Stimulated by Sun et al 2025.[1]
MwoA – migraine without aura
IF – impact factor
RCT – randomised controlled trial
HIT-6 – headache impact test 6
MSQ – migraine specific questionnaire
CGRP – calcitonin gene-related peptide
RR50 – responder rate 50 (a 50% or more reduction in the relevant metric)
VAS – visual analogue scale– key to acronyms
The big news in terms of sham controlled clinical trials of acupuncture in migraine arrived long before I started this blog,[2–4] so I have not highlighted such a trial since the first positive sham controlled trial popped up in the BMJ 5 years ago – see Manual acupuncture for migraine.[5]
The current one is unique because it is the first large (n=198) sham controlled trial from China that is technically negative. By that I mean that there was no statistically significant difference between groups in the primary outcome at the primary end point of the trial.
The trial comes from a well-known group in Chengdu, although colleagues from Luzhou, Kunming, and Zhengzhou were also involved. It is published in the Journal of Evidence-Based Medicine (IF 3.5), which was first published in 2008. It was a prospective multicentre RCT with 2 parallel arms. The sham was non-penetrating and applied to the same points as the penetrating needling. They used the Park sham device in both arms of the trial, which I estimate would have cost them about £20k just for the needles and devices.
Acupuncture was performed 3 times a week for 4 weeks in 30-minute sessions. The points used were GV20, GB20, GB8 (1 cun above the apex of the ear), and one point in each wrist or hand (TE5 or SI3 or LI4 or PC6) and lower leg or foot (GB34 or BL60 or ST44 or LR3). The latter points varied depending on the location of the headache (temporal, occipital, frontal or parietal respectively). So, in total, each session consisted of 9 needle insertions in the acupuncture group and the same number of applications of non-penetrating needles in the sham group.
The outcomes included various metrics from a 4-week headache diary, along with HIT-6, MSQ, rescue medication intake, and serum CGRP changes. Outcomes were measured at baseline, 4 weeks (end of treatment), 8 weeks, 12 weeks and 16 weeks. The primary outcome was the change in 4-week migraine frequency from baseline to 16 weeks. Other metrics from the headache diary included the absolute migraine frequency (rather than the change in frequency), the proportion of responders (RR50 migraine frequency), days with migraine, and average headache severity on VAS.
Note here that RR50 is usually determined on days with migraine rather than migraine frequency. In this trial there needed to be a pain free interval of 48 hours between separate migraine attacks. Since a migraine can, by definition, last anything from 4 to 72 hours, a frequency of 4 migraines per month could equate to anything from 4 to 12 migraine days. The latter is considered to be the gold standard in prevention trials, and it gives a bigger margin for improvement than frequency of attacks.
Migraine frequency was 4.2 in both groups at baseline and dropped to 1.6 in the acupuncture group and 2.4 in the sham group at week 16 (p=0.002). The change scores were -2.6 and -1.9 respectively (p=0.069).
So, the authors were rather unlucky in their choice of primary outcome. If they had chosen the end frequency rather than the change in frequency from baseline, they would have had a definitively positive trial.
There were lots of p values (testing results) listed in this paper (I count 41 in the main paper, excluding baseline tests) and no discussion of correction for multiple testing. Remember that if you set your significance value at p<0.05, you should expect at least 2 significant values by chance alone if you do 40 tests. In fact, there were 10 p values with 2 zeros after the decimal, so, on balance, we can comfortably conclude that there is likely to be a benefit of real acupuncture over non-penetrating sham. There were a further 79 p values in the supplement, 46 of which reached significance, and 28 of these had 2 zeros after the decimal. So, again this is a lot better than chance alone; however, authors should really be more judicious and targeted in their decisions to measure significance.
References
1 Sun M, Xie C, Wang Y, et al. The Prophylactic Effect of Acupuncture for Migraine Without Aura: A Randomized, Sham-Controlled, Clinical Trial. J Evid-Based Med. 2025;e70059. doi: 10.1111/jebm.70059
2 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
3 Linde K, Streng A, Jürgens S, et al. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25. doi: 10.1001/jama.293.17.2118
4 Diener H-C, Kronfeld K, Boewing G, et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol. 2006;5:310–6. doi: 10.1016/S1474-4422(06)70382-9
5 Xu S, Yu L, Luo X, et al. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trial. BMJ. 2020;697:m697. doi: 10.1136/bmj.m697
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