Brief report
Steroids for Migraine Headaches: A Randomized Double-Blind, Two-Armed, Placebo-Controlled Trial

This work was previously presented at the American Academy of Emergency Medicine, Las Vegas, NV, 2007.
https://doi.org/10.1016/j.jemermed.2009.08.022Get rights and content

Abstract

Background: Recurrence of migraine headache after treatment in the emergency department (ED) is common. Conflicting evidence exists regarding the utility of steroids in preventing migraine headache recurrence at 24–48 h. Objective: To determine if steroids decrease the headache recurrence in patients treated for migraine headaches in the ED. Methods: Double-blind placebo-controlled, two-tailed randomized trial. Patients aged >17 years with a moderately severe migraine headache diagnosed by treating Emergency Physician were approached for participation. Enrollees received either dexamethasone (10 mg i.v.) if intravenous access was utilized or prednisone (40 mg by mouth × 2 days) if no intravenous access was obtained. Each medication was matched with an identical-appearing placebo. Patients were contacted 24–72 h after the ED visit to assess headache recurrence. Results: A total of 181 patients were enrolled. Eight were lost to follow-up, 6 in the dexamethasone group and 2 in the prednisone arm. Participants had a mean age of 37 years (±10 years), with 86% female. Eighty-six percent met the International Headache Society Criteria for migraine headache. Of the 173 patients with completed follow-up, 20/91 (22%) (95% confidence interval [CI] 13.5–30.5) in the steroid arm and 26/82 (32%) (95% CI 21.9–42.1) in the placebo arm had recurrent headaches (p = 0.21). Conclusion: We did not find a statistically significant decrease in headache recurrence in patients treated with steroids for migraine headaches.

Introduction

Migraine headaches have a prevalence of 6–17% in the general population and account for approximately 1–2% of emergency department (ED) visits (1, 2). Of patients who suffer from headaches, 9.4% report missing work days more than rarely. Figuring for this in addition to decreased productivity, an average of 4.2 equivalent work days are lost per year due to headaches, migraine being the most common (3). Return visit rates for recurrence among migraine headache patients seen initially in the ED are common, with a rate of 5–11% (4). Acute treatment in the ED includes a myriad of abortive and symptomatic medications. Mitigation and prevention of recurrence of pain is the primary goal, this being highly variable depending upon medication utilization, headache/recurrence definition, and time interval to follow-up. Although it is clear that migraine headaches are a primary response of brain tissue to some trigger, the neurophysiologic pathways have yet to be clearly elucidated. It has been postulated that the headache of migraines is related to activation of sensory neurons, which, in turn, release various peptides that cause a secondary sterile neurogenic inflammation in pain-sensitive areas within the central nervous system.

Blunting this inflammation with glucocorticoid agents, commonly used for painful and inflammatory processes, would make this a potentially viable option in migraine treatment regimens. Steroids, with their sustained half-life, inexpensive cost, and diverse administration routes, are an ideal medication for this purpose.

The objective of this study was to determine whether steroids were effective in preventing the recurrence of pain associated with migraines. If so, this would be an alternative or additive medication that could be added to the clinician's therapeutic armamentarium of migraine treatments. By reducing headache recurrence and return ED visits, this treatment could potentially reduce health care costs as well as increase patient satisfaction.

Section snippets

Study Design

This study was a prospective, randomized, double-blinded, two-armed, placebo-controlled study design to determine the efficacy of steroids in preventing the recurrence of pain associated with migraines treated in the ED.

Setting

The study was performed at a suburban community hospital with an annual volume of 70,000 patients.

Population

The study population comprised consenting, consecutive patients aged >17 years with an ED clinical diagnosis of migraine headache presenting from May 2003 to September 2006.

Results

There were 181 patients eligible to participate in the study (Figure 1). Successfully enrolled patients were randomly assigned to receive either dexamethasone (n = 46), prednisone (n = 48), or placebo (n = 87). No unmasking of patients occurred during the trial. Mean age in years of participants was: 37 (± 10) for the steroid group vs. 38 (± 10) in the placebo group. Females comprised 86% of enrollees. Of enrolled migraine patients, 86% met the International Headache Society Criteria (IHSC) for

Discussion

This study demonstrates that steroids do not prevent the recurrence of migraine headaches in those patients presenting to the ED. Previous studies have attempted to demonstrate the utility of steroids in headache patients without a conclusive outcome. In a subgroup of ED headache patients, ones with migraine headaches, the literature is limited and conflicting as to whether steroids are beneficial. Further, several of these studies have methodological flaws (6, 7, 8, 9, 10).

Innes et al., in a

Limitations and Future Questions

Our study has several limitations warranting further discussion. First, utilization of the IHSC criteria was not applied for enrollment purposes. The study authors felt that most Emergency Physicians do not implement these criteria before treating patients with vascular headaches. Interestingly, subset analysis demonstrated that 86% of our patients met IHSC. This group, when analyzed as a subset, did not demonstrate a significantly different outcome for headache recurrence.

Second, we a priori

Conclusions

Steroids do not seem to significantly decrease headache recurrence in patients treated for migraine. A larger trial may be warranted to determine whether a statistically significant improvement exists.

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