A Head-to-Head Comparison of Percutaneous Mastoid Electrical Stimulator and Supraorbital Transcutaneous Stimulator in the Prevention of Migraine: A Prospective, Randomized Controlled Study

Abstract

This prospective, randomized, multicenter head-to-head outcome study was performed to compare the efficacy and safety of Percutaneous Mastoid Electrical Stimulator (PMES) and Supraorbital Transcutaneous Stimulator (STS) in migraine prevention. This was a prospective, randomized, head-to-head outcome study that involved three medical centers. After a one-month run-in, episodic patients with at least two migraine attacks/month were randomized to receive PMES daily for 45 min or STS daily for 20 min for three months. The primary outcomes were change in monthly migraine days and the 50% response rate. A total of 90 patients were included in this study. We observed statistically significant reduction of migraine days in the third month treatment both in the PMES group and STS group. The difference between the two groups was not significant (60.5% vs. 53.8%, p = 0.88). Of note, 77.8% patients in the PMES group and 62.2% patients in the STS group had a ≥50% reduction of migraine days in the third month (p = 0.070). The change in monthly migraine days, monthly migraine attacks, severity of migraine days, accompanying symptoms during migraine and monthly acute anti-migraine drug intake were not significantly different between the two groups. The change of Headache Impact Test-6 (HIT-6) from run-in to the third-month treatment in the STS group was more remarkable than that in the PMES group (36.5% vs. 25.6%, p = 0.041). The occurrence of discomfort paresthesia was higher in the STS group (13.3% vs. 0%, p = 0.026). PMES and STS treatment were both effective in migraine prevention. The safety and efficacy of PMES and STS were comparable.