The randomisation of nonsense

20. October 2014
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There are things occurring between heaven and earth which one cannot understand – such as the fact that alternative therapies such as homeopathy get tested in clinical trials. In one Cell Press publication, two doctors from the United States are venting their anger on this purposefully.

They have had enough of the situation that for 20 years more and more “completely implausible medication methods that are doomed to failure, or trample on all previously established laws of physics and chemistry”, are supposed to be verified in randomised clinical trials. These are the words of David Gorski, from the Barbara Ann Carmanos Cancer Research Center in Detroit, and Steven Novella from Yale University in New Haven, USA, in their current publication in the magazine Trends in Molecular Medicine. More than 400 results were produced in their PubMed search of “homeopathy randomised clinical trial”, notwithstanding that some of them only represent review articles and do not deal with trials.

Ethical principles violated?

Proponents of such studies have often purported to essentially have the intention of clarifying which alternative healing method is actually effective, write the two scientists. According to Gorski and Novella: “complete rubbish”. Such studies they say have only served to infiltrate academic medicine with pseudo-sciences. Because in evidence-based medicine in actuality the following principle applies: only when a drug has proven its biological plausibility in preclinical studies does its time-consuming and cost-intensive testing on humans in randomised clinical trials occur. What’s more, they indicate, the Declaration of Helsinki on ethical principles for medical research involving human subjects prescribes this. In Germany with respect to the approval of clinical trials the ethics committees refer back to this very declaration.

Principles of action defying all the scientific evidence

In clinical trials of alternative therapies such as homeopathy or reiki, preclinical studies would appear to be irrelevant. And so it is, even though both methods of treatment according to the authors emanate from abstruse principles: in homeopathy, symptoms are treated with agents that just might cause healing symptoms in asymptomatic people. In addition, the substances are supposed to gain effectiveness by way of a rate of dilution as high as 10 to the order of 60.

Both find even more hair-raising the use of Reiki, an alternative healing method particularly popular in the United States. By laying down of hands, a person’s energy flow is supposed to change here with health benefits. “So far it has not been able to be proved that such a flow of energy even exists, let alone that it can be influenced by human hands”, write the two professors. Both approaches they say are not biologically understandable.

Biological plausibility

However, biological plausibility does not mean that the molecular mechanisms of a medical agent would already be comprehensively understood. Rather, a molecular mechanism should not be scientifically so implausible that it be considered impossible. “In other words, the underlying mechanism should not undermine laws and theories of science which are based on reliable and long-established foundations”, say Gorski and Novella.

In homeopathy this, the two scientists say, is the case in several aspects: the “memory of water” and the gain of an agent by dilution contradict all previously known scientific laws. Solely based on these facts, homeopathy should be declared an invalid healing method – without first conducting clinical comparative studies which would come to that conclusion anyway. “The followers of these therapies nonetheless do not get deterred by these negative study results”, says Novella.

Demand grows

“Holistic treatments, which include homeopathy, Reiki, traditional Chinese medicine or such similar things, are ever more frequently requested by patients”, says Gorski. The scientist sees the reason for this in a too impersonal medical system in which the doctor, because of dropping flat rate payments, rushes from patient to patient, in order to cover his or her expenditure and secure his or her income. “These problems should be tackled. And added to that, though – no clinical studies of quackery are needed”.

Too good to be true?

The two professors have already for some years been avowed opponents of alternative medicine. In their blog Science-Based Medicine, a platform for science-based medicine, as they write, Gorski and Novella dedicate themselves to the complicated relationship between science and medicine. They advise patients to remain critical, especially when there is no data present on a method of treatment – whether it is referred to as alternative or not – and the healing promises are too good to be true.

 

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Medicine, Research

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10 comments:

Dr Rainer Klocke
Dr Rainer Klocke

There are indeed things between heaven and earth that are not yet understood, including homeopathy, but unfortunately this article does nothing but repeat old paradigms and adds nothing new to explain how patients can experience genuine health benefits from complementary medicines when a purely substance-based EBM model has failed them. They authors are right, however, that double-blind, placebo-controlled RCTs that test a substance – rather than the disease and an individual patient – are probably a waste of time and resources – it seems to me like trying to grasp the song of nightingale by keeping on taking pictures of the bird. The challenge is to construct trials that are open in their conduct, choice of remedy and yet fully describe the bias involved and go beyond a single case report.

Rainer Klocke
Rheumatologist

#10 |
  0

Without studying Homoeopathy and knowing it in dept how can you people pass judgment and no where it is written that water has memory …. Without having proper knowledge please don’t pass judgement and stop being biased …. It’s a proper science , it’s just being put up in a wrong way …. Homoeopathy is a blessing to medical science …. I don’t understand why some people don’t want it to spread… I would just call them biased and half knowledge is always dangerous.

#9 |
  0

Seit tausenden Jahren haben Schamanen und Medizinmänner mit Hokus-Pokus geheilt. Wirklich geheilt! Dass es einen Zusammenhang zwischen dem Nerven- und Immunsystem gibt, werden selbst die gelehrten Kollegen nicht bestreiten. Viele Spontanheilungen bei verschiedenen Krebsformen sind dokumentier. Warum also mit der wissenschaftlichen Keule auf so harmlose Praktiken wie Reuki oder Homöopathie einschlagen. Außerden sind die Veränderungen der Kristallstruktur der Wassers keine Ammenmärchen, sondern von ernsthaften Wissenschaftlern aus Japan und den Niederlanden dokumentiert. Ich erinnere mich an eine Zeit als ernsthafte Wissenschaftler meinten, der Mensch könne Geschwindigkeiten über 80 KmH nicht überleben.
Reden ist Silber, Wissen ist Gold

#8 |
  0
Dr. med. Adri van der Marel
Dr. med. Adri van der Marel

Didn’t they, David Gorski and Steven Novella, ever hear about the crystalstructure of water ? It is a part of the survey prof. dr. M.C. van Hemert, Faculty of Science, Leiden Institute of Chemistry, Theoretical Chemistry (Office address: Gorlaeus Laboratories, Einsteinweg 55, 2333 CC Leiden), used for his dissertation, which was published in 1981.

Using heavy terms requires good information. Otherwise it leads to nonsense not protected by randomisation.

Adri van der Marel, huisarts (general practitioner)
Westerbuurt 13
1606 AK Venhuizen

#7 |
  0
Dr. med. Adri van der Marel
Dr. med. Adri van der Marel

ja

#6 |
  0
Dr Richard Doehring
Dr Richard Doehring

Any attempt to ban “research” and publication of trials of alternative medicine would simply fuel the conspiracy theories about the persecution of alternative medicine by conventional practitioners, government, “Big Pharma”, etc.

Rather let us welcome such trials and publication, and regard them as useful quality controls on the scientific process, demonstrating over and again the errors that can be created by inadequate randomisation, blinding, and above all by confusing statistical significance with truth (statistical significance always be achievable either by taking a big enough sample or by selectively publishing only that small proportion of trials (2.5% if the typical 5% probability of a Type I error is used), which confirm the expectations of the “researchers”).

Publication bias is over-and-over the root of supposed success of alternative treatments and diagnostics, but it happens in converntional medicine as well, and the nonsense results from alternative medicine are good reminders to us all to remain sceptical of everything!

#5 |
  0
Claudia Conroy
Claudia Conroy

What about meditation’s effect on the healing process and awareness. Brain image studies show the positive result of meditation on brain activity when a subject is exposed to a negative stimulant. Do we consider meditation alternative or adjunctive therapy?

#4 |
  0
Dr Antony Toben
Dr Antony Toben

Patients are waking up, expanding their knowledge e.g. by reading Dr. med. Mag. theol. Ryke Geerd Hamer’s Germanische Heilkunde @ amicidirk.com,germanische-heilkunde.at
The billion $ Pharma and Oncology Industry would close down immediately but world health legislation has VERBOTEN the emergence of most Holistic treatments and labeling them as quackery. See the HIV/AIDS or EBOLA scare! As long as people are believers fear takes over period!
Dr Antony Toben
tonytoben@hotmail.com

#3 |
  0

I hope this article by Gorski and Novella, which is both rational and long overdue, receives attention/ space in the media aimed at the general public.

#2 |
  3
Simon Tarry
Simon Tarry

If the water has a memory surely it would remember the fish urine or human urine as well!!

#1 |
  0


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