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

Guest post by Alan Henness

When I discovered a homeopath admitting on camera that she believed she and her fellow homeopaths had managed to unblind a triple-blinded homeopathy trial they were taking part in, I submitted a complaint to the journal that published the paper on the trial, the university of the researcher who had conducted the trial and the current university of the homeopath who had subsequently moved into research.

The paper concerned is the 2004 paper by Weatherley-Jones et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. This was published in the Journal of Psychosomatic Research.

The homeopath was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.

She gave a presentation at the 2019 conference of the Homeopathy Research Institute. Billed as an International Homeopathy Research Conference, it was subtitled, Cutting edge research in homeopathy. The videos of the conference were sponsored by homeopathy manufacturing giant, Boiron.

My complaint email (see below) explains what I discovered and sets the context. As a result of the investigation by the journal, the current editor along with two former editors have just published a peer-reviewed paper on my complaint and their investigation:

When is lack of scientific integrity a reason for retracting a paper? A case study

Misconduct and unethical behaviour

It’s worth noting how serious the Journal of Psychosomatic Research considered the misconduct they identified by Relton and others. From the Results section of the paper:

We found the presentation by Dr. Relton disturbing on multiple grounds. This admission of unethical behavior calls her scientific integrity into question. The premise for her actions rests on an errant assumption widespread among clinicians, based on anecdotal experience, that one possesses an ultimate knowledge of what works and doesn’t work without the need for rigorous study. The history of medicine, unfortunately, has been littered by countless treatments that practitioners believed in and dispensed, only to be later found not beneficial or even harmful [4]. This underscores the importance of rigorous study for treatments where equipoise exists in the scientific community, as it arguably did for the use of homeopathy for chronic fatigue syndrome. Dr. Relton likely did not hold that equipoise herself, but if she had ethical concerns about the study, the appropriate action would have been to not participate in it. Instead, she purports to have enlisted colleagues to deliberately and systematically undermine the study.

In watching the presentation, the purpose of this admission seemed to be to discount the results of a rigorous but essentially negative study in the context of promoting her own ideas related to trial design. While we cannot know for certain that her motivation was to discount the results of this study, what she said clearly seeks to undermine the credibility of a trial whose results challenged her firmly held but untested beliefs about the benefit of a treatment that she had high allegiance to. Regardless of her intent or what actually happened during the trial, Dr. Relton’s presentation is ipso facto evidence of either an admitted prior ethical breach or is itself an ethical breach for the following reasons. Either she indeed undermined an ambitious effort to study of the efficacy of homeopathy for chronic fatigue syndrome, negating the work of all other investigators, study staff, and participants involved in the study as well as the investment of the public, or she is conducting a late and inappropriate attack on the study’s credibility. Her presentation certainly warrants formal censure from the scientific community, and this paper may contribute to that. Despite this clear indictment, after discussing and considering the complaint of Mr. Henness for several months, we ultimately decided not to retract the paper.

They decided not to retract the paper but instead use it for ethical reflection. However, they concluded I had highlighted “undisputable evidence of scientific misconduct” by the homeopaths concerned:

When is lack of scientific integrity a reason for retracting a paper? A case study

Objective: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immediate past editors expand on the journal’s decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators.

Methods: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case.

Results: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper.

Conclusion: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Ethical misconduct

The authors had additional ethical concerns:

Apart from the intention of ‘circumventing the blind’, there is another unethical aspect to the behavior of Dr. Relton, namely the fact that patients were systematically subject to an intervention (carcinosin administration) that was not part of the original research protocol and to which they did not consent as part of the study. Although the systematic administration of carcinosin was not part of the study protocol, it was administered only to patients taking part in the study, and because they took part in the study. Presumably, these patients were not properly informed, or maybe even misinformed, about the rationale of a double-blind trial design and/or the true reason for administrating carcinosin. Apparently, ‘deep listening and deep understanding’ does not necessarily need to be accompanied by an honest and open attitude towards patients that participate in research. Dr. Relton stated in her lecture ‘I’m not trained to be deceiving people’, but that is exactly what she did. Not only did she deceive patients, but also the researchers and study leaders that she is supposed to collaborate with as a colleague. [emphasis in original]

Sanctions

The authors said:

The authors are of the opinion that in case the misconduct was not conducted by or on behalf of the principal investigator – as is the case here -, the initiative for further action should lie with them. Not only is the principal investigator the one that was deceived, but they are in a better position to report the misconduct to the institution and funding body. If the principal investigator is responsible for the misconduct, the editor is probably the only one that can initiate further action, in which case the researcher’s institution should be informed and requested to take appropriate action.

It will be interesting to see what further action, if any, is taken by Weatherley-Jones as is suggested.

I had already brought my concerns to the attention of both the University of Sheffield and Queen Mary University of London. The former concluded:

This is to confirm that the University of Sheffield has now completed its assessment of this matter, and it has been agreed that it would not be appropriate for the University of Sheffield to undertake a research misconduct investigation of the allegation against Clare Relton, since she is not a current member of University staff, nor was she a member of staff at the time of the clinical trial in question.

In relation to the potential concerns about the reliability of the published research findings, the University is satisfied that the Journal of Psychosomatic Research is consulting with the authors and taking steps to address the concerns as appropriate. The University will therefore be taking no further action.

I received no response from Queen Mary University of London, despite their Principal being copied in on all the relevant correspondence.

I will be writing again to both and Weatherley-Jones now the paper has been published.

Acknowledgements

My thanks to Jess G. Fiedorowicz, Editor, Journal of Psychosomatic, for his thorough investigation of my complaint.


My complaint

Hi

The results of a trial were published in the Journal of Psychosomatic Research in 2004 (see attached copy):

A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome

doi:10.1016/S0022-3999(03)00377-5

Elaine Weatherley-Jones a,*, Jon P Nicholl a, Kate J Thomas a, Gareth J Parry a, Michael W McKendrickb, Stephen T Green b, Philip J Stanley c, Sean PJ Lynch d

a Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK
b Communicable Diseases Directorate, Royal Hallamshire Hospital, Sheffield, UK
c Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
d St. James’s University Hospital, University of Leeds, Beckett Street, Leeds, UK

* Corresponding author. Tel.: +44-114-222-0744; fax: +44-114-222-0749.
E-mail address: e.weatherley-jones@sheffield.ac.uk (E. Weatherley-Jones)

The paper is indexed in PubMed here.

Elaine Weatherley-Jones is listed as the Corresponding author at the Medical Care Research Unit, School of Health and Related Research, University of Sheffield as are others.

One of the homeopaths involved in providing treatment was Clare Relton, currently Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London.

The full list of those involved in providing treatment during the trial is given as:

The Homeopathic Trials Group: Homeopaths— Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom.

Dr Relton gave a talk at the Conference in London of the Homeopathy Research Institute held 14 to 16 June 2019. The video of her talk has recently been published: https://www.hrilondon2019.org/films/#clip=eitxmhl1ilss. I have a copy of this video.

I invite you to watch all 30 minutes of it.

At about five minutes in, she begins to discuss the above trial, having just said she was a non-medical homeopath at the Wellforce Clinic in Sheffield. She is currently listed as Chair of Directors.

She then goes on to describe how she took part as one of the homeopaths in the trial and relates how she came up with “a cunning way of circumventing the blinding”.

I offer the following transcript of the segment of her talk where she discusses this (all transcription errors are mine):

Timestamp 05:12

So while I was still a homeopath in the Wellforce clinic, a researcher from the University of Sheffield which was actually only five minutes away from my clinic which was really handy came along and said, “I’ve got some money from Lord Sainsbury to do a trial of chronic fatigue syndrome of homoeopathy” and she described the design and I remember thinking, “not sure what that’s going to show”.

But anyway there were ten homeopaths recruited in Sheffield and Leeds and we saw patients with chronic fatigue syndrome.

A lot of us were getting patients with chronic fatigue syndrome anyway and particularly if they were never been well since glandular fever couple of doses of carcinosin 30 or 200 and they seem to make a really good recovery.

So we’re pretty confident about taking part in this trial.

So there were 130 or 140 patients recruited to the trial and then allocated to the homeopaths: there were five at our clinic and I was one of them.

Patients would arrive; you would do the normal thing, have the consultation with them. They seemed a bit standoffish, they were quite distant – I couldn’t work out why.

And then at the end of the consultation I had to say to them “well there’s a 50% chance that whatever I prescribe you is going to be a placebo”, which sort of sort of lowered the temperature in the in the in the Consulting room because you know they came because they have chronic fatigue; they came… didn’t come because they wanted to take part in an experimental game.

So we would ring the pharmacy up and tell them our prescription. Helios Pharmacy would then send out either placebo or the real remedy according to the allocation of the patient.

The patient would come back four weeks later and if they were better, great and if they weren’t it was really, really difficult. So, had I got the wrong prescription or were they on placebo?

So after about six months of this we started working out there was a cunning way of circumventing the blinding and we worked out, well if we give them all a dose of carcinosin they’re going to have some reaction: there’s going to be a dream there’s going to be some change and if when they come back at the second appointment they haven’t changed then we know they’re on placebo. So don’t bother doing all that trying to find the right remedy; just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what’s toxic in our systems, about diet and counselling.

So that’s what we did. Because we’re homeopaths. We’re trained to treat people I’m not trained to be deceiving people. That’s what I do, that’s what I did then; that’s what all my colleagues did.

So ok, so the trial ended and at the end the results came out I’m sure quite a few of us are familiar with it.

There were two groups, so there was a group… everybody in the patient… everybody in the trial received treatment… a course of treatment by a homeopath and 50% of them received a placebo remedy 50% the real remedy, the verum.

And the results… both groups got better and the group that received the real remedy improved better than the group that received the placebo but was the difference clinically significant? Not quite. How many trials do we have that? So this trial was so much realisation, so many questions came out of my experience being inside, inside a double-blind placebo randomised controlled trial. What is seen as the… you know the… summit of evidence-based medicine in terms of rigorousness, I  just thought “what is this doing?” I don’t know what… I don’t know what this has shown.

This is what’s called an explanatory trial and I thought well it’s explaining nothing to me, apart from the fact that the system for designing and conducting randomised controlled trials at the moment isn’t working.

So lots of questions.

Timestamp 09:02

The paper states:

Patients were successfully blinded to their group allocation, and therefore we have assumed that whatever the reasons for nonresponse, they are the same for the treatment arm and the placebo arm and that the data are comparable. Therefore, intention to treat analyses was done on actual data plus imputed missing item data, but all unit missing data were excluded from analyses.

and:

Checking of double blinding showed that prediction of treatment group was made by neither homeopaths (j =. 07, P c.60) nor patients (j = 0.11, P c.48).

The trial was of a triple-blind design but there is no mention of the deliberate attempts to circumvent the blinding in the paper. The effects on participants by the actions – inadvertent or otherwise – of Relton and her colleagues are not considered and not known.

I believe the actions of Relton, the other four homeopaths at her clinic whom she clearly implicates in this circumvention of blinding, and possibly the remaining four homeopaths if they were all known to each other and in contact with each other since they were all in the same area of Leeds/Sheffield, compromised the trial design, rendered the results unreliable and seriously undermined the integrity of the paper and its conclusions. I do not believe it matters whether or not they were in fact able to circumvent the blinding, but it does matter that Relton and others believed they had because she admits it led to different behaviour on their part resulting in contamination of the results.

I believe the actions amount to misconduct.

I note additional criticism of this paper by Prof Edzard Ernst (see attached).

I ask that Sheffield University investigate this matter and that along with Queen Mary University of London and the Editor-in-chief of the Journal of Psychosomatic Research, Jess Fiedorowicz, MD, PhD, decide what actions to take. I ask that consideration is given to retracting this unsound paper.

Please consider this email as a formal complaint against Dr Clare Relton and others.

Please acknowledge receipt by return and keep me informed of your progress in investigating this matter and of your conclusions and outcome.

If you require any further information, please do not hesitate to contact me.

Best regards.
Alan Henness

46 Responses to “Undisputable evidence of scientific misconduct” by homeopaths

  • You have to wonder how such a person could ever get a job in teaching about clinical trials. Her lecture was about how to undermine clinical trials. Queen Mary University of London has some serious questions to answer.

    Brilliant work Alan.

  • This is an interesting case in several respects.

    The first breaches of ethics occurred already at the very start: apparently, patients were not informed that they were enlisted in a trial, and neither were they given the choice to opt out. This is Bad.

    Then there’s the ‘cunning way to circumvent the blinding’, which not only was fully based on the delusion that homeopathic substances actually have an effect – but also involved administering all patients the verum, even if they were told that they had a 50% chance that they would receive a placebo.

    And then Mrs. Relton has the gall to come up with this:
    “We’re trained to treat people I’m not trained to be deceiving people. That’s what I do, that’s what I did then; that’s what all my colleagues did.”
    No Mrs. Relton, you have been deceiving people right from the start. You did not tell them that they were supposed to take part in a trial, you apparently did not tell them that they could opt to receive the actual ‘treatment’ (no matter how useless), and later you did not tell them that you gave everyone the verum after all, just because you thought it was unethical NOT to give them the verum, even if that meant messing up the trial.
    Only the fact that, like all homeopaths, you first and foremost deceived yourself could be considered a mitigating circumstance – were it not for the fact that homeopaths really should know better in this day and age.

  • Is it me, or is it funny that their term for placebo is “verum” which means truth. So they basically admit whatever concoction of sugar and water is actually a placebo.

    • I’m not quite certain that I understand what you mean. In normal double-blind trials, ‘verum’ is the accepted term to describe the active substance under test, as opposed to a placebo.
      In homeopathy, there is of course no difference between verum and placebo, and yes, that is quite funny. So maybe they should use the term ‘fictus’ in their trials instead of ‘verum’.

  • This woman has absolutely no idea of ethics or integrity – or much of anything else for that matter.
    She is the lowest form of scoundrel.
    Does she not realize that she has been “deceiving” people from the outset by peddling her useless homeopathic wares which contain nothing but sugar,water or alcohol for the most part and if there should be any “remedy” that it will be entirely irrelevant?

    That this clueless person is supposed to be teaching about clinical trials is horrifying – she couldn’t reason her way out of a paper bag. Queen Mary University of London needs to do an urgent review of her employment and get rid of her – she is an utter embarrassment. Why are they employing a clueless homeopath anyway? Whoever agreed to employ her needs to be sacked as well – complete idiots the lot of them!

    Homeopathy is based on magical thinking – it is a fantasy. It has NO PLACE in a University. And neither does this person.

  • Giving a dose of Carcinosin should have had no effect according Dr Ernst, so it shouldnt have unblinded the trial in any way. If she is supposedly just deluding herself that the remedy is acting, why complain?

    • good to see that you have yet again not understood anything, Roger.

    • @ Roger

      and that like most homeopaths, and like the woman in question, that you have no concept whatsoever of ethics or moral integrity, common decency or intellectual rigour or in fact any standards at all.

      but then one has to ask how could anyone BE a homeopath and uphold any of society’s commonly accepted standards?

      if one’s business model consists of deception and flogging fake products to gullible marks then what else should we expect?

    • @Roger
      Your remark only underlines the notion that Mrs. Relton is not competent to work in any scientific field, because she lets her beliefs and biases as a homeopath prevail over scientific integrity and the scientific method, which is a definite no-no if you’re involved in real research.
      This is further supported by her own words:

      … just use all your other amazing skills you have as a homeopath: the deep listening we have the deep understanding of what we know about what’s toxic in our systems …

      Does this sound like an objective scientist to you? I know of quite a few arrogant doctors and scientists, but rarely do they express their unwarranted self-esteem so unequivocally.

      • @ Richard Rasker

        I agree – but she displays such extraordinary and appalling ignorance of the basic tenets of scientific research and the scientific method, not to mention the total lack of any kind of basic moral or personal integrity that one really has to question what she is doing in the position of:

        “Senior Lecturer in Clinical Trials at the Centre for Primary Care and Public Health at Queen Mary University of London and Honorary Senior Research Fellow, School of Health and Related Research at the University of Sheffield.”

        and one further has to seriously question the sanity and the integrity of the people responsible for appointing her to this position in the first place. Why on earth would they consider appointing a HOMEOPATH of all people – a believer in magic and delusional healing – to a scientific position in a University?
        What could they have been thinking – if they even were thinking? What had they been taking?

        Is public money being used to fund this hare-brained woman in this position? How can anything she teaches or publishes be trusted? She is a fanatical believer in a fantasy method of healing that is pure PSEUDOSCIENCE – so what faith can anybody have in whatever nonsense she spouts from her dais or lectern?
        And she doesn’t even understand what she did wrong in what she thinks is a clever ruse to outwit a clinical trial protocol! And was then stupid enough to boast about it in public on a video!

        Maybe her brain cells have been diluted to 200C?

  • IMO the worst of this was that they administered a treatment (carcinosin, at a homeopathic dose, presumably) that wasn’t in the treatment protocol, so the participants had no informed consent.

    And in any case, how do they now know which medication had the effects that they were studying? That is, other than by the fact that they “know” in advance which of the “treatments” does what.

    How would people react if in a trial of conventional medicine, the researchers decided to break blinding my popping some senna pod extract in the medication for one branch of a trial?

  • But of course Ernst is equally guilty of publishing papers with known fiddles when it suits him…
    Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial
    A White, P Slade, C Hunt, A Hart, E Ernst Thorax 2003;58:317–321
    In this case the laughable ‘glass ceiling’ in which no child with a history of an asthma attack within the previous 12 months was accepted into the trial. Eventually rumbled, the demands to the Editor of Thorax for retraction of this paper by reputable researchers were pitifully ignored.

  • Ahh there’s your wonderful sense of humour coming to the fore. But you know Edzrd I always have the last laugh, becasue every time you make a comment to the press against homoeopathy my sales rocket in response

    • I knew it!!!
      homeopathy is a joke!

      • Please reply to Tony Pinkus’ justifible concerns. Why would you design a trial that has no possibility of succeeding? If this asthma trial that you designed did not allow a chld who had had an asthma attack in the previous 12 months, how can ANY treatment improve upon that?

        As Lucy was known to have said, “You’ve got some ‘xplaiin’ to do!”

        • glad to see that you are wrong as usual:
          All children aged 5–15 years were identified from practice
          records if a diagnosis of asthma was recorded and a prescription for a β agonist and/or corticosteroid inhaler had been
          issued within the previous 3 months. Their parents were sent
          a letter inviting participation in the study. Children who had
          been prescribed oral corticosteroids for acute asthma within
          the previous 12 months were excluded for reasons of safety.
          Children who had previously consulted a homeopath for any
          condition and received a homeopathic prescription were
          excluded, as were children who were unable to complete the
          necessary forms or were thought by their doctor to be unlikely
          to comply with instructions.

          • “Children who had previously consulted a homeopath for any condition and received a homeopathic prescription were excluded, as were children who were unable to complete the necessary forms or were thought by their doctor to be unlikely to comply with instructions”

            But if you say that homeopathy is just a “placebo”, there was no need to exclude children previously treated with homeopathy, unless you will seek to alter the data and generate a false negative. It’s quite possible given your history of manipulating patient records and charts.

          • sorry to hear that you are a bit slow on the uptake: THE TRIAL WAS TO TEST WHERTER HOMEOPATHY IS MORE THAN A PLACEBO!

          • “THE TRIAL WAS TO TEST WHERTER HOMEOPATHY IS MORE THAN A PLACEBO!”

            Oh, that same clinical trial as when it was included in Mathie’s meta-analysis, it didn’t alter the overall results at all.

        • why do you think they are ‘concerns’ without checking?

        • Hey Dana

          Nice of you to confirm once again your inability to comprehend what you read. Have you done anything significant of late?

    • I bet you won’t provide a jot of evidence for that claim, though.

      And always remember, Tony, correlation does not equal causation…

    • Of course they do, Tony. And I’ve got a girlfriend who’s a model. But you wouldn’t know her. She goes to a different school.

    • Ghosh, I must be popular!

    • This is very funny because so far in 2019 several “skeptics” have been sending intimidating notes to scientific journals to retract only articles that report favorable evidence for homeopathy. Only in this case Alan Henness did not succeed and in the same summary Alan is accused of unethical conduct for wanting to censor. Speaking of this situation, it is worth remembering that Alan has a huge record of having supported and being a member of the criminal organization “Sense About Science”, now clearly linked to Monsanto as Carey Gillam and Gary Ruskin have documented. The other fun part is that if the pseudoskeptics want to retract, we could start by sending complaints to the journal Nature to retract the slanderous articles published by Maddox, Steward and Randi against Jacques Benveniste, and also send complaints to The Lancet to retract the meta-analysis of Egger, passing by other articles, such as Ernst published in 2002, that to the end of the day they have a clear evidence of intentional manipulation as shown by Hah. Now I am glad to know that Ernst published an article in Thorax whose manipulation was intentional to achieve a negative case.

      • Yawn yawn yawn. More pathetic Special Pleading.

        Homeopaths see their hapless attempts at research being trashed by scientists and then think they can do likewise with correctly-performed trials which demonstrate that their shaken water has no theraputic effect beyond placebo.

        Pathetic.

        And what, then, of the complaint to the ombudsman about the NHMRC report which has claimed to have been made by the HRI? Would this class as an “intimidating note”? (That their ineffectual whinge appears either not to have been made or has been completely ignored by the ombudsman does not appear to have been addressed by the HRI)

        And the “criminal organisation” Sense About Science?

        For something to be classified as criminal, it is decided by a court of law, not the imaginations of quacks who don’t like their mendacity being repeatedly proven. And you’re mentioning Gary Ruskin, a man with demonstrated links to Kremlin propaganda mouthpiece RT and a track-record of harassing scientists? Oh please. His repeated exercises in making 2+2=wheelbarrow in his ignorant one-eyed campaign against GM foods make him only an object of ridicule. He makes Dana look logical.

        As ever, if homeopathy worked, it would be easy for its proponents to demonstrate it. It doesn’t and they can’t so all they can do is distort data, dodge, obfuscate, whinge and bluff. As you do above. It would be amusing if it wasn’t so pathetic. Run along, now.

        • @Lenny

          Have you any idea how anyone can be a member of an organisation that doesn’t have members?

          But as usual, loads of silly accusations flying around but, like the chiros, not a jot of evidence to back any of it up. You’d have thought they’d have learned by now…

          And yeah, that overwhelming evidence that homeopathy works… homeopaths should be recruited by MI6: that’s got to be the best kept secret of all time.

  • Homeopathy deserves to be scientifically appraised by good quality studies and the results published without bias which could distort future meta-analyses. The study on childhood asthma by White et al published in Thorax has critical flaws which seriously undermine its conclusion. The main weaknesses of the study, which were mentioned by the authors but not given due attention, were the limitations of the primary outcome measure and the mildness of the children’s asthma. However, there is also concealed selection and measurement bias which could have been prevented when planning the trial.
    Available guidelines for the diagnosis of asthma were not properly used for inclusion of patients, leaving room for doubt as to whether or not the included patients had asthma. Classification of asthma severity could be established at entry by using published international paediatric asthma consensus or guidelines. Better physiological measures could have been used—peak expiratory flow results are less reliable than forced expiratory volume in 1 second, which is the most reproducible pulmonary function parameter. All patients were using β adrenergic inhalers and more than two thirds had been prescribed inhaled steroids at baseline and were well controlled; at least 50% of patients in the homeopathic group had had no asthma event in the previous 12 months, suggesting a design bias against homeopathy (ceiling effect). Sample size was calculated without a pilot study and did not allow for the fact that comparisons of the impact of asthma
    treatments on quality of life are likely to involve relatively small effect sizes even when one treatment is clearly superior.4
    My paper on the safety of homeopathy is misquoted; it does not in any way imply that the rate of exacerbations is a “hallmark of successful treatment”. Instead, I stated that “one needs to consider the way practitioners are informing patients of the possibility of such aggravations after using homeopathic medicines, thus creating some expectations that will fulfill what was said in the consultation”.
    Finally, I cannot agree with the statement that the trial was designed with the input of experienced homeopathic practitioners for optimal conditions: individualised prescription of homeopathic medicines needs a good medical understanding of asthma to discriminate between disease-specific and patient- specific or peculiar symptoms. Treatment was by non-medically trained homeopaths without proper medical supervision, and this has implications on the selection of medicines. Medical doctors prescribing homeopathic medicines know what the patient has in terms of conventional diagnosis and can distinguish features typical of the disease from those specific to the individual patient. This was not adequately considered by the authors in planning the study.
    Taken together, these biases seriously undermine the validity of the claimed results. Such shortcomings should be eliminated from future trials of homeopathy for asthma published by respected journals such as Thorax.
    F Dantas
    Professor of Homeopathy, Federal University of Uberlândia, Visiting Professor, Federal University of Sa ̃o Paulo, Rua Pedro de Toledo 920, Sa ̃o Paulo-SP, 04039–020, Brazil; fdantas@climed.epm.br

    • … and, did we respond to this letter?
      could it be that Dantas is not entirely unbiased?

    • @ Tony pinkus

      “Homeopathy deserves to be scientifically appraised by good quality studies …..”

      No it doesn’t. This is a classical example of Tooth Fairy Science. Before you start analysing whether the Tooth Fairy leaves more money for molars than canines, or less money for younger children than older children you would do well to establish that the Tooth Fairy actually exists in the first place.

      Homeopathy defies logic and rational thinking. It was misbegotten and the product of irrational and magical thinking in the first place.
      It defies well-established laws of physics, chemistry and biology.
      There is NO evidence for the “memory of water” or that water can selectively “forget” its contact with sewage and poisons.
      Its basic principles are unproven and illogical and counter to scientific experiment and normal experience.
      After 200 years there is NO good evidence that homeopathy can treat or cure any disease.

      The sheer lunacy of dilutions that require one molecule to be diluted in a volume of the amount of the entire Pacific Ocean, or 200C which requires dilution of 10 to the power of 200 while there are only 10 to to the power of 84 atoms in the entire observable universe clearly demonstrated not only the delusional aspects of homeopathy but also the clear lack of grasp on reality held by any homeopath.

      So no – further studies are NOT needed. We already know the answer. Your fantasy quack SCAM therapy does not work. Further studies are a waste of time and research funds.

    • Homeopathy deserves to be scientifically appraised by good quality studies and the results published without bias which could distort future meta-analyses.

      It has been, Tony. Repeatedly. And the good-quality studies show that it has no effect beyond placebo.

      That you and other quacks don’t like this fact is your problem, not science’s.

  • Its not just the letter Edzard. I spent a good deal of time discussing the protocol for your Asthma study with Adrian White before I agreed to supply remedies. I had not been informed about the criteria for acceptance (ie the glass ceiling) and without this it was actually a commendable design. If I had known I wouldn’t have touched it with a barge pole.

    The trial was agreed to run for 6 months and I provided individual and bespoke prescriptions to each patient as agreed, alongside a placebo version of the same via an intermediary who dispensed this in accordance with the sealed key. The three practitioners held case conferences and so even the prescribing variable was covered to a certain extent. So far so good.

    After several months I realised the prescriptions were only coming from one of the three practitioners but it didn’t occur to me that you would continue the trial if the agreed protocol was changed. At which point Adrian White sheepishly asked if I minded if the study was extended a while. In fact it went on under one practitioner alone for a further year. I was keen to see the study done and supported it because, on the surface it was well designed and valuable.

    Only years later did I have the opportunity to speak to the practitioners themselves. The reason they pulled out is that they were being sent kids with no symptoms of asthma on which to prescribe. They remonstrated with the research lead but were told to continue anyway. At which point they realized the inherent bias was either through ignorance or deception and wanted no part of it.

    I look back on this now with sadness, that had the original protocol agreed been followed this could have been very different and instead of spending your life condemning homoeopathy you might have found cause to support it.

    • one pulled out because she died; she treated her malignant melanoma homeopathically.
      the trial was slower than expected; that happens often.
      as far as I am aware, there were no protocol violations.
      the clause that you seem to dislike was put in on the assistance of the ethics committee if I remember correctly.
      if you had not supplied the remedies, someone else surely would have been found.

    • had the original protocol agreed been followed this could have been very different and instead of spending your life condemning homoeopathy you might have found cause to support it.

      Dream on, Tony. Why would this trial have delivered different results to any other correctly-conducted trial of homeopathy?

  • So lets just recap where we are for the sake of the silent majority reading this. You published an RCT on the homoeopathic treatment of childhood asthma in reputable mainstream journal. The protocol disguises the fact that no children with any significant symptoms of asthma are enlisted on the trial. Now when this very obvious glass ceiling is highlighted by no less than three separate letters published in Thorax demanding retraction of the paper from highly respected and experienced researchers you blithely ignore these as being irrelevant?

    The study design required three homoeopaths to prescribe and agree their individual prescriptions at a case conference before the individual prescriptions for each patient were dispensed. This crucial part of the design was incorporated to remove the uncontrolled variable that would exist if just one homoeopath prescribed for all patients. However, when two of the three homoeopaths left the study after complaining the children who were supposed to have asthma didn’t have anything significant to treat you blithely dismiss this too. The fact that their exit breached the trial protocol doesn’t appear to phase you either?

    And yet when Clare Relton perpetrates a comparatively lesser professional error you jump up and down crying foul. Is this not a clear case of double standards?

    • yes let’s recap:
      1) a guest blogger discloses undeniable fraud
      2) your comment: Ernst cheated too
      3) I show that your accusation is unfounded
      4) you never retract it but claim there were protocol violations nevertheless
      5) I show that you were mistaken
      6) you persist by claiming the protocol was misleading
      7) you also state 2 homeopaths left the study
      8) I explain this is not true; one died
      9) you claim they complained to you (the one who died too?; did you do seances on this subject?)
      10) this is unverified; they did not complain to me
      11) you claim our study participants had no asthma
      12) this is not true
      13) you sound as ridiculous as your homeopathy

      • Ah, yes. Here we have it again. The homeopaths grasp of fact and truth.

        “Fact” = “I said it”
        “Truth” = “I said it”

        three separate letters published in Thorax demanding retraction of the paper from highly respected and experienced researchers you blithely ignore these as being irrelevant?

        Much like the editors of Thorax did as well, then?

        • the editor knew very well that
          1) the letters came from over-enthusiastic homeopaths, or pseudo-scientists
          2) they complained because the study failed to confirm their creed

          • Oh, poor Ernst, you did not approve of my last comments, Why will it be? have I touched a very sensitive nerve that could take an unexpected turn and you discover what Ernst really is? or are you afraid that your “big reviews” will end up being retracted, damaging your already battered reputation?

  • Amusing that Pinkus sees fit to criticise the research of others whilst publishing risible tripe such as this.

    https://hpathy.com/scientific-research/a-pilot-study-with-homoeopathic-secretin/

    An uncontrolled unblinded customer satisfaction survey of homeopathy fans by a homeopathy fan returns positive results.

    Well golly gosh.

  • Clare Relton was a trustee of the Homeopathiy Research Institute (HRI). She has also been a supervisor of various PhD candidates some of whom recieved funding from HRI when she was a trustee. See http://ukhomeopathyregulation.blogspot.com/2019/04/research-ethics-and-conflicts-of.html as an example.

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