A post hoc analysis of migraine-associated symptoms from the phase 3 randomized, double-blind, sham-controlled Trial of External trigeminal nerve stimulation for the Acute treatment of Migraine (TEAM) study
Abstract
Background: The Trial of External trigeminal nerve stimulation (eTNS) for the Acute treatment of Migraine (TEAM) study demonstrated that eTNS use during active migraine resulted in significantly higher rates of resolution of migraine-associated most bothersome symptom (MBS) compared to sham. However, no previous studies have examined the association between pretreatment MBS subtype and efficacy of eTNS treatment for active migraine.
Objective: We conducted a post hoc analysis examining efficacy of eTNS for different pretreatment MBS subtypes using TEAM study data.
Methods: Pretreatment MBS subtypes included photophobia (n = 345), nausea (n = 109), phonophobia (n = 73), and vomiting (n = 11). We examined MBS sub-group × treatment group (verum n = 259; sham n = 279) interaction for each post-treatment outcome to explore differential effects conditional on the total sample. We further explored direct, between treatment group comparisons for each MBS subtype, as well as compared treatment outcomes among all MBS subtypes within the sham, verum, and total sample. Finally, clinical heterogeneity of treatment effect (HTE) was assessed using a 1% absolute treatment effect difference as the clinically important threshold.
Results: Significant sub-group × treatment interactions were found for resolution of MBS at 2 h (p = 0.008), pain relief at 2 h (p = 0.001), rescue medication between 2 and 24 h (p = 0.012), sustained pain freedom at 24 h (p = 0.033), and sustained pain relief at 24…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 345 participants or records.
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