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

medical ethics

1 2 3 78

THE FIRST WORLDWIDE MANIFESTO AGAINST PSEUDOSCIENCE

2750 signatories from 44 countries have signed it [I was number 11] and today is its official launch. I am delighted to present to you the full text of the English version:

 

Let’s be clear: pseudoscience kills. And they are being used with total impunity thanks to European
laws that protect them.
They kill thousands of people, with names and families. People such as Francesco Bonifaz, a 7-yearold boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy [1]. People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain [2]. People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland [3]. People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine”. He died in England [4]. People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France [5]. People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment. She died in Russia [6]. People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark [7]. People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German NewMedicine to treat her breast cancer. She died in Germany [8]. People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in the Netherlands [9].

European directive 2001/83/CE has made –and still makes— possible the daily deception of thousands of hundreds of European citizens [10]. Influential lobbyists have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield to economic interests, especially when it means deceiving patients and violating their rights.

Europe is facing very serious problems regarding public health. Overmedication, multi-resistant bacteria and the financial issues of the public systems are already grave enough, without the additional problem of gurus, fake doctors or even qualified doctors claiming they can cure any disease by manipulating chakras, making people eat sugar or using “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams. More than 150 pseudo-therapies have been identified as being in use throughout Europe. Thousands of citizens lives depend on this being prevented. In fact, according to a recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived [11].

Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks their right to correct information about their health. This way, even if a citizen has a right to refuse medical treatment when he or she is properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could homeopathy —or any other pseudo-therapy— be allowed to continue to be sold to citizens.

Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is then too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.

Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is indeed true. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.
Every country has to face the pseudo-therapies issue in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.

We, the signatories of this manifest, therefore declare that:

1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case
of homeopathy.
2. European laws that protect homeopathy are not acceptable in a scientific and technological
society that respects the right of the patients not to be deceived.
3. Homeopathy is the best known pseudo-therapy, but it is not the only one nor the most
dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology,
biomagnetism, orthomolecular therapy and many more, are gaining ground and causing
victims.
4. Measures must be taken to stop pseudo-therapies, since they are harmful and result in
thousands of people being adversely affected.
5. Europe needs to work towards creating legislation that will help stop this problem.

Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and which has already cost too many lives.

 

[1] Homeopathy boy died of encephalitis. Redazione ANSA, 2017.
http://www.ansa.it/english/news/general_news/2017/05/29/homeopathy-boy-died-of-encephalitis-3_13e02493-
4e62-4787-9162-12d831121ef6.html
[2] Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.
https://www.thelocal.es/20160412/grieving-father-sues-naturopath-over-son-cure-cancer-vitamins-leukaemia
[3] Asthmatic ‘told to give up drugs’. The Irish News, 2001.
https://www.independent.ie/irish-news/asthmatic-told-to-give-up-drugs-26063764.html
[4] Homeopaths warn of further tragèdies. BBC News, 2000.
http://news.bbc.co.uk/2/hi/health/702699.stm
[5] Alternative cure doctor suspended. BBC News, 2007.
http://news.bbc.co.uk/2/hi/uk_news/england/london/6255356.stm
[6] Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.
https://sport24.ru/news/football/2018-08-28-futbolist-rasskazal-tragichnuyu-istoriyu-zheny-ona-umerla-ot-raka-v-25-let
[7] Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.
http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-modbehandleren

[8] The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012.
https://scienceblogs.com/insolence/2012/08/30/the-price-of-refusing-science-based-medical-and-surgical-therapy-inbreast-cancer
[9] Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004.
http://web.archive.org/web/20070208144309/http://www.expatica.com/actual/article.asp?subchannel_i
d=19&story_id=4821
[10] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
[11] Use of complementary and alternative medicine in Europe: Health-related and sociodemographic
determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989251/

The objective of this RCT was to compare the effects of

  • spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
  • to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)

on pain and disability in patients with subacromial pain syndrome (SAPS).

Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.

At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.

The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.

The authors of this trial have impressive looking affiliations:

  • American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
  • Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
  • Research Physical Therapy Specialists, Columbia, SC.
  • Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
  • Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
  • Copper Queen Community Hospital, Bisbee, AZ.
  • BenchMark Physical Therapy, Atlanta, GA.
  • Eastside Medical Care Center, El Paso, TX.
  • Department of Physical Therapy, Georgia State University, Atlanta, GA.
  • Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.

If one expected a well-designed study from all this collective expertise, one would have been disappointed.

Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.

The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:

  1. Acupuncture was effective.
  2. Dry needling was effective.
  3. The electrical current was effective.
  4. Mobilisation made things worse.
  5. Exercise made things worse.
  6. one or multiple positive or negative interactions between the therapies.
  7. The drugs in the experimental group were more effective than those taken by controls.
  8. The experimental group adhered to their drug prescriptions better than controls.
  9. Any mixture of the above.

So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:

  • Any researcher who designs a foreseeably nonsensical trial should go back to school.
  • Any ethics committee that passes such a study needs to retire.
  • Any funder who gives money for it wastes scarce resources.
  • Any reviewer who recommends publication needs to learn about trial design.
  • Any editor who publishes such a trial needs to go.

The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.

I want to thank our friend ‘OLD BOB’ for alerting me to Patrick Holford’s comment on a recent trial of vitamin C for COVID-19. Here are three short quotes from Holford:

… Overall, 5 out 26 people (19%) died in the vitamin C group while 10 out of 28 (36%) receiving the placebo died. That means that vitamin C almost halved the number of deaths. Those on vitamin C were 60% more likely to survive.

… Of those most critically ill, 4 people (18%) in the vitamin C group died, compared to 10 (50%) in the placebo group. That’s two-thirds less deaths. Statistically this meant that of those most critically ill who were given vitamin C, they were 80% less likely to die…

… now there is another proven treatment – vitamin C…

And here is the abstract of the actual trial Holford refers to:

Background: No specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.

Methods: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.

Results: Only fifty-six critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P=0.01). Patients with SOFA scores ≥3 in the HDIVC group exhibited a trend of reduction in 28-day mortality (P=0.06) in univariate survival analysis. IL-6 in the HDIVC) group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P=0.04) on day 7.

Conclusion: This pilot trial showed that HDIVC might show a potential signal of benefit for critically ill patients with COVID-19, improving oxygenation even though it failed to improve IMVFD28.

The following points are, I think, worth mentioning:

  • This was, according to its authors, a PILOT study.
  • It was far too small (n=56) to provide reliable results on mortality.
  • The trial authors know that and interpret their findings with sufficient caution.
  • The primary endpoint, the IMVFD28, showed NO significant difference between the groups.
  • The secondary endpoint: HDIVC infusion exhibited a non-significant trend of reduction in 28-day mortality (P=0.06).
  • In more severe patients (SOFA score ≥3), univariate survival analysis and Cox regression showed a similar results (P=0.07, HR, 0.32 [95% CI 0.10-1.06]).

And what does all of this mean? It means that, in this pilot study, vitamin C failed to produce a significant result. Only in a subgroup analysis related to a secondary endpoint was there a slight advantage of vitamin C. This effect is, of course, interesting and needs further investigation (I am sure that is happening as we speak). It could have some clinical significance but, just as likely, it could just be due to chance. There is not way of knowing which is which.

In other words, to hype the findings and to even make statements such as ‘now there is another proven treatment, vitamin C’ is not just exaggerated, it is irresponsible.

This begs the question: why does Mr Holford do it? In case you don’t already know about this man, go on the Internet, and you will quickly find possible answers. Here is an excerpt from his Wiki page which might give you a clue:

Patrick Holford is a British author and entrepreneur who endorses a range of controversial vitamin tablets. As an advocate of alternative nutrition and diet methods, he appears regularly on television and radio in the UK and abroad. He has 36 books in print in 29 languages. His business career promotes a wide variety of alternative medical approaches such as orthomolecular medicine, many of which are considered pseudoscientific by mainstream science and medicine.

Holford’s claims about HIV and autism are not in line with modern medical thought, and have been criticised for putting people in danger and damaging public health.

In 2006 Holford was discovered to be using his PR advisor to delete critical content from his Wikipedia page…

Holford has been the subject of criticism for his promotion of medically dubious techniques and products including hair analysis, his support of the now struck off doctor Andrew Wakefield, and advocating the use of “non-drug alternatives for mental health” for which he has been given an award by the Church of Scientology-backed Citizens Commission on Human Rights.

SAY NO MORE!

It is today exactly 8 years that I am writing this blog. To mark the occasion, I am trying to write my shortest post ever. It focusses on a question that has often occupied my mind and rarely leaves the comments sections of this blog: What makes a healthcare professional use a bogus SCAM therapy? Think, for instance, of any practitioner of homeopathy. What makes him or her tick? Why does (s)he practice homeopathy and not real medicine? After years of thinking about it, the answer turns out to be really quite simple. There are only three possibilities:

Practitioners who employ disproven treatments either

try to con you

or

they have been conned themselves

or

both.

________________________

Think of it, there is no other explanation!

If, however, you do know of another one, please let me know.

AND THANKS FOR MAKING THIS BLOG A SUCCESS.

 

 

Or perhaps not?
Here is the announcement:

Research by a reputable independent research company done for Securivita a German insurance company shows that those receiving homeopathic care were much better off. Over 15,700 patients were involved in the study which also used a comparison group.

The study showed that in a wide range of patients with various pathological problems that if they had homeopathic care they faired dramatically better than those just getting conventional medicine.

Children having homeopathy treatment from birth, were particularly healthier and with less problems. Over the three year study period, the number of children needing antibiotics decreased by 16.7 per cent in the homeopathy group, whereby it increased by 73.9 per cent in the conventional medical comparison group!

The number of hospitalizations in the comparison group increased by 32.6 per cent whereby in the homeopathy treatment group it decreased by 9.8 per cent!

Adults and children treated homoeopathically had dramatic improvements in allergies, dermatitis, asthma, just to name a few.

These are just a few examples of the remarkable benefits of homeopathic treatment outlined in the study by by the Leipzig Health Forum , an independent analytical institute specializing in health services conducted for Securvita Krankenkasse Insurer.

“We don’t need fewer, but more homeopathic doctors who will continue on this successful path,” says Götz Hachtmann , director of the health insurance company Securvita.

The study is in German and can be found here.

____________________________

Blessed are those who don’t read German (at least in this instance)!

As I am not amongst the blessed, I ought to tell you a bit about the ‘massive’ study. The OHR, the ‘OFFICIAL HOMEOPATHIC RESOURCE’ (btw what makes the OHR ‘official’?) claims that the study can be found here. The OHR is evidently not well enough resourced for translating the German text into English; if they were, they would know that the link goes not to a ‘study’ but to some kind of a glossy marketing brochure about the ‘study’ (there is no actual published scientific paper on the ‘study’). It provides hardly any relevant information; all we learn is that 15 700 individuals who regularly consulted homeopathic physicians were compared over a three year period to an equally sized control group who did not consult homeopathic doctors… And that’s essentially it! No further relevant details are offered.

By contrast, quite a bit of information is offered about the findings, for instance:

  • In the homeopathy group, the hospitalisation rate of depressive patients dropped by 10%, while it increased in controls by 33%.
  • The days off work dropped by 17% vs an increase in controls of 17%.
  • The use of antibiotics decreased by 17% vs an increase of 74%.

And how do they explain these differences?

Yes, you guessed it:

they are due to homeopathy!

One does not need to have a perfumer’s nose to smell a few badly decomposing rats here, for example:

  1. We do not learn how many variables were tested in this ‘study’. Therefore, it is likely that the ‘results’ provided are the positive ones, while the not so positive potential effects of homeopathy remained unmentioned. Perhaps the death rate was higher in the homeopathy group? Perhaps they suffered more heart attacks? Perhaps they had a lower quality of life? Perhaps they caused more costs? Perhaps they committed more suicides? etc. etc.
  2. Even more obvious is the stench of selection bias. The individuals in the homeopathy group were clearly different from the controls to start with. They might have been more health conscious. They clearly were more cautious about antibiotics. They might have been of better general health. They might have been younger. They could have contained more women. They might have been more afraid of going into a hospital. They might have been keener to attend work. In fact, the only variable in which the two groups were comparable is sample size.

Even if we eventually we see this ‘study’ published in a peer-reviewed journal with full methodological details etc., it will not allow even the smartest spin-doctor to establish cause and effect. Its findings would not be more conclusive than those of previously discussed attempts to produce positive evidence for homeopathy. The ‘positive’ findings could have been the result of hundreds of causes, none of which are related to homeopathy.

In a nutshell: this new German ‘study’ is a textbook example for arguing in favour of conducting proper research rather that rampant pseudo-research.

But I must not always be so negative!!!

So, let me try to point out the positive sides of this ‘study’:

The ‘massive independent study’ is a true masterpiece of advertising and marketing for both Securivita and homeopathy.

Well done guys!

I am proud of you!

  • That’s exactly the stuff needed for successfully misleading the public.
  • That’s precisely the info required to increase your cash flow.
  • That’s helpful ‘research’ for convincing politicians.
  • That’s definitely the type of baloney to impresses the Ullmanns of this world.
  • That’s even the sort of ‘science’ which the ‘OFFICIAL HOMEOPATHIC RESOURCE’ cannot recognise for what it truly is:

invalid junk.

This recent review claimed to evaluate the evidence on the use of human and veterinary homeopathy, evidence level 1a studies were considered. Focusing on the external evidence on the use of homeopathy in infections, some evidence level 1a, 1b, 2c studies, and a case report, are described in more detail.

In conclusion, evidence for the effectiveness of human and veterinary homeopathy in general, and in particular, of homeopathic treatment for infections, is available. Especially, individualized homeopathy demonstrates effects at all quality levels according to Cochrane criteria, even in the methodologically high-quality studies. As in most areas of veterinary medicine and medicine, further good/excellent studies are necessary. In compliance with the principles of homeopathy, further methodologically high-quality trials focusing on the homeopathic treatment of infections are the next logical step. The selection of the simile (individually fitting homeopathic medicinal product) by appropriately trained homeopathic doctors/veterinarians is essential for the effectiveness of homeopathy. Implementation of studies at university facilities is a prerequisite for quality assurance. Consequently, further integration of homeopathy at universities is a necessary requirement for the patients’ best interests.

Who wrote this bizarre paper?

The authors who state to have no conflicts of interest are P Weiermayer 1M Frass 2T Peinbauer 3L Ellinger 4

  • 1Tierärztin, Tierarztpraxis Dr. Weiermayer, Diplom der Europ. Akademie für Veterinärhomöopathie (EAVH), Fachtierärztin für Homöopathie, Sprecherin der Sektion Forschung der Wissensch. Gesellsch. für Homöopathie (WissHom), Präsidentin ÖGVH, Wien, Österreich.
  • 2Facharzt für Innere Medizin und Internistische Intensivmedizin, em. Professor für Innere Medizin der Medizinischen Universität Wien, Diplom der Österreichischen Ärztekammer (ÖÄK) für Homöopathie sowie für Begleitende Krebsbehandlung, Wien, Österreich.
  • 3Arzt für Allgemeinmedizin, ÖÄK-Diplom für Homöopathie, Universitätslektor für Allgemeinmedizin und Modulbeauftragter für Komplementärmedizin, Medizinische Fakultät, Johannes Kepler Universität Linz, Österreich.
  • 4Tierärztin, Centaurea, Apeldoorn, Holland.

This already explains quite a lot, I think.

The paper itself is in German, so I will try to make some sense of part of it for you.

In their ‘methods section’, the authors explain that they evaluated meta-analyses and systematic reviews (SRs) of homeopathy for various conditions. Furthermore, they considered the ‘1st and 2nd’ NHMRC reports. Specifically for the question whether homeopathy is the answer to antibiotic resistance, the authors also considered RCTs, observational studies, heath service research and even case-studies. The authors then elaborate at length on the assumptions of homeopathy, on legal issues and on the nature of evidence-based medicine all of which I disregard for the moment (suffice to say that this material has been often and better reviewed before).

When finally discussing the evidence on homeopathy for human conditions, the authors state that, up until 2014, six comprehensive SRs had been published. In their opinion, these are the following 6 papers:

  1. Kleijnen, J., Knipschild, P., Ter Riet, G. (1991): Clinical trials
    of homeopathy. BMJ 302(6772): 316-23.
  2. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F.,
    Hedges, L.V., Jonas, W.B. (1997): Are the clinical effects of
    homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 350(9081): 834–843.
  3. Linde, K., Scholz, M., Ramirez, G., Clausius, N., Melchart,
    D., Jonas, W.B. (1999): Impact of study quality on outcome
    in placebo-controlled trials of homeopathy. J Clin Epidemiol 52(7): 631–636.
  4. Cucherat, M., Haugh, M.C., Gooch, M., Boissel, J.P. (2000): Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol 56(1): 27–33.
  5. Mathie, R.T., Lloyd, S.M., Legg, L.A., Clausen, J., Moss, S.,Davidson, J.R.T., Ford, I. (2014a): Randomised placebocontrolled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 3: 142.
  6. Shang, A., Huwiler-Müntener, K., Nartey, L., Jüni, P., Dörig, S., Sterne, J.A.C., Pewsner, D., Egger, M. (2005): Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 366(9487): 726–32.

(As it happens, I have reviewed these papers here and come to very different conclusions)

Without bothering about a critical assessment of these papers, the authors report that all arrived at a positive conclusion, except the last one. They then claim that the ‘1st’ NHMRC report was partly positive but was initially suppressed by the Australian government. Instead it was replaced with the 2nd NHMRC report which was designed to arrive at a wholly negative conclusion. Likewise, the ‘EASAC Statement’ neglected some of the available positive evidence. These facts, the authors believe, discredits all of these negative reports.

The authors then discuss the various reviews by Mathie et al and point out that, in their view, these papers are superior to all other documents as they arrive at very clearly positive conclusions.

Next the authors focus on the field of veterinary homeopathy, while admitting weaker and weaker evidence, inclusing case-reports. This is also where I lost the will to live and gave up my detailed criticism of the text; the task is too tedious and simply not worth it, I felt.

In summary, here are few points relating to the human evidence:

The authors seem to have no intention of conducting an objective, systematic review. Such a project is essentially based on two principles. Firstly, it needs to include all eligible evidence according to pre-defined criteria. Secondly, it must include a critical evaluation of the admitted evidence. This review fails on both of these principles.

There are virtually dozens of systematic reviews which the authors decided to ignore. Here are just six of them:

  1. … homoeopathy as a whole may be considered as a placebo treatment.
  2. We tested whether p-curve accurately rejects the evidential value of significant results obtained in placebo-controlled clinical trials of homeopathic ultramolecular dilutions. Our results suggest that p-curve can accurately detect when sets of statistically significant results lack evidential value.
  3. We found no evidence to support the efficacy of homeopathic medicinal products
  4. … no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn.
  5. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive.
  6. … the use of homeopathy currently cannot claim to have sufficient prognostic validity where efficacy is concerned.

Why do they do it? A reasonable reply to this question might be, because their findings did not fit the preconceived ideas of the authors. This omission alone makes the article little more than a poorly conceived marketing brochure.

Even more important is the second omission. The paper  lacks any kind of critical evaluation of the included evidence. On the contrary, the authors praise the evidence that generated what they think was a positive result (even in cases where the actual result was not all that positive; for instance: A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions) and bash all negative findings. This goes as far as perpetuating untruth about the two NHMRC reports: what they call the 1st report was a draft that had been rejected because it was deemed to be of sub-standard quality. What is here called the ‘2nd’ report is thus the only valid document ever published. Similarly, the authors pretend that the Mathie reviews were all clearly positive and fail to mention even the most obvious problems with these articles, such as the facts that Mathie was paid by a homeopathy-lobby group or that even he included important caveats in his conclusions.

As to the focus of the review, the question whether homeopathy might be a solution to antibiotic resistance, the authors found virtually no compelling evidence from trials directly comparing antibiotics with homeopathy. This seems to bother the authors little – they conclude that “the data demonstrate the potential of a significant reduction of antibiotic usage through homeopathic treatments”. They seem to have reached this conclusion by turning a blind eye to all the evidence that does not fit their preconceived idea.

As the paper is published in German and in a journal which hardly anyone will ever read, one could easily argue that none of all this does really matter because it is merely a storm in a very small tea cup. Perhaps that’s true. But this paper nevertheless might attain some significance because it is already being heavily promoted by the homeopathy lobby. And no doubt, it will thus be cited in the English literature which, in turn, will be read by people who do not read German, unable to check the original and are thus likely to believe the nonsense promoted by Frass and friends.

For this reason, I want to conclude by making it quite clear that

this ‘review’ is a dilettante attempt to white-wash the evidence on homeopathy and mislead the public.

 

Patients with advanced non-small cell lung cancer (NSCLC) have limited treatment options. Alongside conventional anticancer treatment, additive homeopathy might help to alleviate side effects of conventional therapy. The aim of this study was to investigate whether additive homeopathy might influence quality of life (QoL) and survival in NSCLC patients.

In this prospective, randomized, placebo-controlled, double-blind, three-arm, multi-centre, phase III study, the researchers evaluated the possible effects of additive homeopathic treatment compared to placebo in patients with stage IV NSCLC, with respect to QoL in the two randomized groups and survival time in all three groups. Treated patients visited the university teaching hospital every 9 weeks: 150 patients with stage IV NSCLC were included in the study.

  1. 51 patients received individualized homeopathic remedies plus conventional treatments,
  2. 47 received placebo plus conventional treatments,
  3. 52 control patients without any homeopathic treatment were treated with conventional therapies and observed for survival only.

For groups 1 and 2, the study was double-blind. The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. The remedies were manufactured by stepwise dilution and succussion, thereby preparing stable GMP grade formulations.

QoL as well as functional and symptom scales showed significant improvement in the homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment (p < .001). Median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as versus control (228 days; p < .001). Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).

The authors concluded that QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumour entities are warranted.

First of all, let me thank my friend Dana Ullman for alerting me to this new and interesting study. I have read what seems to be the full paper several times and have to admit that it puzzles me (and perhaps this version is just some type of pre-publication paper). Firstly, there seems to be no methods section (the abstract is followed by several tables and a discussion), and I am left guessing much of the details. Secondly, the paper raises several questions in my mind:

  1. What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?
  2. Was the study under-powered? From my reading of the text, the answer seems to be yes.
  3. What is the full list of conventional treatments the patients received, and did they differ between the 3 groups?
  4. If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical?
  5. What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing.
  6. The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
  7. How well respected is THE ONCLOLOGIST, the journal that published the paper?
  8. Was the article peer-reviewed? If so, by whom?
  9. Was the placebo indistinguishable from the verum?
  10. Was the success of patient-blinding checked?
  11. Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.
  12. Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
  13. The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?

I would be most grateful, if the readers of this blog could assist me in finding answers to some of the above questions.

A 2020 article that I just came across concluded with this rather remarkable statement:

High-dose enzyme therapy is a natural cancer protocol that has been highly successful in treating this much-feared disease.

Since we can find a plethora of similar claims on social media and elsewhere, it is high time, I think, to dedicate a post to this alleged cancer cure.

Enzyme therapy involves the administration of proteolytic enzymes by mouth. Proteolytic enzymes are large molecules that are nevertheless said to be absorbed in the gut before they are dispersed into different compartments of the body where they can be detected in various concentrations. Proteolytic enzymes (serine endopeptidases such as trypsin or chymotrypsin and cysteine endo-proteinases such as bromelain and papain or combinations of those enzymes) have long been available for diverse medical indications, including cancer. They are claimed to exert anticancer activities by restoring the reduced cytotoxic activity of patients’ sera.

Enzyme therapy has been subjected to experimental investigations and to a few studies in cancer patients. A systematic review claimed that, for plasmacytoma patients, systemic enzyme therapy was shown to increase the response rates, the duration of remissions, and the overall survival times.[1]

This statement is based on just one study. Here is its abstract[2]:

Purpose: To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/ vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I-III.

Methods: A cohort of 265 patients with multiple myeloma stages I-III was consecutively treated at our institution in two parallel groups (control group (n = 99): chemotherapy +/-OE for less than 6 months; OE-group (n = 166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model.

Results: Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P = 0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms).

Conclusion: OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.

My searches located no prospective clinical trials supporting the notion that enzyme therapy is an effective cancer cure for any type of human cancer. So, what about the bold statement quoted above? In my view, it is a dangerous and highly irresponsible claim that endangers the lives of many vulnerable cancer patients desperately looking for alternative cancer cures.

REFERENCES

[1] Beuth J. Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? Integr Cancer Ther. 2008 Dec;7(4):311-6. doi: 10.1177/1534735408327251. PMID: 19116226.

[2] Sakalová A, Bock PR, Dedík L, Hanisch J, Schiess W, Gazová S, Chabronová I, Holomanova D, Mistrík M, Hrubisko M. Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma. Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S38-44. doi: 10.1007/s002800170008. PMID: 11561871.

Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).

Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.

He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.

His practical approach in solving cases has earned him accolades and fame throughout the globe.

Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.

He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.

And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:

India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.

This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.

Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:

The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.

These authors commented that

… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…

I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.

‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.

I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?

Indian homeopaths published a remarkable article in the journal ‘HOMEOPATHY’ proposing Mercurius solubilis as genus epidemicus for the current pandemic. Here it is:

From mid-June to mid-July 2020, our team of homeopathic doctors treated 104 patients in two COVID treatment centers—Pandit Bhimsen Joshi Hospital and Sheth P.V. Doshi Hospital—on the outskirts of Mumbai, India, with adjuvant homeopathy. It was observed by the patients, hospital staff, and the management that those patients on adjuvant homeopathy were discharged 3 to 7 days earlier than other comparable patients in the same wards, allowing us gradually to accommodate more severely ill patients who required oxygen, continuous positive airway pressure, or a ventilator.

Twenty-five different homeopathic medicines in total were prescribed to the patients, each receiving individualized treatment according to his or her symptoms. After collecting 143 clinical and individualizing (homeopathic) symptoms of 104 patients and converting those symptoms into rubrics, we repertorized the combined data with the help of the software Hompath, with an aim to arrive at a genus epidemicus. We observed that the medicine Merc Sol was at the top of the combined repertorization chart. After reviewing repertory sheets of all 104 patients, we discovered that Merc Sol was at the fourth or fifth place of all individual repertorization charts as well.

To substantiate our deduction, we studied the Materia Medica of Merc Sol from the original provings of Hahnemann[1] and other sourcebooks.[2] [3] [4] We also searched research articles and case studies about toxicological effects of mercury.[5] [6] [7] [8] These showed that acute exposure to mercury produces an acute respiratory distress syndrome-like presentation, a picture similar to the COVID symptomatology. Moreover, anosmia, aphthae, gastrointestinal and ocular manifestations that are seen in patients with COVID-19 were produced also by mercury the toxin and mercury the homeopathy-proved medicine. This finding is in accordance with the homeopathic Law of Similars: a substance producing a symptom in a healthy person is able to cure a similar symptom in a sick person.

To confirm our hypothesis, we identified 13 common symptoms of Merc Sol, such as indented tongue, salivation, perspiration, and night aggravation, which were present in various intensities in the previously treated 104 patients. We created a 13-point questionnaire and, after obtaining suitable Ethics Committee approval and individual informed consent from the patients, we evaluated 68 further patients in the above-mentioned COVID hospitals. People with at least eight confirmed symptoms from the questionnaire were prescribed Merc Sol 200c thrice a day for a week. In our 2-week study at both the locations, we observed a speedy recovery and a hospital stay reduction by 5 to 7 days in all the 68 patients when Merc Sol was used along with the standard Indian Council of Medical Research clinical protocol. Many of them were not newly admitted patients but were those who exceeded the mandatory minimum hospital stay. We are now using Merc Sol as a preventive medicine for over 1,000 people in a COVID hot-spot area in Powai, Mumbai, with the expressed permission of local authorities.

Following the Hahnemannian method of arriving at a genus epidemicus [9] (§ 99–103), and deducing it from the combined data of symptoms of more than 100 patients, we arrived at the conclusion that Merc Sol, “the deceitful malefic mercury” known for various symptomatic presentations and tissue destruction, is genus epidemicus of this pandemic. Our efforts are in accordance with the logic of homeopathy proffered by Dr. Stuart Close[10]: exact observation, correct interpretation, rational explanation, and scientific construction.

We now appeal to the global homeopathy community to test our findings in their respective areas, designing specific research projects to explore the utility of Mercurius solubilis in the COVID-19 pandemic as genus epidemicus.

If it were not such a serious matter, I might joke that everyone with a dental amalgam filling must be protected from COVID-19. But it is rather too serious to make fun, I am afraid. Therefore, I will just point out to all those homeopaths across the globe who follow their Indian colleagues’ appeal something rather basic: it is bad science to confirm their hypothesis. Science works by falsifying hypotheses. And a proper hypothesis needs, of course, more that the implausible hunches of some evangelic believers in the homeopathic cult.

1 2 3 78
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories