• Yin-Hsuan Lai, Yu-Chen Huang, Liang-Ti Huang, Ruei-Ming Chen, and Chiehfeng Chen.
• Department of Pediatrics, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.
• Neuromodulation. 2020 Aug 1; 23 (6): 721-731.

BackgroundNoninvasive vagus nerve stimulation (nVNS) has been proposed as a new neuromodulation therapy to treat primary headache disorders. The purpose of this study was to analyze the effectiveness and safety of peripheral nerve stimulation of the cervical branch of the vagal nerve for primary headache disorders.MethodsA systematic review and meta-analysis of the literature was carried out on randomized controlled trials of nVNS for treating headaches. We searched the Medline, Embase, and CENTRAL databases until January 29, 2019. A random-effects model was used to report all outcomes. The primary outcomes were a reduction in headache days or attacks and pain-free status within 30 min. Secondary outcomes were: the pain-relief status within 30 min, the pain-relief status at 60 min, abortive medication use, ≥50% responder rate, pain-free status in ≥50% of treated attacks, adverse events, and satisfaction.ResultsIn total, 983 patients were included from six trials. We found that nVNS was effective in achieving a pain-free status within 30 min (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.16~4.44; p = 0.02), pain-relief status within 30 min (OR, 1.8; 95% CI, 1.17~2.78; p = 0.007), pain-relief status at 60 min (OR, 1.93; 95% CI, 1.2~3.1; p = 0.006), a reduction in abortive medication use (OR, 0.61; 95% CI, 0.41~0.92; p = 0.02), and pain-free status in ≥50% of treated attacks (OR, 2.15; 95% CI, 1.27~3.66; p = 0.005) compared to sham-device treatment. There were no significant differences in decreased headache days (standardized mean difference (SMD), -0.159; 95% CI, -0.357~0.04; p = 0.117), adverse events (OR, 1.084; 95% CI, 0.559~2.104; p = 0.811), or satisfaction (OR, 1.45; 95% CI, 0.97~2.17; p = 0.07) between nVNS and sham-device treatment. The ≥50% responder rate could not be determined (OR, 3.34; 95% CI, 0.83~13.33; p = 0.09; I 2 = 73%).ConclusionsCervical nVNS is effective for acute pain relief for migraine and cluster headache.Systematic Review RegistrationPROSPERO registration number CRD42019126009.© 2020 International Neuromodulation Society.

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