Stimulated by an email from a colleague in Australia re Jan et al 2020;[1] plus Cohen et al 2017.[2]
ED –Emergency Department
key to acronyms
BFA – BattleField Acupuncture
IF – Impact Factor
This week I am focussing on the possible role for acupuncture as a non-pharmacological adjunct or alternative analgesic intervention for acute pain in emergency care.
A colleague based in Melbourne asked me to comment on a relatively recent trial of BFA in the ED.[1] This paper first came out a couple of months ago, and since it was underpowered (n=90 & 3 arms) and unremarkable, I did not feel moved to comment at the time. Also, it was on BFA, which is far from being my favourite intervention, and to which I had already given enough airtime (IMHO) on this blog: Ears and the battlefield.
However, the topic of acupuncture in the ED does give me the opportunity to highlight a larger (n=528), and singularly more impressive trial from Melbourne.[2] This paper seemed to come out of nowhere in 2017, and the first I heard about it was in mainstream medical media. It was an ambitious multicentre pragmatic equivalence and non-inferiority trial. Now there’s a bit of a mouthful!
an ambitious multicentre pragmatic equivalence and non-inferiority trial
We have done non-inferiority on here before, but to remind you, a non-inferiority trial aims to demonstrate that an intervention is not worse than (usually) the standard intervention. In order to do this in a valid and statistically robust way, the trial must be powered to measure a minimum clinically relevant inferiority of the test intervention over the standard. Equivalence is one step further statistically, as it requires the power to measure both inferiority and superiority, or rather confirm a lack of both in order for two interventions to be called equivalent.
Cohen et al recruited across 4 large tertiary hospitals in Melbourne and randomised consenting patients presenting with low back pain (n=270), ankle strain (n=166) or migraine (n=92) to receive one of 3 interventions for pain: acupuncture alone; acupuncture plus pharmacotherapy; pharmacotherapy alone.
Tables 4 and 5 in Cohen et al beautifully demonstrate the difference between non-inferiority and equivalence, and both were demonstrated for the whole cohort. So, acupuncture proved to be equivalent to pharmacotherapy and non-inferior to the addition of pharmacotherapy (ie acupuncture was not worse than the combination of acupuncture plus drugs). The numbers were too small in the migraine group, and consequently the confidence intervals too wide to tell whether acupuncture was equivalent to pharmacotherapy or non-inferior to the addition of pharmacotherapy. This is another great illustration (in the same tables) of the importance of sample size when it comes to statistical power.
acupuncture was equivalent to pharmacotherapy
About the same time in 2017 as Cohen et al published in the Medical Journal of Australia (IF 2.05), Jan et al published a systematic review on the same subject in the journal Emergency Medicine Australasia (IF 1.31),[3] and they went on to point out the fact to Cohen et al.[4] Then in the same year they published a slice of the same review, or at least a very similar one, focussing only on ears, in a journal – Medical Acupuncture (IF 0.44) – whose editor in chief invented BFA, and was last author on the paper.[5] One assumes that someone else took on editorial oversight for that paper.
I guess that all this led to the contemporary paper on BFA in the ED.[1]
This was a randomised trial with 3 parallel arms: adjunct BFA; adjunct sham; standard analgesic care (SAC). The adjunct here means that the BFA or sham were in addition to SAC. BFA has been described before on here: Ears and the battlefield. The sham version involved a sham electrical device being brought close to the same points before covering them with tape. The SAC group also got tape applied so that the outcome observers were blind. The conditions selected were abdominal pain, low back pain (not trauma) and limb trauma pain. SAC was quite comprehensive, and probably quite effective, since the pain scores of all participants dropped by almost 50% at 2 hours from a baseline of 6.5 on a 0–10 numerical scale. There were no differences between groups.
There are numerous differences between these trials, but I will just list some of the key ones here:
- sample size (528 vs 90)
- pragmatic vs explanatory
- acupuncture only group included in Cohen et al
- experienced practitioners vs novices (4 hours training in BFA)
- body acupuncture with local needling vs BFA only (an indirect technique)
I am not anti ear acupuncture
I am not anti ear acupuncture, I think it does have value in certain circumstances when direct approaches are impossible or impractical, but it certainly would not be my first choice in an ED. But I fear this lesson may not have been learned by the group concerned, if the lead author’s latest discussion piece is anything to go by.[6]
References
1 Jan AL, Aldridge ES, Visser EJ, et al. Battlefield acupuncture added no benefit as an adjunct analgesic in emergency department for abdominal, low back or limb trauma pain. Emerg Med Australas 2020;:1742-6723.13642. doi:10.1111/1742-6723.13642
2 Cohen MM, Smit DV, Andrianopoulos N, et al. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non‐inferiority trial. Med J Aust 2017;206:494–9. doi:10.5694/mja16.00771
3 Jan AL, Aldridge ES, Rogers IR, et al. Review article: Does acupuncture have a role in providing analgesia in the emergency setting? A systematic review and meta-analysis. Emerg Med Australas 2017;29:490–8. doi:10.1111/1742-6723.12832
4 Jan AL, Rogers I, Visser EJ. Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non-inferiority trial. Med J Aust 2018;208:188–9.
5 Jan AL, Aldridge ES, Rogers IR, et al. Does Ear Acupuncture Have a Role for Pain Relief in the Emergency Setting? A Systematic Review and Meta-Analysis. Med Acupunct 2017;29:276–89. doi:10.1089/acu.2017.1237
6 Jan AL. Lessons Learned in Teaching Battlefield (Ear) Acupuncture to Emergency Medicine Clinicians. Med Acupunct 2020;32:253–62. doi:10.1089/acu.2020.1436
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