Dexamethasone prevents relapse after emergency department treatment of acute migraine: a randomized clinical trial

Abstract

ABSTRACT:Objective: To determine whether the addition of intravenous dexamethasone to standard emergency department (ED) migraine therapy would decrease the incidence of severe recurrent headache 24 to 48 hours after initial treatment. Methods: Patients aged 19 to 65 years whose headache was severe enough to require parenteral therapy and who met International Headache Society migraine criteria were eligible for this randomized, double-blind trial. The study was conducted in the ED of 2 community hospitals, 1 of which was a tertiary referral centre. Exclusion criteria included pregnancy, focal findings, fever, meningismus, allergy to the study drug, active peptic ulcer disease and diabetes mellitus. Demographic and clinical data, including headache severity, were recorded. After abortive therapy (antiemetics, intravenous nonsteroidal agents, dihydroergotamine or opioids), blinded nurses administered dexamethasone (24 mg intravenously) or placebo. Patients recorded headache severity on a Visual Analogue Scale (VAS) at time T = 0, T = 30 minutes and T = 60 minutes and at discharge. They were contacted 48 to 72 hours later and asked whether they had suffered a recurrence of their headache, categorized as class A (severe, provoking another physician visit), class B (severe, interfering with daily activity but not provoking a physician visit), class C (mild, requiring self-medication but not limiting activity) or class D (mild, requiring no treatment). Results: Two of 100 patients were lost to follow-up, leaving 98 in the study sample. Placebo recipients were more likely to be female; other baseline characteristics were similar between groups. Median VAS pain score was 83 mm on ED arrival, 35 mm after initial treatment and 12 mm on discharge. At followup, 65 of 98 patients had suffered headache recurrence. In the placebo versus dexamethasone groups, respectively, the results were 11 versus 0 in class A, 11 versus 9 in class B, 7 versus 11 in class C and 4 versus 12 in class D. Regarding the primary outcome, 9 of 49 dexamethasone patients (18%) and 22 of 49 placebo patients (45%) had severe (classes A and B) recurrent headache (odds ratio 0.28; 95% CI, 0.11 to 0.69; p = 0 .005). Conclusions: Migraine recurrence is common after "successful" ED treatment. Inflammation may be a critical factor in migraine genesis. Intravenous dexamethasone decreases the incidence of severe recurrent headache after ED treatment and should be offered to patients thought to be at risk of recurrent headache.

Does the Addition of Dexamethasone to Standard Therapy for Acute Migraine Headache Decrease the Incidence of Recurrent Headache for Patients Treated in the Emergency Department? A Meta‐analysis and Systematic Review of the Literature

“…34,[37][38][39][40] Two scientific abstracts were included in the final analysis. 35,36 Six primary authors, including both scientific abstract authors, were successfully contacted for additional trial information, including further details regarding adverse events, method of randomization and blinding, and verification of headache relapse rates.…”

“…Exclusion of the trial with the most influence on the results 37 resulted in modified summary RR of 0.87 (95% CI = 0.79 to 0.97). Exclusion of the only trial that reached a statistically significant difference between the dexamethasone and placebo groups 34 resulted in a modified summary RR of 0.90 (95% CI = 0.82 to 0.99). Finally, exclusion of the only trial using oral dosing of dexamethasone, 38 resulted in a modified summary RR of 0.87 (95% CI = 0.79 to 0.95).…”

“…[11][12][13][14][15][16][17][18][19] Although initial controlled clinical trials demonstrated the same high-level of efficacy, [20][21][22][23][24][25][26] the results of several recent ED-based trials have questioned the utility of dexamethasone for this purpose. [27][28][29][30][31][32][33][34][35][36][37][38][39][40] The goals of this systematic review were to critically appraise the existing literature and to provide recommendations for patient care regarding the use of dexamethasone for the prevention of headache relapse in patients with acute migraine headache in the ED. Our primary outcome of interest was the proportion of migraine patients with self-reported symptoms of moderate or severe headache at 24-to 72-hour follow-up evaluation.…”

Intravenous dexamethasone to prevent the recurrence of benign headache after discharge from the emergency department: a randomized, double-blind, placebo-controlled clinical trial

“…We also addressed headache severity at follow-up. By using the end points of "repeat physician visit" and "interfering with normal daily activities" we were able to compare our results with other ED studies 15,16,25 that used similar end points. The 58.3% headache recurrence rate at 48-72 hours follow-up for the placebo group is compatible with previous reported treatment failure rates of 6%-66%.…”

“…Class A and B were rated as "severe," and class C and D were classified as "mild" to allow for direct comparison to previous studies. 15,16,25 Finally, patients were asked to describe any unusual side effects. Our primary outcome was the percentage of patients that experienced headache recurrence at 48-72 hours.…”