Edzard Ernst

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

Boris Johnson said we should take the coronavirus ‘on the chin’ and count on ‘herd-immunity’. This, he claimed, is what his scientific advisers recommended.

I find this very hard to believe and have many doubts and questions.

To start with, I doubt that this is what Johnson’s scientific advisers recommend – it is a solution that SOME of his scientific advisers recommend. And it is a solution that seems easy to follow. It is, however, by no means the only strategy for tacking the pandemic; it is just one of several options.

The fact that all other countries have opted for other solutions, suggests to me that it is an unusual path to go down to. The modellers who obviously like it had to make a number of assumptions; that’s what modellers always have to do and rarely tell us about. But what if not all of these assumptions are correct?

The herd-immunity strategy counts on the fact that, once a certain percentage of the population has taken the infection ‘on the chin’, it is immune and therefore the transmission of the virus within such a population will be dramatically reduced or even zero. The percentage of the population needed for that to happen depends on how contagious the virus is. For the measles virus, herd immunity requires 90% of the population to be immune. For the coronavirus, the figure is said to be 60 – 70%. Is that an assumption or a fact? If it is a current fact, would the figure change, if the virus mutates? Could it be that a mutated virus can re-infect formerly immune people?

But let’s postulate that the herd-immunity assumption is both correct and stable. Johnson’s herd-immunity strategy would thus require that about 40 million Brits get infected with the virus to generate the required herd-immunity. Assuming a mortality rate of 1 – 2%, this means that Johnson is cheerfully accepting 400 000 – 800 000 fatalities.

But, as I said, this scenario is based on wild assumptions. It applies only if the virus does not mutate. And it only applies, if we do not run out of intensive care (IC) beds. However, running out seems possible, perhaps even likely, considering that we have only about half of the French and just one third of the German IC capacity. Sod’s law has it that both might happen. In this case, we might easily have far in excess of 800 000 fatalities. How should we take that ‘on the chin’, Mr Johnson?

Sadly, this is not all; I have further doubts about our PM’s ideas.

The present strategy regarding diagnosis of coronavirus cases is to self-isolate once suspicious symptoms start. Even if someone is seriously ill (with high fever etc.), they are told to stay at home and sit it out. This means we will never know whether these patients had or had not suffered from a coronavirus infection. How then can we ever be sure that the 60% target of infection has been reached? And if we are uncertain about it, how can we be sure that herd-immunity will work in the way the modellers predicted?

Moreover, we now know that people who caught the virus are infective BEFORE they develop symptoms. If that is so, the strategy of self-isolation will be far less effective than predicted. And, given this fact, are we not much more likely to have a sharp peak of cases early on which would make us run out of IC capacity? When that happens, even the pessimistic death rates might turn out to be too optimistic.

It seems to me that Johnson’s herd-immunity strategy is risky to the point of being reckless. It also seems to me that there are very good reasons why other countries have not adopted it.

But what is the solution?

In my view, the solution cannot be to uncritically adopt the theories and assumptions of modellers. This is not a computer game; we are talking about human lives, many human lives!

I wish I new what the best solution is – but I don’t. I merely fear that ‘taking it on the chin’ is not a solution at all. In any case, a wise move for Johnson and his team might be to consider that foreigners might be at least as clever as they are. Subsequently they could carefully study the actions of those countries which managed to bring down their death-rates despite being attacked by the coronavirus.

Papillomas of dogs are benign growths caused by the canine papillomavirus. The oral mucosa and commissures of the lip are most frequently involved. Papillomas often regress spontaneously within a few weeks, and treatment is usually not necessary.

This Indian study tested the combination of 4 homeopathic drugs (Sulfur 30C, Thuja 30C, Graphites 30C, and Psorinum 30C) in 16 dogs affected with oral papillomatosis which was not undergone any previous treatment. Dogs affected with oral papillomatosis, which have not undergone any initial treatment and fed with a regular diet. They were randomly divided into two groups, namely, homeopathic treatment group (n=8) and placebo control group (n=8). The homeopathic combination and placebo (distilled water) was administered orally twice daily for 15 days. Clinical evaluation in both groups of dogs was performed by the same investigator during 12 months. Dogs were clinically scored for oral lesions on days 0, 5, 7, 10, 15, 20, 25, 30, 45, 60, 90, 120, and 150 after initiation of treatment.

The homeopathic treatment group showed early recovery with a significant reduction in oral lesions reflected by clinical score (p<0.001) in comparison to placebo-treated group. Oral papillomatous lesions regressed in the homeopathic group between 7 and 15 days, whereas regression of papilloma in the placebo group occurred between 90 and 150 days. The homeopathic treated group was observed for 12 months post-treatment period and no recurrence of oral papilloma was observed.

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The authors concluded that the current study proves that the combination of homeopathy drugs aids in fastening the regression of canine oral papilloma and proved to be safe and cost-effective.

This could well become the worst SCAM study of 2020. In case you have not already spotted its flaws, here are some of them:

  • the trial was truly tiny; thus the results could easily be false-positive;
  • to make any conclusion about safety after treating 16 subjects is nonsensical;
  • cost-effectiveness was not assessed and therefore conclusions about it are not warranted; if, however, one made a ‘back of the envelope’ calculation, one would be hard-pressed to not find tap water more cost-effective than 4 homeopathic remedies;
  • the graph looks to me very suspect – could it be that someone has been busy prettifying the data?

Nevertheless, I think this paper is remarkable, if only in the way it teaches us how NOT to formulate conclusions of a study. Even if we had 200 dogs in this trial, its findings would not PROVE the efficacy of the intervention. Proof is something a single trial will never deliver. Proof is a debatable concept even after several independent replications, particularly when dealing with something as implausible as homeopathy.

In any case, if your dog has papillomas, do me a favour and avoid homeopathic vets!

This ‘Manifesto of the European Committee for Homeopathy (ECH) and the European Federation of Homeopathic Patients Associations (EFHPA)‘ has just been published. It is worth considering in more detail, I think. So, I will first reproduce the document in its entirety and subsequently provide some critical assessment of it.

Homeopathy: a solution for major healthcare problems in the EU

  • Helps to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance [i],[ii]
  • Increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care [iii],[iv],[v],[vi],[vii],[viii]
  • Can reduce the use of long-term conventional prescription drugs, when integrated in health care [ix]

Homeopathy: safe and cost-effective with a high patient satisfaction

  • Can lead to lower health care costs, when integrated in health care, [x],[xi],[xii],
  • Is safe, with high patient satisfaction [xiii],[xiv],[xv],[xvi]
  • Patients using homeopathy have better outcomes than users of conventional treatment, with similar costs [xvii]
  • Quality, safety and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC

 EU consumers expect and demand homeopathy as part of their health care

  • Reported as the most used medical complementary medicine in Europe [xviii]
  • Three out of four European citizens know about homeopathy and out of them 29% use it for their day-to day health care [xix]

 Scientific evidence of the highest calibre confirms the clinical efficacy of homeopathic   medicine

There is convincing evidence for biological efficacy of homeopathic medicine

  • Irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings [xxvii],[xxviii]

References

[i] Grimaldi-Bensouda L, Bégaud B, Rossignol M, et al. Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One. 2014 Mar 19;9(3):e89990

[ii] Camerlink I, Ellinger L, Bakker EJ, Lantinga EA. Homeopathy as replacement to antibiotics in the case of Escherichia coli diarrhoea in neonatal piglets. Homeopathy. 2010 Jan;99(1):57-62

[iii] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: long-term results of a cohort study with 3981 patients. BMC Public Health 2005; 5:115

[iv]  Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005; 11:793–798

[v] Mathie RT, Robinson TW. Outcomes from homeopathic prescribing in medical practice: a prospective, research-targeted, pilot study. Homeopathy 2006; 95:199–205

[vi] Thompson EA, Mathie RT, Baitson ES, et al. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy 2008; 97:114–121

[vii] Witt CM, Lüdtke R, Mengler N, Willich SN. How healthy are chronically ill patients after eight years of homeopathic treatment?–Results from a long term observational study BMC Public Health 2008;8:413

[viii] Rossi E, Endrizzi C, Panozzo MA, Bianchi A, Da Frè M. Homeopathy in the public health system: a seven-year observational study at Lucca Hospital (Italy). Homeopathy 2009; 98:142–148

[ix] Grimaldi-Bensouda L, Abenhaim L, Massol J, et al. EPI3-LA-SER group. Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study. BMC Complement Altern Med. 2016 May 4; 16:125

[x] Kooreman P, Baars EW. Patients whose GP knows complementary medicine tend to have lower costs and live longer. Eur J Health Econ. 2012 Dec;13(6):769-76

[xi] Baars EW, Kooreman P. A 6-year comparative economic evaluation of healthcare costs and mortality rates of Dutch patients from conventional and CAM GPs. BMJ Open. 2014 Aug 27;4(8):e005332

[xii] Colas A, Danno K, Tabar C, Ehreth J, Duru G. Economic impact of homeopathic practice in general medicine in France. Health Econ Rev. 2015;5(1):55

[xiii] Van Wassenhoven M, Galen Y. An observational study of patients receiving homeopathic treatment. Homeopathy 2004 Jan;93(1):3-11

[xiv] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52

[xv] Witt C, Keil T, Selim D, et al. Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complement Ther Med. 2005;13(2):79-86

[xvi] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52

[xvii] Bornhöft G, Wolf U, von Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S, Thurneysen AE, Matthiessen PF. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment.Forsch Komplementmed. 2006;13 Suppl 2:19-29. Epub 2006 Jun 26. Review

[xviii] Eardley S, Bishop FL, Prescott P, Cardini F, Brinkhaus B, Santos K Ͳ Rey, Vas J, von Ammon K, Hegyi G, Dragan S, Uehleke B, Fønnebø V, Lewith G. CAM use in Europe. The patients’ perspective.Part I: A systematic literature review of CAM prevalence in the EU. 2012. Online retrieved 19-11-2019. https://cam-europe.eu/wp-content/uploads/2018/09/CAMbrella-WP4-part_1final.pdf

[xix] Report of the European Commission, 1997. Online retrieved 15-12-2019 via https://www.hri-research.org/resources/essentialevidence/use-of-homeopathy-across-the-world/

[xx] Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-4.

[xxi] Cucherat M, Haugh MC, Gooch M, Boissel JP.Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33

[xxii] Hahn RG. Homeopathy: meta-analyses of pooled clinical data. Forsch Komplementmed. 2013;20(5):376-81

[xxiii] Mathie RT, Van Wassenhoven M, Jacobs J et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016 Apr; 25:120-5

[xxiv] Mathie RT, Lloyd, SM, Legg, LA, Clausen J, Moss S, Davidson JR, Ford: Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014 Dec 6; 3:142

[xxv] Mathie RT, Clausen J. Veterinary homeopathy: systematic review of medical conditions studied by randomised placebo-controlled trials. Vet Rec. 2014 Oct 18;175(15):373-81.

[xxvi] Mathie RT, Clausen J. Veterinary homeopathy: meta-analysis of randomised placebo-controlled trials. Homeopathy. 2015 Jan;104(1):3-8.

[xxvii] Tournier A, Klein SD, Würtenberger S, Wolf U, Baumgartner S. Physicochemical Investigations of Homeopathic Preparations: A Systematic Review and Bibliometric Analysis-Part 2. J Altern Complement Med. 2019 Jul 10

[xxviii] Witt CM, Bluth M, Albrecht H, Weisshuhn TE, Baumgartner S, Willich SN. The in vitro evidence for an effect of high homeopathic potencies–a systematic review of the literature. Complement. Ther Med. 2007 Jun;15(2):128-38

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Did I state above that the manifesto is worth considering in more detail? I need to retract or modify this statement.

Here are the considerations that are relevant, in my view:

  • The statements in the manifesto are based on wishful thinking and do not reflect the reality based on the best evidence available today.
  • The manifesto is the result of a mixture of cherry-picking and/or misinterpreting the evidence.
  • Most of the cited studies have been discussed on this blog in previous posts which disclose their flaws and/or erroneous conclusions.

So, instead of discussing all the tedious details yet again, I will present here a corrected version of the manifesto:

Homeopathy: no solution for major healthcare problems in the EU

  • Does not help to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance
  • does not increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care
  • Cannot reduce the use of long-term conventional prescription drugs, when integrated in health care

Homeopathy: neither safe nor cost-effective with a high patient satisfaction

  • Cannot lead to lower health care costs, when integrated in health care
  • Is unsafe
  • Patients using homeopathy have no better outcomes than users of conventional treatment, but cause higher costs
  • Quality and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC

 Some EU consumers expect and demand homeopathy as part of their health care

  • Reported as a much-used complementary medicine in Europe
  • Three out of four European citizens know about homeopathy and out of them many use it for their day-to day health care

 Scientific evidence of the highest calibre fails to confirm the clinical efficacy of homeopathic   medicine

  • Clinical effects of homeopathic medicines have been confirmed by systematic reviews and meta- analyses to be no better than placebo

There is no convincing evidence for biological efficacy of homeopathic medicine

  • No irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings

The objective of this analysis was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. The researchers employed a retrospective cohort design for analysis of health claims data from three contiguous US states for the years 2012-2017.

They included adults aged 18-84 years enrolled in a health plan and with office visits to a primary care physician or chiropractor for spinal pain. Two cohorts of subjects were thus identified:

  1. patients who received both primary care and chiropractic care,
  2. Patients who received primary care but not chiropractic care.

The total number of subjects was 101,221. Overall, between 1.55 and 2.03 times more nonrecipients of chiropractic care filled an opioid prescription, as compared with recipients.

The authors concluded that patients with spinal pain who saw a chiropractor had half the risk of filling an opioid prescription. Among those who saw a chiropractor within 30 days of diagnosis, the reduction in risk was greater as compared with those with their first visit after the acute phase.

Similar findings have been reported before and we have discussed them on this blog (see here, here and here). As before, one has to ask: WHAT DO THEY ACTUALLY MEAN?

The short answer is NOTHING MUCH! And certainly not what many chiros make of them.

They do not suggest that chiropractic care is a substitute for opioids in the management of spinal pain.

Why?

There are several reasons. Perhaps the most important ones are that such analyses lack any clinical outcome data, and that comparing one mistake (opioid-overuse) whith what might be another (chiropractic care) is a wrong apporoach. Imagine a scenario where half to the patients had received, in addition to their usual care, the services of:

  • a paranormal healer,
  • a crystal therapist,
  • a shaman,
  • or a homeopath.

Nobody would be surprised to see a very similar result, particularly if all of these practitioners were in the habit of discouraging their patients from using conventional drugs. Or imagine a scenario where half of all patients suffering from spinal pain are entered into an environment where they receive no treatment at all. Who would not expect that this regimen does not dramatically reduce the risk of filling an opioid prescription? But would that indicate that zero treatment is a good solution for managing spinal pain?

The thing is this:

  • If you want to reduce opioid use, you need to prescribe less opioids (for instance, by re-educating doctors to do as they have been told in med school and curb over-prescribing).
  • If you discourage patients to use opioids (as many other healthcare professionals would), many will not use opioids.
  • If you want to know whether chiropractic is effective in managing spinal pain, you need to conduct a well-designed clinical trial.

Or, to put it simply:

CORRELATION IS NOT CAUSATION!

 

A new appointment in the realm of so-called alternative medicine (SCAM) has just been announced:

Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.

Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.

Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.

FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.

Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.

The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.

Sounds exciting, but is Wardle up to the job?

Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:

No 1

Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.

Design: Content analysis.

Setting: Australia, Canada, and the United States of America (USA).

Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.

Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.

Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.

No 2

Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.

So, is Jon Wardle up to the job?

The answer obviously depends on what the job is.

If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!

My critics regularly display a lot of imagination. For instance, some come up with the claim that I have never done any original research.

Well, I have!

How much?

A lot.

The precise answer depends on how you define original research.

Usually, my detractors then focus on clinical trials. Prof Ernst can only criticise and find fault in studies of so-called alternative medicine (SCAM) published by others, they claim, but he never did a single clinical trial in his life!

Well, I have!

The allegation came up recently in a legal case that I am involved in, and I was asked to prove that it is false. I skimmed through my files and found something that I had almost forgotten about. Until my retirement in 2012, I had kept a record entitled THE EVIDENCE, A DOCUMENTATION OF OUR CLINICALLY RELEVANT RESEARCH. The document is based on 470 of our published articles and 35 of our clinical trials (I do not know many SCAM-researchers who have done more).

For the legal case, I also did a Medline-search to get the links of clinical trials including the ones before the Exeter job. The list is quite incomplete but, for what it’s worth, here it is:

  1. Placebo-controlled, double-blind study of haemodilution in peripheral arterial disease Ernst E, et al. Lancet 1987 – Clinical Trial. PMID 2885450
  2. Regular sauna bathing and the incidence of common colds Ernst E, et al. Ann Med 1990 – Clinical Trial. PMID 2248758
  3. A single blind randomized, controlled trial of hydrotherapy for varicose veins Ernst E, et al. Vasa 1991 – Clinical Trial. PMID 1877335
  4. Effects of felodipine ER and hydrochlorothiazide on blood rheology in essential hypertension–a randomized, double-blind, crossover study Koenig W, et al. J Intern Med 1991 – Clinical Trial. Among authors: Ernst E. PMID 2045762
  5. Does pentoxifylline prolong the walking distance in exercised claudicants? A placebo-controlled double-blind trial Ernst E, et al. Angiology 1992 – Clinical Trial. PMID 1536472
  6. Exercise therapy for osteoporosis: results of a randomised controlled trial Preisinger E, et al. Br J Sports Med 1996 – Clinical Trial. Among authors: Ernst E. PMID 8889112 Free PMC article.
  7. Randomized trial of acupuncture for nicotine withdrawal symptoms White AR, et al. Arch Intern Med 1998 – Clinical Trial. Among authors: Ernst E. PMID 9818805
  8. Randomized, double-blind trial of chitosan for body weight reduction Pittler MH, et al. Eur J Clin Nutr 1999 – Clinical Trial. Among authors: Ernst E. PMID 10369493 Free article
  9. A randomized trial of distant healing for skin warts Harkness EF, et al. Am J Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 10781776
  10. Can singing exercises reduce snoring? A pilot study Ojay A and Ernst E. Complement Ther Med 2000 – Clinical Trial. PMID 11068344
  11. A blinded investigation into the accuracy of reflexology charts White AR, et al. Complement Ther Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 11068346
  12. Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial White AR, et al. Cephalalgia 2000 – Clinical Trial. Among authors: Ernst E. PMID 11128820
  13. Spiritual healing as a therapy for chronic pain: a randomized, clinical trial Abbot NC, et al. Pain 2001 – Clinical Trial. Among authors: Ernst E. PMID 11240080
  14. Randomised controlled trial of reflexology for menopausal symptoms Williamson J, et al. BJOG 2002 – Clinical Trial. Among authors: Ernst E. PMID 12269681 Free article.
  15. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials Park J, et al. Acupunct Med 2002 – Clinical Trial. Among authors: Ernst E. PMID 12512790
  16. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery Stevinson C, et al. J R Soc Med 2003 – Clinical Trial. Among authors: Ernst E. PMID 12562974 Free PMC
  17. Randomized, double-blind, placebo-controlled trial of autologous blood therapy for atopic dermatitis Pittler MH, et al. Br J Dermatol 2003 – Clinical Trial. Among authors: Ernst E. PMID 12588384
  18. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial White A, et al. Thorax 2003 – Clinical Trial. Among authors: Ernst E. PMID 12668794 Free PMC article.
  19. Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba Canter PH and Ernst E. Int J Clin Pharmacol Ther 2003 – Clinical Trial. PMID 12940592
  20. Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial Pittler MH, et al. CMAJ 2003 – Clinical Trial. Among authors: Ernst E. PMID 14662662 Free PMC article.
  21. Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial Kanji N, et al. Am Heart J 2004 – Clinical Trial. Among authors: Ernst E. PMID 14999212
  22. Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? Wilcock A, et al. Palliat Med 2004 – Clinical Trial. Among authors: Ernst E. PMID 15198118
  23. Randomised controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee Harlow T, et al. BMJ 2004 – Clinical Trial. Among authors: Ernst E. PMID 15604181 Free PMC article.
  24. Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial Park J, et al. Arch Intern Med 2005 – Clinical Trial. Among authors: Ernst E. PMID 16186474
  25. Autogenic training to reduce anxiety in nursing students: randomized controlled trial Kanji N, et al. J Adv Nurs 2006 – Clinical Trial. Among authors: Ernst E. PMID 16553681
  26. Autogenic training to manage symptomology in women with chest pain and normal coronary arteries Asbury EA, et al. Menopause 2009 – Clinical Trial. Among authors: Ernst E. PMID 18978640
  27. The effects of triple therapy (acupuncture, diet and exercise) on body weight: a randomized, clinical trial Nourshahi M, et al. Int J Obes (Lond) 2009 – Clinical Trial. Among authors: Ernst E. PMID 19274056

Five things I like about the list:

  1. It is long.
  2. It displays a wide variety of subjects.
  3. It hardly depicts me as a ‘pharma shill’.
  4. Most of the trials were published in top journals (suggesting they were of decent quality).
  5. It reminds me how much fun these studies often were (I wrote a chapter about No13 in my memoir, and I could write [very amusing] short stories about No 20 and [less funny but baffling] about No 17 and 23)

So, the next time they claim ‘Prof Ernst never did any clinical trials’, I will be able to shut them up by simply showing them this post.

I am looking forward to it!

As CORONAVIRUS-panicked consumers scramble to buy the last roll of toilet paper, the world is frantically looking for a remedy that is effective against viral infections. On Twitter, I was alerted to a homeopathic remedy (actually, it’s a ‘homotoxicological’ preparation; for more explanation, see here) that promises to do just that. Here is the advertisement in its full beauty:

Dr. Reckeweg R 88 Devirol

Anti-Viral Drops

Indications: Any viral type disease such as measles, mononucleosis, herpes, flu.

Mode of action of main Ingredients

Coxsackie, Diphterinum, Epstein Barr, Herpes simplex, Herpes zoster, Influencinum, Mononucleosis, Morbillinum, Poliomyelitis, V-Grippe:The above ingredients are highly dilutes so that none of the virus remains in the product but that the energy of the virus stimulates the immune system to defend against the intruders. This becomes a safe immunization formula to safely (without side effects) increase the natural defense against virus.

Caryophyllus aromaticus: Natural anti viral.

Euphrasia: Immune stimulant.

Dosage: As a natural immunization formula this anti viral formula is safe for child-ren and should be used 3 drops 3 times a day for 3 days.Every month for the first two years of life.The formula can be adminstered into the umbilicus and rubbed into the skin with the child’s hand.For use with older childern or adults 10 drops 3 times daily to counteract viral di-seases or 10 drops once a day as a preventative.

Remarks: In case of influenza use R6 ;for feverR1;Chickenpox R68;Herps zoster R68,R30;Measles R62;Mumps R1,R26;Cough R8,R9.Remove patient from animal protein and increase vitamin-C use and essential fatty acids.With bacterial involvement R87.With fungal involvement R82.For stress involvement Vita-C forte.EtiologyExposure to virus starts the infiltration leading to the disease.The immune system’s condition during the incubation stage determines the degree and extent of the proliferation of the viral disease.Preventing exposure is important but even more so is keeping a healthy immune system,which allows the virus to do its work without threat to penetrate a cell to proliferate.Virus are modified types of RNA or DNA which carry messages from organisma.In nature virus are kept in check by bacteria and fungus.This tringle of micro organisma supplies a needed balance so that neither of these three becomes dominant. Excess antibiotics upsets this balance and lets virus and fungus grow.

The add which originates from Reckeweg Pakistan even offers an explanation how homeopathy works: It is all based more or less on the theory of the atomic bomb. The bomb gets its energy from the splitting of the nuclei (central cores) of uranium or plutonium atoms. The relationship between mass and energy put forth by the great mathematician Albert Einstein explains how the fission of heavy atoms can produce energy. Similarly, in homoeopathy the drug substances, that is small atoms, are split into even smaller atoms generating more and more energy.

Speechless?

Yes, almost!

If you believe that this is true or that any homeopathic product might work against any viral disease, then you are probably also amongst the crowd who stockpile toilet paper for a disease that does not cause diarhoea.

 

 

PS

In case you want to know what Einstein thought about homeopathy, I can refer you to a previous post: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

 

During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).

Here is the abstract of the Tuchin paper:

Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).

Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.

Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.

Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.

The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:

Objective: To identify adverse effects of spinal manipulation.

Design: Systematic review of papers published since 2001.

Setting: Six electronic databases.

Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.

Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.

Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.

In my view, there are several things that are strange here:

  1. Tuchin published his paper 5 years after mine.
  2. He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
  3. Tuchin never contacted me and never alerted me to his publication.
  4. The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
  5. A ‘replication study’ is a study that repeats the methodology of a previous study.
  6. Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.

But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.

As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.

As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.

Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.

But I think there is a more important point to be made here:

Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.

The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care. 

And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation. 

 

 

Functional Neurology (FN) is an approach used by some chiropractors. One website proudly proclaims that Functional Neurology, sometimes referred to as Chiropractic Neurology, is a term used to describe a variety of evidence-based treatments relating to neurological disorders. And another one informs us that Functional neurology, aka chiropractic neurology, is a healthcare discipline that utilizes neuroplasticity and contemporary clinical neuroscience to both evaluate and rehabilitate patients that suffer from a complex neurological condition or simply want to optimize their performance. A comprehensive neurological examination is performed in order to determine which area of the nervous system is not functioning appropriately. A customized therapy program is then tailored to address each person’s individualized neurological dysfunction.

The specific therapeutic claims that are being made for FN by chiropractors are impressive. The following list is a non-exhaustive attempt to document some of the conditions which functional neurologists claim to be able to treat: ADD/ADHD, Alzheimer’s, Anxiety disorders, Asperger’s Syndrome, Autism, Balance disorders, Blackouts, Blindness, Brain Aging issues, Canal stenosis, Cerebellar disorders,Chronic pain disorders, Cervical myelopathy, Coma, Complex regional pain syndromes, Concentration issues, Depression, Diplopia, Dizziness, Double vision, Dyslexia, Dystonia, Epilepsy, Fainting, Headaches, Heart arrhythmias, Irritable bowel syndrome, Learning difficulties, Memory issues, Mental Health, Migraines, Motion sickness, Movement disorders, Multiple sclerosis, Neglect syndromes, Numbness, Parkinson’s disease, Peripheral neuropathies, Radicular/nerve root conditions, Reflex sympathetic dystrophy, Sexual dysfunction, Sleep apnea, Sleep problems, Snoring, Speech problems, Spinal cord compression, Squints/skew deviations of the eyes, Strokes, Syncope, Tinnitus, Tics, Tourette’s, Tremors, Vertigo and Visual disturbances.

Is any of this backed up by evidence?

A review of FN included 9 articles. The included studies were conducted on adults or children, symptomatic or not, and investigated various interventions consisting of single or multiple stimuli, of varied nature, all primarily said to be provided to stimulate brain areas. Conditions included attention deficit disorders, attention deficit and hyperactivity disorders, autism-spectrum disorders, cortical visual impairment, traumatic brain injury, and migraine. Balance and the “blind spot” were investigated in healthy subjects. Major design and methodological issues were identified in all 9 studies; only 4 were considered as (potentially) appropriate for further scrutiny.

The authors concluded that no robust evidence could be found in relation to the effect or benefit of the tested FN interventions.

In a nutshell: FN is yet another addition to chiro-quackery.

Dr Jens Behnke has attracted my attention several times before (most recently here and here). Today I have decided to admit him into my ‘ALTERNATIVE MEDICINE HALL OF FAME’.

He finds himself in the company of giants:

John Weeks (editor of JCAM)

Deepak Chopra (US entrepreneur)

Cheryl Hawk (US chiropractor)

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

Why does Behnke deserve this honour?

Because, 4 years ago, he made his doctorate under the supervision of Prof Harald Walach, pseudoscientist of the year 2012 and proven teller of falsehoods?

No, there are better reasons.

On Twitter, Behnke describes himself as a research consultant for homeopathy at the Karl and Veronica Carstens-Foundation: Evidence based medicine, CAM, clinical and basic research, health. The Carstens Stiftung say he is ‘programme director integrative medicine’. On facebook, he is merely ‘ ‘Referent of  ‘Redaktion Natur und Medizin’. And on ‘Research Gate’ he lists 12 areas of skills and expertise:

Evidence Based Medicine
Medical & Health Profession Education
Meta-Analysis
Observational Studies
Science Communication
Social Media
Randomized Control Trials
Clinical Research
Philosophy Of Science
Complementary & Alternative Medicine
Integrative Medicine
Homeopathy

If this is not impressive, I don’t know what is! Particularly, if one knows that he is not a medical doctor at all!!!

So, let’s look at the list to decide whether he deserves the honour of becoming a member of my ‘HALL OF FAME’. Specifically, let’s check how many Medline-listed articles he has to his name in each of the above areas:

Evidence Based Medicine = 0
Medical & Health Profession Education = 0
Meta-Analysis = 0
Observational Studies = 0
Science Communication = 0
Social Media = 0
Randomized Control Trials = 0
Clinical Research = 0
Philosophy Of Science = 0
Complementary & Alternative Medicine = 0e
Integrative Medicine = 0
Homeopathy = 0

(No, you don’t need to praise me for my detailed, time-consuming research. It was not difficult and very quick: Jens Behnke, the ‘research consultant, has precisely zero Medline-listed publications).
So has Behnke ever conducted:

  • a meta-analysis? No
  • an observational study? I don’t think so
  • a randomised trial? No
  • any other clinical research? No

In the past, I tended to admit to my HALL OF FAME mainly those SCAM researchers who had published plenty of papers but had no study to their name that drew a negative conclusion. Behnke is not in that league. He is nevertheless worthy for his highly elaborate concept. Remember, he is a ‘research consultant in homeopathy’, and homeopathy obeys different rules than any other form of quackery. One of its axioms holds that LESS IS MORE. And considering this principle, Behnke surely must be THE expert! No publication, in homeopathic logic, evidently means that he is better than anyone else.

So, a warm welcome to our new member Jens Behnke: MAY YOUR UNPRODUCTIVITY AS A EXPERT IN 12 DIFFERENT FIELDS OF INQUIRY LAST FOR MANY MORE YEARS!

And congratulations also to the Carstens Stiftung who have so far spent 36 000 000 Euro on SCAM-research and pay Behnke’s salary as ‘research consultant’: I am sure you guys deserve him!

PS

In case Dr Behnke reads this: it is an internationally accepted standard of honesty and transparency that someone who has a doctor title and works in or comments on medical matters makes it clear that he/she is not medically trained or experienced, that in fact he/she is not a medical doctor. If not, one might think that this person is deliberately trying to mislead the public.

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