Stimulated by Liu et al 2024.[1]
IF – impact factor
RCT – randomised controlled trial
ART – Acupuncture Randomised Trial (part of the Modellvorhaben Akupunktur)
RR50 – responder rate 50 (50 refers to a reduction of 50% or more in headache days)
MMDs – monthly migraine days
NICE – National Institute for Health and Care Excellence
NMA – network meta-analysis– key to acronyms
The double dummy is mentioned again this week. In fact, it features in the title of this paper in Cephalalgia (IF 4.9 and since 2023, a gold open access journal). This one is a head-to-head RCT with 2 parallel arms (n=60). The double dummy in this case refers to the fact that each arm included a sham or placebo of the active treatment in the other arm. So, real acupuncture plus placebo topiramate was compared with real topiramate plus sham acupuncture.
The sham acupuncture was not really a sham at all, it was a selection of points that were deemed not to be indicated for headache. The depth of needling was stated to be 10mm to 15mm in both groups but deqi sensation was not sought in the sham acupuncture group. 10 points were used in both groups, but it is not clear whether that meant 10 needles. The sham group used points in the limbs (LI15, PC3, GB35, LR7, ST37). The real acupuncture group used 5 points on the head (GV20, GV24, GB13, GB8, GB20), which is 8 needles if both sides were used, and a choice of 2 further points from 4 sets of 2 points based on the relevant meridian syndrome. The latter is determined by the main location of the headache.
If you remember the ART migraine trial from 2005, you might be worried about this treatment protocol.[2] In that trial they used superficial needling in the sham group and did not get closer to the head than the shoulder. The use of LI15 in this trial reminded me of that ART trial. The responder rate (RR50) in the sham group of the ART trial was 53%.
There are some important differences though. The population here is chronic migraine, which means they had to have at least 15 headache days and at least 8 migraine days per month. The ART trial population started with 5 days per month of moderate or severe headache, so most of this population would not have met the inclusion criteria for the current trial.
The ART trial used 16 sessions over 12 weeks and the current study applied 36 sessions over the same time frame.
Another major difference, of course, is that the sham acupuncture group got real topiramate. The dose was titrated up over the first 4 weeks from 25mg at night to 100mg or the maximum tolerated dose divided in two equal doses over the day.
MMDs at baseline were 18, and the mean reduction from baseline in the acupuncture group over the first 12 weeks (the intervention period) was 5.6, whilst the reduction in the topiramate group was 2.8 (p=0.004). The RR50 during this period was 33.3% for acupuncture and 6.7% for topiramate.
By my estimates, interpreting the graphical results in the paper, the acupuncture group reached a mean low of 11 MMDs and this persisted during the 3 months follow up. By contrast, the topiramate group reached a mean low of 14 MMDs.
AEs were significantly more common in the topiramate group (8 vs 3). One in each group looks as though it was related to the sham or placebo – needling pain in the topiramate and sham acupuncture group, and dyspepsia in the acupuncture and placebo topiramate group.
Blinding was tested and achieved, with most patients not knowing their group allocation and the others fairly equally guessing correctly and incorrectly.
This seems to be to be a fairly definitive result, although the trial is not huge, and would not have been included by NICE in CG150 – they only included trials with more than 100 patients and so excluded a previous head-to-head trial of acupuncture and topiramate, also published in Cephalalgia.[3] Thus they could happily conclude that topiramate was twice as good as acupuncture, without the annoyance of a trial, rather like this one, which showed the opposite.
I have discussed a couple of relevant NMA’s in the past.[4,5] One that compared acupuncture, topiramate, and botulinum neurotoxin A (see Acupuncture, drugs or Botox for chronic migraine) and another that focussed on acupuncture and propranolol in migraine prophylaxis, but included a lot of other drugs as well (see Acupuncture versus propranolol in migraine). In both cases, acupuncture looks as though it is in the lead, as Klaus Linde’s final Cochrane review on the topic implied.[6]
References
1. Liu L, Chen Q, Zhao L, et al. Acupuncture plus topiramate placebo versus topiramate plus sham acupuncture for the preventive treatment of chronic migraine: A single-blind, double-dummy, randomized controlled trial. Cephalalgia. 2024;44(6):3331024241261080. doi:10.1177/03331024241261080
2. Linde K, Streng A, Jürgens S, et al. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293(17):2118-2125. doi:10.1001/jama.293.17.2118
3. Yang CP, Chang MH, Liu PE, et al. Acupuncture versus topiramate in chronic migraine prophylaxis: A randomized clinical trial. Cephalalgia. 2011;31(15):1510-1521. doi:10.1177/0333102411420585
4. Zheng H, Huang SL, Chen YY, Tang TC, Qin D, Chen M. Topiramate, acupuncture, and BoNT-A for chronic migraine: a network meta-analysis. Acta Neurol Scand. 2021;143(5):558-568. doi:10.1111/ane.13391
5. Chen YY, Li J, Chen M, Yue L, She TW, Zheng H. Acupuncture versus propranolol in migraine prophylaxis: an indirect treatment comparison meta-analysis. J Neurol. 2020;267(1):14-25. doi:10.1007/s00415-019-09510-x
6. Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev. 2016;(6):CD001218. doi:10.1002/14651858.CD001218.pub3
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