Those who cannot remember the past are condemned to repeat it.
- George Santayana
Most people don’t have that willingness to break bad habits. They have a lot of excuses and they continue to produce bad clinical studies.
- Carlos Santana (Well, not the last 4 words.)
One is a guitar player, one is a philosopher. I get them confused.
I think George was in charge of SCAM research at the NIH. It was Dr. Gorski who first used the term Whac-a-Mole to describe what we do. The same badly-done studies are done over and over and misrepresented over and over, with only very minor variations on a theme. This is especially true of acupuncture, the most extensively studied pseudo-medicine in search of something, anything, for which it might be effective. They are still searching.
I loved going mano-a-mano with my kids when they were younger on the Whac-a-Mole machine in the Seaside arcade followed by root beer and elephant ears. It was the last time I beat either of them at any athletic endeavor. So I enjoy Whac-a-Mole, with mechanical rodents or bad research.
It sometime appears that pseudo-medicine researchers try and apply as many of the criteria to their research as possible that Ioannidis identified as rendering a clinical trial suspect.
- Small sample size? Check.
- High dropout rate? Check.
- Bad statistics? Check.
- Inadequate blinding? Check.
- Small effect size? Check.
- Underlying prejudice/bias in favor of an intervention? Check.
- Totally improbable intervention? Check.
Take the BMJ article, “Randomised clinical trial of five ear acupuncture points for the treatment of overweight people”. Please. It applies to this study where ear acupuncture was used as an adjunct to weight loss and found to be effective, only if you lend credence to terribly done clinical trials. Almost every error that could occur in a study, did occur.
Ear acupuncture has an origin story on par with chiropractic or iridology:
Auricular acupuncture therapy is based on the understanding [I do not think it means what you think it means - Ed.] that the external ear represents all parts of the human body, including the internal organs, and provides acupuncture points corresponding to these parts. Auricular acupuncture therapy was discovered by Dr Paul Nogier based on observations that backaches were cured after the patient received a burn on their ear. Dr Nogier pictured an auricle as a fetus that was curled up and upside down; he used his anatomical knowledge to treat diseases by applying pressure to the reaction points that represent the internal organs.
The mind boggles over the inanities that are pseudo-medicine origins. At least they could try and blame cosmic rays. or a radioactive spider (I am DC at heart, Marvel origins are lame. I suppose that will get more discussion than the entry).
Being completely disconnected with reality never stops a pseudo-medical study. Patients received five-point ear acupuncture, one-point ear acupuncture or sham acupuncture for eight weeks:
Treatment I subjects received unilateral acupuncture with indwelling needles at five ear acupuncture points (Shen-men, Stomach, Spleen, Hunger, Endocrine), which are generally used in Korean clinical treatments (see online supplementary figure S1).19 20 Treatment II subjects received an indwelling needle unilaterally at the Hunger acupuncture point only, whose specificity has been reported.19 Treatment groups received acupuncture in one ear on the first visit. One week later, the applied needles were removed and the same treatment was performed on their other ear. The needles used for the treatment groups were tack-like, 0.2×2 (head diameter×point length) mm-sized Dong Bang acupuncture needles. The heads of tack-like needles are fixed on surgical tape so that when the steel points are inserted, the needles remain attached to the skin (Suwon, Korea). The depth of insertion was 2 mm.
The control group received sham acupuncture at the five ear acupuncture points used in treatment I group at their first visit. The needles used for the control group were fixed on surgical tape, but were removed immediately after insertion (2 mm), while the surgical tape remained on the acupuncture points
I suspect that there was such a high drop out in the sham treatment as because they knew they were not getting acupuncture. As the study notes:
we did not test the blinding of the control group; participants in this group might have examined the adhesive dressings in their ears and found no needles.
A lousy placebo renders an already silly and poorly done trial completely meaningless, like most of the acupuncture trials.
Given that “A single doctor of traditional Korean medicine performed all treatments”, it is highly likely that the Clever Hans effect was taking place: subtle clues that suggested who was getting placebo.
Another flaw was while “Compliance with diet and exercise regimen was recorded by the patients and checked weekly at the clinic”, the results were not reported in the study and the main reason people dropped out was issues with following the dietary restrictions.
So while those in the treatment groups lost more weight than the sham group, there are so many flaws in the study that it would be impossible draw valid conclusions. Like almost all acupuncture studies.
My favorite part of the study was the fifth inclusion criteria: “Hygienic individuals”. At least they were clean, which is a good thing. I have seen one patient lose an ear from a piercing and infections are reported with ear acupuncture. Watching the sterile technique demonstration helps me understand why Dr. Oz had a volunteer rather than trying it himself.
But the real reason this trial is not valid is that Korean ear acupuncture is not real acupuncture. Real acupuncture is traditional Chinese. Or Japanese. No wait, hand acupuncture. Or foot acupuncture. No, it’s tongue acupuncture that is the real deal. That’s the ticket. Or perhaps it’s the Micro Acupuncture Point System. So many acupunctures, so little reality.
Compare this to a study with better methodologies: “Patient-Reported Outcomes in Women With Breast Cancer Enrolled in a Dual-Center, Double-Blind, Randomized Controlled Trial Assessing the Effect of Acupuncture in Reducing Aromatase Inhibitor-Induced Musculoskeletal Symptoms.”
This study worked hard to blind patients as to treatment arm:
Although the acupuncturists were not blinded to the assignment, in an effort to minimize the introduction of bias, the acupuncturists followed a prepared script when engaging in conversation with the participants. All other individuals involved in the care of participants were blinded, including the treating oncologist(s), nurses, and study team members. The participants also were blinded to their treatment assignment….Patients in the SA group received nonpenetrating, retractable needles placed in 14 sham acupoints located at the midpoint of the line connecting 2 real acupoints.
The endpoints are patient-reported symptoms, so one could predict the outcome before it happens. Any SCAM compared to a good placebo (i.e. the patient cannot tell it is placebo) will always be equivalent for any outcome that is subjective and better than no treatment. That result was best typified in the NEJM article comparing various fake treatments for asthma. No effect will be seen if the endpoint is objective. All pseudo-medical interventions are like kissing a skinned knee in a child – comforting but with no important physical effects.
Same as it ever was, fake and real acupuncture were equivalent in relieving symptoms. So abandon acupuncture, right? Especially since it is clear that acupuncture has as much basis in reality as the four humor theory of disease. Except for acupuncture based on auricular thermal injury.
I am a classicist. I have what would be the standard, perhaps Copenhagen, interpretation of clinical trials. If a therapy is compared to placebo and they are found to be equivalent, then the therapy does not work and should be abandoned.
There was a recent article in the NEJM where they evaluated patients with “knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis” and treated them with either arthroscopic partial meniscectomy or sham surgery. There was no difference in outcomes and they concluded:
…the results of this randomized, sham-controlled trial show that arthroscopic partial medial meniscectomy provides no significant benefit over sham surgery in patients with a degenerative meniscal tear and no knee osteoarthritis. These results argue against the current practice of performing arthroscopic partial meniscectomy in patients with a degenerative meniscal tear.
Nowhere could I find a review of the article that suggested that arthroscopic surgery worked if only you believe. It is an annoying interpretation of SCAM interventions, that since the outcomes are equivalent to placebo, you are getting an effect from the power of placebo. An example is from the Science 2.0 website:
Sometimes you just have to believe.
Acupuncture has proven to be effective, though it isn’t actually being done. When it comes to hot flashes due to breast cancer treatment, even skin pricks used to simulate acupuncture needle sticks might be enough to generate natural chemicals that improve symptoms, which would explain the results.
I’m sure that pharmaceutical companies would love that standard: if a drug is equal to placebo then use it: then you just have to believe. I remember the immortal words of B. Bunny: “What a Maroon.” I know, innuendo. Somehow rational thought flies out the door when pseudo-medicines comes innuendo.
Regular readers of my entries know my take on the preponderance of the literature as to the nature of the placebo effect: it is mostly a myth. Placebo is medical beer goggles, making diseases appear better when they are not. As I have mentioned in the past, SCAM = Placebo. Placebo = Nothing. Therefore SCAM = Nothing. Simple logic, n’est pas?
Acupuncture is like all pseudo-medicines: it only appears effective in flawed studies. As the methodologies improve, the efficacy fades until well done studies show no effect greater than placebo, aka no effect.