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Intravenous lidocaine vs. NSAIDs for migraine attack in the ED: a prospective, randomized, double-blind study.
Gur, STA, Ahiskalioglu, EO, Aydin, ME, Kocak, AO, Aydin, P, Ahiskalioglu, A
European journal of clinical pharmacology. 2022;(1):27-33
Abstract
PURPOSE Although different forms of lidocaine are used for migraine attack headaches, the effect of intravenous lidocaine is still limited. This study aimed to investigate the effects of intravenous lidocaine infusion for the treatment of migraine attack headaches. METHODS A hundred patients with migraine attacks, aged between 18 and 65, were randomly divided into two groups. The lidocaine group (n = 50) received a 1.5 mg/kg lidocaine bolus and a 1 mg/kg infusion (first 30 min), followed by a 0.5 mg/kg infusion for a further 30 min intravenously. The non-steroidal anti-inflammatory drug (NSAID) group (n = 50) received 50 mg dexketoprofen trometamol and saline at the same volume as the lidocaine at the same time intervals intravenously. The Visual Analog Scale (VAS) pain scores, additional analgesia requirement, side effects, and revisits to the emergency department were recorded. RESULTS The VAS score was significantly lower in the lidocaine group than in the NSAID group for the first 20th and 30th minutes (p = 0.014 and p = 0.024, respectively). There was no difference between the VAS scores for the remaining evaluation times (p > 0.05). In terms of secondary outcomes, rescue medication requirement was not different between the two groups at both the 60th and 90th minutes (p > 0.05). However, the number of patients revisiting ED within 48-72 h was statistically less in the lidocaine group than in the NSAID group (1/50 vs. 8/50; p = 0.031). CONCLUSION Intravenous lidocaine may be an alternative treatment method for patients with migraine attack headaches in the emergency department.
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A prospective, randomized, double-blind trial of intravenous chlorpromazine versus intravenous prochlorperazine for the treatment of acute migraine in adults presenting to the emergency department.
Hodgson, SE, Harding, AM, Bourke, EM, Taylor, DM, Greene, SL
Headache. 2021;(4):603-611
Abstract
OBJECTIVE To compare the efficacy of intravenous chlorpromazine versus intravenous prochlorperazine for the treatment of acute migraine in adults presenting to the emergency department (ED). BACKGROUND Migraine is a common, incapacitating neurological condition. Although chlorpromazine and prochlorperazine are known to be safe, efficacious treatments for migraine, they have never been directly compared. DESIGN We performed a prospective, randomized, double-blind clinical trial at a tertiary hospital in Melbourne, Australia. Adults aged 18-65 years, who presented with migraine, were eligible for recruitment. Sixty-six patients were randomized to either chlorpromazine 12.5 mg or prochlorperazine 12.5 mg, both infused in 500 ml of sodium chloride 0.9% over 30 min. Headache severity score, nausea severity score, and the presence of photophobia and phonophobia were assessed at 0, 30, 60, and 120 min. Adverse effects and the need for rescue therapy were recorded. The primary outcome was a reduction in headache severity score from baseline at 60 min post-commencement of the study medicine infusion. RESULTS Sixty-five patients were included in the analysis. There was a median reduction in headache severity score at 60 min of 3.0 (interquartile range 1.0-4.0) in the chlorpromazine arm versus 2.0 (1.0-4.0) in the prochlorperazine arm (median difference -0.5 (95% confidence interval, -1.9 to 0.9)). We saw no evidence of a difference in secondary outcomes at 30, 60, or 120 min. Side effects were reported in 16/32 (50%) patients in the chlorpromazine group versus 7/33 (21%) in the prochlorperazine group (p = 0.020). Rescue therapy was required in 7/32 (22%) patients in the chlorpromazine group versus 12/33 (36%) in the prochlorperazine group (p = 0.277). CONCLUSIONS Both chlorpromazine and prochlorperazine are efficacious treatments for acute migraine in adult patients presenting to the ED. This trial found no evidence of superiority of either agent over the other. Caution should be used when prescribing these medicines in the borderline hypotensive patient; in that circumstance, prochlorperazine should be preferentially used.
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MAGraine: Magnesium compared to conventional therapy for treatment of migraines.
Kandil, M, Jaber, S, Desai, D, Nuñez Cruz, S, Lomotan, N, Ahmad, U, Cirone, M, Burkins, J, McDowell, M
The American journal of emergency medicine. 2021;:28-33
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Abstract
Due to the healthcare burden associated with migraines, prompt and effective treatment is vital to improve patient outcomes and ED workflow. This was a prospective, randomized, double-blind trial. Adults who presented to the ED with a diagnosis of migraine from August of 2019 to March of 2020 were included. Pregnant patients, or with renal impairment were excluded. Patients were randomized to receive intravenous magnesium, prochlorperazine, or metoclopramide. The primary outcome was change in pain from baseline on a numeric rating scale (NRS) evaluated at 30 min after initiation of infusion of study drug. Secondary outcomes included NRS at 60 and 120 min, ED length of stay, necessity for rescue analgesia, and adverse effects. A total of 157 patients were analyzed in this study. Sixty-one patients received magnesium, 52 received prochlorperazine, and 44 received metoclopramide. Most patients were white females, and the median age was 36 years. Hypertension and migraines were the most common comorbidities, with a third of the patients reporting an aura. There was a median decrease in NRS at 30 min of three points across all three treatment arms. The median decrease in NRS (IQR) at 60 min was -4 (2-6) in the magnesium group, -3 (2-5) in the metoclopramide group, and -4.5 (2-7) in the prochlorperazine group (p = 0.27). There were no statistically significant differences in ED length of stay, rescue analgesia, or adverse effects. Reported adverse effects were dizziness, anxiety, and akathisia. No significant difference was observed in NRS at 30 min between magnesium, metoclopramide and prochlorperazine.
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Intravenous ibuprofen for acute treatment of migraine: A double-blind, randomized, placebo-controlled pilot study.
Yuan, H, Curran, JG, Keith, SW, Hopkins, MM, Silberstein, SD
Headache. 2021;(9):1432-1440
Abstract
OBJECTIVE To evaluate the efficacy and safety of intravenous (IV) Ibuprofen for acute treatment of migraine. BACKGROUND IV nonsteroidal anti-inflammatory drugs (NSAIDs) are an alternative to oral NSAIDs, especially in patients with severe migraine who have emesis or gastroparesis. To date, only three IV NSAIDs (ketorolac, ibuprofen, and meloxicam) are available in the United States for use in moderate and severe pain, but no placebo-controlled trial is available for migraine. We performed a single-center, double-blind, randomized, placebo-controlled pilot study to evaluate the efficacy and safety of IV ibuprofen as an acute treatment of migraine (NCT01230411). METHODS Individuals with episodic migraine were screened at the Jefferson Headache Center. Qualified subjects were treated for migraine attacks within 2-72 h following the headache onset with either 800 mg of IV ibuprofen or placebo in 250 ml saline bolus. Migraine pain intensity (4-point Likert scale) and associated symptoms were assessed at predetermined time points (0.25, 0.5, 1, 1.5, 2, 4, 8, 24 h). The primary endpoint was pain relief at 2 h after infusion. Important secondary endpoints included pain freedom at 2 h, sustained relief over 24 h, use of rescue therapy, and absence of associated symptoms. Adverse events (AEs) were also collected. RESULTS Seventy-four participants were enrolled between 2011 and 2017. Forty-four subjects (female 33/44; 75.0%) with mean (SD) age 41.0 (11.2) 11.2 years came for the treatment. All treated subjects (n = 44) were included in the analysis. Among them, 23 were randomized to receive IV ibuprofen. Both groups were demographically similar except for longer migraine duration (i.e., years lived with disease) in the active treatment than in the placebo group. At 2 h posttreatment, pain relief was found in 74% (17/23) and 48% (10/21) after IV ibuprofen and placebo, respectively (odds ratio [OR] 3.12, 95% CI: 0.88-11.0; p = 0.078). Other secondary endpoints at 2 and 24 h were not significant. The longitudinal repeated-measures analysis within 2 h on ibuprofen treatment showed significant pain relief (OR 2.47, 95% CI 1.08-5.7; p = 0.033) and absence of associated symptoms: photophobia (OR 4.0, 95% CI 1.57-10.3; p = 0.004), phonophobia (OR 3.12, 95% CI 1.16-8.4; p = 0.025), and osmophobia (OR 3.45, 95% CI 1.01-11.8; p = 0.048). AEs were observed in seven subjects in both groups, with arm pain being the most common. No serious AE was reported. CONCLUSION This study did not meet the primary endpoint but showed pain relief and elimination of several associated symptoms within 2 h on repeated-measures analysis. Although limited by small sample size and high placebo response, our results indicate that IV ibuprofen may be a safe and effective option for acute treatment of migraine, but more extensive studies are necessary.
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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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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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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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Reduction in Migraine and Headache Frequency and Intensity With Combined Antioxidant Prophylaxis (N-acetylcysteine, Vitamin E, and Vitamin C): A Randomized Sham-Controlled Pilot Study.
Visser, EJ, Drummond, PD, Lee-Visser, JLA
Pain practice : the official journal of World Institute of Pain. 2020;(7):737-747
Abstract
OBJECTIVE To investigate the preventive effects of a combined antioxidant drug (N-acetylcysteine, vitamin E, and vitamin C [NEC]) on migraine outcomes. Migraine is characterized by increased oxidative stress and neurogenic inflammation in the brain; therefore, antioxidants may have a migraine preventive effect. DESIGN Randomized, double-blind, sham-controlled pilot study. SETTING Australian community. SUBJECTS Adults reporting 2 to 8 migraines per month for at least a year. METHODS After a 1-month baseline period, 35 subjects completed 3 months of treatment with NEC (n = 19) or sham (n = 16) capsules. The primary outcome was the difference in mean number of headaches per month between baseline and final month of the trial for NEC and sham groups; secondary outcomes are listed below. RESULTS For NEC there was a significant decrease in mean number of headaches by 3.0 per month (P = 0.004) compared with 1.4 for sham (P = 0.073); there was no significant difference in these changes between the 2 groups (P = 0.052). Average monthly headache (P = 0.041) and migraine frequency (P = 0.018) were significantly less for NEC vs. sham. In NEC subjects, there was a significant decrease in average monthly migraine days (-3.1), moderate/severe headache days (-3.2), migraine duration, headache pain scores, and acute headache medication use. CONCLUSIONS This is the first randomized controlled trial to find that combined antioxidant therapy with NEC reduces headaches and migraines in adult migraineurs. Given the limitations of this pilot study, an adequately powered randomized controlled trial is planned to further investigate antioxidant prophylaxis in migraine.
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Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial.
Amanat, M, Togha, M, Agah, E, Ramezani, M, Tavasoli, AR, Azizi Malamiri, R, Fashandaky, F, Heidari, M, Salehi, M, Eshaghi, H, et al
Cephalalgia : an international journal of headache. 2020;(7):665-674
Abstract
BACKGROUND Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents. METHODS We carried out a randomized double-blind placebo-controlled trial in the Children's Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents. RESULTS A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: -8.0; 95% confidence interval (CI): -9.3 to -6.6), sodium valproate (difference: -8.3; 95% confidence interval: -9.3 to -7.2), and placebo (difference: -4.4; 95% confidence interval: -5.4 to -3.4) arms. The decrease was statistically greater in cinnarizine (difference: -3.6; 95% confidence interval: -5.5 to -1.6) and sodium valproate (difference: -3.9; 95% confidence interval: -5.8 to -1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: -4.6; 95% confidence interval: -5.2 to -4.0; sodium valproate: -4.0; 95% confidence interval: -4.8 to -3.3; placebo: -2.6; 95% confidence interval: -3.4 to -1.8). The decrease was statistically greater in cinnarizine (difference: -2.0; 95% confidence interval: -3.2 to -0.8) and sodium valproate (difference: -1.5; 95% confidence interval: -2.7 to -0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation. CONCLUSION Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.
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The probiotic Lactobacillus casei Shirota attenuates symptoms of vestibular migraine: a randomised placebo-controlled double-blind clinical trial.
Qi, X, Fan, G, Jia, H
Beneficial microbes. 2020;(5):469-476
Abstract
Vestibular migraine (VM) has emerged as one of the major vestibular syndromes. Although probiotics have exhibited beneficial effects on migraine headache, its effect on VM is not clear. This trial aimed to investigate the treatment efficacy of the probiotic Lactobacillus casei Shirota (LcS) on symptoms of VM. 247 VM patients were enrolled, of which 204 eligible patients receiving either LcS or placebo on a daily basis completed the 4 month study. They were re-visited at 2 and 4 months after study initiation to assess treatment outcomes. The primary endpoints were vestibular symptoms, evaluated by the number of vertiginous attacks during the past week, the Vertigo Severity Score (VSS), and Dizziness Handicap Inventory (DHI) scores. The secondary endpoints were anxiety and depressive symptoms, evaluated using Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) scores. Efficacy of LcS over placebo was not obvious at 2 month follow-up. At 4 month follow-up, while both LcS and placebo groups of VM patients displayed alleviated symptoms, the extents of the improvements were significantly better in LcS group than those of placebo group, with regard to vestibular symptoms using DHI and VSS, as well as anxiety and depressive symptoms using BAI and BDI. Although placebo effect cannot be ignored in intervention for VM patients, the probiotic LcS still exhibits considerable efficacy against VM symptoms over a 4 month study period, supporting further clinical study of a larger and more diverse cohort.