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Cinnarizine as an alternative recommendation for migraine prophylaxis: a narrative review.
Togha, M, Martami, F, Abdollahi, M, Mozafari, M, Cheraghali, H, Rafiee, P, Shafaei, M
Expert review of neurotherapeutics. 2020;(9):943-951
Abstract
INTRODUCTION Despite the available prophylactic and acute drugs for migraine management, this disabling disorder remains undertreated especially among pediatrics. In this review, the authors aim at assessing the preventive role cinnarizine plays in treating migraine based on previously published studies. AREAS COVERED Randomized clinical trials, randomized controlled trials, non-randomized open-label trials, and retrospective studies concerning cinnarizine in migraine prevention in children and adults were reviewed. Especial attention was given to the response rate, migraine characteristics, and tolerability. EXPERT OPINION The majority of reviewed trials demonstrated that cinnarizine is comparable to the conventional drugs used in migraine prophylaxis. However, most of the reviewed studies were limited by a non-controlled open-label design. Due to poor planning and possibility of high placebo responses, particularly in children and adolescents, the interpretation of open-label studies' results should be done cautiously. The evidence shows that cinnarizine's effectiveness was more promising in pediatric migraineurs and adults with migraine-associated vertigo such as vestibular migraine. Therefore, while the efficacy of cinnarizine cannot be dismissed, before reaching a definite conclusion on its effectiveness, it is necessary to do further high-quality RCTs among both children and adults.
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Effect of cinnamon on migraine attacks and inflammatory markers: A randomized double-blind placebo-controlled trial.
Zareie, A, Sahebkar, A, Khorvash, F, Bagherniya, M, Hasanzadeh, A, Askari, G
Phytotherapy research : PTR. 2020;(11):2945-2952
Abstract
Migraine is the most common type of primary headaches. Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain. Cinnamon has anti-inflammatory and neuroprotective properties. Thus, the aim of this study was to assess the effect of cinnamon on migraine attacks and inflammatory status. Fifty patients with migraine were randomized to receive either cinnamon powder (three capsules/day each containing 600 mg of cinnamon) or three placebo capsules/day each containing 100 mg of corn starch (control group) for 2 months. Serum levels of IL-6, CGRP and NO were measured at baseline and at the end of the study. The frequency, severity and duration of pain attacks were also recorded using questionnaire. Serum concentrations of IL-6 and NO were significantly reduced in the cinnamon group compared with the control group (p < .05). However, serum levels of CGRP remained unchanged in both groups. The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group. Cinnamon supplementation reduced inflammation as well as frequency, severity and duration of headache in patients with migraine. Cinnamon could be regarded as a safe supplement to relieve pain and other complications of migraine.
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Effect of coenzyme Q10 supplementation on clinical features of migraine: a systematic review and dose-response meta-analysis of randomized controlled trials.
Parohan, M, Sarraf, P, Javanbakht, MH, Ranji-Burachaloo, S, Djalali, M
Nutritional neuroscience. 2020;(11):868-875
Abstract
Objective: Coenzyme Q10 is an antioxidant and an essential mitochondrial cofactor which has been suggested to improve the clinical features of migraine. Several randomized clinical trials have examined the effects of Coenzyme Q10 on migraine with inconclusive results. The aim of this systematic review and meta-analysis was to evaluate the impact of Coenzyme Q10 supplementation on the frequency, severity, and duration of migraine attacks. Methods: A systematic review of the literature was conducted using ISI Web of Science, PubMed, Cochrane library and Scopus to identify eligible studies up to April 2018. Studies included were randomized clinical trials of Coenzyme Q10 supplementation that reported the frequency, severity, or duration of migraine attacks as a primary outcome. A meta-analysis of eligible studies was performed using the fixed effects model or the random effects model to estimate pooled effect size. Results: Four randomized clinical trials with 221 participants were included. Coenzyme Q10 supplementation significantly reduced the frequency of migraine attacks (weighted mean difference: -1.87 attacks/month, 95% CI: -2.69 to -1.05, p < 0.001) without significant heterogeneity among the studies (I 2 = 36.6%, p = 0.192). Coenzyme Q10 supplementation had no significant effect on severity (weighted mean difference: -2.35 visual analog scale score, 95% CI: -5.19 to 0.49, p = 0.105) and duration of migraine attacks (weighted mean difference: -6.14 h, 95% CI: -13.14 to 0.87, p = 0.086) with high heterogeneity. Conclusion: Pooled analyses of available randomized clinical trials suggest that Coenzyme Q10 supplementation may reduce the frequency of migraine attacks per month without affecting the severity or duration of migraine attacks.
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Unrecognized challenges of treating status migrainosus: An observational study.
Iljazi, A, Chua, A, Rich-Fiondella, R, Veronesi, M, Melo-Carrillo, A, Ashina, S, Burstein, R, Grosberg, B
Cephalalgia : an international journal of headache. 2020;(8):818-827
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Abstract
BACKGROUND Status migrainosus is a condition with limited epidemiological knowledge, and no evidence-based treatment guideline or rational-driven assessment of successful treatment outcome. To fill this gap, we performed a prospective observational study in which we documented effectiveness of treatment approaches commonly used in a tertiary headache clinic. MATERIAL AND METHODS Patients with episodic and chronic migraine who experienced continuous and prolonged attacks for more than 72 hours were treated with dexamethasone (4 mg orally twice daily for 3 days), ketorolac (60 mg intramuscularly), bilateral nerve blocks (1-2% lidocaine, 0.1-0.2 ml for both supraorbital and supratrochlear nerves, 1 ml for both auriculotemporal nerves, and 1 ml for both greater occipital nerves), or naratriptan (2.5 mg twice daily for 5 days). Hourly (for the first 24 hours) and daily (for first 30 days) change in headache intensity was documented using appropriate headache diaries. RESULTS Fifty-four patients provided eligible data for 60 treatment attempts. The success rate of rendering patients pain free within 24 hours and maintaining the pain-free status for 48 hours was 4/13 (31%) for dexamethasone, 7/29 (24%) for nerve blocks, 1/9 (11%) for ketorolac and 1/9 (11%) for naratriptan. These success rates depended on time to remission, as the longer we allowed the treatments to begin to work and patients to become pain free (i.e. 2, 12, 24, 48, 72, or 96 hours), the more likely patients were to achieve and maintain a pain-free status for at least 48 hours. DISCUSSION These findings suggest that current treatment approaches to terminating status migrainosus are not satisfactory and call attention to the need to develop a more scientific approach to define a treatment response for status migrainosus.
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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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Efficacy, Safety, and Acceptability of Pharmacologic Treatments for Pediatric Migraine Prophylaxis: A Systematic Review and Network Meta-analysis.
Locher, C, Kossowsky, J, Koechlin, H, Lam, TL, Barthel, J, Berde, CB, Gaab, J, Schwarzer, G, Linde, K, Meissner, K
JAMA pediatrics. 2020;(4):341-349
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IMPORTANCE Migraine is one of the most common neurologic disorders in children and adolescents. However, a quantitative comparison of multiple preventive pharmacologic treatments in the pediatric population is lacking. OBJECTIVE To examine whether prophylactic pharmacologic treatments are more effective than placebo and whether there are differences between drugs regarding efficacy, safety, and acceptability. DATA SOURCES Systematic review and network meta-analysis of studies in MEDLINE, Cochrane, Embase, and PsycINFO published through July 2, 2018. STUDY SELECTION Randomized clinical trials of prophylactic pharmacologic treatments in children and adolescents diagnosed as having episodic migraine were included. Abstract, title, and full-text screening were conducted independently by 4 reviewers. DATA EXTRACTION AND SYNTHESIS Data extraction was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis network meta-analysis guidelines. Quality was assessed with the Cochrane Risk of Bias tool. Effect sizes, calculated as standardized mean differences for primary outcomes and risk ratios for discontinuation rates, were assessed in a random-effects model. MAIN OUTCOMES AND MEASURES Primary outcomes were efficacy (ie, migraine frequency, number of migraine days, number of headache days, headache frequency, or headache index), safety (ie, treatment discontinuation owing to adverse events), and acceptability (ie, treatment discontinuation for any reason). RESULTS Twenty-three studies (2217 patients) were eligible for inclusion. Prophylactic pharmacologic treatments included antiepileptics, antidepressants, calcium channel blockers, antihypertensive agents, and food supplements. In the short term (<5 months), propranolol (standard mean difference, 0.60; 95% CI, 0.03-1.17) and topiramate (standard mean difference, 0.59; 95% CI, 0.03-1.15) were significantly more effective than placebo. However, the 95% prediction intervals for these medications contained the null effect. No significant long-term effects for migraine prophylaxis relative to placebo were found for any intervention. CONCLUSIONS AND RELEVANCE Prophylactic pharmacologic treatments have little evidence supporting efficacy in pediatric migraine. Future research could (1) identify factors associated with individual responses to pharmacologic prophylaxis, (2) analyze fluctuations of migraine attack frequency over time and determine the most clinically relevant length of probable prophylactic treatment, and (3) identify nonpharmacologic targets for migraine prophylaxis.
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The Efficacy of Topical Basil Essential Oil on Relieving Migraine Headaches: A Randomized Triple-Blind Study.
Ahmadifard, M, Yarahmadi, S, Ardalan, A, Ebrahimzadeh, F, Bahrami, P, Sheikhi, E
Complementary medicine research. 2020;(5):310-318
Abstract
OBJECTIVE Complementary therapies have been increasingly used for the prevention and treatment of migraine so that there is a need for studies in this setting. This study sought to determine the effects of basil essential oil on the severity and frequency of migraine attack headaches. METHODS A triple-blind clinical trial study was performed on 144 patients diagnosed with migraine. Patients were randomly allocated by a stratified method to four groups of 36 titled basil essential oil 2, 4, 6%, and placebo groups. Medications were used topically every 8 h for 3 successive months. In addition, each individual received 325 mg of acetaminophen every 12 h. The severity and frequency of migraine attacks were measured prior to the study, at weeks 2, 4, 8, and 12. The visual analog scale was used to measure pain intensity. The marginal model and generalized estimation equations were used to compare changes in the intensity and frequency of pain over time. RESULTS The interaction of the dose and time factors was significant on both pain intensity (p < 0.001) and frequency of attack (p < 0.001). The odds ratio of higher pain intensity and rate ratio of higher frequency of attack in the intervention groups compared to the placebo group were decreased over the study time. CONCLUSION Time lapse and higher doses of basil essential oil would reduce both the intensity and frequency of migraine attacks.
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Retrospective Chart Review of Intravenous Valproate Sodium as a Preventive Treatment for Patients With Chronic Migraine.
Riggins, N, Ehrlich, A, Sawhney, H, Dapkus, L, Levin, M
Headache. 2020;(3):617-620
Abstract
OBJECTIVE This is a small pilot study to evaluate the effectiveness of an intravenous (IV) valproate sodium therapy protocol for migraine prevention in a population of patients with chronic migraine refractory to multiple preventive medications. BACKGROUND Valproate sodium is an anti-epileptic and mood stabilizer that has been shown to prevent migraine when used daily in oral form. The specific mechanism of action in migraine is unknown, but it may be related to suppressing inflammation and increasing brain Gamma-aminobutyric acid levels. It also may relate to its ability to suppress cortical spreading depression. Multiple studies have suggested that valproic acid and its derivatives may inhibit Calcitonin gene-related peptide. In the present work, we undertook a small pilot study to evaluate the effectiveness of an IV valproate sodium therapy for migraine prevention in a population of patients with chronic migraine refractory to multiple preventive medications. METHODS Fourteen adult patients with chronic migraine were admitted for a 4-day course of IV valproate sodium. Patients received 250 mg of valproate sodium over a standard infusion time of 60 minutes every 8 hours. Most patients received 9 doses over the 4-day course of treatment. One patient had to discontinue after 1 dose of 250-mg valproate sodium, as this patient experienced an increase in his previous symptoms of nausea, vomiting, and vertigo with his first dose. To avoid positive selection bias, we evaluated the first admission for valproate IV therapy in patients with multiple admissions; there was 1 patient with 2 admissions and 1 with 3 admissions for IV valproate sodium. Of note - all admission outcomes for these patients were similar. Headache diaries were reviewed from 1 month before, during, and approximately 2 months after their admission. STATISTICAL ANALYSES Due to the observational nature of the study and small sample size, we did not think that quantitative statistical analysis would add more meaning to this pilot study. Formal quantitative statistical analysis was not performed in this study and descriptive statistical analysis was used due to this being a pilot proof of concept study. Physician clinical judgment in combination with patient reports were used to assign a dichotomous conclusion on clinical improvement for each patient. In the future, we plan to create a larger study, including additional treatment groups for control, such as IV Dihydroergotamine or IV Chlorpromazine, in order to quantify improvement of symptoms. RESULTS A total of 9 out of 13 (69%) patients had an improvement in their headache post-admission and reported a reduction in headache frequency, intensity, and/or use of acute medications 4-6 weeks following their admissions. A total of 5 out of 13 (38%) patients also reported an improvement in headache intensity during the 4-day period of inpatient admission. The other 8 out of 13 (62%) patients reported stable headache pattern. One patient had feelings of restlessness, which improved with prolongation of infusion time to 120 minutes. CONCLUSION These results indicate that this repetitive dosing valproate sodium protocol is a safe and well-tolerated intervention for the treatment of chronic migraine resistant to oral medications. Given the promising outcomes on patient headache improvement with this small pilot study, studies to confirm this benefit in a larger cohort of chronic migraine patients are warranted, preferable with the addition of a blinded control group for comparison.
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Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial.
Yavuz, E, Gulacti, U, Lok, U, Turgut, K
The American journal of emergency medicine. 2020;(11):2254-2258
Abstract
STUDY OBJECTIVE The objective of this study was to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED). METHODS This single-center, randomized, double-blind study was conducted in a tertiary care ED. Eligible patients met the migraine criteria of the International Headache Society were randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol +10 mg metoclopramide. Visual analogue scale (VAS) was used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure was the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures were the presence of adverse effects and the requirement of rescue medicine. RESULTS Patients (n = 150) were randomized into 3 groups with similar VAS scores at baseline. While there was no significant difference between metoclopramide and dexketoprofen trometamol in reducing pain at the 15th and 30th minute (p = 0.618 and p = 0.862, respectively) and between metoclopramide and metoclopramide + dexketoprofen trometamol at the 15th minute (p = 0.074), metoclopramide + dexketoprofen trometamol was superior to both metoclopramide [mean difference: -13.2 mm (95% CI -23.1 to -3.3)] and dexketoprofen trometamol [mean difference: -11.02 mm (95% CI -20.9 to -1.1)] at the 30th min (p = 0.006 and p = 0.025 respectively). The rescue drug was required by 3 patients (6%) were in metoclopramide group, 4 patients (8%) in dexketoprofen trometamol group and one patient (2%) in the metoclopramide + dexketoprofen trometamol group. No side effects were observed in subjects in three treatment groups. CONCLUSION No significant difference in VAS was found between three treatment groups at the 15th minute, but metoclopramide + dexketoprofen trometamol was superior to both metoclopramide and dexketoprofen trometamol at the 30th min.
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Intravenous Migraine Treatment in Children and Adolescents.
Werner, K, Qaiser, S, Kabbouche, M, Murphy, B, Maconochie, I, Hershey, AD
Current pain and headache reports. 2020;(8):45
Abstract
PURPOSE OF REVIEW Pediatric migraine is a common, chronic, and disabling neurological disorder in children and adolescents. Outpatient management is not always effective, and intravenous migraine management may be necessary for headache treatment in the pediatric emergency department. Most current treatment is based on retrospective evidence and there is a lack of well-designed randomized double-blinded controlled pediatric studies. Intravenous drug treatment agents including intravenous fluids, prochlorperazine, diphenhydramine, metoclopramide, dexamethasone, magnesium, valproate and propofol, and dihydroergotamine are reviewed in this paper. RECENT FINDINGS Nineteen studies were reviewed including one prospective randomized double-blind; one single-blinded randomized; one prospective; and one open-label, randomized clinical trial. Most studies were retrospective and the quality of the studies was limited. No definite conclusions can be drawn from the studies, but appropriate prospective trials between major pediatric headache institutions will move pediatric intravenous migraine management forward.