JAMA: A willing accomplice to co-opting “nonpharmacologic” treatments for pain as being “alternative” or “complementary”

That I’m not a fan of the National Center for Complementary and Integrative Health (NCCIH, formerly known as the National Center for Complementary and Alternative Medicine, or NCCAM) should come as no surprise to anyone. Basically, from its very inception as the Office of Alternative Medicine in the early 1990s to its growth to large center with a yearly budget of $120+ million, NCCIH has served one purpose: The promotion and attempted legitimization of quackery and magical thinking in medicine, the better to “integrate” pseudoscientific medicine with science-based medicine. Certainly, the leadership and supporters of NCCIH will deny to high heaven that that’s true, but the history of NCCIH makes such a conclusion inescapable, and when NCCIH can’t “integrate” quackery like acupuncture and naturopathy into medicine, it co-opts science-based modalities like diet and exercise as somehow being “alternative” or not part of mainstream medicine, to claim them for itself because, unlike the pseudoscience, these methods can work.

One of the more amusing yet disturbing aspects of NCCIH over the last five years or so is that its leadership seems to be coming to the realization that the “interesting” forms of “complementary and alternative medicine” (CAM), the far out ones that first attracted its mandated attention (or, more correctly, attracted the attention of NCCIH’s original Congressional patron Senator Tom Harkin) have been a failure. Despite over $1 billion expended over the last 20 years or so, NCCIH has failed to validate homeopathy, acupuncture, naturopathy, reflexology, chelation therapy, or the Gonzalez protocol for cancer. All that leaves are exercise, diet, and lifestyle changes. Undeterred, however, the NCCIH, led by Dr. Josephine Briggs, has continued to charge boldly onward by taking full example of the opioid addiction crisis in this country to represent CAM as “nonpharmacological” approaches to chronic pain. Indeed, a couple of months ago, NCCIH even published a rather poor quality systematic review that purported to show that some forms of CAM were effective against chronic pain and represented nonpharmacological alternatives to opioids.

It’s bad enough when the NCCIH produces a document that was widely derided as not showing what the NCCIH claims it shows; e.g., by Steve Novella and Edzard Ernst. It’s also bad when NCCIH apologists like John Weeks compare such criticism to Donald Trump. Ironically, the comparison to Donald Trump reminds me that the problem with NCCIH presents to medicine is the same problem Donald Trump poses to the body politic. As Trump normalizes misogyny, racism, borderline fascism, and utter cluelessness, NCCIH normalizes pseudoscience and quackery, seeking to “integrate” them as part of medicine. Of course, CAM itself does the same thing, but, just as Trump has become the face of the forces he’s unleashed, the NCCIH is the face of CAM, at least in academia.

It’s continuing to have an effect, too. For example, just this week JAMA, normally viewed as one of the top tier medical journals, published a Medical News & Perspectives article by Jennifer Abbasi entitled As Opioid Epidemic Rages, Complementary Health Approaches to Pain Gain Traction. It’s basically a story about the NCCIH’s systematic review that lacks—shall we say?–adequate skepticism. The first part of the article basically reports the findings of the systematic review; so I won’t comment much on it. If you want to know why the conclusions of the systematic analysis do not flow from the data presented, read the contemporaneous discussions by Steve Novella, Edzard Ernst, and myself.

What’s irritating to me comes in the second part of the article:

Nahin noted that the clinical trials that met the bar for his review tended to be small and participants were limited primarily to older white women. “The review identified a lot of gaps in the data,” he said, adding that “there’s still a lot of research that needs to be done to see whether these data can be generalized to the larger US demographic population.” Nahin also acknowledged that the analysis was somewhat subjective: “As a narrative review geared to busy primary care providers, our conclusions are our qualitative assessments of the literature and are not based on a hard quantitative analysis such as a meta-analysis or meta-regression,” he said.

No, what busy clinicians need is not “qualitative assessments.” What they need are the very “hard quantitative analyses” that Richard Nahin seems to be dismissing as unnecessary or not useful to “busy clinicians.” In fact, it just occurred to me that I missed a part earlier in the study that shows you just how misguided the NCCIH review was:

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Arrrgh! That’s exactly the same raationale that antivaccine activists use. They ignore the quality of the evidence and simply count positive and negative trials. Since in the antivaccine world there are always a lot of crappy “positive” trials while the negative trials that fail to find a link between vaccines and autism or other serious health problems tend to be much larger and more rigorous, just counting positive and negative trials isn’t helpful. In fairness, the NCCIH review didn’t actually ignore the quality of trials. The included trials had to reach minimal quality standards, but within the groups of trials there were trials that didn’t use sham controls along with trials that did. (Guess which ones were negative and which ones were “positive.”)

It’s worse than that, though. NCCIH argues to go “beyond the randomized clinical trial” or “beyond the RCT.” What does that mean? Longtime readers might be able to predict what’s coming next. Certainly I could. Yes, we’re talking “pragmatic trials”:

A next step for the NCCIH, Shurtleff said, is to conduct “pragmatic” studies that look at the effectiveness of complementary health strategies for pain outside of the strict inclusion/exclusion criteria of RCTs. “We’re looking to see how this works in real time in the real world, with all the warts and things that go along with that,” he said.

“At the end of the day, if an approach is successful you’ll be able to generalize it more to everyone with the disease, versus a very small cohort of individuals,” Nahin added.

Such pragmatic studies may begin next year in collaboration with the Veterans Administration and the Department of Defense. These agencies are looking toward complementary health approaches for returning service members, who experience both high levels of chronic pain and other comorbid conditions such as posttraumatic stress disorder and substance abuse, Shurtleff said.

What are pragmatic trials? They’re pretty much as described above. The reason they’re inappropriate for CAM, though, is because pragmatic trials of CAM put the cart before the horse. Pragmatic trials are useful and can provide data that can be very helpful in determining which treatments work in the “real world.” However, they are only useful to test interventions that have already proven themselves to be efficacious and safe in RCTs. RCTs have very strict inclusion and exclusion criteria, and, not infrequently, once an intervention is validated in RCTs and released “in the wild,” so to speak, patients selected for them don’t fit the strict criteria used in the RCTs and the interventions might not be done just as they were in the RCTs. In other words, the real world intrudes. Here’s where pragmatic trials come in. They actually do give a better idea how well an intervention works in “the real world.” Not surprisingly the most common outcome is that treatments that worked well in RCTs don’t work as well in the real world.

For treatments in which the outcome is subjective, however, such as CAM treatments for pain, the results are often the opposite. Pragmatic studies give a false impression of effectiveness. The reason, of course, is that most pragmatic trials don’t include a placebo or sham intervention control; so what is measured tends to be placebo effects more than anything else. That’s why I describe pragmatic trials as putting the cart before the horse. So why is NCCIH doing this if it’s bad science? Do you even need to ask. It’s all about the money:

Madhu K. Singh, MD, a physical medicine and rehabilitation orthopedic physician at Midwest Orthopaedics at Rush in Chicago, praised the NCCIH review as “an excellent overview of the more rigorous RCTs that have been performed” for several common complementary therapies. However, Singh—who emphasizes nonsurgical spine management in her practice—pointed out that many of the approaches aren’t feasible for patients because insurance companies by and large don’t cover them. Because of this, “physicians are often backed into a corner when dealing with a patient’s pain,” she said, referring to the tendency to default to medications.

The IOM report, which emphasized a model of “integrated, interdisciplinary pain assessment and treatment” that includes complementary and alternative medicine (CAM), recommended that reimbursement policies should be revised to accommodate this approach.

Out-of-pocket spending on complementary health treatments for adults and children in the United States added up to $30.2 billion in 2012, according to National Health Interview Survey data. But not every patient can afford to foot the bill themselves, Singh said: “We need to create better access to CAM therapies. By reducing the cost burden on the patient, these therapies become far more accessible.”

Basically, pragmatic trials are being used to generate data to convince third party payers to reimburse for CAM treatments. It’s not good data, but it might be enough.

That’s where NCCIH is doing its real harm.