BACKGROUND: Manual acupuncture (MA) is commonly used as a treatment for migraine in China. However, its specific clinical effects have been challenged on the basis that some of its effects may relate to psychological or 'placebo' mechanisms. OBJECTIVE: To identify the effectiveness of verum MA compared with sham acupuncture for the treatment of migraine. METHODS: Eight electronic databases were searched for randomised controlled trials (RCTs) evaluating the effect of verum versus sham MA on migraine. The quality of included trials was assessed using the 'risk of bias' tool provided by the Cochrane Handbook for Systematic Review of Intervention. RevMan 5.2 software was used for data analysis. RESULTS: Ten trials with 997 participants were included. Most trials had high methodological quality and were at low risk of bias. Meta-analysis showed superior effects of verum MA over sham acupuncture on the total effective rate, reflected by a reduction in the 'not effective' rate (relative risk (RR) 0.24, 95% CI 0.15 to 0.38; p < 0.0001, four trials) and a reduced recurrence rate (RR 0.47, 95% CI 0.28 to 0.81; p = 0.006, two trials), but no significant differences in headache intensity, frequency or duration, accompanying symptoms and use of medication. No severe adverse events related to acupuncture occurred during treatment with either verum or sham MA. CONCLUSIONS: Current clinical evidence suggests that verum acupuncture is superior to sham acupuncture in migraine, reflected by a higher total effective rate and decreased recurrence rate. Nevertheless, further large-scale RCTs with a rigorous design are required to confirm these findings in view of the relative paucity of eligible RCTs and small sample sizes of those included.

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