Respectful Insolence

ResearchBlogging.orgFor some reason, when it comes to so-called “complementary and alternative medicine” (CAM) therapies, acupuncture gets a pass. Homeopathy, for example, is based on ideas so inherently ridiculous that they quite properly attract the scorn of skeptics and advocates of science-based medicine everywhere, stating, as it does, that diluting a remedy to nonexistence makes it stronger, but only if you shake vigorously between each serial dilution step. The same is true of reiki, which, as I’ve said time and time again, is nothing more than faith healing based on Eastern mystical beliefs rather than Christianity. Then there’s reflexology, which claims that every organ in the body maps to a specific location on the hands and feet. Somehow, most people can understand that all of these forms of woo are based on prescientific beliefs unsupported by science, the sort of beliefs that one can understand as having been not unreasonable back before the scientific basis of so many diseases was understood. These days, not so much.

So why does acupuncture get such a pass? Think about it. The principles of acupuncture claim that there’s “life energy,” or qi, that flows through pathways in the body known as meridians and that sticking needles into specific points on these meridians somehow “unblocks” the flow of qi. This “qi” can’t be detected by science. There’s no evidence that it exists, any more than there’s any evidence that meridians exist. Yet, somehow, acupuncture is commonly viewed as one of the more “plausible” CAM modalities by all too many people, including health care professionals. Indeed, acupuncture is very much a bit of “gateway woo,” a proverbial “foot in the door” behind which the real woo pushes its way into the house of science-based medicine, a fixture of nearly every CAM program, used to treat a huge variety of illnesses based on an even huger variety of pathophysiological mechanisms, none related. But acupuncture can apparently do it all! It’s not just for pain. It’s also for goiter, gout, infertility, allergies, exczema, seborrhea, and apparently psoriasis. Whatever disease there is, chances are that you’ll be able to find an acupuncturist claiming that he can treat it and a study claiming that acupuncture is useful for treating it.

I just saw an example of this the other day in the form of a study from the University of Virginia Charlottesville entitled True and Sham Acupuncture Produced Similar Frequency of Ovulation and Improved LH to FSH Ratios in Women with Polycystic Ovary Syndrome. And where did I find out about it? Where else, in a Research Spotlight from the National Center for Complementary and Alternative Medicine (NCCAM) entitled No Difference Between Actual and Simulated Acupuncture for Polycystic Ovary Syndrome, Study Finds. Polycystic ovary syndrome (POS) is a common syndrome among women characterized by irregular or absent menstrual periods, manifestations of too much androgen, including hirsutism (hair where it doesn’t belong) and acne, as well as insulin resistance. It’s a syndrome that commonly leads to infertility, among other problems. So what’s the answer? Acupuncture, of course! The authors set the stage:

Of women seen in a reproductive endocrinology/fertility clinic, 22% had tried acupuncture therapy within 18 months of their initial clinic visit in the United States (6) [12.5% within 6 months in Australia (7) and8%use in the United Kingdom (8)]. The four publications [sample sizes ranged from 24 to 45 women (9 -12)] on acupuncture for women with ovulatory disorders reported acupuncture to be effective for restoring regular menses, regular ovulation, and/or achieving pregnancy.

So what we have here is the typical lousy evidence for the efficacy of acupuncture in anything. Two of the studies were of “electroacupuncture” (which is not acupuncture at all unless the ancient Chinese had access to battery or generator technology); one was of auricular acupuncture; and the other was published in the Journal of Traditional Chinese Medicine, which doesn’t exactly inspire an overwhelming degree of confidence in its results. Be that as it may, the important thing is the current study, at least for purposes of this blog post. It’s a randomized, double-blind, sham-controlled clinical trial involving 84 reproductive age patients with PCOS and no hormonal intervention for at least 60 days prior to the start of the trial. The intervention included 12 sessions of either true or sham acupuncture, and the outcome measures examined included ovulation measured with weekly blood or urine samples and measurements of serum hormones LSH and FSH to determine if they normalize in response to treatment. The randomization schema is illustrated below:

i-b110017424ba7f63d0106a2b1b5db180-schema-thumb-480x437-69478.jpg

As always, whenever I look at an acupuncture study, I look first at the specific sham acupuncture needles used and the specific acupuncture regimen chosen:

Subjects in both groups had 12 acupuncture/sham session: twice each week for the first 4 wk followed by once per week for an additional 4 wk. There were four study acupuncturists, each of whom implemented both protocols. For the true acupuncture treatment, the following bilateral points were stimulated with electroacupuncture: bladder 23, bladder 28, spleen 6, and spleen 9. The following points were manually stimulated: pericardium 6, triple energizer 5, and governor vessel 20. The sham acupuncture was performed with the validated Park sham device (20, 21). The sham device was placed on the skin at standardized points on all four extremities (Achilles tendon and lateral head of the triceps) chosen to avoid standard acupuncture meridians and acupuncture points (22). For further details, see the Supplemental Data, published on The Endocrine Society’s Journals Online web site at http://jcem.endojournals.org.

Here we go again. This study uses so-called “electroacupuncture” as well, which again is not acupuncture at all. At least the Park sham device is a real sham acupuncture device that appears to work well for blinding.

So what does this study show? Guess:

i-aa558146fc3cf1bf23aa73023399ef66-Table2-thumb-480x205-69480.jpg

And:

Both arms demonstrated a similar mean ovulation rate over the 5 months (0.37/month among n 40 true acupuncture and 0.40/month among n 44 sham participants, P=0.6), similar LH to FSH ratio improvement (0.5 and 0.8 true and sham, respectively, P=0.04 after intervention vs. baseline) and a similar decline in LH over the 5-month protocol (P=0.05). Neither arm experienced a change in FSH. There were seven pregnancies (no difference by intervention, P=0.7). Lower fasting insulin and free testosterone were highly correlated with a higher ovulation rate within the true acupuncture group only (P=0.03), controlling for prestudy menstrual frequency and body mass index.

We were unable to discern a difference between the true and sham acupuncture protocols for these women with PCOS, and both groups had a similar improvement in their LH/FSH ratio.

In other words, even using “electroacupuncture,” there’s no difference in any outcome measure that matters between sham and “real” acupuncture. True, the investigators thought they saw some mostly barely statistically significant changes in some hormones:

The researchers found no difference in participants’ monthly ovulation frequencies from either group. Both groups, however, had an improvement in the ratio of luteinizing hormone to follicle-stimulating hormone during the 8-week intervention. But only the actual acupuncture group significantly sustained this improvement during the 3-month followup. In addition, the researchers found that two biological factors (fasting insulin and free testosterone) were inversely correlated with the frequency of ovulation in the actual acupuncture group, but not the sham group.

Great digging through multiple comparisons to find a couple of correlations that probably don’t mean anything! Let’s just put it this way. Who cares? Given the multiple comparisons it was almost inevitable that something would shake out as appearing to be a “positive” correlation. If there’s no difference in the frequency of ovulation or successful pregancies between the two groups, one really has to question the significance of this finding. I mean, really. Look at the number of factors tested for, and look at how the investigators had to contort the data to find that two factors were inversely correlated frequency of ovulation, but only in the acupuncture group.

Also, it’s always amusing to see how the authors try to spin this completely negative study. They first note that their acupuncture protocol and the sham protocol both resulted in the same frequency of ovulation and a similar reduction of the LH to FSH ratio in PCOS. From this they somehow conclude that “this acupuncture protocol was more effective for women with less severe metabolic disturbance (lower fasting insulin) or less androgen production (lower free testosterone) because neither of those factors were related to the ovulation rate among the participants in the sham arm.” Uh, right. They then go on to do a whole lot of handwaving about the fact that sham acupuncture was no different from “true” acupuncture. As is the usual case for true believers, instead of concluding the obvious, mainly that acupuncture doesn’t work and it doesn’t matter where you stick the needles, they try to claim, based on the tiniest of differences described above, that there must be two different physiological mechanisms behind sham and true acupuncture. I suppose that could be true, given that unlike the true acupuncture needles the sham acupuncture needles were never hooked up to the electricity, but so what? There was no detectable physiological difference where it counted. Not that that stops our woo-loving investigators from finishing with this howler of a conclusion:

This study suggests that this acupuncture regimen may be beneficial to women with lower fasting insulin and free testosterone levels. This is good news for women with PCOS who are seeking pregnancy because acupuncture may be a nonpharmaceutical option for them without any known fetal or multiple gestation risks. The safety of acupuncture is documented (31) and supported by few adverse events in this trial.

There is a clinical need for treatment options for women who are clomiphene resistant; thus, research on acupuncture treatment in this population would have high clinical value. It would also be informative to investigate the pathophysiology of both true and sham acupuncture. Not only is it confusing to the public to learn that a placebo is equivalent to an active intervention, but it also raises questions about the active intervention that may or may not be warranted.

And what do the investigators base their speculation that acupuncture might be a nonpharmacologic option for women with PCOS trying to get pregnant? Certainly not on anything in this paper. But it is safe. Too bad it isn’t effective. In any case, the conclusion, as they say, does not follow from the data. How on earth did this get past the peer reviewers?

However it managed to slip through review, I must admit that I chuckled heartily at the last paragraph, particularly the last sentence. In fact, I’d add that it’s clearly not confusing just to the public that placebo is equivalent to the active intervention. It’s confusing to the investigators too. The correct answer to that conundrum is that acupuncture doesn’t work for this condition, but instead the authors do backflips of logic to try to torture their data into supporting a therapeutic effect for acupuncture in PCOS. Given that, it’s utterly ridiculous to claim that it would be useful to investigate the pathophysiology of both true and sham acupuncture. Why? Because neither work more than placebo! It also shows, contrary to the authors’ views, that the questions about the active intervention raised by this study are more than warranted. Sadly, the authors just can’t see that, and neither, apparently, can NCCAM, which funded the study.

REFERENCE:

Pastore LM, Williams CD, Jenkins J, & Patrie JT (2011). True and Sham Acupuncture Produced Similar Frequency of Ovulation and Improved LH to FSH Ratios in Women with Polycystic Ovary Syndrome. The Journal of clinical endocrinology and metabolism PMID: 21816787

Comments

  1. #1 Ender
    September 27, 2011

    It’s a real pity, acupuncture always seemed like one of those ones where it might turn out there was a theraputic effect, the GP we shadowed in the second year of our course gave me some acupuncture for my knee and it certainly had an effect on my hand (where the needles were).

    Difference between me and someone emotionally invested in acupuncture? I read the studies showing little difference between placebo and treatment and said “Oh, I guess it doesn’t”, and I read the positive studies and the fact that they are all shaky/unblinded/without a proper control and didn’t say “I know that their result was correct and the better run experiments are wrong”.

  2. #2 hullflyer
    September 27, 2011

    I have always believed that the reason acupuncture is often used as “gateway woo” is that there could be a plausible, scientific explanation for how it could work other than “qi”, such as the insertion of the needles stimulating extra production of the body’s own painkillers and anti-inflammatories.

  3. #3 Stuartg
    September 27, 2011

    Back around 1990 I talked with an anaesthetist who had spent several months in Beijing on a sabbatical placement. Even then the Beijing clinicians would use almost no acupuncture. Instead, they tended to rely on the few “western” medications they could source.

    His best tale was of a “demonstration” leiomyomectomy done before an audience of politicians.

    First, acupunture needles and IV access were inserted. Then, whilst one “anaesthetist” twiddled the needles, the second injected IV diazepam and pethidine. He then went on to administer a rectal sheath block using prilocaine. (Needles still being twiddled.) Further prilocaine was later used on the uterine peritoneum. The politicians retired believing they had seen surgery performed using only acupuncture as anaesthesia.

    As my colleague commented, the surgery could have been performed entirely without the acupuncture and achieved the same results.

    After hearing that, along with many other (scathing) anecdotes about the use of acupuncture during his period in Beijing, I decided to reserve judgment until I saw any evidence of efficacy.

    I still haven’t seen any evidence of efficacy of acupuncture, including this study. My judgment came down against acupuncture a few years ago.

    Thanks for the post.

  4. #4 Amenhotepstein
    September 27, 2011

    Both groups, however, had an improvement in the ratio of luteinizing hormone to follicle-stimulating hormone during the 8-week intervention. But only the actual acupuncture group significantly sustained this improvement during the 3-month followup.

    But you KNOW that this is the only quote the woo-meisters will be talking about. “Acupuncture provides sustained improvement of hormonal ratios in infertile women! Want a baby? Come on down to our clinic and get poked!”

  5. #5 Collin
    September 27, 2011

    I think the reason acupuncture is accepted is because Westerners are afraid the Chinese will be upset if it isn’t. This rides on the tires of fairness, but actually it’s the opposite. It’s implying that Chinese culture doesn’t have a place for science. The only way to counter this is for an organization of Chinese Americans to step forward and remind everyone what everyone should’ve realized a long time ago — that science is a worldwide endeavor, and that it’s an insult to claim that any culture doesn’t have a place for it.

  6. #6 Heliantus
    September 27, 2011

    Sometimes I become well aware that English is my second language, and that the true meaning of some sentences still escapes me. By example, when reading this,

    True and Sham Acupuncture Produced Similar Frequency of Ovulation and Improved LH to FSH Ratios in Women with Polycystic Ovary Syndrome.

    I understood that there was no difference between the tested treatment, and the negative control (“sham”). But apparently, I’m reading it wrong.

  7. #7 puppygod
    September 27, 2011

    Acupuncture indeed is gateway woo. Fortunately, for me it was gate out – acupuncture was probably the last woo that I thought “might have some truth behind” on my way from youthful fascination of everything supernatural to the bona fide scepticism today.

    As some posters mentioned before, acupuncture at a glance seems plausible. When you throw the qi babble out, you have a very real physical intervention: puncturing skin at certain points. For someone with some superficial knowledge about neural system (phantom limb pains or other quirks) it doesn’t seem inconceivable that sticking needles does something. Actually, even without all that ‘ancient oriental secret knowledge’ fluff it wouldn’t be unreasonable to explore possibility that direct stimulation of afferent nerves at certain points could “overload” neural pathways effectively reducing sensation of pain. It SEEMS reasonable.

    It isn’t. Now we know it. Studies upon studies proved that it doesn’t work that way. Also, traditional acupuncture is BS – it’s neither ancient or consistent (maps of meridians are wildly different), and have a very real risks (like infections). I understand that it’s tempting even for health professionals – possibly more than other woo, thanks to Dunning-Kruger effect – but it’s time to get over it and put it on the heap of failed hypotheses, where it belongs.

  8. #8 CC
    September 27, 2011

    Heliantus: no, you read that sentence correctly. It does in fact mean that there was no difference between the tested and control treatments.

    It’s the study authors who seem to be unable to read the results correctly!

  9. #9 James Sweet
    September 27, 2011

    So why does acupuncture get such a pass?

    Because you’re actually doing something that could plausibly have a biological effect. It could have turned out like chiropractic, where the initial justification was mystical hogwash, many practitioners still claim too much, but they sort of “accidentally” discovered a therapy that can be effective for some conditions. You yourself said you once considered it to have at least a baseline plausibility that other CAM modalities don’t have.

    Except of course that it didn’t pan out that way. Data, people, data!

    Random list of hypotheses that sounded prima facie plausible, have been refuted by data, but that people keep arguing for anyway:
    1) Acupuncture
    2) Supply-side economics (specifically, lowering taxes to stimulate investment)
    3) Death penalty as a deterrent

    I could go on…. Data, people! Argh!

  10. #10 Dan Gaston
    September 27, 2011

    Is it not normal in most of the medical research literature, when calculating p-values, to adjust for multiple comparisons? I work in evolutionary biology (phylogenetics) and we work with p-values quite frequently for everything from sequence extremely sophisticated statistical tests. If I ever tried to report uncorrected p-values the reviewers would flay me alive.

    And it isn’t like a Bonferoni correction is hard, in fact it is extremely easy to do. Of course it is also extremely conservative so things are less likely to turn out to be significant.

  11. #11 Mu
    September 27, 2011

    I don’t know, seems to be the study says poking (or pretending to) the woman with needles increases your chance to get pregnant. A whole new avenue for kinky bedroom toys.

  12. #12 Mojo
    September 27, 2011

    Not only is it confusing to the public to learn that a placebo is equivalent to an active intervention…

    Perhaps it would be less confusing if it was put the other way round. The public ought to be able to figure out what “the intervention is equivalent to placebo” means.

  13. #13 Denice Walter
    September 27, 2011

    Obviously a *real* OMD would not have chosen to use acupuncture alone but would have orchestrated a symphony of holistically integrated treatments starting with *dong quai*, a female herbal tonic used since antiquity to synchronise and balance the entire *yin* Qi system, as well as teas ( ginger is estrogenic/ green tea counteracts androgens), and would probably burn moxa on the *d’an t’ien* point situated on the abdomen directly above the uterus/ ovaries. And meditation, *Then* you’d see significant differences!

    I’m joking. But that’s probably how they might respond to the results. In general, woo-meisters, whether they call upon the “mysteries of the East” or go European-style (it’s always the “doctors in Germany” prescribing herbal remedies), they often speak about using more than one woo. They are not simplistic like pharma-based SBM! ” One pill for one ill!” No, we’re talking total life-style-ism here. ( continued).

  14. #14 DavidCT
    September 27, 2011

    The paper got through peer review largely because the “peers” were also likely to be quackademics. The paper will still have an impact since many readers will not get beyond the abstract and the conclusion sections. That being the case, it will be counted as more evidence that woo works.

  15. #15 Techskeptic
    September 27, 2011

    The principles of acupuncture claim that there’s “life energy,” or qi, that flows through pathways in the body known as meridians and that sticking needles into specific points on these meridians somehow “unblocks” the flow of qi. This “qi” can’t be detected by science. There’s no evidence that it exists, any more than there’s any evidence that meridians exist.

    I really think we as skeptics should stop saying this or at least keep up with the claims better. Most people I talk to about acupuncture have moved beyond this and agree that there is no magical force. The new thinking is that yes, they were wrong that there is a magic force but in fact our network of nerves and blood vessels are kinda what the ancient chinese actually meant but could not know. Yes its a big equivocation, but nonetheless its the thinking. yes its stupid, but its the thinking.

    However if we are going to point out that acupuncture is ridiculous we should be pointing it out against what the people using it actually thinks it is. Its not blocking of Qi, its blocking (or freeing up of blocks) of energy that is in the nerves. And you cant deny that there is energy passing through the nerves can you?

  16. #16 Denice Walter
    September 27, 2011

    All of which gives them several “outs”: complicated protocols such as these would make compliance difficult, thus any failure could be viewed as that of the “patient” not the therapies: ” Well, you did it wrong!”. The totality of Multi-Varying Woo would make research more difficult including the fact that compliance would be measured solely by subject report. In addiition, the concept increases their mystique, sounds good as ad copy.

    If you peruse NaturalNews, you’ll see how Mike & Co suggest sets of therapies- you should modify your diet drastically along several variables: organic, raw, local, high fibre, etc.; you should increase exercise – do more than one activity; become more “spiritual” ( whatever that is). Of course, these suggestions give them more stuff to sell you.

    A certain well-known woo-meister boasts about his 40+ lifestyle-modification “clinical trials” (sic) a/k/a”Health Support Groups” all of which show success for multiple serious illnesses. He has the Data!

    I can’t draw here but imagine this: Subjects are asked to modify their diet ( vegan, organic, mostly raw, high fibre, etc), start myriad supplements ( listed here and in the product list), filtre water ( system suggested and sold at website’s store), clean environment,exercise aerobically 1 hour a day plus weight training, reduce stress, and become more “spiritual”. Several measures are taken “before” and “after” the 3 month intervention. Most are self-reports about improvement.

    You see where I’m going of course. There are about 100 independent and 20 dependent variables. Compliance and evaluation are self-reported. “Drop outs” serve as “controls”. This is the type of “research” woo-advocates often use as “data” ( the other type of “research” translates to reading stuff you like on the net). This is not a parody, it is accurate reportage.

    “Oh, what a tangled web we weave….”

  17. #17 Andrew Bellemer
    September 27, 2011

    @9 I’m also sort of shocked that this made it through peer review without having an post-hoc adjustments to the significance cutoffs for the t-tests (at least I couldn’t find any discussion of them in the methods section).

    One thing that I did find, however, is that some of their significant p-values came from analyzing both groups, not finding anything significant, dropping some participants from both groups, and then re-analyzing. Their reasons for dropping some points from the analysis sound scientifically valid, but it’s still dangerous statistical territory to be analyzing and re-analyzing the same data points, especially without any post-hoc correction.

  18. #18 Karen Delaney
    September 27, 2011

    I will admit that there are times when I read Respectful Insolence and find myself with a pencil and paper, making notes so I can be sure I’m understanding what I’m reading. I started this post, and I thought, so, they managed to prove it didn’t work…but then they posted it on their website and said it proved it did work…which would be insane… but it turned out that really was what I was reading. Desperation and fear must be very strong drivers for people who use woo. How else could anyone view something so perfectly negative as a positive?

  19. #19 Mojo
    September 27, 2011
  20. #20 Todd W.
    September 27, 2011

    @puppygod

    direct stimulation of afferent nerves

    Except that directly hitting a nerve would hurt like a…ahem…it would hurt a lot, wouldn’t it?

    One other interesting thing to note is that they didn’t just compare acupuncture (or electroacupuncture) to sham needles. The one’s getting the active treatment got pierced in different locations than the ones who were merely prodded. This, of course, casts even more doubt onto the validity (or lack thereof) of acupuncture, at least in terms of meridians.

    Another study to throw on the pile that says, “It doesn’t matter where or even if we pierce you, you’ll still just receive the non-specific effects associated with extra and/or exotic treatment that makes you think things improve even though they don’t.”

  21. #21 Scott Cunningham
    September 27, 2011

    Well, it was just as I thought. Another case of shouting “Wow! Negative controls are the best medicine ever!” Even if it were true, the study would be unpublishable rubbish because there were no proper controls. Authors who do this aren’t just blotting out reality for fantasy and wilfully misunderstanding negative controls once. They’re doing it twice in a minute. If they believe their own spin, they should have deferred publication until they could do more experiments comparing accupuncture and sham accupuncture against sham sham accupuncture.

  22. #22 Marry Me, Mindy
    September 27, 2011

    Not only is it confusing to the public to learn that a placebo is equivalent to an active intervention,

    Add me to the list of those who find this statement very puzzling. When actual treatment gives the same results as no treatment, the usual conclusion is that the treatment doesn’t really work, NOT that no treatment DOES work.

    This “sham acupuncture is just as good as real acupuncture” is complete nonsense. The proper assessment is that _real_ acupuncture is not better than sham acupuncture.

  23. #23 Tina S
    September 27, 2011

    I will read the article but must ask: why on earth would anyone want needles stuck into their skin on purpose like this? Aren’t medical needles bad enough? Do some folks just need to have more shots and blood drawn to get their needle fix?

  24. #24 Pareidolius
    September 27, 2011

    These are not stupid people writing this paper, therefore this is yet another case of Terrifying Researcher Self-delusion (TRSd).

  25. #25 anarchic teapot
    September 27, 2011

    This is sickening. The “study” is being reported by Reuters under the headline “Electro-acupuncture boosts IVF success in study” and of course the shills are tweeting it everywhere.

    http://in.reuters.com/article/2011/09/27/us-electro-acupuncture-idINTRE78Q4DK20110927

  26. #26 cervantes
    September 27, 2011

    It seems that what they are trying to claim is that they observed improvement in both groups (in one measure, of dubious clinical significance). Ergo, therefore either sticking needles in acupuncture points or making people believe you are doing so are both effective, but why confuse people by not doing “real” acupuncture?

    Of course what their claim really comes down to is that they have an uncontrolled, within subjects design trial of a set of two different procedures which they conclude post hoc to be equivalent, in which they observed a pre/post change in one parameter among many, for which they did no significance test (I don’t see any test of their before and after comparisons) and no comparison to natural history, and which was not their original hypothesis anyway. Based on this nothing, which they don’t even clearly specify, they claim they have found an effective intervention.

    That is absurd.

  27. #27 Matthew Cline
    September 27, 2011

    Isn’t the sham acupuncture used inappropriate, since the active intervention arm of the study used electricity? Shouldn’t the sham procedure be to insert the needles at random places and apply electricity?

  28. #28 kd
    September 27, 2011


    Not only is it confusing to the public to learn that a placebo is equivalent to an active intervention, but it also raises questions about the active intervention that may or may not be warranted.

    When an alleged “active” intervention does not perform better than placebo, the obvious conclusion should be that the “active” intervention is not an effective therapy.


    It would also be informative to investigate the pathophysiology of both true and sham acupuncture.

    So nice of the study authors to give us such a good example of one of those “unwarranted questions!” Why investigate the mechanism of action of a therapy that doesn’t work?

    So a group of pro-acupuncture researchers set out to do a placebo-controlled study and, when the data did not support their desired outcome, they reinterpreted the control group data as belonging to a second intervention, and concluded from so doing that the placebo itself warrants further study! Wow.

    So take it from alt med, Big Pharma. The next time a multi-billion-dollar study of a new potential drug isn’t looking good, you may wish to shift some of those research dollars over to investigating the sugar pill itself. It might be the cure for diabetes! (Well, maybe if dilluted to 30C…)

    In alt-med, when your intervention doesn’t outperform placebo, that doesn’t mean your intervention is ineffective. It just means the placebo becomes a candidate for a new alt-med modality…

  29. #29 Mary
    September 27, 2011

    Many people may not know this, but because of the wacky organic regulations in the US there’s a lot of alt-med used on their animals. I was in a discussion recently at an organic dairy site where they presented the book they used for treatments, which includes homeopathy. I demanded evidence for this–peer reviewed–and I got crank papers from alt-med sources. It was horrifying. I jokingly asked if they also have the cows wear power bands or do acupuncture. Unfortunately it turned out they are. Well, not the power bands….I hope.

    And then they told me I was being disrespectful for asking.

    Cow acupuncture. I kid you not.

  30. #30 Dangerous Bacon
    September 27, 2011

    “Cow acupuncture. I kid you not.”

    Sorry, skeptical person, but cow acupuncture is great for bovine fertility problems – including cystic ovaries.

    “Acupuncture is beneficial in a whole range of problems in cattle, including many of the most financially important conditions…Acupuncture can be useful in most fertility issues, including anestrus, cystic ovaries, retained or cystic corpus luteum, silent heat, pseudopregnancy, impotence, penile paralysis, inflammation of the reproductive tract, retained placenta, uterine prolapse, prevention of abortion or to induce parturition (Lin and Panzer, 1992).”

    “Acupuncture on animals is done using sterilised single-use needles. These are only about 0.20-0.25mm wide, as the picture shows. It is rarely painful and over 95% of patients are comfortable with acupuncture.”

    One is generally advised not to stand behind the 5% of cows which are not comfortable with acupuncture.
    I don’t see electroacupuncture being used for our bovine friends, but another wrinkle adds even more benefits.

    “For many conditions in cows, moxibustion is used. This means the use of heat, from burning a herb called moxa (mugwort), at an acupuncture point. The skin is protected with a salve, and then the loose moxa is placed on top and lit. Alternatively, a needle may be inserted and a disc of compressed moxa fixed to the top and lit. The heat penetrates the skin and stimulates the acupuncture point. This technique is used when the cow is diagnosed as suffering from ‘cold’.”

    Remember, it’s very safe, and a skilled cow acupuncture practitioner can make lots of moo-la.

  31. #31 Dangerous Bacon
    September 27, 2011

    “Cow acupuncture. I kid you not.”

    Sorry, skeptical person, but cow acupuncture is great for bovine fertility problems – including cystic ovaries.

    ht_tp://www.squidoo.com/cowacupuncture” rel=”nofollow”>

    “Acupuncture is beneficial in a whole range of problems in cattle, including many of the most financially important conditions…Acupuncture can be useful in most fertility issues, including anestrus, cystic ovaries, retained or cystic corpus luteum, silent heat, pseudopregnancy, impotence, penile paralysis, inflammation of the reproductive tract, retained placenta, uterine prolapse, prevention of abortion or to induce parturition (Lin and Panzer, 1992).”

    “Acupuncture on animals is done using sterilised single-use needles. These are only about 0.20-0.25mm wide, as the picture shows. It is rarely painful and over 95% of patients are comfortable with acupuncture.”

    One is generally advised not to stand behind the 5% of cows which are not comfortable with acupuncture.
    I don’t see electroacupuncture being used for our bovine friends, but another wrinkle adds even more benefits.

    “For many conditions in cows, moxibustion is used. This means the use of heat, from burning a herb called moxa (mugwort), at an acupuncture point. The skin is protected with a salve, and then the loose moxa is placed on top and lit. Alternatively, a needle may be inserted and a disc of compressed moxa fixed to the top and lit. The heat penetrates the skin and stimulates the acupuncture point. This technique is used when the cow is diagnosed as suffering from ‘cold’.”

    Remember, it’s very safe, and a skilled cow acupuncture practitioner can make lots of moo-la.

  32. #32 Stu
    September 27, 2011

    “Drop outs” serve as “controls”.

    What a wonderful way of putting it. You know what that reminds me of? AA!

  33. #33 adelady
    September 27, 2011

    I luuuurve acupuncture. Except it’s not acupuncture at all. Can’t stand needles of any sort. Laser is the way to go.

    Have no idea how or why it works – let alone for whom and for which conditions. But obviously some sort of stimulation seems to do the trick for my chronic pain and joint/muscle problems.

    Also fan…tas…tic for hand strain/weakness injury (self-inflicted by idiotic persistence with a particular task). But, whatever it is, it ain’t acupuncture the way it’s normally portrayed.

    My own view is that friends who ‘swear by’ acupuncture are really responding to the enforced half hour of immobility after needles are inserted. They’d get exactly the same benefit from a spa, massage, meditation, yoga session or the like that imposes stillness, relaxation, quietness and freedom from the fuss and bother of work and family activities.

  34. #34 Buckaroo
    September 27, 2011

    It also seems to me that they were lacking a control group whom had no treatment, also this is a terrible small group of people.

  35. #35 kevin R
    September 28, 2011

    I would be more than happy to see NCCAM fund more studies of this type. Despite the efforts of woo-meisters to spin it otherwise, it shows very clearly that there is no significant difference between actual and simulated(pretend) acupuncture. How is that anything but a victory for SBM.

  36. #36 Matthew Cline
    September 28, 2011

    @kevin R:

    I would be more than happy to see NCCAM fund more studies of this type. … How is that anything but a victory for SBM.

    NCCAM has already funded lots of studies that have turned out negative, yet all those negative studies don’t seem to have made any difference. The money would be better spent on other areas of research.

  37. #37 lilady
    September 28, 2011

    Isn’t it disingenuous for the NIH (National Institutes of Health) to have NCCAM under its banner. Wouldn’t the billions of dollars spent to disprove psuedoscience “medicine”, “therapies” and “nutritional supplements” be better spent at any of the other *NIH Institutes or Centers to actually do scientific research and to collaborate with researchers outside of the NIH?

    *NIH Institutes

    * National Cancer Institute (NCI)
    * National Eye Institute (NEI)
    * National Heart, Lung, and Blood Institute (NHLBI)
    * National Human Genome Research Institute (NHGRI)
    * National Institute on Aging (NIA)
    * National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    * National Institute of Allergy and Infectious Diseases (NIAID)
    * National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    * National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    * Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    * National Institute on Deafness and Other Communication Disorders (NIDCD)
    * National Institute of Dental and Craniofacial Research (NIDCR)
    * National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    * National Institute on Drug Abuse (NIDA)
    * National Institute of Environmental Health Sciences (NIEHS)
    * National Institute of General Medical Sciences (NIGMS)
    * National Institute of Mental Health (NIMH)
    * National Institute on Minority Health and Health Disparities (NIMHD)
    * National Institute of Neurological Disorders and Stroke (NINDS)
    * National Institute of Nursing Research (NINR)
    * National Library of Medicine (NLM)

    NIH Centers

    * Center for Information Technology (CIT)
    * Center for Scientific Review (CSR)
    * John E. Fogarty International Center (FIC)
    * National Center for Complementary and Alternative Medicine (NCCAM)
    * National Center for Research Resources (NCRR)
    * NIH Clinical Center (CC)

    The formation of the NCCAM is a perfect example of political will over science and could easily be de-funded and its “function” of testing junk science be handed over to other NIH institutes and Centers. Keeping it intact with ever-increasing funding only adds credence and legitimacy to CAM practitioners. Truly a scandalous waste of taxpayer money.

  38. #38 Pat
    September 28, 2011

    Forgive me, but I found “menstrual periods” very funny. I thought what other kind of periods are there and then remembered that Orac is not a woman.

  39. #39 kevin R
    September 28, 2011
    the money would be better spent on other areas of research

    Mathew Cline

    I agree 100% but that is not the political reality we live in. Politicians pander to whoever can deliver money and votes and Woo is a multibillion dollar industry with a lot of political and popular support. It isn’t going to go away anytime soon. If CAM is going to feed at the public trough–and it is–then SBM needs to keep insisting it demonstrate some efficacy. Yes, it takes time and money away from real research, but allowing CAM to claim successes based on “anecdotal evidence” and “other ways of knowing” is not a winning strategy.

  40. #40 Leigh Jackson
    September 28, 2011

    “…this acupuncture protocol was more effective for women with less severe metabolic disturbance (lower fasting insulin) or less androgen production (lower free testosterone) because neither of those factors were related to the ovulation rate among the participants in the sham arm.”

    If non-sham acupuncture can be recommended for women with the specified factors, it follows that sham acupuncture can be recommended for women without these factors. It’s nuts to recommend only the use of “real” acupuncture and not the use of sham when both are equally effective. And however safe needling may be, non-needling has got to be safer still.

    When results like these are used this way, acupuncture research looks to be nothing more than a racket.

  41. #41 Jack
    September 28, 2011

    I have a few arguments against this article, as well as the design of the study.

    However, let me say something a little outrageous instead:

    It turns out that the placebo effect, within the context of an acupuncture treatment, raises a woman’s chance of getting pregnant. Are you going to deny that woman treatment because it’s woo? remember, the placebo effect will be enhanced by going to an acupuncturist who specializes in fertility, as opposed to joining a study.

    You say the acupuncturist is a charlatan. She says I got pregnant.

    Why don’t we study what the placebo effect is good for and use it. It IS safe, compared to medicine and surgery.

  42. #42 Chris
    September 28, 2011

    Jack:

    It turns out that the placebo effect, within the context of an acupuncture treatment, raises a woman’s chance of getting pregnant.

    [citation required]

    Why don’t we study what the placebo effect is good for and use it. It IS safe, compared to medicine and surgery.

    Exactly what conditions requiring surgery do you propose to substitute a placebo? Acute appendicitis?

    And if you got pregnant, I hope your name is “Jacqueline.”

  43. #43 daedalus2u
    September 28, 2011

    One of the reasons that placebos work so well for PCOS is that PCOS is usually characterized by low nitric oxide. NO is the normal autocrine and paracrine regulator of androgen synthesis. It inhibits the rate limiting enzyme, so low NO then causes high androgen levels (observed in PCOS) which then triggers increased hair growth (observed in PCOS), so as to expand the niche where the bacteria I am working with normally live. This expanded niche would (in the wild) increase production of NO and nitrite which would be absorbed and which would then down-regulate androgen synthesis.

    The cycle: low NO, high androgens, hair growth, expanded niche for ammonia oxidizing bacteria, increased NO is part of the normal regulatory pathway. Anything that raises NO levels (such as placebos) is going to help conditions that are characterized by low NO (like PCOS).

  44. #44 JustaTech
    September 28, 2011

    @41 Jack:I’m sorry, but i simply cannot agree with your conclusion that because women in both study groups got pregnant, this means that both the “real” and “sham” acupuncture worked. Isn’t it much more likely that this outcome was happenstance? Just becaue a woman has POS doesn’t mean that it is impossible for her to get pregnant, it is simply much harder. In fact, i would be shocked if none of the study participants in either group got pregnant. Each person presents a slightly different disease profile, that is why you need a big sample size, to deal with those outliers.

    Granted, it would have been a stronger study with a no-treatment control arm, but I really don’t think that the conclusion that you have reached is the most logical.

    (And really, a study with a p-value of 1? Even if it was only for one condition (self-reported acne), I am totally amazed that the authors would even try to draw the conclusion that their treatment groups are different. Yay null hypothesis!)

  45. #45 Mary
    September 28, 2011

    @Dangerous Bacon: what a surprised, a non-peer reviewed web page of an alt-med veterinarian….

    I’m sure they make moo-la. Gullible people seem to have significant cash for reasons that I cannot fathom.

  46. #46 kd
    September 28, 2011

    It turns out that the placebo effect, within the context of an acupuncture treatment, raises a woman’s chance of getting pregnant.

    I think a different kind of poking must be going on in that acupuncturist’s office.

  47. #47 Leigh Jackson
    September 28, 2011

    @daedalus2u
    The study’s authors found that the two arms showed differential but equal effects: true acupuncture being associated with low androgen patients, sham acupuncture with high androgen patients.

    The design of the study means that the null hypothesis cannot be ruled out: it’s possible that neither treatment had any effect on fertility.

    Assuming that true acupuncture is a placebo your hypothesis would predict greater fertility in the sham group, which was not observed. Either your hypothesis fails or true acupuncture is more effective than a placebo.

    There’s a mountain of evidence pointing to acupuncture being a placebo; this study included.

  48. #48 daedalus2u
    September 29, 2011

    Leigh, true acupuncture and sham acupuncture are both placebos. The only mechanism(s) by which they have any positive effects are via placebo effects.

    Placebos do “work” for some things, that is why CAM has so many adherents. They have seen their CAM placebo “work”. But how good a placebo a particular CAM practice is depends on the charisma of the CAM practitioner and how susceptible that particular patient is at that particular time to that particular placebo administered by that particular CAM practitioner.

    My guess is that for the patients who got pregnant, the particular treatment they got (true or sham) was an effective placebo for them and that improved their endocrine profile such that they ovulated and got pregnant. Maybe they would have gotten pregnant anyway, they probably would have gotten pregnant if any other equally effective placebo was used. With a better placebo, even more would have gotten pregnant.

    My point is that effective placebos have physiological effects. Those as yet unknown physiological effects are triggered by placebo effects through as yet unknown mechanisms. If we knew what those as yet unknown effects actually were, then perhaps they could be triggered by something other than placebos.

    The constellation of symptoms that characterize PCOS are associated with a shifting of NO mediated physiological signaling pathways to lower NO levels. The constellation of symptoms that characterized a lessening of the symptoms of PCOS are associated with a shifting of NO mediated physiological signaling pathways to higher NO levels. Effective placebos do tend to shift physiological signaling pathways to higher NO levels. Therefore is is not a surprise to me that administering a placebo could result in improvement of PCOS.

  49. #49 W. Kevin Vicklund
    September 29, 2011

    One of the reasons that placebos work so well for PCOS is that PCOS is usually characterized by low nitric oxide.

    [citation needed]

  50. #50 elburto
    September 29, 2011

    Hang on – there’s a rabbit away here (Local dialect phrase for “Somethings not right”) and I’m not talking about d2u’s ever-predictable NO obsession.

    The study mentions that none of the patients were using hormonal treatments, yet across groups there was an uptick in pregnancy and ovulation, with reduced insulin resistance and fewer androgens. Well that’s probably because hormone treatment does absolutely bugger-all for PCOS, while the gold-standard for treatment is using metformin at an average dose of 1500mg per day.

    The laziest of doctors throw a prescription for a combined pill at women with PCOS saying “This will regulate your period”, but nobody has menstrual periods on OCPs as they suspend the cycle. Instead the patient gets a monthly withdrawal bleed during the placebo week of the pills, and the PCOS is merely masked. Symptoms return as soon as the pill is discontinued.

    Clomiphene (to induce ovulation) is only used where metformin fails to reduce insulin resistance (and therefore testosterone levels that inhibit ovarian function) enough that spontaneous ovulation and regular menstrual cycles return.

    Does the study mention anywhere if any of the subjects were using metformin? Their “no hormonal treatments for 60 days prior” is a clever trick, because most people (including doctors) assume that PCOS is a purely hormonal reproductive issue, rather than an endocrine one. So, if any of the test subjects were using metformin then an already worthless test has been rendered truly worthy of the bin.

  51. #51 daedalus2u
    September 29, 2011

    How about this?

    Determinants of insulin responsiveness in young women: Impact of polycystic ovarian syndrome, nitric oxide, and vitamin D.

    http://www.ncbi.nlm.nih.gov/pubmed/21741493

    ADMA is an endogenous inhibitor of nitric oxide synthase. Its presence causes the inhibition of NOS and reduces NO levels.

    Polycystic ovary syndrome is associated with severe platelet and endothelial dysfunction in both obese and lean subjects.

    http://www.ncbi.nlm.nih.gov/pubmed/19027116

    Endothelial dysfunction is associated with low NO.

  52. #52 Leigh Jackson
    September 29, 2011

    daedalus2u
    The relevant effects in this study were not physiological unless ovulation and pregnancy count as such. Rates of ovulation and pregnancy were equal for both arms. We do not know whether the same results would have occurred without intervention.

    The fact that one arm was associated with low and the other with high androgen levels had no bearing on ovulation or pregnancy rates.

    The only thing that this study shows for certain is that manually and electrically stimulated needling of acupuncture points is no more effective than non-stimulated non-needling of non-acupuncture points for PCOS related infertility. That is, acupuncture is no more effective than placebo.

    Whether acupuncture or sham had any bearing on ovulation or pregnancy is a matter of pure speculation.

    Electro-acupuncture cannot be said to be good news for women with PCOS seeking pregnancy on the basis of this study. To recommend it as being a very safe intervention and not recommend the equally effective (or non-effective, as the case may be) sham acupuncture, which is safer still, is perverse.

  53. #53 Noadi
    September 29, 2011

    I don’t know, seems to be the study says poking (or pretending to) the woman with needles increases your chance to get pregnant. A whole new avenue for kinky bedroom toys.

    New? Sorry, kinky folks beat you to that a long time ago. Play piercing has been around in the BDSM community for a very long time.

    As for acupuncture in general, as has been said it appeals because if has some plausibility. You are actually doing something that provokes a physiological response even though “qi” is a pre-scientific notion. Alchemists actually did make some advances even though their actions were based on some pretty ridiculous premises. It’s possible to hit on the right answer for the wrong reason.

    Endorphins do reduce the perception of pain. The problem is that endorphins are a short term solution they wear off quite quickly. Maybe someone might have some short term relief with acupuncture (and by short term I mean like 10-20 minutes) but beyond that it’s totally placebo. Those natural pain killers only evolved to keep us going long enough that we don’t get eaten by a predator.

  54. #54 Matthew Cline
    September 29, 2011

    @Jack:

    It turns out that the placebo effect, within the context of an acupuncture treatment, raises a woman’s chance of getting pregnant. Are you going to deny that woman treatment because it’s woo?

    Assuming it the placebo effect in these circumstances does actually increase the chance of getting pregnant, a doctor using it would require lying to the patient, which is something that doctors are no longer supposed to do.

  55. #55 Anne
    October 1, 2011

    As a TCM student, I find the general perception of acupuncture by the medical community troubling, but considering the explanations we offer for the effectiveness of the treatments, I’m not surprised. As someone who also studies Mandarin Chinese, I have to say that I find it ridiculous that TCM schools continue to promote the de Morant’s mis-translation of the word “qi” as “life force energy”. Qi has many meanings, none of which are “energy”. Qi means “air”, “vapor”, or “the essence of air” (oxygen, in modern bio-medical terms). Qi also means “function”, as in the function of an organ. Another meaning is “temperature” If you read an ancient Chinese medical text, the word “qi” could refer to any number of these things, depending on the context. Acupuncture, historically, was never an “energetic medicine”. Modern TCM practitioners use traditional terms like “Kidney Qi definciency” which sound very “woo” if you don’t know the correct meaning of the word “qi”. But, as TCM students, we really have to have a foot in both worlds, so to speak. We have to have a modern biomedical understanding of disease processes (after all, we are living in the 21st century). There is no way that states such as California, New Mexico or Florida would allow us to practice as Primary Health Care providers if we did not have an understanding of physiology, pharmacology, pathology, anatomy, etc. However, since we are studying a 2,000 year old medicine, we also have to play translator, to a certain extent. For example, the ancient Chinese had no knowledge of hormones, so they attributed all endocrine function to the Kidney organ. Consequently, the herbs that discovered that appeared to help with these endocrine issues were referred to as “Kidney tonics”. When we as modern TCM practitioners say that a patient has a “Kidney pathology” we have to know that what we are really referring to is the endocrine system, and we have to know what affect the “Kidney tonic” we are prescribing is actually having on the body. Unfortunately, when we use this kind of language, people seem to think that we are referring to the literal Kidney organ, and they say “that’s not right”. But we’re not referring to the literal Kidney organ. In any case, it’s frustrating because we are required by law to use certain terminology (ancient Chinese medical terminology), all of which makes us sound rather ignorant, even though we aren’t. Ah well.

  56. #56 Marcus Ranum
    October 2, 2011

    With all the years that acupuncture has had in which to demonstrate a significant, lasting effect – it’s way past time to stick a fork in it and declare it “done!”

  57. #57 JoeVet
    October 3, 2011

    @55 Anne your are not helping your profession here. TCM is patently unsafe because it is unregulated. It is not uncommon for TCM to be spiked with other herbs or real prescription meds in dangerously high doses. The efficacy and safety of the products are unreliable as one would expect from 2000 year old “science”. Your interpretations of kidney treatments actually meaning endocrine treatments demonstrates not only poor terminology but that the developers of these meds had no real understanding of what they were treating. Old is not better when science is discussed and TCM is old enough to be dangerously irrelevant.

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