Efficacy and safety of transcutaneous supraorbital nerve stimulation versus topiramate for migraine prevention: a non-inferiority randomized trial
Abstract
BACKGROUND: Migraine remains a predominant neurological disorder that requires effective preventive therapies. Although topiramate is a well - recognized first - line pharmacotherapeutic approach, its use is often restricted by adverse reactions. Transcutaneous supraorbital nerve stimulation (tSNS) has emerged as a non - pharmacological alternative; however, its comparative efficacy remains unclear. This research aimed to directly compare the efficacy and safety of tSNS and topiramate in migraine prevention. METHODS: In this randomized, open - label, active - controlled trial, 232 adult migraineurs were randomly allocated to either tSNS or oral 25 mg topiramate for a 4 - week duration, followed by an 8 - week follow - up. The primary outcome was the proportion of responders. Secondary outcomes included changes such as monthly migraine days, severe headache days, days of acute medication use, and scores on the Headache Impact Test − 6. Non - inferiority testing with a pre - specified margin of 10% was also performed. RESULTS: The tSNS group exhibited significantly lower responder rates than the low - dose topiramate group (20.6% vs. 33.9%), surpassing the 10% non - inferiority margin (p = 0.712, 95% CI: − 0.260 to − 0.007). Logistic regression affirmed the superior efficacy of 25 mg daily topiramate compared to the tSNS (adjusted OR = 2.32, 95% CI: 1.22–4.42, p = 0.011). When analyzing the secondary outcomes, the tSNS seemed to display efficacy in reducing severe headache…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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