Yet another study promoting acupuncture for chronic pain is being touted, and yet again the study is scientifically essentially worthless. The study is the Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE) protocol conducted at Memorial Sloan Kettering Cancer Center (MSK). MSK is promoting this as the largest clinical trial of its kind, showing that two kinds of acupuncture (electroacupuncture and auricular acupuncture) work for chronic pain following recovery from cancer.
The TLDR version of the critique is that – this study is not placebo controlled. There are three arms to the study: electroacupuncture, auricular acupuncture, and usual care. Evaluators are blinded to group allocation, but the subjects themselves are not blinded in any way. They know they are getting acupuncture, and they know what it is supposed to do. Why would anyone bother to do a large clinical trial with pain as the main outcome that is not properly blinded? The answer is clear when you read the promotion of the study results.
The main outcome of the study was reported pain level at week 12, with the electroacupuncture group reporting 1.9 points lower pain on the 1-10 scale, and auricular acupuncture 1.6 points. Two points on the scale is generally considered to be clinically significant, so this would be generally considered a modest result at best. This is also well within range of what we can see from pure psychological placebo effects. Introduce any novel element into a therapeutic management, and there will be some expectation of benefit. Further, the more invasive the treatment, the greater such placebo effects are – so needles produce more of a placebo effect than pills, and add electrical shocks and you will get a little more placebo effect.
In short, the results of this trial are completely compatible with placebo effects. There is absolutely no justification for concluding that the acupuncture interventions produced any physiological effect on pain. The trial was never designed to demonstrate efficacy. So why do it at all?
This and similar studies are designed for one thing, to promote acupuncture and more broadly Traditional Chinese Medicine, and all of “Integrative” Medicine. This is propaganda, not science.
Ostensibly the study justification was to show non-inferiority of auricular acupuncture to electroacupuncture, which it actually failed to do. The study was therefore not designed to show that either intervention has actual efficacy, just that the former is as good as the latter. But again, the study did not reach this outcome, and so in that sense this is a negative study. But negative studies never get in the way of promoting acupuncture. Despite failure to demonstrate non-inferiority, and the fact that this was not an efficacy study, MSK promotes the study results as “Two Kinds of Acupuncture Can Relieve Pain in Cancer Survivors”.
The MSK promotion, by their Integrative Medicine Service, reveals the strategy. First, they assume that acupuncture works:
Studies have shown that acupuncture can help with pain, fatigue, insomnia, neuropathy, and nausea.
No, actually they haven’t. The myth of acupuncture is built upon studies just like this one – that are not designed to show efficacy, or that have serious methodological problems, or that are negative in their outcomes but promoted as positive anyway. When you finally get to acupuncture studies that are properly blinded and controlled, the results are generally negative. Systematic reviews generally conclude that the evidence is weak but an effect cannot be ruled out, or simply that more rigorous studies are needed. For no indication, however, has acupuncture met the burden of evidence, showing a consistent statistically significant and clinically significant effect under proper blinding conditions.
The research is also contaminated, as this study is, with mixed interventions, like “electroacupuncture”, which is essentially transdermal electrical nerve stimulation. Doing TENS at alleged acupuncture points does not stop it from being TENS – this is deliberately muddying the waters in order to falsely claim a specific effect from acupuncture.
We also know that acupuncture has almost zero plausibility. There is no “map” from the ear to the physiological function of the body. There is no chi or other mysterious force at work. Acupuncture points don’t even exist. There is no consistency among acupuncture trials as to which are the “correct” points to use. There is no relationship between training and outcome. You can clumsily fake your way through an acupuncture treatment, pretending to stick needles in random places, and as long as you are friendly and positive with the patient, you will get the full “acupuncture” effect.
This is all consistent with acupuncture being an elaborate placebo, and nothing else. This study does nothing to change that conclusion.
But it is easy to see how the study is being used. In the MSK promotion, when asked about what he hopes comes from the results, study author Jun Mao said:
I hope these results lead to more insurance coverage for cancer survivors receiving acupuncture.
That is the reason for the study – design a study that does not test efficacy and can only have positive outcomes so that it can be used to promote your brand and lobby for insurance coverage. Acupuncture promoters are also not above exploiting a crisis for this purpose (as David Gorski pointed out here several years ago). The first three words of the abstract are, “The opioid crisis…”
Studies like this one are, in my opinion, unethical. Acupuncture is a disproven hypothesis that should be rejected. But if there are those who still cling to this mythology and wish to study it, the only ethically appropriate studies are ones that ask if acupuncture works and are properly designed to answer that question. This study is not.