The randomisation of nonsense
20. October 2014
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.
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.
“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.