A recent review of thousands of Veterans Administration (VA) medical records concluded that there was no significant difference in self-rated pain intensity between veterans who received complementary and integrative healthcare treatments (chiropractic care, acupuncture or massage) and those who did not. This calls into question the both the VA’s aggressive campaign to incorporate integrative medicine into veterans’ healthcare and the promotion of integrative treatments as a solution to the opioid crisis.
The researchers, who reported their findings in the journal Pain Medicine, observed that several meta-analyses of randomized and non-randomized trials showed small to moderate effects of acupuncture, massage and spinal manipulation (which they collectively refer to as “Complementary and Integrative Health” or “CIH”) on pain intensity “relative to no treatment or usual care.” (Of course, as David Gorski and others have pointed out, what matters is how the treatment compares to sham treatment, but never mind.) However, they noted, trials were conducted in small samples (<100 patients) over short follow-up durations (<6 months). Therefore, they concluded, these trials might not be representative of the natural course of chronic pain or the patients who suffer from it.
Thus, the authors wanted to evaluate the effectiveness of acupuncture, massage and chiropractic care on chronic pain using a different method and a much larger population. Researchers culled a study sample of almost 310,000 musculoskeletal disorder (MSD) cases from VA medical records. Each veteran was followed from initial diagnosis until death, loss to VA care, or for a maximum of 3 years. From these cases, they identified 7,621 who received one or more clinical visits for acupuncture, massage or chiropractic care during the study period. Self-reported pain scores of CIH recipients were then compared to what are referred to as “non-CIH recipients,” that is, veterans who did not have acupuncture, massage or chiropractic care visits during the same period (n=301,656), using statistical methods we’ll return to in a moment.
We sought to evaluate CIH effectiveness on chronic pain . . . among a large cohort of US veterans receiving care in VHA facilities. Our hypothesis was that treatment with CIHs should have a modest benefit on reducing intensity of chronic pain. Accordingly, we expect that on average veterans who received one or more courses of CIH therapies would report less intense pain than those who did not receive such therapies, after appropriate control of potential selection and confounding biases inherent to observational data. [Emphasis added.]
Like others who are overly sanguine about the value of CIH for pain, the authors note the high burden of chronic pain among veterans and concern over the “opioid epidemic” (their quotation marks, not mine). And, as is also the case with others who promote CIH, their optimism is curious, in light of their admission that:
randomized trial evidence for CIH is inadequate.
To test their hypothesis, the authors used what is called “Propensity Score” (PS)-based causal methods. Without getting too much into the statistical weeds (where I would be totally lost), PS-based methods, according to these researchers:
attempt to tackle potential selection and confounding biases in a similar fashion to randomized trials by resampling hypothetically more comparable treatment and control groups . . .
The authors say that the “real world effectiveness” of CIH treatments on chronic pain have yet to be investigated by PS methods, thus their choice of methodology. I note that it is possible to investigate “real world effectiveness” of treatments with inadequate randomized trial evidence of effectiveness only because we are dealing with CIH here. In real, or “conventional,” medicine, not knowing whether a treatment works or not normally bars its use and a vast database tracking the use of unproven treatments on patients simply would not exist.
Basically, they carry this out by matching individual patient characteristics, or, in statistics parlance, “covariates,” in the two groups to avoid confounding factors. These included co-morbidities such as hypertension and diabetes, mental health diagnoses like PTSD, substance abuse, and opioid use. When compared head-to-head, without removing potential confounders, CIH recipients scored almost a point higher on pain intensity ratings. Application of various propensity score methods reduced this disparity to about a third of a point and eventually equalized the scores.
(If you want to know more about their methods, you can read the article. Although “the work is written by US Government employees and is in the public domain,” I could find it only in Pain Medicine, which is behind a paywall.)
Thus, contrary to their hypothesis:
we evaluated CIH approaches among >300,000 veterans with musculoskeletal pain over three years and did not find a significant difference in self-rated pain intensity between those receiving and not receiving the approaches. PS-based causal methods were able to balance [confounders between the two groups], yet they failed to “recover” the potential CIH benefit reported from some randomized trials.
In other words, when you use treatments with inadequate, or even negative, clinical trial evidence in the real world they are not magically transformed into effective treatments. Whodathunk?
The authors do admit it’s possible that their results:
may actually reveal the clinical truth that such CIH therapies may not have an overall benefit as expected, [but – wait for it – the inevitable qualifier!] at least as delivered in current practice. Indeed, the effect sizes reported from randomized trials are generally small to moderate, with multiple negative findings.
Of course, as we know, one never says “never” in complementary and integrative medicine research. The authors suggest – you guessed it –
further research is needed.
That’s because, they say, CIH approaches “may be” effective for certain subgroups, or certain types of chronic pain, or patients with “unique characteristics,” or at different doses, or with better matched confounders among patient groups (more than the 35 covariates accounted for in this study, that is), or at different frequencies, or different durations, or without potential misclassifications of CIH exposure, or with different analytical methods, or different study populations.
Given the inadequate evidence for CIH effectiveness for chronic pain and the mounting concern over side effects of chronic opioid treatment, further studies using innovative and rigorous research methodologies and more comprehensive and precise data on CIH “dose,” both randomized and observational data are warranted.
Nope. Don’t buy it. We’ve been waiting for this elusive potential of integrative medicine to reveal itself for over a quarter of a century, and it hasn’t happened yet. Funded in part at taxpayer expense by the CAM cash cows of NCCIH (over $2 billion) and the military (who together funded this study), we know:
- Acupuncture’s proposed mechanism of action is highly implausible. It has already been the subject of thousands of clinical trials and the evidence for its use in treating chronic pain, and anything else for that matter, is unconvincing. It is a theatrical placebo.
- “Chiropractic care” is often subluxation-based diagnosis and treatment and assorted other pseudoscience. Anything beneficial chiropractors do (such as spinal manipulation and mobilization, in appropriate cases) can be done just as well by physical therapists, who practice evidence-based healthcare.
- Massage therapy, while relaxing, is not supported by sufficient evidence (also here) for pain relief and is full of quack practices like reiki, reflexology, polarity therapy and cranial sacral therapy.
Unfortunately, this study is highly unlikely to affect the practices of the firmly entrenched military-integrative complex at the VA, in the form of its Office of Patient Centered Care and Cultural Transformation. Under its auspices, the VA has abandoned even the pretense of requiring evidence of effectiveness and incorporated quack practices like reiki and reflexology into veterans’ healthcare, a move of dubious legality under federal law.
Integrative medicine proponents at the VA are part of a much larger effort to promote the incorporation of pseudoscience into medicine, most recently as a magic bullet for the opioid crisis. Spinning negative trial results into positive PR is an art form in integrative medicine.
In fact, that’s an excellent reason not to waste more money doing studies of CAM: They don’t affect the practice of integrative medicine one bit.