Migraine prevention with percutaneous mastoid electrical stimulator: A randomized double-blind controlled trial.
Objective To evaluate the effectiveness and safety of episodic migraine prevention with the percutaneous mastoid electrical stimulator (PMES). Methods This was a randomized, double-blind, and sham-controlled trial that involved four medical centers. Episodic patients with at least two migraine attacks every month were randomly 1:1 to PMES or sham stimulation treatment. The treatments were performed daily for 45 minutes over 3 months. The primary outcomes were change in migraine days per month and the 50% response rate. Results The PMES group had a significantly greater reduction of migraine days in the third month than the sham group (-71.3% vs. -14.4%, p < 0.001). The 50% response rate of migraine days in the PMES group (≥50% reduction of migraine days compared with the baseline) was significantly higher than that in the sham group (82.5% vs. 17.5%, p < 0.001). In the PMES group, 60% of the patients had a ≥75% reduction of migraine days in the third month, and 35% of the patients had no migraine attack in the third month. No patients in the sham group had a ≥75% reduction of migraine days. There were no adverse events in either group. Conclusion Treatment of migraine using non-invasive PMES was safe and effective.
1 Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, China.
Yang
Y
Juan
2 Department of Neurology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Ou
O
Shu
3 Department of Neurology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Lou
L
Jinhe
4 Department of Neurology, Chongqing Emergency Medical Center, Chongqing, China.
Yang
Y
Na
1 Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, China.
Deng
D
Yushuang
3 Department of Neurology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Dong
D
Weiwei
1 Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, China.
He
H
Lanying
1 Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, China.
Wang
W
Jian
D000328:Adult; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008416:Mastoid; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
Migraine; percutaneous mastoid electrical stimulator; treatment