Authors unhappy as “battlefield acupuncture” paper earns an expression of concern

A journal has slapped an expression of concern on a 2021 paper reporting on the utility of self-administered “battlefield” acupuncture in soldiers, citing readers who said the FDA has not approved the devices for that use – a point the authors, who object to the move, dismissed as irrelevant and misleading. 

The study, which appeared in Medical Acupuncture, looked at the experiences of a dozen veterans at an Ohio VA hospital who’d purportedly self-administered acupuncture to treat chronic pain. According to this 2010 article from the U.S. military

Battlefield acupuncture is a type of ear (auricular) acupuncture–needling is done to the external part of the ear. The concept that the ear has a connection to all parts of the body dates back to the origins of traditional French, German, and Chinese medicine …  

The needles [typically]  look like tiny gold earrings and can stay in the ear for up to several days or longer. After each application, the patient walks around for about 2 minutes to determine whether effects on pain are occurring and whether further applications are needed.

The technique was pioneered by Richard C. Niemtzow, a physician and now-retired Air Force colonel who was reportedly the first full-time physician acupuncturist in the Armed Forces. Niemtzow also is the editor-in-chief of Medical Acupuncture

The paper was titled “Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project” and it was published online in October. According  to the expression of concern:

The journal has received communications from several sources raising significant concerns regarding the claims made in this article as they pertain to the self-administration of Battlefield Acupuncture and patient self-use of acupuncture needles. Each communication states that acupuncture needles are considered FDA-approved medical equipment and are not intended for patient self-administration. 

An official inquiry with the authors’ institution has been launched by the editors and publisher of the journal. Such an inquiry may be a protracted process but the journal will update this notice once a resolution has been reached.

Brian James

Brian James, a pain specialist at the Chillicothe VA Medical Center and  the first author of the paper, said he and his colleagues were blindsided by the expression of concern and disagree with the journal’s decision to flag the paper: 

The criticism does not have anything to do with the data or scientific content of the study. Many people I have spoken with, including other physician acupuncturists and higher up people in the VA complementary medicine field, think that this expression of concern is unusual and unfounded. No one I corresponded with in the chain of approval had any objection to this study. I am not aware of any actual physicians who have objected to this study and I have not been told who objected, although I am aware of a chiropractor acupuncturist and other non-physician acupuncturists in the VA who objected.

The criticism is only because we allowed patients to self-administer with these small needles, which is consistent with well-established medical practices of allowing patients to use sharps on themselves for other medical conditions such as blood sugar testing in diabetes. …  It was literally an IRB-approved clinical trial to see if this was feasible and safe on a small scale to see if a larger study is warranted. The objection is literally “you can’t do this because it’s not FDA approved for this.” Taking the logic of their objection at face value and applying it consistently to other clinical trials would mean that you could only investigate new things for conditions and indications for which they are already approved by the FDA (which obviously is a non-sensical assertion).

James – whose group submitted a detailed response to the expression of concern (less a rebuttal than a proposed way forward) that has not been published but which we have received permission to post – added that he is:

waiting for the publishing company to remove the expression of concern, which is not due to any scientific objection as previously stated. I suspect [it] is due to someone trying to gatekeep this modality of acupuncture.

Meanwhile, a spokesperson for MaryAnn Liebert, which owns Medical Acupuncture, told us it would be publishing a letter to the editor from an author unrelated to James’ group “by the end of this week.”

Update, 2100 UTC, 1/7/21: The letter to the editor has been published.

Update, 2200 UTC, 1/19/21: James asked that we add a note saying that his “statements in this article are his personal opinion and do not represent the views of the VA organization or the federal government.”

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25 thoughts on “Authors unhappy as “battlefield acupuncture” paper earns an expression of concern”

  1. The FDA approval criticism is asinine. The FDA is not required to approve an IDE for a trial if the device and trial are seen by the IRB to not post a significant risk to participants.

    The IRB is allowed to serve as a “surrogate” in the less cases.

    1. Thank you, Matilda. No one in the review process mentioned the possibility of this having to have an IDE and your comment helped me find clear information that is clearly applicable to this study.

  2. It’s grimly amusing that a study on acupuncture was retracted for reasons other than the fact that acupuncture has never been proven to do a damn thing for patients beyond perhaps the placebo effect.

    1. In this case, an aberrant spinoff of acupuncture that was dreamed up in 1950 by a French con-man (Paul Nogier) on the basis of an imagined similarity between the shapes of the ear and the human fetus.

      At least it’s is a form of quackery – sorry, Complementary Medicine – that vets don’t have to worry about, because (e.g.) horse ears do not look like horses.

      “The concept that the ear has a connection to all parts of the body dates back to the origins of traditional French, German, and Chinese medicine”

      This claim to antiquity highlights the fact that everyone involved in this scam is a charlatan.

      1. Clearly it’s a scam, but in this case I agree that the reason for the expression of concern makes no sense. The fact that something is approved or not by some governmental agency has absolutely no bearing on scientific results.

        1. Just imagine the impact of this!!! In many PCMH clinics in the armed forces they provide this fraudulent therapy instead of scientifically proven therapies, such as Botox. Money issues?

          1. We provide Botox at our VA for spasticity, dystonia and migraines. The provider who does these also is trained in BFA.

            We do not use this in lieu of proven modalities. It is simply an option that is available for people to try and seems to provide modest, temporary relief for some types of chronic pain for a subset of patients.

      2. I agree, I don’t believe in the inverted fetus concept (which is ludicrous and untestable) and no one is appealing to antiquity here. The fact that relatively untrained people seemed to be able to get similar effects argues to some extent that the “point” locations don’t matter critically and that a more generalized effect (including possibly the placebo effect or a general neuromodulatory effect) may be operative. All the participants in this study chose to participate because they received modest but noticeable pain relief for several days per application over multiple instances. No miraculous claims are being made here and none should be. No one is making any money off this either (to my knowledge).

        There is a least one functional MRI study available that seem to show relative suppression of pain-related areas after auricular acupuncture and some post-operative studies that show reduction in pain medication use. Those studies are cited in the paper. Again, no one is making grandiose claims for miraculous efficacy and I hope this study will actually facilitate a larger and statistically powered study that will determine NNT for a well-defined treatment response. If the NNT turns out to be ridiculously large then it will probably be a good argument that acupuncture is largely due to placebo. However, as someone who has offered this treatment as an option for a while, its efficacy for any given individual does not seem correlated to treatment expectations.

        The study has not been retracted and I don’t expect it to be.

  3. The reason behind the belief for Battlefield Acupuncture working is not that the eat looks like a human fetus at all, it’s a scientific process which interferes with the pain signals to the brain via the nerves that go through the ear. If Smut Clyde had ever experienced the pain relief given by Battlefield Acupuncture then he would have never written the comment he did. I have experienced this first hand and have seen many others experience the pain relief. Just because someone doesn’t agree with something because they don’t understand it, doesn’t mean it should be denied people that do benefit from it.

    1. Yes, we don’t believe that the ear is a holographic representation of an inverted fetus, that is ludicrous. This is an option that is available for vets that seems to work for a decent subset, no one is claiming it is a miraculous cure for anything and no one should.

    2. So why do the proponents of BA feel obliged to make up an ancient provenance for it (“dates back to the origins of traditional French, German, and Chinese medicine”) which simply isn’t true?

      It is certainly possible that after Nogier pulled the whole “ear = fetus” fantasy out of his butt and used it to map various points of the ear to corresponding body parts, his entire fantasy coincidentally turned out to be true, but it seems implausible.

      In your experience, do the locations of ‘ear needling’ matter, so that one system of Auricular Acupuncture points is correct and rival systems are wrong? Or does the patient benefit regardless of the position of the piercing?

      1. Smut Clyde:
        I agree, I don’t believe in the inverted fetus concept (which is ludicrous and untestable) and no one is appealing to antiquity here (at least not this provider).

        The fact that relatively untrained people seemed to be able to get similar effects argues to some extent that the “point” locations don’t matter critically and that a more generalized effect, including possibly the placebo effect and/or or a general neuromodulatory effect, may be operative. All the participants in this study chose to participate because they received modest but noticeable pain relief for several days per application over multiple instances. No miraculous claims are being made here and none should be. No one is making any significant amount of money off this either (to my knowledge).

        There is a least one functional MRI study available that seem to show relative suppression of pain-related areas after auricular acupuncture and some post-operative studies that show reduction in pain medication use. Those studies are cited in the paper. Again, no one is making grandiose claims for miraculous efficacy and I hope this study will actually facilitate a larger and statistically powered study that will determine NNT for a well-defined treatment response. If the NNT turns out to be ridiculously large then it will probably be a good argument that acupuncture is largely due to placebo or that only a small subset respond. However, as someone who has offered this treatment as an option for a while, its efficacy for any given individual does not seem correlated to treatment expectations and it has a reasonable chance of providing modest relief for a reasonable time frame for a decent subset of patients.

        The study has not been retracted and I don’t expect it to be. I hope that this study advances science and improves patient care. If that ultimately means disproving the modality, then at least it will discourage people from wasting time and resources with what is a currently popular option.

        1. no one is appealing to antiquity here (at least not this provider).

          In the interview quoted in the main post, Dr. Niemtzow invokes the Appeal to Antiquity and dwells on the topographic body-to-ear mapping, so to my mind these are valid areas for criticism.

          a more generalized effect, including possibly the placebo effect and/or or a general neuromodulatory effect, may be operative

          I agree. And I can see why “rigorous RCTs” might be a low priority for practitioners who’ve seen positive results, and for whom pain reduction comes first.

          1. Yeah, I can see how it’s confusing when different people say different things. I hope my work can help argue for a more generalized mechanism and I plan on writing a paper about it soon.

            Not everyone who practices acupuncture believes in all the gobbledygook. I am not principally an acupuncture practitioner but I hope my research shed some of the mystical hijinks it’s associated with.

            BFA seems to be useful enough for enough people for pain that I continue to offer it. I have no incentive to offer it other than that it seems to work for a decent subset of patients and I have gotten a few to reduce reliance on medication. I don’t get paid on the basis of providing it and I don’t repeat it in a patient unless they have decent initial results.

            It also worked well enough for me for a severe three-week back pain flare in residency (after “regular” acupuncture and conventional treatments didn’t do anything) that I was convinced of its value for some. I also thought it was borderline ridiculous that it actually worked as well as it did for me (based on my scientific medical training it was just outlandish that it did seem to work well).

            I am glad this post is generating discussion. I am committed to good science whether or not I have to slay any of my beliefs in modalities at the altar of truth.

        2. Dr. James – thanks for interacting with comments on Retractionwatch.

          Did the UC IRB provide any comments on FDA regulation of the device? Moving from a prescription use device administered by a physician to a patient administered prescription use device is complicated and *might* require a de novo classification submission by the manufacturer to FDA.

          If UC has some in-house device expertise, perhaps have a chat. Likewise with billing unless the trial award covered everything.

          Good luck.

          1. Liz,

            I also found as Matilda said that an IRB approval that is in the minimal risk category obviates the need for an IDE. Thank you for your interactions is this is my first project and the first one at the facility I am at in a very long time.

  4. Liz,

    The IRB did not have any issue with the protocol and did not mention that this may require a new device application. It is difficult for me to imagine that they would have failed to mention this if they had been concerned about it, much less approved the study if they had thought it necessary.

    I believe the FDA definition does not explicitly forbid this (my interpretation, which may be wrong) as the patients were using it as directed by a licensed practitioner. Furthermore, the FDA definition of acupuncture needles clearly describes regular long acupuncture needles (that are definitely more dangerous) rather than the 2 mm ear studs we used. I would definitely not give the longer acupuncture needles to patients for self-administration.

    Again, I would like to emphasize that the objection has nothing to do with the data or scientific merit of the study and that we obtained what we believed was appropriate permission for this small pilot study in good faith and through the appropriate mechanism. No one is recommending that this be implemented on a large scale or handing out needles to patients on a regular basis. This was just a pilot study to see if a larger one was feasible.

    1. Dr James
      I come in peace 🙂 IRBs are not infallible all the time.

      I suspect this is part of the difficulty: “Notably, this study was approved as an “expedited” category, which signified that the reviewers classified it with the same risk level usually reserved for questionnaire-type interventions.”

      From the Common Rule at 45 CFR 46 (research eligible for expedited review)
      https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html

      “Research Categories

      1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      … (drugs left out)
      b. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.”

      (ii) isn’t applicable? See p. 5
      https://www.accessdata.fda.gov/cdrh_docs/pdf/K983798.pdf

      With expedited review the IRB chair delegates review and approval to a qualified individual, though it’s not clear that full board review would have decided differently.

      In an ideal world the manufacturer would provide information to the IRB or contact FDA if they had questions.

      The foregoing should not be understood to imply I suspect the VA or the federal government made an error.

      1. Liz, I appreciate your input.

        Yes, I could have worded that better, which I have discussed with the publisher. I have proposed to revise the language to just say “notably, this was approved in the expedited review category.” This categorization also apparently allows investigation of a device without a new IDE application. If you have any further insight, I would be glad to receive it.

  5. Disclaimer: The statements and comments expressed by Dr. James in the article above (and the comments) are his personal views and do not represent the views of the VA organization or the United States government.

  6. I think the fact that it met exemption for “minimal risk” according to the IRB and thus would not require an IDE application would still allow it to be approved legitimately this way even it it had a previous categorization. I will continue to dialogue with the involved parties.

  7. Liz,

    I think this applies as it was determined to be minimal risk by the IRB :

    Nonsignificant Risk Device
    Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters.

    A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to the FDA for approval. Submissions for nonsignificant device investigations are made directly to the IRB of each participating institution. Sponsors should present to the reviewing IRB an explanation why the device does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to the FDA within five working days [§812.150(b)(9)]. The FDA considers an investigation of a nonsignificant risk device to have an approved IDE when the IRB concurs with the nonsignificant risk determination and approves the study.

  8. The study design was fundamentally flawed. There was a tiny, biased sample (12 cherry-picked subjects who previously reported pain relief after BFA) and no control group. So any observed improvement is indistinguishable from the placebo effect and/or regression to the mean. This is Research Methods 101 stuff!

    Indeed, pain ratings would be expected to go down regardless of whether the treatment was efficacious. I’m not saying BFA is ineffective (though it might be). I’m saying this study did not and could not bring us any closer to knowing whether BFA is effective.

    Even a small-sample, low-budget “pilot study” should be designed in a methodologically sound way. Otherwise we’re just wasting time and resources while cluttering the literature with meaningless, uninterpretable findings.

    1. Andrew,

      Thank you for your comment and I appreciate your input.

      This was a feasibility study to see if it was even practical to do a large-scale study. We definitely are not making claims about the efficacy of BFA based on this study. The plan will be to consider a large, well-powered multi-center trial after this.

      We chose people that were known responders so they could comment subjectively about the pain relief they received from self-administration vs. provider-administered acupuncture.

      This is the first study to our knowledge that assesses self-administration of acupuncture. We were not trying to prove efficacy or safety in this case as it was not a clinical investigation. Most feasibility studies have around 10 patients and they are used to determine whether investing in a larger study is worthwhile.

      Dr. James

    2. Thank you for sharing your accurate comments. There are some information/selection biases and critical methodology mistakes in this project that should have rendered this draft utterly disqualified from even the first peer review, if there was such mechanism in place. The author is fighting the journal resolution in the wrong forum. The real question here is why the author did not seek guidance from the VA research department…

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