Randomized Clinical Trial of Intravenous Valproate (Orifil) and Dexamethasone in Patients with Migraine Disorder

Department of Neurology, Mashhad University of Medical Sciences, Mashhad, Iran
Iranian Journal of Medical Sciences 06/2013; 38(2 Suppl):150-5.
Source: PubMed


Background: Intravenous Valproate (IVVP) has been used in the treatment of migraine in some studies; however, it is far better known in the management of status epilepticus.

Methods: Consecutive patients with migraine in our Headache Clinic were enrolled in this prospective, randomized clinical trial in 2011. The patients were randomized into two therapeutic groups, one receiving 900 mg IVVP (Orifil) and the other 16 mg IV Dexamethasone (IVDEX) diluted in 150 CC normal saline and infused for 10 minutes. Worst severity of pain before treatment and least severity at 3 hours after the infusion using a 0-10 point numeric rating scale were recorded. An interview with the patient was performed 72 hours after treatment to detect a possible relapse of headache.

Results: Thirty-one migraine status patients, comprising 28 women and 3 men at a mean±SD age of 33.355±12.373 SD, were investigated. Differences in the therapeutic effects of IVVP (Orifil) and IVDEX on pain score were not significant between the two groups (t=0.933, df=29; P=0.358). Relapse of headache occurred in 68.42% of the IVVP (Orifil) group and 66.67% of the IVDEX group. Distribution of relapse was not significantly different between the two therapeutic groups of patients (P=0.870).

Conclusion: IVVP (Orifil) was similar in efficacy to IVDEX as abortive therapy in patients with migraine status. IVVP (Orifil) appears to offer a safe and well-tolerated abortive treatment.

Trial Registration Number: IRCT13891146234N2

40 Reads
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Headaches recur in up to 87% of migraine patients visiting the emergency department (ED), making ED recidivism a management challenge. We aimed herein to determine the role of corticosteroids in the acute management of migraine in the ED and outpatient care. Advanced search strategies employing PubMed/MEDLINE, Web of Science, and Cochrane Library databases inclusive of a relevant gray literature search was employed for Clinical Studies and Systematic Reviews by combining the terms "migraine" and "corticosteroids" spanning all previous years since the production of synthetic corticosteroids ca. 1950 until August 30, 2014. Methods were in accordance with MOOSE guidelines. Twenty-five studies (n = 3989, median age 37.5 years, interquartile range or IQR 35-41 years; median male:female ratio 1:4.23, IQR 1:2.1-6.14; 52% ED-based, 56% randomized-controlled) and four systematic reviews were included. International Classification of Headache Disorders criteria were applied in 64%. Nineteen studies (76%) indicated observed outcome differences favoring benefits of corticosteroids, while six (24%) studies indicated non-inferior outcomes for corticosteroids. Median absolute risk reduction was 30% (range 6%-48.2%), and 11% (6%-48.6%) for 24-, and 72-hour headache recurrence, respectively. Parenteral dexamethasone was the most commonly (56%) administered steroid, at a median single dose of 10 mg (range 4-24 mg). All meta-analyses revealed efficacy of adjuvant corticosteroids to various abortive medications-indicating generalizability. Adverse effects were tolerable. Higher disability, status migrainosus, incomplete pain relief, and previous history of headache recurrence predicted outcome favorability. Our literature review suggests that with corticosteroid treatment, recurrent headaches become milder than pretreated headaches and later respond to nonsteroidal therapy. Single-dose intravenous dexamethasone is a reasonable option for managing resistant, severe, or prolonged migraine attacks. © International Headache Society 2015 Reprints and permissions:
    Cephalalgia 01/2015; DOI:10.1177/0333102414566200 · 4.89 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Despite the impact of sodium valproate and dexamethasone on migraine headache, the efficacy of the two drugs has not been properly investigated and compared. This trial compared the effect of the two drugs on acute migraine headache. Methods: This double blind randomized clinical trial was conducted on patients aged 18 to 65 years with acute migraine headache who referred to the emergency departments of Beasat and Farshchian Hospitals in Hamadan, Iran, from April 2012 to June 2014. Patients were randomly assigned to receive a single-dose of either 400 mg sodium valproate or 16 mg dexamethasone plus 50 ml saline normal solution within 15 min intravenously. The severity of headache in the two groups was evaluated at baseline, 0.5 and 2 hours later using the Visual Analog Scale (VAS) on a scale of 0 to 10. Results: Of 104 patients enrolled, 72 patients remained for analysis. The effect of both sodium valproate and dexamethasone on acute migraine headache was statistically significant at 0.5 and 2 hours post-treatment compared to pre-treatment (P=0.001). The severity of headache based on VAS reduced form 8.20 (7.72, 8.68) before treatment to 5.31 (4.74, 5.89) and 3.66 (2.99, 4.33) at 0.5 and 2 hours after treatment, respectively, in patients receiving sodium valproate and from 8.46 (8.05, 8.86) before treatment to 5.46 (4.81, 6.11) and 3.59 (2.84, 4.35) at 0.5 and 2 hours after treatment, respectively, in patients receiving dexamethasone. Both drugs were highly effective in improvement of acute headache in patients without aura. However, sodium valproate significantly improved the acute headache in patients with aura but dexamethasone did not. The severity of headache based on VAS reduced form 8.50 (7.40, 9.60) before treatment to 4.67 (2.40, 6.93) and 3.50 (1.78, 5.22) at 0.5 and 2 hours after treatment, respectively, in patients with aura receiving sodium valproate and from 8.80 (7.76, 9.84) before treatment to 7.20 (4.98, 9.42) and 6.20 (2.43, 9.97) at 0.5 and 2 hours after treatment, respectively, in patients with aura receiving dexamethasone. Conclusions: This trial indicated that, in overall, intravenous sodium valproate is not superior to intravenous dexamethasone in treatment of acute migraine attacks. However, in patients with aura, only sodium valproate but not dexamethasone is effective in headache relief. This issue needs further investigations. Trial registration: IRCT201202199014N1.
    PLoS ONE 03/2015; 10(3):e0120229. DOI:10.1371/journal.pone.0120229 · 3.23 Impact Factor

Preview (2 Sources)

40 Reads
Available from