Stimulated by Barnard et al, and Wang et al.
Barnard et al is the first randomised controlled trial (RCT) of acupuncture versus sham in osteoarthritis (OA) of the carpometacarpal joint (CMCj) of the thumb. Indeed, it may be the first controlled trial of acupuncture in this condition.
Technically, of course, there may be OA in other joints as well, such as the STT (ScaphoTrapezoTrapezoid) complex, and the authors refer to basal thumb joint OA, rather than specify the precise joint.
They chose to use the original non-penetrating needle invented by Konrad Streitberger. These needles are designed to touch the skin, but rather than penetrate, the coiled handle slides down over the shaft, giving the visual impression of the needle going into the point.
I first met Konrad a couple of years after his publication in the Lancet, and I remember the first words I blurted out on meeting him: “Blimey you’re young!”
I had imagined him as a grey-haired anaesthetics professor, but he had invented the retractable needle as a medical student, so he was relatively newly qualified and working as a trainee in anaesthetics at the time. At the same meeting I met Klaus Linde for the first time, and he also surprised me by launching into an apologetic explanation for the errors I had picked up post-publication in his first systematic review of acupuncture for headache. To me, at the time, he was a famous name in research, and I was a beginner, so I felt like a usurper in this interaction. This paper grew into the first Cochrane review on headache, later criticised for pooling data on migraine and tension-type headache by the same sort of EBM evangelists that went on to pool data for trials of acupuncture in all varieties of pain. The excuse was: “If acupuncture works in pain, it ought to work in all varieties just the same!” This is clearly not a statement that would be made by any clinician with even the most limited experience in practice.
My introduction to Konrad and Klaus was at an international consensus meeting on controls in acupuncture research. We had famous names from over the globe, but the Bandolier boys (another set of EBM evangelists) from just up the road (Oxford), rudely refused their invitation from Jacky. I remember her telling me what was written in the reply she received from one of them: “…I’ve got at least two things that day that pay my salary!”
The consensus meeting certainly seemed as if it was a success, and the results were published in what became a relatively well cited paper (184 citations to date) in the acupuncture literature. On reading through it again I see that we were quite positive about Konrad’s novel placebo needle.
Time would subsequently show that the effects measured in clinical trials using telescopic non-penetrating needles as sham controls were still rather small, with the exception of trials of electroacupuncture (EA) to muscles in OA knee.
It is perhaps no surprise then that this small trial (n=74) in CMCj OA did not show any difference between real and sham acupuncture, but both groups demonstrated clinically relevant and statistically significant changes following six sessions of treatment over a 3-week period.
Obviously, I would have strongly advised this group against a sham control in such a small trial. Particularly since Klaus calculated in 2010 that in chronic pain you would need 400 in each arm of a parallel arm RCT to measure a significant benefit of acupuncture over sham. Such a large trial would be impossible for a single centre, so my favourite alternative would be the ARC design from the Modellvorhaben. That is treatment versus waiting list until the primary outcome, then treatment applied to the waiting list group, who know they will get treated eventually, so are not too despondent at the time the outcome is measured.
The authors note that the size of the effect in both acupuncture groups was similar to that of steroid injection,[10,11] but not as good a multimodal hand therapy.
They also noted that there was bleeding in the sham group, although this was not as frequent as it was in the real acupuncture group.
The second paper I am highlighting in this blog was published in a journal that I never read or cite… at least not until now! I guess in my early days of reading acupuncture research, this was one of the few acupuncture journals from China that had abstracts in English. The abstracts were enough for me not to look further as the results claimed appeared to be miraculous. I remember the first abstract that did not claim a cure rate of 100% – it was only 96% in this case, but the condition being treated was deaf mutism.
So, what urged me to look at this paper?
The condition was one thing… you don’t see many RCTs of acupuncture in PHN (post-herpetic neuralgia), and the other was the fact that there was a difference measured between the two acupuncture interventions in a trial with 140 patients.
Actually, there were multiple interventions in both groups, but the groups only differed by the addition of segmental paraspinal EA, which was added in the treatment group. Both groups got manual acupuncture to leg points, surrounding needling with some needles attached to EA, moxibustion and something I am guessing was interferential, although referred to as ‘intermediate frequency treatment’.
As you might imagine the treatment group was significantly better in terms of VAS pain. The cure rate was only 50.75% in this group, but the ‘markedly effective rate’ reached the sort of level I have come to expect from this journal (98.51%).
I guess I regret highlighting it now, but I was amused with the irony of a segmental paraspinal EA intervention published in a journal of TCM.
I was also amused by the translation of qi as ‘gas’ in the text:
“The penetration depth of the needle is 1.5-3cm, and twirling is applied to create gas.”
Of course, gas is a correct translation for qi, but we use the Pinyin form by convention in the English acupuncture literature. Perhaps this paper was translated by an algorithm and not checked by a human with knowledge of the subject?
1 Barnard A, Jansen V, Swindells MG, et al. A randomized controlled trial of real versus sham acupuncture for basal thumb joint arthritis. J Hand Surg Eur Vol Published Online First: 25 March 2020. doi:10.1177/1753193420911326
2 Wang L, Qiu L, Zheng X, et al. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chinese Med 2020;40:121–7.
3 Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998;352:364–5. doi:10.1016/S0140-6736(97)10471-8
4 Melchart D, Linde K, Fischer P, et al. Acupuncture for Recurrent Headaches: A Systematic Review of Randomized Controlled Trials. Cephalalgia 1999;19:779–86. doi:10.1046/j.1468-2982.1999.1909779.x
5 Melchart D, Linde K, Berman B, et al. Acupuncture for idiopathic headache. In: Melchart D, ed. Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd 2001. CD001218. doi:10.1002/14651858.CD001218
6 Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009;338:a3115. doi:10.1136/bmj.a3115
7 White AR, Filshie J, Cummings TM. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med 2001;9:237–45. doi:10.1054/ctim.2001.0489
8 Linde K, Niemann K, Schneider A, et al. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials. BMC Med 2010;8:75. doi:10.1186/1741-7015-8-75
9 Cummings M. Modellvorhaben Akupunktur–a summary of the ART, ARC and GERAC trials. Acupunct Med 2009;27:26–30. doi:10.1136/aim.2008.000281
10 Meenagh GK, Patton J, Kynes C, et al. A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Ann Rheum Dis 2004;63:1260–3. doi:10.1136/ard.2003.015438
11 Heyworth BE, Lee JH, Kim PD, et al. Hylan Versus Corticosteroid Versus Placebo for Treatment of Basal Joint Arthritis: A Prospective, Randomized, Double-Blinded Clinical Trial. J Hand Surg Am Published Online First: 2008. doi:10.1016/j.jhsa.2007.10.009
12 Ahern M, Skyllas J, Wajon A, et al. The effectiveness of physical therapies for patients with base of thumb osteoarthritis: Systematic review and meta-analysis. Musculoskelet Sci Pract 2018;35:46–54. doi:10.1016/j.msksp.2018.02.005