The long-term prophylactic effects of acupuncture for migraine are uncertain.OBJECTIVE To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. DESIGN, SETTING, AND PARTICIPANTSThis was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.INTERVENTIONS Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. MAIN OUTCOMES AND MEASURESParticipants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.RESULTS A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P < .001); the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).CONCLUSIONS AND RELEVANCE Among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01687660

A bout 6%-8% of men and 16%-18% of women in the United States and England experience migraines, with or without an aura.1,2 A prevalence of 1% has been reported in mainland China, 3 compared with 4.7% in Hong Kong and 9.1% in Taiwan.4,5 A recent Cochrane meta-analysis suggests that acupuncture as migraine prophylaxis is safe and effective and should be considered as a treatment option for willing patients. Although the specific effects acupuncture are controversial, acupuncture, as it is currently practised, clearly differentiates between real acupuncture points and nonacupuncture points. The Chinese Government launched the National Basic Research Program to obtain more data about the specificity of acupuncture points. 7Trials from Italy and Brazil 8,9 showed that acupuncture was more effective than sham acupuncture in preventing migraines, but other trials have reported no differences. [10][11][12][13] There is no evidence that one acupuncture strategy is more effective than another for treating migraines. According to acupuncture theory, a headache on the lateral side is usually defined as a Shaoyang headache. In Jinkuiyi, 14 migraines are said to affect the yang meridians (including the Taiyang, Yangming and Shaoyang meridians). In Lingshu, 15 the Shaoyang meridians are said to go through the lateral side of the body, therefore the Shaoyang meridians are thought to be superior for treating migraines. Some points on the Shaoyang meridians are regarded as being more specific for migraines than other points. Research CMAJ Background: Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture. Methods:We performed a multicentre, singleblind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyangspecific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5-8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migrainespecific quality of life.Results: Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5-8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks [13][14][15][16] was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.Interpretation: Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.