Evidence and the Eastern paradigm of medical treatment

Remember the trial a couple of years ago that showed that group support participation was associated with prolonged survival among women with metastatic breast cancer?

I’ve thought a lot about that over the years. Isn’t it interesting that something as simple as a supportive environment can make a difference in what researchers consider to be the hardest endpoint there is: survival? In our dualistic view of the human organism, we think of support as acting in the realm of the psyche, and not the physical. And yet, here is the evidence of a psychological exposure somehow making a tangible physiologic difference.

Now, how do we do evidence-based medicine? Well, we look for clinical studies that tell us whether and how well a treatment works for a particular condition. For the rabid evidenistas among us the most valid design to provide such evidence is a randomized controlled trial, since it has the most internal validity (i.e., we are in fact likely to be studying what we think we are studying). When we pat ourselves on the back on a randomization well done, we cite the balance in the fairly obvious demographic and clinical characteristics in the two (or more) comparator groups, namely, age, gender, comorbidities, the burden of acute illness, and the like.

We rarely bother with their social or psychological milieu; in fact edging up to evaluating that may be viewed by some as engaging in quackery. Well, true, these exposures are ephemeral and somewhat abstract, but look at the breast cancer study… Just because it is difficult to study and we do not have validated tools for them currently, does not mean that we can ignore, or worse yet, disparage, their potential influence. Isn’t there a saying to the effect that we cannot discover that which we do not currently have the tools to understand?

And speaking of inadequate tools, a related sticky wicket comes to mind: heterogeneity. I say it is related because we do not even dare look at the underlying non-physiologic heterogeneity as I mentioned above. What may surprise the uninitiated more, however, is the fact that we do not have good tools to identify physiologic heterogeneity. And as most appreciate, heterogeneity demands large numbers of subjects to study to get a detectable effect. In fact, our research enterprise is set up to do mammoth studies for often a miniscule difference (think cardiology trials requiring 20,000 patients to demonstrate a fall in mortality from 0.5% to 0.25%). It is very likely that by using this sledge hammer method to craft the fine jewel of evidence we are missing huge chunks of useful information.

And if this is the case for our Western paradigm of medical treatment, how does it play out in our study of Eastern and other non-traditional modalities? Don’t take me wrong; I am not suggesting having blind faith in homeopathy, for example. But I am curious about how cultural psychology may influence responses to such treatments as Ayurvedic medicine, say. Perhaps it only “works” in conjunction with meditation and yoga? An “Eastern bundle” anyone?

The point is I do not know the answers to these questions. What I do know is that with our approach to evidence building we are looking at a vast castle through a key hole: we are only seeing small swaths of reality. My final point is this: because so much remains in the dark, we need to be humble when exploring evidentiary basis for any intervention. A parochial attitude equating gaps in our understanding to lack of effectiveness makes us seem like the Inquisition persecuting Galileo for defining an alternate reality which turned out in the long run to be the truth we live by.

Marya Zilberberg is founder and CEO of EviMed Research Group and blogs at Healthcare, etc.

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The epistemelogical question posed here is a deep and difficult one. There is no doubt that RTCs and other scientific mechanisms for evaluating causal relationships and treatment effects have limitations. However, the tone of the article is almost psotmodern in its suggestion that truth is a cultural construct and that science is a Western phenomenon. Do antibiotics only work for Europeans? Should we only vaccinate people if they believe in vaccination? I suspect the author would clearly say “No” to both of these questions, yet they are not much farther down the postmodernist highway than she has started travelling.
The characterization of this “western” science as dualistic is a strawman since mainstream science follows the model of methodological naturalism, which says non-material, spiritual entities have no role in theorizing or investigation of medical problems. There is no dualism between mind and body because mind is body, and pain and anxiety are real and physical manifestations of illness as liver transaminase elevations and hypertension. They must be studied and treated as any other manifestation of illness, and while this involves behavioral interventions, such as social support networks, as well as pharmacological and other more blatantly physiological interventions, it is a mistake to suggest that “Western” medicine does not have just as powerful a role to play in ameliorating these sources of suffering as it does for more obviously bodily aspects of disease. Granted, the current healthcare delivery system is not very good at supporting patient’s psychological needs, and alternative medicine providers often do a much better job of this regardless of the efficac (or lack thereof) or their ostenisble treatment modalities. But this is a failure of physicial training and the structure and economics of the health care system, not a failure of the scientific method.
The reference to Galileo is a cliche that alternative medicine advocates often invoke to suggest that heresy is automatically true and resistance to implausible ideas is automatically irrational and mistaken, even a form of oppression. This is simply an example of the availability bias, in which the memorable is seen as representative. The reality is that most iconoclasts and wild visionaries really are wrong and we simply don’t remember their names. All ideas should be ruthlesslessly criticized, with an open by very demanding mind, and those that have merit will thrive while those that do not will die.
The unfortunate and inevitable implication of the critique Dr. Zilberberg makes is that we should be more accepting of claims that have not been or cannot be validated by rigorous scientific methods. This is not humility but simply surrender in the face of the methodological and philosophical difficulties of studying certain pehnomena, such as subjective experiences like pain and their effect on disease outcomes. The bulk of human history, in which we relied on non-scientific methods of studying and treating disease, is a vast wasteland of failed ideas, and the last few hundred years is an almost unimaginable series of triumphs by comparison. The answer to the swaths of darkness around us is not to dim or turn down our flashlight, but to make it bigger and brighter so it can illuminate what we cannot yet see. and true humility is a recognition that our feelings and intuitions have so thoroughly and consistently failed us as guides to what is true and what is not that we must accept dispassionate, objective scientific investigation as superior, however limited it may yet be and however we might yearn to follow our heart or our gut.
Finn
“Remember the trial a couple of years ago that showed that group support participation was associated with prolonged survival among women with metastatic breast cancer?”
No, what I remember is that while one or two small, poorly designed studies have had this result, larger, better-designed studies have found no such effect. As noted in Bio-Medicine on 10/21/2007: “Moreover, a recent comprehensive review by Dr, Coyne and Dr, Stephen Palmer of the University of Pennsylvania and Michael Stefanek of the American Cancer Society failed to find credible evidence in the available studies for the claim that cancer patients participation in psychotherapy or support groups prolonged their lives.”
Clarissa Kripke
Health care is a spiritual practice. On the first day of medical school they warned us, “Beware of studying from old tests. The questions are the same from year to year, but the answers change.”
anonymous
Re the study about support groups for women with breast cancer; Perhaps the women who attended the support group meetings fared better because they were well enough in the first place to leave the house. The women who were sicker, and ultimately died, may not have had the energy or may simply have opted to spend their time in other ways.
Those studies are cited all the time as “evidence” when in fact all they demonstrate is a weak correlation.
pat
Here is another way to look at it. Generally, illness in a person is viewed as being isolated in that person. In reality, a person is constantly interacting with the rest of the world. We breath things in and out of our body, shed skin cells, support a world of bacteria and other organisms, consume various substances and rid ourselves of substances. Atoms and molecules come and go within and without, some no doubt exchanged with other humans, and we are subject to light, cosmic rays, gravity and magnetic forces. So really we are not an isolated entity. Just making a point that we may not really be taking all relevant influences into consideration. Maybe other schools of medicine are, although they may not refer to these influences with our terminology. Just a thought.

Evidence and the Eastern paradigm of medical treatment

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