Of all the forms of quackery that have been “integrated” into medicine of late, arguably one of the most popular is acupuncture. It’s offered in fertility clinics. It’s offered in hospitals and medical clinics all over the place. The vast majority of academic medical centers that have embraced quackademic medicine offer acupuncture. (Quackademic medicine, for those not familiar with the term we reserve for the study of alternative medicine in academic medical centers that really should recognize it as quackery.) Hell, quite a few that haven’t embraced quackademic medicine offer acupuncture. Basically, acupuncture is the gateway drug of “complementary and alternative medicine” (CAM) that is often a harbinger of the harder stuff, like naturopathy and homeopathy. Basically, if you believe its adherents, acupuncture can work for practically any symptom caused by pretty much any condition.
It’s also pure placebo medicine, or, as David Colquhoun and Steve Novella put it, acupuncture is a “theatrical placebo.” As I’ve asked time and time again, Can we finally just say that acupuncture is nothing more than an elaborate placebo? Can We? As I’ve said before, if you look at the evidence for acupuncture critically and in its totality, acupuncture has no specific effects and no effects distinguishable from placebo. Indeed, it doesn’t matter where the needles are inserted, in “real” or “sham” acupuncture points, or even if the needles are actually inserted in the skin. It’s all the same.
One of the most popular uses for acupuncture is to treat menopausal symptoms. I’m familiar with this literature because the anti-estrogen drugs used to treat hormone-responsive breast cancer often produce menopausal symptoms. Indeed, among practitioners of “integrative medicine” (the art of integrating quackery with real medicine), there’s a great deal of enthusiasm for acupuncture for menopausal symptoms. Never mind that clinical studies have been consistently unimpressive. None of this, however, prevents acupuncture advocates from continuing to do clinical trials.
Here comes another one from a couple of months ago that I heard about over the weekend. It’s hot off the presses in Annals of Internal Medicine by Carolyn Ee et al from Australia and Canada, specifically, Melbourne Medical School, University of Melbourne; Royal Melbourne Institute of Technology University; Southern Cross University, Queen’s University in Ontario, and Monash Health in Clayton, Victoria, Australia. It is a randomized clinical trial of acupuncture for hot flashes. What’s different about it is that it’s a clinical trial for regular menopausal hot flashes, not for hot flashes caused by breast cancer treatment, as most of the clinical trials of acupuncture for hot flashes that I read are. Let’s take a look.
Basically, this trial enrolled women older than 40 in the late menopausal transition or postmenopause with at least 7 moderate hot flashes daily. Hilariously (I have to laugh so that I don’t cry, thinking of the resources wasted on this therapy and the unethical nature of it all, given that acupuncture is mystical pseudoscience) the authors further note that these women thus met the criteria for traditional Chinese medicine diagnosis of kidney yin deficiency. Curious just what the heck “kidney yin deficiency” is, I looked it up. Here’s a description. First of all, kidney yin is:
When The theory of yin and yang is used to explain the organic structure of the human body; the physical form pertains to yin, while activities or functions pertain to yang. The physical forms are the material basis for functions, while functions are the motivating power for physical forms. They are mutually complementary. TCM views the kidneys as the center of the body's yin and yang, the "congenital foundation," or the origin of life. In other words, the kidneys store the primordial yin and primordial yang (also called kidney yin and yang), which is the place where nutrients are stored and physiological functions take place.
Kidney yin, also called primordial yin, true yin or true water, is the foundation of the yin fluid of the whole body; it moistens and nourishes the organs and tissues.
TCM kidneys Kidney yang, also called primordial yang, true yang or true fire, is the foundation of the yang qi of the whole body; it warms and promotes the functions of the organs and tissues.
This is, of course, utterly unscientific, based as it is on concepts not at all unlike the concepts behind “traditional Western medicine,” namely the idea that “imbalances” in something are the cause of all disease. In the case of traditional Western medicine, it’s an imbalance in the four humors. In traditional Chinese medicine, it’s an imbalance in the five elements. In any case, what are the symptoms of kidney yin deficiency? Not surprisingly, some of them resemble menopause:
Presentations of kidney yin deficiency include: soreness and weakness of the lumbar regions and knees, dizziness, ringing in the ears, hearing problems, a dry mouth and throat, a hot sensation in the palms, soles and chest, spontaneous sweating, constipation, and seminal emission. The pulse is weak or fine and rapid; the tongue is red and covered with a light coating of fur. Kidney yin deficiency syndrome always produces signs of yin vacuity internal heat.
According to Ee et al:
Women were included if they were postmenopausal (>12 months since their final menstrual period) or in the late menopausal transition (follicular-stimulating hormone level ≥25 IU, amenorrhea ≥60 days, and VMSs), had a mean HF score of at least 14 (equal to 7 moderate VMSs daily) (16), or had kidney yin deficiency diagnosed using a structured Chinese medicine history as well as a tongue and pulse examination performed by experienced acupuncturists (Appendix Figures 1 and 2). Kidney yin deficiency, of which night sweats is a cardinal symptom, is a Chinese medicine clinical syndrome diagnosed in 76% to 81% of symptomatic postmenopausal women (17, 18).
They were even kind enough to provide a questionnaire to diagnose kidney yin deficiency (click to embiggen)
As you can see, this questionnaire is so vague as to be pointless. Certainly, it’s not enough to diagnose menopause. After all, there are no questions about frequency of menstrual periods or when the subject’s last menstrual period was, and the questionnaire includes information about Chinese pulse diagnosis, which is not reproducible, and Chinese tongue diagnosis, which is basically reflexology on the tongue.
So far, not so good.
Basically, 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). The study was blinded, but not completely. Study design was a stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. Overall, it wasn’t a bad design as far as acupuncture studies go. True, it lacked blinding of the treating acupuncturist, which would have been required for a true double-blind study design, but it did use a pretty good acupuncture sham, the fake retractable needles that don’t break the skin also inserted in the “wrong” places. Participants received 20 minute acupuncture sessions (or sham acupuncture sessions) twice weekly for two weeks and then weekly thereafter.
So what were the results? Do you even have to ask? Basically, this was a completely negative trial, which is why I wasn’t as concerned about whether or not the acupuncturists were blinded or not. (This would have been a much bigger issue if there had been a positive result.) At the end of the eight week treatment period, Mean hot flash scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (P = 0.77). Hot flash scores declined about 40% in both groups and persisted for six months. The investigators couldn’t find evidence of an advantage of acupuncture over sham acupuncture on quality of life, anxiety, or depression. That’s about as negative as it gets. I do have to give the investigators credit. They didn’t try too hard to torture the data to provide the result they wanted with post hoc analyses, as many investigators carrying out clinical trials are tempted to do.
They did, however, try to make excuses. Indeed, the shorter version of the whole discussion section seems to be: How can it possibly be that we didn’t find acupuncture to be superior to sham for menopausal hot flashes? They noted:
Our findings are consistent with those from a recent Cochrane review (10), which reported that acupuncture was more effective than no treatment and had a moderate effect size but was not efficacious when compared with sham. Although another recent meta-analysis reported moderate standardized effect sizes of acupuncture of −0.35 and −0.44 for HF frequency and severity (13), this analysis pooled data from sham-controlled trials and trials comparing acupuncture with no treatment. In addition, the shortcomings of the included studies (small sample sizes, high attrition rates, and failure to use intention-to-treat analyses) may have inflated the treatment effects.
Which, of course, leaves the question of why bother to do this study in the first place, given that there’s enough evidence out there to do a Cochrane review and that review found no evidence that acupuncture was more efficacious in menopausal hot flashes than sham acupuncture, and there was enough evidence to do a meta-analysis whose results were probably due to the inclusion of low quality evidence. There was (and is) no strong clinical or scientific rationale to do randomized studies of acupuncture for menopausal hot flashes.
This next paragraph made me chuckle out loud as I read it:
The first limitation of our trial and acupuncture clinical research more broadly is the lack of an inert sham comparison treatment. Although the Park sham device was the best available sham acupuncture method at the time of study design, its validity as an effective control treatment needs further determination. It creates a needle-prick sensation, essential for the patient to believe that a needle has been inserted; however, this sensation produces minor physiologic effects (26). The interpretation of sham-controlled acupuncture trials must occur within this context. However, what we have successfully examined is the effect of needling compared with pressure from a blunt needle. Second, despite our broad recruitment strategy, our findings can only be generalized to Caucasian Australian women with kidney yin deficiency. Nonetheless, 87% of otherwise eligible women met criteria for symptoms of kidney yin deficiency, consistent with previous studies (17, 18). Third, our method of Chinese medicine diagnosis was a simplified version of usual practice and failed to define secondary diagnoses. In addition, our acupuncturists could not be blinded, but we provided comprehensive training and performed quality assurance visits to minimize bias. Finally, our findings cannot be generalized to women with bilateral salpingo-oophorectomy or worsening of VMSs after breast cancer; we excluded these women because they have more severe VMSs (47, 48). Future research should examine the role of acupuncture in breast cancer.
Yes, let’s count the excuses. The sham needles weren’t an adequate control. Our findings can’t be generalized to all women with menopause but only to Caucasian Australian women who also—by the way—have kidney yin deficiency. Our method of traditional Chinese medicine diagnosis was too simplified. Our acupuncturists couldn’t be blinded. We can’t generalize our findings to women with menopause doe to surgery or to breast cancer treatment. So let’s study the role of acupuncture in alleviating menopausal symptoms in breast cancer patients.
Oh wait. There’s already sufficient evidence out there (e.g., studies like this one) to show that acupuncture doesn’t work for menopausal symptoms in breast cancer patients; that is, other than studies that don’t bother to blind anybody.
So once again, we have yet another study that shows that acupuncture doesn’t work, and once again we have investigators who refuse to believe their own results and have to be dragged, kicking and screaming, by the data to the conclusion that their hypothesis was false. Even then, they can’t help making lots of excuses and planning their next study even though this one was totally negative.
Same as it ever was.
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Did they correlate their results with their midi-chlorian count
I take it "kidney yin deficiency" is supposed to be contrasted with conditions like "heart yin deficiency", "brain yin deficiency", "gonad yin deficiency", etc. Or, for that matter, "kidney yang deficiency" (which would be equivalent to "kidney yin excess"). And I suppose that in principle a patient could have "kidney yin deficiency" and "heart yang deficiency" simultaneously.
The standard words we use to describe this kind of solution to the complex problem of medicine: Simple, elegant, and wrong.
"Presentations of kidney yin deficiency include...seminal emission."
Did they control for that finding in the postmenopausal women?
It almost seems that Orac writes about *nothing but* quackery and alternative medicine.
Maybe if real medicine was more effective,
and real doctors did a better job of educating the ailing,
Orac wouldn’t be railing,
for 2,000 words every day.
I see your ability to use the search function on this site is about as good as your ability to hold a rational argument....
“Presentations of kidney yin deficiency include…seminal emission.”
Ohh jeez, the NSFW things I could say related to that. WTF the annals of internal medicine journal were thinking.
Am I doing something wrong? That link "hot off the presses in Annals of Internal Medicine" is taking me to a library log-in. And I see that the article is behind a paywall.
Oh well time to wander down to the university. Exams are almost over so grabbing a library terminal for a minute to download the article should be easy enough.
It's a bit embarrassing to see a Queen's name there, speaking as an alumnus, but at least the author is not from the Faculty of Medicine. Turns out that he is in the School of Rehabilitation Therapy. "Simon French,B.App.Sc.(Chiropractic), M.P.H., Ph.D., is an Assistant Professor in the Rehabilitation Science program and holder of the Canadian Chiropractic Research Foundation Professorship."
I know a couple of other faculty from the School and much of what they do seems pretty good. Hopefully French just was a bit off when he agreed to get involved. However those "Chiropractic" terms are not reassuring and the School's web-site is about as uninformative re faculty as any I have seen.
I really enjoyed how they selected subjects:
they use either SB measures or one based in TCM diagnosis.
AS if those measures were somehow related to each other.
What if some people with yin deficiency didn't experience menopause at all- especially those with 'seminal emissions'?
The sham needles weren't of the right type?
I need a drink.
I'm not surprised that a just-published article is behind a paywall. I would guess that Orac copied and pasted the link by which he accessed the article. Even without that detail, I'd probably still be unable to read the article: even though I work at a university, said university does not have a medical school.
Speaking of links, I suspect Orac intended the word "QUESTIONNAIRE" to be a link to the questionnaire he discusses, but as of this writing there is no link.
That's me after an evening in the pub, that is.
Apart from the seminal emission, you understand.
The questionnaire is there. For some reason WordPress published a version back from the latest, which didn't yet have any images.
See Noevo says (#4),
It almost seems that Orac writes about *nothing but* quackery and alternative medicine.
I'd like Orac to write about why quackery and alternative medicine continue to use some harmful products in their pseudoscience marketplace.
Tthe FDA is proposing a ban on such products:
Statistically, one out of 20 trials involving acupuncture or homeopathy should reach p = 0.05 significancy. No reason to lose our time studying them.
It's actually higher than that, as John Ioannidis showed. Due to bias, issues in carrying out clinical trials, etc., we expect considerably more than 5/100 trials of homeopathy to be "positive." That 1 in 20 number is the lowest it can be when we set our p-value to 0.05. It's an "ideal world" number. The real number will always be higher.
I agree with you, but how to disprove them except by considering that there is a general institutional problem in confusing procedures and science.
And it is every bit as vague and useless as you claim. Not to mention innumerate: it claims that the maximum symptom score is 36, but the actual highest possible is 30 (ten boxes that can be between 0 and 3). With two possible "bonus" points for tongue and pulse (and no description of the criteria by which a patient would earn those "bonus" points).
That's only true if all of your errors are random errors. Systematic errors will usually make this false positive rate higher, and those errors are frequently not accounted for in statistical analysis. Bias, as Orac says, is a major source of systematic error in medical trials. That includes most study design issues, since the purpose of well-designed controls is to minimize observer and experimenter bias.
In principle, overestimating systematic errors can result in inflated p-values, such that fewer than 1 in 20 studies would see a positive result by chance. In practice, that almost never happens. It is far more common for systematic errors to be underestimated (if not outright ignored) than to be overestimated.
Again, I agree. The point I wanted to make is that there will be many trials showing positive results for acupuncture and homeopathy, and we cannot deal with that if we consider science only from a procedural point of view.
Once again, acupuncture doesn’t work for menopausal hot flashesanything.
I went into an art gallery today, they wouldn't sell me the vegetables I needed for tonight's dinner.
The car shop who were doing some work on my car also didn't stock the newspaper and magazine I wanted to buy.
Your point is?
Dogmatic man drones
More rigid than Curia
I think I've found a scientifically valid usage for accupuncture needles, one that would be totally reliable and evidence based in their approach and usage.
Microwave antennae for a phased array in the centimeter and shorter wavelength.
Note the lack of a medical usage for the damned things. Still, they're stainless steel (usually), hence corrosion resistant, the appropriate length (and can be adjusted in the connector for precision length) and in that, useful for more than landfill fill.
For medical uses, I don't know, perhaps as a door stop or to keep a window propped open, assuming at least a case quantity?
For in reality, the headline is:
Extra! Extra! Read all about it! Accupuncture study complains of a lack of proper sham therapy, fails to note irony in the study complaint.
@Daniel: One thing to keep in mind is that there is nothing magical about a p-value of 0.05. Many fields, including medicine, have traditionally adopted this significance threshold as a compromise between the ability to generate enough data (which in this context means enrolling enough participants) to get a significant result and the need to have a sufficiently stringent threshold to weed out spurious results. Other fields such as particle physics, where the experiment can be repeated thousands or even millions of times, can and do insist on a stricter threshold: particle physics, for instance insists on a 5σ threshold, which is about p<3*10^-7 (for comparison, p<0.05 is about 2σ). The reason the threshold is so strict for particle physics is because they have been burned too many times by 3σ significances that turned out to be spurious.
Given the routine occurrence of spurious p<0.05 results in medicine, one can argue that a stricter threshold is needed. The difficulty is that, as you change the number of participants, the p value of a non-spurious result decreases as the square root of that number, so that, e.g., you would need 25 times as many participants to get a significance of p<0.01 as to get p<0.05. Which for studies involving human subjects is prohibitively expensive when it is even possible.
For medical uses, I don’t know
For non-medical use, there's always lace knitting.
It is not a question of threshold. A threshold at p<0.01 would allow a certain number of homeopathic trials to show significance while preventing serious projects to be carried out. The issue is hypothesis driven research versus ad hoc (interest driven) analysis of data. The whole process of hypothesis driven research means defining precisely what is the hypothesis, and which experiment would disprove it. Working for disproving a hypothesis is not what is encouraged in the current way of assessing scientific activity by publications. In addition, understanding some hypotheses may mean a certain level of knowledge and/or intelligence. There cannot be any hypothesis on homeopathy.
In addition, a problem in biomedical sciences is that physics requires a minimum of intelligence, which may be lacking in biochemistry.
What is needed in biomedical sciences is a process of cooptation based on knowledge and intelligence, and not on "productivity" (USA) or "services rendered" to the boss (France).
Hi there. Was wondering what your view was on the fact that nobody today is getting the 90 nutrients that the human body requires everyday to function, and why doctors aren't mentioning this. Thanks!
My vindaloo recipes don't require nearly so many ingredients, and these don't really serve as nutrients by the end of the cooking, I suspect. Is vinegar a nutrient?
I'd wager it is because it doesn't need mentioning? Unless you have literally the worst diet in the world, you'll get everything you need through your fo-
*assassinated by Big Supplement*
Arnold Vindaloo -
My view is that the doctors don't metion it because most of the people they see aren't suffering from missing nutrients. In fact, a lot of people they see are suffering from too many nutrients.
Most people today are living much longer than the average of a few decades ago, suggesting there's no big problem with missing nutrients.
Perhaps you can tell us how you came up with such a wierd statement. You get extra marks if you can keep it within 50 words.
After googling "90 nutrients", I found that this claim was mostly made by one Dr Joel Wallach. Do you know what studies he based this claim on, and if some other scientists replicated this ?
the fact that nobody today is getting the 90 nutrients that the human body requires everyday to function,
If we need them to function, but we're not getting them, then we're dead. This is contrary to experience.
I have learned not to trust any theory that predicts my own non-existence.
the tongue is red and covered with a light coating of fur.
Your own, or someone else's?
The furry tongue sock is a welcome addition to your cold weather ensemble, much like the nose mitten.
I think I prefer the nose mitten.
@31 Dr Joel Wallach the veterinarian with the huge product line?
Was wondering what your view was on the fact that nobody today is getting the 90 nutrients that the human body requires everyday to function, and why doctors aren’t mentioning this".
I am a doctor and the only explanation I can find is that we are all dead. This might limit my ability of mentioning this or anything.
My vindaloo recipes
Dinner at Narad's!
I can recommend it.
It'll be dinner at mom's house for me tomorrow; just have to hang in there for one more day/night, then a longish flight tomorrow. Looking forward to it.
I do worry that some of these people apparently have advanced degrees from the top Instuitions in my home City.
At first I thought it was a student prank.
Let me see if I follow.
They did a study which proved that Sham accupuncture worked as well as "real" accupunture. Eg it didnt.
The reason is that the Sham accupuncture is to "real"
BTW I am enjoying the posts in here.
There's a lot of talk in this thread about seminal emission, but the more import thing is the seminal omission (intellectual integrity) producing an excess of yin leaving the argument weak as water.
I think that was Effie you are channeling.
Kylie was more a "so excellent" type of person.
Once again the paper ends with "more research is needed " or a variation thereof. One day we might see a paper end with "no further research is needed as enough evidence shows there is nothing here to see" - this would be a paper worth reading.
It's not "fact", it's hogwash. That's why.
Hot flashes can be awful. The sweats are just as bad if not worse. Fortunately, I know that "this, too, shall pass". And NO ONE is coming near me with a freaking acupuncture needle.
What's with all the heavy metals in the 90 nutrients pill? I thought nutritionists were generally anti-heavy-metals!
Hi there. Dr.Joel Wallach conducted proper experiments in the lab using monkeys and other animals. He was also given an award for his findings, albeit the MDs did not like it because he proved that all diseases link back to nutritional deficiencies. Also; most trace minerals play a part in healthy optimised brain function. Even if it sounds like "nonsense", this should be looked into more. Has a proper experiment conducted disproving Dr. Wallach? Thanks.
I am not here to spread hate. I am just an inquiring mind.
Can you give the references of these "proper experiments" or this award ?
I am also pretty wary of anyone who extrapolate something on humans from animal data, without checking with proper clinical trials after the preliminary research.
Is that Dr. Joel D. Wallach, DVM, ND?
Doing a quick pubmed search he MAY have been the author of "Hypoglycemic shock in captive alligators." and "Frostbite and its sequelae in captive exotic birds", though it's difficult to know for sure.
It's not obvious to me that there are any pubmed indexed papers by him regarding nutritional deficiencies being the cause of all diseases.
Dr. Joel Wallach won a G.O.D award from the UN.