Manual acupuncture for migraineBMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m1096 (Published 25 March 2020) Cite this as: BMJ 2020;368:m1096
All rapid responses
Concerning the Xu et al. study on treating migraine with acupuncture, the author of the accompanying editorial stated that a significant strength of this study was the authors’ choice of control intervention [1, 2]. We certainly agree that nonpenetrating sham/placebo acupuncture needles are important tools that can be used to evaluate the efficacy of acupuncture in a variety of clinical trials. However, in the study published by Xu et al., the use of sham needles was severely undermined by critical deficiencies in study design that ultimately prevent us from drawing any significant conclusions whatsoever.
In the Xu et al. study, there were non-negligible differences between the penetrating needles and the nonpenetrating sham/placebo interventions. Apart from the needles, the following factors potentially influenced the outcome of this study: (1) the number of needles used, (2) the acupuncture points at which the needles were applied, (3) treatments utilizing additional acupoints that were provided only to those in the acupuncture group, and (4) the positioning of the patients in the supine vs. prone position during treatment. Given these technical discrepancies, one cannot conclude with any certainty that the significant improvement in migraine symptoms among those in the acupuncture group can be attributed to needle penetration alone.
For the patients’ position, all patients in acupuncture group received therapy while in the supine position; these patients were able to observe the practitioner who was performing acupuncture. One can easily envision a situation in which the practitioner's enthusiasm and expectations might be conveyed to the patient. By contrast, patients in the sham group were placed in a prone position and were unable to observe or to interact with the practitioner. It has long been clear that interaction and establishment of a therapeutic relationship between the practitioner and subject is the strongest component of any placebo effect . Considering the unmasked practitioners, further, it is critical to recognize that the practitioner’s knowledge of who was and was not receiving treatment with penetrating needles might result in subtle behaviors that can influence the outcome of this study . The fact that the patients were positioned differently during these treatments could have a significant confounding impact on the results obtained.
For these reasons, studies to detect a specific effect of acupuncture such as this must be carefully designed with rigorous attention to details , as bias and nonspecific results can be introduced even when employing strong tools such as single-blind sham/placebo needles.
1. Angus H. Manual acupuncture for migraine new trial moves acupuncture from complementary therapy to evidence based treatment. BMJ 2020;368:m1096.
2. 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;368:m697.
3. Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008;336:999.
4. Gracely RH, Dubner R, Deeter WR, et al. Clinicians’ expectations influence placebo analgesia. Lancet 1985;1:43.
5. Vase L, Baram S, Takakura N, et al. Specifying the non-specific components of acupuncture analgesia. Pain 2013;154:1659-1667.
Competing interests: No competing interests
As a long term follower of the clinical trial data for acupuncture, I was pleased to read the positive message in this editorial, and the positive result in the associated research paper by Xu et al.
I would just like to point out an error in the data quoted, which has a very important impact on the interpretation of the relative efficacy and effectiveness of acupuncture compared with alternative drug treatments in the prophylaxis of migraine headache.
The data I refer to is the reduction in migraine days per month. Heather quotes 2.1 for acupuncture, from the linked research paper by Xu et al, and 3.7 for the CGRP receptor monoclonal antibody (erenumab) from Goadsby et al. Both figures are correct, but they are not comparable. The correct figure for erenumab 70mg is just 1.4 days reduction in migraine days per month, compared with 2.1 for acupuncture.
The figure 3.7 refers to the uncontrolled change from baseline for the higher dose of erenumab. The equivalent figure for acupuncture from the linked trial is 3.9.
So, in terms of the absolute reduction in migraine days per month (3.9 vs 3.7 or 3.2) as well as the difference over control (2.1 vs 1.9 or 1.4), acupuncture is associated with higher mean values than both high dose and standard dose erenumab respectively.
It should be noted that the baseline in migraine days per month was over 8 in Goadsby et al, and around 6 in Xu et al  so if anything this would favour the drug in this casual comparison.
Superiority to drugs in migraine prophylaxis is not new, however, as this was noted by Linde et al in the Cochrane review Heather quoted. She chose to emphases the small but statistically significant effect of acupuncture over sham, and overlook the fact that acupuncture was also superior to prophylactic drugs to a similar degree.
It is true to say that the research by Xu et al is the first sham controlled trial of acupuncture in migraine prophylaxis to demonstrate a significant effect over sham acupuncture in a single trial, although the pooled data from Linde et al had already given us a taste of what was to come.
The interpretation of sham controlled trial data for acupuncture is often controversial, as it allows a NICE guideline (CG150) to state that topiramate is twice as good as acupuncture, when head to head research clearly shows the opposite.
It seems to me that NICE and Cochrane need to come head to head on this one, so to speak.
1 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
2 Goadsby PJ, Reuter U, Hallström Y, et al. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med 2017;377:2123–32. doi:10.1056/NEJMoa1705848
3 Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of episodic migraine. Cochrane database Syst Rev 2016;:CD001218. doi:10.1002/14651858.CD001218.pub3
4 White A, Cummings M. Inconsistent placebo effects in NICE’s network analysis. Acupunct Med 2012;30:364–5. doi:10.1136/acupmed-2012-010262
5 NICE guideline on headaches: diagnosis and management of headaches in young people and adults. http://guidance.nice.org.uk/CG150. 2012.
6 Yang C-P, Chang M-H, Liu P-E, et al. Acupuncture versus topiramate in chronic migraine prophylaxis: A randomized clinical trial. Cephalalgia 2011;31:1510–21. doi:10.1177/0333102411420585
Competing interests: MC is the salaried medical director of the British Medical Acupuncture Society (BMAS), a membership organisation and charity established to stimulate and promote the use and scientific understanding of acupuncture as part of the practice of medicine for the public benefit. MC is an associate editor for Acupuncture in Medicine. MC has a very modest private income from lecturing outside the UK, royalties from textbooks and a partnership teaching veterinary surgeons in Western veterinary acupuncture. MC has no private income from clinical practice in acupuncture. His income is not directly affected by whether or not he recommends the intervention to patients or colleagues, or by whether or not it is recommended in national guidelines. MC has not chaired any NICE guideline development group with undeclared private income directly associated with the interventions under discussion. He has participated in a NICE GDG as an expert advisor discussing acupuncture (CG88). MC has used Western medical acupuncture in clinical practice following a chance observation as a medical officer in the Royal Air Force in 1989. His opinions are formed by data that spans the range of quality and reliability, much of which is in the public domain. MC has a logical mistrust of the motives of anyone who advertises an interest or hobby in being a ‘Skeptic’, as opposed to using appropriate scepticism within their primary profession, or indeed organisations that claim to promote generic ‘science’ as opposed to actually engaging in it.