Acupuncture or Quackupuncture

Before proceeding on with my critique of Barrett's article on herbs begun in the last post, I want to address the mention made of the same author's quite damning Quackwatch Acupuncture Article. In that article Barrett dismisses not only the current state of acupuncture research but also the philosophical underpinnings of oriental medicine altogether. He references a couple of articles from the Skeptical Inquirer to further buttress his case. One is on pseudoscience in China. It unfairly lumps together all forms of Chinese healing techniques. A more balanced critique from within the profession discusses the effects of the well known historical decline of acupuncture and the effects of that decline. Another is an oft referenced article by an MD named George Ulett. Ulett is actually a proponent of the type of neural stimulation achieved with acupuncture, he just dismisses all traditional theory as useless. However just becuase acupuncture can be practiced effectively without resort to traditional theory, it must be pointed out that studies that show this also show the success of acupuncture when purposely using traditional theory. Wouldn't it be just as true to say such a study proves one does not need modern science to practice acupuncture. Such a studies actually seem to show that both modern science and classical chinese theory are both effective at developing treatment strategies. I think all parties are eventually going to have to come to terms with this repeated finding.

The preliminary results of a large German Acupuncture Study hit the news in Europe last winter. It was a hotly debated topic on a professional forum I moderate as part of the Chinese Herb Academy. The study seemed to show that so-called sham acupuncture was equally effective as "real" acupuncture. Sham acupuncture involves the placement of needles on points that were not traditionally mapped in the "classics". However there are some serious questions about this study.

What are we to make of so-called sham acupuncture. On one hand, acupuncture works, but it doesn't seem to matter where you stick the needles. On the other hand, I assume the patients thought the tx was real. What would happen if you told the patients the experiment was to see if they could bear torture. I wonder if the results would be different. If acupuncture works regardless of points selected, but only if the patient believes they are receiving a therapeutic procedure, we are in a bind. It is illegal to administer placebos and pretend they are therapy. And if we spill the beans on the sham, then it won't work anymore.

The study did not show that acupuncture was ineffective. It worked quite well for most patients. Basic TCM
worked phenomenally. Much better than placebo or glorified relaxation. But sham acupuncture worked just as well in a small cohort of 900 that were examined for this effect. Using a supposedly more sophisticated style of acupuncture would not have changed the fact that sham acupuncture had a very high effectiveness rate. Rather than showing we need a more sophisticated style is necessary to make CM work, this study is being interpreted as showing that it does not matter at all what you do. It works regardless.

--- In chineseherbacademy@yahoogroups.com, "anonymous"
wrote:
> 1) has any investigation shown that greater education (many courses) gives
better clinical results?
>
> 2) IF sham is equal to "real" in double blinded investigations, then we should
look if results in the clinic (non-blinded) are better that blinded.


I think people are missing the point. By western medical standards, the results of this study were phenomenal. It did not show that regular and sham acupuncture both were equally ineffective. It showed they both were amazingly effective. Far more effective than placebo in all cases and even better than WM in others. If one included better educated practitioners (px) or studied real clinical patients, it would be hard to get better results than those already reported. But even if that was the case, it would still not negate the significant results that came from sham acupuncture. It would only show that trained acupuncturists could do a little better in the clinic than newbies involved in research. But if you think about it, that is a given in medicine. Individuals in a clinic can always do better than the controlled research. Clinic maximizes placebo effects. However research equalizes and averages differences in skill and training and intellect. It tells you what the average patient with the average px can expect. And remember if some px fall above the average, just as many fall below.

--- In chineseherbacademy@yahoogroups.com, "anonymous"
wrote: This is because we cannnot be certain (in advance) that the "Non-Active" points really
> are that. As many on the lists have said, any stimulus anywhere
> on the body can have some effects.

The fact that the results of either sham or regular acupuncture are far better than placebo proves that something "active" is going on in either case. It never occurred to me that this is merely the same as the placebo effect. but I
think you missed the point of my concern. It is not that sham points are inactive. I agree with you that this is a misleading terms. However, if one can get not only decent, but excellent, effects regardless of where one places
the points, then it does suggest that that traditional theory does not matter in this process.

One would still need to needle the patient, so some training in anatomy and technique and medicine in general are still necessary for this process. It could not be performed by a monkey. However, it is interesting to hear about non-insertion needling at the same time as we discuss this study. I would assume that non-insertion needling would be considered a sham approach to stimulating the points by most medical researchers. But it maybe is the case that all such approaches are "active"; it just does not matter which one you choose. The sham acupuncture must have been done by those who knew they were performing a sham, while regular acupuncture was done by believers. This should have skewed the results even more in favor of regular acupuncture. The fact that sham did just as well under these conditions suugests that the action is much more than placebo.

I do also consider placebo to be a true physiological response. If the physiology changes, it is real. Under controlled circumstances, placebo is low (30%) but jumps to as high as 90% for some conditions in a private clinic. It is no doubt the care of the doctor that also heals. So how much education is necessary to practice medicine and who gets to do it? Medicine is major financial drain on our society and if much of it can be performed with LESS training, than we should be thankful and move on.

--- In chineseherbacademy@yahoogroups.com, "anonymous" <> wrote:
"Patients were allocated at random to one of three treatment groups:
> real acupuncture plus standard medical care; sham acupuncture
> (needles were simply stuck into non-acupuncture points) plus standard
> medical care; or standard medical care alone."
Seems that 'standard medical care' should be consider part of the
> equation.

How does this change the results? One way to balance variables in a study is to include the normal mode of treatment for each group. Standard treatment has powerful placebo effects because it is the cultural norm. If standard treatment is not given to each group, then it may appear that standard treatment (tx) is far more effective than alternative tx. this study shows how much better people do with sham or real vs. no acu at all. are you suggesting that the standard care somehow affected the sham group differently than the real group? In addition, I assume standard care meant things like antiinflammatories, exercise and traction, which I would expect all our patients to be doing anyway. so this may be realisic since most patients seek out either WM care or both WM and CAM. very few (4% according to a harvard study) use only CAM .

"So do the German mega-studies suggest effectiveness or ineffectiveness? Apparently, there is less room for interpretation than one might think. One of the German investigators, Professor H J Trampisch from Bochum University, recently provided the answer. When asked whether these results demonstrate the success of acupuncture his response was decisive: "No, this cannot be. In our studies, we clearly determined that acupuncture will be deemed effective only if it is significantly superior to sham acupuncture. If this is true, the
biggest trials in the history of acupuncture might be the beginning of the end of this therapy."

We need to either do better or prove the studies flawed when they are finally published. If it turns out that doing certain styles of acupuncture can reliably give results more on the order of 95% or better for some complaint, then we may have a case. At least if the medical acupuncture fails, they would know where to refer. But we have to reconcile to the fact that europe is a socialist union and decisions about things like acupuncture are going to be made on a centralized cost benefit analysis. Canada and australia and new zealand will follow suit. Even more american insurers and workers comp will drop acupuncture services from coverage. The clock is ticking. Research or politics. We especially need herbal research as this is where are bound to have great success and thus preserve some foothold.

Basically I figure there are two groups of people. those who are waiting for evidence before they use or refer for acupuncture (that would be the 97% of the population that does not currently use acu). And the other 3% who out of either desperation or philosophy have chosen to give acupuncture a try. However, of the latter group, only the diehard believers are likely to keep coming when the evidence suggests the procedure is a sham. I would submit that this group of true believers is minute. The fact is that we have been sitting with heads in the sand again. We have assumed that our personal anecdotes and clinical experience would be enough to prove to our patients that acupuncture worked. We have spent a decade making arguments why we don't need to do research, why it doesn't apply to us, why its not fair to judge us on this standard, as if western culture was just going to disappear. I think our patient support, such as it is, is quite flimsy in reality. I think we have been given the benefit of the doubt by some in the absence of evidence to the contrary. It has been suggested that all we need to do to keep progressing is to keep parading our happy patients in front of legislators.

Once upon a time a lot of happy patients and docs loved a procedure called mammary artery ligation. It was the main procedure for angina in the fifties. Everyone thought it was highly successful. However a carefully designed
study proved that a sham operation that merely left a shallow scar without actually opening the chest and ligating the artery was actually more effective than the procedure itself. Doctors and patients screamed bloody murder, but in a few years, the procedure had all but disappered and was never heard from again. Pay attention to politics. The memory of the public is short and flawed. Put on the news that acupuncture is a sham and in a few years, most folks who got relief from needles will be claiming it was all in their heads. It also makes me wonder what kind of lawsuits this open for the huge number of patients who have spent a lot of money on acupuncture without success, especially if the px made any claims of success rates prior to treatment. For example, many peole put the WHO conditions apporved for acupuncture on their literature. This could easily be called a false advertising claim as none of these claims hs any proof to back it up.

fMRI's show that some acupuncture points affect specific brain areas and nearby sham points do not. This is reported by Kaptchuk in the Annals of internal medicine in 2002. He also reports and cites that the impossibility of blinding the acupuncturist plus other factors results in acupuncture studies exhibiting a high placebo effect which may make it impossible to distinguish between sham and actual intervention. Given that normal placebo rates are 30% and that sham points may cause some generalized endorphin response on top of this and that failure to blind the px results in another increment of placebo, it is easy to see how even sham acupuncture would have pretty good results. However it has been physiologically proven that acupuncture has specific CNS effects, so there is something more than sham going on. Its just hard to detect due to study control issues.

Nevertheless, the fact remains that good results can be had with minimal training, it would seem. Whether we like it or not, it is up to us to to prove we can do better. I think there are ways to design studies that address these issue without resorting to the cop-out that this method does not work for acupuncture. That attitude will just result in losing everything the profession has gained. After reading Kapchuk and looking at his other citations, I think the German researchers were not careful enough to address certain key issues. Their studies are flawed and thus can be contested.

There are some excellent points to consider about sham acupuncture and the nature of a "control". This so-called control is not really a control at all. On the other hand, the mere fact that the "sham" group does so well is still troubling. Whatever it reveals about the flaws in the study design, it also demonstrates that effective acupuncture can be performed with total disregard for traditional theory, point location and selection. So it may not technically be a sham, but the result is still troubling to me.

Outcomes studies are not adequate to demonstrate the cost effectiveness of a therapy. While you might be able to argue that an outcomes study shows that acupuncture in a normal clinical setting is an effective procedure for a wide range of complaints, that is not the sole variable in determining the viability of a therapy. While some doctors are rejecting the current HMO system and going back to cash based practices, it is pure fantasy to think
this trend will rapidly overwhelm the current status quo. 40,000,000 americans are uninsured and can't afford insurance, much less out of pocket care. Another group that size is on medicare or medicaid. Much of Europe
uses socialized medicine and that is actually why this study was undertaken - to determine if the German government would continue paying for acupuncture services. When it comes to a purely market based medicine, all that matters is outcomes. And because of this, some patients will continue to pay for acupuncture out of pocket because they prefer it to the fully covered alternatives. However when it comes to medicare, worker's comp, insurance, HMO's, etc., cost must go hand in hand with effectiveness.

On this level, it would seem to me that if you can train people to do "sham" or some form of minimal medical acupuncture in just a two year associate degree instead of 2-4 years undergrad plus 4 years masters that the savings to the healthcare system would be immense. With students making so minimal an investment in their careers, they could not expect to make more than $20 per hour, which would dramatically lower the cost of the service to patients and so on. With these issues in mind,I do not believe the decisonmakers will ever accept pure outcomes research. So I propose two other options. One is to compare acupuncture to standard therapies. Such a study could equalize some confounding variables regarding blinding by making each group (WM and CM) equally "unblinded". Rather than sorting out dr./pt. interaction and belief and intention, just try to make sure
these are pretty much the same in each group. Now such a study won't show what each therapy does all by it lonesome, but you should be able to compare the differences in each group after adding a sole variable, such as acumoxa vs. physical therapy. It then wouldn't matter if there was a sham or not. If acumoxa did better than an already covered service, logic would dictate it now be covered.

In addition, all future research should address the fMRI issue. You can't say the sham is the same as the real point when they have different effects on brain function. But we still may be left with the nagging fact that shamupuncture works. And this will no doubt bolster the cases of those who want acupuncture to be practiced by nurses and Physical Therapists. However it is not too soon to consider whether we should be devoting our resources to battles we cannot win. I have never felt it was worth fighting over the issue of who can insert needles into the body. I think now more than ever it is a losing cause to try and block MDs and lower tiers of the profession from doing medical acupuncture. We really need to somehow prove what we do works better and is more cost effective than alternatives. Because I see no reason for authorities to listen to us when we demand control of our turf, yet have no evidence to prove why we should be in charge. And other evidence does exist to challenge our very premise, that one must be expertly versed in chinese medicine in order to practice acupuncture.

--- In chineseherbacademy@yahoogroups.com, anonymous wrote:
And you are ready to throw out thousands of years of medical theory over this one study? To me your position is more than needlessly alarmist, in short, it lacks wisdom."

I think there are serious problems with this study and it is incumbent upon us to show the flaws in design and prove that a proper study will yield different results. I am troubled not only by this sham result, but dozens of other smaller studies that show the same thing. This is not one study negating thousands of years of theory. It is a recurring trend in acupuncture research that cannot be denied. I have offered ideas about more valid research and also the use of MRI's to prove the so-called sham is not the same as so-called real acupuncture. As for thousands of years of theory, I have made my position clear in past writings. Just because someone said it don't make it true. Paul Unschuld has clearly demonstrated that many chinese medical ideas served cultural needs and did not survive just due to medical efficacy (PDF). In other words, belief and bias was a big deal throughout all of Chinese Medical history. It is naive to assume that all Chinese ideas are efficacious or will translate effectively to a radically different culture. I categorically reject that we must have some faith in our tradition. We must have evidence pure and simple.

Longtime readers will realize that my tone is much less conciliatory than it used to be. I often advised people to settle down on these issues. But anyone who thinks a study of 500,000 people to be released in a few years is not a matter for alarm does not view time the way I do. A study of that size will overwhelm most other studies which have all largely been dismissed due to poor design and small sample rates. The only thing the NIH says has been proven about acupuncture is its use in nausea. There are literally a handful of so-so studies and the rest were rejected. Everything else "needs more research".

So there really is no true counterweight to this German study. This one study could dramatically impact lawmakers and insurers. The lead German researcher suggests the preliminary results point to eliminating acupunctue from the national healthcare service. This has certainly alarmed German patients. 4 years is right around the corner if we want to head off these guys at the pass, rather than try and play damage control after the fact. It will take us at least four years to get our own studies underway and producing enough preliminary results of our own to counter the German report when it comes out. What some call an alarmist lack of wisdom, I call strategic planning. It is certainly correct that the true believers will not support a guy who begins with skepticism rather than faith, but I am pretty sure mainstream decisionmakers are more interested in a skeptic doing research than a true believer.