Clinical trials of integrative medicine: testing whether magic works? 1


clinicaltrialsYou might perhaps be wondering what the term “integrative medicine” actually means, well if curious and you asked, you would get distinctly different answers. For those that support the concept you will be advised that “it treats the “whole person,” focuses on wellness and health rather than on treating disease, and emphasizes the patient-physician relationship“, however … (you guessed this was coming, right?) … it is in reality an umbrella that covers the non-science based complementary medicine and is simply a re-branding of it to make it more acceptable to the mainstream.

In other words, if you see the words “integrative medicine”, then you are in effect being given a big bright red neon sign that announces “Here be woo”.

Does it face criticism from real doctors? In fact it does, for example here.

What is rather frightening about all this stuff is that it is not real medicine and contains rather a lot of stuff that does not actually work at all. In a 1998 article in The New Republic, Arnold S. Relman, a former editor of The New England Journal of Medicine stated that

“There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of ‘integrative medicine.’ Nor, as Andrew Weil and his friends also would have us believe, are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not”

A New Commentary Paper has been published in a reputable journa

David H. Gorski (of the Departments of Surgery and Oncology at Wayne State University School of Medicine, and the Barbara Ann Karmanos Cancer Institute), along with Steven P. Novella (of the Department of Neurology at Yale University), have jointly published a commentary within “Trends in Molecular Medicine” (a reputable peer-review journal), that is entitled …

Clinical trials of integrative medicine: testing whether magic works? 

The journal article is excellent, is worth a read, is not too long, and the full text is accessible.

The quick summary (extracted from the paper) is this …

Over the past two decades complementary and alternative medicine treatments relying on dubious science have been embraced by medical academia. Despite low to nonexistent prior probability that testing these treatments in randomized clinical trials (RCTs) will be successful, RCTs of these modalities have proliferated, consistent with the principles of evidence-based medicine, which underemphasize prior plausibility rooted in science. We examine this phenomenon and argue that what is needed is science-based medicine rather than evidence-based medicine. 

Essentially the point that they are making in the paper in this …

  • Normally, the reason you do a clinical trial is that you already have some good evidence that the treatment will in fact work on humans, and that for example previous cell cultures tests, and then animal tests have yielded positive results, so taking the next step into human clinical trials is fully justified. – They propose the term “Science-Based Medicine” to describe this natural progress.
  • However, what appears to be happening is that integrative medicine is not doing this, and is instead leaping directly into clinical trials with no justifiable reason for doing so, and no prior evidence that it actually works at all, and also often no scientific basis for how it might actually work.

In other words, the key point is this …

RCTs [Randomised Controlled Trials] of highly improbable modalities continue to be funded and performed, not because of any compelling scientific rationale or prescientific evidence but rather because they are popular.  

You would think that once an RCT has established that a specific modality under test fails to perform, it would then be abandoned, but no, it just keeps rolling on anyway and the negative results are simply ignored. What is also shocking is that these IM trials not only have no sound basis for ever taking place, but also can result in real harm …

Another example is the trial to test an ‘alternative’ treatment regimen for pancreatic cancer that involves extreme dietary modifica- tions, juices, large quantities of supplements, and coffee enemas. After several years, abandonment of the RCT format for an unblinded ‘patient’s choice’ design, and considerable controversy over delays in publication, the results, when finally reported [14], were disturbing. One year survival of subjects undergoing this protocol was nearly fourfold worse than subjects receiving standard- of-care chemotherapy 

So  in summary …

All clinical trials, not just RCTs, should be based on scientifically well-supported preclinical observations that justify them, preferably with biomarkers to guide patient selection and follow-up. Until specific CAM and IM modalities achieve that level of preclinical evidence, RCTs testing them cannot be scientifically or ethically justified. That is science-based, rather than evidence-based, medicine.

Or to put that another way, let’s have science-based medicine and filter out all the pseudo-science stuff that does not actually work, and stop wasting valuable resources testing stuff that has already been demonstrated many times over to be ineffective.

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