OP-ED

A Holistic View of Evidence-Based Medicine

David Katz MDOn Tuesday of this week (4/29/14), I was on the Katie Couric Show to discuss Integrative Medicine.

Somewhat ironically, I returned from Manhattan that same day to a waiting email from a colleague, forwarding me a rather excoriating critique of integrative medicine on The Health Care Blog, and asking me for my opinion.

The juxtaposition, it turns out, was something other than happenstance. The Cleveland Clinic has recently introduced the use of herbal medicines as an option for its patients, generating considerable media attention.

Some of it, as in the case of the Katie Couric Show, is of the kinder, gentler variety. Some, like The Health Care Blog — is rather less so. Which is the right response?

One might argue, from the perspective of evidence based medicine, that harsh treatment is warranted for everything operating under the banner of “alternative” medicine, or any of the nomenclature alternative to “alternative” — such as complementary, holistic, traditional, or integrative.

One might argue, conversely, for a warm embrace from the perspective of patient-centered care, in which patient preference is a primary driver.

I tend to argue both ways, and land in the middle. I’ll elaborate.


First, I am a card-carrying member (well, I would be if they issued cards) of the evidence-based medicine club. I am a conventionally trained Internist, and run a federally funded clinical research laboratory. I have taught biostatistics, evidence-based medicine, and clinical epidemiology to Yale medical students over a span of nearly a decade. I have authored a textbook on evidence-based medicine.

But on the other hand, I practice Integrative Medicine, and have done so for nearly 15 years. And I represent Yale on the steering committee of the Consortium of Academic Health Centers for Integrative Medicine.

Odd as it may seem, I consider these platforms entirely compatible. I did not go into Integrative Medicine because I believe “natural” is reliably better or safer than “scientific.” I respect the often considerable prowess of modern medical technology and pharmaceuticals.

And, frankly, I have never much cared whether a therapy derived from a tree leaf, or a test tube. I have cared about whether it was safe, and whether it was effective.

As an Internist taking care of patients for many years, one thing was painfully clear: I could not make everyone better. And while this deficiency might have been my personal shortcoming, it was much more than that. Modern medicine couldn’t make everyone better.

We tended to fall down particularly when it came to treating chronic pain, or chronic fatigue. We tended to stumble rather badly over any condition with “syndrome” in the title (as opposed to a “disease,” a “syndrome” is a description of symptoms generally lacking a clear explanation).

Integrative Medicine — a fusion of conventional and “alternative” treatments — provided patients access to a wider array of options. So, for instance, if medication was ineffective for anxiety or produced intolerable side effects, options such as meditation, biofeedback, or yoga might be explored.

If analgesics or anti-inflammatories failed to alleviate joint pain or produced side effects, such options as acupuncture or massage could be explored.

The array of potential options extends, of course, to herbal remedies and nutriceuticals as well — the apparent focus at the Cleveland Clinic. And, more controversially, it potentially extends to modalities that conventionally trained clinicians find implausible, such as homeopathy or energy therapies. I won’t get too deep into such weeds today, but have done so before.

Here are a few key considerations from my perspective.

1. Evidence is not a reliable differentiator of conventional and alternative medicine. By the standards that now prevail, more than 50 percent of conventional medical practice is not truly “evidence based.” Some years ago, colleagues and I were charged in a CDC grant to chart the evidence related to complementary and alternative medicine.

We would up inventing a technique called “evidence mapping,” since adopted by the World Health Organization and applied to an international traumatic brain injury program. Our finding was that in the realm of alternative medicine, some practices are rather well studied, some are understudied and some unstudied. Much like conventional medicine, in other words.

2. To the extent that evidence does differentiate conventional and alternative medicine, it’s often because — in the pursuit of evidence — cart and horse routinely swap positions and money cracks the whip. If the horse pulled the cart, then what gets studied would be what is needed, and what looks promising. But in our world, what gets studied often begins with what can be patented. It now costs nearly a $billion to bring a new FDA approved drug to market.

The only rationale for spending that much is the likelihood making back much more — and that only occurs when the product in question is exclusive and propriety, i.e., patented. There is a classic demonstration of the power of this influence.

More than a decade ago, a study of about 50 people followed for about three months was used to “prove” that coenzyme Q 10 was ineffective for treating congestive heart failure. At about the same time, a study of nearly two thousand people followed for years proved that the proprietary drug, carvedilol, was effective. The difference at the time was not really evidence — it was money.

A great deal more money was spent on the carvedilol trial — because no one can patent coenzyme Q 10.

More than a decade later, we now have evidence that coenzyme Q 10, when added to standard therapy for heart failure, can reduce mortality by as much as 50 percent. That is a stunning effect for something that has been “alternative” medicine all this time, and was declared useless by the conventional medical establishment.

Unless we are willing to practice money-based medicine, or patent-based medicine, we are obligated to recognize that the playing field for generating evidence is not level. It is tilted steeply in favor of patent holders.

3. Evidence is not black or white. It comes in shades of gray. Clinical decisions are easy if a treatment is known to be dangerous and ineffective, or known to be safe and uniquely effective. But what if a given patient has tried all the remedies best supported by randomized clinical trials, but has “stubbornly” refused to behave as the textbooks advise and failed to get better?

Or what if a patient just can’t tolerate the treatments with the most underlying evidence? One option is to tell such a patient: See ya! But I think that is an abdication of the oaths we physicians took. When the going gets tough, we are most obligated to take our patients by the hand, not wave goodbye.

To address this very scenario, colleagues and I have developed and published a construct that examines therapeutic options across five domains: safety; efficacy; quality of evidence; therapeutic alternatives; and patient preference. If a patient is otherwise running out of options and is in need, trying something that is likely to be safe and possibly effective — makes sense.

If there is something that is likely to be safer and more effective, then that should be used first.

But by recognizing and prioritizing the obligation to blend responsible use of evidence with responsiveness to the needs of patients that often go on when the results of large randomized, clinical trials have run out — we can wind up, inadvertently even, in the realm of Integrative Medicine.

That’s how I got here.

The needs of my patients led and I followed. And yes, the wider array of treatment options I can offer working side by side with my naturopathic colleagues absolutely does mean I have been able to help patients I otherwise could not.

Integrative Medicine should not involve a choice between responsible use of evidence and responsiveness to the needs of all patients. It should combine the two. We should do the best we can with the evidence we have, but recognize that high quality evidence may start to dwindle before our patient’s symptoms start to resolve.

We should resolve to confront this challenge with our patients, not leave them to fend for themselves.

The belief that treatments are intrinsically better just because they are “natural” is fatuous and misguided. Smallpox, botulinum toxin and rattlesnake venom are natural. Nature is not benevolent.

But the belief that conventional medicine is reliably evidence-based is equally fatuous. Much of what we do is simply tradition. And much of the evidence we get is more about money than other imperatives. Often in the world of alternative medicine, the problem is not evidence of absent effects — but a relative absence of evidence, in turn engendered by an absence of patents and financial incentives.

The history of coenzyme Q10 is a precautionary tale if ever there was one.

Integrative Medicine is not an invitation to supplant evidence with wishful thinking. It is an invitation to a wider array of treatment options, and the prospect of effectively addressing patient need more of the time. Realizing such potential benefits — at the Cleveland Clinic, or anywhere else — requires both open mindedness and careful skepticism.

It calls for a holistic view of the full array of therapeutic options, and the recognition that both conventional and alternative medicine are home to baby and bathwater. Differentiating can be hard — and we and our patients should be confronting that challenge together.

David Katz, MD, MPH, FACPM, FACP, is the founding (1998) director of Yale University’s Prevention Research Center, and author of  recently published book, Disease-Proof. This piece first appeared at The Huffington Post.

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@StoryOfHealthDavid L. Katz@BobbyGvegasjohn irvineAndrey Pavlov Recent comment authors
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@StoryOfHealth
Guest

This is the best summary I’ve seen of what is actually happening in EBM and how it affects the practice of allopathic and other systems of medicine. Thank you.

Anoop Kumar, MD

@BobbyGvegas
Guest

Grrrr…. THCB is blocking my links again.

See my Dec 4th REC Blog post on Mario Bunge.

Andrey Pavlov
Guest
David L. Katz
Guest

I disagree that every medical student learns to work along a hierarchy of evidence, turning to the ‘next best thing’ most likely to help a patient in need. I think many learn that there is either a meta-analysis or large RCT to back up a therapy, or it should be ignored entirely. I would also note that forces in our culture conspire against the utilization of non-proprietary, low-profit modalities. It’s just naive not to notice this, or think otherwise. Finally, there are ‘traditional’ treatments that in many cases have been used for centuries. While the accumulation of such experience is… Read more »

Andrey Pavlov
Guest

Dr. Katz, I once again genuinely thank you for your continued discussion in the matter. I can absolutely assure you that I care not from where or whom a therapy comes – so long as I can be convinced it can help my patient I will use it. I find it interesting that you disagree on the topic of medical students learning the hierarchy of evidence. In my first year of medical school we had an entire year-long course on it, with exercises, projects, and questions on our exams pertaining to it. Similar for a number of friends and classmates… Read more »

@BobbyGvegas
Guest

the idea of “traditional treatments that… have been used for centuries.”
__

a.k.a “Argument from Tradition”

Andrey Pavlov
Guest

Well said, BobbyGVegas.

Andrey Pavlov
Guest

As mentioned before I am an anecdotal case in which there was a clear outcome — 4 years of daily meds, following by the “alternative” intervention” followed by complete discontinuation. I realize N of 1 does not a study make, but I think Dr. Katz’s middle ground is the right answer. Except that your clear outcome can only demonstrate a correlation, not a causation. And any student of the sciences should be able to inform you of how easily we can be led astray by that. Which is why an n=1 trial is worth extraordinarily little except, in rare cases,… Read more »

Andrey Pavlov
Guest

John, you say: Or is it your position that the case is officially closed on ALL forms of integrative and alternative medicine? I’m willing to accept that many of these practices are myths and various forms of magical thinking as you put it, but that’s inevitable. For every answer we ask a hundred and fifty questions, or some equally improbable ratio. I am saying that there makes no sense to have such a category in the first place. Particularly not as a means to enable the proffering of therapies with a lack of evidence. What purpose does it serve to… Read more »

@BobbyGvegas
Guest

“Which brings me to “integrative medicine.” What, exactly, is being integrated?”
___

I guess when you “integrate” the unscientific with the scientific, you somehow — in contradiction to the “conjunctive fallacy” — STRENGTHEN science.

p(s) < 1.0
p(a) p(s)

‘eh?

@BobbyGvegas
Guest

Oops, the browser template chokes on inequality symbols. Let me re-state:

p(s) LT 1.0
p(a) LT 1.0

ergo,

p(s) x p(a) GT p(s)

Al Lewis
Guest
Al Lewis

As mentioned before I am an anecdotal case in which there was a clear outcome — 4 years of daily meds, following by the “alternative” intervention” followed by complete discontinuation. I realize N of 1 does not a study make, but I think Dr. Katz’s middle ground is the right answer. As for your answer, it seems too dogmatic under the circumstances. When I taught economics (at Harvard, as long as commenters seem to be sharing their Harvard credentials), I used to tell the students: “In economics the answer is almost never ‘all’ or ‘nothing.’ ” Alternative medicine would seem… Read more »

Andrey Pavlov
Guest

Point #1 is nothing more than a tu quoque argument. Regardless of whether your statistics are actually correct (and they are arguably not) it has nothing to do with the question at hand. Whether “conventional medicine” is 100% evidence based or 0% evidence based does not endorse nor impugn so-called alternative medicine. Point #2 is valid but incomplete. Yes, undoubtedly patentability and profit drive pharmaceutical development. And this does include some perverse incentives. However, it is incorrect to say that natural products are unpatentable. Even CoQ10 products can be patented – either by brand name or by process of development.… Read more »

Vik Khanna
Guest

The reality is that there isn’t enough time, money, and humanity available to test every conventional or alternative therapy and rate its effectiveness and thus make thoughtful decisions about access to it, with or without reimbursement. Forget about rating its value, which will vary between patients. It seems to make that we are also losing sight of two other important issues: the placebo effect and the value of experience. For my late father, acupuncture proved to be an important source of relief from intractable back pain, when no other therapy proved useful (late 1960s, early 1970s). Was it placebo or… Read more »

David L. Katz
Guest

We disagree on a number of points, clearly- but I will only address one. The difference between, for instance, co Q10 as “alternative” medicine and co Q10 as “conventional” medicine is measured in years, if not decades. Yes, the research in this case did eventually get done- but it was ten years after under-powered studies were used to declare the ‘co Q10 for heart failure hypothesis’ dead. Does that happen with a conventional drug: it is studied in too small a sample, little is seen, and the ‘hypothesis’ that the drug could work is declared ‘dead’? It does not. You… Read more »

Andrey Pavlov
Guest

Dr. Katz, thank you for taking the time to respond. I am generally overly wordy so I’ll try and be concise as best I can. In essence, I am reading your argument as saying that in the face of immediate patient need we should lower the standards of evidence to allow for less evidence based therapies to be administered to our patients and that further this is what “CAM” allows us to do. In other words, “CAM” is nothing more than a term for creating a double standard in which therapies with inadequate evidence to support them can be ethically… Read more »

David L. Katz
Guest

Actually, I prefer no separate category. What matters is how we proceed when we have exhausted all of the ‘high quality’ evidence, but our patient’s need remains inadequately addressed. Call that CAM, or ‘the next best thing,’ or the ‘art’ of medicine. The rubric matters little; getting the job done matters a lot. The method we use in my clinic is the CURE construct on p. 27 of this paper-

http://www.iom.edu/~/media/Files/Activity%20Files/Quality/IntegrativeMed/Preventive%20Medicine%20Integrative%20Medicine%20and%20the%20Health%20of%20the%20Public.pdf

Andrey Pavlov
Guest

Once again, thank you for your time Dr. Katz. Superficially we certainly agree. I wholeheartedly agree that ultimately getting the job done is what matters and there are, as you know, many barriers to achieving that in practice beyond the limitations of scientific knowledge. Your CURE construct is also superficially agreeable. But it also strikes me as excessively vague. It also, once again, does not jibe with your use of homeopathy. All of your categories include a patient preference for something that works. Homeopathy cannot work. It seems that here we disagree on the what constitutes that scale of evidence.… Read more »

Vik Khanna
Guest

The two most important phrases in this very useful post are: “money cracks the whip” and “Much of what we do is simply tradition.” Interestingly, in terms of reimbursement, tradition drove payment and still does. The thing that troubles me most about the conventional vs. alternative approach is our inability to talk about the elephant in the room: reimbursement. Because we reimburse by tradition (and not evidence) for many things that physicians do, should we give the same deference to alternative therapies and their practitioners? Clearly, they would love that opportunity because once they’ve gained entry to the big tent… Read more »

Dino William Ramzi
Guest

There is no such thing as alternative medicine or traditional medicine. There is only medicine with evidence and medicine without evidence. You are quite right that evidence does not differentiate the two, there is unclear thinking in both, inference stretching the conclusion of the empirical proof. The question is where are you comfortable setting the bar.

As far as applying the data rationally in the context of the patient’s preference, that is an old idea. It was first described by Donabedian under the concept of optimality.

Al Lewis
Guest
Al Lewis

Like you I am very firmly in the undecided camp. There are pluses and minuses. I myself have benefited from alternative medicine in that i had been taking Prevacid every day for 3 years to control indigestion. Then I was in a local supermarket and asked one of the employees where something was located. He said he didn’t know because he didn’t work in the store but was rather restocking the shelves with his company’s product. I thanked him and began to walk away. Out of the blue, totally unprompted, he asked: “Do you ever get indigestion?” Well, needless to… Read more »

Nowell Solish
Guest

The philosophy of integrated medicine in medical science is totally a complete health care of the patient. Definitely, this evidence based medication strategy is good because we can not guarantee any treatment 100% successful. Yes, we can do the best for our patient if we follow this complete strategy. Only focusing on disease is not a perfect way. We should focus overall health of the patient. We should see every possible aspect of the available ways of treating the condition.