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Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial
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 w...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368536/ https://www.ncbi.nlm.nih.gov/pubmed/25793707 http://dx.doi.org/10.1371/journal.pone.0120229 |
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author | Mazaheri, Shahir Poorolajal, Jalal Hosseinzadeh, Akram Fazlian, Mohammad Mahdi |
author_facet | Mazaheri, Shahir Poorolajal, Jalal Hosseinzadeh, Akram Fazlian, Mohammad Mahdi |
author_sort | Mazaheri, Shahir |
collection | PubMed |
description | 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: ClinicalTrials.gov IRCT201202199014N1 |
format | Online Article Text |
id | pubmed-4368536 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-43685362015-03-27 Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial Mazaheri, Shahir Poorolajal, Jalal Hosseinzadeh, Akram Fazlian, Mohammad Mahdi PLoS One Research Article 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: ClinicalTrials.gov IRCT201202199014N1 Public Library of Science 2015-03-20 /pmc/articles/PMC4368536/ /pubmed/25793707 http://dx.doi.org/10.1371/journal.pone.0120229 Text en © 2015 Mazaheri et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Mazaheri, Shahir Poorolajal, Jalal Hosseinzadeh, Akram Fazlian, Mohammad Mahdi Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title | Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title_full | Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title_fullStr | Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title_full_unstemmed | Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title_short | Effect of Intravenous Sodium Valproate vs Dexamethasone on Acute Migraine Headache: A Double Blind Randomized Clinical Trial |
title_sort | effect of intravenous sodium valproate vs dexamethasone on acute migraine headache: a double blind randomized clinical trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368536/ https://www.ncbi.nlm.nih.gov/pubmed/25793707 http://dx.doi.org/10.1371/journal.pone.0120229 |
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