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N C C A M Research Blog

Perspectives on Complementary and Alternative Medicine Research

August 20, 2013
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

Director
National Center for Complementary and Alternative Medicine

View Dr. Briggs' biographical sketch

Transcript

Today’s Journal of the American Medical Association includes a Viewpoint from my deputy director, Jack Killen, and myself. In this essay, we call for a fresh, more nuanced and balanced conversation about research into complementary and alternative practices.

As a result of research over the past 14 years, we know a lot more now than we did when NCCAM was founded in 1999. For example, we have a much better handle on when and for what reasons Americans use specific complementary interventions, where we need to focus concerns about safety, and what research approaches are best.

We also know a great deal more about the potential of complementary approaches to contribute to the management of chronic pain. Our current focus, on pain management, is driven by real world use data.

Our current research agenda reflects major evolution in research priorities. It recognizes that some of these practices are useful and can reasonably be integrated into care, some are not useful, some are dangerous and merit regulatory attention, and many are somewhere in between.

So, let’s start a fresh conversation, based not on generalities, but on the areas of this field that warrant investigation—for safety and for their potential roles in addressing difficult symptoms and conditions.

I do hope you will look at our viewpoint essay in JAMA and share your thoughts with us.

Learn more:

Comments

Comments are now closed for this post.

I wholeheartdly agree that more reseach should be done into other forms of Rx than the ones that come out of test tubes - but because so often they are not “patentable” private corps won’t touch them  - so I think we need to push for more and more gov’t funding and facilities to test these therapies. This, no doubt, will meet resistence from those private profit centered enterprises, so i think those in the medical field who do understand the enormous potential value of these non patentable therapies had best gird their loins and prepare to enter the ring in ways they have avoided doing before - I applaud Dr. Briggs for her advocacy of further testing, though i could not read the gated article … I have a suggestion - though it may not be practicable - i have used an “alternative therapy” for some time now - Phyllanthus niruri (or Chanca Piedra in common parlance) and was able, on one occasion at least, to confirm that it appears to lower urine calcium levels , which is a major factor in renal calculi formation for those with idiopathic hyperciuria, but this was something that would not be pursued by MDs in any sort of “official” manner. There have been studies in other countries on this herb, and it apparently has some rather remarkable potential in this and other areas …. I am a retired physician - and would be more than willing to participate in trials to evaluate this drug - and it seemed to me that it would be possible to elicit the participation of people like myself, who have a professional understanding of “informed consent”, in trials conducted by willing practitioners who deal with the condition ….. One could start with people who are already using these modalities so that there would be no question of a healthcare practitioner “prescribing” a treatment not yet “cleared” by the FDA …. Let us enlist more medical folk as “subjects”  - heaven knows there are enough of us out there with “conditions” who are using “alternative” therapies … Wonder if it would be useful to put out a call for any MDs, RNs etc who would be willing to participate in organized testing of therapies that they themselves feel may be quite useful because of anecdotal ecidence from their patients but who are not free to professionally prescribe them at this point - preliminary confirmation of their usefulness in this manner would justify further investigation - i.e. an intermediary between “anecdote” and “confirmed” …. 

Hello Dr. Briggs, Thank you for opening up the conversation about CAM.  In your viewpount piece you delineate a rather sharp contrast between those who eschew modern medicine and go for “all natural” cures and those who are skeptical and “completely dismiss complimentary approaches”. You add that the “only unifying factor being that we’re still exploring their safety and value”. In previous online discussions with Dr. Killen he stated that it is not possible to define CAM consistently and in fact ended up writing a post about why the NCCAM does not concern itself with defining CAM. Yet at the same time “[t]here are compelling reasons to explore many CAM modalities.” How can it be that there is a compelling reason to explore something which we can’t even seem to be able to define, except in the most vague and exclusionary terms? But moreso, I am still confused. As a soon-to-be-graduated 4th year medical student it seems to me that all of medicine is constantly being explored and reviewed for safety and value. The USPTF recently updated the guidelines for screening mammograms and determined them to be of a little less value than previously. Does that make them an “alternative” modality? Not terribly long ago Xigris was found to be of no benefit and possibly harmful. It was since pulled from the market Does that it make it an “alternative” medicine?  The obvious answers are, of course, no. But based on what criteria? After much discussion back and forth with Dr. Killen (I used to post as “nybgrus”) he ended up writing an entire new post about how the definition of CAM wasn’t of primary concern to the NCCAM. Now you proffer an exceedingly vague definition. The only thing that could be adequately described by such a definition is, well, everything. Everyhting is constantly being explored for safety and value. And when something is demonstrated to be of value, we incorporate it into our practice and simply call it medicine. When it is harmful, we eschew it.  I personally believe that everything should be investigated. As a scientist, our goal should be the gathering of knowledge and understanding of the world and universe around us. As a medical scientist, we should use that knowledge to help our patients and avoid harming them. But the study of everything should not become the study of anything. History has shown us that we can be mislead and go down the path of N-rays and col fusion. It was Richard Feynman who said, “The first principle is that you must not fool yourself, and you are the easiest person to fool.” And the standards of investigation should, of course, be uniform and informed by the knowledge we have already garnered in a logical, rational, and consistent approach. Furthermore, in medicine, we should ascribe to the precautionary principle since once again history has shown us that an untested management or therapy has much more likelihood to do harm or, at best, do nothing than provide a benefit. Heck, we know that even modalities well tested can not uncommonly lead to unforseen harms or situations may change rendering them harmful. We should also be ready to dismiss effects small enough to be constantly yielding equivocal studies since any benefit that may be there is of no use in a resource limited health care environment.   So I simply continue to fail to see how “CAM” can exist and be studied as a separate entity. Nobody can seem to define it well and every definition proferred is simply one that fits the study of any medical modality. I’ve also perused through the 2012 list of projects competing for or funded. The vast majority of those have nothing to do with CAM - most are simply pharmacognosy studies. Many of them are studies of exercise physiology like the effects of yoga on health. Some of them are indeed something one might call “CAM” and the only thing I can find to delineate that is the fact that they have been studied before and have a very low prior probability and many negative studies. Which raises the other issue - it is common for very science based modalities to be called CAM for no good reason. Investigating the bioactive properites of plants and natural compounds is not alternative, it is pharmacognosy. My own post graduate research was in the anti-aging effects of Rhodiola rosea, yet I do not consider that at all “alternative.” And exercise physiology is a very main stream modality - we know the health benefits of exercise and any good physician should alway recommend diet, lifestyle, and exercise improvement to his or her patients. Massage and relaxation are similarly not alternative; we are aware of the neurophysiological responses to stress and anxiety and the biopsychosocial model of medical care which incorporates those aspects have been “mainstream” for decades now.  The biggest problem I find is that unlike medical science, topics labeled “CAM” seem to never be eschewed once negative data demonstrates its disutility. We got rid of Xigris after good data demonstrated it was of no benefit in sepsis. Yet we are still funding studies desperately trying to find some particular formulation of Echinacea that might have some effect on URI’s despite more and more robust data demonstrating no clinically significant effect (and even no statistically significant effect). We still doggedly pursue acupuncture even after many good studies demonstrate it doesn’t matter where you place the needles or even if needles are placed at all, with study after study demonstrating no benefit beyond placebo. Would we be so willing to continue testing - and offering! - a drug to our patients that had been demonstrated to be no better than placebo? Or testing highly implausible modalities like Reiki and homeopathy. On every conceivable scientific level, both modalities cannot possibly be of use to patients and fall well within Dr. Feynman’s cautionary principle. Yet we find homeopaths on the National Advisory Council for Complimentary and Alternative Medicine. How can serious medical scientists even entertain the idea of continued study and “integration” of modalities like homeopathy into medical care? So I’ll close by saying that I appreciate the efforst on your part and Dr. Killen to reshape and improve the NCCAM by becoming more rigorous in scientific inquiry. But I’ll pose to you the same questions I asked of him: what is it that defines CAM as anything separate to be studied uniquely? It seems to me that any plausible modality should be investigated under whatever umbrella it may best fall. What is it that the NCCAM can uniquely offer in terms of rigorous scientific investigation that cannot be done at any other IC in the NIH?

@Aquifer: It is a fallacy that so-called “natural medicines” are not patentable. I wrote about this in a comment over at Science Based Medicine complete with references demonstrating that indeed medicinal uses of plants and herbs are quite patentable. I do not have the reference handy but will attempt to find it again and will post it up here when I do.  However the point is that the common complaint that these “wonderful and efficiacious” and “all natural” herbal remedies are not researched because they are not patentable is indeed false. The reality is that it is simply much easier and much more lucrative to eschew the studies and use the provisions of the DSHEA to imply health and efficacy claims and sell it anyway. Which is why the supplement industry has grown from a few hundred million dollars pre-1994 DSHEA to well over $30 billion today.

The article highlights the importance and benefits of researching complementary and alternative practices as a result of their increasing popularity. 

@Andrey Pavlov - Thanks for accepting the invitation to share your thoughts.  I wanted to respond to you since Dr. Briggs has been out of the office.  You ask two questions: What is it that defines CAM (complementary and alternative medicine) as anything separate to be studied uniquely? What is it that NCCAM can uniquely offer in terms of rigorous scientific investigation that cannot be done at any other institute or center in NIH?

 

As we argued in the JAMA perspective, “CAM” is not a distinct entity that can be clearly demarcated from conventional medicine. On the other hand it is clear that there is a diverse array of interventions around the margins of modern medicine that are being used by the public and by health care providers. NCCAM has been given lead responsibility at NIH for investigating whether these practices are useful or not, and which are dangerous and merit greater regulatory attention. We neither can nor should attempt to invest in everything, so our continual challenge is to determine how best to invest a small fraction of NIH’s resources in research across that array. We believe we have developed a compelling research agenda and set of priorities for that investment.

 

What NCCAM uniquely offers at NIH is scientific expertise in the methodology for studying these interventions. For example, NCCAM’s policies and practices for applying the tools and methods of pharmacology and pharmacognosy to investigation of herbal medicines, dietary supplements, and probiotics address the atypical regulatory status of these products and set the pace at NIH for research on these products. Similarly, we understand the unusual challenges confronting study of procedure-based mind and body practices, and have expertise in the methods needed to do this research.

 

Research projects frequently overlap the mandates and areas of scientific expertise of NIH institutes and centers. When that happens we collaborate to ensure that the science is sound and does not duplicate other related work. In this regard our colleagues at NIH often consult us, just as we consult them.

Dr. Killen, Thank you for taking the time to respond, it truly does mean a lot to me and I value the ability to have such discourse. I’ll attempt brevity in my response, though that is not my strong suit. Firstly, I’d like to relate a story about a classmate of mine. He had never heard of the NCCAM nor anything about the kind of research it does. He is, however, quite the scientist himself and has been and is currently engaged in much bench science research. In other words, he is a friend with whom I can discuss ideas and refine my understanding of scientific protocols and rigorous research.  In short, he was surprised and very underwhelmed at the previous research conducted by the NCCAM and blog posts by yourself and Dr. Briggs relevant to our current discussion. I say this not to pile on some argumentum ad populum, but merely as one example to point out that I have tried to read and understand the arguments you and Dr. Briggs have put forth as best as I can, and have even brought in outside perspective in case my own views are unknowingly biased. Yet in every case the central questions remain.  More to the point, while it is superficially reasonable to have an entity that investigates these so-called fringe practices otherwise known as CAM, the reality is that scientific research is not done in a vacuum. It rests on philosophical principles and exists within a political and cultural milieu.  In the past, the research the NCCAM has been engaged in has been, quite frankly, utterly ridiculous. Spending over $600k to research whether intercessory prayer can lower HIV viral titers simply cannot be justified on any rational, rigorous, scientific basis. I won’t belabor my post with further examples and indeed there was a tacit admission of the highly questionable research focus of the NCCAM in your posts about pior plausibility.  It is admirable that now there is a renewed focus on actually employing rigorous criteria for prior plausibility and scientific research. But the issue is that this is not the history upon which the NCCAM was founded, nor even what one of its original sponsors (Tom Harkin) seems to still feel the purpose is when he said: ”One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.” This statement embodies exactly the opposite of the scientific process.  And now with more rigorous standards we find that indeed the bulk of what the NCCAM has been investigating has shifted rather dramatically. As I have argued before, the only really unifying theme of CAM is that it is a body of modalities and interventions with extremely low prior plausibility. Which is precisely what the NCCAM had been researching before. Now, we move to what are almost entirely science based studies which genuinely have no rationale for being called CAM. Pharmacognosy - which comprises the vast majority of the investigations the NCCAM is now funding - cannot reasonably be called CAM. It is a venerable science based practice. The same with exercise.  So it is my argument that when the vast majority of your research focus becomes overlapped with other IC’s by simply making criteria more rigorous, then I can simply see no specific reason or rationale for existing in the first place. As you say, IC’s can overlap and thus collaborate, but when the only things that don’t overlap are highly implausible like homeopathy and chiropractic there isn’t much room left for an entire IC to be funded.  And I would further argue that by investigating otherwise science based modalities and calling it “CAM” at the level of an NIH IC, it does lend false legitimacy to much more fringe practices. Practices which themselves have been demonstrated to be harmful, wasteful, or displace actual medical treatment to the harm of individuals.  You claim that the “NCCAM uniquely offers at NIH is scientific expertise in the methodology for studying these interventions” yet pharmacnosy and exercise physiology research has been done long before even the Office of Alternative Medicine existed. And continues to be done irrespective of the NCCAM. So I still fail to see the utility of having an entire IC devoted to doing nothing a different IC couldn’t do if it had a share of the NCCAM’s funding while still wasting a little bit of money on highly improbable research and lending false legitimacy to the concept of CAM. You yourself state that ““CAM” is not a distinct entity that can be clearly demarcated from conventional medicine” yet if you look at what is actually happening that statement can’t be reconciled with reality. What is “Integrative Medicine?” It is supposed to be a combination of the best of “conventional” medicine and the best of “CAM.” If CAM can’t be defined as a distinct entity and is not demarcated from “conventional” medicine, what exactly are we integrating? Why are there entire departments in so-called “Integrative Medicine” at many hospitals and medical schools? Why are there courses in medical school on “CAM”? We can’t seem to define it any differently because, by any rigorous scientific definition, it is merely something that hasn’t been investigated or that has been demonstrated to have no utility. Yet it is continually argued that it is “popular” and this then justifies its “integration” with “conventional” medicine, all whilst ignoring the fact that there simply is no difference between CAM and “conventional” medicine except the level of evidence. And anything that has evidence of efficacy is and should become “conventional” medicine, not “integrated” into it.  The entire vernacular and what is actually occurring belies the much more insiduous effects of such false legitimacy and allows for rank quackery like homeopathy and naturopathy to become licensed and “integrated” into actual medical care, much to the detriment of our patients. Yoga for exercise for our cancer patients? Excellent science based adjunct to care. Reiki and homeopathy from a naturopath? Utter waste of resources and time which does nothing except validate magical thinking. And it is for these reasons that I continually challenge the role and definitions (or rather lack thereof) of the NCCAM and the study of CAM as anything separate than merely the study of medicine. Because every time I think more deeply, every new resource I read, every new perspective I ask for all leads to the same conclusion; that the only thing that defines “CAM” is an ideological concept of health and medicine rooted in cognitive bias and logical fallacy with exceedingly low prior probability.  I don’t expect my posts to be the destruction of CAM and quite frankly I am pleasantly suprised that I’ve received any sort of response at all from you and I thank you for it. I’m not even 100% certain that I am correct in my thoughts, though I continually challenge them and have yet to find a satisfactory rebuttal. But I do feel that this is an exceedingly important topic and hope that making my thoughts public and part of the NCCAM discourse can at least stimulate thought and conversation such that even if I am utterly wrong it will merely serve to strengthen the benefits of medical research. In the meantime I remain unconvinced of the utility of the study of so-called CAM and have no evidence to demonstrate that it is anything but an politicoideological construct that has nothing to do with rigorous scientific inquiry.