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1.
Levetiracetam as preventive treatment in adults with migraine: an up-to-date systematic review and quantitative meta-analysis.
Tsaousi, G, Pourzitaki, C, Siafis, S, Kyrgidis, A, Grosomanidis, V, Kouvelas, D, Papazisis, G
European journal of clinical pharmacology. 2020;(2):161-174
Abstract
PURPOSE The aim of this systematic review was to evaluate current evidence on the efficacy and safety of levetiracetam as migraine prophylaxis in adult patients suffering from migraine attacks. METHODS PubMed, Scopus, Cochrane Central Register of Controlled Trials, and International Web of Science were searched (last search in August 2018) for studies investigating levetiracetam for migraine prophylaxis in adults. Both randomized and non-randomized trials were eligible. Efficacy was the primary outcome, but tolerability was also investigated. The study is registered on PROSPERO, number CRD42018088900. RESULTS Nine studies, enrolling 215 patients, were included. Levetiracetam decreased the frequency of attacks with headache in all studies, with a pooled mean difference of -3.02 (95% CI: -4.59 to -1.45; I2 = 0%), -4.65(-7 to -2.3; I2 = 0%), and -5.71 (-8.60 to -2.82; I2 = 0%) at 1, 3, and 6 months compared with baseline. Three randomized controlled trials were included, and levetiracetam was superior to placebo in two but was inferior to sodium valproate in reducing headache frequency. Similar results were found in the other indices of efficacy, and levetiracetam was generally well tolerated. CONCLUSION Levetiracetam may be a relatively safe and efficacious treatment for the prophylaxis of migraine based on limited evidence, most from uncontrolled studies. Further evidence from randomized controlled trials is necessary.
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2.
Use of melatonin versus valproic acid in prophylaxis of migraine patients: A double-blind randomized clinical trial.
Ebrahimi-Monfared, M, Sharafkhah, M, Abdolrazaghnejad, A, Mohammadbeigi, A, Faraji, F
Restorative neurology and neuroscience. 2017;(4):385-393
Abstract
BACKGROUND Melatonin is known to be effective in curing migraine. OBJECTIVE This study aimed to investigate the therapeutic effect of melatonin versus sodium valproate in the prophylaxis of chronic migraine. METHODS This randomized, double-blind, placebo-controlled clinical trial included patients with chronic migraine who were divided into three equal sized groups, and baseline therapy with nortriptyline (10-25 mg) and propranolol (20-40 mg) was used. Patients in groups A, B, and C were adjunctively treated daily with 3 mg melatonin, 200 mg sodium valproate, and a placebo, respectively. The patients underwent treatment for 2 months and follow-up was done at baseline (baseline), first (I) and second month (II). Attack frequency (AF), attack duration, attack severity, Migraine Disability Assessment (MIDAS) score (within 3 months in two steps), analgesic intake, and drug side effects between the groups and during follow-up were compared. RESULTS The mean of monthly AF (melatonin: baseline: 4.2, I: 3.1, II: 2.5, p = 0.018; valproate: baseline: 4.3, I: 3.1, II: 2.3, p = 0.001; placebo: baseline: 4.1, I: 3.8, II: 3.8 p = 0.211), attack duration (hr) (melatonin: baseline: 19.8, I: 10.1, II: 8.7, p < 0.001; valproate: baseline: 19.5, I: 10.2, II: 8.8, p < 0.001; placebo: baseline: 19.6, I: 15.4, II: 14.1, p = 0.271), attack severity (melatonin: baseline: 7.3, I: 5.4, II: 3.5, p < 0.001; valproate: baseline: 7.4, I: 5.3, II: 3.4, p = 0.000; placebo: baseline: 7.3, I: 6.4, II: 6, p = 0.321), and MIDAS score (melatonin: baseline: 15.2, II: 8.9, p = 0.005; valproate: baseline: 16.1, II: 8.3, p = 0.001; placebo: baseline: 16, II: 12.1, p = 0.44), were significantly reduced in the melatonin and sodium valproate groups, but not in the placebo groups. Adverse events were reported in 11 patients (10.47%): 2 (5.71%) during melatonin treatment, 8 (22.85%) during valproate, and 1 (2.85%) during placebo. CONCLUSION The adjuvant treatment with melatonin was found to be superior to the placebo and had the same clinical efficacy as sodium valproate, but with higher tolerability. Melatonin may prove to be an efficient substitute for sodium valproate, as a chronic migraine prophylaxis.
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3.
Effect of intravenous sodium valproate vs dexamethasone on acute migraine headache: a double blind randomized clinical trial.
Mazaheri, S, Poorolajal, J, Hosseinzadeh, A, Fazlian, MM
PloS one. 2015;(3):e0120229
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 ClinicalTrials.gov IRCT201202199014N1.
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4.
Comparison of therapeutic effects of magnesium sulfate vs. dexamethasone/metoclopramide on alleviating acute migraine headache.
Shahrami, A, Assarzadegan, F, Hatamabadi, HR, Asgarzadeh, M, Sarehbandi, B, Asgarzadeh, S
The Journal of emergency medicine. 2015;(1):69-76
Abstract
BACKGROUND There is controversy about the efficacy of currently used treatment modalities to alleviate migraine headaches. OBJECTIVE We aimed to evaluate and compare the effects of magnesium sulfate and combined use of dexamethasone/metoclopramide on relieving acute migraine headache. METHODS We randomly divided 70 patients who had been referred to an emergency department, into two equal treatment groups with the two treatment plans, and analyzed pain severity at baseline using a numeric rating scale (NRS). We gave dexamethasone/metoclopramide to one group and magnesium sulfate to the other group, and evaluated pain severity at 20 min and at 1- and 2-h intervals after infusion. Finally, we used repeated-measure and two-way analysis of variance for intra- and inter-group evaluations of pain severity and complications, respectively. RESULTS We found no significant differences in demographic data and pain severity at baseline (8.2 vs. 8.0) between the two groups (p < 0.05). In the dexamethasone/metoclopramide group, pain severity (mean ± standard deviation) was 7.4 ± 1.4 (p = 0.36), 6.0 ± 2.4, and 2.5 ± 2.9 (p < 0.0001) at 20-min, 1-h, and 2-h intervals after treatment, respectively, with statistically significant differences between the baseline values and 1-h and 2-h interval values. Administration of magnesium sulfate was associated with decreased pain severity at the three intervals (5.2 ± 1.7, 2.3 ± 1.9, and 1.3 ± 0.66, respectively), exhibiting significant differences compared to baseline values and the corresponding time intervals in the dexamethasone/metoclopramide group (p < 0.0001). CONCLUSIONS According to the results, magnesium sulfate was a more effective and fast-acting medication compared to a combination of dexamethasone/metoclopramide for the treatment of acute migraine headaches.
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5.
Intravenous Valproate versus Subcutaneous Sumatriptan in Acute Migraine Attack.
Ghaderibarmi, F, Tavakkoli, N, Togha, M
Acta medica Iranica. 2015;(10):633-6
Abstract
Migraine is a common and incapacitating neurologic disorder manifesting with episodic moderate to a severe headache and other symptoms such as photophobia, phonophobia, nausea, and vomiting. Triptans and ergot compounds have been used as treatment options for an acute migraine headache for many years. Triptans are considered the first line of treatment in patients with moderate to a severe migraine. Although the triptans are commonly used at any time during a migraine attack; they are more efficacious when used in the early stages of a migraine. Intravenous valproic acid has been shown to be well tolerated, safe, and with rapid onset of action in patients with acute moderate to severe and even refractory migraine. Sodium valproate is a Food and Drug Administration (FDA)-approved drug for prophylaxis of a migraine with and without aura. In this study, the main goal was to compare the effectiveness of sumatriptan versus valproate in an acute migraine. A randomized clinical trial including 37 patients with an acute migraine was considered to compare the effectiveness of sumatriptan versus valproate. The patients were divided into two groups. In first group, 6 mg subcutaneous of sumatriptan and in the second group 15 mg/Kg of valproate was administered. The outcomes including pain and drug adverse effects were compared across the groups. A total of 37 patients (7 male and 30 female) were evaluated in two groups. The difference between two groups regarding sex and age was not significant (P>0.05). The mean pain scores reduced from 8.3 to 4.7 and from 8.3 to 2.2 after one hour of treatment in sumatriptan and valproate groups, respectively. Response to treatment in valproate group was faster and more effective than sumatriptan group (P<0.05).The results indicated that valproate was more effective and with the faster response in patients with an acute migraine in comparison with sumatriptan without any recurrence and remarkable side effects.
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6.
Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine.
Friedman, BW, Garber, L, Yoon, A, Solorzano, C, Wollowitz, A, Esses, D, Bijur, PE, Gallagher, EJ
Neurology. 2014;(11):976-83
Abstract
OBJECTIVE We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department (ED) with acute migraine. METHODS This was a double-blind comparative efficacy trial. Patients were randomized to 1,000 mg sodium valproate, 10 mg metoclopramide, or 30 mg ketorolac, each administered as an IV drip over 15 minutes. The primary outcome was improvement in headache by 1 hour, measured on a verbal 0 to 10 scale, at baseline and 60 minutes later. Important secondary outcomes included (1) need for rescue medication in the ED, and (2) sustained headache freedom. RESULTS Three hundred thirty patients were enrolled over 30 months beginning in October 2010. Baseline characteristics were comparable among the 3 arms. On the primary outcome, patients receiving IV valproate improved by a mean of 2.8 (95% confidence interval [CI]: 2.3, 3.3) on the 0 to 10 scale; those receiving IV metoclopramide improved by 4.7 (95% CI: 4.2, 5.2); and those receiving IV ketorolac improved by 3.9 (95% CI: 3.3, 4.5). On the secondary endpoints, 69% (95% CI: 60%, 78%) of patients receiving valproate required rescue medication, compared with 33% (95% CI: 24%, 42%) of metoclopramide patients and 52% (95% CI: 42%, 63%) of those assigned to ketorolac. Sustained headache freedom was achieved in 4% (95% CI: 0%, 7%) of those randomized to valproate, 11% (95% CI: 5%, 17%) of metoclopramide patients, and 16% (95% CI: 9%, 23%) receiving ketorolac. In the metoclopramide arm, 6% (95% CI: 3%, 12%) of patients reported feeling "very restless" after investigational medication administration. CONCLUSIONS Valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide demonstrated superiority to ketorolac on several endpoints. CLASSIFICATION OF EVIDENCE This study provides Class I evidence that in ED patients with acute migraine, IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes.
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7.
Effects of acetaminophen and ibuprofen in children with migraine receiving preventive treatment with magnesium.
Gallelli, L, Avenoso, T, Falcone, D, Palleria, C, Peltrone, F, Esposito, M, De Sarro, G, Carotenuto, M, Guidetti, V
Headache. 2014;(2):313-24
Abstract
AIM: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium. METHODS Children ranging from the ages of 5 to 16 years with at least 4 attack/month of primary migraine were eligible for participation the study. A visual analog scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study). RESULTS One hundred sixty children of both sexes aged 5-16 years were enrolled and assigned in 4 groups to receive a treatment with acetaminophen or ibuprofen without or with magnesium. Migraine pain endurance and monthly frequency were similar in the 4 groups. Both acetaminophen and ibuprofen induced a significant decrease in pain intensity (P < .01), without a time-dependent correlation, but did not modify its frequency. Magnesium pretreatment induced a significant decrease in pain intensity (P < .01) without a time-dependent correlation in both acetaminophen- and ibuprofen-treated children and also significantly reduced (P < .01) the pain relief timing during acetaminophen but not during ibuprofen treatment (P < .01). In both acetaminophen and ibuprofen groups, magnesium pretreatment significantly reduced the pain frequency (P < .01). CONCLUSIONS Magnesium increased the efficacy of ibuprofen and acetaminophen with not age-related effects.
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8.
[A comparative study of the effectiveness of topiramate and flunarizine in independent series of chronic migraine patients without medication abuse].
Gracia-Naya, M, Ríos, C, García-Gomara, MJ, Sánchez-Valiente, S, Mauri-Llerda, JÁ, Santos-Lasaosa, S, Artal-Roy, J, Latorre-Jiménez, AM
Revista de neurologia. 2013;(8):347-53
Abstract
INTRODUCTION Topiramate and onabotulinumtoxin A have proven to be effective in chronic migraine with or without medication abuse according to recent criteria of the International Headache Society's Headache Classification. AIMS To show that flunarizine is as effective as topiramate in cases of chronic migraine without medication abuse. PATIENTS AND METHODS We conducted a prospective, non-randomised, comparative study of two groups of patients paired by age and sex, with chronic migraine without abuse, who had been treated preventively for the first time with topiramate or flunarizine. RESULTS Forty patients treated with flunarizine were assigned a patient of their same sex and age who was being treated with topiramate. The mean rate of reduction in intense migraines in the topiramate group was 59% and in the flunarizine group, 58.5% (p = 0.9444); the responder rate at four months of treatment did not show any significant differences either, the figures being 75% for topiramate and 70% for flunarizine (p = 0.6236). The mean reduction of other headaches in the topiramate group was 57% and in the flunarizine group, 64% (p = 0.4261); the responder rate at four months of treatment was similar in the two groups: 76%. The percentage of dropouts from treatment was higher with topiramate (19.5%) than with flunarizine (10%) (p = 0.3493). No serious side effects occurred in either of the groups. In all, 78.9% of the patients who took topiramate said they were satisfied with the drug versus 75% of those in the flunarizine group (p = 0.7903). CONCLUSIONS Flunarizine proved to be as effective as topiramate in the treatment of chronic migraine without medication abuse.
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9.
The effects of cinnarizine versus sodium valproate in migraine prophylaxis.
Bostani, A, Rajabi, A, Moradian, N, Razazian, N, Rezaei, M
The International journal of neuroscience. 2013;(7):487-93
Abstract
AIM: The aim of this randomized, double-blind, parallel-group study was to compare the efficacy and safety of low-dose cinnarizine and sodium valproate in migraine prophylaxis. METHODS A total of 104 patients were treated during a 12-week treatment period. Cinnarizine dose of 25 mg and 200-mg sodium valproate were administered every 12 hours. During follow-up period, frequency, intensity and duration of migraine attacks, symptoms associated with headache, analgesics use, as well as drugs' side effects were studied. Participants completed Migraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) questionnaires before and after treatment. RESULTS Frequency, intensity and duration of migraine headaches as well as MIDAS score and administration of symptomatic medications decreased significantly between repeated follow-up visits in both groups. Reduction of 4-week migraine frequencies in patients receiving cinnarizine and valproate was 36.4% and 55%, respectively, and the difference between two groups was statistically significant (p < 0.001). CONCLUSION Our results showed that administration of 25-mg cinnarizine every 12 hours can significantly decrease headache duration (p ≤ 0.001) and headache frequency (p ≤ 0.001) in patients with migraine. These results suggest that cinnarizine may be an appropriate substitution for first-line migraine prophylaxis such as valproate.
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10.
Acute migraine therapy: recent evidence from randomized comparative trials.
Mett, A, Tfelt-Hansen, P
Current opinion in neurology. 2008;(3):331-7
Abstract
(1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria.(2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved tolerability over sumatriptan.(3) Combination indomethacin/caffeine/prochlorperazine most likely has similar therapeutic efficacy to triptan therapy, with further research needed to complete understanding of any potential differences between these treatments.(4) Multi-targeted combination therapy with a triptan plus a non-steroidal anti-inflammatory (NSAID), such as sumatriptan/naproxen sodium, is more effective in acute migraine treatment than monotherapy with either agent alone.(5) It is unclear whether triptans offer clinically relevant benefits over aspirin or NSAIDs in migraine patients. Thus NSAIDs, particularly effervescent aspirin, should be considered the first-line treatment of migraine attacks.