May 11 2017

Open Letter to FDA on Acupuncture

The FDA recently amended their draft proposal for: FDA Education Blueprint for Health Care Providers
Involved in the Management or Support of Patients with Pain. The draft proposal includes this statement:

“Nonpharmacologic therapies – includes psychological, physical rehabilitative, surgical approaches; and complementary therapies.”

And below further defines, ” Complementary therapies – e.g., acupuncture, chiropracty”

Recommending:

“HCPs should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multidisciplinary approach to pain management.”

While the current problems with opioid overuse are significant and adequate pain management remains a challenge, introducing unscientific methods will not help health consumers and will only waste resources. Introduction of these recommendations for unscientific methods does not reflect scientific consensus, but intense lobbying by proponents who stand to financially gain from their inclusion.

Acupuncture specifically has been studied extensively, with thousands of clinical trials, and yet proponents have not been able to demonstrate that acupuncture is effective for any indication, including pain. In short, acupuncture does not work.

A 2009 systematic review of acupuncture studies for pain (Madsen et al) is typical of the research. They found:

DATA SYNTHESIS:
Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials. The clinicians managing the acupuncture and placebo acupuncture treatments were not blinded in any of the trials. One clearly outlying trial (70 patients) was excluded. A small difference was found between acupuncture and placebo acupuncture: standardised mean difference -0.17 (95% confidence interval -0.26 to -0.08), corresponding to 4 mm (2 mm to 6 mm) on a 100 mm visual analogue scale. No statistically significant heterogeneity was present (P=0.10, I(2)=36%). A moderate difference was found between placebo acupuncture and no acupuncture: standardised mean difference -0.42 (-0.60 to -0.23). However, considerable heterogeneity (P<0.001, I(2)=66%) was also found, as large trials reported both small and large effects of placebo. No association was detected between the type of placebo acupuncture and the effect of acupuncture (P=0.60).
CONCLUSIONS:
A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

Nothing has changed in the years since. The most rigorous trials for acupuncture, ones in which subjects are properly blinded and adequate controls are use, show no difference between verum (true) acupuncture and sham or placebo acupuncture. For example, a 2013 review of acupuncture for low back pain concluded:

“Compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life, but these effects were not observed when compared to sham acupuncture.”

This pattern is typical – when acupuncture is compared to no treatment, which is an unblinded comparison, there is a difference. When compared in a properly blinded fashion to placebo acupuncture, there is no difference. The only scientific interpretation of this pattern of results is that acupuncture provides no specific benefit, the results are placebo effects only.

Thousands of studies in acupuncture clearly show that acupuncture points do not exist. They have no basis is physiology or anatomy. Further, and unsurprisingly, needle location does not affect treatment outcome. In fact, needle insertion does not affect outcome, when compared to simulated insertion (such as poking the skin with tooth picks). Since the operational definition of acupuncture is inserting needles into acupuncture points, it is fair to say that acupuncture does not work.

By officially recommending acupuncture as a treatment for pain the FDA is essentially “approving” the efficacy claims for acupuncture.

Would the FDA, however, approve a drug if the most rigorous clinical trials all showed no difference in efficacy between the drug and a placebo, and only showed a difference in subjective outcome in unblinded comparisons?

Acupuncture proponents are essentially arguing that both their drug (acupuncture) and the placebo of their drug work by some unknown mechanism. This turns scientific logic on its head, however. The standard interpretation, the one on which the entire FDA drug approval process is based, is that in order to prove efficacy you must demonstrate a clinically significant difference between treatment and placebo in a properly blinded comparison.

Acupuncture has failed to demonstrate such efficacy after thousands of studies, and it therefore seems unlikely it ever will.

I urge the FDA not to abandon its scientific principles under lobbying pressure from special interest groups, or out of desperation from dealing with an intractable problem.

24 responses so far

24 Responses to “Open Letter to FDA on Acupuncture”

  1. Gammaon 11 May 2017 at 8:32 am

    “This pattern is typical – when acupuncture is compared to no treatment, which is an unblinded comparison, there is a difference. When compared in a properly blinded fashion to placebo acupuncture, there is no difference. ”

    This seems to be utterly unscientific approach to study acupuncture. Real question is not whether needling at so called “acupuncture points” has any difference in relation to needling at some random points, which can be called “alternative acupuncture” in lack of better term (pun intended). I doubt if there is even full consensus where those acupuncture points are located. And if there is, it doesn’t matter, because there seems to be good reasons to think that possible effect of acupuncture is based on needling itself, and there is no need for specific exact spots.

    This might make blinding more difficult, but you have to live with that – you can make scientific studies even with surgery so why not effects of needling. You cannot just make things up, claiming that if some specific spot hasn’t a power to make a difference in relation to “alternative acupuncture”, therefore use of the needling in the acupuncture doesn’t have any effect in general. That doesn’t simply follow. I’m not saying needling has some medical effect, but using some kind of “alternative acupuncture” as a control is clearly not a correct approach to study a real question in relation to acupuncture.

    And about reference to pain killers. I suspect one can hardly put them to the same medical context with the acupuncture. As you said “the current problems with opioid overuse are significant and adequate pain management remains a challenge”. I suspect there is no such overuse problems with acupuncture…

  2. edamameon 11 May 2017 at 10:03 am

    Have there been studies comparing acupuncture, nothing, and placebo pills (instead of placebo acupuncture)?

  3. Sarahon 11 May 2017 at 11:15 am

    The FDA is operating in a world of double standards.

  4. RickKon 11 May 2017 at 11:16 am

    Expensive sugar pills have a stronger analgesic effect than cheap sugar pills:

    https://today.duke.edu/2008/03/placeboprice.html

    Does that mean the FDA should approve sugar pills for pain relief?

  5. trumpproctoron 11 May 2017 at 11:49 am

    The problem with acupuncture is because it deals with the very subjective “loosy goosy” realm of aches and pains. Any outcomes that are solely derived by the answer to the question “So, how do you feel?” need to be taken with a grain of salt (a 2000lb grain of salt).

    Because it deals with pain, it’s very susceptible to falsely attributing working just due to regression to the mean. I’ve had friends do the “well it worked for me” song and dance, when in reality, would they have felt better even if they had no acupuncture at all? Had the acupuncture not “worked” for them and someone told them that sonic tuning forks would relieve their pain and they “regressed to the mean” after a sonic tuning fork treatment, they would believe and be giving personal anecdotes that sonic tuning forks are effective in treating pain… “It worked for me”!

    And according to our buddy Egnor, (in a previous thread about the historicity of Jesus) personal anecdotes are some of the highest standards of evidence we have! *rolls eyes*

  6. Karl Withakayon 11 May 2017 at 11:52 am

    “Acupuncture proponents are essentially arguing that both their drug (acupuncture) and the placebo of their drug work by some unknown mechanism.”

    The thing that gets me about this special pleading is, if it were true, why not use the lower risk and less invasive technique of acupoking that doesn’t involve needle insertion and all the associated risks that come with needle penetration?

    If the benefit is the same, use the one with less risk, right?
    If location doesn’t matter, then why waste training and education time on it?

    Why does anyone who makes the unknown mechanism claim continue to promote acupuncture over sham acupuncture?

  7. Karl Withakayon 11 May 2017 at 12:03 pm

    edamame:

    “Have there been studies comparing acupuncture, nothing, and placebo pills (instead of placebo acupuncture)?”

    Yes, but you cannot blind the subjects in such a study as to what type of treatment they are receiving.

    Generally, the more elaborate the inert intervention, the greater probability and degree of a placebo response. (nothing/counseling < sugar pill < saline injection, etc)

    That's the reason for the development of sham acupuncture that eschews both of the major claimed components of acupuncture, needle insertion and needle location, so you can blind the recipient.

  8. fbrosseaon 11 May 2017 at 12:41 pm

    @Edamame you may want to check out http://www.bmj.com/content/early/2005/12/31/bmj.38726.603310.55?ck=nck

    it’s interesting how perceived pain decrease more in the sham acupuncture group. Granted this is a small study.

  9. edamameon 11 May 2017 at 1:46 pm

    Karl: You are right that there are a lot of reasons such a study would be flawed, one being proper blinding, the other being the controls aren’t matched properly to the treatment.

    This also would be balanced with potential flaws in acupuncture studies that use sham acupuncture in which the “placebo” may not be a true placebo if it causes localized adenosine release, which is a known analgesic, and many of its proponents believe that is a the mechanism of pain relief of acupuncture. Hence, saying it is a placebo is like using aspirin as a placebo in a study of tylenol.

    Here is a highly relevant study published in the BMJ that showed little difference between placebo pill and sham acupuncture. There were some differences at some points in time on some measures, but mostly small, and sometimes placebo pill had bigger effect:
    https://www.ncbi.nlm.nih.gov/pubmed/16452103

    Another highly relevant study:
    https://www.ncbi.nlm.nih.gov/pubmed/23935833
    They compared placebo pill, sham acupuncture, rest, and real electroacupuncture in a multiple session crossover study. Interestingly, they found no signficant difference, but then proceeded to use “post hoc” analysis:

    While the null hypothesis of global F-test for the effect of treatment on the pain tolerance outcome could not be rejected, it should be noted that an exploratory post-hoc analysis using a test for detecting trends across the treatment groups did reveal a significant progression in the strength of treatment effects when the treatments were ordered as rest control condition< placebo Tylenol = sham acupuncture < electroacupuncture.

    I think this is the kind of statistical bullshit that Novella warns us about.

    Also Karl, your first point is very well taken. If the effect is no greater than pinching someone or other “treatments” that could trigger localized adenosine release that dulls pain, why the hell do acupuncture with all its risks etc? I guess some people want deeper needle insertion to have deep adenosine release at hard-to reach places? But then we get into crazy risk levels. Just take a dang aspirin.

  10. chikoppion 11 May 2017 at 1:51 pm

    Cite all the studies you like. I got over my last cold by not having acupuncture done. Not having acupuncture done is a miraculous cure being suppressed by doctors and pharmaceutical something, something, etc. Also, toxins.

  11. edamameon 11 May 2017 at 1:58 pm

    Note also in the previous study, even with their post-hoc analysis they found placebo pill equal to sham acupuncture. This is very damning for the proponents of acupuncture who would want to say that the sham acupuncture is having an effect due to adenosine release, so is not a true placebo.

    I have often argued here that this might be a possibility. It seems it is not, based on these studies, in which case I am starting to veer toward Dr Novella’s conclusions about acupuncture.

    A final line of defense from the acupuncturists gets back to one of Karl’s concerns: can you really double-blind the acupuncture/sham acupuncture? It turns out it is really hard to do this, that people (in particular the acupuncture practitioner) are pretty good at telling them apart:
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4352029/

    However, this only counts against the proponents of acupuncture: the onus on them is to perform proper blinding and show their treatment works.

  12. Steven Novellaon 11 May 2017 at 2:01 pm

    Karl – you are correct. I would argue that, using the very studies proponents use to promote acupuncture, the only ethical treatment to use is:

    An untrained but sympathetic practitioner randomly poking the skin with toothpicks.

    Years of training makes no difference. Location and needle insertion make no difference.

    The very studies they use indicate that training as an acupuncturist has zero value.

  13. mumadaddon 11 May 2017 at 2:24 pm

    I wonder if there’s a market for ‘alternative’ acupuncture? Harness the full power of placebo, with almost zero risk.

  14. mumadaddon 11 May 2017 at 2:26 pm

    Would it be unethical to use CAM marketing strategies to dupe people into less risky placebos?

  15. Karl Withakayon 11 May 2017 at 5:04 pm

    “An untrained but sympathetic practitioner randomly poking the skin with toothpicks. ”

    Well, they may need to be trained in the theatricality aspects of acupuncture administration, and it may make a difference to the perceptions of the recipient if the administrator of shamupuncture/ acupoking claims training and expertise.

  16. Karl Withakayon 11 May 2017 at 5:14 pm

    Placebo ethics are a complicated and much debated quagmire.

  17. Karl Withakayon 11 May 2017 at 5:28 pm

    edamame

    “This also would be balanced with potential flaws in acupuncture studies that use sham acupuncture in which the “placebo” may not be a true placebo if it causes localized adenosine release, which is a known analgesic, and many of its proponents believe that is a the mechanism of pain relief of acupuncture. Hence, saying it is a placebo is like using aspirin as a placebo in a study of tylenol. ”

    Does localized adenosine release in the amounts produced by acupuncture needling have a non local analgesic effect? Typically, acupuncture points are not local to the site being treated for. ie: Needling for left wrist pain might be done at a distant location like the right shoulder.

    Additionally, such a discussion assumes acupuncture for treatment of pain, which most practitioners of acupuncture do not limit themselves to. If that’s the claim of method of action, that precludes use of acupuncture for other purposes & conditions.

  18. Steven Novellaon 12 May 2017 at 7:06 am

    Gamma – you missed the part about poking the skin with toothpicks. That has been controlled for also – even if you don’t insert needles, but just simulate the sensation, the effect is the same.

    So needling anywhere doesn’t work.

  19. trumpproctoron 12 May 2017 at 8:43 am

    Karl – “Additionally, such a discussion assumes acupuncture for treatment of pain, which most practitioners of acupuncture do not limit themselves to.”

    True, and that just makes it more “magical bullshit”, when it’s claimed it also cures:

    General: Allergies, Asthma, Sinusitis, Headaches, TMJ, Back Pain, Sciatica, Musculoskeletal Problems, Insomnia, Anxiety, Dizziness, Depression, High Blood Pressure, Chronic Fatigue, Fibromyalgia, Addictions, Indigestion, Constipation, Sexual Dysfunction, Post-Operative Recovery, Palliative Care.

    Women’s Health: Menstrual Irregularities, Menopause, Conception Difficulties, Pregnancy, Childbirth, Lactation Difficulties, Postpartum, Ovarian and Uterine Problems.

    Men’s Health: Prostate, Infertility, Impotence.

    Pediatrics: Asthma, Cough, Digestive Problems, Behavioral Problems, Ear Infections, Sleep Problems.

    Preventative Health: Prevention, Stress Management, Wellness, Seasonal Attunement

    Muscle, Bone and Nerve Pain
    and Diseases Sprains / Strains Back Pain Leg Pain Foot Pain Stiff Shoulders and Neck Lumbago Sciatica Tennis Elbow Carpal Tunnel syndrome and Painful Joints TMJ; Toothache Headache and Migraines Rheumatism; Arthritis Facial Paralysis; Bell’s Palsy Fibromyalgia

    Obstetrics and gynecology Menstrual Pain and Cramping PMS Menopause Infertility Fetal Malposition

    Addictions Tobacco Narcotics Alcohol Weight Loss

    Diseases of the heart and
    blood vessels Angina High blood pressure Obesity Drug addiction Smoking

    Digestive disorders Indigestion Stomach ulcers Gall stones Diarrhea Constipation Nausea and vomiting Irritable Bowel Syndrome

    Diseases of the respiratory system Allergies Asthma Bronchitis Sinusitis

    Diseases of the nervous system Stroke Neuralgia Stress, anxiety, depression and other nervous disorders Nerve paralysis Headaches/migraines

    Yea, a single magical treatment that cures/treats all that. If that isn’t a major red flag of bullshit, I don’t know what is. What is depressing about this list though is I found it on the University of Miami School of Medicine’s website, and not as a “Look at this bullshit” list, but as a “people find acupuncture effective in treating these things” list.

    Remind me to make sure none of my doctors graduated from the University of Miami School of Medicine.

  20. edamameon 12 May 2017 at 9:02 am

    Karl adenosine release is localized to insertion point afaik from the rodent studies. Though I suppose it could relieve pain elsewhere, in theory, if there was a sensory nerve passing by from that other location and that nerve’s activity could be suppressed via adenosine.

  21. Nidwinon 12 May 2017 at 9:12 am

    The issue with an improbable adenosine release by needle poking is that there are well known side effects of adenosine that haven’t been reported through acupunture as far as I know.

    Anyway,

    The irony is that when acupunturists become “ill” they don’t go to a fellow acupunturists but to the doctor or hospital.

  22. BillyJoe7on 12 May 2017 at 9:50 am

    “adenosine release is localized to insertion point afaik from the rodent studies”

    They stuck acupuncture needles into the rodents’ knees, which would be analagous to sticking a nine inch nail into your knee.

    Here is David Gorski’s take:
    https://sciencebasedmedicine.org/another-overhyped-acupuncture-study-misinterpreted/

    Here is Steven Novella’s take:
    https://sciencebasedmedicine.org/potential-new-mechanism-of-pain-relief-discovered/

  23. Karl Withakayon 12 May 2017 at 10:39 am

    edamame

    “Karl adenosine release is localized to insertion point afaik from the rodent studies.”

    Yes, but since that is almost universally not how acupuncture is not practiced, those studies are not studying acupuncture, they are studying localized dry needling. Those studies are no more relevant to the practice of acupuncture than ones using application of “alectroacupuncture” which is also not acupuncture.

    Any results from such studies cannot in any way be generalized to the practice of acupuncture, its underlying principles, or its claimed method of acting. You really can’t eliminate the chi point localization and/ or needle penetration (or add electricity) and claim you’re still talking about acupuncture.

    “Though I suppose it could relieve pain elsewhere, in theory, if there was a sensory nerve passing by from that other location and that nerve’s activity could be suppressed via adenosine.”

    Sure, we can speculate about a whole bunch of things for which we have no evidence, and we could even use those speculations as the basis for some preliminary investigations (such as looking into whether such a phenomenon even seems to exist), but I see no reason to ponder such speculations at this time.

    A hypothesis is a proposed explanation for a phenomenon. You have to establish that the phenomenon actually exists before you spend time searching for an explanation.

    See also: Tooth Fairy Science.

  24. zorrobanditoon 17 May 2017 at 7:55 pm

    We do acupuncture on horses. We do it quite a lot, actually. See http://www.acupunctureproducts.com/horse_acupuncture_chart.html

    I’m not quite sure what to make of this. Horses of course are not susceptible to suggestion (at least we hope they are not) nor, I assume, to the placebo effect. I assume that the skeptics would say that any improvement in any condition the horse might be suffering from would be imaginary, not in the horse, but in the owner.

    Horse owners swear by acupuncture, however.

    I have a friend, a westerner, a surgeon, who was also trained in acupuncture in Beijing. He came by with his needles and I said, OK, how does it work?

    He said, well, your chi….

    I said no no, no chi, give me an explanation that makes sense to me.

    He said, we do not have a clue. But the last thing I did before I left Beijing was to assist at a craniotomy at which the only anesthesia was acupuncture. Don’t tell me it doesn’t work, it works.

    I am not a physician. I’ve never tried acupuncture. I don’t know anything about it. Is it possible that some mechanism is at work that we simply don’t understand?

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