Mar 25 2011
Here we go again. What if I said to you that drug X and a placebo of drug X (i.e. a placebo) worked better for the relief of a subjective symptom than no treatment, but no different from each other? I conclude from this that the “drug cohort” (whether the real drug or the placebo of the drug) did better than the no-treatment control group. This may mean that the drug works through a general care effect and patient expectancy.
Let’s say, rather, that a pharmaceutical rep were saying this about their latest drug. It would be obvious that the drug company decided to use some Orwellian new speak in order to contrive a sentence in which they get to say that their drug works (by a general care effect). And in order to obscure the fact that their drug worked no better than placebo, they refer to both the drug and the placebo as the “drug cohort” and compare them both to a no-treatment group. The “drug cohort” had an effect.
In the real world of scientific medicine (not the bizarro world of CAM), when a treatment works no better than the placebo control we conclude that – the treatment does not work. Looking past all the obvious spin above, a more honest conclusion would simply be – drug X does not work for the tested symptom. Period. There is no “drug cohort”, and you don’t have to confuse the reader by calling placebo effects a “general care effect” or “expectation.” These are placebo effects.
Acupuncture still exists in the CAM bizarro world, and has not crossed over to the real world of scientific medicine. This is because, in my opinion, acupuncture does not actually work. It is not based upon any legitimate principles of physiology or anatomy, its underlying theories are mostly pre-scientific superstitions, and proponents cannot demonstrate in controlled clinical trials that it is more effective than placebo.
In the past, before the world collectively lost its mind, when a treatment consistently failed to demonstrate any plausible mechanism and any effect greater than placebo in clinical trials, eventually it would be discarded as a dead end – a failed hypothesis. But today treatments that fail to demonstrate any basis in reality or any clinical effect happily live on in the world of complementary and alternative medicine (CAM).
In the CAM world, rather than adjusting beliefs to the evidence, proponents adjust their approach to and interpretation of the evidence in order to accommodate their beliefs. For example, I wrote two days ago on Science-Based Medicine about Dr. Tonelli, who wrote:
Orthodox medicine should consider abandoning demands that CAM become evidence-based, at least as “evidence” is currently narrowly defined, but insist instead upon a more complete and coherent description and defense of the alternative epistemic methods and tools of these disciplines.
Let’s see how a recent acupuncture study avoids the “trap” of “narrowly” defining evidence (meaning defining evidence as actual evidence for efficacy).
Just published in PLoS One is an article comparing verum acupuncture (where needles are inserted into alleged acupuncture points) to sham acupuncture (in this case, fake needles were not inserted, just pressed against the skin, and not at the alleged proper acupuncture points) in the treatment of radiation-induced nausea in cancer patients. These two treatment groups were compared to a no-intervention group (usual care).
This is a reasonable trial design. It controls for the two main variables of acupuncture: needle insertion, and the existence of alleged acupuncture points. And it included a third usual care group.
The results of the study are fairly clear – there was absolutely no difference between the verum acupuncture and sham acupuncture groups (who had 7% and 6% nausea respectively). Both groups experience less nausea than the standard care group, at 15%.
In the real world, the interpretation of this result is very straightforward. Acupuncture does not work for radiation-induced nausea – it showed no difference between acupuncture and placebo acupuncture. Of course both groups showed improved over the standard care group – and the study even documents why. Those subject receiving acupuncture, whether real or sham, had an expectation of benefit. Those receiving standard care did not have an expectation of benefit. Therefore any measured difference between these groups is due to the usual placebo effects that we control for in clinical trials.
Expectation can lead to not only a perceived decrease in symptoms, but decreased reporting of symptoms. Patients who think they are getting the treatment know they are expected to report an improvement, and so some will. Patients who are expecting a benefit may also have an elevated mood or decreased anxiety and this will affect their perception of their symptoms. The same is true of the attention from the caregiver – it may increase mood and reduce anxiety.
These effects are part of what we collectively call placebo effect, and is precisely why we do placebo-controlled trials when trying to figure out if an intervention has specific efficacy. We know there will be a measured benefit from the ritual of patient care – that is the baseline. And we know this effect is enhanced by various factors, such as expectation, the introduction of a novel element into patient care, and any type of physical contact.
If all we see in clinical trials are these kinds of non-specific placebo effects, then we conclude that the treatment itself has no physiological effect – i.e. it does not work.
It is remarkable that PLoS One allowed this study past peer-review with the conclusions as stated.
Patients treated with verum or sham acupuncture experienced less nausea and vomiting compared to patients receiving standard care, possibly through a general care effect or due to the high level of patient expectancy.
This kind of spin is highly deceptive, and is a failure of the peer-review process in this and similar cases. But it seems to becoming standard fare for CAM modalities – the double standard is in full effect.
Worse than the report itself is the press release, which boldly claims, “Acupuncture is Equally Effective with Simulated Needles.” This is spin that would make the most cold-hearted industry marketers blush or make P.T. Barnum proud. But it gets worse. In the body of the press release they quote:
“It’s important to remember that the effects of the treatment are valuable to the patients, even if they can be said to have been caused by unspecific factors, such as the manner in which the patients were taken care of and their positive expectations,” says Dr Enblom. “So our next step is to study which part of the acupuncture procedure actually are of importance, to make possible the use of those components to further increase quality of care.”
Let me paraphrase – our study shows nothing else than the fact that acupuncture does not work for radiation-induced nausea. But we are desperate not to admit that and to hide that inconvenient fact with confusing statements about placebo effects. Even better – we are actually going to try to justify further research into acupuncture by stating that we need to study the very placebo effects that show that acupuncture does not work.
Dr. Enblom wonders which components of acupuncture are producing the perceived benefit. I will give her a clue – it’s not the acupuncture component. Yet again we see evidence that it does not matter where you stick the needles, or even if you stick the needles (in other words, do actual acupuncture). All that matter is that you give the patient positive attention. Acupuncture is therefore nothing than a worthless (and not entirely safe) superstitious ritual that is being wrapped around good bedside manner, and then trying to take credit for the nonspecific benefits of the good bedside manner.
In a way it’s brilliant (in an evil deceptive way, that is). I have to admire it, like the way you admire Hannibal Lecter. They actually got away with showing acupuncture does not work, and then stating in the conclusions of a peer-review article that the treatment worked. Then in their press release calling for more research to show how it worked – when the answer is already in front of them. It didn’t work, there were only non-specific placebo effects.
Acupuncture = fail
Orwellian newspeak CAM marketing = another (regrettable) win
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