Yawn...another overhyped acupuncture study

Blogging on Peer-Reviewed ResearchNever let it be said that Orac doesn't give the people what they want.

Well, most of the time, anyway.

What I'm referring to is a recent German study about acupuncture for low back pain that's been making its way around the media. I had actually been planning on commenting about it yesterday, but Iranian President (and Holocaust denier) Mahmoud Ahmadinejad's speech at Columbia University intervened and took me on one of my occasional diversions away from science and medicine into the history of the Holocaust, Holocaust denial, and politics. In just that two day interval, I've been deluged with e-mail about this particular study (well, I did get several, anyway), making me think that I'd better answer the call and give my readers what they want.

What's most annoying about this study is not so much the study itself but rather how it's being represented. For example, look at these headlines:

Not surprisingly, these stories completely miss the point.

For example, here's what the BBC (which really should know better) says:

Acupuncture - real or sham - is more effective at treating back pain than conventional therapies, research suggests.

A German team found almost half the patients treated with acupuncture felt pain relief.

But the Archives of Internal Medicine study also suggests fake acupuncture works nearly as well as the real thing.

In contrast, only about a quarter who received drugs and other Western therapies felt better.

The researchers, from the Ruhr University Bochum, say their findings suggest that the body may react positively to any thin needle prick - or that acupuncture may simply trigger a placebo effect.

One theory is that pain messages to the brain can be blocked by competing stimuli.

Researcher Dr Heinz Endres said: "Acupuncture represents a highly promising and effective treatment option for chronic back pain.

Here's what MedPage Today (which really, really should know better) said:

BOCHUM, Germany, Sept. 24 -- Acupuncture offers an effective alternative to conventional therapy for low-back pain, investigators here reported.

Almost twice as many patients responded to acupuncture versus conventional therapy, Heinz G. Endres, M.D., of Ruhr-University Bochum, and colleagues, reported in the Sept. 24 issue of Archives of Internal Medicine.

However, sham acupuncture worked just as well as verum, or true, acupuncture, they reported.

"Acupuncture constitutes a strong alternative to multimodal conventional therapy," the authors concluded. "Acupuncture gives physicians a promising and effective treatment option for chronic low-back pain, with few adverse effects or contraindications."

Notice how both articles completely gloss over a key observation: That "sham" acupuncture was seemingly just as effective as "real" acupuncture. Why is this important? Remember that acupuncture as a discipline claims that the insertion of needles in specific points in the body can relieve pain and have therapeutic effect. These points on the body are known as "meridians" and placing needles into these meridians is claimed to "unblock" or restore the "flow" of qi or the "life force." Never mind that there is no anatomic or physiologic basis for meridians, nor can ;em>qi be detected or measured, much less any change in the flow of qi due to sticking thin needles into specific points on the skin. "Sham" acupuncture, which, as I've discussed before, is an absolutely necessary control in any serious clinical trials to test acupuncture, is the placement of needles in locations other than the correct meridians.

So why is this key observation that sham acupuncture is as effective as acupuncture? Simple! The fact that it doesn't matter where the needles are placed is clear evidence that the entire "theoretical" underpinning of traditional Chinese medicine underlying acupuncture is a load of fetid dingo's kidneys. If it doesn't matter where needles are placed, then, as expected, meridians have no anatomical or physiological meaning. As Ben Goldacre put it:

But even more interestingly, the pretend acupuncture group, where they just bunged needles in any old place with a bit of ceremony, did just as well as the people having proper, posh, theatrical, genuine acupuncture.

In other words, if sticking needles into the skin has any effect on low back pain, it is not due to any magic--like qi. It has to be due to a physiological mechanism that good, old-fashioned, materialistic reductionist science can work out if given sufficient time and resources. In fact, it seems inappropriate even to call this acupuncture, because it doesn't at all depend on the traditional Chinese medicine concepts that underlie acupuncture. Of course, only some news reports are emphasizing this point properly. Instead, what we are treated with are truly silly statements like this:

Dr James Young, of Chicago's Rush University, said: "We don't understand the mechanisms of these so-called alternative treatments, but that doesn't mean they don't work."

It doesn't mean that they do "work" either. This study is weak evidence at best supporting a therapeutic effect due to sticking needles into the skin in terms of reducing the pain from chronic low back conditions. Let's take a look. Here's the abstract:

Background To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain.

Methods A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean ± SD age, 50 ± 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement.

Results At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001.

Conclusions Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

As in all studies, particularly studies of alternative medicine modalities, pay very close attention to the inclusion and exclusion criteria:

Main inclusion criteria were as follows: age 18 years or older, clinical diagnosis of chronic low back pain for 6 months or longer, mean Von Korff Chronic Pain Grade score7 of grade 1 or higher and a Hanover Functional Ability Questionnaire score of less than 70%, no previous acupuncture for treatment of chronic low back pain, and signed informed consent. Primary exclusion criteria were previous spinal surgery; previous spinal fractures, infectious, or tumorous spondylopathy; and chronic pain caused by other diseases.

One point that leaps right off the page is that the patient population studied had had chronic low back pain for at least 6 months and, based on that duration and the patients' willingness to try acupuncture, we can reasonably infer that their pain probably wasn't responding particularly well to conventional therapy. This makes it unsurprising that the reported response rate in the standard therapy group was so low, given that it was just getting more of the same treatment. Other exclusion criteria included sciatica from other disease, infections, abuse of pain medication. In other words, none of the patients in the study had a clear, anatomic cause for their pain that could be corrected. I must emphasize that this in no way means that their pain isn't real; much if not most back pain doesn't reveal an obvious anatomical cause. What it does say is that, if you have chronic back pain that's due to a herniated disc, spondylosis, an injury causing a fracture (even if that fracture healed) a systemic disorder like rheumatoid arthritis, or other anatomic or physiologic causes that can be detected by radiological studies or other objective tests, the results of this study do not apply to you, at least not very well, anyway. (Remember my recent post about evidence-based guidelines and how guidelines based on evidence from studies that didn't study a relevant population are less reliable?) From my perspective, then, you'd be better off using surgery or other conventional, evidence-based therapies. And that's a big point right off the bat that you won't find in any of the news reports.

Then, there's a real question about the blinding in this study. Obviously, the patients in the conventional group knew what they were getting. Among the two groups of acupuncture patients, the "real" acupuncture were inserted 5 to 40 mm (yikes--40 mm = 1.57 inches!), while "sham" acupuncture needles were inserted only 3 mm. The outcome measures are also a bit dicey, as the response rate was defined without much justification as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale or a 12% improvement or better on back-specific functional status measured by the Hanover Functional Ability Questionnaire and measured at 1.5, 3, and 6 months. Moreover, there is a group of patients who were excluded from the analysis for using "proscribed" treatments (for the acupuncture group, nonsteroidal antiinflammatory drugs for no more than two days a week; for the "conventional therapy" group, not well specified). As described in Pyjamas in Bananas:

But more intriguing is the requirement that no proscribed therapy be used, or the patient is then assigned to the unresponsive category.

The initial figures are 58%, 68%, and 71% responders for conventional, sham, and verum acupuncture respectively. Yet, once those who took "proscribed" treatments (we are not clearly told what these "proscribed treatments" might be for conventional therapy, for acupuncture it is anything other than rescue treatment for acute episodes of pain with nonsteroidal anti-inflammatory drugs to be taken on no more than two days per week up to the maximum daily dose during the therapy period and only one day per week during follow-up) are classed as non-responders, and those who missed the 6 month assessment, these figures were 27%, 44%, and 47%.

Since failure to attend follow-up was 6%, 3%, 3%, this suggests a whopping quarter of all patients were classified as non-responders for using proscribed therapies. Now given the generous allowance of painkillers allowed to the acupuncture groups we might think this is just fine since their acupuncture clearly wasn't working for them, but what were the conventional therapy subjects being excluded for?

The bottom line appears to be:

So what we have here is a study comparing sticking needles into patients versus conventional therapy (presumably delivered by the same doctors) where only the interviewers (assessing outcome) were blinded, and where somehow, only half of patients were given analgesics in the conventional therapy group, where the acupuncture therapy group were allowed analgesics two days a week, and where half of conventional therapy responders were excluded for having 'proscribed' treatment that is never defined or quantified.

This analysis looks as though it is based primarily on a close reading of Table 5 in the paper and appears to be correct, but it's even worse than that. These excluded patients were moved to the "nonresponder" group. After correcting for the use of "proscribed" treatments, over 50% of responders to conventional therapy were moved to the nonresponder group, whereas only around 35% of responders from the sham acupuncture and 33% of responders to acupuncture were moved to the nonresponder group. At the very least, this certainly accentuated the difference between the conventional therapy group and the acupuncture groups, which were not so large in the first analysis, making a relatively small difference into a large difference. What should have been done is that these patients using "proscribed" treatments should have been excluded from the analysis altogether, rather than moved to the "nonresponder" group.

That all puts a rather different spin on the whole study that the media reports don't tell you about, doesn't it?

When I first read about this study and scanned the abstract the other day, I started out rather impressed. True, the study definitely did not support the theoretical framework that is claimed to support acupuncture as a discipline, but it did seem to indicate that sticking 14-20 needles in the skin could relieve low back pain better than conventional therapy. After a careful reading I'm not so sure that this is true anymore or that this isn't just another example of how elaborate procedures and rituals can produce strong placebo effects.

At least the study results forced the authors to admit this much:

The comparison of sham vs verum acupuncture was intended to differentiate the physiologic (specific) from the psychologic (nonspecific) effects of acupuncture. Among the nonspecific effects for both forms of acupuncture are positive patient expectations about acupuncture paired with negative expectations about conventional medicine, more intensive physician contact, and the experience of an invasive technique (needling). Given that the 2 forms of acupuncture are indistinguishable to the patient, any differences in outcomes between the 2 forms must be attributable to specific treatment effects. However, the 2 forms did not differ insofar as the primary outcome. This cannot be explained solely by positing the existence of additional,previously unknown acupuncture points or regions because in the sham acupuncture, needles were inserted only very shallowly and without elicitation of Qi. Several other hypotheses must be considered instead: (1) there are no specific acupuncture effects at all; (2) the specific acupuncture effect is very small and is overlaid by nonspecific effects; and (3) there exist specific acupuncture effects, the nature of which is still unknown,that lead to symptom improvement independent of point selection and depth of needling.

Or you could conclude that the whole concept of meridians and qi is a crock.

I've said before that I'm not as hostile to acupuncture as I am to woo like homeopathy. This is because there may well be physiological explanation for any effects observed, where such cannot be true for homeopathy, which is nothing more than the administration of water or other diluent with no active ingredient. That being said, this article is not nearly as strong evidence for the efficacy of acupuncture to treat low back pain as it has been made out to be in the press, while it is a very strong piece of evidence against concepts underlying traditional Chinese medicine.

ADDENDUM: Steve Novella has also done a nice analysis. I particularly like his suggestion for special needles that would blind the practitioner to whether or not the needle was inserted or not.

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Good post Orac.
I am always baffled by the chronic credulity of media torwards any kind of new cures and especially "alternatives" cures. Someone ought to tightens the requirements for the reporting of science news.

By Alex the Canuck (not verified) on 26 Sep 2007 #permalink

I've said before that I'm not as hostile to acupuncture as I am to woo like homeopathy.

That doesn't make a lot of sense. They both work the same way. They're both founded on a bunch of ridiculous assertions. They both drain time and money from the pursuit of real medicine. Etc.

Is it just that more $$$ is wasted on homeopathy?

When I heard about this study, the first thing I thought of was the placebo effect, which, it seemed to me, was the strongest conclusion you could make. Then when you described the patients who were excluded, it was enough to make me question the relevance of the results to most people with chronic back pain. Then you pointed out the other problems with procudures, and the whole thing seems pretty well done for me.

They both work the same way. They're both founded on a bunch of ridiculous assertions.

Yes that may be true. But the point is that homeopathy is literally a null treatment, something that ordinary people do every day anyway: just drink a glass of water. Actupuncture, while having a rediculous origin and no coherent explanation, is at least doing something, so there is at least the possibility that something has a physiologic effect of some sort. It's like the difference between wearing a crystal necklace and putting cow dung on an open wound. At least for the cow dung there is a measurable, physical process at work that plausibly might have some effect on the body. For the crystals and homeopathy, the only plausible process at work is entirely mental.

-Kevin

That doesn't make a lot of sense. They both work the same way. They're both founded on a bunch of ridiculous assertions. They both drain time and money from the pursuit of real medicine. Etc.

Is it just that more $$$ is wasted on homeopathy?

Well what I think Orac is saying is that there may be some actual physiological benefits to Acupuncture that have exactly zero to do with qi but may have something to do with a real physical effect. More studies on that vs. on the life force gibberish could show actual benefits (or show none).

Whereas Homeopathy is purely nonsense and has been shown so repeatedly.

"That doesn't make a lot of sense. They both work the same way. They're both founded on a bunch of ridiculous assertions."

Not necessarily. There could (vaguely) plausibly be some undiscovered kink in the human nervous system that provides a phsyiological mechanism for acupuncture (real or sham) to work beyond placebo. Whereas there is no plausible mechanism whatsoever for homeopathy to work.

By Ginger Yellow (not verified) on 26 Sep 2007 #permalink

It has always been clear that the theory behind acupuncture is nonsense. The supposed qi channels do not exist, nor do they correspond to nerve pathways in any simple way. But there are plenty of examples (in conventional medicine, as well as nonconventional) of treatments working fortuitously even though the theory was wrong.

So this study investigated whether there is anything to the specific locations and depths of acupuncture points, and the answer was "no." That leaves open the question of whether this is entirely a placebo effect, or whether there is some physiological effect of being randomly pricked by needles that relieves pain.

This would be a tricky question to answer, because you would need to divorce the needle experience from the expectation of benefit. Perhaps you could do a study of people getting tattoos, with a pre-tattoo survey and a post-tatoo survey, and buried in among a bunch of other questions, you could include questions about pain. But you'd then need an appropriate control group undergoing some non-needle experience.

"After a careful reading I'm not so sure that this isn't just another example of how elaborate procedures and rituals can produce strong placebo effects."

Maybe there's something important to bed side manner and spending time with patients -- and physicians instead of insurers and gov't bureaucrats should have more control over the delivery of services to patients.

Thanks for the review of the study. I didn't expect the press reports to be accurate, but, I'd hoped they at least had gotten the main findings accurately summarized. Disappointed again. That's what happens when "science reporters" have no science training.

Orac -- do you think it's possible that you and some other research scientists could get appointed to be science reporters for some of the major news services? I realize that the stories wouldn't be so breathlessly dramatic, but, at least they wouldn't be consistently cow dung.

Nice post Orac.

By Matt the heathen (not verified) on 26 Sep 2007 #permalink

I like this posting.

It has additional, further reaching implications into other Chi-related genuine woo, including Accupressure, or accupuncture without needles and Dim mak or Death Touch, which is accupressure intended to kill someone.

I would point out that if you knock out the underpinnings behind accupuncture, which has some scent of legitimacy to people, you automatically knock down these other related ideas.

I actually saw a television spot on this study the other day. The body of the news brief presented the study acurately as you have stated. Basically that sham acupunture was as effective as real acupuncture.

Not sure why this became newsworthy because the guts of the story didn't support the headlines they presented? Has the whole world gone mad or is the television news just got increasingly more blatant at yelling fire in a crowded theater?

Another rubber hand episode of human brain verses perception.

By Uncle Dave (not verified) on 26 Sep 2007 #permalink

Thanks all for the explanation!

So accupuncture's entire potential therapeutic benefit boils down to:
a) placebo effect
b) the stimulus of the needle might actually do something we don't understand

Placebo effect I can understand (and it sounds like the experiments involving fakeupuncture pretty much put the screws into the coffin on that topic) which leaves the needle stimulus. When they did the fakupuncture why didn't they stick the needles in as far? Seems like they deliberately blew the experiment.

Wearing a crystal around your neck could have a physical effect, too! I mean, it shifts your weight slightly forward - which could have a medicinal effect on your buttocks.

It seems like accupuncture is being handled more gently than homeopathy, yet it seems pretty clear that it's just pure woo-woo too. Why is that?

Once again, media has burried the lead: "Placebo works as well as accupuncture, and better than conventional therapy, for chronic back pain sufferers who have not previously responded to conventional therapy." Or, better: "New, cheap, effective therapy for chronic low back pain! Have a pal stick thin, sterile needles into you at random points."

My mother sought acupuncture a few years ago for a different problem -- stress and anxiety. I thought it was a dumb thing to do, but she did it anyway (she's hopelessly attached to woo of various kinds). While she did eventually move on to conventional (and effective) treatments, she did derive some benefit from the acupuncture. My assessment though, was that it was nothing to do with needles being stuck in her so much as 1: lying still and quietly and thinking about something other than what was usually bothering her and 2: the acupuncturist took quite a lot of time talking to her, sympathizing with her, saying complimentary things about her. Judging from the anthropological literature on woo (which is what I know best), while the theatrical components of unconventional therapies are often cited for their possible psychological effects, the other, less exciting part that is less often considered is the great amount of talk -- a crude form of psychotherapy, in other words -- that goes on in and around them. It gets missed, of course, because it is thought to be incidental to "the cure" whereas it's probably about the most useful part of it (given that the magical "therapies" aren't going to help).

I think Clare hits a valid point. For a lot of complaints having someone listen to you attentively is helpful. For the most part your Doctor will do that - for about 15 seconds.

I tried acupuncture for migraine many years ago. My MD had studied in China for a year and was open to its use in his otherwise more conventional practice. Placebo or otherwise, I found it somewhat helpful, but the effect was not long-lasting; I had to return for treatment on a regular basis. Over time, we both agreed it would be better to try other drug-based remedies.

An interesting sidelight of it all was the pulse-taking, looking at the tongue, and the different methods of measuring the health of a patient. Again, maybe all just woo in its purest form.

At the time, I was trying to have a baby. The doc mentioned that a certain kind of pulse "like a greasy pearl," I think, indicated ovulation. Indeed, I could feel that, but that's hardly a confirmation of its use as a diagnostic tool. I did manage to conceive the first month we tried.

Getting to my point(finally!) I still wonder if some of the diagnostic tools used in acupuncture, which are never used in Western medicine, may have some benefit whether or not acupuncture is efficacious. It isn't entirely unreasonable to imagine that there are additional physiological signs that can indicate illness but which are not used/understood by western methods.

Before Scientific Method, people had to rely on trial and error to diagnose and treat illness. They had to go on what the actual body could tell them, rather than be able to run blood tests, etc. Lots of people died, but they still do today. I just hate the idea of throwing out the baby woo as well as that big tub full of woo water.

By wenchacha (not verified) on 26 Sep 2007 #permalink

I agree that the 'theories' behind acupuncture and shiatsu are woo, considering the practice evolved thousands of years ago before anyone had a clue about how the human body really works.

That being said, I suffered a spinal injury years ago, and was partially incapacitated. The only thing that brought significant pain relief (and believe me I tried everything) was 1. painkillers and 2. shiatsu therapy (acupressure, but the original japanese style). The real kind, done by someone with at least 10 years of practice. Also interesting is that regular treatments (every 3 weeks or so) definitely lowers the baseline pain. For me it was a massive improvement in quality of life. The thing about painkillers, you can't take them every day forever unless you want an ulcer.

I'm a research chemist with a PhD, by the way. And I'm not a fan of woo-based medicine. But it's a little premature to discount things like shiatsu therapy when they do in fact work for many people, and they involve something not all that strange to begin with (massage therapy as opposed to drinking bat juice). It seems to have an overall calming effect on the nervous system, and it is definitely a very different effect from other types of massage therapy. It also seems to work well to unlock muscle cramping and tight spots. I have also tried the medically sanctioned 'pressure point' / 'trigger point' therapy by trained physiotherapists and it was a poor cousin to real shiatsu therapy.

I've seen similar placebo type studies in which *any* back manipulation, be it from a chiropractor (which I think is probably much closer to woo), or a massage therapist, helps people with spinal problems or back pain. I think that's true, that massage therapy in general even if unskillful is a benefit. Longer term though I'm pretty sure that evens itself out though. Also, shiatsu does involve personal attention, but there is no talking during the sessions and no sympathy talk necessarily. I view it as a particular type of massage therapy. I was told that acupuncture involves a higher level of reaction from the nervous system, which I felt was more than I could take.

I believe in the case of shiatsu, there is something to it, and that we are just missing the real explanation. Acupuncture and acupressure tend to work of similar charts of where to apply pressure / needles. I think it's worth more investigation from the medical community. For me the effect was dramatic, sustainable, and long term. And let's face it, 'western' medicine does not have any good ways to deal with the chronically ill or in pain. Taking drugs every day is just not the answer and it's not terribly effective once you factor in the side effects.

By anonforthisone (not verified) on 26 Sep 2007 #permalink

I am from Germany and have followed the whole acupuncture debate over the past few years.
Our universal health care system had to cough up over 2 billion euros in the past 5 years for this crap.
The icing on the cake was - when after 5 years of data collection and another year of data processing the chairman of the committee announced: "We know now that `real` acupuncture doesn't work because sham acupuncture is just as effective. And because of this we will from now on pay for treatment only in specific cases like chronic back pain and headaches and only if it is being done by specially trained physicians."
I'm not making this up!

What nobody dared to say or write about is the fact that the "standard treatment" program they compared it with didn't work at all. No evidence-based-way-forward visible here.

No judgement or doubt about individual cases of pain relief from me. No doubt that some people seem to get some sort of pain relief; heck the study showed that some people seem to think it helped.

The real issue was the fact that the story was reported as "cure for back problems".
When the data was presented, it showed virtually no statistical evidence with which to support the title of the story. Almost half who were given false acupuncture treatment also reported pain relief.

Patient - Doctor, can you help my brother, he thinks he's a chicken.
Doctor - Help him? I think I can cure him of that.
Patient - What, and give up the eggs?

By Uncle Dave (not verified) on 26 Sep 2007 #permalink

'm a research chemist with a PhD, by the way. And I'm not a fan of woo-based medicine. But it's a little premature to discount things like shiatsu therapy when they do in fact work for many people, and they involve something not all that strange to begin with (massage therapy as opposed to drinking bat juice).

I used to have a massage therapist who came regularly. She was fantastic because her attitude was, "I just do what feels good and relaxes you." There was no woo, no chi, no intellectual baggage at all - just "these muscles always feel good when you rub on them!"

For some reason we have to hang all these intellectual baggage on something that doesn't really need a lot of reasoning behind it. When my horse P-nut rubs his butt against the post in the barn is he adjusting his pony-qi or is it just that it feels nice? When I rub my dog's belly and he kicks his hind leg with joy is it because I have found some amazing reflexological relationship or is it just the dogs sometimes do that and almost always like having their bellies rubbed?

You know, this almost begs for someone to write a book on how to adjust your dog's poo-chi

Great analysis! I will have to go back and read the paper again.

I think a few things were missed in the post and the comments. First, the placebo effect is actually a "real" effect. Even if you could show acupuncture did work, and it was entirely due to the placebo effect -- it still would actually work. (Presumably, so would other types of placebo therapy.)

Second, even if you could show that acupuncture doesn't work for the general population, there's still a chance it could work *for certain individuals*. So I think we shouldn't be too quick to dismiss anecdotal evidence. The anecdotes may in fact show that that particular treatment does work for those telling the story. (Maybe it's the placebo effect, but even so: still works.) If someone swears that acupuncture works for them, who are we to deny it? If they swear acupuncture works (full stop), well, them's fightin' words.

I think the bottom line of this post is that the study design may have inflated the apparent effectiveness of sham treatment. I am certainly not disagreeing with that.

By Mister Troll (not verified) on 26 Sep 2007 #permalink

Great post, Orac! I feel the same when the media claims that this-or-that 'totally calls into question current evolutionary theory.'

Count on the Germans to do such a well-designed, detail-oriented study.

My take-away message was "Qi=woo".

My take-away message "Qi=woo"

I would suggest that a more accurate message is that Qi is misunderstood. In simple truth, Qi is a name for something that most people in the west have an erroneous conception of. Do you consider the burn you feel with lactic acid build-up to be woo? Qi is a name that was originated by a bunch of religious guys lots of years ago to describe a set of physical feelings, including endorphin rushes, lactic acid build up, sexual orgasm and fight or flight mechanism. Since they were religious, they invented a catch-all explanation for these things that have one name and they tied the reasons into their mythology.

Qi is just an inaccurate name with a lot of unrealistic backage for something we know a lot more about under other names.

Marcus Ranum: "When they did the fakupuncture why didn't they stick the needles in as far?"

Maybe they were afraid of harming the patient. It is one thing to deeply stick needles in places where they've been stuck in deeply before, which appears to have been the case with the acupuncture that they've been doing. It is another thing to stick in needles in more-or-less random locations.

Marcus Ranum: "It seems like accupuncture is being handled more gently than homeopathy, yet it seems pretty clear that it's just pure woo-woo too. Why is that?"

At least part of it is that it is much easier to do double-blind tests on homeopathy because it is trivial to create a placebo substitute for a homeopathic remedy; a vial of tap water will do the trick quite nicely. It's much trickier to come up with a placebo counterpart to acupuncture, especially one that won't harm the patient.

Hildy,

That study is dubious; the same acupuncturist did both the sham and "real" acupuncture. Thus, the treating practitioner was not blinded to the treatment. And, of course, the lack of a conventional treatment control arm is a serious shortcoming.

J. J. Ramsey writes:
It's much trickier to come up with a placebo counterpart to acupuncture, especially one that won't harm the patient.

I agree.

But... but... but... if sticking random pins into the patient might "harm" them why is accupuncture tolerated? I mean, why are we extending accupuncture the courtesy of assuming that it's at least harmless? Because it's ancient woo and ancient woo gets more slack than new woo?

It sounds like accupuncture has already established that (as long as you avoid the eyes) it's "harmless" to shove pins 1" deep into people. If doing that is improper for a doctor in a controlled experiment then it's equally improper when grandfather woo does it.

Great post.

1) The MedpageToday article ends with (CAPS mine): "The findings are at odds with previous studies that have shown a difference between true and sham acupuncture, said Eric Manheimer, a clinical research associate at the University of Maryland in Baltimore. More than ONE study has shown at least a TREND in favor of true acupuncture." Some reporting bias, perhaps?

2) Now, I'd claim that part of the discussion relies on whether taxpayer's money is involved or not. If it is, we need to support real treatments. If it isn't, and people are willing to pay to maximize their placebo effects...that is their choice. The study does seem to show that some patients benefited from the theater.

What would you say to a patient that comes to your office and says (btw, I am not a doctor): Dr. Orac, look, I have tried conventional therapy for my back pain for 6 months, and it doesn't work. We have not found any anatomical problem. What is the most impactful "thing" I can do to maximize placebo effect and feel better? I promise you I have the ability to believe, at will, in whatever I choose to.

OK, this is an obvious attempt to winn the 500,000 comment contest but hey, a guy's gotta have a hobby.

Anyway, a few years ago I had severe lower back pain and could hardly move. I tried an acupuncturist and AFTER a few hours I felt much better. My 'guess' is that it acted as a deep muscle massage. If you've ever had acupuncture, you know that when the needle is put/twisted in the correct place (nerve bundle?), it's like a major hit to the corresponding muscle group. Just like a massage but able to get to deeper muscles.

Like I said, just my humble opinion.

obviously I meant win, not winn.

obviously, this was another crack at the 500,000.

In the study design, for the sham acupuncture, they decided on a lesser needle depth to avoid replicating any of the processes of the verum acupuncture. They wished to make it as different as possible,and to avoid the "de Qi" sensation supposedly aroused by the verum acupuncture.

Or maybe the positive response to both the "real" and sham acupuncture was like the old joke of the doctor stomping on the guy's foot when he had a pain in his neck.

The guy forgot about the pain in his neck.

Did I win? Did I win?

It's very plausible that some spots on the back (that is where most acupuncture is done, right?) would allow deeper needle insertions than others - it's also plausible that most of the ones that allow truly deep insertions are "already used" by "real acupuncture".

Futhermore, the simple fact that "real acupuncture" uses needles inserted to a depth of 40mm with no harmful effects does not show that needles can be inserted into the body to that depth with no harmful effects - it merely shows that needles can be inserted into the body in those locations to that depth.

Sometimes we can't generalize.

By Michael Ralston (not verified) on 26 Sep 2007 #permalink

About the inclusion criteria, I think the main population being studied are people with spondylosis.

Spondylosis is just degenerative changes of the spine, which is very common in the older population, and is most often in the cervical and lumbar spine. Lumbar spondylosis is the catch-all for all isolated back pain, that has no other organic cause (like tumour, infection, spondylolysis, autoimmune, etc.)It can be asymptomatic, or can cause back pain.

Unfortunately, which there is no effective treatment. Surgery is not indicated. Conventional treatment would be pain relief (e.g. NSAIDs) and physiotherapy (with back strengthening exercises). There's nothing the spinal surgeons can do for this. Combined with its high prevalance, it's the most common cause of chronic low back pain (upper back pain before uncommon and almost always pathological).

No arguments with the rest of your incredibly detailed and well thought-out post. Despite the authors' arguments, I fail to see why the "Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement." It would be better if these patients were excluded from the final analysis altogether... unless it was better to the authors to get a significant result by "massaging the data", as we call it.

Unfortunately, if this study applies to the large population with degenerative low back pain, it means that acupuncture (in the classic Qi style) is not a modality they can pursue for effective relief. And it's arguable if poking needles in skin provides pain relief.

Looks like it's back to the physiotherapist and pharmacist. Darn it!

Wow, I'm surprised that folks didn't pay attention to that analysis of how the non-responder pool was tilted, so that a lot of the responses keep going ahead as if the study said Anything usefull at all. I am tending to agree that the non(s) should have been entirely dropped from the analysis, or alternatively Anyone who used Any amount of analegesic, regardless of group, be placed with the non(s).

I'm sure the statistician had to work for a while to make this spin on the numbers look as good as they did.

Spin Spin Spin, its making me dizzy.

I believe we are seeing a disturbing fallout of the 500,000 comment prize offer.
OK, did I win?

By Uncle Dave (not verified) on 27 Sep 2007 #permalink

Uncle Dave, to what are you alluding??

OK, did I win?

This post is a perfect example of a scientist forgetting what it means to be a scientist. I'm a martial arts instructor, and was a biology major in college, so I've done a fair amount of research (and my own little testing) on chi (or qi, depending on your preference). And what I've found is that no there's no evidence it exists, but many of the things that the Chinese and other Asian cultures attribute to chi actually do work/happen. Just there's no evidence for a cosmic force.

You outright said it in your post: It's possible acupuncture works. Of course it's not because it aids in the flow of chi. But there really is substantial (and mounting) evidence that somehow, acupuncture has a physiological effect. Experiments were done on dogs, demonstrating that it reduced nausea and pain (though exactly how they measured the pain eluded me). Tell me THAT is just a placebo effect... Then there's the fun part: Seemingly one of the main effects of acupuncture IS the placebo effect. Just it's somehow kicked in physiologically. If I still had the one report I did on it, I could give the specific pain pathways and all, but it somehow does cause a certain circuit in the brain to fire, and release endogenous opiates, dulling pain.

So no, chi isn't what's making me punch harder, or making the pain go away in acupuncture. But, like many things in science, the traditional practice is built off of an actual scientific efficacy. If you have any doubt about the history of this, look at something like the idea of "miasma" (bad air). Many scientists felt THAT was what caused diseases, as when things were kept clean and sweet smelling, infections and illness were less. Turns out it was viruses and bacteria causing most of that, but it saved a lot of lives.

Stop saying that acupuncture doesn't work. It probably does (some of it at least). And we're slowly understanding how, and perfecting the technique. Last I looked at it, there was a cool new electro-acupuncture that seemed to work even better than traditional.

By Mr.Funsocks (not verified) on 27 Sep 2007 #permalink

Mr.Funsocks - it may well be the case that sticking needles in people has a physiological effect, and this may well ameliorate chronic pain - but the bottom line is that the flaws in this study mean that we cannot conclude anything one way or the other. The almost total lack of blinding, the pre-selection of non-responders to conventional treatment, the poor quality interventions in the 'conventional' therapy arm and the very short period of conventional therapy, and the unclear nature of the 'proscibed' therapies all make this a poor study.

Mr. Funsocks:

I never said acupuncture "didn't work." I said that this study is very poor evidence that it does and very strong evidence that conceptual underpinning behind acupuncture is bogus. I pointed out that sticking needles into people might have a physiological effect. However, given the inconsistencies in studies and results, the very modest effects reported in "positive" studies, I conclude that acupuncture either does not work or that its effects are so modest that they're not worth the rather considerable effort that most acupuncture regimens (most of which involve several sessions a week over weeks to months) are not worth the bother.

Reading all of this... It just makes me want to scream.

If we just get standard practitioners to spend 15 minutes in a calm/relaxing setting than we're all set. A doctors visit is now like stopping at McDonalds (well at an airport, with a mind numbing wait.)

Go to a plastic surgeon, they've all figured this out (which is why they also can convince you to do some rather bizarre things.)

By Evinfuilt (not verified) on 28 Sep 2007 #permalink

Oh heck, I'll shoot the elephant in the room. The reason acupuncture and other woo gets special treatment is because it didn't come out of the west so they can call all dissenters bigots. Of course they ignore the fact that it was only in the west (and near east, yay ancient middle east) that men were brave enough to cast aside religious taboos and hack open dead bodies to figure out how they work. In many eastern religions it is even now considered taboo to enter or view a human body in any way, especially a dead one. Meridians, qi, these were all attempts to describe an anatomy that you were never allowed to actually look at. Not surprisingly, they got it wrong. Not because they were stupid, or in any way inferior, just less willing to toss aside ancient taboo's. Sorry if I sound irritated, I used to know a Chinese doctor who would rant and rave how stupid all this was any time someone wanted him to perform his peoples traditional medicines. I suppose a euro-american doctor would complain just as much if someone wanted him to perform a blood-letting to resolve a cold.

I'll agree with 'anonforthisone' above -- I've had acupressure sessions with someone who had over a decade's serious training both for migraine and for lower back spasm. Both worked within 20 minutes. Same procedure from someone with a few months' training, no effect.

The experienced person told me about getting instruction from a Japanese man who had been teaching Shiatsu for decades, who spoke no English, taught it all by gesture and hands-on example. But he understood English fine. At one point one of the students was saying over and over, "but what's it supposed to _feel_ like when I'm holding the points, what am I looking for to happen?"

And he was doing pantomime to answer --- moving one hand in a circle, moving the other along the axis, over and over.

Suddenly one of the students said "He's ... miming cleaning out a plugged toilet with a snake."

The teacher clapped his hands, pointed at that student, and smiled.

I dunno what the heck is going on when it's done right. I don't need to believe anything peculiar is happening. But watching primates together, I'm darned sure something's going on with touch that we're short of in our culture.

I also recall a study done, oh, in the 1950s sometime in which researchers sat and watched people in cafes and counted how often they touched each other in public conversations. Numbers were like France 100 times, Britan 2 times, United States zero times.

Something's happening there.

Look at a really old original 'Acupuncture' doll, not the modern ones --- and the 'meridians' and 'points' are as thick on the skin as the rails and switches in a major railroad station. There's more 'meridians' than unmarked skin. I think that's the real point of it all, not to find some point by a map, but to feel the person being touched and find some response in the breath, in the muscle tension, in the pulse.

That works for me.

By Hank Roberts (not verified) on 01 Oct 2007 #permalink

I haven't kept up with research in the field of myofascial pain recently (its been 5 years), hopefully some of you have. From my understanding, it was well established that the motor endplate potential of "trigger points" has an additional random component, c.f. normal motor endplates which have no random component.

I thought this was well studied; that the effect of acupuncture/trigger point therapy, is simply to reduce the basal potential of the motor endplate to reduce the number of involuntary action potentials due to the random component.

I certainly believe that Qi/Ki/Prana/[insert your favorite magic here] was simply the practitioners best explanation of the day given the absence of the ability to investigate the effects systematically.

While practitioners of acupuncture or [potentiall] other energy healing methods may not like it, they have based their beliefs and techniques on something that was made up to rationalise a physiological effect seen thousands of years ago.

What's those famous sayings: (from wikipedia)
1. When a distinguished but elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.
2. The only way of discovering the limits of the possible is to venture a little way past them into the impossible.
3. Any sufficiently advanced technology is indistinguishable from magic.

Ben.

orac: I realise the limitations of single-blind studies; it's like the sham surgery studies though in that it's very difficult to ever blind a proceduralist who conducts a study. at least the assessors were blinded.

the "real" acupuncture were inserted 5 to 40 mm

Four centimeters! That's scary. Some of the patients must have an enormous blubber layer... at least I hope so. :-o I mean, vaccination hurts, and that's just one needle. :-S

By David MarjanoviÄ (not verified) on 06 Oct 2007 #permalink

double blind and triple blind tests are ok, but i believe that better testmionies always arrive from the suffering. I am sure that if you trawl the world outside of rationality you will find a lot more people who are willing to take alternative treatments. and it is generally because other medications have failed.

Placebo is beginning to be as much a supersitition as any other. Anything you dont understand but which works is a placebo.

I had a homeopath in my compound who used to treat infants, infants as young as six months. And many a time his remedies were better than equivalent allopathic remedies from the best hospitals around.

Will an infant feel a placebo effect? I am not so sure. If so why does not a allopathic drug act as a placebo in the same case? You can be reasonable yet stupid, because you have personally not checked. Is it not wiser to take some treatments and find out? Or talk to someone who has had a good effect from these things? Observation, remember Bacon always, observation before reasoning.

How many of you reading this know that once Aristotle thought that procupines grabbed their thorns from their back and threw it at the offending party? The master of logic, had yet a zoo in his own backyard.

In the responses above, many people have actually benefited from acupuncture and have written it. it is well known that the base principles of almost all oriental disciplines is not very logical when compared to evidence based western approaches.

but they have worked for people long before these stuff were even thought of. It is also known that many of the oriental concepts are quite subtle, no western guy thought of a simple concept like zero.

Woo is held in regard not only because it has eastern origins but because many a time, the eastern sciences have been shown to be subtle if not entirely accurate. and only long after it has been trashed. let us therefore hold the jury rather than rush to a decision.

You should understand that the originators of this art must have also tried to figure out why and how and reasoned based on what they knew. it is only that its practitioners made it dogma, writers like this are also dogmatists, having never observed but daring to comment on things based on pure reason. how stupid?

western science also moves from one dogma to another. coffee is good, coffee is bad, aspirin is good, aspirin is bad, aspirin is good again.

as i wrote for a related post, snakes were held to respond to snake charmers not by sight, their eyesight being poor but by reading vibration. If you think of it, that is bullshit, yet western science propagated the idea until one day it was found that some snakes have infra red vision.

Let us accept that we are trying to understand something through the tools we have at our disposal. it is possible that the tools may be limited.

But to trash something you dont understand or that does not work according to your ideas of delimitation bodes bad for real science, the science that wonders, observes reasons and checks before it comments.

And these things sometimes need a change in perspective, a perspective that comes only with new discoveries. YOu say that energy fields are non existent, suppose science finds them a century later.

Imagine talking to Newton about quantum decoherence or nano technology or such modern stuff. OH and do you know that Newton once put a needle into his eye. was he trying acupuncture?

So let us wait before we judge. We know so little and the world is so large. and remember, like westerners today who have the time for science and debate, a few centruies back it was the east that had the time and approach. most of math and science owe to eastern sciences.

they are nothing but subtle, reason needs observation and nice if the writer and his supporters did a bit of it on their own rather than waste time propounding based on what they know. and strongly.

logic without real observation can lead to wrong results as lamarck famously found out. Darwin's patience is perhaps a lesson for such writers, who sound scientific but lose that when dealing with something they are not comfortable with.

just because it does not work in double blinds does not mean that it is wrong, medical science is also moving to person based medicine over and above mere evidence based common medicine, as our knowledge of genetics becomes clearer, that will be the norm perhaps, a concept and approach that homeo and ayurveda have long been propounding.

let the case rust...

I am sure that if you trawl the world outside of rationality you will find a lot more people who are willing to take alternative treatments.

Says it all, really.

Thank you for that. I'm surrounded by woowoo types -- homeopathy, acupuncture, crystals, astrology the lot -- Generally lovely people, but with about as much sense as a bag of pebbles. I'm with Billy Connolly on this one.

Kudos for the "fetid dingo's kidneys" reference -- this is from Douglas Adams, no?

There's actually a great review of the empirical literature on how random needle sticks alone may accomplish the effect in the book Why Zebras Don't Get Ulcers. I think it's curious that the study in an above quote suggests that random placement of needles implies psychological causality - to my mind (I'm a clinical psychologist with a specialization in behavior medicine), the success of both varieties of sham accupuncture support a physiological explanation unknown to acccupuncturists.

To throw in an additional bit of information, however, I'd point out that despite the importance of good physical therapy, most treatment trials targeting chronic pain I'm aware of that don't offer but actually require PT suffer high dropout rates. I haven't had the opportunity to read this study yet, but would be curious as to whether or not PT was mandatory, and what outcomes looked like for those that participated in that component.

By Matthew Skinta (not verified) on 26 Nov 2007 #permalink

Well gee whiz, the lady with a stroke whose tongue went from 45 degrees deviated to less than 5 after I needled her, must have been deluded. Particularly since it had been deviated for a year and a half and it has been essentially straight for 7 years since. And she stopped drooling and regained her balance. Must be placebo.

You don't need to stain a meridian. Look for the spaces between the muscle bellies and the organs where fluid flows so hydronium ions can be exchanged. Meridians show up on a SQUID magnometer too. And Korean and German scientists showed that radioisotopes injected into acupuncture points follow meridians decades ago.

As for the study in question, it is quite hard to find a placebo point in the back area needled. A rudimentary knowledge of acupuncture tells us that there are not only the conventional points, but tendinomuscle channels that cover most of the area and Huatojiaji points (named after a Chinese physician of 1700 years ago.) Makes me think this study was designed by a 250 hour continuing ed MD videocourse acupuncturist who didn't know much about acupuncture. If a placebo is active it isn't a real placebo.

(I do agree about conventional nonresponders and novel techniques, but do we really know whether all patients were acupuncture naive? Acupuncture is pretty common as a back treatment.)

By Karen V (L.Ac.) (not verified) on 27 Nov 2007 #permalink

Acupuncture Side Effects
When performed by a properly trained and licensed practitioner, acupuncture is safe and effective, free from adverse or addictive side effects. Quite often, a sense of relaxation and well-being occurs during and after treatments. While undergoing therapy for one ailment, other problems may resolve concurrently. This is a common side benefit that again demonstrates the value of balancing the quality and quantity of "vital energy" within the entire person.

http://www.tcmadvisory.com
tcmadvisory3@yahoo.com

I had a torn groin muscle for months. I was in physical therapy for a month, which included pain killers, massage therapy, and chiropractic sessions. These, unfortunately, had zero impact on the injury, but they were covered through a workman's comp claim, so I gave them their due. I found it humorous that the chiropractor could pop all of the same joints during every single session I had. This suggested to me that he could probably do the same thing every single day, so he wasn't really fixing anything. I can crack my knuckles everyday, but I don'e believe I am doing them any great benefit, as they seem to return to a specific state on a daily basis. A friend who had success healing a back injury with acupuncture suggested I give it a try. I did not believe in the practice but I trusted this friend, and he was not the type of individual who would strike me as superstitous or new-age. I took the business card he handed me and set up an appointment. The acupunturist had been practicing for over 30 years. His English was less than perfect, but we managed to communicate my issue (mostly by pointing and some facial pantomiming of pain). He stuck some needles in various points around my body, with a few in the area of injury, and walked out of the room. When he came back 20 minutes later, he took them out and gestured for me to stand up, and lift my knee (which I could not do at all when I walked in). I was amazed at the increased mobility, and an equally surprising 50% decrease in pain. The first sign of relief in months. The appointment was on a monday. He asked me to come back friday for a second visit. Now I was wondering how many trips I would have to take, but at the very least I had found substantial, measurable relief, and agreed for round two, and scheduled it for the coming friday. Now here's what really grabbed my attention, and my understanding of the human body's ability to heal; over the next three days, the muscle injury got better and better and better. My injury was continuing to improve without further treatment. This didn't make any real sense to me, so I just noted the changes as objectively as I could. Friday I went for my second appointment and by the end of the session, I could barely feel anything wrong, and had full range of motion. He hadn't put a single needle in the location of the injury on this visit. I had some in my legs, feet, arms, hands and one on my head. There is no science to support this kind of phenomena in western culture, but the results warrant further study. I told him about the continuing benefits and through his broken English, he was able to tell me that what he had done was allow my body to heal itself the way it knows how. It sounded strange to me and my western beliefs, but that is exactly what happened. My symptoms continued to improve over the weekend, and by monday, one week after the first treatment, I had absolutley no pain, not even a hint that the area had ever been injured.
I have since used acupuncture on a number of completely unrelated injuries and illnesses, and all of them were alleviated with one, two, or three sessions at the most. I am amazed at the number of people who can throw their "woo!" at everything undiscovered, unexplainable, or unknown to western sciences and medical practices without trying it out for themselves and objectively recording their own experience. Acupuncture does not need belief to work. It is not a faith based science or medicine. I had no faith in the process but my experience with it led to my new belief in its potential.
The practice has definite results, with the added benefit of zero side effects. Western medicine cannot say that about any of its healing modalities. Drugs are dangerous, and alter the chemical make-up of our bodies, and most are designed to mask symptoms, and not fix the root cause. Surgery removes organs and tissue that your body was designed to have. Most of western medical practices are based on symptom relief, and disease naming. When your body is ill, it is trying to tell you something. We here in the west have become so lazy with the care of our own bodies, that we leave it up to high-profit pharmaceutical companies and slash-and-burn surgeons to make problems go away overnight. Guess what, my friends, if you haven't changed the way you live, the way you feed yourself, the way you excersise, the way you deal with stress, or the way you treat others, your body will continue to get ill. But in America, there's a drug for everything, and a hot, chemically-overloaded toxic meal just minutes away. Your health is your responsibility. Your body is designed for self-healing. It does this 24 hours a day, until YOU do something to hinder its natural ability. There are of course, exceptions to this, and the life saving work of brilliant doctors and surgeons is necessary. Acupuncture is a good starting point to get your body back on track and in a state of self-healing, but if you don't listen to your body, it will fail you.

By Mu Ji Sahng (not verified) on 30 Jan 2008 #permalink

Mu Ji Sahng,

Read a bit about anecdotes:
http://www.sciencebasedmedicine.org/?p=33#comments
You will see why we do not accept your anecdotes, as well as how you fool yourself into believing them.

Also, go to www.quackwatch.com and read about acupuncture, it is not without risks. You can also find more articles, there, about why useless treatments seem to be effective.

HI.DEAR
AM LOOKING FOR RECOGNISE COLLAGE OR UNIVERSETY TO STUDY ACUPUNCURE& CHINEASE MEDICENE ANY WHERE INTHE WARLD
THANKS FOR HELPING ME.

By DR,JAMELA HELAL (not verified) on 12 May 2008 #permalink