That Pain Reprocessing Therapy study is way too good to be true
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Today, for a change of pace, I will review a scientific paper without saying much about the science itself.
Ashar et al is a paper in a good journal, JAMA Psychiatry, about a study with an impressively positive result for “Pain Reprocessing Therapy” for low back pain.1 This is a psychological treatment based on the big claim that back pain is powered by the mind, and can be relieved by changing your mind: “substantial and durable relief” just from a “shifting” patient “beliefs about the causes and threat value of pain.”
The results aren’t just good, they’re great, they’re bloody amazing — far better than we have come to expect for any kind of treatment for any kind of serious chronic pain, let alone a psychological therapy.
The results are clearly too good. I urge you not to take these results at face value. Even if the results are real, the interpretation is highly suspect, and it’s probably not what it looks like.
The conflict-of-interest elephant in the room
Normally when I write about a study, I dig into the actual science, but today I am going to skip over the details of the experiment and go straight to the only thing that really matters here: the startlingly substantial and numerous conflicts of interest, all dutifully disclosed by the authors (as no doubt required by the journal), and yet seriously under-reported by virtually everyone else.
Many people badly want this study to be copacetic. Hell, I do too! But not so much that I can “see no evil.”
This clinical trial was conducted and reported by authors who stand to benefit greatly from its absurdly positive result. A paper like this is a valuable and profitable win for mind body medicine in general, and for PRT in particular! Ka and ching!
It so it doesn’t really matter what flaws this paper does or not seem to have (and remember that stronger biases tend to conceal flaws). The only way anyone should ever trust this result is when it has been replicated by researchers without quite so much skin in the game.
COI is an over-rated sin in science
So there’s a conflict of interest — so what? Historically, the worst science has often been funded by people with a strong stake in the results.
But it’s not always a deal-breaker. The same bias that can corrupt science often comes from the same enthusiasm needed to pay for it in the first place! It’s not reasonable to expect science to only ever be done by people without any skin in the game. Dispassionate objectivity in science is largely a myth. (Journalism too, by the way.)
So it’s a pet peeve of mine that some skeptics use the slightest whiff of COI to dismiss studies. Knee jerk COI condemnation isn’t “skeptical,” it’s just sloppy cynicism.
The severity of a COI has to be evaluated on a case-by-case basis. So let’s evaluate this case…
The COI dramatis personae
Author Alan Gordon “developed Pain Reprocessing Therapy (PRT), a cutting-edge protocol for treating chronic pain,” and promotes that brand on the website PainReprocessingTherapy.com. Obviously he can profit substantially from this study, and it is in fact being used to sell PRT: the website claims that the study “validated Pain Reprocessing Therapy as the most effective current treatment for chronic pain.”2
Author Dr. Howard Schubiner is famous for his research and books about the power of the mind, such as Unlearn Your Pain. Spend a couple minutes browsing UnlearnYourPain.com, and it’s clear that Schubiner has a “brand” and that it’s star surely rises higher with any science that seems to support any mind-over-pain claim.
And there’s more!3 But I’ve made my point: Schubiner’s presence alone would be enough to raise major concerns about the risk of bias here, and Gordon just clinches it, and the others are just COI gravy.
Once more with feeling: even COIs this glaring do not mean the study is wrong. But it does mean we must reserve judgement. (Probably for a long time.)
Historical context: all this has happened before, and all this will happen again
Mind body medicine has a long shameful history of excessive and premature claims. Many of the most prominent quackeries of all time have been fuelled by the fervent human desire to believe in the power of the mind. A claim like “you can cure your pain by changing your attitude” is nearly impossible to stop — it sells itself, because we so badly want it to be true. It is the perfect soil in which to plant seeds of neurological truth, to fertilize them with book sales and TED talks … and scientific papers. And those seeds have been turning into commercial empires for decades.
Minor variations on this claim have been tested ad nauseam, but have yet to demonstrate any kind of reliable healing power of the mind. What are the odds that this new candidate is what we’ve all been hoping for? I wouldn’t bet on it.
Maybe PRT works. But this study alone cannot possibly do the job of showing that it does. Even if it was perfect. Which it ain’t.
Okay, maybe just one thing about the actual science
There is one notable flaw in the study I cannot resist highlighting: the control groups are kind of terrible. They can’t really “control” anything.
Ashar et al. told the people in the placebo group that the injections were saline solution, so … yeah, not actually a placebo control there.4
And the usual-care group had the same problem they always do: you can do literally anything to people that’s “unusual,” and it will probably outperform “usual,” and that doesn’t mean it’s effective. Dr. Edzard Ernst called this design “unethical pseudo-science.”5
- Ashar YK, Gordon A, Schubiner H, et al. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 01;79(1):13–23. PubMed 34586357 ❐ PainSci Bibliography 51974 ❐
- Notice the over-reaching! Even if the study was perfect, it was just a study of PRT for “back pain” not all “chronic pain”! You see this routinely with trials that get cited to sell: the results are exaggerated and distorted at every level. You start with p-hacking of the raw data. That compromised data then often gets described as something a bit more impressive in the “discussion” section of the paper, e.g. saying that the results show a “trend” instead of just being “statistically insignificant,” a notoriously common way to make scientific lemonade out of data lemons. Another layer of hyperbole is usually added in the abstract, which, like a movie trailer, makes the whole thing sound better than it actually is. Then there’s the press release and all the copy-paste journalism, which is where things really start to go off the rails. But the greatest exaggerations always come from the people citing the paper to help sell their wares, and this is a perfect example. There’s no way in hell that “most effective current treatment for chronic pain” would have made it past JAMA Psychiatry reviewers.
Curiously, the full conflict of interest disclosure is included in the JAMA Pyschiatry version, but not the PubMed Central version. Seems like a major omission in this case:
Conflict of Interest Disclosures: Dr Ashar reports grants from the National Institutes of Health during the conduct of the study and personal fees from UnitedHealth Group, Lin Health, Inc, Pain Reprocessing Therapy Center, Inc, and Mental Health Partners of Boulder County outside the submitted work. Mr Gordon is a consultant with UnitedHealth Group, director of the Pain Psychology Center and the Pain Reprocessing Therapy Center, and is the author of the book The Way Out. Dr Schubiner is the co-owner of Freedom From Chronic Pain, Inc, earns book royalties for Unlearn Your Pain, Unlearn Your Anxiety and Depression and Hidden From View; serves as a consultant with UnitedHealth Group, Karuna Labs, and Curable Health; and receives personal fees from OVID Dx outside the submitted work. Mrs Uipi serves as a consultant for UnitedHealth Group. Dr Dimidjian reports being a co-founder of Mindful Noggin, Inc, and received royalties from Guilford Press and Wolters Kluwer as well as funding from The National Institutes of Health. Dr Lumley reports personal fees from CognifiSense, Inc, outside the submitted work. Dr Wager reports grants from the National Institutes of Health and the Foundation for the Study of the Therapeutic Encounter, and funding to support trainees from the Radiological Society of North America and the German Research Foundation; he is on the Scientific Advisory Board of Curable Health. No other disclosures were reported.
- Presumably to compensate for that obvious sabotage of the placebo group, they also told them that placebo is powerful. There was a method to this madness: they were clearly leveraging the (extremely dubious) claim that you can still get a placebo effect as long as you “sell” it (see “open-label placebo”). But even if that works, all it achieves here is confounding the study with a huge methodological curve ball.
- Ernst E, Smith K. More Harm than Good? The Moral Maze of Complementary and Alternative Medicine. 1st ed. 2018 ed. Springer International Publishing; 2018. p. 76.
Ernst and Smith regarding another study, which by happy coincidence is an extremely similar one, Cherkin, with the same flawed design (and which I have also strongly criticized):
In other words, this is yet another trial with the “A + B versus B” design. As with our other examples, because A + B is always more than B (even if A is just a placebo), this study design could never have generated a negative result! The results are therefore entirely compatible with the notion that the two tested treatments, MSBR and CBT, are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.
The “A + B versus B” design can only produce positive findings. Any such study allegedly testing the effectiveness of therapy XY and concluding that “it is effective” ought to be categorised as unethical pseudo-science.