Thursday, June 28, 2012

The “Integrative Pain Management” Controversy

Integrative Pain ManagementIntegrative pain management — combining the wisdom of nature with the rigors of modern science — is a growing movement in the pain field today. Yet, it is controversial, with some claiming that “integrative” is just the latest buzzword for a collection of superstitions, myths, or pseudoscience that have gone by various names through the years. The epicenter of the integrative medicine debate, in the United States at least, is at the National Center for Complementary and Alternative Medicine (NCCAM).

NCCAM is one of 27 institutes and centers that make up the U.S. National Institutes of Health (NIH) and is the government’s lead agency for scientific research on complementary and alternative medicine (CAM). The Center sponsors and conducts research using scientific methods to study CAM, which is defined simply by NCCAM as a group of diverse medical and health care interventions, practices, products, or disciplines that are not generally considered as part of conventional medicine.

In a recent posting at the NCCAM Research Blog [here], agency Director, Josephine P. Briggs, MD, explores what “integrative” means and concedes that the term has various connotations. She observes that the legislation authorizing the Center in the late 1990s clearly emphasized integration, as follows:

“The Director of the Center shall, as appropriate, study the integration of alternative treatment, diagnostic and prevention systems, modalities and disciplines with the practice of conventional medicine as a complement to such medicine and into health care delivery systems in the United States.”

Briggs admits that there are a lot of “rough edges” surrounding the interface of conventional medicine on one side of the debate and the use of complementary/alternative health approaches on the other. She states:

“From one end, ‘integrative medicine’ offers a holistic, gentle, patient-centered approach that will solve many our Nation’s most pressing health care problems. At another end, ‘integrative care’ represents an evasive rebranding of modern equivalents of ‘snake oil’ by practitioners who raise unrealistic hopes and promote approaches that are not sensible, supported by evidence, or proven safe.”

Briggs further asserts that NCCAM’s understanding of the term “integration” begins with 3 well-documented facts:

  1. Individuals, healthcare providers, and healthcare systems are already and on a large scale incorporating practices that have origins outside of mainstream medicine into multipronged treatment and health-promotion approaches.

  2. This “integrative” trend among providers and healthcare systems is increasing, driven by emerging evidence in at least some cases that perceived benefits of integrative care are real and/or meaningful, such as in the management of chronic pain.

  3. However, with few exceptions, data to guide evidence-based decision making about safety and efficacy of many “integrative modalities” are at best preliminary.

Regarding the last point, this is where NCCAM comes in, Briggs maintains. The Center is focusing its resources on building better evidence to clarify whether interventions that are already being integrated into healthcare practices — and, for which there seems to be a reasonable scientific case for investing valuable resources — are safe and effective. For example, she notes, NCCAM is deeply invested in clarifying the role of nonpharmacological approaches as components of pain management.

Briggs believes that the word “integrative” is a useful construct that is simple, pragmatic, and focuses on major trends in 21st Century health care. However, on the other side of the debate, there is a great deal of skepticism expressed; for example, a commenter to the blogpost by Briggs states:

“Medicine should be based on sound science, rather than appeals to popularity. And, unfortunately for CAM, the majority of it lacks a sound, scientific basis. This is why I very strongly object to it being called medicine, even with the qualifiers ‘integrative’ or ‘complementary.’ As to treating the ‘whole person,’ I agree that this is part of the physician's job. It involves talking to the patient and treating them as a person, addressing their psychological needs as well as the physical. But that does not mean that physicians should clap onto magical thinking or pander to such in their patients. If a patient expresses interest in some modality that has no scientific basis or any good evidence that it would actually help them, the physician should take the time to explain, in a manner that will lead to understanding without alienating the patient, why that modality is unlikely to be of any help.”

Another responder to Briggs remarks, at a different blog [here], observes:

“Notice how Dr. Briggs characterizes ‘integrative medicine’ on the one hand as being all soft and fuzzy, the equivalent of mom and apple pie. Who could argue with ‘holistic, gentle, patient-centered’ approaches? Well, actually, I can, because the word ‘holistic’ is meaningless in this context. A good science-based primary care doctor is ‘holistic.’ …. Much of ‘integrative medicine’ represents, more than anything else, a return to pre-scientific beliefs, such as vitalism, miasmas, and illnesses being caused and cured by, in essence spirits or gods or magic. After all, Reiki is nothing more than a form of faith healing, and most energy medicine is nothing more than magic, the belief that if you wish for something really, really hard, you can bend the universe to do your bidding and provide you with that thing, in this case, healing.”

Writers at the popular blog, ScienceBasedMedicine.org (SBM), have been particularly skeptical of integrative medicine approaches and how NCCAM is investing tax dollars. Ben Kavoussi, MS — summarizing an earlier article by Eugenie Mielczarek and Brian Engler — comments [here]:

“…since 1992, there have been over 1000 monetary awards by NCCAM to fund hundreds of clinical trials. None of them has revealed anything new that would justify the current annual expenditure of $134 million. Some of these funded studies are beyond absurd: $250,000 was wasted to determine whether waving hands over fatty rabbits will decrease their cholesterol. Did it? Almost ten years later, we still don’t know! Public funds were also wasted to study the efficacy of prayer to cure AIDS or to hasten recovery from breast-reconstruction surgery. Other funded studies involved the use of ancient Indian remedies for type 2 diabetes, magnets for arthritis, carpal tunnel syndrome or migraine headaches, and coffee enemas for pancreatic cancer. It is not surprising that none of these studies showed any efficacy beyond the placebo effect.”

Other writers at SBM, such as David Gorski [here], frequently eschew what they describe as “quackademic medicine.” This term is intended to summarize everything wrong with the increasing embrace of CAM, or integrative medicine, into academic medical centers. Gorski believes that medical education is increasingly “normalizing” what was once rightly called quackery. In his opinion, this movement is being fueled by NCCAM as well as by private organizations, such as the Bravewell Collaborative [website here].

Outspoken SBM authors and commenters have consistently railed against the scientific validity of almost all forms of CAM — including homeopathy, Reiki and all other variations of “energy healing,” acupuncture, traditional Chinese medicine, unproven nutraceuticals, and many others — as well as disciplines like chiropractic and naturopathy that they consider as unscientific and apart from mainstream medicine. Many of their lengthy, evidence-based arguments seem to make good sense in supporting their contention that some of the most popular “integrative” practices may ultimately make for bad medicine.

COMMENTARY: We have often written about research on CAM and integrative approaches for pain management in these Pain-Topics UDATES [eg, series here], describing strengths and weaknesses of the evidence. Last January 2012, we also wrote [here] about criticisms of NCCAM for its willingness to invest in research on CAM therapies that seem to spring more from people's unfettered imaginations than sound scientific principles.

Snake OilWe are concerned that when it comes to pain management — with symptomatology and prognosis so often dependent on the subjective dispositions of patients — both historically and today there have been a great many opportunities for the propagation and practice of what can only be called quackery. For example, “snake oil” is more than just a figure of speech; it was once an actual product allegedly derived from rattlesnakes and promoted as an instantaneous remedy for a broad range of painful ailments [see advertisement at right].

Still, there could be a bit of truth in the rattlesnake “oil” mythology, since venoms of various types have led to important discoveries with medicinal value. The powerful intrathecal analgesic, ziconotide, is made from a toxin found in marine snail venom. And, in fact, proteins in the venom of rattlesnakes are under investigation as a treatment for cancer [news item here]; so, there some day may be a resurgence of “snake oil,” but in a different and scientifically-validated formulation.

Despite this, we would agree that there are many “snake oil” hucksters in the traditional sense peddling pain remedies that are of unproven and doubtful value. Hardly a week goes by that we do not receive a press release or a new book (usually self-published) touting a new treatment, interventional procedure, or device that will “cure” one pain condition or another. In almost all cases, via the clever wording of therapeutic claims and indications (very unlike the blatant promises on the old “snake oil” label), these products and approaches elude regulation by agencies like the U.S. Food and Drug Administration.

While there is rarely sufficient and/or valid clinical research evidence to support their safety or efficacy, there are always plenty of patient testimonials implying the curative powers of the huckstered products or approaches. An important question is, should these be eschewed outright as quackery or are they worthy of further testing? Who will decide on this and do the necessary research? At present, NCCAM is the only agency with the mission, the funding, and the resolve to pursue the requisite scientific research — keeping the hucksters honest, as it were.

According to NCCAM’s definition, “integrative (or integrated) medicine” combines both conventional medicine treatments and those CAM therapies for which there is valid clinical evidence of safety and efficacy. A pernicious danger of an integrative approach is when either (a) there might be unidentified safety concerns with the CAM therapy making it potentially harmful, or (b) patients seek unproven CAM remedies for their maladies before or instead of considering and exploring science-based approaches offered by conventional medicine.

Persons with chronic pain are particularly susceptible to the appeals of hucksters promising implicit “cures,” or even relief, for conditions that have long eluded effective management by conventional medicine. They can hardly be blamed for their eagerness to try anything at all that seems reasonable and relatively safe and affordable. However, it is dismaying when desperate patients with pain exhaust personal finances and emotional capital by seeking the promised but elusive remedies of CAM approaches that were never scientifically validated to begin with.

A multifaceted approach to pain management has much to offer in terms of potential benefits for patient care; but, it is essential that all agencies, organizations, and healthcare providers attracted to the allure of Integrative Pain Management cautiously consider the quality of evidence in support of each modality, or lack thereof, in helping their patients to make prudent treatment decisions.

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6 comments:

Bob Twillman, Ph.D. said...

I think one of the tricky aspects of this discussion is the definition of "CAM". What treatments are included in that designation? Is it only things like energy healing and homeopathy, which seem to most scientists and clinicians to be implausible on the surface and rather far from the mainstream? Or does it go so far as to include all treatments not delivered by a physician, such as psychotherapy, physical therapy, or massage therapy? What about things like chiropractic and osteopathic manipulation, both of which ARE delivered by physicians?

If we think about integrative pain management as involving the integration of pharmaceuticals; procedures; and non-pharmaceutical, non-procedural interventions, then I think we also need to consider something else: These interventions do not have to be accepted en bloc. It is possible to accept some of these interventions and not others, and still call what you are doing "integrative". I suspect many providers would even be comfortable rank-ordering these other types of interventions, and accepting only the top X of them, whatever X is in their own book.

I guess I'm once again calling for a greater consideration of the gray areas here, because I think the black-and-white, all-or-nothing approach risks throwing out babies with bath water.

SB. Leavitt, MA, PhD said...

Thank you for your comments above, Dr. Twillman, which make good sense. In balance, I also think it is worthwhile to examine what the skeptics have to say at blogs like SBM [here].

They would argue that any modality, whether or not delivered by a physician, that has a sound scientific rationale and a solid base of clinical evidence for efficacy is no longer complementary or alternative -- it is a part of medicine. Much of what falls within CAM today has not made the grade; it is wannabe medicine that is of dubious value and a waste of time and money, they believe.

They make some valid points; although, I often do not agree with their sweeping generalizations and strong criticisms that sometimes border on contempt prior to adequate investigation. Yet, a problem with “gray area medicine” is that it also is the realm of zealous promoters of unproven “cures,” of which there seem to be many in the pain management field.

Unknown said...

As a pain medicine specialist and also a physician acupuncturist, I am very aware of the issues described. I have been at the some NIH sponsored CAM conferences where I've wanted to crawl under the table after hearing some of the outrageous claims of some CAM practitioners.
That being said, I also should note that with regard to the treatment of chronic pain for many of the treatments we commonly use, ranging from surgery and epidural steroids for chronic low back pain to opioids for chronic pain, we have little scientific evidence.
I remember once discussing reimbursement for acupuncture with the representative of an insurance carrier. I was told that they couldn't cover it because its efficacy hadn't been demonstrated in controlled studies published in the top medical journals. After I agreed this was a valid point, I then asked whether they would stop paying for back surgeries as these also lack this support. The response: "That's what we've always paid for so we can't stop."
Steven A. King, M.D.

SB. Leavitt, MA, PhD said...

Thank you, Dr. King, for your comments above. I agree with you, and I’ve been very critical in these UPDATES about the quantity and, especially, the quality of research evidence in the pain field. There does tend to be better evidence for safety and efficacy regarding regulated pharmacotherapies, but even this can be insufficient at times. In more cases than not, each patient is an n-of-1 experiment when it comes to the treatment they receive for pain. As you know, we are not as far along as we think when it comes to the science and treatment of pain, which is the most common of all ailments.

Anonymous said...

After visiting the emergency room for and needing surgery I was booted out of my then pain management. I called my insurance and they gabe me the number to Interventional Pain Managrment. After years of morphine ER with roxicoone amd/or dilaudid, this new 'intervential' PM so graviously nd cautiouslyrescribed me 7.5 percocet without additional extended release. Their reason? "We have the DEA looking over our shoulder and our goal is enough injections that eventually you ill have zero pain medication." Apparently the "interventional" aspect in not intervention of pain but drug intervention under the cloak of Pain Management. After two monrhs I fired them and am on my own. After a recent fall I had an ER doctor tell me that after the years of 'allegedly' (they almost reached my pain) strong opiates I was prescribed, there was nothing they could prescribe that would work. They gave me 3shots of dilaudid and sent me on my way. I've been told by pain management that wont take me, that since I have no pain doctor, "you are free to do or take whatever you want while you dont have a doctor"! Is that an invitation or free ticket to be ome a heroin user? Perhaps marijuana? Good heavens i quit smoking that as a teen because i hayed the effects. Well, i enjoyed a few years pain free and even returned to school. Too bad I wont finish and now I will leach off society and perhabt joins this epidemic of street addicts so Ican obtain help? Once I become an addiction I can then receive methadone which works good for pain if I understand correctly. So my real question is, where do I find heroin and who will show me how to do it? Where is the FDA/DEA brochure on that?

Anonymous said...

Anon (above), I understand your post. I think more and more people are in the same boat. Integrative pain therapy often equates a successful outcome as one that involves NO opioids, at any cost, despite continued severe pain experienced by the patient.

Society (and especially the medical community), has turned its back on anyone who has relied on opioid therapy for treatment of chronic (non-cancer) pain. Everyone is an addict. ALL opioids are bad....for everyone. What are people supposed to do? As insane as it sounds, I understand the reasons for contemplating illicit drug use. THAT'S CRAZY! People who have found significant relief from opioids, who are abandoned and abused, have few options.

How on earth, did this vulnerable, unlucky, sick, group of people, become so disposable? What is wrong with our society that we treat chronically ill people with such contempt & hatred? How scary is it, that our own government is leading the witch hunt?

No one cares about us anymore.