Shares

Nobody seems to know exactly how to define “integrative medicine” (“IM”) or to demonstrate what it does that is superior to the “conventional” kind. There is a lot of talk about addressing the “whole person” and not just the disease, patient-centeredness and the like, all of which are already aspects of conventional medicine. But, however defined, the central idea seems to be that if you incorporate complementary and alternative ( CAM ) into conventional medicine the practice of medicine will improve tremendously.

Despite not having any clear idea of what IM is, or does, the military, prestigious medical institutions, hospitals, and individuals practitioners are eager to imprint the integrative medicine brand firmly on their public images. Hence the Consortium of Academic Medical Centers for Integrative Medicine, a newly minted medical specialty in integrative medicine, societies devoted to integrative medicine practitioners, CME courses, conferences, and so on.

But – whoops! – proponents, in their overblown hype for IM, apparently didn’t give enough thought to the fact that there isn’t much of an evidence base for this loosely-defined but supposedly superior system. And – whoops again! – you can’t really research something unless you know what it is you are researching. These little oversights have brought about efforts to decide which of the competing definitions of integrative medicine should prevail and, whatever it is, whether there is any evidence of benefit for the patient.

Several journal articles over the last few years have taken a crack at these problems. Today we look at three of them, a series on the subject by Ian D. Coulter, Raheleh Khorsan, Cindy Crawford (no, not that Cindy Crawford) and An-Fu Hsiao, appearing in the Journal of Manipulative and Physiological Therapeutics (2010), Evidence-Based Complementary and Alternative Medicine (2011), and Integrative Medicine Insights (2013).

What is integrative medicine? Good question.

In the first article, the authors identify what they see as two issues: (1) no clear definition of what constitutes IM, and (2) no taxonomy of IM practices to guide a research agenda. In other words, this is going to be a tough one. But they wade right in and come up with two definitions competing for the top spot. The first is the “adjunctive” model:

Medicine that reemphasizes the relationship between patient and physician, and integrates the best of complementary and alternative medicine with the best of conventional medicine.

The “best” of CAM ? I take it that “best” is not equated with “evidence of effectiveness” or even “biological plausibility,” because we know that, so far, neither has been convincingly demonstrated for CAM practices. Even the authors admit that evidence is not a necessary criterion for choosing, as you shall see below. Without those standards, I’m not sure how a selection of the “best” would be made.

Then there is the “collaborative” model of IM, sometimes referred to as Integrative Health Care (“IHC”), described in this quote from another researcher (emphasis mine):

1) an interdisciplinary, non-hierarchical blending of both CAM and conventional medicine that provides a seamless continuum of decision-making and patient-centered care and support; 2) employs a collaborative team approach guided by consensus building, mutual respect, and a shared vision of health care that permits each practitioner and the patient to contribute their particular knowledge and skills within the context of a shared, synergistically charged plan of care; 3) seeks, through a partnership of patient and practitioners to treat the whole person, to assist the innate healing properties of each person, and to promote health and wellness as well as the prevention of disease; and 4) results in more effective and cost-effective care by synergistically combining therapies and services in a manner that exceeds the collective effect of the individual practice.

In other words, the medical doctor is just one person on the team, with no more say-so than the acupuncturist, chiropractor, naturopath, or homeopath. Or the reiki, therapeutic touch, cranial sacral, reflexology, or crystal therapy practitioner. Or, presumably, practitioners of whatever assorted treatments or diagnostic methods that could be (and will be) invented in the future.

It is interesting to note that nothing in the collaborative model actually requires the services of a CAM practitioner. For example, if we accept that a “synergistically charged plan of care” has any meaning in the first place, there is no reason to think it couldn’t be achieved through a combination of “conventional” health care practitioners, such as medical doctors, physical therapists, nutritionists, trainers, nurses and psychologists, all employing a “shared vision of care” that consists of biologically plausible and evidence based diagnostic methods and treatments. So why the insistence on the “blending of CAM and conventional methods?”

As to the second issue, the taxonomy of practices, the authors decide that there isn’t any. For one thing, there is no agreement on:

what practices are permitted. This ranges from those who only include evidence-based practices to those who include either practices that “have stood the test of time” or those practices in most demand by the public.

Putting aside the issue of what IM practitioners might think is evidence-based CAM , the authors are refreshingly honest in explicitly admitting that IM can be based on something other than actual evidence. It is fortunate that conventional medicine did not employ this same standard. Otherwise doctors would still be bleeding patients and laudanum would be an over-the-counter remedy.

After coming down firmly on the side of the collaborative model, the authors then set out to see exactly what is out there, evidence-wise. As it turns out, pretty much nothing. A lot of discussion about how to construct an IM practice but little in the way of demonstrating that any patient will actually benefit from it. Most articles focused on describing practice models and conceptual/philosophical models, whereas there are fewer randomized controlled trials and observation studies. As the authors note, this lack of consensus on a clear definition and taxonomy for integrative medicine represents a major methodological barrier on conducting systematic literature review and meta-analyses.

And the evidence supporting integrative medicine? Not there.

Even with these obstacles, Coulter et al. soldier on to see what might be useful in this morass of uncertainties. Which brings us to the second article. The authors reiterate their conclusion that the collaborative model is the only way to go and that the mere inclusion of CAM in conventional medicine practice isn’t really integrative medicine at all. In fact, they say the adjunctive model might actually be a bad idea because integration “without a unifying paradigm or joint management” risks adverse interactions between the CAM and conventional treatment. In other words, medical doctors cannot be trusted to recommend CAM treatments to their patients.

So they set out to review and summarize the randomized controlled trials (RCTs), controlled clinical trials (CCTs), and systematic reviews on the collaborative brand of integrative health care (through mid-2009) and to make recommendations for future research.

I am not competent to comment on the design of their search or its results. But several things are noteworthy. First, although their search methods yielded almost 12,000 citations, only 6 studies fit their search criteria. None of the studies demonstrated cause and effect, only correlation. All used a combination of CAM compared to usual care, therefore none could correlate a positive result with any particular intervention. (Which makes me wonder – are researchers to try a never-ending combination of CAM and conventional treatments until they hit on those that “work?”) All included some treatments appropriated from conventional care and rebranded as CAM , including relaxation, health education and coaching, and stress management. One included “off-site prayer,” also branded as CAM . Most outcomes were measurements of highly subjective results (e.g, mood). Even then, the results were less than impressive. The authors themselves noted the lack of credible controls for the placebo effect, lack of long-term benefit assessment, and insufficient sample size.

The authors then discuss (again) how researchers don’t really know what IM is or how to measure its effectiveness (if any) or what outcomes they should measure to determine effectiveness. There is a lot of what Steve Novella calls “special pleading,” the argument that less exacting standards of research must be applied to CAM and IM:

the claimed inherent holistic nature of Integrative Health Care in which the social, psychological, spiritual, physical, and behavioral components oriented towards support and the stimulation of healing and the achievement of wholeness (i.e., the whole system) present special challenges with respect to design of clinical studies and especially with respect to the calculation of a total effect size.

And (quoting another author):

the lack for trial [sic; of trials?] might also reflect that controlled trials may be an inappropriate research model here and that what are required are methods for whole systems research. “Thus, unlike biomedical research that typically examines parts of health care and parts of the individual, one at a time, but not the complete system, integrative outcomes research advocates the study of the whole. The whole system includes the patient-provider relationship, multiple conventional and CAM treatments, and the philosophical context of care as the intervention. The systemic outcomes encompass the simultaneous, interactive changes within the whole person.”

The conclusion?

There is still insufficient evidence from trials to strongly support the higher efficacy of integrative medicine regimen compared with usual care.

Strongly support? That is quite an understatement. It seems more accurate to say that there is no evidence of higher efficacy.

And, of course:

Additional high quality RCTs and CCTs are therefore needed to build a stronger evidence-based body of knowledge. This is the same recommendation that has been made for CAM .

The third article reiterates what is, and is not, true IM, and notes the difficulty the lack of an agreed-upon definition can hinder, or even mislead, the researcher. One comment of note:

They [ CAM practices] may lack biomedical explanations, but as they become better researched, some physical therapy modalities, diet, and acupuncture become widely accepted, were as others (humors and radium therapy) quietly fade away. . .

Again, I’d have to disagree. It doesn’t seem that research results have any effect on acceptance. IM practitioners employ CAM no matter what the research says. In fact, the authors themselves admitted that. And diets and physical therapy aren’t “ CAM .” In fact, I imagine the American Association of Physical Therapists would be alarmed to hear this. Finally, despite what the authors think, the humors are alive and well in naturopathy.

The U.S. Army to the rescue!

By now you might be wondering what all of this has to do with the U.S. Military. The answer: the research and writing for all three articles was supported by the U.S. Army Medical Research and Materiel Command under Award No. W81XWH-07-02-0076 through the Samueli Institute. And in each the authors express their appreciation to Dr. Wayne Jonas for his guidance and recommendations.

I don’t know why it is the Army’s job to sort out what is and isn’t true IM or what is or is not evidence for or against it. After all, it seems the Army has other, more pressing claims on its limited research funds, such as suicide prevention or the infectious disease research program.

This infiltration of integrative medicine into the military is further explicated in an 2012 Explore article by a different author:

the bottom line for the military is to identify safe and effective treatments that can be implemented on a widespread basis within the current military infrastructure . . . This includes modalities such as acupuncture, yoga, homeopathy, and mind-body techniques . . . This is where the Samueli Institute comes in. For the last decade, [Samueli] has been making the case, through rigorous research, for the military in integrative medicine.

Homeopathy? Rigorous research? Here’s an example. In 2001, the Department of Defense asked Samueli:

to evaluate research done by Jacques Benveniste . . . in which he asserted the ability of water to retain a “memory of substances previously dissolved in it to arbitrary dilution.”

I do wonder who gave the Department of Defense the idea that this research was warranted. Beneveniste’s claim had been thoroughly debunked several years earlier, not that there was any reason whatsoever to believe it in the first place unless you were a supporter of that “perfect quackery,” homeopathy. Not surprisingly, “the Institute’s researchers were not able to demonstrate these biological effects.” However, according to Dr. Jonas, all was not lost, because:

what was more interesting about this project was the emergence of a “social management” process for doing research in controversial areas, bringing together investigators who come in with biases on both sides of the issue. This was the first time a conflict management process was used in science to test a hypothesis.

In other words, we don’t need the scientific method to test a hypothesis in “controversial areas.” We need a “social management process” in which science is just another “bias.” Apparently, the Department of Defense is sold, because it:

has since supported the development of using balanced methodologies to bring together other disparate opinions that would otherwise not be investigated.

Let’s hope this new approach doesn’t metastasize into other areas of Department of Defense research such as, say, designing a new fighter jet. Otherwise, the Department might use this “social management process” to investigate the possibility that a perpetual motion machine could power a jet and physics would become just another “bias.”

A blank check drawn on the taxpayers’ account.

This series of three posts began with what I thought would be one post on a couple of bills before Congress promoting more CAM and more chiropractors in the VA health care system. But what I found was more disturbing.

Actual research confirmed that integrative medicine is an undefined set of practices centering on the unproven concept that the integration of unproven (or disproven) CAM into conventional medicine somehow results in a whole that both is greater than the sum of its parts and beneficial to patients. And now promoters want to go on what amounts to a taxpayer-funded wild goose chase to see if they can drum up some evidence that their claims are true. This apparently will require an endless set of randomized controlled trials and assorted other studies (and maybe some “social management process”) combining different alternative therapies with different conventional therapies. Some of these studies have already been done, with unimpressive results and without anyone ever having whittled down, from a laundry list of variables, a working model of integrative medicine everyone can agree on. And after all this expense, there is little indication IM practitioners will base their decisions on the evidence anyway. If they aren’t paying attention to the evidence now, why would they do so later?