Migraine is one of the most prevalent and disabling neurological disease. The current treatments are limited. Acupuncture is a promising complementary and replacement therapy, but further clinical evidence is needed. Besides, the influence of acupuncture on migraine is not an immediate effect, the mechanism of this effect is not clear yet. This study is to provide further clinical evidence for the anti-migraine effects of acupuncture and explore the mechanism. Herein, a randomized controlled trial (48 participants in total; 10 normal controls and 38 migraineurs) was performed. The 38 migraine patients were divided into blank control, sham acupuncture, and acupuncture. The baseline characteristics were assessed for 2 weeks before the study. After that, patients were subjected to two courses of treatment, each of which lasted 5 days, with an interval of 1 day between the two courses (11 days in total). Outcome data collection, fMRI measurement, and blood sample collection were performed before and at the end of the treatment period. Effectiveness of treatment was evaluated using pain questionnaire. The fMRI data was analysed. Blood plasma was collected for metabolomics and proteomics studies. Results showed that acupuncture effectively relieves migraine symptoms, and not merely via the placebo effect. The anti-migraine mechanism involves a complex network which is related to regulating the blood oxygen levels, reversing brain energy imbalance and regulating inflammation. Brain regions of migraineurs affected by acupuncture include the limbic system and default mode network, and regions involved in cognitive and emotional processing of pain, sleep, and attention.
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