal contradictions

According to the homeopathic “law of similarity”, a remedy is able to cure the symptoms in an ill person that it can invoke in a healthy one. This is one of the pillars of homeopathy; it is even where the name is derived from (“homeopathy” = “similar to suffering”). Obviously, this must also apply in the reversal, so that a remedy can trigger the symptoms in a healthy person that it can cure in an ill one. Homeopathic drug “provings”, and with this the homeopathic database for prescribing proper remedies to patients, is dependent on the fact that healthy subjects take a remedy and record the symptoms that occur afterwards.

First off, if this was true, homeopathic remedies would be extremely dangerous –  after all, according to homeopaths, you can cure and therefore cause all kinds of acute and chronic illnesses with homeopathic remedies, which is in contrast to the claimed gentleness and safety of their use. Homeopathy follows the logic that every intake of their remedies will cause an “effect”, a healing one when it was “perfectly appropriate” and a harmful one when this is not the case. Either a homeopathic remedy can cause undesirable effects (“side effects”) , or the drug trials do not work, and therefore the bases of homeopathic prescriptions, the so-called Materia Medica, are rubbish.

Either way, any specific therapy of patients would be impossible. Either because the doctrine is wrong, and the remedies are ineffective, or because the properties of the remedies are unknown and the effects a practitioner may evoke are unpredictable.

Homeopaths even agree that not being able to identify the right remedy at first go is quite possible, meaning that homeopathic remedies are wrongly prescribed quite frequently. This would turn homeopathy into a very risky therapy: since the wrong remedy would identify the patient as “healthy” concerning the drug-specific symptoms and start to create them.  Or does the remedy somehow know, even if it was wrongly prescribed, that the person is ill, though concerning another drug, and then it suppresses its urge to cause its own individual proving symptoms?

Over-the-counter sale of homeopathic medicines without a prescription would have to be banned, because a layperson would be far less able to identify the proper remedy for themselves. And by the way: Either a detailed anamnesis is required for the proper choice of drugs – then the OTC-sale of the remedies is a kind of fraud –, or the remedies can be ordered according to perfunctory diagnosis, then the extensive first anamnesis is humbug.

  • Outer contradictions

An explanation, i.e. an effective model of homeopathy, should be able to describe, for example, how the efficacy of a source material is enhanced by dilution and shaking. And how this is transferred to the patient when the source material is diluted out of the solution, and how the remedies differentiate whether the patient is ill or not.

Even for this basic process there is no explanation that would not fundamentally contradict our current understanding of physics, chemistry and physiology in one form or another. Of course, this explanation should also include why under similar conditions in similar processes these effects do not occur outside of homeopathy.

In technology and day-to-day life, there are many procedures where the “efficacy” of a substance is controlled by maintaining certain concentrations of the active substance in question. Drinking water is treated by removing the accompanying impurities of the natural surface water to such an extent that the maximum concentrations of pollutants are within the limits prescribed in the regulations for potable water. It’s similar for the treatment of water for medical purposes, the production of decaffeinated coffee, alcohol-free beer, skimmed milk, etc. None of these substances have as yet been found to be affected by shaking – for example, by vigorously slamming the coffee cup on the table. The effect of dilution could never be completely or partially removed – better: inverted – by succussion. Shaking or stirring is often used to mix substances and homogenize the concentrations. If homeopathic assumptions were correct, the very first bump on the table would increase the strength of the coffee.  After all, potentizing is said to be very powerful: 10 beats of shaking are sufficient to transfer the effectiveness to 99 times the volume of the solvent – and to even enhance the effect.

It is also inexplicable why this immense increase of power only happens when the solution is diluted in advance, and not when the liquid is shaken without being diluted before. An explanation has to account for this, too. Otherwise, at least liquid homeopathic drugs should not be sold, because random shaking movements during transport to the pharmacy, or later in the shopping bag or a pocket, would result in random increases of efficacy, which in turn would have to lead to an unpredictable result with the patient (Hahnemann, the inventor of homeopathy, was sure of this – it is reported that this was initial for the idea of using globules; therapists who could not see such an “transport effect” were taunted by him).

Furthermore, the model would have to provide an explanation for the fact that the amplification only affects the substance used as a mother tincture – and only the desired properties that is, not a toxic effect for instance – not the inevitable impurities of alcohol or water used as a solvent.

  • Conclusion

It may not be exactly correct to postulate the “impossibility” of such a model, because this cannot be proven. One can, however, consider how much of current science needs to be rewritten in order to explain the alleged mode of operation of homeopathy as well as the non-occurrence of these effects outside the homeopathic environment.

Revolutionary insights are usually honored with a Nobel Prize. In order to illustrate the extent of the contradiction between homeopathy and the natural sciences, the German physicist Martin Lambeck once pointed out how many Nobel Prizes would have to be awarded if the assumptions of homeopathy were actually scientifically proven [2]. His count reached well over 90. The introduction of the theory of relativity or quantum physics were mere trifles in comparison.

What scientists really say

Homeopaths like to quote scientists as witnesses for the claimed efficiency of their drugs and remedies, but quite frequently do so in a crude and misleading way, as found in HRI’s reference of Luc Montagnier.

Montagnier is a virologist who in 2008 was awarded the Nobel Prize for his work on the AIDS virus. In 2010, he gave an interview to the journal Science in which he answered questions about one of his – by the way highly controversial – papers [3]. In this article, he claimed to have found that some bacteria emit electromagnetic waves – and that these can be detected in the solution even when the bacteria are filtered off and the solution is further diluted [4]. The HRI quotes a passage from the interview, but only three short sentences out of context in which Montagnier sounds as if he would actually confirm homeopathy. However, here is the complete quote with HRI’s partial quote highlighted:

Q: Do you think there’s something to homeopathy as well?
L.M.: I can’t say that homeopathy is right in everything. 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. We find that with DNA, we cannot work at the extremely high dilutions used in homeopathy; we cannot go further than a 10-18 dilution, or we lose the signal. But even at 10-18, you can calculate that there is not a single molecule of DNA left. And yet we detect a signal. 

(original wording)

A wonderful example of cherry-picking: Montagnier actually said the phrase the HRI quotes, yes, but in the same breath he also contradicted some basic assumptions of homeopathy. If the HRI had the intention to inform its readers about the real background of Montagnier‘s work, then they should have mentioned:

  • It’s the DNA that causes the effect. The efficacy of inorganic substances or simple organic compounds would therefore remain unexplained.
  • Not even all organisms seem to produce the effect, but only certain bacteria.
  • The dilutions were only active in a comparatively narrow range, depending on the species of bacteria, between D8 and D12, i.e. not in the absurdly high dilutions as is customary in homeopathy (C200 and even higher).
  • The effects last only for a comparatively short period of less than 48 hours, and in no case for such a long period of time in which homeopathic remedies may even reach their customer.
  • The effect becomes weaker with increasing dilution and disappears completely above D18, whereas in homeopathy considerably higher potencies with correspondingly stronger dilutions are in use and are regarded as particularly effective.

There’s nothing there to support homeopathy.

Change in science

Again and again, according to the HRI, science is subject to constant change, which is supposed to suggest that the present knowledge is probably false:

“What the scientific establishment considers impossible at one point in time is a proven fact at a later stage “.

This statement is complete nonsense and is based on a completely wrong understanding of science.

In fact, science is constantly evolving and gaining better and more comprehensive insights in the processes of nature. Of course, “mistakes” also occur, meaning that hypotheses are made and considered to be confirmed, but later prove to be inaccurate. Finding errors and shortcomings, gradually and laboriously pushing out the limits of knowledge, improving the inadequate, replacing the wrong with (probably) more correct things, this is the core of scientific work. Usually, scientists who have disproved particularly sound hypotheses are awarded a Nobel Prize. These included, for example, Barry Marshall and Robin Warren, who were awarded the Nobel Prize in Medicine in 2005 for demonstrating that gastric ulcers can be attributed to bacterial infections, which was previously considered impossible because bacteria were not believed to survive gastric acid (this was, by the way, considered impossible, but not completely incompatible with natural laws).

This example, which is also cited by the HRI, does not prove that our knowledge is wrong, but rather that true science can detect and correct errors and thus obtain ever better knowledge of the actual facts. There are conclusions and hypotheses that may prove to be inaccurate later on, and these may be considered valid for quite a long time before, but with the scientific methodology it is possible to exclude inaccurate views.

If you want to describe the situation in one sentence, you can better use a quote from the Swiss internist Wilhelm Löffler:

“Almost all the errors of medicine that live on in popular belief were once scientifically accepted theories.”

There are also laws of nature that cannot be modified or replaced by anything else. These laws of nature are the absolute limit to speculation on “everything is possible” and “science cannot yet understand…”. It is by no means the case that everything that is considered impossible today will almost inevitably represent proven wisdom tomorrow, like the HRI tries to suggest. Perpetua mobilia are impossible and will remain so, also like a speed beyond the speed of light. And: where there is nothing, there is nothing that works.

Summary

Even though our knowledge of the ways of the world is still far from complete, it is very unlikely that one day a medical efficacy of homeopathic preparations will be explained, especially with the effects claimed in the various homeopathic repertories. The contradiction between homeopathic teaching and established knowledge of science, technology and everyday life is far too big. In the end, it would not only be necessary to find an explanation of the efficacy, but also to show why these effects do not occur in similar processes outside homeopathy. This means that for large parts of physics, biology and chemistry, completely new and contradiction-free explanatory models must be presented (the physicist and science theorist Thomas S. Kuhn expressly demanded the replacement of old paradigms only “including central concepts”).

This is so highly improbable that it can be considered impossible with highest probability, comparable to the probability of finding an atom/molecule of the mother tincture in a bottle of C200 potency. 1:10380 is not equal to zero – however, it is small enough for all practical purposes to be taken as zero.


Sources / References:

[1] European Academies Science Advisory Council: “Homeopathic products and practices: assessing the evidence and ensuring consistency in regulating medical claims in the EU“, EASAC:September 2017, Link

[2] Lambeck M.: Irrt die Physik? Über alternative Medizin und Esoterik, 3. erweiterte Auflage, Verlag C.H.Beck 2015, ISBN 3406670962

[3] Newsmaker Interview ‚French Nobelist Escapes ‚intellectual Terror‘ to Persue Radical Ideas in China‘, Science 330 (2010) p. 1732

[4] Montagnier L, Aissa J, Ferris S, Montagner JL, Lavalle C: Electromagnetic Signals are Produced by Aqueous Nanostructures Derived from Bacterial DNA Sequences‘, Intersiscip Sci Comput Life Sci (2009) 1: 81-90


In the series “Criticism on our criticism on homeopathy” we also published:

Part I:  “There is no evidence

Part II: “Missing positive trials

Part IV: “They’re just Sugar Pills!

Learn more about the fundamentals of cognitive ability in the natural sciences: “What does ‘proved’ mean?


Picture credits: Fotolia_130625327_XS

Criticism on criticism on homeopathy – #4: “They’re just sugar pills!”

“There’s nothing in it – They’re just sugar pills!”

… is the next thesis from homeopathic criticism to which the Homeopathy Research Institute dedicates the fourth part of its thirteen-part series in order to refute it. The HRI refers to the alleged evidence from “basic research on homeopathy” that globules are “more” than “sugar balls”.

To anticipate the conclusion – the globules are and remain sugar globules on closer inspection. While it is more correct to say that the globules contain “nothing effective” (and “more sugar in sugar” does not work from a certain point), it is explained below that the term “sugar balls” nevertheless hits the nail on the head.

“Laboratory experiments have shown that homeopathic remedies are not just sugar beads.”… this is what the HRI tells us. But what are they instead – and above all, what does this have to do with any proof of the validity of homeopathy? What is the statement when the HRI tells us: “The test results show that homeopathic remedies cannot be pure water or pure sugar. “Because that’s obviously the case, homeopathic remedies can be effective.” That’s a logical circular reasoning, but no proof.

This can be noted first: The attempt to prove physical-chemical changes in high potencies in any way has nothing to do with a proof of the correctness of Hahnemann’s homeopathy – independent of possible results – mainly because there is no idea how this could be causally related to a medicinal effect of homeopathy in the human body. Such a thing is rather a seemingly rational attempt to save the homeopathic building, since the concept of a “mental vital force” can no longer be conveyed in a scientific context – and rightly so.

In addition, the works quoted do not stand up to critical scrutiny neither in the interpretation nor of the results or in terms of design and implementation. They are either very controversial (antibodies to white blood cells, apparently this is the well-known work of Benveniste [1] – keyword water memory [2]) or only of very small effect strength and even contradict the homoeopathic doctrine (Endler); more about the latter can be found in the detailed article on the topic on Dr. Norbert Aust’s blog “Taking of Evidence in Homeopathy”[3] [4].

The fact that these two works are presented by the HRI as the top results in basic homeopathic research speaks for itself.

The following excursus shows how far away homeopathic basic research and the defence of HRI are from homeopathy in another respect:

One should also be aware that Hahnemann’s closed concept of homeopathy is not compatible with the search for or the proof of a “material”, i.e. with physical-chemical methods detectable effects in high potency drugs. Hahnemann constituted the “spiritual life force” (vis vitalis) as the supporting pillar of his homeopathy and the “spiritual medicinal power” in the remedy as the counterpart.

“Our vital force, as a spirit-like dynamis, cannot be attacked and affected by injurious influences on the healthy organism caused by the external inimical forces that disturb the harmonious play of life, otherwise than in a spirit-like (dynamic) way, and in like manner, all such morbid derangements (diseases) cannot be removed from it by the physician in any other way than by the spirit-like (dynamic1, virtual) alterative powers of the serviceable medicines acting upon our spirit-like vital force, which perceives them through the medium of the sentient faculty of the nerves everywhere present in the organism, so that it is only by their dynamic action on the vital force that remedies are able to re-establish and do actually re-establish health and vital harmony, after the changes in the health of the patient cognizable by our senses (the totality of the symptoms) have revealed the disease to the carefully observing and investigating physician as fully as was requisite in order to enable him to cure it.” (§ 16 Organon, 6th edition, trans. Boericke)

He vehemently condemned the “atomists” and “materialists”, who already at his time insisted that a mechanism of action could only be assumed if it was based on material interactions. He believed that he had found the “proof” for his concept of a non-material medicinal power in the use of magnetism as a homeopathic remedy (he deals with this in detail in the 6th edition of his “Organon”). This is not at all consistent with the research conducted by the HRI on the material verifiable and measurable effects of high potencies:

“How can they finally rhyme with their atomistic, material concepts of the effects of medicines that a well-prepared magnetic steel rod, […], can produce such a tremendous change of mood in our condition that we suffer severe pathological complaints from it, or, to such an extent that a magnetic rod can heal quickly and permanently the most violent evils to which it is appropriate as a medicine, conceals them in the above way, approaches them to the body, even approaches them only for a short time? Atomist! atomist! you for wisely in your limitation seeming atomist! say, what weighable magnetic heal penetrated there into the body to make those, often tremendous changes in his condition? Isn’t a centillion part of a grain (a fracture that has 600 digits to denominator) still infinitely heavy for the very imponderable part, for the kind of spirit that flowed from the magnetic rod into this living body? …” (Hahnemann, Reine Arzneimittellehre, 2nd edition, II. part, p. 212).

More than diluting?

The nevertheless very “materialistic” view of “basic research” is often presented as “progressiveness” or “further development”. The fact that these are unsuitable attempts at rationalisation is, however, clearly shown elsewhere: Hahnemann’s dogma that the shaking transfers “information” (the “spiritual medicinal power”) to the solvent and thus represents more than an increasing dilution of the original substance (up to the point where only solvent is shaken with solvent) is held unswervingly by the homeopaths. Quote HRI:

“The physical and chemical changes caused by shaking, and how they enable water to absorb the information of the substances diluted in it, are the big questions that researchers are trying to answer.”

It is probably more the case that no answer can be found here, because false and nonsensical questions are assumed. It would be correct to ask whether such phenomena exist, only then does it make sense to ask how this happens. However, this question already contains the premise, the unproven assumption, that there are actually effects in high potency dilutions (“possibility of water to absorb information about substances diluted therein”), which “only” require research.

This is the inadmissible argumentation with the “false premise”, which one “smuggles” into a discussion as given, in order to be able to lead a sham debate based on it. The premise at issue here, that water is capable of absorbing information by homeopathic potentiation, is unproven, there is no evidence for this, not even plausibility. Thus an argument based on this is invalid from the outset. However, there are the physical-chemical principles that have proven themselves in everyday life and technology, which tell us that a dilution is and remains a dilution and does not mutate into an ominous “transfer of information” because a homeopathic mother substance is involved. A specific effect that could transfer “information”, “vibrations”, “frequencies” or “energies” to the water is not known. [5]

In this respect, one must regard the HRI’s reference to the efforts of the “researchers” as a rhetorical-argumentative trick, with which an unproven and implausible premise is imposed on the debate. In practice – what are we talking about at all? In addition to these fundamental considerations, one should bear in mind what actually are the real orders of magnitude to which the attempt of homeopathic basic research to prove specific effects leads. Even if you are familiar with the system of homeopathic potentiation, you might be surprised if you consider the practical question of which product quantities can be produced with which potentiation.

During potentiation, the concentration of the drug decreases rapidly. As already mentioned, even low potencies show concentrations of active substances which are not sufficient for physiological reactions. Even a low potency of D6 contains more unavoidable impurities of the carrier substance (even at the highest purity level available) than the original substance. 100 kg 6X globules (purity 99.6 %) contain 400 g of random impurities and 0.001 g (!) mother tincture active ingredient.

The picture shows a 20-ton-lorry as desribed in the textLet us continue with a simple rule of three. One gram of mother tincture can be used to make 100 tons of Globuli 6X. You need five articulated lorries, each with a lifting capacity of 20 tons, to transport this quantity.

The picture shows a Panamax bulk carrier which can be loaded with 1,260 tons, as described in the article.12X produces so many globules from one gram of mother tincture that 1,250 bulk carriers of the PANAMAX class (each with a capacity of 80,000 tons) can just load them – all together with an active substance content corresponding to one third of a piece of sugar cube.

And here we have by no means arrived at what homeopaths in the true sense call “high potencies”, which generally means potentizations from 30C onwards.

Summary

Indeed, globules D6 and higher are pure sugars, in the sense that the impurities always present in the material are much higher than the content of what is supposed to be present as a homoeopathically specific substance. This already applies to potencies far below the range which is described by homeopathy as high potency. No basic research on homeopathy has so far produced a result which disproves this point of view. Even if one were to regard the results presented as correct, they do not constitute a basis for proving the effectiveness or a mechanism of action of homeopathy – there is no even plausible idea of causality.more than 20 years of intensive research in several institutions, with the express aim of “proving” homeopathy (“confirmatory research”), – without anything having been found so far which could somehow be regarded as the cause of the allegedly radical effectiveness of homeopathy? This should not be presented in a positive way.

[1] https://de.wikipedia.org/wiki/Jacques_Benveniste

[2] Refutation in: Memory in water revisited, Nature (1994), Abstract: https://www.ncbi.nlm.nih.gov/pubmed/8255290?dopt=Abstract

3] http://www.beweisaufnahme-homoeopathie.de/?p=2093

[4] http://www.beweisaufnahme-homoeopathie.de/?p=2131

[5] For detailed information on shaking / potentiation in the Homöopedia (in German): http://www.homöopedia.eu/index.php/Artikel:Schütteln

A detailed article on the HRI thesis discussed here has been published on the blog “Beweisaufnahme in Sachen Homöopathie” (“Taking of Evidence in Homeopathy”) by Dr. Norbert Aust.

Previously published by INH in the series “Criticism on criticism on homeopathy”:

Part I – Scientific evidence
Part II – “Positive studies missing”
Part III – “Scientists say homeopathy is not possible”


Picture credits: Fotolia_130625327_XS /
Wikimedia Commons: (C) CostaPPPR / (C) Konrad Kaufmann / (C) Daizotec, Hanoi, Vietnam

Open letter of the INH to the interview with Dr. Tournier (HRI) on “Homöopathie online”.

Homeopathy online, the online portal of the German Central Association of Homeopathic Physicians, titled on 27 September 2017 : “Interview: How a positive homeopathy study turned into a negative one”. Under this heading, an interview is published with the head of the British Homeopathy Research Institute (HRI), Dr. Alexander Tournier, on the mistakes and deficiencies allegedly contained in the major homeopathy review of the Australian health authority NHMRC of 2015.
The INH has thereon addressed the following Open Letter to the Central Association of Homeopathic Physicians:

 

To the
German Central Association of Homeopathic Physicians (DZVhÄ)
by email

05.10.2017

Homeopathy-Online, 27 September 2017:
Interview: “How a positive study turned into a negative study” (in German)

Ladies and Gentlemen,

It is understandable that after the publication of the assessment of homeopathy by the European Academies Science Advisory Council (EASAC) – the umbrella organisation of the European Academies of Science – you are in a somewhat precarious position. It is understandable that you are trying to refute the results. We are surprised, however, that you have not found a better solution than to once again address the criticisms of the large-scale review published on behalf of the Australian Ministry of Health in 2015.

In her interview published on Homöopathie-Online, Dr. Tournier merely repeats the previously known arguments against this study, without, however, being able to present evidence for the previously unproven allegations or to offer new points of view for the arguments that have long since been refuted. Tournier makes the most massive accusation that can be made against scientists, namely to have falsified the results, i.e. to have deliberately published false results, only in order to – yes, why actually? In view of this serious accusation, however, this provides remarkably little substance:

    • The alleged 200-page report on the points of criticism is not being presented.
    • There is no evidence of the existence of a previous valid study which was rejected because of its alleged positive result.
    • The NHMRC states quite correctly that the literature search and the public submissions together resulted in over 1800 text passages, 225 of which met the inclusion criteria. This is a common procedure, even required in the CONSORT Statement for transparency of reporting. Mr. Tournier does not seem to know this.
    • Studies with less than 150 participants were also admitted, which were evaluated with the GRADE procedure recommended by the WHO. Obviously Mr Tournier did not read the work correctly or completely, so he missed that.
    • The quality requirements are in line with the usual guidelines of the Cochrane Collaboration for “Reliable evidence” in evidence-based medicine.
    • None of this contradicts a scientific standard, as Mr Tournier claims.
    • Prof. Peter Brooks was not the chairman of the working group, as Mr. Tournier could easily conclude by reading the relevant sections of the summaries.

Details can be found on our information page on the web.

At this point, we would like to raise the question of whether a complaint has actually been lodged with the Commonwealth Ombudsman. We would question whether this is the right place to remove a scientific disagreement, it is more of a complaints body where Australian citizens can defend theirselves against unjustified acts of the government. Nevertheless, we are looking forward to the results of this complaint.

The ombusdman usually works rather quickly – over 80% of cases are dealt with in less than three months – so there should be an answer by now. We note that the Australian Homeopathy Associations do not comment on this. and also the authors of the study have not yet been involved in the procedure, which leads us to the above question.

Finally, we would like to point out that the results of the NHMRC point in exactly the same direction as the other seven systematic reviews on homeopathy published since 1991, including the work published in 2017 by R.T. Mathie, a staff member of the Homeopathy Research Institute, and therefore staff member of Mr. Tournier:

There is no strong evidence that the effectiveness of homeopathy in any clinical picture goes beyond placebo!

In this respect, the discussion about the methodology of the study seems somewhat academic: even if the alleged discrepancies were actually present, they do not seem to have had much influence on the result.

Many greetings
Information Network Homeopathy
Natalie Grams
Norbert Aust
Udo Endruscheit

Study uncovers: With alternative medicine many cancer patients die earlier than necessary!

If the doctor tells you that he has diagnosed cancer, then this is an incisive event for everyone. What to do now? Conventional treatment, i.e. chemotherapy, radiation, surgery or hormone therapy, depending on the severity and stage of the disease? Or alternative medicine, be it homeopathy, acupuncture, dietary change (dietetics), other approaches such as methods of traditional Chinese medicine, electro-carcinoma therapy, pseudo-natural therapies such as amygdalin therapy, gemstone therapy or coffee enemas – or perhaps completely offside methods such as using pendulums, mental healing, Reiki? Or is cancer a consequence of unresolved conflicts?
All this and much more has been and is used by cancer patients.

Anyone who undergoes conventional therapy with cancer is highly likely to live longer than if he or she were treated with alternative medicine. This conclusion can be drawn from a paper that researchers at Yale University in New Haven (Connecticut, USA) have now published [1].

Skyler B. Johnson and his colleagues searched the U.S. Cancer Registry for patients with breast, prostate, lung or colon cancer, the most common types of cancer, and – instead of conventional treatment – underwent “other unproven cancer therapies performed by non-medical personnel”, preferring some form of alternative medicine. 281 patients were found and, for comparison, twice the number of patients who had undergone conventional therapy with the same diagnosis and other conditions (age, sex, income, etc.) were sought. Patients whose tumors had already metastasized, in whom the cancer had reached the final stage or in whom the data were unclear were not considered.

The results are sobering for the followers of alternative medicine, as the following graph, calculated from the data of the study, shows. Here the number of deaths in both treatment groups is listed, the data for conventionally treated patients were also converted to 280 initial participants. Blue dots should represent 10 living patients, red dots 10 deceased:

It is obvious that at any time the number of deaths under alternative therapy is about twice as high as in conventionally treated people. After seven years, about half of the patients had died under the alternative therapy, while only a quarter had died under the conventional therapy. Depending on the type of cancer, the difference was even more pronounced: In breast cancer, the risk of death was five times higher with alternative medical therapy and four times higher with colorectal cancer than with conventional treatment.

A small but significant side consideration:

Let’s put ourselves in the time frame after seven years. Of the 280 patients originally treated as alternatives, 138 are still alive – although 67 more in the case of conventionally treated patients, namely 205. We can expect that the 138 alternative patients will probably swear by the fact that alternative medicine has helped them, that they are happy to have renounced the “evil” orthodox medicine, are convinced that this is the only way they can defeat their cancer without the assassination attempts “Big Pharma”. This can be exploited in a media-effective way and posted on the practice pages of the respective therapists as a victory message.

However, none of the 67 who died too early compared to conventional therapy will be able to tell their story. For example, what it feels like to go to a real doctor shortly before the end and then come to the conclusion that the prospects for a few more years of life would not have been bad at all if you had only come earlier. Since these 67 nameless patients, whose premature deaths can only be recorded statistically, or their surviving dependants do not present themselves in a closed talk show, they can be dismissed as regrettable individual cases. After all, deaths also occur with conventional therapies. The premature death of these people remains largely unknown to the outside world.

The trust in alternative medicine has caused too early a death for 67 out of 280 people here! The course of the disease was not necessarily negatively affected – but because patients were led to believe that there was an effective alternative medicine, they did not perceive the obviously more effective conventional treatment. This is about the question “Who is harmed by alternative medicine?”

Even more: Looking into the future and counting the trends further into the future, there will continue to be relatively more deaths in the “alternative medicine” treated group, due to the late effects of an untimely or completely omitted effective therapy. In purely mathematical terms, this would mean that in the 13th year after the start of therapy, all “alternative” treated patients would have died, while a good half – around 140 – of conventionally treated patients would still be alive.

In this context, one inevitably remembers Steve Jobs, the legendary Apple boss, who still had time to recognize his mistake of trusting in alternative medical treatment – but not enough time to correct it. His biographer reports how important it was for Jobs to communicate this to the general public. Jobs explained his mistake with the sentence: “I think if you just don’t want to admit something, don’t acknowledge that it exists, then you can fall into “magical thinking”. Not a lack of intelligence, but a lack of rationality.

Although the researchers were unable to separate the individual alternative medical therapies on the basis of the statistical data collected, it can be assumed that the difference is not significant. They were all procedures that were similar in that they had no evidence of efficacy.

When transferring the results to the totality of all cancer patients, it may be necessary to make certain limitations, since some important influencing variables were not recorded. However, the group data tend to point in a different direction, with patients of alternative therapies being younger, more affluent, better educated and less burdened with additional diseases, but also in a later stage of cancer. So it may not always be the case that almost a quarter of patients in alternative medicine die prematurely within seven years, but the trend is unlikely to be reversed.

A decision for alternative medicine in an existing cancer diagnosis could therefore turn out to be a big mistake.


Author: Dr. Norbert Aust

Many thanks to Udo Endruscheit and Natalie Grams for their good contributions.


[1] Johnson SB, Park HS, Gross CP, Yu JB: Use on Alternative Medicine for Cancer and its Impact on Survival; JNCI J Natl Cancer Inst (2018) 110(1): djx145, doi: 10,1093/jnci/djx145


Picture credits: Fotolia_99355604_XS

What does “proved” mean?

Evidence in Natural Science

Eine Ansammlung von Fragezeichen, die die im Beitrag beschriebene Erkenntnisproblematik symbolisiert“Scientifically proven” or “scientifically refuted” are statements that are often heard, but they are not precise. More correct would be the formulation “according to previous knowledge” – or more extensively “according to previous knowledge gained with scientific methods, which have proven themselves because of their extraordinarily high explanatory potential”. (1).

Statements such as “homeopathic effects can be proven” or “homeopathic effects can be refuted” cannot be decided purely logically (like a mathematical task), i.e. not by disregarding all observations. Neither can one decide purely formallogically whether our observations are correct. Statements about correctness are always tainted with the flaw that we cannot get one hundred percent certainty. Errors can never be excluded. Also an inner consistency is no guarantee for correctness (“truth”). This is the Critical rationalism, Karl Popper’s theory of science, which is generally accepted and practiced today and uses the method of falsification, the “false proof” (testing the validity of a theory by trying to debunk it).

The practice, however, is that apart from the contradiction-free system of the laws of nature – so far considered valid (strictly speaking “provisionally”) – we do not know a second contradiction-free system of laws of nature – and we cannot even imagine it! And that the laws of nature considered valid so far have the highest explanatory potential that we know. The physicists still have a lot of unexplained phenomena on their “to-do-list”, but they obviously have no need (again: until now) for further “tools” – no physicist seems to miss a fifth basic force. Even if not everything is explained yet, the explanatory potential of the scientific findings (important: they are “our” findings) is extraordinarily high. Until today, there has not been a single reason to explain the natural with the supernatural. Even if this cannot be “safely” ruled out for the future: If one excludes it “because of experience”, then that is completely sufficient. We can live well with the residual error: It is extremely small.

We don’t need more than our carefully gained experience either (however, this does not mean personal individual experience, but the portfolio of all scientifically obtained observation data). We have to find our way in our cosmos. And we brilliantly complete this task with our “set of insights”. In this cosmos no living being needs a “feeling” (possibility of recognition) for a 4th or 5th dimension. We can survive with our cognitive ability for a maximum of 3 dimensions. Measured against this goal, one may claim: Evolution, which allows us to recognize “only” three dimensions, has obviously not done much wrong.

Homeopathy and “Proof”

Homeopathy is not a glass bead game. It is not a question of certifying or denying a theoretically possible validity of homeopathy or other therapies with formal-logical and “hair-splitting” methods, of arguing it into a formally existing “knowledge gap”. Homoeopathy cannot be formally declared invalid “a priori” (although the statement is legitimate that because of the incompatibility of its premises with sound knowledge the probability of its validity is conceivably low) – accuracy freaks may enjoy this and be satisfied with it. For the important questions of practical application in daily practice, it is sufficient if homeopathy is declared invalid “a posteriori”, i.e. “in the aftermath”, measured against its actual effects: There are no demonstrable phenomena of efficacy beyond the placebo effect (failure due to empiricism). And homoeopathy violates our previously valid and proven findings (lack of external consistency).

Anyone who wants to rely on the expectation that a new, contradiction-free system of knowledge will someday ensure that homeopathy will still be possible in the future – because it will fit into the new system – can trust with equal justification that a new system will also be found for gravity. He can then already jump from Empire-State-Building in confidence in these future insights (oh what, a 10-m-tower is quite enough). We do not participate in these speculations and prefer to stay on the ground until gravity actually has repulsive instead of attractive forces …

We hold it there with Prof. Otto Prokop, a decisive and convincingly arguing homeopathy critic who wrote aptly in the middle of the last century:

“What is considered true in natural science is what fits harmoniously into the overall system of knowledge. (…) A hypothesis, if it is to satisfy, must be able to be brought into meaningful connection with all associated facts. (…) The limits within which there is objectification are the limits of the real world.” (2)

And what does philosophy say?

We can willingly concede to the philosophers (science theorists, epistemologists) that there is a difference between “security – in philosophical and formal-logical rigour” and “security – in everyday language use”. But: “Security – in philosophical and formallogical strictness” is an unattainable goal for everything. The term cannot be used outside formal logic: There is nothing that could fulfill this claim. With strict philosophical and formal-logical certainty, one cannot exclude neither yetis, fairies, elves, leprechauns … nor Sir Bertrand Russell’s teapot circling around Jupiter, which he used to illustrate this statement.

It is interesting, however, that precisely those who are philosophically strict in “not being able to exclude” and who demand this strictness are absolutely negligent in the popular conclusion derived from it, “Everything whose existence cannot be excluded is existent”. This conclusion is philosophically untenable and simply wrong – it is the aforementioned attempt to take advantage of an apparent “gap” in the system of evidence.

If such a conclusion were correct, then thinking would be an “act of creation”: I imagine something. No one can prove the non-existence of the imagined. So the imagined is existent and real. Wrong! For the term “security – in philosophical strictness” one can’t “buy anything”, so to speak. The term merely floats as such, as an mere idea in the spiritual heights – outside the “boundaries of the real world”. As valuable for decision-making in everyday life it correspondents to assets deposited on a planet in the Andromeda Nebula.

When we say that homeopathy has been refuted, we mean the “weak” refutation in everyday language – and we are more than extremely sure not to make a relevant mistake thereby. To limit ourselves to the “accuracy of everyday language” when the higher-quality “philosophically rigorous accuracy” is in principle – without exception – unattainable: this is not reprehensible. On the contrary, it is a necessary condition for us to be able to communicate about anything at all. If we wanted to wait for one hundred percent certainty, then we would have to remain in eternal inaction.

Author: Dr. med. Wolfgang Vahle


(1) Remark: Proofs in mathematics are created according to strict logical rules, rules that may not automatically being transferred to the “real world”. The mathematical proof e.g. that there are infinitely many prime numbers is of a completely different caliber than “proofs” in the natural sciences. The demands that mathematics makes on proofs cannot be met by the natural sciences.

Mathematicians do not even agree whether mathematics is immanently anchored in nature or whether it is a human invention that is only – completely inexplicably – capable of precisely describing natural phenomena. Mathematics itself belongs to the STEM disciplines, but it is probably not a natural science in the proper sense.

And although mathematics can prove much more by purely logical conclusions than the natural sciences by observation with theoretical reappraisal, it is also not possible for mathematics to achieve “truth” (= “correctness of assumptions”) and “logical consistency” simultaneously within an axiom system. This has been shown by the logician Kurt Gödel in his “incompleteness theorems“. Strictly formallogically true statements do not exist within a system, but only from the outside, from “higher points of view” so to speak.

And what if one is already at the “highest observer level”? Then, unfortunately, one must be content with the fact that the truth of a statement cannot be proved strictly logically. This also applies to the statements “homeopathic effects can be proven” or “homeopathic effects can be refuted”: strictly formallogically this is not possible.

(2) O.u.L. Prokop, Homeopathy and Science, Stuttgart 1957 (S. 2, 31)


Learn more about the empirical knowledge situation on homeopathy: “Criticism on criticism on homeopathy #3 – “Homeopathy is impossible”


Picture credits: Gerd Altmann on Pixabay

Was hinter einer “positiven Studie” von Homöopathen steckt – ein Beispiel

Der nachstehende Beitrag erhellt exemplarisch, was sich so manches Mal hinter Veröffentlichungen der homöopathischen Szene verbirgt.


Auf seiner Facebook-Seite hatte der DZVhÄ (Deutscher Zentralverein homöopathischer Ärzte) am 14. April 2016 um 13.37 Uhr einen Artikel des American Institute of Homeopathy mit einem eigenen Link eingestellt (Link inzwischen erloschen).

Eine erstaunt und verwirrt dreinblickende junge Dame, als Versinnbildlichung der hier besprochenen erstaunlichen
Äh… wie bitte?!?

Hierin wird berichtet, ein gewisser Dr. Leonard Torok aus Medina/Ohio/USA hätte bei Knieoperationen homöopathische Zubereitungen von Arnica eingesetzt und dabei bemerkenswerte Erfolge erzielt. Dies sei anhand von Messungen der Menge Blut festgestellt worden, die während mehrerer Operationen zur Implantation eines künstlichen Kniegelenks gefiltert und dem Patienten wieder zugeführt wurde. Im Jahr bevor Dr. Torok Arnica einsetzte, hätte der Blutverlust im Durchschnitt 650 ccm betragen. Nach 17 von Dr. Torok mit Hilfe von Arnica ausgeführten Operationen hätte der Statistiker des Krankenhauses die Versuchsreihe abgebrochen, weil “statistisch signifikante Ergebnisse” vorgelegen hätten. Der durchschnittliche Blutverlust dieser 17 Patienten habe nur bei 170 ccm gelegen.

Insgesamt hätten die Untersuchungen ergeben, dass die Patienten weniger unter Schmerzen zu leiden gehabt hätten, weniger Schwellungen aufgetreten seien, die Ausheilung schneller erfolgte, der Aufenthalt im Krankenhaus kürzer war, weniger Narkosemittel eingesetzt werden musste und die Patienten daher auch weniger unter den Folgen der Narkose litten (Übelkeit etc.).

Dr. Torok habe daraufhin 10 Jahre lang bei seinen Operationen homöopathisches Arnica eingesetzt und sei vor kurzem in Ruhestand gegangen.

Soweit der DZVhÄ. Was sagt das aus?

Zunächst einmal nichts, denn es fehlt an allen detaillierten Angaben, die eine Bewertung ermöglichen würden und es werden auch keine Quellen genannt, in denen man sich weiter informieren könnte.

Also müssen wir die Sache selbst recherchieren. (Alle Internetzugriffe am 23.04.2016)

Erste Station: Google Scholar, die Suchmaschine für wissenschaftliche Veröffentlichungen.

Eine Suche in Google Scholar mit “Leonard Torok” als Autor bringt nur fünf Treffer, keiner davon hat auch nur im Entferntesten mit Homöopathie zu tun.

Zweite Station: PubMed, die Suchmaschine für medizinische Veröffentlichungen:

Mit Leonard Torok als Autor findet man nichts, mit Leonard Torok in der Volltextsuche findet man eine Studie zur Freigabe eines Medikaments für Alzheimer. Also auch Fehlanzeige.

Dritte Station: CORE HOM Datenbank der Carstens-Stiftung zu klinischen Studien zur Homöopathie:

(a) Suche nach Leonard Torok als Autor ist erfolglos.

(b) Eine Suche nach Arnica als eingesetztem Mittel ergibt in Summe 106 Treffer, davon vier zur Implantation eines künstlichen Kniegelenks. Dabei handelt es sich bei allen vier Arbeiten (Brinkhaus 2006, Lüdtke 1998, Wilkens 2000, Wilkens 2003) um Berichte über die gleichen Untersuchungen, die immer vom gleichen Autorenteam auf unterschiedliche Weise veröffentlicht wurden. Dabei handelt es sich um Untersuchungen, die an der Charité in Berlin durchgeführt wurden, diese haben also nichts mit unserem Dr. Torok zu tun. Nebenbei: Es ergab sich keine deutliche positive Wirkung des Einsatzes von Arnica.

Zusammengefasst bis hierher:

In dem Artikel wird behauptet, da hätte jemand einen überwältigenden Erfolg mit Arnica als homöopathischem Mittel erzielt. Dies würde sich doch hervorragend dazu eignen, damit den lange gesuchten ultimativen Wirksamkeitsnachweis für die Homöopathie zu erbringen – aber diese Sensation hat keinen Niederschlag in irgendwelchen Fachveröffentlichungen gefunden, noch nicht einmal als ein in Kreisen der Homöopathen verbreiteter Fallbericht.

Wer ist Leonard Torok?

Eine Google-Suche führt tatsächlich zu einem Dr. Torok in Medina/Ohio, der in der entsprechenden Klinik gearbeitet hat und dessen biografische Daten zur Beschreibung passen. Dieser wird einmal als Orthopäde (Link erloschen …), einmal als Spezialist für “ganzheitliche Medizin und Dermatologie”  (Link erloschen …) geführt. Einmal sind Knieoperationen sein Spezialgebiet, dann wieder Akne, Neurodermitis und andere Hautkrankheiten. Aus den biographischen Daten ist zu ersehen, dass es sich dabei durchaus um die gleiche Person handelt.

Auf einer anderen Webseite (Link erloschen …) wird wieder die gleiche Person beschrieben, diesmal allerdings als jemand mit vertieften Kenntnissen der “ganzheitlichen Medizin”, was wir hierzulande als Alternativ- und Komplementärmedizin bezeichnen würden: Zu seinen Spezialgebieten zählen TCM, Klangschalentherapie, Neurofeedback (“neurotherapy”), Hypnose, Verhaltensmedizin (“behavioral medicine”), Bioresonanz (“electrodermal screening”), Craniosakraltherapie, Osteopathie (“somatoemotional release”) und fortgeschrittene Homöopathie (“advanced homeopathy”)

Hier (Link erloschen … )profiliert er sich als Kosmetiker.

Ach ja, über seine angeblichen durchgreifenden Erfolge bei Knieoperationen erfährt man auf allen diesen Seiten: nichts.

Das Krankenhaus, an dem die umwerfenden Erfolge erzielt worden sein sollen, ist das Medina Hospital, das, nach der Webseite (Link erloschen …) zu urteilen, zur Cleveland Clinic gehört. Folgt man dort den Links zur Orthopädie und Knieproblemen, erfährt man nichts über den segensreichen Einsatz der Homöopathika. Möglicherweise sind Angaben in den Informationsbroschüren enthalten, die man sich downloaden kann, wenn man sich mit einer amerikanischen Postleitzahl (zip-code) registriert. Ich habe als Einwohner Südbadens davon Abstand genommen.

Eine gründliche Suche nach Veröffentlichungen des Krankenhauses sowie nach dem Stichwort “homeopathy” auf der Webseite führte zu keinem einschlägigen Suchergebnis.

Zur Cleveland Clinic gehört noch ein Lerner Research Institute, das für die Jahre 1999 bis 2014 Jahresberichte zur Forschung herausgegeben hat, also durchaus den gesamten Zeitraum abdeckt, in denen Dr. Torok seine einmaligen Erfolge erzielte (Link erloschen …). Eine Volltextsuche nach “Torok” ergab in keinem der Berichte einen Treffer. Auch die Suche nach dem Namen “Torok” auf der Webseite blieb erfolglos.

Also, lieber DZVhÄ: Woher wisst Ihr das eigentlich, was Ihr hier behauptet? Es gelingt nicht, irgendeiner Information hierzu habhaft zu werden, die die Grundlage für Euren Artikel bilden könnte. So wie sich das darstellt, kann es sich bei dem veröffentlichten Artikel auch um ein völliges Phantasieprodukt handeln, dem Ihr da aufgesessen seid.

Aber nehmen wir einfach mal an, dass das, was der DZVhÄ da schreibt, tatsächlich stimmt. Wie ist das zu interpretieren?

Alles was wir über den durchgeführten Vergleich wissen, ist folgendes:
During the year prior to this experiment, the average blood loss during and after surgery was 650cc. During the experiment, the 17 patients in the study had an average blood loss of 170cc, representing a 74% decrease.
(Während des Jahres vor dem Versuch betrug der durchschnittliche Blutverlust während und nach Operationen 650 ccm. Während des Versuchs verzeichneten die 17 teilnehmenden Patienten einen durchschnittlichen Blutverlust von 170 ccm.)

Belastbare Evidenz erfordert, so ist der gegenwärtige Kenntnisstand, kontrollierte und verblindete Vergleichsstudien, bei denen eine größere Zahl von Patienten nach einem Zufallsprinzip auf zwei Gruppen aufgeteilt wird. Eine der Gruppen erhält das zu prüfende Mittel, die andere das Placebo bzw. das Vergleichsmittel bekannter Wirksamkeit. Durch die Randomisierung – die Aufteilung nach einem Zufallsprinzip – soll sichergestellt werden, dass die Ausgangssituation in beiden Gruppen vergleichbar ist. Durch die (doppelte) Verblindung wird sichergestellt, dass in beiden Gruppen das Verhältnis zwischen Behandler  / Betreuer und Patienten nicht durch “Vorwissen” dazu beeinflusst wird, wer welche Mittel erhält.  Nur so ist sichergestellt, dass man auch die Effekte des Mittels erfasst und sich Wunschdenken oder einseitige Placeboeffekte im Ergebnis nicht wiederfinden.
Was davon findet sich hier?

Es wurden zwei Gruppen betrachtet – aber waren diese vergleichbar? Bei der Vergleichsgruppe handelt es sich um alle Patienten eines Jahres – und es wird noch nicht einmal gesagt, dass dies nur Patienten waren, denen ein künstliches Kniegelenk eingesetzt wurde. Man unterstellt das, wenn man die Nachricht liest, unwillkürlich, aber geschrieben ist das nicht. Da steht “… after surgery …”, nicht “… after knee-surgery …”. Selbst wenn es sich bei allen um die gleichen Operationen handelte, ist nicht ersichtlich, ob andere möglicherweise den Erfolg der Operation bestimmende Faktoren vergleichbar waren (z.B. Alter, Geschlecht, Gewicht …).

Wir erfahren, dass die Patienten von Dr. Torok weniger Blutverlust zu verzeichnen hatten. Wenn dem tatsächlich so war und die Gruppen vergleichbar waren – lag das notwendigerweise an dem homöopathischen Mittel?

Ganz und gar nicht. Alles, worin sich das Vorgehen Dr. Toroks von dem unterschied, was die anderen Mediziner taten, die im Jahr zuvor die Operationen durchgeführt hatten, kann zu diesem Unterschied geführt haben. Hätte man feststellen wollen, ob tatsächlich die Homöopathika einen Einfluss hatten, dann hätte man den Patienten verblindet entweder Arnica oder ein Placebo geben müssen und alle hätten von Dr. Torok operiert werden müssen. Natürlich auch ohne dass dieser wusste, wer welches Mittel eingenommen hat. Dann hätte man das sehen können.

Überhaupt, wie kam man eigentlich darauf, ausgerechnet den Blutverlust als das Beurteilungskriterium heranzuziehen? Das ist höchst ungewöhnlich. Ein Blick in die oben erwähnte Datenbank zu den Arnica-Studien zeigt, dass generell nach Operationen eher die Ausbildung von Hämatomen (“blaue Flecke”, die Schwellung an der Eingriffsstelle oder auch das Ausmaß der Schmerzen betrachtet wurden. Das Ausmaß des Blutverlusts wird nur einmal in 36 Untersuchungen genannt, die sich mit Operationen und Wundheilung befassen. Wie kam Dr. Torok auf die Idee, genau dies zu messen?

Oder kam er gar nicht vorher auf die Idee, sondern hat einfach eine ganze Menge Daten ermittelt, wie ja auch aus der Aufzählung der Vorteile hervorgeht und für diesen Bericht wurde einfach das beste der Ergebnisse herausgefischt? Dann ist das eine völlig wertlose Angabe, denn wenn man nur ausreichend Daten erfasst, wird man immer (!) etwas finden können, das sich positiv entwickelt und auch zu einem signifikanten Ergebnis geführt hat.

Der richtige Weg ist vorab festzulegen, anhand welcher Größen man seinen Erfolg bewerten wird – und dabei zu begründen, nach welcher logischen Überlegung oder aufgrund welcher Vorkenntnisse man davon ausgehen kann, warum das Mittel genau so wirkt. Alles andere sind Zufallstreffer, die man unter den verschiedenen Fehlschlüssen eingruppieren könnte, sei es der Texas Sharpshooter, das Rosinenpicken oder auch Data mining. Alles Dinge, mit denen man scheinbar überzeugende Resultate erzeugen kann, auch wenn das betrachtete Mittel unwirksam ist.

Der Texas Sharpshooter schießt erst auf ein Scheunentor, schaut, wo er getroffen hat, malt hinterher die Zielscheibe drum herum und sagt: “Schaut, wie toll ich ins Schwarze getroffen habe!” Rosinenpicken bedeutet, dass man aus dem großen Ganzen die paar Dinge heraussucht, die einem gefallen. Data mining ist einfach der Vorgang, sehr viele Daten zu ermitteln, wobei durch die natürliche Streuung immer auch positive Resultate dabei sind.

Da wir gerade beim Zufall sind: Nachdem was der DZVhÄ schreibt, wurde der Versuch vorzeitig abgebrochen, weil die Daten signifikant waren. Es ist ein bei einem Wirksamkeitsnachweis völlig unzulässiges Vorgehen, dann schnell aufzuhören, wenn die Daten gerade gepasst haben.

Auch hier muss man vorab eine Vorgehensweise festlegen und sich daran halten. Man überlegt sich üblicherweise, wie groß der Effekt ist, den man erwartet. Hieraus kann man mit statistischen Verfahren ermitteln, wie viele Versuche man braucht, um das Ergebnis in der unvermeidlichen Streuung der Messwerte deutlich erkennen zu können. Bricht man die Versuchsreihe dann ab, bevor man diese Versuchszahl abgearbeitet hat, ist das Ergebnis nur ein Zufallstreffer – und mehr auch nicht.

Zusammenfassung:
Der DZVhÄ behauptet, ein Dr. Torok habe in den USA unter Einsatz von homöopathischem Arnica ganz erhebliche Verbesserungen bei Knieoperationen erzielt. Unabhängig davon, dass dieser Dr. Torok ein recht umtriebiger Mensch zu sein scheint, der über eine erstaunliche Menge von Spezialkenntnissen verfügt, hat sich dieser angebliche Erfolg anscheinend in keiner auffindbaren Veröffentlichung niedergeschlagen. Das, was wir vom DZVhÄ darüber erfahren, lässt die Vermutung aufkommen, dass es sich um ein Zufallsergebnis handelt und überhaupt nichts mit dem Einsatz homöopathischer Arnica zu tun hatte.

Weiter so, DZVhÄ! Solche Evidenz trägt die Katze auf dem Schwanz weg – vor dem Frühstück.


Nachsatz, 07.10.2019

Das Erlöschen sämtlicher Link-Referenzen, die überhaupt auffndbar waren, machen den Artikel nicht etwa weniger aktuell, sondern eher noch interessanter. Wer sich auf solche “Belege” beruft, braucht eigentlich niemand mehr, der sich die Mühe macht, sie zu widerlegen.

Eine aktuelle Websuche nach “Dr. Leonard Torok” ergab einen Treffer in der Mitgliederliste des American Institute of Homeopathy, der wiederum auf eine “Ohio Holostic Medicine” hinweist. Dabei handelt es sich laut Google um eine Akupunkturklinik, wo Dr. Torok sich offenbar ein weiteres Tätigkeitsfeld erschlossen hat. Diese Einrichtung befindet sich in der Nähe des American Institute of Homeopathy und verfügt nicht über eine eigene Webpräsenz, scheint aber zu einem größeren “Cluster” von Einrichtungen der alternativen Szene “vor Ort” zu gehören.

Ein Schelm, wer Schlimmes dabei denkt. Die Katze hat’s eben einfach auf dem Schwanz davongetragen.


Autor: Dr. Norbert Aust

Diesen Text hatten wir als Kommentar auf der Facebook-Seite des DZVhÄ (Deutscher Zentralverein homöopathischer Ärzte) am 24.04.2016 unter deren Link zu der “Studie” gepostet. Eine Reaktion darauf haben wir nicht erhalten.


Bild von Robin Higgins auf Pixabay

Homeopathy: Individuality vs. Confusion of Symptoms

The “individual” homeopathy – is it really that?

Five apples - four exactly the same in black and white and one as a symbol of the individual in natural red.
Individuality… ?

Homeopathy is said to be a very individual therapy. Even the smallest differences between two patients can cause them to be administered different remedies, even though they otherwise have the same complaints.

Imagine if you had eczema on your skin – a very itchy spot – and you were visiting a homeopath. The homeopath would take an anamnesis with you. This would reveal that you are also prone to depression, occasionally have headaches, mild gastritis (inflammation of the stomach lining) and sometimes have asthma symptoms in summer – apparently you are allergic to certain grass pollen. If you are additional afraid of being alone, then Arsenicum album would be the remedy for you. If you had exactly the same symptoms, all that just been mentioned, but being alone does not bother you, but instead of you are afraid of burglars and mirrors, then Pulsatilla would be the remedy of choice.

As sensitively as remedies are prescribed, so precisely is homeopathy adapted to the entire human being. No other doctor can keep up, this remedy is just right for you – only for you.

So much for the good news.

The bad news is that this prescription is completely unrelated to reality. Because, one should ask, how does one know what effect the remedies have?

When selecting remedies, homeopaths are guided by so-calles repertories, i.e. inventories in which it is listed which remedy should be effective for which symptoms. These data were determined in so-called homeopathic drug tests, in which healthy test subjects took the remedies and recorded the symptoms they subsequently experienced. It is assumed that a remedy can cure the symptoms it causes in a healthy person. This is the similarity rule of homeopathy, the basic pillar after which homeopathy was named.

We can therefore say that when taking Arsenicum album
– someone got depression
– someone got a headache
– someone got a gastritis.
– someone was allergic to something
– someone had asthma attacks.
– someone was afraid of being alone.

But were these “someones” the same person? What if the person who was afraid of being alone suffered from shingles? What if the person who had asthma was prone to coercive behavior? Or was the one with eczema suffering from insomnia? The remedy would only be tested in these combinations, not necessarily in the one you have as a patient.

Quintessence: The symptoms that led you to choose the drug are unlikely to have occurred in any of the examiners all together. The individuality of homeopathy is limited solely to the collection of the symptoms in the patient – the individuality of the examiners plays no role at all. If the patient is a small petite temperamental young woman and the examiner is a tall heavy phlegmatic older man – that doesn’t matter at all, symptom is symptom.

Do you notice what a mirage is being built up? The individual prescription on the basis of the symptoms determined in the anamnesis is meaningless. If the anamnesis had any significance for the means choice, then the accompanying circumstances of the examiners would also have to have been recorded during the drug testing and then recorded in the drug picture. But they are not, as you can easily convince yourself. Another contradiction that neither attracts the attention of homeopaths nor seems to disturb them.

But to really talk about the whole burden of life with someone who seems to be interested in it is good, no question. But homoeopaths are not trained for it!

Source Drug pictures: www.homeowiki.org


Picture credits: Gerd Altmann on Pixabay

 

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Wir, GWUP e.V. (Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften e. V.) (Vereinssitz: Deutschland), verarbeiten zum Betrieb dieser Website personenbezogene Daten nur im technisch unbedingt notwendigen Umfang. Alle Details dazu in unserer Datenschutzerklärung.